METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

KVK-Tech, Inc.

Designación común internacional (DCI):

METHYLPHENIDATE HYDROCHLORIDE

Composición:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Methylphenidate hydrochloride extended-release 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 extended-release tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [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 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 extended-release tablets, 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 extended-release tablets, 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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 tablets and any potential adverse effects on the breastfed infant from Methylphenidate hydrochloride extended-release tablets 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 tablets for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of Methylphenidate hydrochloride extended-release tablets in pediatric patients less than 6 years have not been established. The long-term efficacy of Methylphenidate hydrochloride extended-release tablets in pediatric patients has not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including Methylphenidate hydrochloride extended-release tablets. 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/m 2 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/m 2 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/m 2 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/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown. Methylphenidate hydrochloride tablet has not been studied in the geriatric population. Methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a Schedule II controlled substance. CNS stimulants, including Methylphenidate hydrochloride extended-release tablets, have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, 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 stimulants may 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 extended-release tablets, 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 extended-release tablets 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 extended-release tablets. 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 extended-release tablets. 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.

Resumen del producto:

Methylphenidate hydrochloride extended-release tablets, USP are available as follows: Tablets 10 mg – White to off-white, round, biconvex tablets debossed “K75” on one side and plain on the other side. Bottles of 60 NDC 10702-075-06 Bottles of 100 NDC 10702-075-01 Tablets 20 mg – White to off-white, round, biconvex tablets debossed “K76” on one side and plain on the other side. Bottles of 60 NDC 10702-076-06 Bottles of 100 NDC 10702-076-01 Note: Methylphenidate hydrochloride extended-release tablets are color additive free. Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [see USP controlled room temperature]. Protect from moisture. Dispense in tight, light-resistant container, as defined in the USP, with a child-resistant closure. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets, USP by a medicine takeback 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 tablets, USP 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 tablets, USP in the household trash.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

EXTENDED RELEASE TABLET
KVK-Tech, Inc.
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MEDICATION GUIDE
Methylphenidate Hydrochloride Extended-Release Tablets CII
(meth’’ il fen’ i date hye’’ droe klor’ ide)
What is the most important information I should know about
Methylphenidate hydrochloride extended-
release tablets?
Methylphenidate hydrochloride extended-release tablets is a federal
controlled substance (CII) because it
can be abused or lead to dependence. Keep Methylphenidate
hydrochloride extended-release tablets in a
safe place to prevent misuse and abuse. Selling or giving away
Methylphenidate hydrochloride extended-
release tablets may harm others, and is against the law. Tell your
doctor if you or your child have ever
abused or been dependent on alcohol, prescription medicines or street
drugs.
The following have been reported with use of methylphenidate
hydrochloride 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 methylphenidate
hydrochloride extended-release tablets.
Your doctor should check your or your childs blood pressure and heart
rate regularly during treatment
with methylphenidate hydrochloride extended-release tablets.
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 methylphenidate
hydrochloride extended-release tablets.
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
•
new psychotic symptoms (such as hearing voices, believing things that
are not true, are
suspicious) or new manic symptoms
Tell your doctor abo

Ficha técnica

METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE- METHYLPHENIDATE
HYDROCHLORIDE EXTENDED RELEASE TABLET
KVK-TECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP CII SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
USP CII.
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 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 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 extended-release tablet is a central
nervous system (CNS) stimulant
indicated for the treatment of Attention Deficit Hyperactivity
Disorders (ADHD) and Narcolepsy (1). (1)
DOSAGE AND ADMINISTRATION
_Methylphenidate hydrochloride extended-release tablets_ (2.2):
• May switch to Methylphenidate hydrochloride extended-release
tablets when the 8-hour dosage of
Methylphenidate hydrochloride extended-release tablets corresponds to
the titrated 8-hour dosage of
methylphenidate hydrochloride tablets.
• Must be swallowed whole and never crushed or chewed. (2)
DOSAGE FORMS AND STRENGTHS
• Extended-Release Tablets: 10 mg and 20 mg (3) (3)
CONTRAINDICATIONS
• Known hypersensitivity to methylphenidate or other product
components of Methylphenidate
hydrochloride extended-release tablets (4).
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or
use of an MAOI within the
preceding 14 days (4). (4)
WARNINGS AND PRECAUTIONS
• _Serious Cardiovascular Events_: Sudden death has been reported in
association with CNS-stimulant