Methylphenidate Hydrochloride (CD) (Page 4 of 8)

8.2 Lactation

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.

8.4 Pediatric Use

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.

8.5 Geriatric Use

Methylphenidate hydrochloride extended-release capsules (CD) have not been studied in patients over the age of 65 years.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Methylphenidate hydrochloride extended-release capsules (CD) contain methylphenidate hydrochloride, a Schedule II controlled substance.

9.2 Abuse

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.

9.3 Dependence

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).

10 OVERDOSAGE

Human Experience
Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.

Overdose Management
Consult with a Certified Poison Control Center (1-800-222-1222) for guidance and advice on the management of overdosage with methylphenidate. Provide supportive care, including close medication supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdosage.

11 DESCRIPTION

Methylphenidate hydrochloride extended-release capsules (CD) contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules provide 30% of the dose by the immediate release (IR) component and 70% of the dose by an extended release (ER) component in a single bead type. Methylphenidate hydrochloride extended-release capsules (CD) is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration.

Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo -methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C14 H19 NO2 •HCl. Its structural formula is:

structure

Methylphenidate hydrochloride, USP is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.

Methylphenidate hydrochloride extended-release capsules (CD) also contain the following inactive ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.

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