Proluton Depot 500 AMP
Hydroxyprogesterone Caproate
500mg
Zydus Pharmaceuticals
Pack size | 1ml |
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Available as:
Indications
Proluton Depot 500 AMP is used for:
Preterm Labor, Amenorrhoea; Abnormal uterine bleeding
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)
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.
Child Dose
Renal Dose
Administration
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
Interactions
Increased clearance when used with enzyme inducers e.g. carbamazepine and phenytoin. May inhibit metabolism of ciclosporin.
Adverse Effects
Side effects of Hydroxyprogesterone Caproate :
>10%
Injection site pain (34.8%),Injection site swelling (17.1%),Urticaria (12.3%)
1-10%
Pruritus (7.7%),Injection site pruritus (5.8%),Nausea (5.8%),Injection site nodule (4.5%),Diarrhea (2.3%)
Frequency Not Defined
Thromboembolic events,Angioedema,Depression,Decreased glucose tolerance,Fluid retention,Jaundice,Hypertension,Vaginal bleeding
Mechanism 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
Proluton Depot 500 500mg AMP manufactured by Zydus Pharmaceuticals. Its generic name is Hydroxyprogesterone Caproate. Proluton Depot 500 is availble in Nepal.
Farmaco Nepal drug index information on Proluton Depot 500 AMP is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.