Inn drugs in bangladesh

Inn Drugs in Bangladesh CHAPTER-01 Pharmacy

The mortar and pestle, an internationally recognized symbol to represent the pharmacy profession Pharmacy (from the Greek φάρμακον 'pharmakon' = drug) is the health profession that links the health sciences with the chemical sciences, and it is charged with ensuring the safe and effective use of medication. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to patient care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes. The term is also applied to an establishment used for such purposes. The first pharmacy in Europe (still working) was opened in 1241 in Trier, Germany.

The word pharmacy is derived from its root word pharma which was a term used since the 1400– 1600's. In addition to pharma responsibilities, the pharma offered general medical advice and a range of services that are now performed solely by other specialist practitioners, such as surgery and midwifery. The pharma (as it was referred to) often operated through a retail shop which, in addition to ingredients for medicines, sold tobacco and patent medicines. The pharmas also used many other herbs not listed.

In its investigation of herbal and chemical ingredients, the work of the pharma may be regarded as a precursor of the modern sciences of chemistry and pharmacology, prior to the formulation of the scientific method.

Disciplines Pharmacy, tacuinum sanitatis casanatensis (XIV century)The field of Pharmacy can generally be divided into three primary disciplines: • Pharmaceutics • Medicinal chemistry and Pharmacognosy • Pharmacy practice The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clear-cut; and often, collaborative teams from various disciplines research together.

Pharmacology is sometimes considered a fourth discipline of pharmacy. Although pharmacology is essential to the study of pharmacy, it is not specific to pharmacy. Therefore it is usually considered to be a field of the broader sciences.

Other specializations in pharmacy practice recognized by the Board of Pharmaceutical Specialties include: cardiovascular, infectious disease, oncology, pharmacotherapy, nuclear, nutrition, and psychiatry. The Commission for Certification in Geriatric Pharmacy certifies pharmacists in geriatric

pharmacy practice. The American Board of Applied Toxicology certifies pharmacists and other medical professionals in applied toxicology.

Pharmacists Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Many pharmacists are also small-business owners, owning the pharmacy in which they practice.

Pharmacists are represented internationally by the International Pharmaceutical Federation (FIP).

They are represented at the national level by professional organisations such as the Royal Pharmaceutical Society of Great Britain (RPSGB), the Pharmacy Guild of Australia (PGA), the Pakistan Pharmacists Society(PPS) and the American Pharmacists Association (APhA). See also: List of pharmacy associations.

In some cases, the representative body is also the registering body, which is responsible for the ethics of the profession. Since the Shipman Inquiry, there has been a move in the UK to separate the two roles.

History of pharmacy Paleopharmacological studies attest to the use of medicinal plants in pre-history.

The earliest known compilation of medicinal substances was the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD. Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.

Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC. The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article.

The Greek physician Pedanius Dioscorides is famous for writing a five volume book in his native Greek Περί ύλης ιατρικής in the 1st century AD. The Latin translation De Materia Medica (Concerning medical substances) was used a basis for many medieval texts, and was built upon by many middle eastern scientists during the Islamic Golden Age. The title coined the term materia medica.

In Japan, at the end of the Asuka period (538-710) and the early Nara period (710-794), the men who fulfilled roles similar to those of modern pharamacists were highly respected. The place of pharmacists in society was expressly defined in the Taihō Code (701) and re-stated in the Yōrō Code (718). Ranked positions in the pre-Heian Imperial court were established; and this organizational structure remained largely intact until the Meiji Restoration (1868). In this highly stable hierarchy, the pharmacists -- and even pharmacist assistants -- were assigned status superior to all others in health-

related fields such as physicians and acupuncturists. In the Imperial household, the pharmacist was even ranked above the two personal physicians of the Emperor.

In Baghdad the first pharmacies were established in 754 under the Abbasid Caliphate during the Islamic Golden Age. By the 9th century, these pharmacies were state-regulated.

The advances in made in the Middle East in botany and chemistry led medicine in medieval Islam substantially to develop pharmacology. Muhammad ibn Zakarīya Rāzi (Rhazes) (865-915), for instance, acted to promote the medical uses of chemical compounds. Abu al-Qasim al-Zahrawi (Abulcasis) (936-1013) pioneered the preparation of medicines by sublimation and distillation. His Liber servitoris is of particular interest, as it provides the reader with recipes and explains how to prepare the `simples’ from which were compounded the complex drugs then generally used. Sabur Ibn Sahl (d 869), was, however, the first physician to initiate pharmacopoedia, describing a large variety of drugs and remedies for ailments. Al-Biruni (973-1050) wrote one of the most valuable Islamic works on pharmacology entitled Kitab al-Saydalah (The Book of Drugs), where he gave detailed knowledge of the properties of drugs and outlined the role of pharmacy and the functions and duties of the pharmacist. Ibn Sina (Avicenna), too, described no less than 700 preparations, their properties, mode of action and their indications. He devoted in fact a whole volume to simple drugs in The Canon of Medicine. Of great impact were also the works by al-Maridini of Baghdad and Cairo, and Ibn al-Wafid (1008-1074), both of which were printed in Latin more than fifty times, appearing as De Medicinis universalibus et particularibus by `Mesue' the younger, and the Medicamentis simplicibus by `Abenguefit'. Peter of Abano (1250-1316) translated and added a supplement to the work of alMaridini under the title De Veneris. Al-Muwaffaq’s contributions in the field are also pioneering.

Living in the 10th century, he wrote The foundations of the true properties of Remedies, amongst others describing arsenious oxide, and being acquainted with silicic acid. He made clear distinction between sodium carbonate and potassium carbonate, and drew attention to the poisonous nature of copper compounds, especially copper vitriol, and also lead compounds. He also describes the distillation of sea-water for drinking.

In Europe pharmacy-like shops began to appear during the 12th century. In 1240 emperor Frederic II issued a decree by which the physician´s and the apothecary´s professions were separated.

Types of pharmacy practice areas Pharmacists practice in a variety of areas including retail, hospitals, clinics, nursing homes, drug industry, and regulatory agencies. Pharmacists can specialize in various areas of practice including but not limited to: hematology/oncology, infectious diseases, ambulatory care, nutrition support, drug information, critical care, pediatrics, etc.

Community pharmacy A pharmacy (commonly the chemist in Australia, New Zealand and the UK; or drugstore in North America; retail pharmacy in industry terminology; or Apothecary, historically) is the place where most pharmacists practice the profession of pharmacy. It is the community pharmacy where the dichotomy of the profession exists—health professionals who are also retailers.

Community pharmacies usually consist of a retail storefront with a dispensary where medications are stored and dispensed. The dispensary is subject to pharmacy legislation; with requirements for storage conditions, compulsory texts, equipment, etc., specified in legislation. Where it was once the case that pharmacists stayed within the dispensary compounding/dispensing medications; there has been an increasing trend towards the use of trained pharmacy technicians while the pharmacist spends more time communicating with patients.

All pharmacies are required to have a pharmacist on-duty at all times when open. In many jurisdictions, it is also a requirement that the owner of a pharmacy must be a registered pharmacist (R.Ph.). This latter requirement has been revoked in many jurisdictions, such that many retailers (including supermarkets and mass merchandisers) now include a pharmacy as a department of their store.

Likewise, many pharmacies are now rather grocery store-like in their design. In addition to medicines and prescriptions, many now sell a diverse arrangement of additional household items such as cosmetics, shampoo, office supplies, confectionary, and snack foods.

Hospital pharmacy Pharmacies within hospitals differ considerably from community pharmacies. Some pharmacists in hospital pharmacies may have more complex clinical medication management issues whereas pharmacists in community pharmacies often have more complex business and customer relations issues.

Because of the complexity of medications including specific indications, effectiveness of treatment regimens, safety of medications (i.e., drug interactions) and patient compliance issues ( in the hospital and at home) many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency and sometimes followed by another residency in a specific area. Those pharmacists are often referred to as clinical pharmacists and they often specialize in various disciplines of pharmacy. For example, there are pharmacists who specialize in haematology/oncology, HIV/AIDS, infectious disease, critical care, emergency medicine, toxicology, nuclear pharmacy, pain management, psychiatry, anticoagulation clinics, herbal medicine, neurology/epilepsy management, paediatrics, neonatal pharmacists and more.

