METHYLPHENIDATE HYDROCHLORIDE (CD)- methylphenidate hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Methylphenidate hydrochloride extended-release capsules (CD) are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules (CD). Angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules (CD). Anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6)] . - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7)]. - Methylphenidate hydrochloride extended-release capsules (CD) contain sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules (CD), during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388. Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations). No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m2  basis. However, spina bifida was observed in rabbits at a dose 53 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre-and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride extended-release capsules (CD), can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Animal Data In embryo-fetal development 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. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m2  basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m2  basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adults 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 (3 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 (6 times the MRHD of 60 mg/day given to adults 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 (~2 times the MRHD given to adolescents on a mg/m2  basis). Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release capsules (CD) and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules (CD) or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. The safety and effectiveness of methylphenidate hydrochloride extended-release capsules (CD) for the treatment of ADHD have been established in pediatric patients 6 to 15 years of age. The safety and effectiveness of methylphenidate hydrochloride extended-release capsules (CD) in pediatric patients younger than 6 years of age have not been established. Long-term efficacy of methylphenidate hydrochloride extended-release capsules (CD) in pediatric patients have not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules (CD). Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.6)]. Juvenile Animal Toxicity Data . In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the MRHD on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown. Methylphenidate hydrochloride extended-release capsules (CD) have not been studied in patients over the age of 65 years. Methylphenidate hydrochloride extended-release capsules (CD) contain methylphenidate hydrochloride, a Schedule II controlled substance. CNS stimulants, including methylphenidate hydrochloride extended-release capsules (CD), other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physicological effect. Drug addiction is a cluster of behavioral, cognitive, and psychological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Both abuse and misuse may lead to addiction, and some individuals may develop addiction even when taking methylphenidate hydrochloride extended-release capsules (CD) as prescribed. Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Individual who abuser CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which can result in overdose and death [see Overdosage (10)].   To reduce the abuse of methylphenidate hydrochloride extended-release capsules (CD), assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants [see How Supplied/Storage and Handling (16)] , monitor for signs of abuse while on therapy, and re-evaluate the need for methylphenidate hydrochloride extended-release capsule (CD) use. Physical Dependence Methylphenidate hydrochloride extended-release capsules (CD) may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by a withdrawal signs and symptoms after abrupt discontinuation or significant dose reduction of a drug. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride extended-release capsules (CD) may produce tolerance from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Product summary:

How Supplied Methylphenidate hydrochloride extended-release capsules (CD) are available in six strengths (see Table 4): Strength Capsule Color Imprinting on Capsule Cap and Body Capsules per Bottle NDC Number 10 mg light green opaque cap /white opaque body “93” over “5295” 100 NDC 0093-5295-01 20 mg light turquoise blue opaque cap/white opaque body “93” over “5296” 100 NDC 0093-5296-01 30 mg light brown opaque cap /white opaque body “93” over “5297” 100 NDC 0093-5297-01 40 mg light brown opaque cap/white opaque body “93” over “5298” 100 NDC 0093-5298-01 50 mg light blue opaque cap/white opaque body “93” over “5292” 100 NDC 0093-5292-01 60 mg white opaque cap/white opaque body “93” over “5293” 100 NDC 0093-5293-01 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules (CD) by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules (CD) with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard methylphenidate hydrochloride extended-release capsules (CD) in the household trash.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RELEASE
Teva Pharmaceuticals USA, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Methylphenidate Hydrochloride (meth'' il fen'' i date hye'' droe klor'
ide)
Extended-Release Capsules (CD) CII
What is the most important information I should know about
methylphenidate hydrochloride extended-release capsules (CD)?
Methylphenidate hydrochloride extended-release capsules (CD) can cause
serious side effects, including:
•
Abuse and dependence. Methylphenidate hydrochloride extended-release
capsules (CD), other methylphenidate containing medicines, and
amphetamines have a high chance for abuse and can cause physical and
psychological dependence. Your healthcare provider should check your
child for signs of abuse and dependence before and during treatment
with methylphenidate hydrochloride extended-release capsules (CD).
•
Tell your healthcare provider if your child has ever abused or been
dependent on alcohol, prescription medicines, or street drugs.
•
Your healthcare provider can tell you more about the differences
between physical and psychological dependence and drug addiction.
•
Heart-related problems, including:
•
sudden death in children who have heart problems or heart defects
•
increased blood pressure and heart rate
Your healthcare provider should check your child carefully for heart
problems before starting treatment with methylphenidate hydrochloride
extended-release capsules (CD).
Tell your healthcare provider if your child has any heart problems,
heart defects, high blood pressure, or has a family history of these
problems.
Your healthcare provider should check your child’s blood pressure
and heart rate regularly during treatment with methylphenidate
hydrochloride
extended-release capsules (CD).
Call your healthcare provider or go to the nearest hospital emergency
room right away if your child has any signs of heart problems such as
chest
pain, shortness of breath, or fainting during treatment with
methylphenidate hydrochloride extended-r

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE (CD)- METHYLPHENIDATE
HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (CD) SAFELY
AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-
RELEASE CAPSULES (CD).
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES (CD), FOR ORAL
USE, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES
(CD), OTHER METHYLPHENIDATE CONTAINING PRODUCTS, AND AMPHETAMINES,
HAVE A HIGH
POTENTIAL FOR ABUSE AND DEPENDENCE (5.1, 9.2, 9.3)
ASSESS THE RISK OF ABUSE PRIOR TO PRESCRIBING AND MONITOR FOR SIGNS OF
ABUSE AND
DEPENDENCE WHILE ON THERAPY (5.1, 9.2)
INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsules (CD) are a
central nervous system (CNS)
stimulant indicated for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in pediatric
patients 6 to 15 years of age (1)
DOSAGE AND ADMINISTRATION
Take orally once daily in the morning, before breakfast (2.3)
Swallow whole with the aid of liquids, or sprinkle contents onto a
small amount of applesauce and give
immediately (2.3)
Do not crush or chew the capsule or capsule contents (2.3)
Recommended starting dose is 20 mg once daily. Dosage may be increased
10 mg to 20 mg at weekly
intervals; do not exceed 60 mg per day (2.2)
DOSAGE FORMS AND STRENGTHS
_Extended-release capsules:_ 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
(3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other components of
methylphenidate hydrochloride
extended-release capsules (CD) (4)
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the
preceding 14 days (4)
Use in patients with patients with hereditary problems of fructos