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Daytrana

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Daytrana

DAYTRANA®
(methylphenidate) Transdermal System

WARNING

DRUG DEPENDENCE

Daytrana should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

DRUG DESCRIPTION

Daytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is:

DAYTRANA® (methylphenidate) Structural Formula Illustration

Patch Components

Daytrana contains methylphenidate in a multipolymeric adhesive. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the patch size and wear time.

The patch consists of three layers, as seen in the figure below (cross-section of the patch).

Cross-section of the patch  Illustration

Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing, (2) a proprietary adhesive formulation incorporating Noven Pharmaceuticals, Inc.'s DOT Matrix™ transdermal technology consisting of an acrylic adhesive, a silicone adhesive, and methylphenidate, and (3) a fluoropolymer-coated polyester protective liner which is attached to the adhesive surface and must be removed before the patch can be used.

The active component of the patch is methylphenidate. The remaining components are pharmacologically inactive.

What are the possible side effects of methylphenidate transdermal (Daytrana)?

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.

Stop using methylphenidate and call your doctor at once if you have:

  • fast, pounding, or uneven heartbeats, feeling light-headed, fainting;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, seizure);
  • redness, swelling, itching, or blistering where the skin patch was worn (may also spread to other...

Read All Potential Side Effects and See Pictures of Daytrana »

What are the precautions when taking methylphenidate transdermal (Daytrana)?

Before using methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; 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: high blood pressure, blood circulation problems (such as Raynaud's disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood...

Read All Potential Precautions of Daytrana »

Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.

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Daytrana - User Reviews

Daytrana 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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