Hospital pharmacies can usually be found within the premises of the hospital. Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting. Most hospital medications are unit-dose, or a single dose of medicine. Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications given intravenously. This is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities. Several hospital pharmacies have decided to outsource high risk preparations and some other compounding functions to companies who specialize in compounding.

Clinical pharmacy Clinical pharmacists provide a direct patient care service that optimizes the use of medication and promotes health, wellness, and disease prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside Hospitals and clinics. Clinical pharmacists often collaborate with Physicians and other healthcare professionals to improve pharmaceutical care. Clinical pharmacists are now an integral part of the interdisciplinary approach to patient care. They work collaboratively with physicians, nurses and other healthcare personnel in various medical and surgical areas. They often participate in patient care rounds and drug product selection. In most hospitals in the United States, potentially dangerous drugs that require close monitoring are dosed and managed by clinical pharmacists.

Compounding pharmacy Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.

Compounding pharmacies specialize in compounding, although many also dispense the same noncompounded drugs that patients can obtain from community pharmacies.

Consultant pharmacy Consultant pharmacy practice focuses more on medication regimen review (i.e. "cognitive services") than on actual dispensing of drugs. Consultant pharmacists most typically work in nursing homes, but are increasingly branching into other institutions and non-institutional settings. [10] Traditionally consultant pharmacists were usually independent business owners, though in the United States many now work for several large pharmacy management companies (primarily Omnicare, Kindred Healthcare and PharMerica). This trend may be gradually reversing as consultant pharmacists begin to work directly with patients, primarily because many elderly people are now taking numerous medications but continue to live outside of institutional settings. Some community pharmacies employ consultant pharmacists and/or provide consulting services.

The main principle of consultant pharmacy is Pharmaceutical care developed by Hepler and Strand in 1990.

Internet pharmacy Since about the year 2000, a growing number of Internet pharmacies have been established worldwide. Many of these pharmacies are similar to community pharmacies, and in fact, many of them are actually operated by brick-and-mortar community pharmacies that serve consumers online and those that walk in their door. The primary difference is the method by which the medications are requested and received. Some customers consider this to be more convenient and private method rather than traveling to a community drugstore where another customer might overhear about the drugs that they take. Internet pharmacies (also known as Online Pharmacies) are also recommended to some patients by their physicians if they are homebound.

While most Internet pharmacies sell prescription drugs and require a valid prescription, some Internet pharmacies sell prescription drugs without requiring a prescription. Many customers order drugs from such pharmacies to avoid the "inconvenience" of visiting a doctor or to obtain medications which their doctors were unwilling to prescribe. However, this practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and an individual's overall suitability for use of a medication. There also have been reports of such pharmacies dispensing substandard products.

Of particular concern with internet pharmacies is the ease with which people, youth in particular, can obtain controlled substances (e.g., Vicodin, generically known as hydrocodone) via the internet without a prescription issued by a doctor/practitioner who has an established doctor-patient relationship. There are many instances where a practitioner issues a prescription, brokered by an internet server, for a controlled substance to a "patient" s/he has never met. In the United States, in order for a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a licensed practitioner acting in the course of legitimate doctor-patient relationship. The filling pharmacy has a corresponding responsibility to ensure that the prescription is valid. Often, individual state laws outline what defines a valid patient-doctor relationship.

Canada is home to dozens of licensed Internet pharmacies, many which sell their lower-cost prescription drugs to U.S. consumers, who pay one of the world's highest drug prices. [citation needed] In recent years, many consumers in the US and in other countries with high drug costs, have turned to licensed Internet pharmacies in India, Israel and the UK, which often have even lower prices than in Canada.

In the United States, there has been a push to legalize importation of medications from Canada and other countries, in order to reduce consumer costs. While in most cases importation of prescription medications violates Food and Drug Administration (FDA) regulations and federal laws, enforcement is generally targeted at international drug suppliers, rather than consumers. There is no known case of any U.S. citizens buying Canadian drugs for personal use with a prescription, who has ever been charged by authorities.

Veterinary pharmacy Veterinary pharmacies, sometimes called animal pharmacies may fall in the category of hospital pharmacy, retail pharmacy or mail-order pharmacy. Veterinary pharmacies stock different varieties and different strengths of medications to fulfill the pharmaceutical needs of animals. Because the needs of animals as well as the regulations on veterinary medicine are often very different from those related to people, veterinary pharmacy is often kept separate from regular pharmacies.

Nuclear pharmacy Nuclear pharmacy focuses on preparing radioactive materials for diagnostic tests and for treating certain diseases. Nuclear pharmacists undergo additional training specific to handling radioactive materials, and unlike in community and hospital pharmacies, nuclear pharmacists typically do not interact directly with patients.

Military pharmacy Military pharmacy is an entirely different working environment due to the fact that technicians perform most duties that in a civilian sector would be illegal. State laws of Technician patient counseling and medication checking by a pharmacist do not apply.

Pharmacy informatics Pharmacy informatics is the combination of pharmacy practice science and applied information science. Pharmacy informaticists work in many practice areas of pharmacy, however, they may also work in information technology departments or for healthcare information technology vendor companies. As a practice area and specialist domain, pharmacy informatics is growing quickly to meet the needs of major national and international patient information projects and health system interoperability goals. Pharmacists are well trained to participate in medication management system development, deployment and optimization.

Issues in pharmacy Separation of prescribing from dispensing In most jurisdictions (such as the United States), pharmacists are regulated separately from physicians. Specifically, the legislation stipulates that the practice of prescribing must be separate from the practice of dispensing. These jurisdictions also usually specify that only pharmacists may supply scheduled pharmaceuticals to the public, and that pharmacists cannot form business partnerships with physicians or give them "kickback" payments. However, the American Medical Association (AMA) Code of Ethics provides that physicians may dispense drugs within their office practices as long as there is no patient exploitation and patients have the right to a written prescription that can be filled elsewhere. 7 to 10 percent of American physicians practices reportedly dispense drugs on their own.

In other jurisdictions (particularly in Asian countries such as China, Hong Kong, Malaysia, and Singapore), doctors are allowed to dispense drugs themselves and the practice of pharmacy is sometimes integrated with that of the physician, particularly in traditional Chinese medicine.

In Canada it is common for a medical clinic and a pharmacy to be located together and for the ownership in both enterprises to be common, but licensed separately.

The reason for the majority rule is the high risk of a conflict of interest. Otherwise, the physician has a financial self-interest in "diagnosing" as many conditions as possible, and in exaggerating their seriousness, because he or she can then sell more medications to the patient. Such self-interest directly conflicts with the patient's interest in obtaining cost-effective medication and avoiding the unnecessary use of medication that may have side-effects. This system reflects much similarity to the checks and balances system of the U.S. and many other governments.

A campaign for separation has begun in many countries and has already been successful (like in Korea). As many of the remaining nations move towards separation, resistance and lobbying from dispensing doctors who have pecuniary interests may prove a major stumbling block (e.g. in Malaysia).

The future of pharmacy In the coming decades, pharmacists are expected to become more integral within the health care system. Rather than simply dispensing medication, pharmacists will be paid for their patient care skills.

This shift has already commenced in some countries; for instance, pharmacists in Australia receive remuneration from the Australian Government for conducting comprehensive Home Medicines Reviews. In the United Kingdom, pharmacists (and nurses) who undertake additional training are obtaining prescribing rights. They are also being paid for by the government for medicine use reviews. In the United States, pharmaceutical care or Clinical pharmacy has had an evolving influence on the practice of pharmacy. Moreover, the Doctor of Pharmacy (Pharm.D.) degree is now required before entering practice and many pharmacists now complete one or two years of residency or fellowship training following graduation. In addition, consultant pharmacists, who traditionally operated primarily in nursing homes are now expanding into direct consultation with patients, under the banner of "senior care pharmacy.

