Silenor

Silenor™
(doxepin) Tablets for Oral Administration

DRUG DESCRIPTION

Silenor (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively.

Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure:

Silenor™
  (doxepin) Structural Formula Illustration

Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NO•HCl.

Each Silenor (doxepin tablets) tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1.

What are the possible side effects of doxepin (Silenor) (Silenor)?

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

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

  • fast, pounding, or uneven heart rate;
  • confusion, hallucinations, unusual thoughts or behavior, seizure (convulsions);
  • new or worsening symptoms of depression (mood or behavior changes, anxiety, trouble sleeping, feeling agitated, thoughts about suicide or hurting yourself.
  • easy bruising or bleeding, unusual...

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What are the precautions when taking doxepin tablets (Silenor)?

Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amoxapine); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems urinating (urinary retention), a certain eye problem (glaucoma).

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including...

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Last reviewed on RxList: 4/2/2010
This monograph has been modified to include the generic and brand name in many instances.

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Silenor - User Reviews

Silenor User Reviews

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Report Problems to the Food and Drug Administration

 

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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