Generic
Norgestrel + Ethinyl Estradiol + Ferrous Fumarate
2 brands available in the market
At a glance
Norgestrel + Ethinyl Estradiol + Ferrous Fumarate is a combination oral contraceptive used for prevention of pregnancy. Norgestrel is a progestin and ethinyl estradiol is an estrogen that inhibit ovulation and affect cervical mucus and endometrium to make conception unfavourable.
Description
Combination oral contraceptives (COC) act by suppression of gonadotropins. Primary mechanism is inhibition of ovulation, other alterations include changes in cervical mucus (increase difficulty of sperm entry) and endometrium (reduce likelihood of implantation). Each pack contains 21 active tablets (0.3 mg norgestrel + 0.03 mg ethinylestradiol) and 7 inert iron tablets (75 mg ferrous fumarate).
Indications
- Contraception
Therapeutic class
Oral Contraceptive Preparations
Pharmacological class
Progestin + Estrogen Combination
Pharmacology
Combination oral contraceptives suppress gonadotropins to inhibit ovulation, thicken cervical mucus to inhibit sperm penetration, and alter endometrium to prevent implantation.
Mechanism of action
Provides contraception by inhibiting ovulation and making conception unfavourable.
Dosage
Adult Dose (Oral):
- Start on day 1 of menstrual cycle
- 1 active tablet daily for 21 days, then 7 inert (iron) tablets
- Take at the same time each day
- No break between packs
Administration
- Take at the same time each day
- Swallow tablet whole
- May be taken with or without food
Missed dose
If more than 3 hours late or miss a pill, use a back-up method of birth control for the next 2 days.
Side effects
Common Side Effects (>10%):
- Edema
- Weakness
- Amenorrhea
- Breakthrough bleeding
- Change in menstrual flow
- Spotting
- Anorexia
Others: DVT, thrombophlebitis, depression, dizziness, headache, nervousness, somnolence, breast tenderness, galactorrhea, abdominal pain, nausea, vomiting, weight change, cholestatic jaundice. Potentially Fatal: Hepatic tumours; increased risk of thromboembolism.
Precautions & warnings
- Sex-steroid dependent cancer, past ectopic pregnancy, malabsorption syndromes, functional ovarian cysts, active liver disease, recurrent cholestatic jaundice, history of jaundice in pregnancy, history of CV or renal impairment, DM, asthma, epilepsy, migraine, depression, conditions exacerbated by fluid retention, hypertension, hypercalcaemia, CV and gall bladder diseases
Contraindications
- Pregnancy
- Undiagnosed vaginal bleeding
- Severe arterial disease (or family history of atherogenic lipid profile)
- Liver adenoma
- Porphyria
- After evacuation of hydatidiform mole
- History of breast cancer
- Hepatic impairment
- Thrombophlebitis or thromboembolic disorders
- Oestrogen-dependent tumour
- Smoking >40 cigarettes daily
- >50 years
- BMI >39 kg/m²
Drug interactions
- Reduced contraceptive effectiveness with antibiotics, anticonvulsants and drugs that may increase contraceptive steroids clearance (bosentan, rifampicin, rifabutin, barbiturates, primidone, phenytoin, carbamazepine, oxcarbazepine, topiramate, griseofulvin, aprepitant)
- Severe pruritus and jaundice with troleandomycin, avoid concurrent use
- Decreased contraceptive effectiveness with anti-HIV protease inhibitors
- Increased tacrolimus levels
- May increase theophylline, selegiline and tizanidine levels
Food interactions
May be taken with or without food.
Use in pregnancy
Use in Pregnancy: Norgestrel + Ethinyl Estradiol is highly unsafe during pregnancy (Category X); do not use during pregnancy.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning.
Pediatric use
Not intended for use in children.
Geriatric use
Elderly may require dose adjustment.
Renal / hepatic impairment
Renal Impairment: Caution; monitor blood pressure.
Hepatic Impairment: Do not administer in hepatic impairment.
Overdose effects
Limited information on overdose; symptomatic treatment.
Storage conditions
Store in a dry place, away from light; keep out of reach of children.
Chemical structure
Norgestrel + Ethinyl Estradiol + Ferrous Fumarate