Symbols

Bowl of Hygeia

The green Greek Cross used in Argentina, France, the United Kingdom and other countries

The red stylized "A" used in Germany

Caduceus (used erroneously)

Rod of Asclepius

Mortar and pestle

Recipe symbol

Hanging Show Globe

CHAPTER-02 INTRODUCTION OF INN International Nonproprietary Names (INN) identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.

Guidelines on the Use of INNs for Pharmaceutical Substances (1997) The INN system as it exists today was initiated in 1950 by a World Health Assembly resolution WHA3.11 and began operating in 1953, when the first list of International Nonproprietary Names for pharmaceutical substances was published. The cumulative list of INN now stands at some 7000 names designated since that time, and this number is growing every year by some 120-150 new INN. Since its inception, the aim of the INN system has been to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.

As unique names, INN have to be distinctive in sound and spelling, and should not be liable to confusion with other names in common use. To make INN universally available they are formally placed by WHO in the public domain, hence their designation as "nonproprietary". They can be used without any restriction whatsoever to identify pharmaceutical substances.

Another important feature of the INN system is that the names of pharmacologically-related substances demonstrate their relationship by using a common "stem". By the use of common stems the medical practitioner, the pharmacist, or anyone dealing with pharmaceutical products can recognize that the substance belongs to a group of substances having similar pharmacological activity.

The extent of INN utilization is expanding with the increase in the number of names. Its wide application and global recognition are also due to close collaboration in the process of INN selection with numerous national drug nomenclature bodies. The increasing coverage of the drug-name area by INN has led to the situation whereby the majority of pharmaceutical substances used today in medical

practice are designated by an INN. The use of INN is already common in research and clinical documentation, while their importance is growing further due to expanding use of generic names for pharmaceutical products.

EXECUTIVE SUMMERY Recommendations from the INN Ad-Hoc Meeting on Biologicals, Geneva, 23-24 April 2007 The objective of this meeting, which brought together representatives from various national nomenclature institutions, from the innovator and generics industry, from the INN Biological Advisers and from the INN Expert Group, was to discuss and review in-depth the INN policies for naming and defining biological medicinal substances, and to submit recommendations to be discussed by the full INN Expert Group during the 44th INN Consultation in May 2007.

Following is the outcome of the discussions: 1. INN Policies on post-translational modifications of proteins: • • •

• •

Existing INN definitions of glycoproteins are inadequate and should be reviewed in terms of current knowledge and consistency of application.

More information should be requested at the time of application for an INN. Arguments were made for and against the present practice of including specific Greek letters to differentiate different glycoforms of a given molecular entity (e.g. epoetin). In view of the lack of consensus, no change in the INN nomenclature policy pertaining to post-translational modifications is recommended at this time. The proposal of eliminating the Greek letter therefore should not be considered, even in a prospective manner.

Consideration should be given as to how much information should be included in the name and how much in the definition, bearing in mind that there are protein modifications other than glycosylation (e.g. phosphorylation, lipidation).

Consideration should also be given to drawing up a list of internationally agreed codes to reflect different production processes (such as E. coli, yeast, CHO cells etc). The use of such codes would not be part of the INN but discretionary, and used in labeling when regulatory authorities wished to distinguish different production systems.

2. INN Policies for Monoclonal Antibodies •

The nomenclature rules for monoclonal antibodies are complex. Current developments in the use of different antibody types (e.g. IgG 1, 2) with different functions, antibody fragments and “glyco-engineering” is adding to this complexity. Consideration should be given to establishing a small expert group to review these developments and to make specific recommendations on INN policy for monoclonal antibodies.

3. INN Policies on Vaccines and Gene, Cell and Tissue Therapies Vaccines • •

• •

No major changes are foreseen in the policies for naming vaccines, which are a diverse group of biologicals.

The WHO Expert Committee on Biological Standardization should continue to assign international and proper names to prophylactic vaccines. Consideration should be given to reviewing current inconsistencies in nomenclature and to extending the scheme to all prophylactic vaccines, as well as to developing internationally agreed abbreviations.

Some small peptides used in the treatment of cancers should be considered as therapeutic immunostimulants rather than vaccines and be given INNs. Close liaison between the INN Expert Group and the Expert Committee on Biological Standardization should be established to monitor nomenclature policies in this evolving field

• • •

and to consider appropriate policy on specialized issues, such as viral vectors for use as cancer vaccines. Gene, Cell and Tissue Therapy.

No change in the INN policy for gene, cell and tissue therapies is recommended for the time being.

Cells and tissues, including stem cells, are considered to be outside the remit of the INN system.

The Expert Committee on Biological Standardization should consider developing guidelines for the quality control and safety evaluation of stem cells and tissue engineered medicinal products.

4. INN Policies on Blood Products • • • •

No changes should be made to existing policies since these were already well established.

Recombinant DNA-derived substances should therefore continue to be assigned INNs but the complexities already referred to with respect to post translational modification of proteins, as well as intended modifications, need to be taken into account.

All naturally-derived blood products should still be considered to be outside the remit of the INN system.

Nomenclature policies in this evolving field should be monitored through close liaison between the INN Expert Group and the Expert Committee on Biological Standardization, who consults with the International Society on Thrombosis and Haemostasis as well as the Blood Regulators Network.

5. INN Policies on Transgenic Products and Enzymes Transgenic Products • • •

It is recommended that there be no separate policy for products derived from transgenic animals or plants.

The codes developed to reflect different manufacturing processes mentioned above should include transgenic systems. Enzymes No changes are proposed in the policy for assigning INNs to naturally-derived or biotechnology-derived enzymes. However this position may need review in future.

USE OF INN

Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national or, as in the case of the European Community, by international legislation. As a result of ongoing collaboration, national names such as British Approved Names (BAN), Dénominations Communes Françaises (DCF), Japanese Adopted Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INN. Some countries have defined the minimum size of characters in which the generic nonproprietary name must be printed under the trade-mark labelling and advertising. In several countries the generic name must appear prominently in type at least half the size of that used for the proprietary or brandname. In some countries it has to appear larger than the trade-mark name. Certain countries have even gone so far as to abolish trade-marks within the public sector.

To avoid confusion, which could jeopardize the safety of patients, trade-marks cannot be derived from INN and, in particular, must not include their common stems. As already mentioned the selection of further names within a series will be seriously hindered by the use of a common stem in a brandname.

SELECTION OF INN The names which are given the status of an INN are selected by the World Health Organization on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. The process of INN selection follows three main steps: - a request/application is made by the manufacturer or inventor; - after a review of the request a proposed INN is selected and published for comments; - after a time-period for objections has lapsed, the name will obtain the status of a recommended INN and will be published as such if no objection has been raised.

INN is selected in principle only for single, well-defined substances that can be unequivocally characterized by a chemical name (or formula). It is the policy of the INN programme not to select names for mixtures of substances, while substances that are not fully characterized are included in the INN system in exceptional cases only. INN is not selected for herbal substances (vegetable drugs) or for homoeopathic products. It is also the policy of the INN programme not to select names for those substances that have a long history of use for medical purposes under well-established names such as those of alkaloids (e.g. morphine, codeine), or trivial chemical names (e.g. acetic acid).

An INN is usually designated for the active part of the molecule only, to avoid the multiplication of entries in cases where several salts, esters, etc. are actually used. In such cases, the user of the INN has to create a modified INN (INNM) himself; mepyramine maleate (a salt of mepyramine with maleic acid) is an example of an INNM. When the creation of an INNM would require the use of a long or inconvenient name for the radical part of the INNM, the INN programme will select a short name for such a radical (for example, mesilate for methanesulfonate).

In the process of INN selection, the rights of existing trade-mark owners are fully protected. If in the period of four months following the publication of a proposed INN, a formal objection is filed by an interested person who considers that the proposed INN is in conflict with an existing trade-mark, WHO will actively pursue an arrangement to obtain a withdrawal of such an objection or will reconsider the proposed name. As long as the objection exists, WHO will not publish it as a recommended INN. CHAPTER-03 IRBESARTAN DESCRIPTION Arbit contains Irbesartan INN which is a antihypertensive drug. It antagonizes angiotensin II receptor.

