Minds On Meds

Mental Health Medications

ADHD Medications

Metadate CD, Page 3

Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Metadate CD in the treatment of ADHD was established in one controlled trial.

OVERDOSAGE

Signs And Symptoms

Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.

Recommended Treatment

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage as indicated. Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for METADATE CD overdosage has not been established.

The prolonged release of methylphenidate from METADATE CD should be considered when treating patients with overdose.

Poison Control Center

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.

DOSAGE AND ADMINISTRATION

METADATE CD is administered once daily in the morning, before breakfast.

METADATE CD may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see PRECAUTIONS: Information for Patients).

Dosage should be individualized according to the needs and responses of the patient.

Initial Treatment

The recommended starting dose of METADATE CD is 20 mg once daily. Dosage may be adjusted in weekly 10-20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.

Maintenance/Extended Treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with METADATE CD. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use METADATE CD for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose Reduction And Discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

HOW SUPPLIED

METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules are available in six strengths:

10 mg, green/white capsules, imprinted with “UCB 579″ in white letters on the green cap, and “10 mg” in black letters on the white body of the capsule.

Bottles of 10
NDC 54868-5397-1
Bottles of 30
NDC 54868-5397-0

20 mg, blue/white capsules, imprinted with “UCB 580″ in white letters on the blue cap, and “20 mg” in black letters on the white body of the capsule.

Bottles of 10
NDC 54868-4718-1
Bottles of 30
NDC 54868-4718-0

30 mg, reddish-brown/white capsules, imprinted with “UCB 581″ in white letters on the reddish-brown cap, and “30 mg” in black letters on the white body of the capsule.

Bottles of 10
NDC 54868-0668-1
Bottles of 30
NDC 54868-0668-0

50 mg, purple/white capsules, imprinted with “UCB 583″ in white letters on the purple cap, and “50 mg” in black letters on the white body of the capsule.
Bottles of 10
NDC 54868-6234-1
Bottles of 30
NDC 54868-6234-0

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Keep out of the reach of children.

REFERENCE

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. American Psychiatric Association 1994. 4th ed. Washington D.C.

For Medical Information
Contact: Medical Affairs Department
Phone: (866) 822-0068
Fax: (770) 970-8859

Marketed by UCB, Inc.
Smyrna, GA 30080

Manufactured by UCB Manufacturing, Inc.
Rochester, NY 14623

9E 09/2010

METADATE CD is a registered trademark of the UCB Group of companies

©2010, UCB, Inc., Smyrna, GA 30080
All rights reserved. Printed in U.S.A.

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146


MEDICATION GUIDE

METADATE CD®
(methylphenidate HCl, USP) Extended-Release Capsules CII

Read the Medication Guide that comes with METADATE CD before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with METADATE CD.

What is the most important information I should know about Metadate CD?
The following have been reported with use of methylphenidate HCl, USP and other stimulant medicines.


1. Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.


Your doctor should check you or your child carefully for heart problems before starting METADATE CD.


Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with METADATE CD.


Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking METADATE CD.
2. Mental (Psychiatric) problems:
All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.


Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking METADATE CD, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What Is METADATE CD?

METADATE CD is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

METADATE CD may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

METADATE CD should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

METADATE CD is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep METADATE CD in a safe place to prevent misuse and abuse. Selling or giving away METADATE CD may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take METADATE CD?

METADATE CD should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.
  • have severe high blood pressure or a heart problem
  • have hyperthyroidism
  • are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in METADATE CD. See the end of this Medication Guide for a complete list of ingredients.

METADATE CD should not be used in children less than 6 years old because it has not been studied in this age group.

METADATE CD may not be right for you or your child. Before starting METADATE CD tell your or your child’s doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • tics or Tourette’s syndrome
  • seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can METADATE CD be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. METADATE CD and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking METADATE CD.

Your doctor will decide whether METADATE CD can be taken with other medicines.


Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking METADATE CD without talking to your doctor first.

How should METADATE CD be taken?

  • Take METADATE CD exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take METADATE CD once each day in the morning before breakfast. METADATE CD is an extended release capsule. It releases medicine into your body throughout the day.
  • METADATE CD can be taken with or without food.
  • Swallow METADATE CD capsules whole with water or other liquids. If you cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule.
  • From time to time, your doctor may stop METADATE CD treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking METADATE CD. Children should have their height and weight checked often while taking METADATE CD. METADATE CD treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much METADATE CD or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of METADATE CD?


See “What is the most important information I should know about METADATE CD?” for information on reported heart and mental problems.


Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision

Common side effects include:

  • headache
  • decreased appetite
  • stomach ache
  • nervousness
  • trouble sleeping
  • dizziness

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.


This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information

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

How should I store METADATE CD?

  • Store METADATE CD in a safe place at room temperature, 59 to 86°F (15 to 30°C). Protect from moisture.
  • Keep METADATE CD and all medicines out of the reach of children.

General information about METADATE CD

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use METADATE CD for a condition for which it was not prescribed. Do not give METADATE CD to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about METADATE CD. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about METADATE CD that was written for healthcare professionals. For more information about METADATE CD call 1-866-822-0068.


What are the ingredients in METADATE CD?


Active Ingredient:
methylphenidate HCl
Inactive Ingredients: sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethylcellulose aqueous dispersion, dibutyl sebacate, gelatin, and titanium dioxide.

The individual capsules contain the following coloring agents:
10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide
20 mg capsules: FD&C Blue No. 2
30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide
40 mg capsules: FDA/E172 Yellow Iron Oxide
50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide


This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by UCB, Inc.
Smyrna, GA 30080
Manufactured by UCB Manufacturing, Inc.
Rochester, NY 14623
METADATE CD is a registered trademark of the UCB Group of companies
©2009, UCB, Inc., Smyrna, GA 30080
All rights reserved. Printed in U.S.A.
2E 06/2009

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Label

Once Daily

Metadate CD®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

10 mg


A Medication Guide is required
for every prescription dispensed.

Please use accompanying Medication Guide.

Rx Only

Principal Display Panel -- 10 mg Capsule Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Label

Once Daily

Metadate CD®
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

20 mg


A Medication Guide is required
for every prescription dispensed.

Please use accompanying Medication Guide.

Rx Only

Principal Display Panel -- 20 mg Capsule Label
(click image for full-size original)