Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Meftal-Spas tablets (Generic Mefenamic Acid and Dicyclomine Hydrochloride tablets) are used for the treatment of irritable bowel syndrome, stomach and intestinal cramping, abdominal pain and dysmenorrhea (menstrual cramps).

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Active Ingredients The active pharmaceutical ingredients contained in Meftal-Spas tablets are Mefenamic Acid and Dicyclomine Hydrochloride.

Mefenamic Acid 250 mg and the anti-spasmodic Dicyclomine Hydrochloride 10 mg (also known as Dicycloverine). This tablet is more well known as Meftal 250 mg.

The Meftal Spas "DS" version that is also marketed has double strengths of the same constituent agents with Mefenamic Acid 500 mg and Dicyclomine Hydrochloride 20 mg. This tablet is more well known as Meftal 500 mg.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Chemical Structure - Mefenamic Acid

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Chemical Structure - Dicyclomine Hydrochloride

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Meftal-Spas Tablets Meftal-Spas Tablets are manufactured by Blue Cross Laboratories Limited, India in the strengths of 260 mg (Mefenamic Acid 250 mg and Dicyclomine Hydrochloride 10 mg) and 520 mg (Mefenamic Acid 500 mg and Dicyclomine Hydrochloride 20 mg). ( Website: https://bluecrosslabs.com/ )

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Uses of Meftal-Spas Tablets Meftal-Spas is an effective anti-inflammatory, analgesic and antispasmodic combination of Mefenamic Acid and Dicyclomine Hydrochloride. This combination effectively treats the irritable bowel syndrome, stomach and intestinal cramping, and menstrual cramps by relaxing the smooth muscles and reducing the prostaglandin levels.

Mefenamic Acid ia an analgesic with Non steroidal anti-Inflammatory properties. It acts by binds the prostaglandin synthetase receptors COX-1 and COX-2, inhibiting the action of prostaglandin synthetase. It is used for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain, inflammation, and fever.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Uses of Meftal-Spas Tablets Dicyclomine Hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. It Action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholinereceptor sites, a direct effect upon smooth muscle (musculotropic).

It is used to treat a certain type of intestinal problem called irritable bowel syndrome. It helps to reduce the symptoms of stomach and intestinal cramping. This medication works by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines.

Combination of Mefenamic Acid and Dicyclomine Hydrochloride has a Synergistic effect.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Uses of Meftal-Spas Tablets This Combination is a highly effective and used in the treatment of spasmodic dysmenorrhoea, intestinal colic, biliary colic, ureteric colic.

Mefenamic Acid is a medication that helps in reducing the pain in the body.Antipyretic is a drug that helps in reducing the fever by reducing the temperature of the body to the normal temperature. Anti-inflammatory is a kind of medication that is mainly for reducing the inflammation by controlling the pain. Lastly Dicyclomine Hydrochloride helps in offering relief to the cramps of the stomach, bladder and intestine.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Recommended Dosage The dosage of Meftal-Spas tablets (Generic Mefenamic Acid and Dicyclomine Hydrochloride tablets) is given below: Treatment is generally required till the time dysmenorrhea (menstrual cramps) symptoms persist i.e., 3 to 5 days during the menses. Therapy should not be given for longer than 7 days at a time. Meftal-Spas / Meftal-Spas DS tablets should be taken preferably with or after food.

Alternatively the dosage should be administered as prescribed by the physician.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Contraindications Meftal-Spas tablets are contraindicated in patients with a hypersensitivity to Mefenamic Acid, Dicyclomine Hydrochloride or any other component of this medication.

This medicine is also contraindicated in the following cases: Pre-existing asthma and aspirin-sensitive asthma.

Active ulceration/bleeding or chronic inflammation of upper or lower GI tract.

Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Pre-existing renal disease/obstructive uropathy.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Contraindications Meftal-Spas tablets are also contraindicated in the following cases: Glaucoma.

Myasthenia gravis.

Last trimester of pregnancy.

Lactation.

Inflammatory bowel disease, paralytic ileus and intestinal atony.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Storage Instructions

Meftal-Spas tablets (Generic Mefenamic Acid and Dicyclomine Hydrochloride tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F).

Keep this as well as all other medicines away from children and pets.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings Mefenamic Acid: Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction (MI), and stroke, which can be fatal.