INDICATIONS. Arbit is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION. The recommended initial dose of arbit is 150 mg once daily. Patients requiring further reduction in blood pressure should be treated with 300 mg once daily. Arbit may be administered with or without food.

CONTRAINDICATION Arbit is contraindicated in patients who are hypersensitive to any component of this product.

DRUG INTERACTIONS. No significant drug interaction has been found in studies with Hydrochlorothiazide, Digoxin, Warfarin, and Nifedipine.

SIDE EFFECTS. In placebo-controlled clinical trials the adverse event, which occurred in at least 1% of patients treated with irbesartan and at a higher incidence versus placebo, included diarrhoea, dyspepsia, trauma, fatigue, and upper respiratory infection. Irbesartan use was not associated with an increased incidence of dry cough, as is trpically associated with ACE inhibitor use.

USE IN SPECIAL POPULATIONS. Paediatric: There is no data on safety and effectiveness of Irbesartan in children.

Geriatric: In elderly subjects (age 65-80 years), on dosage adjustment is necessary.

Commercial Packs Arbit® 75 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Irbesartan INN 75 mg.

Arbit® 150 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Irbesartan INN 150 mg.

LANSOPRAZOLE DESCRIPTION The active ingredient in Lansoprazole Delayed-Release Capsules, Lansoprazole for Delayed-Release Oral Suspension and Lansoprazole SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure:

INDICATIONS Lansoprazole Delayed-Release Capsules, Lansoprazole SoluTab Delayed-Release Orally Disintegrating Tablets and Lansoprazole For Delayed-Release Oral Suspension are indicated for: Short-Term Treatment of Active Duodenal Ulcer Lansoprazole is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

DOSAGE AND ADMINISTRATION Lansoprazole is available as a capsule, orally disintegrating tablet and oral suspension, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with Lansoprazole.

HOW SUPPLIED Lansoprazole Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with the TAP logo and “Lansoprazole 15” imprinted on the capsules. The 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and “PREVACID 30” imprinted on the capsules.

SIDE EFFECTS Clinical Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. The adverse reaction profiles for Lansoprazole Delayed-Release Capsules and Lansoprazole for Delayed-Release Oral Suspension are similar. In general, Lansoprazole treatment has been well-tolerated in both short-term and long-term trials Incidence of Possibly or Probably Treatment-Related Adverse Events in Short-Term, PlaceboControlled Lansoprazoled Studies Body as a Whole Abdominal Pain Digestive System Constipation Diarrhea Nausea

2.1

1.2

1.0 3.8 1.3

0.4 2.3 1.2

DRUG INTERACTIONS Lansoprazole causes a profound and long-lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that lansoprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, digoxin).

CONTRAINDICATIONS. Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation of Lansoprazole.

Amoxicillin is contraindicated in patients with a known hypersensitivity to any penicillin.

Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, and any of the macrolide antibiotics.

TEGASEROD DESCRIPTION DRUG CLASS AND MECHANISM: Tegaserod is an oral medication for the treatment of constipation and constipation–predominant irritable bowel syndrome (IBS) in women. IBS is a chronic gastrointestinal disorder characterized by recurrent abdominal pain or discomfort and altered bowel function which may be either constipation or diarrhea. As many as 20% of American adults may suffer from IBS. PREPARATIONS White, round tablets of 2 and 6 mg.

STORAGE Tegaserod tablets should be stored at room temperature, 59–86°F (15–30°C).

PRESCRIBED FOR Tegaserod is used for the short–term treatment of women with IBS whose primary bowel symptom is constipation. It also is approved for the treatment of chronic, idiopathic constipation in men and women less than 65 years of age.

DOSING The usual dose of tegaserod is 6 mg twice daily, most frequently for 4 to 12 weeks. Tegaserod can be taken with or without food. Older persons do not require lower doses than younger persons.

DRUG INTERACTIONS There are no known drug interactions with tegaserod. Other drugs that increase intestinal contractions will likely lead to more diarrhea if used together with tegaserod.

PREGNANCY No ill effects were seen in the fetuses of pregnant rats given 15 times the human dose and rabbits given 50 times the human dose of tegaserod (on a per–weight basis). Nevertheless, there are no adequate studies of tegaserod in pregnant women. Therefore, physicians must weight the potential benefit of giving tegaserod during pregnancy against the unknown risk.

NURSING MOTHERS Tegaserod is secreted into the breast milk of nursing rats. Very high doses of tegaserod in mice cause tumors. Due to the demonstration of these tumors and the lack of safety data in children, physicians must weigh the potential benefit of giving tegaserod to nursing women against the unknown risk to the infant.

SIDE EFFECTS Tegaserod is well tolerated in most patients. The most commonly reported side effects are headache (1 in 6 patients), abdominal pain (1 in 8), and diarrhea (1 in 11). Only diarrhea has been reported substantially more frequently than with placebo treatment (sugar pill). Rarely the diarrhea is severe,

leading to hospitalization for dehydration and requiring intravenous fluids. Ischemic colitis has been seen rarely in patients taking tegaserod although it is not clear if there is a causal relationship. Patients who develop signs of ischemic colitis––worsening abdominal pain, bloody diarrhea––should stop taking tegaserod and contact their physicians.

ROSUVASTATIN CALCIUM DESCRIPTION Rosuvastatin Calcium is a synthetic lipid-lowering agent. Rosuvastatin is an inhibitor of 3-hydroxy-3methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMGCoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0.

INDICATIONS Rosuvastatin Calcium is indicated 1.

2.

3.

As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidemia (Fredrickson Type IIa and IIb); As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); To reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Therapy in Different Risk Categories CHDa or CHD Risk Equivalent (10-year risk > 20%

< 100 mg/dL

≥ 100 mg/dL

2+ Risk Factors (10-year risk ≤ 20%)

< 130 mg/dL

≥ 130 mg/dL

0-1 Risk Factors

< 160 mg/dL

≥ 160 mg/dL

≥ 130 mg/dL (100-129 mg/dL:drug optional)b ≥ 130 mg/dL 10-year risk 10-20% ≥ 160 mg/dL 10-year risk < 10% ≥ 190 mg/dL (160-189 mg/dL) (LDL-lowering drug optional)

a CHD = coronary heart disease. b Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C < 100

mg/dL cannot be achieved by TLC. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. c Almost all people with 0-1 risk factor have 10-year risk < 10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.

DOSAGE AND ADMINISTRATION The patient should be placed on a standard cholesterol-lowering diet before receiving Rosuvastatin Calcium and should continue on this diet during treatment. Rosuvastatin Calcium can be administered as a single dose at any time of day, with or without food.

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Type IIa and IIb) The dose range for Rosuvastatin Calcium is 5 to 40 mg once daily. Therapy with Rosuvastatin Calcium should be individualized according to goal of therapy and response. The usual recommended starting dose of Rosuvastatin Calcium is 10 mg once daily. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions, who have predisposing factors for myopathy, and as noted below for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency (see CLINICAL PHARMACOLOGY, Race, and Renal Insufficiency, and Drug Interactions). For patients with marked hypercholesterolemia (LDL-C > 190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. After initiation and/or upon titration of Rosuvastatin Calcium, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

HOW SUPPLIED Rosuvastatin Calcium Tablets are supplied as: 5 mg tablets: Yellow, round, biconvex, coated tablets identified as “Rosuvastatin Calcium” and “5” debossed on one side and plain on the other side of the tablet.

STORAGE Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from moisture.

SIDE EFFECTS Rosuvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. In clinical studies of 10,275 patients, 3.7% were discontinued due to adverse experiences attributable to rosuvastatin. The most frequent adverse events thought to be related to rosuvastatin were myalgia, constipation, asthenia, abdominal pain, and nausea.

