Zoana
Generic Name
Drospirenone + Ethinyl Estradiol
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zoana 500 mg tablet | ৳ 10.07 | ৳ 40.28 |
| zoana 100 mg suspension | ৳ 35.24 | N/A |
Description
Overview of the medicine
Zoana is a combined oral contraceptive pill used to prevent pregnancy. It contains synthetic female hormones, drospirenone (a progestin) and ethinyl estradiol (an estrogen), which work together to inhibit ovulation, thicken cervical mucus, and alter the uterine lining. It is also indicated for the treatment of moderate acne and premenstrual dysphoric disorder (PMDD) in women who elect to use an oral contraceptive.
Uses & Indications
Dosage
Adults
One active tablet daily for 21 consecutive days, followed by 7 days of placebo tablets (or no tablets), then a new pack is started. Tablets should be taken at the same time each day.
Elderly
Not indicated for postmenopausal women. The efficacy and safety have not been established in this population.
Renal_impairment
Contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) or acute renal failure. Use with caution in mild to moderate impairment with close monitoring of potassium levels.
How to Take
Take one tablet orally at the same time each day, with or without food. Start with the first active tablet on the first day of menstruation or the first Sunday after menstruation begins. Follow the arrows on the blister pack.
Mechanism of Action
Zoana primarily works by inhibiting gonadotropin secretion, which in turn prevents ovulation. It also causes changes in the cervical mucus, making it more difficult for sperm to penetrate the uterus, and alters the endometrium, making it less receptive to implantation.
Pharmacokinetics
Onset
Contraceptive effect begins after 7 consecutive days of active pill use. A back-up method is recommended for the first 7 days of the first cycle.
Excretion
Primarily via urine and feces for both components, as metabolites. Drospirenone is mainly excreted via feces (60%) and urine (40%); ethinyl estradiol is primarily excreted via urine (40%) and feces (60%).
Half life
Drospirenone: ~30 hours; Ethinyl Estradiol: ~24 hours (terminal half-life).
Absorption
Rapidly absorbed after oral administration. Bioavailability of drospirenone is about 76-85%, and ethinyl estradiol is about 44%. Peak plasma concentrations are reached within 1-2 hours for both components.
Metabolism
Both extensively metabolized in the liver. Drospirenone primarily via hydroxylation; ethinyl estradiol primarily via aromatic hydroxylation and subsequent glucuronidation/sulfation.
Side Effects
Contraindications
- History of thrombosis (arterial or venous), including deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- Severe hepatic disease or liver tumors
- Severe renal insufficiency or acute renal failure
- Adrenal insufficiency
- Known or suspected breast cancer or other estrogen- or progestin-sensitive cancer
- Undiagnosed abnormal uterine bleeding
- Pregnancy or suspected pregnancy
- Hypersensitivity to any component of the formulation
Drug Interactions
Warfarin
Combined oral contraceptives can alter the effects of anticoagulants.
Rifampicin
Reduces contraceptive effectiveness due to enzyme induction.
St. John's Wort
Reduces contraceptive effectiveness.
Grapefruit juice
May increase ethinyl estradiol levels by inhibiting CYP3A4.
Anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital)
May reduce contraceptive effectiveness through hepatic enzyme induction.
HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors
May alter plasma concentrations of estrogen and progestin.
Storage
Store below 30°C (86°F) in a dry place, away from direct light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overdose may cause nausea, vomiting, and withdrawal bleeding in women. Serious adverse effects have not been reported. Treatment is symptomatic and supportive; there is no specific antidote.
Pregnancy & Lactation
Contraindicated during pregnancy. If pregnancy occurs, discontinue immediately. Not recommended during breastfeeding as it may reduce milk production and pass into breast milk, potentially affecting the infant. Non-hormonal birth control methods should be considered during lactation.
