Caprogen Injection
Hydroxyprogesterone Caproate
250 mg/ml
Nuvista Pharma Ltd
| Pack size | |
|---|---|
| Unite Price | 350.00 BDT |
Indications
Caprogen Injection is used for:
Preterm Labor, Recurrent miscarriage, Amenorrhoea, Abnormal uterine bleeding, Palliative treatment of advanced, inoperable endometrial carcinoma
Adult Dose
Intramuscular
Preterm Labor
Indicated for prevention of preterm labor in a singleton pregnancy for patients aged 16 years or older who have a history of spontaneous preterm birth
250 mg IM qWeek
Initiate between the 16th and 20th week of gestation and ending at the 37th week of gestation or birth (whichever is first)
Recurrent miscarriage
Adult: 250-500 mg wkly during the 1st half of pregnancy.
Amenorrhoea; Abnormal uterine bleeding
Adult: Single dose of 375 mg; may repeat at 4-wkly intervals if needed. After 4 days of desquamation, or if there is no bleeding within 21 days after admin of the drug, may initiate cyclic therapy that includes an oestrogen. For cyclic treatment (28-day cycle): Administer 20 mg of estradiol valerate on day 1, and on day 15, administer 250 mg of hydroxyprogesterone caproate and 5 mg of estradiol valerate. May repeat cyclic therapy at 4-wkly intervals as needed.
Palliative treatment of advanced, inoperable endometrial carcinoma
Adult: Usual dose: >1 g, may repeat once or more times wkly. Usual range: 1-7 g/wk. Discontinue treatment if relapse occurs or if the objective response is not achieved after 12 wk of treatment.
Hepatic Impairment
Not studied; product is extensively metabolized in liver; potential for reduce elimination
Child Dose
Safety and efficacy not established
Renal Dose
Not studied in patients with renal impairment
Administration
IM Administration
Inject IM over 1 minute in upper outer quadrant of the gluteus maximus
Inject IM over 1 minute in upper outer quadrant of the gluteus maximus The solution if viscous and oilyThe solution if viscous and oily
1-mL vial does not contain preservatives and is for single dose use
Once opened, the 5-mL multidose vial must be used within 5 weeks
Contra Indications
Undiagnosed vaginal bleeding, breast cancer, pregnancy, lactation. Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or a history of these conditions. Markedly impaired liver function.
Precautions
Physical examination is advised prior to starting therapy. Hepatic impairment, mental depression. Monitor blood glucose in diabetic patients. Discontinue treatment upon signs of thromboembolic and thrombotic disorders. Discontinue treatment if unexplained, sudden or gradual, partial or complete loss of vision, protopsis, diplopia or papilledema, retinal vascular lesions or migraine occur. Caution when used in patients with conditions that might be worsened by fluid retention (e.g. asthma, seizure disorders, migraine, cardiac or renal dysfunction).
Pregnancy-Lactation
Pregnancy
Indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show a difference in adverse developmental outcomes between children of progesterone caproate-treated women and children of control subjects
However, these data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the treated women received the drug during the first trimester of pregnancy
Animal data
In animal reproduction studies, IM administration to pregnant rats during gestation at doses 5 times the human dose equivalent based on a 60-kg human was not associated with adverse developmental outcomes
Lactation
Not indicated during time period when breastfeeding would occur
Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate
Published studies have reported no adverse effects of progestins on the breastfed child or on milk production
Interactions
Increased clearance when used with enzyme inducers e.g. carbamazepine and phenytoin. May inhibit metabolism of ciclosporin.
Side Effects
Side effects of Hydroxyprogesterone Caproate :
Mode of Action
Hydroxyprogesterone caproate stimulates luteal actions, changes in uterus and vagina as seen in early pregnancy. It also has prolonged uterotrophic effect. Contractile response of the myometrium to oxytocin is inhibited.
Note
Caprogen 250 mg/ml Injection generic name is Hydroxyprogesterone Caproate. Caprogen 250 mg/ml Injection is manufactured by Nuvista Pharma LtdCaprogen is availble in all over Bangladesh.
Mes BD drug index information on Caprogen Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.