Depo Monat

Medroxyprogesterone acetate, estradiol cypionate.

Each mL contains Medroxyprogesterone acetate 50 mg and Estradiol cypionate 10 mg.

Pharmacology: Pharmacokinetics: Absorption of Medroxyprogesterone acetate (MPA) and Estradiol cypionate (17β-estradiol; E₂) from the injection site is prolonged after an intramuscular injection of Depo Monat. The time to maximum plasma concentration (T_max) typically occurs within 1 to 10 days post-injection for MPA and 1 to 7 days post-injection for E₂ (17β-estradiol).
Elimination half life: Residual Medroxyprogesterone acetate (MPA) concentrations at the end of monthly injection of Depo Monat are generally below 0.5 ng/ml, consistent with its apparent elimination half life of 15 days. Most MPA metabolites are excreted in the urine as glucuronide conjugates with only small amount excreted as sulfates. Following the peak concentration, serum E₂ levels typically decline to 100 pg/ml by day 14 and are consistent with the apparent elimination half life of 7 to 8 days. Estrogen metabolites are primarily excreted in the urine as glucuronide and sulfates.

For contraceptive injection.

Recommended Dose: The recommended dose of Depo Monat for monthly contraceptive injection is 0.5 ml administered by intramuscular injection.
(Strength of active ingredients = Medroxyprogesterone acetate 25 mg and Estradiol cypionate 5 mg.)
Mode of Administration: Shake well before use and administration is 0.5 ml by intramuscular injection.
The first injection should be given during the first 5 days of a normal menstrual period.
Second and Subsequent Injection: Monthly (28 to 30 days) after previous injection, not to exceed 33 days.
If the patient has not adhered to the prescribed schedule (greater than 33 days since last injection) or pregnancy should be considered and she should not receive another injection until pregnancy is ruled out.
Shortening the injection interval could lead to change in menstrual pattern.
Nursing mothers: Depo Monat should be administered no earlier than 4 weeks after delivery if not breastfeeding.
Depo Monat should be administered no earlier than 6 weeks after delivery if breastfeeding.

Overdose and Treatment: Overdosage of a drug combined hormonal contraceptive may cause nausea and vomiting, and vaginal bleeding or other menstrual irregularities in females.

Hypersensitivity to medroxyprogesterone acetate and Estradiol cypionate or any component of the formulation.
Pregnancy or suspected pregnancy.
Thromboembolism, liver dysfunction.
Cerebral vascular or coronary artery disease.
Undiagnosed abnormal genital bleeding.
Carcinoma of the endometrium or breast.
Diabetes with vascular involvement.

Patients with thromboembolism and liver dysfunction are contraindicated.
Not recommended in women with the risk of thrombotic events e.g. with the history of thrombophlebitis, obesity, diabetes and high blood pressure.
Should be used with caution in women who smoke and older than 35 years; consult the physician if necessary.
Consult the physician if undesirable effects occurred.
Depo Monat does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Women using Depo Monat for long term may cause weight gain.
Women using Depo Monat should have an annual history and physical examination.

Pregnancy: Pregnancy or suspected pregnancy are contraindicated.
Lactation: Estrogen administration to nursing mother has been shown to decrease the quantity and quality of breast milk. However, women who are breastfeeding should not start taking combined hormonal contraceptives until 6 weeks postpartum.

Women using combined hormonal contraceptive may have adverse reaction e.g. Thromboembolism, Cerebral hemorrhage, Gallbladder disease, Hepatic adenomas or benign liver tumors, Hypertension, Myocardial infarction, Pulmonary embolism, Thrombophlebitis, Abdominal pain, Acne, Alopecia, Amenorrhea, Asthenia, Breast tenderness/pain, Decreased libido, Depression, Dizziness, Dysmenorrhea, Emotional lability, Enlarged abdomen, Headache, Menorrhagia, Metrorrhagia, Nausea, Nervousness, Vaginal moniliasis, Vulvovaginal disorder, weight gain.

Effects of other drugs with Depo Monat: Aminoglutethamide administered concomitantly with Depo Monat may decrease the serum concentration of Medroxyprogesterone Acetate.

Protect from light and temperature not exceeding 30°C. Shake well before use.

Depot Contraceptives

G03AA17 - medroxyprogesterone and estradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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