DRUG INTERACTIONS Cyclosporine When rosuvastatin 10 mg was coadministered with cyclosporine in cardiac transplant patients, rosuvastatin mean Cmax and mean AUC were increased 11-fold and 7-fold, respectively, compared with healthy volunteers. These increases are considered to be clinically significant and require special consideration in the dosing of rosuvastatin to patients taking concomitant cyclosporine (see WARNINGS, Myopathy/Rhabdomyolysis, and DOSAGE AND ADMINISTRATION).

CONTRAINDICATIONS Rosuvastatin is contraindicated in patients with a known hypersensitivity to any component of this product.

Rosuvastatin is contraindicated in patients with active liver disease or with unexplained persistent elevations of serum transaminases (see WARNINGS, Liver Enzymes).

EFAVIRENZ DESCRIPTION Efavirenz (brand names Sustiva® and Stocrin®) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1.

For HIV infection that has not previously been treated, the United States Department of Health and Human Services Panel on Antiretroviral Guidelines currently recommends the use of efavirenz in combination with lamivudine/zidovudine or tenofovir/emtricitabine as the preferred NNRTI-based regimens in adults and adolescents.

Indications Efavirenz is used to treat HIV infection. It is never used alone and is always given in combination with other drugs. The decision on when to start treatment should take into account CD4 count, HIV viral load, treatment history, resistance profiles and patient preference.

Since the preliminary publication of the results of the ACTG 5142 trial in 2006 which compared efavirenz against lopinavir, efavirenz has been used as first line treatment in preference to the protease inhibitors. The ACTG 5095 trial showed that the potency of efavirenz is maintained at all CD4 counts and HIV viral loads.

Dosing The usual adult dose of efavirenz is 600mg per day (usually given at bedtime); or 800mg daily when given concurrently with rifampicin as part of treatment of co-infection with tuberculosis.

Drug interactions • • •

Efavirenz is metabolized in the liver, and possesses both inhibitory and inducing effects on the 3A4 isoform of the cytochrome P450 system. This means efavirenz may interact with other drugs metabolized in the liver, requiring either increased or decreased dosages.

Efavirenz lowers blood levels of most protease inhibitors. Dosages of amprenavir, atazanavir, or indinavir may need to be increased. The blood levels of saquinavir are dramatically lowered, so that the two drugs cannot be used simultaneously.

St John's wort and garlic supplements may decrease efavirenz blood levels.

Adverse effects • • • • • •

Psychiatric symptoms, including insomnia, confusion, memory loss, and depression, are common.

Rash, nausea, dizziness and headache may occur.

Efavirenz can cause birth defects and should not be used in women who might become pregnant.

Safety in children has not been established.

Use of efavirenz can produce a false positive result in some urine tests for marijuana.

Abuse of efavirenz for supposed hallucinogenic and dissociative effects has been reported in South Africa.

LAMIVUDINE

DESCRIPTION Lamivudine (2',3'-dideoxy-3'-thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI).

It is marketed by GlaxoSmithKline with the brand names Epivir and Epivir-HBV. Lamivudine has been used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. It improves the seroconversion of e-antigen positive hepatitis B and also improves histology staging of the liver. Long term use of lamivudine unfortunately leads to emergence of a resistant hepatitis B virus (YMDD) mutant. Despite this, lamivudine is still used widely as it is well tolerated.

MECHANISM OF ACTION Lamivudine is an analogue of cytidine. It can inhibit both types (1 and 2) of HIV reverse transcriptase and also the reverse transcriptase of hepatitis B. It needs to be phosphorylated to its triphosphate form before it is active. 3TC-triphosphate also inhibits cellular DNA polymerase.

Lamivudine is administered orally, and it is rapidly absorbed with a bio-availability of over 80%.

Some research suggests that lamivudine can cross the blood-brain barrier. Lamivudine is often given in combination with zidovudine, with which it is highly synergistic. Lamivudine treatment has been shown to restore zidovudine sensitivity of previously resistant HIV. Several mutagenicity tests show that lamivudine should not show mutagenic activity in therapeutic doses.

DOSING For adults with HIV (or children over 12), the dose is 300mg once daily, or 150mg twice a day.

Lamivudine is never used on its own in the treatment of HIV. For the treatment of adults with hepatitis B, the dose is 100mg once daily. If co-infected with HIV, then the dose is as for HIV. For a child 3 months to 12 years old, about 1.4-2 mg per lb. of body weight twice a day, no more than 150 mg per dose.

FEXOFENADINE HYDROCHLORIDE DESCRIPTION Fexofenadine Hydrochloride, the active ingredient of ALLEGRA tablets, ALLEGRA ODT and ALLEGRA oral suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1

hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α, hydrochloride. It has the following chemical structure.

α-dimethyl

benzeneacetic

acid

INDICATIONS Seasonal Allergic Rhinitis ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.

DOSAGE AND ADMINISTRATION ALLEGRA Tablets Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria Adults and Children 12 Years and Older. The recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.

SIDE EFFECTS Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to fexofenadine hydrochloride in 5083 patients in trials for allergic rhinitis and chronic idiopathic urticaria. In these trials, 3010 patients 12 years of age and older with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 20 to 240 mg twice daily or 120 to 180 mg once daily. A total of 646 patients 6 to 11 years of age with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 60 mg twice daily. The duration of treatment in these trials was 2 weeks. A total of 534 patients 6 months to 5 years of age with allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 30 mg twice daily.

DRUG INTERACTIONS Antacids Fexofenadine hydrochloride should not be taken closely in time with aluminum and magnesium containing antacids. In healthy adult subjects, administration of 120 mg of fexofenadine hydrochloride (2 x 60 mg capsule) within 15 minutes of an aluminum and magnesium containing antacid (Maalox®) decreased fexofenadine AUC by 41% and Cmax by 43%.

WARNINGS Included as part of the PRECAUTIONS section.

PRECAUTIONS Phenylketonurics ALLEGRA ODT contains phenylalanine, a component of aspartame. Each 30 mg ALLEGRA ODT contains 5.3 mg phenylalanine. ALLEGRA products other than ALLEGRA ODT do not contain phenylalanine.

CONTRAINDICATIONS ALLEGRA tablets, ALLEGRA ODT and ALLEGRA oral suspension are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of ALLEGRA. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

CELECOXIB DESCRIPTION (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure:

INDICATIONS Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). CELEBREX is indicated: 1.

2.

3.

For relief of the signs and symptoms of osteoarthritis.

For relief of the signs and symptoms of rheumatoid arthritis in adults.

For relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

For osteoarthritis and rheumatoid arthritis, the lowest dose of CELEBREX should be sought for each patient. These doses can be given without regard to timing of meals.

Osteoarthritis For relief of the signs and symptoms of osteoarthritis the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice per day.

HOW SUPPLIED CELEBREX 50-mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body.

SIDE EFFECTS Of the CELEBREX treated patients in the premarketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients have received a total daily dose of CELEBREX of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID). Approximately 3,900 patients have received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

DRUG INTERACTIONS General Celecoxib metabolism is predominantly mediated via cytochrome P450 2C9 in the liver.

Coadministration of celecoxib with drugs that are known to inhibit 2C9 should be done with caution.

In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of cytochrome P450 2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by P450 2D6.

ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking CELEBREX concomitantly with ACE-inhibitors.

PRECAUTIONS General CELEBREX cannot be expected to substitute for corticosteroids or to treat cortico-steroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroidresponsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of CELEBREX in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions.

CONTRAINDICATIONS CELEBREX is contraindicated in patients with known hypersensitivity to celecoxib.

CELEBREX should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.

CELEBREX should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS-Anaphylactoid Reactions, and PRECAUTIONS-Preexisting Asthma).

CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

LEVOCETIRIZINE DESCRIPTION Levocetirizine (as levocetirizine dihydrochloride) is a third generation non-sedative antihistamine, developed from the second generation antihistamine cetirizine. Chemically, levocetirizine is the active enantiomer of cetirizine. Levocetirizine works by blocking histamine receptors. It does not prevent the actual release of histamine from mast cells, but prevents it binding to its receptors. This in turn prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hayfever.

