API

Ethinyl Estradiol (0.03mg) + Desogestrel (0.15mg)

Drug classification

Combined oral contraceptive; estrogen-progestin combination.

Dosage form

Film-coated oral tablet containing ethinyl estradiol and desogestrel.

API strength per dosage

Dose

Novelon is typically taken as one tablet daily for 21 consecutive days, followed by a 7-day tablet-free interval. Not recommended before menarche. Use with caution or avoid in hepatic impairment; contraindicated in severe liver disease. No dose adjustment specified for renal impairment. Always follow prescribing information and consult a healthcare professional.

Mechanism of action

Novelon combines ethinyl estradiol (estrogen) and desogestrel (progestin), which suppress gonadotropin (FSH, LH) secretion via negative feedback on the hypothalamus and pituitary. This inhibits ovulation, thickens cervical mucus (impeding sperm), and alters endometrial lining, reducing implantation likelihood. Targets: estrogen and progesterone receptors, hypothalamic-pituitary-ovarian axis.

Indications

Contraception

Side effects

Nausea Stomach pain Headache Irregular uterine bleeding Weight gain Breast pain

Pregnancy category

Novelon is contraindicated in pregnancy; discontinue if pregnancy occurs. No indication for use during pregnancy; exposure may increase risk of fetal harm.

Precautions

History of thromboembolic disorders, hypertension, migraine, smoking (especially age >35), liver disease, diabetes, undiagnosed vaginal bleeding, breast cancer history, regular blood pressure monitoring, assess for signs of thrombosis, monitor for mood changes, monitor liver function, counsel on missed doses and drug interactions.

Contraindications

Known or suspected pregnancy, history of thromboembolic disorders, cerebrovascular or coronary artery disease, known or suspected breast cancer, undiagnosed vaginal bleeding, liver tumors or disease, hypersensitivity to ingredients, high risk of arterial or venous thrombosis.