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Prothyra

12:00
Prothyra®
Tablets

COMPOSITION
Each tablet Prothyra® 5 mg contains:
Medroxyprogesterone Acetate .................................. 5 mg

Each tablet Prothyra® 10 mg contains:
Medroxyprogesterone Acetate .................................. 10 mg

DESCRIPTION
Medroxyprogesterone acetate, a derivative of progesteron, is pregn-4-ene-3,20-dione, 17 (acetyloxy)-6-methyl-,(6 alpha)-.
Medroxyprogesterone acetate is a white to off-white, odourless, crystalline powder, stable in air and has a melting point between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether and insoluble in water.

ACTIONS
Pharmacology : Medroxyprogesterone acetate, administered orally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. It is a progestational agent devoid of estrogenic activity. Minimal androgenic and anabolic effects may occur. While parenterally administered medroxyprogesterone acetate inhibits gonadotropin production, which in tum prevents follicular maturation and ovulation, available data indicate that this does not occur when the usual recommended oral dosage is given as a single daily dose.

INDICATIONS
Secondary amenorrhea and dysfunctional uterine bleeding due to hormonal imbalance in the absence of organic pathology, eg fibroids or uterine cancer and endometriosis.

DOSAGE AND ADMINISTRATION 
Secondary Amenorrhea: 5 - 10 mg daily for 5 - 10 days.
Dysfunctional Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology: 5 - 10 mg daily for 5 - 10 days, starting on the 16th or 21st  day of the cycle. Treatment is given for 2 consecutive cycles and then discontinued to see if the dysfunction has regressed. Withdrawal bleeding usually occurs within 3 - 7 days after discontinuing therapy.
Note: For inducing an optimum secretory transformation of an endometrium that has been adequately primed with estrogen therapy, 5-10 mg daily for 10 days starting on the 16th for functional uterine bleeding.
Endometriosis: 10 mg, 3 times a day for 90 days beginning on cycle day.
Breakthrough bleeding, which is self-limited, may occur in 30 - 40% of patients treated. No additional hormonal therapy is recommended for the management of this breakthrough bleeding.

CONTRAINDICATIONS
Patients with carcinoma of the breast or reproductive organs (known or suspected to be oestrogen-dependent); liver diseases or dysfunction; missed abortion; pregnancy, either in diagnosis or therapy (see Warnings); thrombophlebitis, thromboembolic disorders or cerebral apoplexy, or patients with a past history of these conditions; undiagnosed vaginal bleeding; known sensitivity to Prothyra® tablet; undiagnosed urinary tract bleeding: and undiagnosed breast pathology.

WARNINGS
Before using Prothyra®, the status of the patient should be carefully evaluated. This evaluation should exclude the presence of genital or breast neoplasia before considering the use of Prothyra®. Prothyra®, especially in high doses used for cancer therapy, may cause weight gain and fluid retention. Caution should be exercised in treating patients with pre-existing medical condition that might be adversely affected by weight gain or fluid retention.
The high doses of Prothyra® used in the treatment of cancer patients may, in some cases, produce Cushingoid symptoms, e.g. moon faces, fluid retention, glucose intolerance and blood pressure elevation.
In the treatment of carcinoma of breast occasionally cases of hypercalcaemia have been reported. Any patient who develops an acute impairment of vision, proptosis, diplopia or migraine headache should be carefully evaluated opthalmologically to exclude the presence of papilloedema or retinal vascular lesions before continuing medication. Some patients receiving Prothyra® may exhibit a decreased glucose tolerance. The mechanism for this is not known. This fact should be borne in mind when treating all patients and especially known diabetics.
A negative pregnancy test should be demonstrated before starting therapy with Prothyra®. Discontinue medication if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilloedema or retinal vascular lesions, medication should be withdrawn.
The age of the patient constitutes no absolute limiting factors although treatment with Prothyra® may mask the onset on the climacteric.

Use In pregnancy & lactation:
Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk but there is no evidence to suggest that this presents any hazard to the child as the effect of this on nursing infant has not been determined.
The administration of large doses to pregnant women has resulted in the observation of some instances of female foetal masculinisation. Doctors should therefore check that patients are not pregnant before commencing treatment.

PRECAUTIONS
Patients with a history of treatment for mental depression should be carefully monitored while receiving Prothyra® therapy. Some patients may complain of pre-menstrual like depression while on Prothyra® therapy.
Pathologists should be informed of the patients ingestion of Prothyra® if endometrial or endocervical tissue is submitted for examination.
Caution should be exercised in treating patients with epilepsy, asthma, cardiac renal dysfunction. The following laboratory tests may be affected by the use of Prothyra®:
Gonadotropin levels, plasma progesterone levels, urinary pregnanediol levels, plasma testosterone levels (in the male), plasma estrogen levels (in the female), plasma cortisol levels, glucose tolerance test and motyrapone test.
A decrease in glucose tolerance has been observed in some patients on progesterones. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy. Before using Prothyra®, the general medical condition of the patient should be carefully evaluated.
Prothyra® should be used under the supervision of a specialist and the patients kept under regular surveillance. Occasional uterine bleeding may occur in patients treated with high dose therapy. Animal studies show that Prothyra® possesses adrenocorticoid activity. This has also been reported in man; therefore, patients receiving large doses continuously and for long periods should be observed closely.
Treatment with progesterone in the premenopausal patient may mask the onset of the climacteric.

ADVERSE REACTIONS
The following events listed in order of seriousness rather than frequency of occurrence, have been occasionally associated with the use of progestogens:
Anaphylaxis and anaphylactoid like reactions.
Thromboembolic disorders: Thrombophlebitis, and pulmonary embolism.
Central Nervous System: Nervousness, insomnia, somnolence, fatigue, depression, dizziness, headache and tremor.
Skin and Mucous Membranes: Urticaria, pruritus, rash, acne, hirsutism and alopecia.
Gastrointestinal: Nausea
Breast : Tenderness and galactorrhea.
Miscellaneous: Pyrexia, change in weight and moon faces.
Break through bleeding, spotting, change in menstrual flow, amenorrhea, edema, change in weight (increase or decrease), change in cervical erosion and cervical secretions, cholestatic jaundice.

INTERACTIONS
Aminoglutethimide administered concomitantly with Prothyra® may significantly depress the bioavailability of Prothyra®.

HOW SUPPLIED
Box, 3 blister @ 10 tablets, 5 mg Reg. No.: DKL0431806910B1
Box, 3 blister @ 10 tablets, 10 mg Reg. No.: DKL0131806910A1

STORAGE
Store at room temperature, 25°C - 30°C.

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Manufactured by :
PT SUNTHI SEPURI
Tangerang, Indonesia

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