Provera

Provera

medroxyprogesterone

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Medroxyprogesterone acetate
Indications/Uses
Endometriosis. Menopausal vasomotor symptoms. Treatment & diagnosis of secondary amenorrhea. Dysfunctional (anovulatory) uterine bleeding from abnormal levels of hormones w/ no uterus pathology eg, myoma uteri, uterine cancer. Opposition of endometrial effects of estrogen in menopausal women being treated w/ estrogen [hormone therapy (HT)].
Dosage/Direction for Use
Endometriosis 10 mg tid for 90 consecutive days, starting on 1st day of menstrual cycle. Menopausal vasomotor symptoms 10-20 mg once daily given continuously. Secondary amenorrhea Treatment: 2.5-10 mg once daily for 5-10 days, for 3 consecutive cycles. Diagnosis: 2.5-10 mg once daily for 5-10 days. Dysfunctional (anovulatory) uterine bleeding 2.5-10 mg once daily for 5-10 days for 2-3 cycles & then discontinue if dysfunction has regressed. Opposition of endometrial effects of estrogen in menopausal women being treated with estrogen HT Women taking 0.625 mg of conjugated estrogen or an equiv daily dose of another estrogen Continuous regimen: 2.5-5 mg once daily. Sequential regimen: 5-10 mg once daily for 10-14 consecutive days of 28-day or mthly cycle.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known or suspected breast malignancy. Undiagnosed vag bleeding. Severe liver dysfunction. Known or suspected pregnancy.
Special Precautions
Discontinue in patients who develop VTE while undergoing therapy. Not recommended in patient w/ history of VTE. Not to be re-administered if sudden partial or complete loss of vision, proptosis, diplopia, or migraine occur, & exam reveals papilledema or retinal vascular lesions. Investigate unexpected vag bleeding during therapy. Patients w/ pre-existing medical condition that might be adversely affected by fluid retention. Carefully monitor patients w/ history of treatment for clinical depression, epilepsy, asthma, migraine, cardiac or renal impairment; diabetics. Increased risk of breast cancer; CV events eg, MI, CHD, stroke, VTE & pulmonary embolism; CV morbidity in the 1st yr of use & CHD events; ovarian cancer in women using for ≥5 yr; probable dementia in post-menopausal women ≥65 yr. May decrease the levels of endocrine biomarkers eg, plasma/urinary steroids (eg, cortisol, estrogen, pregnanediol, progesterone, testosterone), plasma/urinary gonadotrophins (eg, LH & FSH), sex-hormone-binding-globulin. Complete medical & family history should be taken prior to initiation of hormone therapy. Pre-treatment & periodic physical exam eg, BP, breasts, abdomen, & pelvic organs, including cervical cytology. Evaluate bone mineral density in long-term treatment, & ensure adequate Ca & vit D intake. Other doses of oral conjugated estrogens w/ medroxyprogesterone acetate & other combination & dosage forms of HT. Contraindicated in pregnancy. Lactation. Not recommended in women ≥65 yr in preventing dementia.
Adverse Reactions
Headache; nausea; dysfunctional uterine bleeding (irregular, increase, decrease, spotting). Drug hypersensitivity; depression, insomnia, nervousness; dizziness; alopecia, acne, urticaria, pruritus; cervical discharge, breast pain & tenderness; pyrexia, fatigue; increased wt.
Drug Interactions
May decrease serum conc & efficacy w/ aminogluthetimide.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA02 - medroxyprogesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Provera tab 10 mg
Packing/Price
100's
Form
Provera tab 5 mg
Packing/Price
100's
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