PROGEST Capsules Composition:
Each PROGEST S.G.Cap contains:
Progesterone (micronized) 100 mg
PROGEST Capsules Properties :
progest s.g Caps (for oral and vaginal use) contain progesterone. the natural female hormone with both progestational action and antiestrogenic effect. PROGEST
compensates for progesterone deficiency when endogenous progesterone secretion is absent or reduced as in cases of menstrual irregularities associated with dysovulation pre menstrual syndrome PMS and dysfunctional uterine bleeding progest is clinicly effective in the managment of irregular menstrual cycles secondary amenorrhea, dysmenorrhea, menorrhagia and premenstrual tension progest is also used with an estrogen as hormone replacement therapy HRT in menopausal women to reduce the increased risk of estrogen-induced endometrial hyperplasia. PROGEST is highly beneficial in assisting pregnancy in cases of
habitual or threatened abortion and during in vitro fertilization (IVF) cycles. The presence of progesterone in micronized form with high bioavailabilily makes PROGEST S.G.Caps highly efficient (oral and vaginal) dosage forms alternative to progesterone injectable preparations with excellent patient compliance.
PROGEST Capsules Pharmacokinetics:
Following administration of progest s.g caps orally or vaginally progesterone is rapidly absorbed from the site of administration peak plasma concentrations are achieved within 1-3 hours following oral administration and 2-6 hours following vaginal application the drug is 96-99% bound to plasma proteins and is extensively metabolized in the Iiver and gut into conjugated metabolites that are excreted mainly in urine. Progesterone crosses the placenta and trace amounts appear in breast milk.
PROGEST Capsules Indication. :
Oral:
– Treatment of secondary amenorrhea. dysmenorrhea, menorrhagia and 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 eslrogen-induced endometrial hyperplasia in menopausal women receiving estrogen Hormone Replacement Therapy (HRT).
PROGEST Capsules vaginal :
to help pregnancy as in cases of :
– Repeated abortion and threatened abortion.
– In vitro fertilization (lVF) cycles.
– Hypolerlility or primary or secondary sterility.
– As an alternative to the oral route in case of oral intolerability of the drug.
PROGEST Capsules Dosage:
Oral :
– Treatment of progesterone insufflciency (secondary ameoorrhea, dysmenorrhea, menorrhagia, dysfunctional uterine bleeding), premenstrual syndrome (PMS), and
other menstrual irregularities due to dysovulation 2-3 capsules(200 mg – 300 mg), daily, taken as one capsule (100 mg) in the morning and 1-2 capsules (100 mg)
– Prevention of endometrial hyperplasia: 2 capsules (200 mg) daily, taken as one capsule (100 mg) in the morning and one capsule (100 mg) at bedtime or 2 capsules
200 mg daily, taken once at bedtime for 14 days, sequentially with estrogen as Hormone Replacement Therapy (HRD per 28 day cycle).
– To preventhabituat or repeated abortion: one capsule (100 mg) on day 13 and 14 of the cycle, then 2 capsules (200 mg) in single or 2 divided doses daily from day 15
to day 25 of the cycle. From day 26 of the cycle, and if pregnancy occurs, the dose can be increased to a maximum of 6 capsules (600 mill divided in 3 equal doses daily until day 60, and treatment can be continued at the end of the 12th week of pregnancy (first trimester).
– ln threatened abortion: 2-4 capsules (200 mg – 400 mg) daily, in two divided doses until the end of the 12th week of pregnancy (first trimester).
– To assist luteal phase in hypofertility or primary or secondary sterility: 2 – 3 capsules (200 mg – 300 mg) in two divided doses, daily for 10 days starting on 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 (first trimester).
PROGEST Capsules Contraindications:
Hypersensitivity to progesterone, undiagnosed vaginal bleeding, missed or incomplete abortion, breast malignancies.
Precaution:
use cautiously in patients with cardiovascular or renal impairment, diabetes mellitus, asthma, epilepsy and migraine or other conditions which may be aggravated by fluid retention progesterone should also be used with care in women with history of depression and those susceptible to thromboembolism
PROGEST Capsules Side effects :
progest s.g CaPS are safe and well-tolerated. GI disturbances, changes in appetite or weight (oral), fluid retention, melasma, ulticaria, fatigue, drowsiness or mental depression and alteration in lipid profile may occur. When some intolerance or vertigo occurs with oral administration, it is advisable to minimize the oral dose to 200 mg daily.
Packing:
abox containing 24 progest s.g caps
Storage :
keep at temperature 15-30 c away from moisture
keep out of the reach of children
Produced by :
pharco pharmaceuticals