INDICATIONS Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.

DOSAGE AND ADMINISTRATION Adults & Children over 6 years of age one curin tablet (Levocetrizine dihydrochloride 5mg) once daily.

Patients with renal impairment: The recommended dose in patients with moderate renal impairment is one Curin tablet every two days. In those with sever renal impairment; the dose interval should be increased to every three days. Patients with end stage renal disease should not be given Levocetirizine.

CONTRAINDICATIONS. Curin is contraindicated in patients who are hypersensitive to any of the ingredients of this medication.

SIDE EFFECTS Levocetirizine is called a non-sedating antihistamine as it does not enter the brain in significant amounts, and is therefore unlikely to cause drowsiness. However, some people may experience some slight sleepiness or fatigue. It should be used with caution when working with machines. You should also make sure you know how this medicine affects you before you perform potentially hazardous activities.

COMMERCIAL PACK Levocetirizine Tablet: Each box contains 10 blister strips of 10 tablets. Each film coated tablet contains Levocetrizine Dihydrochloride INN 5mg.

GLIMEPIRIDE DESCRIPTION AMARYL速 (glimepiride) Tablets is an oral blood-glucose-lowering drug of the sulfonylurea class.

Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder formulated into tablets of 1-mg, 2-mg, and 4-mg strengths for oral administration. AMARYL tablets contain the active ingredient glimepiride and the following inactive ingredients: lactose (hydrous), sodium starch glycolate, povidone, microcrystalline cellulose, and magnesium stearate. In addition, AMARYL 1-mg tablets contain Ferric Oxide Red, AMARYL 2-mg tablets contain Ferric Oxide

Yellow and FD&C Blue #2 Aluminum Lake, and AMARYL 4-mg tablets contain FD&C Blue #2 Aluminum Lake.

INDICATIONS AMARYL is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. AMARYL may be used concomitantly with metformin when diet, exercise, and AMARYL or metformin alone do not result in adequate glycemic control.

DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of diabetes mellitus with AMARYL or any other hypoglycemic agent. The patient's fasting blood glucose and HbA1c must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels should be performed to monitor the patient's response to therapy.

HOW SUPPLIED AMARYL tablets are available in the following strengths and package sizes: 1 mg (pink, flat-faced, oblong with notched sides at double bisect, either imprinted with “AMA RYL” on one side, or imprinted with “AMA RYL” on one side and the Hoechst logo on both sides of the bisect on the other side) SIDE EFFECTS Adult Patients The incidence of hypoglycemia with AMARYL, as documented by blood glucose values < 60 mg/dL, ranged from 0.9-1.7% in two large, well-controlled, 1-year studies. (See WARNINGS and PRECAUTIONS.) AMARYL has been evaluated for safety in 2,013 patients in US controlled trials, and in 1,551 patients in foreign controlled trials. More than 1,650 of these patients were treated for at least 1 year.

CONTRAINDICATIONS AMARYL is contraindicated in patients with 1.

Known hypersensitivity to the drug.

2.

Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

DESLORATADINE DESCRIPTION BRAND NAME: Clarinex DRUG CLASS AND MECHANISM

Desloratadine is an oral, long-acting antihistamine that is similar chemically to loratadine (Claritin). It is used to treat the symptoms caused by histamine. Histamine is a chemical that is responsible for many of the signs and symptoms of allergic reactions, for example, swelling of the lining of the nose, sneezing, and itchy eyes. Histamine is released from histamine-storing cells (mast cells) and then attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergy. Desloratadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of H1 receptor-containing cells by histamine.

PREPARATIONS Tablets, 5 mg and syrup, 0.5mg/1mL STORAGE Store tablets and syrup at 25°C (77°F).

PRESCRIBED FOR Desloratadine is used for the treatment of allergies and chronic urticaria (hives) in adults and children 12 years of age or older.

DOSING The recommended dose for adults and children 12 years or older is 5 mg daily. Syrup can be used for children two years and older with the dose dependent on the age of the child. Desloratadine can be taken with or without food.

DRUG INTERACTIONS In controlled clinical studies there were no interactions with other drugs that affected the safety or effectiveness of Desloratadine.

PREGNANCY Desloratadine has not been studied in pregnant women.

NURSING MOTHERS: Desloratadine passes into breast milk and should therefore be used with caution in nursing mothers.

SIDE EFFECTS The most common side effects of Desloratadine are weakness, sore throat, dry mouth and sleepiness.

FLUCONAZOLE DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension and as a sterile solution for intravenous use in glass and in Fluconazole Plus plastic containers.

Fluconazole is designated chemically as 2, 4-difluoro-α, α 1-bis (1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13H12F2N6O and molecular weight 306.3. The structural formula is

INDICATIONS Fluconazole is indicated for the treatment of: 1.

Vaginal candidiasis (vaginal yeast infections due to Candida).

2.

Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.

3.

Cryptococcal meningitis. Before prescribing Fluconazole (fluconazole) for AIDS patients with cryptococcal meningitis, DOSAGE AND ADMINISTRATION Dosage and Administration in Adults Single Dose Vaginal candidiasis: The recommended dosage of Fluconazole for vaginal candidiasis is 150 mg as a single oral dose.

Multiple Doses SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS HOW SUPPLIED Fluconazole Tablets: Pink trapezoidal tablets containing 50, 100 or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister.

SIDE EFFECTS In Patients Receiving a Single Dose for Vaginal Candidiasis.

During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with Fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to Fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.

DRUG INTERACTIONS Drug Interaction Studies and CONTRAINDICATIONS.) Clinically or potentially significant drug interactions between Fluconazole and the following agents/classes have been observed.

ESOMEPRAZOLE DESCRIPTION Esomeprazole is a proton pump inhibitor (brand names Nexium速; Lucen速; Esopral速 and Axagon速 in Italy) developed and marketed by AstraZeneca which is used in the treatment of dyspepsia, peptic

ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome. Esomeprazole is the S-enantiomer of omeprazole (marketed as Losec/Prilosec), and AstraZeneca claims improved efficacy of this single enantiomer product over the racemic mixture of omeprazole.

PHARMACOLOGY Main article: Proton pump inhibitor Esomeprazole is a proton pump inhibitor which reduces gastric acid secretion through inhibition of H+/K+-ATPase in gastric parietal cells. By inhibiting the functioning of this enzyme, the drug prevents formation of gastric acid. HETA. CLINICAL USE Main article: Proton pump inhibitor Use in Helicobacter pylori eradication Esomeprazole is combined with the antibiotics clarithromycin and amoxicillin (or metronidazole in patients with β-lactam hypersensitivity) in the 10-day eradication triple therapy for Helicobacter pylori. Infection by H. pylori is the causative factor in the majority of peptic and duodenal ulcers.

DOSAGE FORMS Esomeprazole is available as delayed-release capsules in the United States or as delayed release tablets in Australia and Canada (containing esomeprazole magnesium) in strengths of 20 mg and 40 mg; and as a powder (esomeprazole sodium) for intravenous injection/infusion. Oral esomeprazole preparations are enteric-coated, due to the rapid degradation of the drug in the acidic conditions of the stomach. This is achieved by formulating capsules using the multiple-unit pellet system.

DRUG INTERACTIONS Esomeprazole potentially can increase the concentration in blood of diazepam (Valium) by decreasing the elimination of diazepam in the liver. Esomeprazole may have fewer drug interactions than omeprazole.

SIDE EFFECTS Esomeprazole, like other PPIs, is well-tolerated. The most common side effects are diarrhea, nausea, vomiting, headaches, rash and dizziness. Nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps and water retention occur infrequently.

LORATADINE DESCRIPTION Loratadine is a drug used to treat allergies, and marketed for its nonsedating properties. It is marketed

by Schering-Plough under several trade names such as Claritin, Claritine, Clarityn or Clarityne depending on the market; by Lek as Lomilan; by Ranbaxy as Roletra; and by Wyeth as Alavert. It is also available as a generic. In a version marketed as Claritin-D or Clarinase, loratadine is combined with pseudoephedrine, a decongestant; this makes it somewhat useful for colds as well as allergies, but adds a potential side-effect of insomnia, nervousness and anxiety.

