Daytrana

DRUG DESCRIPTION

Daytrana™ (methylphenidate transdermal system) is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is ?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™ (methylphenidate transdermal) 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.

Four dosage strengths are available:

Nominal Dose
Delivered (mg)
Over 9 Hours*
Dosage Rate*
(mg/hr)
Patch Size
(cm?)
Methylphenidate
Content per Patch
(mg)
10 1.1 12.5 27.5
15 1.6 18.75 41.3
20 2.2 25 55
30 3.3 37.5 82.5
*Nominal in vivo delivery rate in pediatric subjects aged 6-12 when applied to the hip, based on a 9-hour wear period.

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

Layers 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 any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling light-headed, fainting;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • redness, swelling, itching, or...

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 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: certain mental/mood conditions (e.g., agitation, psychosis), severe anxiety/tension, a certain eye disease (glaucoma), personal or family history of uncontrolled movements/outbursts (motor tics, Tourette's syndrome), seizures, problems with heart structure (e.g., valve problems), history of heart attack or stroke, heart/blood vessel disease (e.g., irregular...

Read All Potential Precautions of Daytrana »


Daytrana Consumer (continued)

SIDE EFFECTS: Mild redness/irritation of the skin under the patch may occur. This will usually improve even if the patch is left on. If this effect persists or worsens, notify your doctor or pharmacist promptly. If swelling, severe irritation, or red bumps appear on the skin around or under the patch, contact your doctor immediately.

Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, stuffy nose, dry mouth, constipation, or (rarely) drowsiness may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, uncontrolled movements (twitching, shaking), uncontrollable outbursts of words or sounds (e.g., Tourette's syndrome), unexplained weight loss, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts, hallucinations).

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, weakness on one side of the body, slurred speech, confusion, sudden vision changes, seizures, jaw/left arm pain, chest pain, fainting, fast/pounding/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using methylphenidate, tell your doctor or pharmacist if you are allergic to it; 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: certain mental/mood conditions (e.g., agitation, psychosis), severe anxiety/tension, a certain eye disease (glaucoma), personal or family history of uncontrolled movements/outbursts (motor tics, Tourette's syndrome), seizures, problems with heart structure (e.g., valve problems), history of heart attack or stroke, heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy, recent heart attack).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of alcohol/drug abuse, high blood pressure (hypertension), family history of sudden death/irregular heartbeat/rhythm, overactive thyroid (hyperthyroidism), family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), history of seizures.

This drug may make you dizzy, lightheaded, or rarely drowsy. It may also cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Children younger than 6 years may be at greater risk for the side effects of this medication.

This drug may affect your child's growth rate, weight, and final adult height, especially in children younger than 6 years. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Check your child's weight and height, and consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Daytrana Patient Information Including Side Effects

Brand Names: Daytrana

Generic Name: methylphenidate (transdermal) (Pronunciation: meth il FEN ih date)

  • What is methylphenidate transdermal (Daytrana)?
  • What are the possible side effects of methylphenidate transdermal (Daytrana)?
  • What is the most important information I should know about methylphenidate transdermal (Daytrana)?
  • What should I discuss with my health care provider before using methylphenidate transdermal (Daytrana)?
  • How should I use methylphenidate transdermal (Daytrana)?
  • What happens if I miss a dose (Daytrana)?
  • What happens if I overdose (Daytrana)?
  • What should I avoid while using methylphenidate transdermal (Daytrana)?
  • What other drugs will affect methylphenidate transdermal (Daytrana)?
  • Where can I get more information?

What is methylphenidate transdermal (Daytrana)?

Methylphenidate is a central nervous system stimulant. In affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Methylphenidate may also be used for other purposes not listed in this medication guide.

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 any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling light-headed, fainting;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • redness, swelling, itching, or blistering where the skin patch was worn (may also spread to other areas);
  • headache with fever, weakness, joint pain, diarrhea, and/or vomiting;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches); or
  • confusion, crying, feeling irritable.

Less serious side effects may include:

  • vision problems;
  • mild skin redness, bumps, or itching;
  • nausea, vomiting;
  • loss of appetite, weight loss;
  • sleep problems (insomnia); or
  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methylphenidate transdermal (Daytrana)?

Do not use methylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days.

Do not use this medication if you are allergic to methylphenidate or if you have glaucoma, tics (muscle twitches) or Tourette's syndrome, or severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse).

Methylphenidate may be habit-forming. Keep track of how many patches have been used from each new package you receive. Methylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Children using this medication should be warned never to remove the skin patch and place it onto another person. Serious side effects may result.

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