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DB-10

DB-10

medroxyprogesterone

Manufacturer:

Unicure

Distributor:

Option One

Marketer:

Evexia
Full Prescribing Info
Contents
Medroxyprogesterone acetate.
Description
Each uncoated tablet contains: Medroxyprogesterone Acetate 10 mg.
Indications/Uses
For the treatment of menorrhagia and secondary amenorrhoea and mild to moderate endometriosis. And may also be used in the palliative treatment of some hormone-dependent malignant neoplasms.
Dosage/Direction for Use
The usual dose of medroxyprogesterone tablets is 5mg/10 mg daily. Secondary amenorrhoea is treated for 5 to 10 days. Uterine bleeding is treated for 5 to 10 days beginning on day 16 or 21 of the menstrual cycle. Endometrial hyperplasia is treated for 12 to 14 consecutive days beginning on the day 1 or 16 of the menstrual cycle.
Contraindications
Use with caution in: Decreased kidney function; epilepsy; asthma; women who suffer from migraines; heart blood pressure; women with a history or risk of blood vessels (thromboembolism, eg deep vein thrombosis or pulmonary embolism); diabetes; women with a history of depression.
Not to be used in: Decreased liver function; liver disease; severe disease of the arteries, eg that has caused angina or a heart attack; cancer of the breast or reproductive organs; abnormal vaginal bleeding of unknown cause; pregnancy; rare heredity blood disorder called porphyrias.
This medicine should not be used if patient is allergic to one or any of its ingredients. Please inform the doctor or pharmacist if the patient has previously experienced such allergy. If the patient has experienced an allergic reaction, stop using the medicine and inform the doctor or pharmacist immediately.
Special Precautions
Before the patient takes this medication, tell the doctor the patient's medical history (and family history), including: high blood pressure, seizures, migraine headaches, diabetes, asthma, heart disease or blood vessel problems, (e.g., stroke, heart attack), liver or kidney disease, blood clots, history of cancer, high blood level of cholesterol or fats, depression, excessive weight gain or fluids retention during menstrual cycle, jaundice (yellowing of skin or eyes). Because this drug can interfere with laboratory test, tell the doctors and laboratory personnel that the patients takes medroxyprogesterone. Due to the risk of fetal harm, this medication must not be used during pregnancy (especially during the first four months of pregnancy). If the patient become pregnant or possibly be pregnant, inform the doctor immediately. This drug passes into breast milk. Though there have been no reports (to date) of problems in nursing infants, breast-feeding while using very high doses of this medication is not recommended. Consult a doctor before breast-feeding.
Use In Pregnancy & Lactation
Pregnancy: Medroxyprogesterone inhibits fertility at high doses. It should not be given during pregnancy.
Nursing mothers: Medroxyprogesterone is secreted in breast milk. The effect on the infants has not been determined.
Side Effects
Breast tenderness and leakage of liquid from the nipple occur rarely with medroxyprogesterone. Various skin reactions, including hives, acne, hair growth and hair loss, also have been reported occasionally. Break-through bleeding (Menstrual-like bleeding in the middle of the menstrual cycle), vaginal spotting of blood, changes in menstrual flow, increased or decreased weight, nausea, fever, insomnia, and jaundice have all been reported.
Blood clots are an occasional serious side effect of progestin therapy, and cigarette smokers are risk for clots. Therefore patients requiring progestin therapy are strongly encouraged to quit smoking. Diabetic patients may experience difficulty controlling blood glucose when taking medroxyprogesterone for unclear reason, Therefore increased monitoring of blood sugar and adjustment of medications for diabetes is recommended.
The Women’s Health Initiative (WHI) Study found an increased risk of heart attacks, stroke, breast cancer, blood clots, and pulmonary emboli (blood clots that lodge in the lungs) in postmenopausal women (50-70 years old) who took medroxyprogesterone should not be used for the prevention of heart disease or dementia. Although medroxyprogesterone alone has not been demonstrated to promote breast cancer, since breast cancer has progesterone receptor, physician usually avoid using progestins in women who have had breast cancer.
Drug Interactions
Aminoglutethimide (Cytadren) may increase the elimination of medroxyprogesterone by the liver leading to a decreased in the concentration of medroxyprogesterone in blood and possibly a reduction in effectiveness of the medroxyprogesterone.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
L02AB02 - medroxyprogesterone ; Belongs to the class of progestogens.
G03DA02 - medroxyprogesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
DB-10 tab 10 mg
Packing/Price
100's
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