Progesterone SC injection 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 are undergoing In Vitro Fertilization (IVF) with or without Intracytoplasmic Sperm Injection (ICSI).

Progesterone is a naturally occurring female hormone that is essential for endometrial receptivity, embryo implantation, and the successful maintenance of pregnancy. Low progesterone levels or inadequate response to progesterone may lead to infertility and pregnancy loss. Progesterone works by binding to and activating its nuclear receptor (PR), which plays a key role in maintaining the endometrium and preparing it for 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: Drugs that induce the hepatic cytochrome P450-3A4 enzyme system (such as rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin, or St. John’s Wort containing herbal products) may increase the elimination of progesterone and reduce its bioavailability. On the other hand, ketoconazole and other CYP3A4 inhibitors may decrease progesterone elimination and increase its bioavailability. Since progesterone may affect diabetic control, adjustment of antidiabetic medication may be necessary. Progestogens may also inhibit cyclosporine metabolism, leading to increased plasma cyclosporine levels and possible toxicity.

With Food and Others: Food may increase the bioavailability of orally administered progesterone. In postmenopausal women receiving 200 mg micronized progesterone capsules, food intake increased AUC and Cmax values without affecting Tmax compared to fasting conditions.

Progesterone should not be used in patients with any of the following conditions:

• Hypersensitivity to progesterone or any of the excipients
• Undiagnosed vaginal bleeding
• Known missed abortion or ectopic pregnancy
• Severe hepatic dysfunction or liver disease
• Known or suspected cancer of the breast or genital tract
• Active arterial or venous thromboembolism, severe thrombophlebitis, or a history of these conditions
• Porphyria
• History of idiopathic jaundice, severe itching (pruritus), or pemphigoid gestationis during pregnancy

Common side effects include headache, abdominal bloating, abdominal pain, nausea, vomiting, constipation, uterine spasm, vaginal bleeding, breast tenderness, breast pain, vaginal discharge, vulvovaginal itching, discomfort, inflammation, ovarian hyperstimulation syndrome (OHSS), injection site reactions such as irritation, pain, itching, swelling, hematoma, induration, and fatigue.

USFDA Pregnancy Category B. Limited and inconclusive data are available regarding the risk of congenital abnormalities, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. Progesterone is excreted in human breast milk and should not be used during breastfeeding.

Progesterone should be discontinued if myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis is suspected.

Caution is required in patients with mild to moderate hepatic dysfunction.

Patients with a history of depression should be monitored closely, and treatment discontinuation should be considered if symptoms worsen.

Since progesterone may cause fluid retention, patients with epilepsy, migraine, asthma, cardiac disease, or renal impairment require careful monitoring. Diabetic patients should be closely observed because progesterone may reduce insulin sensitivity and glucose tolerance.

Sex steroid use may also increase the risk of retinal vascular disorders; therefore, special caution is needed in women over 35 years, smokers, and those with risk factors for atherosclerosis. Treatment should be stopped if transient ischemic attacks, sudden severe headaches, or vision problems related to papillary edema or retinal hemorrhage occur.

High doses of progesterone may cause drowsiness. Management includes discontinuation of progesterone along with appropriate symptomatic and supportive treatment.

Hormone replacement therapy for menopausal symptoms, Female sex hormones

For indications and dosage, please refer to the package insert. To be sold only on the prescription of a registered physician. Store below 25°C in a dry place, protected from light. Keep out of the reach of children.