Crisanta-LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Crisanta-LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) are used as oral contraceptive in women. This medicine is also used for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Other uses include treatment of symptoms of Premenstrual Dysphoric Disorder (PMDD) in women. The effectiveness of Drospirenone (DRSP) and Ethinyl Estradiol (EE) for PMDD when used for more than three menstrual cycles has not been evaluated.

DRSP and EE has not been evaluated for the treatment of premenstrual syndrome.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Active Ingredients The active ingredients present in Crisanta-LS tablets are Drospirenone and Ethinyl Estradiol.

Each film-coated Crisanta-LS tablet contains 3.0 mg of Drospirenone and 0.02 mg of Ethinylestradiol (Ethinyloestradiol or Ethinyl Estradiol).

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Chemical Structure - Drospirenone

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Chemical Structure - Ethinyl Estradiol

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Crisanta-LS Tablets Crisanta-LS Contraceptive Pills are manufactured by Cipla Limited, India and is offered to the consumer in a blister pack of 24 pills or tablets. The suffix LS denotes 'Low Strength' formulation.

(Website: https://www.cipla.com/ )

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Uses of Crisanta-LS Tablets Crisanta-LS (Drospirenone and Ethinyl Estradiol combination) is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Recommended Dosage The dosage of Crisanta-LS tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) is given below: Crisanta-LS consists of 24 tablets of a monophasic combined hormonal preparation. The dosage of Crisanta-LS is one tablet daily for 24 consecutive days followed by 4 pill-free days per menstrual cycle.

How to take Crisanta-LS: Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum effectiveness, CRISANTA-LS must be taken exactly as directed, in the order directed on the pack. Single missed pills should be taken as soon as remembered.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Recommended Dosage The dosage of Crisanta-LS tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) is given below: How to Start Crisanta-LS: During the first cycle of Crisanta-LS use, instruct the patient to take one tablet of Crisanta-LS daily, beginning on Day 1 of her menstrual cycle (the first day of menstruation is Day 1).

She should take one tablet daily for 24 consecutive days followed by 4 pill-free days.

Crisanta-LS should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Crisanta-LS can be taken without regard to meals. If Crisanta-LS is first taken later than the first day of the menstrual cycle, it should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Recommended Dosage The dosage of Crisanta-LS tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) is given below: Subsequent Packs of Crisanta-LS: The patient should begin her next and all subsequent 24-day regimens of Crisanta-LS on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her tablets on the next day after the 4 pill-free days, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Crisanta-LS is started later than the day following the 4 pill-free days, the patient should use another method of contraception until she has taken Crisanta-LS daily for 7 consecutive days.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Contraindications Crisanta-LS is contraindicated in patients with a hypersensitivity to Drospirenone, Ethinyl Estradiol or any other component of this medication.

The other contraindications are given below: Women over 35 years old who smoke should not use Crisanta tablets. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.

Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Contraindications The other contraindications are given below:

Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication.

History of migraine with focal neurological symptoms.

Diabetes mellitus with vascular involvement.

Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.

Use of direct-acting antiviral (DAA) medicinal products containing Ombitasvir, Paritaprevir, or Dasabuvir, and combinations of these Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Contraindications The other contraindications are given below: Presence or history of liver tumours (benign or malignant).

Severe renal insufficiency or acute renal failure.

Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts).

Undiagnosed vaginal bleeding.

Known or suspected pregnancy.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Storage Instructions

Crisanta-LS Tablets (Generic Drospirenone and Ethinyl Estradiol 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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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Warnings Vascular risks: Stop Crisanta-LS tablets if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing Drospirenone (DRSP) may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing Levonorgestrel or some other progestins. Before initiating Crisanta-LS tablets in a new COC user or a woman who is switching from a contraceptive that does not contain Drospirenone, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Warnings Liver disease: Discontinue Crisanta-LS tablets if jaundice occurs.

High blood pressure: Do not prescribe Crisanta-LS tablets for women with uncontrolled hypertension or hypertension with vascular disease.

Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Crisanta-LS. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

Headache: Evaluate significant change in headaches and discontinue Crisanta-LS tablets if indicated.

Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Side Effects The most frequent Drospirenone and Ethinyl Estradiol Tablets (Crisanta-LS Tablets) side effects with an incidence rate of 2% or greater in contraception and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%).

The most frequent Drospirenone and Ethinyl Estradiol Tablets (Crisanta-LS Tablets) side effects with an incidence rate of 2% or greater in PMDD clinical trials were: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Overdose There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. Drospirenone is a spironolactone analogue having antimineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

There has not yet been any experience of overdose with Drospirenone and Ethinyl Estradiol. On the basis of general experience with combined oral contraceptives, symptoms that may possibly occur in case of taking an overdose of active tablets are nausea, vomiting and withdrawal bleeding.

Withdrawal bleeding may even occur in girls before their menarche, if they accidentally take the medicinal product. There are no antidotes and further treatment should be symptomatic.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Crisanta-LS Tablets During Pregnancy Drospirenone and Ethinyl Estradiol tablets (Crisanta-LS tablets) have been classified by the US FDA as Pregnancy Category X.

Drospirenone and Ethinyl Estradiol (Crisanta-LS tablets) is not indicated during pregnancy.

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

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Crisanta LS Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

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Crisanta-LS tablets (Generic Drospirenone and Ethinyl Estradiol tablets) by Cipla Limited, India.

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