Hystrogest

Uncategorized

Indications:

Oral

Treatment of secondary amenorrhea . dysmenorrhea , menorrhagia & other menstrual irregularities due to dysovulation

Management of pre-menstrual syndrome (PMS)

Dysfunctional uterine bleeding.

Breast pain (post-partum) or benign breast disorders

Prevention of estrogen induced endometrial hyperplasia in menopausal women receiving estrogen hormone replacement therapy (HRT

Vaginal

To assist pregnancy as in case of repeated and threatened abortion

Invitro fertilization (IVF)

Primary or secondary sterility

As an alternative to the oral route in case of oral intolerability of the drug

Description

Properties S.G Capsule for oral and vaginal use contains progesterone , the natural female hormone :

It compensates for progesterone deficiency when endogenous progesterone secretion is absent or reduced as in case of menstrual irregularities associated with dysovulation, pre menstrual syndrome (PMS) and dysfunctional uterine bleeding

Hystrogest is Clinically effective the management of irregular menstrual cycles , secondary amenorrhea , dysmenorrhea , menorrhagia & premenstrual syndrome

Hystrogest is also used with estrogen as hormone replacement therapy (HRT) in menopausal women to reduce the increased risk of estrogen – induced endometrial hyperplasia

Hystrogest is highly beneficial in assisting pregnancy in cases of habitual or threatened abortion & during in vitro fertilization (IVF) the presence of progesterone is micronized form with high bioavailability  makes Hystrogest S.G Capsule highly efficient (Oral & Vaginal) dosage forms compared to progesterone injectable preparations with excellent patient compliance

 

Indications:

Oral

Treatment of secondary amenorrhea . dysmenorrhea , menorrhagia & other menstrual irregularities due to dysovulation

Management of pre-menstrual syndrome (PMS)

Dysfunctional uterine bleeding.

Breast pain (post-partum) or benign breast disorders

Prevention of estrogen induced endometrial hyperplasia in menopausal women receiving estrogen hormone replacement therapy (HRT

Vaginal

To assist pregnancy as in case of repeated and threatened abortion

Invitro fertilization (IVF)

Primary or secondary sterility

As an alternative to the oral route in case of oral intolerability of the drug

Dosage oral :

Treatment of progesterone insufficiency (secondary amenorrhea , menorrhagia , dysmenorrhea and dysfunctional uterine bleeding ) premenstrual syndrome (PMS) , and other menstrual irregularities due to dysovulation :

1-2 caps ( 200-400mg) daily for 10 days or as prescribed by the physician

Prevention of endometrial hyperplasia :

1 capsule (200mg) daily taken as one capsule at bedtime for 14 days sequentially with estrogen as hormone replacement therapy (HRT) per 28days

 

Vaginal :

To prevent habitual or repeated abortion :

1 capsule from day 14 of the cycle to day 25 of the cycle , from day 26 of the cycle , and if pregnancy occurs , the dose can be increased to the maximum of 3 capsules (600mg) divided to 3 equal doses daily until day 60, and the treatment can be continued till the end of the 12th week of pregnancy (1st trimester)

In Threatened Abortion :

1-2cap(200-400mg) daily in 1-2 equal doses until the end of the 12th week of pregnancy (1st trimester)

To assent the luteal phase during in vitro fertilization (IVF CYCLES) :

2-3 caps (400-600mg) daily in 2-3 divided doses daily starting from the day of injection of HCG (human chorionic gonadotrophin) hormone until the end of 12th week of pregnancy

To assist the luteal phase in hypo-fertility , primary or secondary sterility:

1-2caps (200-400mg) in 2 divided doses , daily 10 days starting on the day 17 of the cycle, when no menstruation occurs or pregnancy is diagnosed , treatment should be restarted rapidly and continued until the end of the 12th week of pregnancy (1st trimester)

 

Contraindications:

Hypersensitivity to progesterone, undiagnosed vaginal bleeding , missed or incomplete abortion , breast malignancies or tumors (known or suspected )and liver dysfunction.

Precautions:

Use Cautiously in patients with cardiovascular or renal impairment , diabetes mellitus , asthma , epilepsy & migraine or other conditions which may be aggravated by fluid retention , progesterone should aslo be used with care in women with history of depression and those susceptible to thromboembolism.

Side Effect:

Safe and well tolerated GIT disturbance , change in appetite or weight (oral) , fluid retention , melasma , articaria , fatigue ,drowsiness or mental depression and alteration in serum lipid profile may occur .

when somnolence or vertigo occurs with oral administration it is advisable to minimize the oral dose to 200mg daily to be taken at bedtime or the drug should be given by the vaginal route .

Pregnancy and lactation:

Reported studies have not relied out the possibility of harm ; therefore , progesterone -containing preparations should be used during the 1st trimester of pregnancy under medical supervision .

No reports indicate any adverse effect on suckling infants due to the use of progesterone-containing preparations during lactation.

Drug Interactions:

Progesterone metabolism may be enhanced by liver enzyme inducing drugs, such as carbamazebine , griseofulvin, phenobarbital, phyenytoin & rifampicin.

progesterone bioavailability may be increased by inhibitors of cytochrome p450 3A4, ketoconzole

Interference With Laboratory Test:

progesterone may increase glucose level , liver function test values and clotting factors 7,8,9&10 , it may decrease pregnanediol excretion and alter thyroid function test results.

Overdose & Treatment (only by oral route)

Accidental ingestion of high doeses of progesterone may result in sever GIT disturbances , including nausea , vomiting , abdominal pain & uterine cramps ,treatment is supportive and symptomatic and involves gastric lavage.

Packing :

Box containing 2 blisters (PVC/Alu) each of 15 soft Gelatin Capsules and inner leaflet.

Storage:

Keep at temperature not exceeding 30 celsius in dry place keep our of the reach of children .

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