INDICATIONS Loratadine is indicated for the symptomatic relief of allergy such as hay fever (allergic rhinitis), urticaria (hives), and other skin allergies.

For allergic rhinitis (hay fever), loratadine is effective for both nasal and eye symptoms: sneezing, runny nose, itchy or burning eyes.

DOSE Treatment by mouth (oral) â&#x20AC;˘ ADULT and CHILD over 6 years: 10 mg daily â&#x20AC;˘ CHILD 2-5 years: 5 mg daily MECHANISM OF ACTION Loratadine is a tricyclic antihistamine, which selectively antagonizes peripheral histamine H1receptors. Histamine is responsible for many features of allergic reactions.

Loratadine has a long-lasting effect and does not normally cause drowsiness because it does not readily enter the central nervous system.

SIDE-EFFECTS Non-sedating antihistamine As a non-sedating antihistamine, loratadine causes less sedation and psychomotor impairment than the older antihistamines because it penetrates the blood brain barrier only to a slight extent. Any drowsiness, which is unlikely, may diminish after a few days of treatment.

LOSARTAN POTASSIUM DESCRIPTION Losartan Potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.

Its empirical formula is C22H22ClKN6O, and its structural formula is:

INDICATIONS Hypertension Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.

DOSAGE AND ADMINISTRATION Adult Hypertensive Patients Losartan Potassium may be administered with other antihypertensive agents, and with or without food.

Dosing must be individualized. The usual starting dose of Losartan Potassium is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment Losartan Potassium can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.

HOW SUPPLIED No. 3612 â&#x20AC;&#x201D; Tablets Losartan Potassium, 25 mg, are light green, teardrop-shaped, film-coated tablets with code MRK on one side and 951 on the other. They are supplied as follows: NDC 0006-0951-54 unit of use bottles of 90 NDC 0006-0951-28 unit dose packages of 100 NDC 0006-0951-82 bottles of 1,000m NDC 0006-0951-87 bottles of 10,000.

SIDE EFFECTS Hypertension Losartan Potassium has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year. In general, treatment with Losartan Potassium was welltolerated. The overall incidence of adverse experiences reported with Losartan Potassium was similar to placebo.

PRECAUTIONS General Hypersensitivity: Angioedema.

Impaired Hepatic Function Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function.

CONTRAINDICATIONS Losartan Potassium is contraindicated in patients who are hypersensitive to any component of this product.

SPARFLOXACIN DESCRIPTION Sparfloxacin tablets contain sparfloxacin, a synthetic broad-spectrum antimicrobial agent for oral administration. Sparfloxacin, an aminodifluoroquinolone, is 5-Amino-1-cyclopropyl-7- (cis-3, 5-

dimethyl-1-piperazinyl) -6, 8-difluoro-1 , 4-dihydro-4-oxo-3-quinolinecarboxylic acid. Its empirical formula is C19H22F2N4O3.

INDICATIONS Sparfloxacin is indicated for the treatment of adults (>/= 18 years of age) with the following infections caused by susceptible strains of the designated microorganisms: Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, or Streptococcus pneumoniae.

DOSAGE AND ADMINISTRATION Sparfloxacin can be taken with or without food.

The recommended daily dose of Sparfloxacin in patients with normal renal function is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 24 hours for a total of 10 days of therapy (11 tablets).

HOW SUPPLIED STRENGTH 200 mg

SIZE DESCRIPTION MARKINGS Blister NDC 627794-011- Awhite film coated, round bi convex Pack of 11 11 tablet debossed with B over 11 one (RespiPac TM) side of the tablet and blank on the other side Bottle of 55 011-55

Store at Controlled Room Temperature 20 to 25째C (68 to 77째F).

SIDE EFFECTS In clinical trials, most of the adverse events were mild to moderate in severity and transient in nature.

During clinical investigations with the recommended dosage, 1585 patients received sparfloxacin and 1331 patients received a comparator. The discontinuation rate due to adverse events was 6.6% for sparfloxacin versus 5.6% for cefaclor, 14.8% for erythromycin, 8.9% for ciprofloxacin, 7.4% for ofloxacin, and 8.3% for clarithromycin.

DRUG INTERACTIONS Digoxin: Sparfloxacin has no effect on the pharmacokinetics of digoxin.

Methylxanthines: Sparfloxacin does not increase plasma theophylline concentrations. Since there is no interaction with theophylline, interaction with other methylxanthines such as caffeine is unlikely.

Warfarin: Sparfloxacin does not increase the anti-coagulant effect of warfarin.

Cimetidine: Cimetidine does not affect the pharmacokinetics of sparfloxacin.

PRECAUTIONS General: Adequate hydration of patients receiving sparfloxacin should be maintained to prevent the formation of highly concentrated urine.

CONTRAINDICATIONS Sparfloxacin is contraindicated for individuals with a history of hypersensitivity or photosensitivity reactions.

Torsade de pointes have been reported in patients receiving sparfloxacin concomitantly with disopyramide and amiodarone. Consequently, sparfloxacin is contraindicated for individuals receiving these drugs as well as other QT c -prolonging antiarrhythmic drugs reported to cause torsade de pointes, such as class Ia antiarrhythmic agents.

VALSARTAN DESCRIPTION Valsartan is a nonpeptide, orally active and specific angiotensin II antagonist acting on the AT1 receptor subtype.

Valsartan is chemically described as N-(1-oxopentyl)-N-[[2â&#x20AC;˛-(1H-tetrazol-5-yl) [1,1â&#x20AC;˛-biphenyl]-4yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is.

INDICATIONS Hypertension Valsartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Heart Failure Valsartan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Valsartan significantly reduced hospitalizations for heart failure. There is no evidence that Valsartan provides added benefits when it is used with an adequate dose of an ACE inhibitor.

DOSAGE AND ADMINISTRATION Hypertension The recommended starting dose of Valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

HOW SUPPLIED

Valsartan is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages.

SIDE EFFECTS Hypertension Valsartan has been evaluated for safety in more than 4,000 patients, including over 400 treated for over 6 months, and more than 160 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse experiences with Valsartan was similar to placebo.

DRUG INTERACTIONS No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.

CONTRAINDICATIONS Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

GATIFLOXACIN DESCRIPTION TEQUIN contains gatifloxacin, a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration. Chemically, gatifloxacin is (±)-1-cyclopropyl-6-fluoro-1, 4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid sesquihydrate.

The chemical structure is:

INDICATIONS Gatifloxacin is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

DOSAGE AND ADMINISTRATION The recommended dosage for Gatifloxacin Tablets or Gatifloxacin Injection is described in Table 4.

Doses of Gatifloxacin are administered once every 24 hours. These recommendations apply to all patients with a creatinine clearance 40 mL/min. For patients with a creatinine clearance  40 mL/min, see the Impaired Renal Function subsection.

SIDE EFFECTS Over 5000 patients have been treated with gatifloxacin in single- and multiple-dose clinical efficacy trials worldwide.

In gatifloxacin studies, the majority of adverse reactions were described as mild in nature.

Gatifloxacin was discontinued for adverse events thought related to drug in 2.7% of patients.

DRUG INTERACTIONS Gatifloxacin can be taken 4 hours before ferrous sulfate, dietary supplements containing zinc, magnesium, or iron (such as multivitamins), or aluminum/magnesium-containing antacids without any significant pharmacokinetic interactions Milk, calcium carbonate, cimetidine, theophylline, warfarin, or midazolam.

CONTRAINDICATIONS Gatifloxacin is contraindicated in persons with a history of hypersensitivity to gatifloxacin or any member of the quinolone class of antimicrobial agents.

