LEVONELLE, Levonorgestrel, Tablet The tablet is roun, Medicine and Disease information

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LEVONELLE overview

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

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Related DrugsDrug Details

LEVONELLE

Drug Class Description :

Progestogens.

Generic Name :

Levonorgestrel

Drug description :

The tablet contains 1500 microgram of levonorgestrel

Presentation :

Tablet The tablet is round and white.

Indications :

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

Adult Dosage :

For oral administration: One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse.

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.

Levonelle 1500 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 barrier method (e.g. condom, diaphragm or cap) until the next menstrual period starts. The use of Levonelle 1500 does not contraindicate the continuation of regular hormonal contraception.

Children: Levonelle 1500 is not recommended in children.

Very limited data are available in women under 16 years of age.

Child Dosage :

Not recommended.

Contra Indications :

Hypersensitivity to the active substance levonorgestrel or any of the excipients.

Special Precautions :

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method. Emergency contraception does not prevent a pregnancy in every instance.

If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Levonelle 1500 following the second act of intercourse may therefore be ineffective in preventing pregnancy.

If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded. If pregnancy occurs after treatment with Levonelle 1500, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy is likely to be low, as Levonelle 1500 prevents ovulation and fertilisation. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.

Levonelle 1500 is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of Levonelle 1500.

Levonelle 1500 contains 142.5 mg lactose. This should be taken into account in women with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

After Levonelle 1500 intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. Women should be advised to make a medical appointment to initiate or adopt a method of regular contraception. If no withdrawal bleed occurs in the next pill-free period following the use of Levonelle 1500 after regular hormonal contraception, pregnancy should be ruled out.

Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.

Levonelle 1500 is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.

Use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.

Interactions :

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers.

Drugs suspected of having the capacity to reduce the efficacy of levonorgestrel containing medication include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. John's Wort), rifampicin, ritonavir, rifabutin, griseofulvin.

Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism.

Adverse Reactions :

The most commonly reported undesirable effect was nausea. The following undesirable effects were observed in two different studies ^{1, 2}.

Body System	Frequency of adverse reactions
	Very common (>1/10)	Common (>1/100)
Endocrine system	Bleeding not related to menses*	Delay of menses more than 7 days ** Irregular bleeding and spotting
Nervous system		Dizziness< Headache
Gastrointestinal system	Nausea Low abdominal pain	Diarrhoea Vomiting
Reproductive system and breast		Breast tenderness
General	Fatigue

¹ Task Force on post-ovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet, 1998; 352:428-433

(n=977; data on 0.75 mg levonorgestrel tablet taken as two doses with a 12-hour interval)

² Hertzen et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet. 2002; 360:1803-1810

(n=1,359; data on Levonelle 1500 taken as a single dose of 1.5 mg)

^* n=1,011 out of 1,359

^** n=1,334 out of 1,359

Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 7 days of the expected time.

If the next menstrual period is more than 5 days overdue, pregnancy should be excluded

Manufacturer :

Bayer

Drug Availability :

(POM)

Drug Updated :

24 June 2009

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