Pevisia
Generic Name
Ethinyl Estradiol + Dienogest
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Description
Overview of the medicine
Pevisia is a combination oral contraceptive containing ethinyl estradiol (an estrogen) and dienogest (a progestin). It is primarily used to prevent pregnancy and may also be prescribed for the treatment of moderate acne and symptoms of endometriosis in women who choose oral contraception.
Uses & Indications
Dosage
Adults
One tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval or placebo tablets. Start on day 1 of the menstrual cycle.
Elderly
Not indicated for postmenopausal women. No specific dosage adjustment for elderly women prior to menopause, but generally not used.
Renal_impairment
No specific studies in renal impairment. Use with caution.
How to Take
Take one tablet at approximately the same time each day, with or without food. Follow the arrows on the blister pack. Start a new pack after the 7-day interval.
Mechanism of Action
Pevisia prevents pregnancy primarily by inhibiting ovulation, altering cervical mucus to impede sperm penetration, and changing the endometrium to prevent implantation. Dienogest also has antiandrogenic properties.
Pharmacokinetics
Onset
Contraceptive effect usually starts after 7 consecutive days of active pill intake if taken correctly from the first day of the menstrual cycle.
Excretion
Metabolites are primarily excreted via urine and feces.
Half life
Ethinyl Estradiol: Approximately 12-24 hours; Dienogest: Approximately 9-10 hours.
Absorption
Ethinyl Estradiol and Dienogest are rapidly and almost completely absorbed after oral administration. Peak plasma concentrations are reached within 1-4 hours.
Metabolism
Both are extensively metabolized in the liver, primarily via CYP3A4 for dienogest and first-pass metabolism for ethinyl estradiol.
Side Effects
Contraindications
- Presence or history of thrombosis (venous or arterial)
- Known or suspected estrogen-dependent tumors
- Severe hepatic disease
- Undiagnosed vaginal bleeding
- Hypersensitivity to active substances or excipients
- Migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
Drug Interactions
Antibiotics
Some antibiotics (e.g., ampicillin, tetracycline) may decrease effectiveness (advise backup contraception).
HIV medications
Certain HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors.
Enzyme-inducing drugs
Enzyme-inducing drugs (e.g., phenobarbital, phenytoin, rifampicin, St. John's Wort) may reduce contraceptive effectiveness.
Drugs affecting hepatic metabolism
Drugs affecting hepatic metabolism (e.g., ciclosporin, lamotrigine).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No serious adverse effects reported with overdose. Symptoms may include nausea, vomiting, and withdrawal bleeding in females.
Pregnancy & Lactation
Contraindicated during pregnancy. Not recommended during breastfeeding as it may reduce milk production and alter milk composition. Small amounts of active substances may pass into breast milk.
Side Effects
Contraindications
- Presence or history of thrombosis (venous or arterial)
- Known or suspected estrogen-dependent tumors
- Severe hepatic disease
- Undiagnosed vaginal bleeding
- Hypersensitivity to active substances or excipients
- Migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
Drug Interactions
Antibiotics
Some antibiotics (e.g., ampicillin, tetracycline) may decrease effectiveness (advise backup contraception).
HIV medications
Certain HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors.
Enzyme-inducing drugs
Enzyme-inducing drugs (e.g., phenobarbital, phenytoin, rifampicin, St. John's Wort) may reduce contraceptive effectiveness.
Drugs affecting hepatic metabolism
Drugs affecting hepatic metabolism (e.g., ciclosporin, lamotrigine).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No serious adverse effects reported with overdose. Symptoms may include nausea, vomiting, and withdrawal bleeding in females.
Pregnancy & Lactation
Contraindicated during pregnancy. Not recommended during breastfeeding as it may reduce milk production and alter milk composition. Small amounts of active substances may pass into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved by regulatory authorities worldwide
Patent Status
Generic versions available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated efficacy in contraception, moderate acne, and endometriosis-related pain. Studies consistently show high contraceptive reliability and a favorable safety profile compared to older generation OCs.
Lab Monitoring
- Regular blood pressure monitoring
- Lipid profile (periodically)
- Liver function tests (if symptoms suggest hepatic impairment)
- Glycemic control (in diabetics)
Doctor Notes
- Assess cardiovascular risk factors before prescribing.
- Monitor blood pressure regularly.
- Counsel patients on adherence and missed dose management.
- Discuss benefits and risks thoroughly with the patient.
Patient Guidelines
- Take the tablet at the same time every day.
- Do not stop taking the tablets without consulting your doctor.
- Use backup contraception (e.g., condoms) for the first 7 days of the first pack or if you miss pills.
- Report any severe chest pain, sudden breathlessness, or severe headache immediately.
- Regular gynecological check-ups are recommended.
Missed Dose Advice
If a tablet is missed by less than 12 hours, take it immediately and continue with the next tablet at the usual time. Contraceptive protection is not reduced. If missed by more than 12 hours, contraceptive protection may be reduced. Refer to package leaflet for detailed instructions based on week of cycle.
Driving Precautions
Pevisia is not known to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain a healthy lifestyle.
- Quit smoking.
- Discuss any pre-existing medical conditions with your doctor.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.