Clinical Pharmacology Details


Levonorgestrel


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Indications & Dose:

Emergency contraception



Females of childbearing potential: 1.5 mg for 1 dose, taken as soon as possible after coitus, preferably within 12 hours but no later than after 72 hours continued Contraception


INTRA-UTERINE DEVICE


Contraception | Menorrhagia



Females of childbearing potential: Insert into uterine cavity within 7 days of onset of menstruation, or any time if replacement, or any time if reasonably certain woman is not pregnant and there is no risk of conception (additional precautions (e.g. barrier methods) necessary for next 7 days), or immediately after first-trimester termination by curettage; postpartum insertions should be delayed until at least 4 weeks after delivery; effective for 5 years


Prevention of endometrial hyperplasia during oestrogen replacement therapy



Females of childbearing potential: Insert during last days of menstruation or withdrawal bleeding or at any time if amenorrhoeic; effective for 4 years


DOSE ADJUSTMENTS DUE TO INTERACTIONS


When used orally as an emergency contraceptive, the effectiveness of levonorgestrel is reduced in women taking enzyme-inducing drugs (and for up to 4 weeks after stopping); a copper intra-uterine device should preferably be used instead. If the copper intra-uterine device is undesirable or inappropriate, the dose of levonorgestrel should be increased to a total of 3 mg taken as a single dose accordingly]; pregnancy should be excluded following use, and medical advice sought if pregnancy occurs.


There is no need to increase the dose for emergency contraception if the patient is taking antibacterials that are not enzyme inducers. With the progestogen-only intra-uterine device, levonorgestrel is released close to the site of the main contraceptive action (on cervical mucus and endometrium) and therefore progestogenic sideeffects and interactions are less likely; in particular, enzymeinducing drugs are unlikely to significantly reduce the contraceptive effect of the progestogenonly intrauterine system and additional contraceptive precautions are not required.

Contraindications:

Active thrombophlebitis or thromboembolic disorders, undiagnosed abnormal genital bleeding, pregnancy, acute liver disease, liver tumors, breast cancer, hypersensitivity, Intrauterine Device: congenital or acquired uterine anomaly including fibroids, acute pelvic inflammatory disease or history unless subsequent intrauterine pregnancy, postpartum endometritis or infected abortion in past 3 mo, uterine or cervical neoplasia or unresolved, abnormal Pal smear, untreated lower genital tract infections, genital actinomycosis, history of ectopic pregnancy

Side Effects:

Cautions:

Precautions:

Diabetes mellitus, impaired liver function, conditions aggravated by fluid retention, history of depression, contact lens, wearers

Interaction:

Drugs
Carbamazepine, phenobarbital, phenytoin: Decreased efficacy of levonorgestrel, pregnancy has occurred

Warnings:

Adverse Effects:

Lactations:

Pregnancy category X: compatible with breast feeding

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Dizziness, headache, nervousness


CV: Edema


EENT: Contact lens intolerance


GI: Weight gain, change of appetite, nausea


GU: Ovarian cysts, amenorrhea, cervicitis, irregular bleeding, many bleeding days, prolonged bleeding, spotting, vaginitis, galactorrhea, mastalgia


METAB: Altered glucose tolerance 


MS: Musculoskeletal pain


SKIN: Acne, dermatitis, hirsutism, hypertrichosis, infection at inj site; pain, itching at inj site, scalp hair loss


MISC: Breast tenderness, change in breast size, gynecomastia

Patient And Carer Advice: