Progesterone Micronised (SC injection)

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 undergoing In Vitro Fertilization (IVF) with or without Intracytoplasmic Sperm Injection (ICSI).

Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss. Progesterone binds and activates its nuclear receptor, PR, which plays an important part in the signaling of stimuli that maintain the endometrium during its preparation 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 known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin or St. John's Wort (Hypericum perforatum-containing herbal products) may increase the elimination rate and thereby decrease the bioavailability of progesterone. In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of progesterone. Since progesterone can influence diabetic control an adjustment in antidiabetic dosage could be required. Progestogens may inhibit Cycloporine metabolism leading to increased Plasma-Cycloporine concentrations and a risk of toxicity.

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 Cmax values, but had no influence on Tmax in comparison to a fasting state.

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

• Hypersensitivity to progesterone or to any of the excipients
• Undiagnosed vaginal bleeding
• Known missed abortion or ectopic pregnancy
• Severe hepatic dysfunction or disease
• Known or suspected breast or genital tract cancer
• Active arterial or venous thromboembolism or severe thrombo- phlebitis, or a history of these events
• Porphyria
• A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.

Headache, Abdominal distension, Abdominal pain, Nausea, Vomiting, Constipation, Uterine spasm, Vaginal haemorrhage, Breast tenderness, Breast pain, Vaginal discharge, Vulvo-vaginal pruritus, Vulvo-vaginal discomfort, Vulvo-vaginal inflammation, OHSS, Administration site reactions, such as irritation, pain, pruritus and swelling, Injection site haematoma, Injection site induration, Fatigue.

USFDA pregnancy category B. There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. Progesterone is excreted in human milk and this should not be used during breast-feeding.

Progesterone should be discontinued if any of the following conditions are suspected:

Myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis.

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

Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.

Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy.

Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users >35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary oedema or retinal haemorrhage.

High doses of progesterone may cause drowsiness. Treatment of overdose consists of discontinuation of Progesterone together with initiation of appropriate symptomatic and supportive care.

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

For indications and dosage please see the package insert. To be sold only on the prescription of a registered physician. Store below 25ºC. & dry place. Keep away from light. Keep out of the reach of children.