Mala-N

Ethinyl Estradiol (0.02mg) + Levonorgestrel (0.10mg)
Price: ₹80 - ₹120 per pack of 21 tablets
Mfr: Cipla Ltd. | Form: Tablet (Blister Pack of 21 tablets)

📋 Clinical Overview

A low-dose, biphasic combined oral contraceptive (COC) pill containing a synthetic estrogen (Ethinyl Estradiol) and a second-generation progestin (Levonorgestrel). It is a widely used, highly effective, and reversible method of contraception in the Indian market. It works primarily by inhibiting ovulation, thickening cervical mucus, and altering the endometrium.

💊 Dosage & Administration

Adult: One tablet orally, once daily, at approximately the same time each day. Standard regimen: 21 active tablets followed by a 7-day hormone-free interval (or 7 placebo pills). For 28-day packs, follow pack instructions.

Note: Take with or without food. If gastrointestinal upset occurs, take with food. Start on Day 1 of menstrual cycle (no backup needed) or on Sunday after period begins (backup contraception needed for first 7 days). For postpartum (non-breastfeeding), start at 4 weeks. For post-abortion, start immediately. If a pill is missed, refer to specific missed pill guidelines (within 12-24 hours).

⚠️ Contraindications

  • Thrombophlebitis or thromboembolic disorders (current or history)
  • Cerebrovascular or coronary artery disease (current or history)
  • Known or suspected carcinoma of the breast or other estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Known or suspected pregnancy
  • Severe or uncontrolled hypertension (≥160/100 mmHg)
  • Diabetes with vascular complications
  • Major surgery with prolonged immobilization
  • Active viral hepatitis, severe decompensated cirrhosis, hepatic tumors
  • Known hypersensitivity to any component

🔬 Mechanism of Action

The combination exerts a synergistic contraceptive effect through multiple mechanisms: 1) Inhibition of the mid-cycle gonadotropin surge (LH and FSH) from the pituitary, preventing ovulation. 2) Production of a thick, viscous cervical mucus hostile to sperm penetration and capacitation. 3) Induction of endometrial atrophy, making it unsuitable for implantation.

🤕 Side Effects

  • Nausea, vomiting
  • Headache (including migraine)
  • Breast tenderness, enlargement
  • Breakthrough bleeding, spotting (especially in first 3 cycles)
  • Amenorrhea or changes in menstrual flow
  • Mood changes, depression
  • Weight change
  • Acne (may improve or worsen initially)
  • Decreased libido

🤰 Special Populations

Pregnancy: Pregnancy Category X. ABSOLUTELY CONTRANDICATED. Discontinue immediately if pregnancy is confirmed. No known teratogenic risk from inadvertent use in early pregnancy.

Driving: No direct effect. However, patients experiencing dizziness, migraine, or visual disturbances should avoid driving or operating machinery.

🔄 Drug Interactions

Enzyme Inducers (e.g., Rifampicin, Rifabutin, Carbamazepine, Phenytoin, Phenobarbital, Primidone, Topiramate, Modafinil, St. John's Wort)Marked decrease in Ethinyl Estradiol and Levonorgestrel plasma levels, leading to contraceptive failure and breakthrough bleeding.Major
Broad-spectrum Antibiotics (e.g., Ampicillin, Tetracyclines, Griseofulvin)Possible reduction in contraceptive efficacy due to altered gut flora and reduced enterohepatic recirculation of EE.Moderate
Antiretroviral Protease Inhibitors & NNRTIs (e.g., Ritonavir, Efavirenz)Variable effects; some increase, some decrease hormone levels. Consult specific guidelines.Major
Ascorbic Acid (High Dose), AtorvastatinMay increase Ethinyl Estradiol plasma levels.Minor
Warfarin, other CoumarinsEthinyl Estradiol may decrease anticoagulant effect; monitor INR closely.Moderate
CyclosporineEthinyl Estradiol may increase Cyclosporine levels, risk of toxicity.Moderate
LamotrigineEthinyl Estradiol significantly reduces Lamotrigine levels, increasing seizure risk.Major
TizanidineEthinyl Estradiol may potentiate hypotensive and sedative effects.Moderate

🔁 Alternatives to Mala-N

Same composition (Ethinyl Estradiol (0.02mg) + Levonorgestrel (0.10mg)), different brands:

Mala-D L Pill ECROZ Ovral-L