Provera

Provera

medroxyprogesterone

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Medroxyprogesterone acetate
Indications/Uses
10 mg: Secondary amenorrhea, dysfunctional uterine bleeding due to hormonal imbalance in the absence of organic pathology eg, fibroids/uterine cancer, endometriosis. 100 mg: Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women. Adjunctive &/or palliative treatment of recurrent &/or metastatic endometrial or renal carcinoma.
Dosage/Direction for Use
10 mg Secondary amenorrhea 2.5-10 mg daily for 5-10 days. Dysfunctional uterine bleeding due to hormonal imbalance in the absence of organic pathology 2.5-10 mg daily for 5-10 days starting on the 16th or 21st day of cycle. Given for 2 consecutive cycles & then discontinued. Dysfunctional uterine bleeding (inducing optimum secretory endometrium transformation that is primed w/ estrogen therapy) 5-10 mg daily for 10 days starting on the 16th. Endometriosis 10 mg 3 times daily for 90 days on the 1st day of cycle. 100 mg Recurrent endometrial & renal cancer 200 mg-400 mg daily. Recurrent breast cancer in postmenopausal women 400-800 mg daily.
Administration
May be taken with or without food: May be taken w/ meals to increase absorption. 
Contraindications
Hypersensitivity. Undiagnosed vag bleeding; liver dysfunction or active liver disease; current or history of thrombophlebitis, thromboembolic disorders or cerebral apoplexy. Known or suspected pregnancy. 10 mg: Patients w/ breast carcinoma (estrogen-dependent); missed abortion. Known or suspected malignancy of the breast. 100 mg: Undiagnosed urinary tract bleeding, breast pathology.
Special Precautions
Not to be used in prevention of CV disease or dementia. Increased risks of MI, stroke, invasive breast cancer, pulmonary emboli & DVT in postmenopausal women (50-79 yr). Increased risk of developing probable dementia & mild cognitive impairment in postmenopausal women ≥65 yr. Not recommended in patients w/ history of venous thromboembolism. Discontinue treatment in cases of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, & retinal thrombosis); patients who develops venous thromboembolism. May cause wt gain, fluid retention. Discontinue medication in sudden partial or complete loss of vision or sudden onset of proptosis, diplopia or migraine, exam reveals papilledema or retinal vascular lesions. Carefully observe patients w/ diabetes, history of treatment for mental depresion, epilepsy, migraine, asthma, cardiac or renal dysfunction. Adequate diagnostic measures in case of undiagnosed vag bleeding. If endometrial or endocervical tissue is submitted for exam inform the pathologist. Gonadotropin levels, plasma progesterone levels, urinary pregnanediol levels, plasma testosterone levels (in male), plasma estrogen levels (in female), plasma cortisol levels, glucose tolerance test, metyrapone test & sex-hormone-binding-globulin test may be affected w/ use of Provera. Concomitant use w/ aminoglutethimide may significantly depress bioavailability. May produce cushingoid symptoms; exhibit suppressed adrenal function & decrease ACTH & hydrocortisone blood levels. May cause partial adrenal insufficiency during metyrapone testing. May mask the onset of the climacteric. Before initiating treatment carefully evaluate the status of the patient; medical & family history & check for negative pregnancy test. Pretreatment physical exam should include breast & pelvic organs as well as papanicolaou smear. Not recommended during the 1st 4 mth of pregnancy. Lactation. 10 mg: Exclude presence of genital or breast neoplasia before initiating the treatment. 100 mg: Treatment of breast carcinoma may cause hypercalcaemia. Occasional uterine bleeding in patients w/ high dose therapy. Observe closely patients receiving large doses continuously & for long period.
Adverse Reactions
Insomnia; headache, nausea, dizziness; fatigue. 10 mg: Dysfunctional uterine bleeding (irregular, increase, decrease, spotting). Hypersensitivity; depression, nervousness; alopecia, acne, urticaria, pruritus; cervical discharge, breast pain & tenderness; pyrexia; increased wt. 100 mg: Wt fluctuation, increased appetite; tremors; vomiting, constipation; hyperhidrosis; erectile dysfunction; oedema/fluid retention.
Drug Interactions
Decreased efficacy w/ aminoglutethimide. 10 mg: CYP3A4 inducers &/or inhibitors may affect metabolism.
ATC Classification
L02AB02 - medroxyprogesterone ; Belongs to the class of progestogens.
Presentation/Packing
Form
Provera tab 100 mg
Packing/Price
10 × 10's (Rp1,583,656/boks)
Form
Provera tab 10 mg
Packing/Price
3 × 10's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in