METHYLPHENIDATE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylphenidate hydrochloride tablets are indicated for the treatment of: - Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults - Narcolepsy - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylacticreactions, have been reported in patients treated with methylphenidate[seeAdverse Reactions (6.1)]. - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 daysfollowingdiscontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. 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 52 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, 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. Data 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 (15times 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 adolescents 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 adolescents 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 and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride 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 for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of methylphenidate hydrochloride in pediatric patients less than 6 years have not been established. The long-term efficacy of methylphenidate hydrochloride in pediatric patients has not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7)] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m2 basis. 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 4 times the MRHD of 60 mg/day given to children 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 (8 times the MRHD given to children on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to children on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown. Methylphenidate hydrochloride has not been studied in the geriatricpopulation. Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a Schedule II controlledsubstance. CNS stimulants,including methylphenidate hydrochloride, have a high potential for abuse. Abuse is characterized by impaired control over drug use despiteharm, and craving. 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. Abusers of CNS stimulantsmay chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see Overdosage (10)] . To reduce the abuse of CNS stimulants, including methylphenidate hydrochloride, 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 reevaluate the need for methylphenidate hydrochloride use. Tolerance Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the   drug's desired and/or   undesired effects over time) can occur during chronic therapy with CNS stimulants, including methylphenidate hydrochloride. Dependence Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist)may occur in patients treated with CNS stimulants, including methylphenidate hydrochloride. 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.

Product summary:

10 mg tablets: Round, light blue to blue uncoated tablet, debossed with "A63" on one side and functionally scored on other side, may have mottled appearance. NDC 63629-9471-01 Bottles of 100 Tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drugdisposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tabletsby a medicine takeback program or by an authorized collector registered with the Drug EnforcementAdministration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets 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 tablets in the householdtrash. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPHENIDATE HYDROCHLORIDE- METHYLPHENIDATE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METHYLPHENIDATE HYDROCHLORIDE TABLETS.
METHYLPHENIDATE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE AND DEPENDENCE
_SEE FULL PRESCRIBING INFORMATIONFORCOMPLETE BOXED WARNING._
CNS STIMULANTS, INCLUDING METHYLPHENIDATE HYDROCHLORIDE TABLETS, 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 is a centralnervoussystem(CNS) stimulant
indicated for the treatment of
Attention Deficit Hyperactivity Disorders(ADHD) and Narcolepsy(1). (1)
DOSAGE AND ADMINISTRATION
_Methylphenidate Hydrochloride Tablets _(2.2):
Pediatric Patients 6 Years and Older:Start with 5 mg twice daily
(before breakfast and lunch), titrating
the dose weekly in 5- to 10- mg increments. Dosages above 60 mg/dayare
not recommended.
Adults: Average daily dosage is 20 mg to 30 mg,administered 2 or 3
times daily,preferably 30 to 45
minutes before meals. Maximum total daily dosage is 60 mg.
DOSAGE FORMS AND STRENGTHS
Tablets: 5mg, 10mg, and 20 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other product components
of methylphenidate
hydrochloride tablets (4).
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use
of an MAOI within the
preceding 14 days (4).
WARNINGS AND PRECAUTIONS
_Serious CardiovascularEvents_:Sudden death has been reported in
association with CNS-stimulant
treatment at usual doses in pediatric patients with structural cardiac
abnormalities or other serious
heart problems.In adults, sudden death, stroke, and
myocardialinfarct