PROLUTON DEPOT 1 INJ 250MG/ML

국가: 인도

언어: 영어

출처: Central Drugs Standard Control Organization

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제품 특성 요약 제품 특성 요약 (SPC)
04-05-2024

유효 성분:

Hydroxyprogesterone Caproate

제공처:

Zydus (G.Rem)

ATC 코드:

G03DA03

복용량:

250MG/ML

약제 형태:

INJ

구성:

1

패키지 단위:

250 mg x 1 mL x 1ml

치료 그룹:

Oestrogens & Progesterones & Related Synthetic Drugs

치료 영역:

hydroxyprogesterone

치료 징후:

Habitual abortion, Imminent abortion, Infertility due to corpus luteum insufficiency, Primary & secondary amenorrhea

제품 특성 요약

                                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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