PROLUTON DEPOT 1 INJ 250MG/ML
Country: India
Language: English
Source: Central Drugs Standard Control Organization
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
Hydroxyprogesterone Caproate
Available from:
Zydus (G.Rem)
ATC code:
G03DA03
Dosage:
250MG/ML
Pharmaceutical form:
INJ
Composition:
1
Units in package:
250 mg x 1 mL x 1ml
Therapeutic group:
Oestrogens & Progesterones & Related Synthetic Drugs
Therapeutic area:
hydroxyprogesterone
Therapeutic indications:
Habitual abortion, Imminent abortion, Infertility due to corpus luteum insufficiency, Primary & secondary amenorrhea
Summary of Product characteristics
PROLUTON DEPOT 1 INJ 250MG/ML
PROLUTON DEPOT 1 INJ 500MG/2ML
INDICATION & DOSAGE
_Intramuscular
_Recurrent miscarriage
_Adult: _250-500 mg wkly during the 1st half of pregnancy.
_Intramuscular
_Amenorrhoea
_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.
_Intramuscular
_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.
_Intramuscular
_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.
CONTRAINDICATIONS
Undiagnosed vaginal bleeding, breast cancer, pregnancy,
lactation. Thrombophlebitis, thromboembolic
disorders, cerebral apoplexy or a history of these conditions.
Markedly impaired liver function.
SPECIAL PRECAUTIONS
Physical examination is advised prior to starting therapy.
Hepatic impairment, mental depression.
Monitor blood glucose in diabetic patients.
Discontinue treatment upon signs of throm
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