A combined oral contraceptive (COC) pill containing a high-dose estrogen (0.05mg Ethinyl Estradiol) and a progestin (0.25mg Levonorgestrel). It is a monophasic, fixed-dose combination primarily used for contraception and the management of menstrual disorders. This specific high-dose formulation is less commonly prescribed today due to the availability of lower-dose options with improved safety profiles, but it remains relevant for specific clinical scenarios in the Indian market, such as managing heavy menstrual bleeding or as a step-down therapy from higher doses.
Adult: One tablet orally once daily, preferably at the same time each day. For contraception: Start on Day 1 of menstrual cycle (no backup needed) or on Sunday after period begins (requires backup for first 7 days). Take for 21 consecutive days followed by a 7-day pill-free interval (or 7 placebo pills). Withdrawal bleed occurs during pill-free interval.
Note: Take with or without food. If a dose is missed >12 hours, contraceptive efficacy may be reduced. Follow the 'missed pill' guidelines: Take missed pill as soon as remembered, and next pill at usual time (may take two in one day). Use backup contraception (condoms) for next 7 days if >1 pill is missed. If vomiting/diarrhea occurs within 3-4 hours of intake, consider it a missed pill.
The combination exerts contraceptive effects through multiple synergistic mechanisms: 1) Inhibition of ovulation via suppression of the mid-cycle gonadotropin (LH and FSH) surge from the pituitary. 2) Thickening of cervical mucus, creating a barrier to sperm penetration. 3) Alteration of the endometrium, making it less receptive to implantation.
Pregnancy: Pregnancy Category X. ABSOLUTELY CONTRANDICATED. Discontinue immediately if pregnancy is confirmed. No known teratogenic risk from accidental use in early pregnancy ('pill in pocket' concept).
Driving: Usually no effect. However, patients who experience dizziness, migraine, or visual disturbances should exercise caution.
| Enzyme Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort) | Significantly reduce contraceptive efficacy, leading to breakthrough bleeding and pregnancy risk. | Major |
| Antibiotics (e.g., Ampicillin, Tetracyclines, Griseofulvin) | May reduce efficacy by altering gut flora and enterohepatic circulation of EE. | Moderate |
| Antiretroviral Protease Inhibitors & NNRTIs (e.g., Ritonavir, Nevirapine) | Alter metabolism; some decrease efficacy, some increase hormone levels. | Major |
| Warfarin | Ethinyl Estradiol may decrease anticoagulant effect; progestins may increase it. Monitor INR closely. | Major |
| Cyclosporine | Ethinyl Estradiol may increase Cyclosporine levels, risk of toxicity. | Moderate |
| Lamotrigine | Ethinyl Estradiol significantly reduces Lamotrigine levels, increasing seizure risk. | Major |
| Ascorbic Acid (High Dose), Atorvastatin | May increase Ethinyl Estradiol levels. | Minor |
Same composition (Ethinyl Estradiol (0.05mg) + Levonorgestrel (0.25mg)), different brands: