Mirena Implant system / Intrauterine

Levonorgestrel
52mg/System
BAYER OY
Pack size 1 Intrauterine System
Dispensing mode POM
Source FINLAND
AgentPHARMAWORLD
Retail Price 528.00 AED

Indications

Mirena Implant system / Intrauterine is used for: Contraception, Emergency contraception, Menopausal hormone replacement therapy, Menorrhagia,

Adult Dose

Oral Emergency contraception Adult: 1.5 mg as soon as possible or within 72 hr of coitus. Alternatively, 750 mcg as soon as possible or within 72 hr of coitus followed by a 2nd dose 12 hr later. Most effective if taken as soon as possible after unprotected intercourse Menopausal hormone replacement therapy Adult: As progestogenic component: 75-250 mcg for 10-12 days of a 28-day cycle. Contraception Adult: Monotherapy: 30 or 37.5 mcg daily.

Child Dose

Renal Dose

Administration

May be taken with or without food.

Contra Indications

Pregnancy, undiagnosed vaginal bleeding, severe arterial disease; liver adenoma, porphyria; after recent evacuation of hydatidiform mole; history of breast cancer; hepatic impairment.

Precautions

Sex-steroid dependent cancer, past ectopic pregnancy, malabsorption syndromes, functional ovarian cysts, active liver disease, recurrent cholestatic jaundice, history of jaundice in pregnancy, CV or renal impairment, DM, asthma, epilepsy, migraine, conditions aggravated by fluid retention, depression and thromboembolism (high doses); lactation.

Pregnancy-Lactation

Pregnancy Use of is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant likelihood of ectopic pregnancy is increased and there is increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove product if possible, if pregnancy occurs in a woman; if product cannot be removed, follow pregnancy closely Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman; however, there have been reported cases of masculinization of external genitalia of female fetus following exposure to progestins at doses greater than those currently used for oral contraception; animal reproduction studies not conducted Lactation Published studies report presence of LNG in human milk; small amounts of progestins (approximately 0.1% of total maternal doses) were detected in breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported with a LNG-releasing IUS; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child therapy or from underlying maternal condition

Interactions

Reduced efficacy with enzyme-inducing drugs; aminoglutethimide. May inhibit ciclosporin metabolism.

Adverse Effects

Side effects of Levonorgestrel : >10% Headache (12%), Acne (15%), Ovarian cysts (13%), Enlarged follicles (12%), Amenorrhea (1-12%), Abdominal pain (12%), Uterine/vaginal bleeding alterations (52%), Intermenstrual bleeding/spotting (23%), Vulvovaginitis (20%), Ectopic pregnancy (≤50%) 1-10% Depression (4%), Migraine (2%), Alopecia (1%), Dysmenorrhea (9%), Menorrhagia (6%), Breast tenderness (3-9%), Pelvic pain (6%), Leukorrhea (5%), Vaginal discharge (4%), Pelvic infection (1%) <1% Angioedema, Cervical perforation, Failed insertion, Sepsis, Uterine bleeding, Device breakage Potentially Fatal: Thrombocytopenia, stroke.

Mechanism of Action

Levonorgestrel, a nortestosterone derivative, is an active isomer of norgestrel. It is a potent inhibitor of ovulation and has androgenic activity.

Note

Mirena 52mg/System Implant system / Intrauterine manufactured by BAYER OY. Its generic name is Levonorgestrel. Mirena is availble in United Arab Emirates. Farmaco UAE drug index information on Mirena Implant system / Intrauterine is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Levonorgestrel :