Ovocease®

Therapeutic Area:

Generic Name:

Levonorgestrel

Dosage Form:

Levonorgestrel

Drug Dose

Therapeutic Indications:

Levonorgestrel is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

Mechanism of Action:

Inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Method of Administration:

Take one tablet of Levonorgestrel orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Plan B can be used at any time during the menstrual cycle.

Notes

Contraindications:

Levonorgestrel is contraindicated for use in the case of known or suspected pregnancy.

Interactions:

Some drugs may cause emergency birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.

Pregnancy and Lactation:

Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.

Lactation

In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth or development of the infant.

Warning and Precaution:

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Levonorgestrel. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Levonorgestrel.

Adverse Reactions:

The most common adverse events (>10%) in the clinical trial for women receiving Levonorgestrel included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%).

Storage:

Store below 30 and protect from light and moisture.