METHYLPHENIDATE HYDROCHLORIDE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lupin Pharmaceuticals,Inc.

INN (International Adı):

METHYLPHENIDATE HYDROCHLORIDE

Kompozisyon:

METHYLPHENIDATE HYDROCHLORIDE 5 mg in 5 mL

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Methylphenidate hydrochloride oral solution is indicated for the treatment of: -   Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older -   Narcolepsy Methylphenidate hydrochloride oral solution is contraindicated in patients: - with known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride oral solution. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6)]. - receiving 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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride oral solution, 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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m2 basis. However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults. 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 7 times the MRHD given to adults (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 oral solution, 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 65 times the MRHD of 60 mg/day given to adults on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (19 times the MRHD given to adults 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 (12 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 (4 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 (7 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 adults 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 oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution 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 oral solution for the treatment of ADHD have been established in pediatric patients six years of age and older. The safety and effectiveness of methylphenidate hydrochloride oral solution in pediatric patients under six years of age have not been established. The long-term efficacy of methylphenidate in pediatric patients has not been established. Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride oral solution. 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 -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 (5 mg/kg/day) is less than 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 oral solution has not been studied in the geriatric population. Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride, a Schedule II controlled substance. Methylphenidate hydrochloride oral solution has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)]. Methylphenidate hydrochloride oral solution can be diverted for nonmedical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological 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. Misuse and abuse of methylphenidate may cause increased heart rate, respiratory rate, or blood pressure; 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 with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride oral solution, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection. Physical Dependence Methylphenidate hydrochloride oral solution may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including methylphenidate hydrochloride oral solution include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. Tolerance Methylphenidate hydrochloride oral solution may produce tolerance. 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).

Ürün özeti:

How Supplied Methylphenidate hydrochloride oral solution is a colorless, grape flavored liquid available in the following strengths: Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride oral solution 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 oral solution 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 oral solution in the household trash.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Lupin Pharmaceuticals,Inc.
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SPL MEDGUIDE
Methylphenidate Hydrochloride (METH-il-FEN-i-date-hye-droe-KLOR-Ide)
oral solution, CII
What is the most important information I should know about
methylphenidate hydrochloride oral
solution?
Methylphenidate hydrochloride oral solution can cause serious side
effects, including:
•
Abuse, misuse, and addiction. methylphenidate hydrochloride oral
solution has a high chance for
abuse and misuse and may lead to substance use problems, including
addiction. Misuse and abuse
of methylphenidate hydrochloride oral solution, other methylphenidate
containing medicines, and
amphetamine containing medicines, can lead to overdose and death. The
risk of overdose and
death is increased with higher doses of methylphenidate hydrochloride
oral solution or when it is
used in ways that are not approved, such as snorting or injection.
•
Your healthcare provider should check you or your child's risk for
abuse, misuse, and addiction
before starting treatment with methylphenidate hydrochloride oral
solution and will monitor you
or your child during treatment.
•
Methylphenidate hydrochloride oral solution may lead to physical
dependence after prolonged
use, even if taken as directed by your healthcare provider.
•
Do not give methylphenidate hydrochloride oral solution to anyone
else. See "What is
methylphenidate hydrochloride oral solution?"for more information.
•
Keep methylphenidate hydrochloride oral solution in a safe place and
properly dispose of any
unused medicine. See "How should I store methylphenidate hydrochloride
oral solution?" for
more information.
•
Tell your healthcare provider if you or your child have ever abused or
been dependent on alcohol,
prescription medicines, or street drugs.
•
Risks for people with serious heart disease. Sudden death has happened
in people who have heart
defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for
heart problems before starting
treatment with methylphenidate hydrochlor

Ürün özellikleri

METHYLPHENIDATE HYDROCHLORIDE - METHYLPHENIDATE
HYDROCHLORIDE SOLUTION
LUPIN PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLPHENIDATE
HYDROCHLORIDE ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION.
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE, MISUSE AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION HAS A HIGH POTENTIAL FOR
ABUSE AND
MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER,
INCLUDING
ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING
METHYLPHENIDATE
HYDROCHLORIDE ORAL SOLUTION, CAN RESULT IN OVERDOSE AND DEATH (5.1,
9.2, 10):
BEFORE PRESCRIBING METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION, ASSESS
EACH
PATIENT'S RISK FOR ABUSE, MISUSE, AND ADDICTION.
EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE RISKS, PROPER STORAGE
OF THE DRUG,
AND PROPER DISPOSAL OF ANY UNUSED DRUG.
THROUGHOUT TREATMENT, REASSESS EACH PATIENT'S RISK AND FREQUENTLY
MONITOR FOR SIGNS
AND SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION.
INDICATIONS AND USAGE
Methylphenidate hydrochloride is a central nervous system (CNS)
stimulant indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and
pediatric patients 6 years of age and
older (1)
Narcolepsy (1)
DOSAGE AND ADMINISTRATION
Pediatric patients 6 years and older: Starting dose is 5 mg twice
daily (before breakfast and lunch);
increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is
not recommended. (2.2)
Adults: Administer in divided doses 2 or 3 times daily, preferably 30
to 45 minutes before meals.
Average dosage is 20 to 30 mg daily. Maximum recommended daily dosage
is 60 mg. (2)
DOSAGE FORMS AND STRENGTHS
Oral solution: 5 mg per 5 mL and 10 mg per 5 mL. (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to methylphenidate or other components o