Hydrogest 250 mg/ml (IM Injection)
Medicine Details
| Category | Details |
|---|---|
| Generic | Hydroxyprogesterone caproate |
| Company | Renata limited |
| Also available as |
Indications
- Reducing the risk of preterm birth in women with a history of spontaneous preterm birth
- Prevention of preterm labor in patients with a history of spontaneous preterm birth
Description
Synthetic steroid hormone similar to medroxyprogesterone acetate and megestrol acetate. Ester derivative of 17a-hydroxyprogesterone formed from caproic acid (hexanoic acid)
Pharmacology
Plays a vital role in regulation of the female reproductive system, important for successful implantation of the embryo and maintenance of pregnancy. Binds to progesterone receptors in the uterus, ovaries, breasts and central nervous system.
Dosage & Administration
Administer intramuscularly at a dose of 500 mg or 250 mg once weekly. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.
Administration
- Clean the ampoule top with an alcohol swab before use
- Draw up 1 ml of drug into a 2 ml syringe
- Inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection recommended
- Applying pressure to the injection site may minimize bruising and swelling
Contraindications
- History of thrombosis or thromboembolic disorders
- Known or suspected breast cancer, other hormone-sensitive cancer
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- Uncontrolled hypertension
Side Effects
- Injection site reactions (pain, swelling, pruritus, nodule)
- Hives
- Itching
- Nausea
- Diarrhea
- Blood clots Symptoms: Leg swelling, Redness in the leg, warm spot on the leg, Leg pain worsens when bending foot
- Allergic reactions: Hives, Itching, Swelling of the face
Pregnancy & Lactation
- Pregnancy: Category B, no adequate and well-controlled studies in the first trimester, no teratogenic risks demonstrated in a study of pregnant women receiving the drug during their second and third trimesters
- Lactation: Detectable amounts of progestins identified in breast milk. Discontinue drug at 37 weeks of gestation or upon delivery.
Precautions & Warnings
- Discontinue if thrombosis or thromboembolism occurs
- Consider discontinuing if allergic reactions occur
- Monitor pre-diabetic and diabetic women receiving Hydrogest
- Monitor women with conditions affected by fluid retention
- Monitor women with a history of clinical depression; discontinue Hydrogest if depression recurs
- Carefully monitor women who develop jaundice while receiving Hydrogest
- Carefully monitor women who develop hypertension while receiving Hydrogest
Use in Special Populations
- Pediatric Use: Not indicated for use in pediatric patients. Safety and efficacy not established in pediatric patients <16 years of age
- Geriatric Use: Not evaluated in women >65 years of age. Not intended for use in postmenopausal women. Safety and efficacy not established in postmenopausal women
- Hepatic Impairment: Contraindicated in patients with liver tumors or active liver disease
- Renal Impairment: Effect of renal impairment on pharmacokinetics not evaluated
Overdose Effects
No adverse events associated with overdosage
Therapeutic Class
Hormone preparations for other uses
Storage Conditions
Store at controlled room temperature between 15°C to 30°C. Protect from light. Keep out of the reach of children