Methylin

Name: Methylin

Uses of Methylin

Methylin is a prescription medication used to treat attention-deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Mallinckrodt, Inc.

Methylin Interactions

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylin 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 Methylin.

Your doctor will decide whether Methylin 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 Methylin without talking to your doctor first.

Methylin Precautions

The following have been reported with use of Methylin and other stimulant medicines.

  • 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 Methylin.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Methylin.

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 Methylin.

  • 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 Methylin, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Do not take Methylin 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.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in Methylin

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

Inform MD

Before starting Methylin, 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)
  • skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives/glues (patch form)

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

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Methylin FDA Warning

Methylin is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylin in a safe place to prevent misuse and abuse. Selling or giving away Methylin 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.

Drug Dependence

Methylin 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.

Before Using Methylin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of methylphenidate have not been performed in the geriatric population.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Brofaromine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • Selegiline
  • Toloxatone
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion
  • Donepezil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.
  • Bipolar disorder (manic-depressive illness), history of or
  • Depression, history of or
  • Hypertension (high blood pressure) or
  • Priapism (painful or prolonged erection of the penis) or
  • Psychosis (mental illness), history of or
  • Raynaud disease or
  • Seizures, history of or
  • Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.
  • Coronary artery disease or
  • Heart attack, recent or
  • Heart disease (eg, cardiomyopathy) or
  • Heart failure or
  • Heart rhythm problems (eg, ventricular arrhythmia), history of or
  • Hyperthyroidism (overactive thyroid) or
  • Stroke, history of—Use with caution. May make side effects become worse.
  • Phenylketonuria—The chewable tablet contains aspartame, which can make this condition worse.

Use in Children Under Six Years of Age

Methylin should not be used in children under 6 years, since safety and efficacy in this age group have not been established.

Drug Dependence
Methylin 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.

Pregnancy

Teratogenic Effects. Pregnancy Category C – In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (4 times the MRHD on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (equal to the MRHD on a mg/m2 basis).

Adequate and well-controlled studies in pregnant women have not been conducted. Methylin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Adults

Tablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

ER Tablets: Methylin ER tablets have a duration of action of approximately 8 hours. Therefore, Methylin ER tablets may be used in place of Methylin tablets when the 8-hour dosage of Methylin ER corresponds to the titrated 8-hour dosage of Methylin. Methylin ER tablets must be swallowed whole and never crushed or chewed.

How is Methylin Supplied

Each Methylin™ (methylphenidate HCl tablet USP) 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a on the other side.

  Bottles of 100........................NDC 0406-1121-01   Bottles of 1000......................NDC 0406-1121-10

Each Methylin™ (methylphenidate HCl tablet USP) 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.

  Bottles of 100........................NDC 0406-1122-01   Bottles of 1000......................NDC 0406-1122-10

Each Methylin™ (methylphenidate HCl tablet USP) 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a on the other side.

  Bottles of 100........................NDC 0406-1124-01   Bottles of 1000......................NDC 0406-1124-10

Protect from light. Dispense in tight, light-resistant container with child-resistant closure.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Each Methylin™ ER (methylphenidate HCl extended-release tablet USP) 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a on the other side.

  Bottles of 100........................NDC 0406-1423-01

Each Methylin™ ER (methylphenidate HCl extended-release tablet USP) 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a on the other side.

  Bottles of 100........................NDC 0406-1451-01

Note: Methylin™ and Methylin™ ER tablets are color-additive free.

Dispense in tight, light-resistant container with child-resistant closure.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from moisture.

is a trademark of Mallinckrodt Inc.

Methylin is a trademark of Mallinckrodt Inc.

Mallinckrodt Inc.
Hazelwood, MO 63042 USA

COVIDIEN™

Mallinckrodt

Printed in U.S.A.

L20M12

Rev 04/2010

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