CARBONYL IRON DESCRIPTION Carbonyl iron is a highly pure (97.5% for grade S, 99.5+% for grade R) iron, prepared by chemical decomposition of purified iron pentacarbonyl. It usually has the appearance of grey powder, composed of spherical microparticles. Most of the impurities are carbon, oxygen, and nitrogen.

INDICATIONS Iron supplements are used in medicine to treat iron-deficiency anemia.

First, it must be clear that iron deficiency and not another factor (e.g. chronic, low-grade, undetected blood loss such as fecal occult blood) causes the anemia. Preventive measures must be discussed with the patient (for example when the patient is on a strict vegetarian diet because inorganic iron in plants has a lower bioavailability, or elderly patients with a poor diet).

SIDE EFFECTS Side effects of therapy with iron are most often diarrhea or constipation and epigastric abdominal discomfort. Taken after a meal, side effects decrease but there is an increased risk of interaction with other substances. Side effects are dose-dependent, and the dose may be adjusted.

CONTRAINDICATIONS Documented hypersensitivity and anemias without proper work-up (i.e. documentation of iron deficiency). Hypersensitivity reactions can be very dramatic if iron is administered intravenously.

PRECAUTIONS Children who ingest tablets may become intoxicated, in which case they should be taken to an emergency department. Some formulations (like carbonyl-iron) may be safer.

PIOGLITAZONE HYDROCHLORIDE DESCRIPTION Pioglitazone Hydrochloride is an oral antidiabetic agent that acts primarily by decreasing insulin resistance. Pioglitazone Hydrochloride is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes).

Pharmacological studies indicate that Pioglitazone Hydrochloride improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone Hydrochloride improves glycemic control while reducing circulating insulin levels.

INDICATIONS Pioglitazone Hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). Pioglitazone Hydrochloride is indicated for monotherapy. Pioglitazone Hydrochloride is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.

HOW SUPPLIED Pioglitazone Hydrochloride is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg Tablet: white to off-white, round, convex, non-scored tablet with “Pioglitazone Hydrochloride” on one side, and “15” on the other.

SIDE EFFECTS Over 8500 patients with type 2 diabetes have been treated with ACTOS in randomized, double-blind, controlled clinical trials. This includes 2605 high-risk patients with type 2 diabetes treated with ACTOS from the PROactive clinical trial. Over 6000 patients have been treated for 6 months or longer, and over 4500 patients for one year or longer. Over 3000 patients have received ACTOS for at least 2 years.

Upper Respiratory Tract Infection Headache Sinusitis Myalgia Tooth Disorder Diabetes Mellitus Aggravated Pharyngitis

8.5 6.9 4.6 2.7 2.3 8.1 0.8

13.2 9.1 6.3 5.4 5.3 5.1 5.1

DRUG INTERACTIONS In vivo drug-drug interaction studies have suggested that pioglitazone may be a weak inducer of CYP 450 isoform 3A4 substrate.

An enzyme inhibitor of CYP2C8 (such as gemfibrozil) may significantly increase the AUC of pioglitazone and an enzyme inducer of CYP2C8 (such as rifampin) may significantly decrease the AUC of pioglitazone. Therefore, if an inhibitor or inducer of CYP2C8 is started or stopped during treatment with pioglitazone, changes in diabetes treatment may be needed based on clinical response.

PRECAUTIONS General

Pioglitazone Hydrochloride exerts its antihyperglycemic effect only in the presence of insulin.

Therefore, Pioglitazone Hydrochloride should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Hypoglycemia: Patients receiving Pioglitazone Hydrochloride in combination with insulin or oral hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.

CONTRAINDICATIONS Initiation of Pioglitazone Hydrochloride in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated Pioglitazone Hydrochloride is contraindicated in patients with known hypersensitivity to this product or any of its components.

CILOSTAZOL DESCRIPTION Cilostazol is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III).

The empirical formula of cilostazol is C20H27N5O2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl) butoxy]-3,4-dihydro-2 (1H)-quinolinone, CAS-73963-72-1.

The structural formula is:

INDICATIONS Cilostazol is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.

DOSAGE AND ADMINISTRATION The recommended dosage of Cilostazol is 100 mg b.i.d. taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during coadministration of such inhibitors of CYP3A4 as ketoconazole, itraconazole, erythromycin and diltiazem, and during coadministration of such inhibitors of CYP2C19 as omeprazole.

HOW SUPPLIED Pletal is supplied as 50 mg and 100 mg tablets. The 50 mg tablets are white, triangular, debossed with Pletal 50, and provided in bottles of 60 tablets (NDC #59148-003-16).

The 100 mg tablets are white, round, debossed with Pletal 100, and provided in bottles of 60 tablets (NDC #59148-002-16).

SIDE EFFECTS Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. Cilostazol (n=1301) or placebo (n=973), with a median treatment duration of 127 days for patients on Cilostazol and 134 days for patients on placebo.

DRUG INTERACTIONS Since Cilostazol is extensively metabolized by cytochrome P-450 isoenzymes, caution should be exercised when Pletal is coadministered with inhibitors of CYP3A4 such as ketoconazole and erythromycin or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem, an inhibitor of CYP3A4v.

PRECAUTIONS Cilostazol is contraindicated in patients with congestive heart failure. In patients without congestive heart failure, the long-term effects of PDE III inhibitors (including Cilostazol) are unknown. Patients in the 3-6 month placebo-controlled trials of Cilostazol were relatively stable (no recent myocardial infarction or strokes, no rest pain or other signs of rapidly progressing disease) and only 19 patients died (0.7% in the placebo group and 0.8% in the group on Cilostazol). The calculated relative risk of death of 1.2 has a wide 95% confidence limit (0.5-3.1). There are no data as to longer-term risk or risk in patients with more severe underlying heart disease.

CONTRAINDICATIONS Cilostazol and several of its metabolites are inhibitors of phosphodiesterase III. Several drugs with this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV congestive heart failure. Cilostazol is contraindicated in patients with congestive heart failure of any severity.

Percent Mean Improvement in Maximal Walking Distance at Study End for the Eight Randomized, Double-Blind, Placebo-Controlled Clinical Trials

Table: Another List of INN Drugs

Sl no.

Generic Name

Brand Name

Manufacturers

Indication

1.

2.

Tiemonium Misoprostol

Onium Isovent

Orion Square

3.

4.

5.

6.

7.

Rabeprazole Nitazoxanide Candesartan Torasemide Levosalbutamol

Finix Zox Candesa Tomide Aire

Opsonin Square General Acme Delta

8.

9.

10.

Montelukast Eszopiclone Duloxetine

Monas Sono Dulox

Acme Acme Acme

11.

12.

13.

Sertralina Repaglinide Cefpodoxime

Sera Reglin CP tab

Acme General Acme

14.

Sefpirome

Force inj

Square

15.

Levofloxacin

Evo

Beximco

16.

Moxifloxacin

Odycin

Beximco

17.

Itraconazole

Itra

Square

18.

Ornidazole

Ornil

Opsonin

19.

Etoricoxib

Eto

Delta

20.

Tacrolimus

Tacrol

Acme

REFERENCE 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Beximco Pharmaceuticals Square Pharmaceuticals Opsonin Pharmaceuticals Reneta Pharmaceuticals Delta Pharmaceuticals Sk+F Pharmaceuticals Chemeco Laboratories ACI Pharmaceuticals Qimp Internet

GIT Disease.

Healing of GU & DU in the absence of NSAID. Treatment Of GERD. Treatment of diarrhoea.

Treatment of hypertension.

Treatment of hypertension.

Treatment & prevention of bronchospasm in adult.

Treatment of Asthma.

Treatment of Insomnia.

Treatment of major depressive disorder.

Depressive Illness.

Treatment of NIDDM. Treatment of Infectious disease caused by microorganism.

Treatment of Infectious disease caused by microorganism.

Treatment of Infectious disease caused by microorganism.

Treatment of Infectious disease caused by microorganism.

Treatment of Fungal disease Treatment of Amoebiasis, Giardiasis.

Treatment of relief of pain in musculoskeletal & soft tissue inflammations.

Treatment of Eczema.