COMPOSITION

Each Soft Gelatin Capsule contains :

GESTMATE 200

Natural Micronised Progesterone...... 200mg

GESTMATE 100

Natural Micronised Progesterone...... 100mg


DESCRIPTION

Gestmate contains Natural Micronised Progesterone, which has actions similar to the native progesterone. Luteal phase defect (LPD) is a condition characterized by inadequate secretion or action of progesterone during the menstrual cycle. Typically, LPD is diagnosed when there is a lag of more than two days in the development of the endometrium (the lining of the uterus, where an egg implants). It is known to affect about 3 - 4% of infertile women, and up to 5% in women with a history of recurrent, spontaneous abortions. However, LPD can be found in up to 30% of isolated cycles of normal women. Using natural micronized progesterone therapy for managing LPD yields success rate of approximately 50%.
 
CLINICAL PHARMACOLOGY
Gestmate is widely used in the treatment of conditions such as threatened abortions, habitual abortions, female infertility and Luteal Phase Dysfunction & as a luteal phase support in ART procedures.

Prepared by the micronization Process, micronized progesterone (Gestmate) enhances the absorption profile of progesterone and enables rapid dissolution. Further, soya lecithin oil, the excipient used for suspension of progesterone, also increases the absorption and exhibits better efficacy.
 
INDICATIONS AND USAGE

     Threatened abortion OR prevention of habitual abortions due to Luteal insufficiency.
     Female infertility due to Luteal insufficiency.
     Luteal phase support in ART procedures.

CONTRAINDICATIONS

    Oral route contraindicated, in case of severe hepatic dysfunction.
    Allergy (hypersensitivity) to progesterone, progesterone-like drugs, or any of the inactive                   ingredients in the capsules.
    Suspected cases of pregnancy and nursing mothers.
    Unexplained vaginal bleeding.
    Recent case of miscarriage

PRECAUTIONS

    The use of Gestmate should be restricted to the cases of Corpus Luteal Deficiency only.
    Gestmate is not known to be teratogenic; however, it should be given only till the 1st trimester of pregnancy, either by vaginal route OR, by oral route.
    Gestmate administered in the 2nd & 3rd trimester of pregnancy can lead to development of cholestatic jaundice of pregnancy, OR hepatocellular liver disease.
    Gestmate is not a treatment for threatening premature labor.

ADVERSE REACTIONS
Although, generally well tolerated, following effects may occur with oral route like Somnolence & Dizziness. The daily dose should be reduced / rescheduled
Intermittent bleeding / Shortening of the cycle: Treatment should be started late in the cycle, i.e. Start treatment on the 19th instead of the 17th day.
 
DOSAGE AND ADMINISTRATION

    Threatened abortion or prevention of habitual abortions due to Luteal insufficiency: Daily dose of 200 - 400 mg in two divided doses, until the 12th week of pregnancy
    Female infertility due to Luteal insufficiency: Daily dose of 200 - 300 mg in two divided doses, from 17th - 26th day. If pregnancy occurs, continue the treatment till week 12.