Aygestin - Comprehensive Usage Guide: instructions, indications, composition, side effects
Composition
- Active Ingredient: Norethindrone acetate
- Excipients: May include lactose monohydrate, corn starch, magnesium stearate, and other inactive ingredients depending on the formulation.
Official Forms
- Tablets: Available in various strengths, including 5 mg tablets.
Pharmacological Group
Aygestin belongs to the pharmacological group of progestins (ATC code: G03AC01).
Pharmacological Properties
- Pharmacodynamics: Norethindrone acetate is a synthetic progestin that exhibits similar actions to endogenous progesterone. It exerts its contraceptive effects primarily by inhibiting ovulation, altering cervical mucus viscosity, and modifying the endometrium to prevent implantation.
- Pharmacokinetics: Following oral administration, norethindrone acetate is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations are achieved within 1 to 2 hours. It undergoes extensive hepatic metabolism and is primarily excreted in the urine as metabolites.
Indications
Aygestin is indicated for the treatment of:
- Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as secondary amenorrhea, dysfunctional uterine bleeding, and endometriosis.
- Progestin deficiency in conditions requiring hormonal supplementation, such as menopausal hormone therapy.
Contraindications
Aygestin is contraindicated in individuals with:
- Known or suspected pregnancy
- Undiagnosed vaginal bleeding
- History of thromboembolic disorders
- Liver dysfunction or disease
- Breast cancer or other estrogen- or progestin-sensitive malignancies
- Hypersensitivity to norethindrone acetate or any component of the formulation
Interactions
Norethindrone acetate may interact with other medications, including:
- Drugs that induce hepatic enzymes (e.g., rifampin, phenytoin), potentially reducing norethindrone acetate efficacy
- Drugs that inhibit hepatic enzymes (e.g., ketoconazole, erythromycin), potentially increasing norethindrone acetate concentrations and the risk of adverse effects
Specifics of Use
- Aygestin tablets should be taken orally once daily, with or without food, as directed by a healthcare provider.
- The dosage and duration of therapy depend on the indication and patient response. Treatment may be initiated at any time in the menstrual cycle.
- For abnormal uterine bleeding, the recommended dosage is typically 2.5 to 10 mg daily for 5 to 10 days, starting on the fifth day of the menstrual cycle.
- For menopausal hormone therapy, the recommended dosage is typically 2.5 to 5 mg daily for 21 to 25 days of each menstrual cycle, combined with estrogen therapy.
Pregnancy and Breastfeeding
- Aygestin is contraindicated during pregnancy due to the potential risk of fetal harm.
- Norethindrone acetate is excreted in breast milk, and breastfeeding is not recommended during Aygestin treatment.
Dosage and Administration
- Dosage adjustments may be necessary in patients with renal impairment or hepatic impairment to prevent drug accumulation and minimize the risk of adverse effects.
Overdose
In case of overdose, supportive measures should be initiated, and medical attention should be sought immediately. Symptoms of norethindrone acetate overdose may include nausea, vomiting, breast tenderness, and menstrual irregularities.
Side Effects
Common side effects of Aygestin may include:
- Headache
- Breast tenderness
- Nausea
- Abdominal pain
- Menstrual irregularities
- Fatigue
Storage and Shelf Life
Aygestin tablets should be stored at controlled room temperature (20-25°C) in a dry place, protected from light and moisture. The expiration date should be checked before use.
These comprehensive instructions provide essential information on the composition, pharmacological properties, indications, contraindications, interactions, administration, side effects, and storage of Aygestin, aiding healthcare professionals and patients in safe and effective medication use. Always consult a healthcare provider for personalized medical advice.