Hypertension: NSAIDs, including mefenamic acid, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.

Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Mefenamic acid should be used with caution in patients with fluid retention or heart failure.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings Mefenamic Acid: Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including mefenamic acid, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Hepatic Effects: Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including mefenamic acid. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings Mefenamic Acid: Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injuries. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.

Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to mefenamic acid. Mefenamic acid should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Skin Reactions: NSAIDs, including mefenamic acid, can cause serious cutaneous adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis,which can be fatal. These serious events may occur without warning.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings Mefenamic Acid: Hematological Effects: Anemia is sometimes seen in patients receiving NSAIDs, including Mefenamic acid. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Mefenamic acid, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

Preexisting Asthma: Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal.

Drug / Laboratory Test Interactions: Mefenamic acid may prolong prothrombin time.

Therefore, when the drug is administered to patients receiving oral anticoagulant drugs, frequent monitoring of prothrombin time is necessary.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings

Dicyclomine Hydrochloride: Cardiovascular conditions: Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure, and in cardiac surgery, where they may further accelerate the heart rate and result in worsening of conditions.

Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted.

Psychosis in patients sensitive to anticholinergic drugs: signs and symptoms resolve within 12 to 24 hours after discontinuation of Meftal-Spas tablets.

Myasthenia Gravis: overdose may lead to muscular weakness and paralysis.

Meftal-Spas tablets should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase.)

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Warnings

Dicyclomine Hydrochloride: Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with Meftal-Spas tablets would be inappropriate and possibly fatal.

Salmonella dysenteric patients: Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

Ulcerative colitis: Meftal-Spas tablets should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon.

Prostatic hypertrophy: Meftal-Spas tablets should be used with caution in these patients; may lead to urinary retention.

Hepatic and renal disease: should be used with caution.

Geriatric: use with caution in elderly who may be more susceptible to Meftal-Spas tablets adverse events.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Side Effects The most serious side effects due to Mefenamic Acid involve the gastrointestinal tract. Diarrhoea occasionally occurs following the use of mefenamic acid. Although this may occur soon after starting treatment, it may also occur after several months of continuous use.

Check with your doctor immediately if any of the following side effects occur: More common side effects are Bloody urine, bloody, black or tarry stools, decreased frequency or amount of urine, heartburn, increased bleeding time, increased blood pressure, increased thirst, indigestion, itching, skin rash, loss of appetite, lower back or side pain, nausea, pale skin, severe stomach pain, cramping, or burning, stomach bloating, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual bleeding or bruising, unusual tiredness or weakness, vomiting, vomiting of material that looks like coffee grounds, severe and continuing, weight gain and weight loss.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Side Effects The most serious side effects due to Dicyclomine Hydrochloride include cardiovascular and central nervous system symptoms. The most common side effects (in more than 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Overdose - Mefenamic Acid Symptoms: Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Mefenamic acid has a tendency to induce tonic-clonic (grand mal) convulsions in overdose. Gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Treatment: Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Overdose - Dicyclomine Hydrochloride Symptoms: Symptoms of dicyclomine overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS. stimulation. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Treatment: Treatment should consist of gastric lavage, emetics, and activated charcoal. It is not known whether dicyclomine is dialyzable. Sedatives (barbiturates/benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

Meftal-Spas Tablets During Pregnancy

Mefenamic Acid has been classified by the US FDA as Pregnancy Category C. Dicyclomine Hydrochloride has been classified by the US FDA as Pregnancy Category B. For this combination product, there are no adequate and well controlled studies available in pregnant women. Congenital abnormalities have been reported with use of non-steroidal anti-inflammatory drugs (NSAIDs) in humans; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of premature closure of the ductus arteriosus), use of Mefenamic Acid in the last trimester of pregnancy is contraindicated. The onset of labor may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs, including Mefenamic Acid, should not be used during the first two trimesters of pregnancy or labor unless the potential benefit to the patient outweighs the possible risk to the foetus.

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Meftal-Spas (Generic Mefenamic Acid and Dicyclomine Hydrochloride Tablets)

For more details on Meftal-Spas Tablets click here

Meftal-Spas (Mefenamic Acid and Dicyclomine Hydrochloride tablets)

by Blue Cross Laboratories Limited, India.

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