Depofemme

Depofemme

medroxyprogesterone

Manufacturer:

Dyna Drug

Distributor:

Dyna Drug
Full Prescribing Info
Contents
Medroxyprogesterone acetate.
Description
Depofemme also contains the following excipients: Polyethylene glycol 3350, polysorbate 80, sodium chloride, methyl paraben, water for injection to make 1 mL.
Action
Pharmacology: Depofemme administered parenterally as an IM injection provides long-acting progestational effect by inhibiting gonadotropin production, which in turn prevents follicular maturation and ovulation. This will cause a long-term unovulation in women of reproductive age. Depofemme causes progestational changes in the cervical mucus, in which it becomes more viscous, inhibiting sperm penetration into uterus. This steroid also produces morphological changes of endometrium, thereby increasing the difficulty of nidation.
Indications/Uses
Used as a contraceptive injection for a period of 3 months.
Dosage/Direction for Use
One vial containing medroxyprogesterone acetate 150 mg every 3 months, given deep IM. It should be certain that the recipient is not pregnant in the 1st injection. For this purpose, it is recommended to give the injection during the first 5 days after the onset of a normal menstrual period, if not breastfeeding, within the first 5 days of postpartum, and after the 6th postpartum week if breastfeeding.
Contraindications
Vaginal bleeding of unknown cause. Mammary pathologic changes of unknown cause. Pregnancy (either for diagnosis or treatment). Patient who is sensitive to medroxyprogesterone acetate. Active thrombophlebitis or has history of thromboembolic disorder or cerebral vascular disease. Liver function disorder.
Warnings
A recipient showing signs and symptoms of thromboembolic abnormalities should be re-assessed before treatment of Depofemme is continued. Recipient suffering from acute visual defects, proptosis, diplopia or migraine, eye tissue should be examined carefully to prevent papilloedema or injury in the retinal blood vessels before treatment is continued. The use of progestin during pregnancy must not be continued, use as a diagnostic test for pregnancy is also not recommended.
Special Precautions
Before considering the use of Depofemme, the recipient should undergo an appropriate medical examination of breast and pelvic organs as well as a Papanicolaou test. It should be administered with caution to women with a history of mental depression. Discontinue therapy if necessary. Diabetic patients should be carefully monitored. Masking effects against climacteric signs should be born in mind. It might affect certain endocrine or liver function test.
In case of abnormal result, the test should be repeated 4-6 months after the drug has been withdrawn. It is not recommended to treat secondary amenorrhea or functional uterine bleeding, due to the prolonged action and the resulting difficulty in predicting the time of withdrawal bleeding following injection. In this case, oral therapy should be the choice of treatment. Pathologists should be informed of the recipient's use of Depofemme if relevant specimen is submitted. The following laboratory test may be affected: Gonadotropin level, plasma progesterone level, urinary pregnanediol level, plasma testosterone level (in male), plasma estrogen level (in female), plasma cortisol level, glucose tolerance test, metyrapone test.
Use In Pregnancy & Lactation
Depofemme is contraindicated in pregnancy (either for diagnosis or treatment).
Side Effects
Anaphylactic reaction. Local reaction, discoloration at the injection site. It is recommended to directly inform the recipient at the start of treatment that menstrual cycle changes eg, irregular bleeding and spotting might occur. Also, for sometime, excessive bleeding occurs especially at the start of the treatment. This can be overcome by administration of ethinyl estradiol 0.05-0.1 mg daily for 7-21 days. After repeated injections, amenorrhea and unovulation can last for up to 18 months or some time longer.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
G03AC06 - medroxyprogesterone ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Susp for inj 150 mg/mL (vial, aqueous, sterile suspension, w/ auto-disable syringe) x 1 mL x 1's.
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