PROGESTERONE INJECTION, USP 50 MG — DIN 02531828

What is PROGESTERONE INJECTION, USP?

PROGESTERONE INJECTION, USP 50 MG contains PROGESTERONE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02531828, held by HIKMA CANADA LIMITED, supplied as SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 28-Apr-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is PROGESTERONE INJECTION, USP used for?

This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Not for intravenous injection. Amenorrhea – 5 to 10 mg for 6 to 8 consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding 48 to 72 hours after the last injection. This may be followed by spontaneous normal cycles. Functional Uterine Bleeding – 5 to 10 mg daily for 6 days. Bleeding may be expected to cease within 6 days. When estrogen is given as well, the administration of progesterone is begun after 2 weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued. Progesterone is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection. This is true whether the preparation is in an oil or an aqueous vehicle. The latter is particularly painful.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a history of these conditions; known or suspected carcinoma of the breast; undiagnosed vaginal bleeding; missed abortion; as a diagnostic test for pregnancy; known sensitivity to the active substance (progesterone) or any ingredient in the drug formulation; known sensitivity to sesame oil/seeds; known or suspected carcinoma of the breast or genital organs; liver dysfunction or disease.

Warnings and precautions

THE USE OF PROGESTATIONAL AGENTS DURING THE FIRST FOUR MONTHS OF PREGNANCY IS NOT RECOMMENDED. The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. Discontinue medication pending examination of there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion or threatened abortion. There is no adequate evidence that such use is effective and there is evidence of potential harm to the fetus when such drugs are given in the first four months of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum which progestational agents could not be expected to influence. In addition, the use of progestational agents, with their uterine relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. Therefore, the use of such drugs during the first four months of pregnancy is not recommended. Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. One study estimated a 4.7 fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggests that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 in 1000. If the patient is exposed to progesterone during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus. Detectable amounts of progestogens have been identified in the milk of the mothers receiving them. The effect of this on the nursing infant has not been determined. Masculinization of female fetus has occurred when progestogens have been used in pregnant women. Because progestational drugs may cause some degree of fluid retention, conditions which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac, or renal dysfunction, require careful observation. In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. The pathologist should be advised of progestin therapy when relevant specimens are submitted. There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy. Acute eosinophilic pneumonia has been reported in patients receiving progesterone in sesame oil. In reported cases associated with progesterone in sesame oil, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting progesterone in sesame oil and improved when progesterone in sesame oil was discontinued and a different formulation of progesterone and/or steroid the