Microgest AQ-25 SC Injection

Microgest AQ-25 is indicated for progesterone supplementation in women up to and including 34 years of age who are unable to use or tolerate vaginal preparations and undergoing In Vitro Fertilization (IVF) with or without Intracytoplasmic Sperm Injection (ICSI).

This contains the active ingredient Progesterone. Progesterone is a hormone normally found in females. It is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal glands. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain a pregnancy.

Route of Administration: SC injection only.

Adult: Once daily injection of 25 mg from day of oocyte retrieval for up to 10 weeks of total duration, usually until 12 weeks of confirmed pregnancy.

Pediatrics (0 to 18 years): The safety and efficacy of Progesterone in pediatric patients has not been established.

Geriatrics (>65 years of age): No clinical data have been established in patients over the age of 65.

With Medicine: Ketoconazole inhibits the metabolism of Microgest. Barbiturates, Hydantoins, Carbamazepine, Meprobamates, Phenylbutazone or Rifampin may interfere with the activity of administered progestins.

With Food and Others: Food can increase the bioavailability of progesterone administered orally. When micronized progesterone capsules were given to postmenopausal women at a dose of 200 mg, concurrent food consumption increased the AUC and C max values, but had no influence on T max in comparison to a fasting state.

Progesterone is contraindicated in the following patients: Hypersensitivity, Undiagnosed vaginal bleeding, known missed abortion or ectopic pregnancy, Liver dysfunction or disease, Known or suspected breast or genital tract cancer, Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events, Porphyria, history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.

Common: Uterine cramping, Vaginal bleeding, Ovarian hyperstimulation syndrome, Antepartum hemorrhage, Vomiting.

Rare: Retinal vascular lesions, arterial or venous thromboembolism, Jaundice

Progesterone classified in FDA pregnancy category B. It is not recommended during pregnancy, labor or delivery and in mothers who are breast feeding.

Caution should be exercised in administration of Microgest AQ-25 in patients with: Severe Renal Insufficiency, Diabetes Mellitus, Seizures, Migraine, Headache, Heart Diseases, Depression. Efficacy in women 35 years of age and older, and in women over 30 kg/m² have not been established.

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones