Four Star
Concise Prescribing Info
Contraception; menorrhagia; protection from endometrial hyperplasia during estrogen replacement therapy.
Dosage/Direction for Use
Insert 1 unit into the uterine cavity. 1 administration is effective for 5 yr. Release rate: 20 mcg/24 hr.
Hypersensitivity. Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; lower genital tract infection; infection of the womb after delivery; infection of the womb after abortion during the past 3 mth; infection of the cervix; cell abnormalities in the cervix; cancer or suspected cancer of the cervix or womb; undiagnosed abnormal vag bleeding; abnormality of the cervix or womb including fibroids if they distort the cavity of the womb; conditions associated w/ increased susceptibility to infections; active liver disease or liver tumor.
Special Precautions
Take special care in presence of migraine, or asymmetrical visual loss; exceptionally severe headache; jaundice; marked increase in BP; confirmed or suspected hormone-dependent tumors, including breast cancer; severe disease of arteries eg, stroke or heart infarction. Increased risk of venous blood clots. Use w/ caution in women who have congenital heart disease or valvular heart disease at risk of infective inflammation of the heart muscle. Monitor blood glucose conc in diabetic users. Increased risk of pelvic infection immediately & during the 1st mth after insertion. May penetrate or perforate the wall of the womb. Pain & dizziness may be experienced after insertion. Ovulatory cycles w/ follicular rupture usually occur in women of fertile age. Degeneration of the follicle is sometimes delayed & development of the follicle may continue. Before insertion, perform exam (eg, Pap smear, tests for infections including STDs) as necessary, & gynecological exam to determine position & size of the womb. Contains barium sulphate making it visible in X-ray exam. Check intrauterine 4-12 wk after insertion, then regularly thereafter, at least once yrly. Risk of extrauterine pregnancy. Remove device as soon as possible in case of pregnancy.
Adverse Reactions
Vag bleeding; symptoms of vag infection eg, itching, or unusual or increased vag discharge; headache or dizziness; abdominal pain or distention; nausea; acne, hair loss, excessive body hair; breast pain or swelling; pelvic or back pain; wt gain; depressive or altered mood or nervousness; decreased sexual desire; skin rash, urticaria, eczema; expulsion of the system.
ATC Classification
G02BA03 - plastic IUD with progestogen ; Belongs to the class of intrauterine contraceptives used in contraception.
Mirena intrauterine system 52 mg
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