Synarel

Synarel®
(nafarelin acetate) nasal solution

CENTRAL PRECOCIOUS PUBERTY

DRUG DESCRIPTION

SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to the nasal mucosa. Nafarelin acetate, the active component of SYNAREL Nasal Solution, is a decapeptide with the chemical name: 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-serylL-tyrosyl-3-(2-naphthyl)-D-alanyl-L-leucyl-L-arginyl-L-prolyl-glycinamide acetate. Nafarelin acetate is a synthetic analog of the naturally occurring gonadotropin-releasing hormone (GnRH). Nafarelin acetate has the following chemical structure:

Synarel® (nafarelin acetate) Structural Formula Illustration

SYNAREL Nasal Solution contains nafarelin acetate (2 mg/mL, content expressed as nafarelin base) in a solution of benzalkonium chloride, glacial acetic acid, sodium hydroxide or hydrochloric acid (to adjust pH), sorbitol, and purified water.

After priming the pump unit for SYNAREL, each actuation of the unit delivers approximately 100 μL of the spray containing approximately 200 μg nafarelin base. The contents of one spray bottle are intended to deliver at least 60 sprays.

What are the possible side effects of nafarelin nasal (Synarel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • heavy or continued menstrual bleeding;
  • pelvic pain or swelling;
  • increased thirst, increased urination;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision, speech, or...

Read All Potential Side Effects and See Pictures of Synarel »

What are the precautions when taking nafarelin acetate for central precocious puberty (Synarel)?

Before using nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (e.g., leuprolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unexplained abnormal vaginal bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels.

This medication...

Read All Potential Precautions of Synarel »

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

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Synarel - User Reviews

Synarel User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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