Side Effects
Contraindications
- History of thrombosis (arterial or venous), including deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- Severe hepatic disease or liver tumors
- Severe renal insufficiency or acute renal failure
- Adrenal insufficiency
- Known or suspected breast cancer or other estrogen- or progestin-sensitive cancer
- Undiagnosed abnormal uterine bleeding
- Pregnancy or suspected pregnancy
- Hypersensitivity to any component of the formulation
Drug Interactions
Warfarin
Combined oral contraceptives can alter the effects of anticoagulants.
Rifampicin
Reduces contraceptive effectiveness due to enzyme induction.
St. John's Wort
Reduces contraceptive effectiveness.
Grapefruit juice
May increase ethinyl estradiol levels by inhibiting CYP3A4.
Anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital)
May reduce contraceptive effectiveness through hepatic enzyme induction.
HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors
May alter plasma concentrations of estrogen and progestin.
Storage
Store below 30°C (86°F) in a dry place, away from direct light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overdose may cause nausea, vomiting, and withdrawal bleeding in women. Serious adverse effects have not been reported. Treatment is symptomatic and supportive; there is no specific antidote.
Pregnancy & Lactation
Contraindicated during pregnancy. If pregnancy occurs, discontinue immediately. Not recommended during breastfeeding as it may reduce milk production and pass into breast milk, potentially affecting the infant. Non-hormonal birth control methods should be considered during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date, as indicated on the packaging.
Availability
Available in pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy of drospirenone/ethinyl estradiol in contraception with a Pearl Index of 0.1-0.7. Trials also confirmed its effectiveness in treating moderate acne and reducing symptoms of PMDD. Safety profiles have been established through large-scale studies.
Lab Monitoring
- Blood pressure monitoring (regularly)
- Lipid profile (periodically, especially in patients with pre-existing dyslipidemia)
- Liver function tests (if symptoms of liver dysfunction arise)
- Glucose tolerance (for diabetic patients or those at risk of diabetes)
- Potassium levels (in patients with renal impairment or concomitant potassium-sparing drugs)
Doctor Notes
- Thoroughly assess patient history for risk factors of venous thromboembolism (VTE) and arterial thromboembolism (ATE) before prescribing.
- Counsel patients on the critical importance of consistent, daily tablet taking for maximal efficacy and minimal breakthrough bleeding.
- Educate patients about the black box warning regarding smoking and cardiovascular risks, especially for women over 35.
- Monitor blood pressure regularly and advise on lifestyle modifications.
- Discuss non-contraceptive benefits, such as improvement in PMDD symptoms and acne, which may enhance patient compliance.
Patient Guidelines
- Take one tablet daily at the same time without fail to maintain contraceptive efficacy.
- Do not skip any tablets, especially active ones. Refer to the patient information leaflet for missed dose instructions.
- Use back-up contraception (e.g., condoms) if a dose is missed, if vomiting or severe diarrhea occurs within 3-4 hours of taking a tablet, or if you are taking interacting medications.
- Consult your doctor regularly for check-ups, especially for blood pressure monitoring and to discuss any concerns or side effects.
- Be aware of the symptoms of serious side effects like blood clots (e.g., persistent leg pain, sudden shortness of breath, chest pain) and seek immediate medical attention if they occur.
Missed Dose Advice
If one active tablet is missed, take it as soon as remembered and take the next tablet at the usual time (even if this means taking two tablets in one day). If two or more active tablets are missed, follow the specific instructions in the patient information leaflet, which typically includes taking the last missed tablet, discarding previous missed tablets, and using back-up contraception for 7 days.
Driving Precautions
Generally, Zoana does not impair the ability to drive or operate machinery. However, if you experience side effects like dizziness, migraine, or vision disturbances, avoid driving or operating machinery until these symptoms resolve.
Lifestyle Advice
- Avoid smoking, especially if you are over 35, due to increased risk of serious cardiovascular events.
- Maintain a healthy diet and engage in regular exercise to support overall health.
- Report any unusual symptoms or changes in your health immediately to your doctor.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
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