CLOMID TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CLOMIPHENE CITRATE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CLOMIPHENE CITRATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Zentiva k.s.

Ciri produk

CLOMID ® 50MG TABLET
1. NAME OF THE MEDICINAL PRODUCT
Clomid 50mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clomifene Citrate 50mg
3 PHARMACEUTICAL FORM
Tablet.
Flat face bevel edged tablet (beige) with M logo scored line.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Clomid 50mg Tablet is indicated for the treatment of ovulatory failure. Clomid 50mg Tablet is indicated
only for patients in whom ovulatory dysfunction is demonstrated, who meet the conditions described in
this prescribing information and for whom clomifene is not contraindicated. Other causes of infertility
must be excluded or adequately treated before giving Clomid 50mg Tablet.
4.2 Posology and method of administration
Route of Administration
Oral
Adults Only:
The recommended dose for the first course of Clomid 50mg Tablet is 50mg (1 tablet) daily for 5 days.
Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-
induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of
50mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at
this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100mg daily
(two 50mg tablets given as a single daily dose) for 5 days should be given. This course may be started as
early as 30 days after the previous one. Increase of the dosage or duration of therapy beyond 100mg/day
for 5 days should not be undertaken.
The majority of patients who are going to respond will respond to the first course of therapy, and 3
courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the
diagnosis should be reevaluated. Treatment beyond this is not recommended in the patient who does not
exhibit evidence of ovulation.
Long-term cyclic therapy.
Not recommended.
The relative safety of long-term cyclic therapy has not