Synarel (Nafarelin Acetate for Central Precocious Puberty) Drug Information: Overdosage and Contraindications

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May 27, 2012

Synarel

Puberty »

What is puberty?

Puberty is the time at which a growing boy or girl begins the process of sexual maturation. Puberty involves a series of physical stages or steps that lead to the achievement of fertility and the development of the so-called secondary sex characteristics, the physical features associated with adult males and females (such as the growth of pubic hair). While puberty involves a series of biological, or physical, transformations, the process can also have an effect on the psychosocial and emotional development of the adolescent.

When does puberty occur?

The onset of puberty varies among individuals. Puberty usually occurs in girls between the ages of 10 and 14, while in boys it generally occurs later, between the ages of 12 and 16. In some African American girls, puberty begins earlier, at about age 9, meaning that puberty occurs from ages 9 to 14.

Adolescent girls reach puberty today at earlier ages...

Read the Puberty article »

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Synarel

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OVERDOSE

In experimental animals, a single subcutaneous administration of up to 60 times the recommended human dose (on a μg/kg basis, not adjusted for bioavailability) had no adverse effects. At present, there is no clinical evidence of adverse effects following overdosage of GnRH analogs.

Based on studies in monkeys, SYNAREL is not absorbed after oral administration.

CONTRAINDICATIONS

Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in SYNAREL;
Undiagnosed abnormal vaginal bleeding;
Use in pregnancy or in women who may become pregnant while receiving the drug. SYNAREL may cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rats, but not in mice or rabbits after administration of SYNAREL during the period of organogenesis. There was a dose-related increase in fetal mortality and a decrease in fetal weight in rats (see Pregnancy Section). The effects on rat fetal mortality are expected consequences of the alterations in hormonal levels brought about by the drug. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus;
Use in women who are breast-feeding (see Nursing Mothers Section).

Last reviewed on RxList: 1/30/2012
This monograph has been modified to include the generic and brand name in many instances.