Mirena娩凡瑙

Mirena

levonorgestrel

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Levonorgestrel
Indications/Uses
Contraception; idiopathic menorrhagia; protection from endometrial hyperplasia during oestrogen replacement therapy.
Dosage/Direction for Use
Contraception & idiopathic menorrhagia Women of fertile age Insert 1 unit into the uterine cavity w/in 7 days of the onset of menstruation. 1 administration is effective for 5 yr. Initial release: Approx 20 mcg/day. Post-partum insertion Postpone insertion until uterus is fully involuted. Do not insert earlier than 6 wk after delivery. Protection from endometrial hyperplasia during oestrogen replacement therapy Insert at any time in an amenorrhoeic woman, or during the last days of menstruation or w/drawal bleeding. Should be removed after 4 yr.
Contraindications
Hypersensitivity. Known or suspected pregnancy; confirmed or suspected hormone dependent tumours including breast cancer; current or recurrent pelvic inflammatory disease; cervicitis; current genital infection; postpartum endometritis, infected abortion during the past 3 mth; conditions associated w/ increased susceptibility to infections; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal genital bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; liver tumour or other acute or severe liver disease; acute malignancies affecting the blood or leukaemias except when in remission; recent trophoblastic disease while hCG levels remain elevated. Active or previous severe arterial disease eg, stroke or MI when Mirena is used in conjunction w/ an oestrogen for HRT use.
Special Precautions
Before insertion, a complete personal & family medical history should be taken. Re-examine patient 6 wk after insertion & where clinically indicated. Prior to insertion, pregnancy & endometrial pathology should be excluded & genital infection should be successfully treated. Consider removal of the system should any of the following conditions exist or arise for the 1st time during treatment: Migraine w/ aura, unusually severe or unusually frequent headache, jaundice, marked increase in BP, malignancies affecting the blood or leukaemias in remission, use of chronic corticosteroid therapy, past history of symptomatic functional ovarian cysts, active or previous severe arterial disease eg, stroke or MI, severe or multiple risk factors for arterial disease, thrombotic arterial or any current embolic disease, acute venous thromboembolism. Women using hormonal contraception should be encouraged to give up smoking. Caution in postmenopausal women w/ advanced uterine atrophy. Insertion & removal may be associated w/ some pain & bleeding. Perforation of the uterine corpus or cervix may occur, most commonly during insertion. In case of difficult insertion &/or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered. The procedure may precipitate fainting as a vasovagal reaction, or a seizure in an epileptic patient. Remove Mirena in case of recurrent endometritis or pelvic infections or severe acute infections. Expulsion of the system or lost threads leading to system failure. Increased menstrual flow or unexpected bleeding may be indicative of expulsion. Increased relative likelihood of ectopic pregnancy when a woman becomes pregnant w/ Mirena in situ. Ovulatory cycles w/ follicular rupture usually occur in women of fertile age. Depressed mood & depression. Low-dose levonorgestrel may affect glucose tolerance; monitor blood glucose conc in diabetic users. Not suitable for use as a post-coital contraceptive. Has not been studied in women w/ renal impairment; women >65 yr. No relevant indications for use before menarche.
Adverse Reactions
Uterine/vag bleeding including spotting, oligomenorrhoea, amenorrhoea. Depressed mood/depression, nervousness, decreased libido; headache, migraine; dizziness; abdominal pain, nausea; acne, hirsutism; back pain; ovarian cysts, pelvic pain, dysmenorrhoea, vag discharge, vulvovaginitis, breast tenderness, breast pain; intrauterine contraceptive device expelled; increased wt.
Drug Interactions
Increased or decreased plasma conc of progestin w/ many HIV/HCV PIs & NNRTIs. Increased plasma conc of progestin w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice.
MIMS Class
Other Contraceptives
ATC Classification
G02BA03 - plastic IUD with progestogen ; Belongs to the class of intrauterine contraceptives used in contraception.
Presentation/Packing
Form
Mirena intrauterine system 52 mg
Packing/Price
1's
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