Primolut Depot

Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.

• Suggested dosages are presented in the therapy guide
• Because of the low viscosity of the vehicle, Hydroxyprogesterone Caproate Injection, USP may be administered with a small gauge needle
• Care should be taken to inject the preparation deeply into the upper outer quadrant of the gluteal muscle following the usual precautions for intramuscular injection
• Since the 250 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose
• Note: Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
• Protect from light
• Store vial in its box
• Store upright
• Discard any unused product within 5 weeks after first use
• THERAPY GUIDE CYCLIC THERAPY SCHEDULE: (28-day cycle; repeated every 4 weeks); Day 1 of each cycle: 20 mg Estradiol Valerate Injection, USP 2 weeks after Day 1: 250 mg Hydroxyprogesterone Caproate Injection, USP and 5 mg Estradiol Valerate Injection, USP 4 weeks after Day 1
• This is Day 1 of next cycle SUGGESTED CYCLIC REGIMEN Indications Dosage Started Repeated Stopped Comments Amenorrhea (primary and secondary): Abnormal uterine bleeding due to hormonal imbalance in the absence of organicpathology, such as submucous fibroids or uterine cancer. 375 mg Any time - - Genital malignancy should be excluded before hormone therapy is started. …

• Information for The Patient Counsel patients that hydroxyprogesterone caproate injections may cause pain, soreness, swelling, itching or bruising
• Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site

• Hydroxyprogesterone caproate is contraindicated in patients with known or suspected carcinoma of the breast, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding; liver dysfunction or disease; missed abortion, and in those with a history of hypersensitivity to the drug
• Hydroxyprogesterone caproate is also contraindicated as a diagnostic test for pregnancy and in patients with current or history of thrombotic or thromboembolic disorders

Thrombotic and Thromboembolic Events Discontinue the medication pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Medication should be stopped if examination reveals papilledema or retinal vascular lesions. Allergic reactions Hypersensitivity reaction to progestins have been reported. Hydroxyprogesterone caproate is contraindicated in women with a history of hypersensitivity to a progestin. Glucose tolerance Progestins may decrease glucose tolerance and the blood glucose concentration should be monitored in diabetic users.

A. Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins. B. neuroocular lesions (e.g., retinal thrombosis and optic neuritis); nausea; vomiting; gastrointestinal symptoms (such as abdominal cramps or bloating); edema; breakthrough bleeding, spotting, or withdrawal bleeding; breast tenderness; changes in body weight (increase or decrease); headache; increase in cervical mucus; allergic rash; abscess; pain at the injection site; migraine headaches. C. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.