Levonorgestrel (Emergency Contraception)

Registered South African indications:

• Emergency contraception

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Porphyria
• Severe hepatic impairment
• Pregnancy or suspected pregnancy
• Depression not well controlled with treatment
• A history of depression with the use of hormonal contraceptives

Cautions

• Patients who are at risk of ectopic pregnancy
• Severe malabsorption syndromes
• Repeated use during the same menstrual cycle
• Increased body mass index (BMI)
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

Emergency contraception - within 72hrs of unprotected sex/failure of contraceptive method

• Oral (tab): 1.5mg, immediately as a single dose

Dose should be taken preferably within 12hrs, and no later than 72hrs after unprotected intercourse

If vomiting occurs within 3hrs of taking the tablet, repeat dose immediately

If enzyme-inducing drugs used during the last month, non-hormonal emergency contraception recommended OR take a double dose of levonorgestrel 

Can be used at any time during the menstrual cycle unless menstrual bleeding is overdue

After using emergency contraception it is recommended to use a local barrier method until the next menstrual period starts; The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception

If pregnancy occurs after treatment with levonorgestrel, the possibility of an ectopic pregnancy should be considered

Not indicated for use in premenarchal children

Pregnancy

• Not indicated for use in pregnancy
• Levonorgestrel should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the fetus but there are no clinical data on the potential consequences if doses greater than 1.5 mg of levonorgestrel are taken

Breastfeeding

• Compatible
• Levonorgestrel is secreted into breast milk. Potential exposure of an infant to levonorgestrel can be reduced if the breastfeeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following levonorgestrel administration

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Severe: Contraindicated

Elderly

• Not indicated for use in geriatric patients

Porphyria Information

• Probably porphyrinogenic (PRP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Fatigue

Gastrointestinal Disorders

• Nausea and vomiting
• Lower abdominal pain
• Diarrhoea

Genitourinary Disorders

• Bleeding not related to menses
• Delay of menses more than 7 days
• Irregular menstruation
• Breast tenderness

• CYP3A4 inducers
• Barbiturates
• Phenytoin
• Carbamazepine
• St John's wart
• Rifampicin
• Ritonavir
• Rifabutin
• Griseofulvin
• Ciclosporin

None routine. Specific cases may require

• Pregnancy test

Levonorgestrel binds to progesterone and oestrogen receptors in the female reproductive tract, breasts, hypothalamus and pituitary. The net effect of binding to these receptors is decreased release of gonadotropin releasing hormone from the hypothalamus and blunting of the pre-ovulatory luteinizing hormone surge. It also has a number of local effects which include thickening of cervical mucous (which hinders sperm passage to the uterus) and alterations to the endometrium which may affect implantation.

Tablet 0.75mg

• Norlevo (Actor) originator
• Plan B (Elttab)
• Vonel (Ranbaxy)

Tablet 1.5mg

• Escapelle (Pharmaplan) originator
• Medilevo (Actor Pharma)
• Medinor (Actor Pharma)

Also available in the following forms: Tablet (contraceptive) and intra-uterine device.