Alaradate(Methylphenidate Hydrochloride)
Therapeutic Group: Non-sedating antihistamine agent
Presentation
AlaradateTM 10: Each tablet contains Methylphenidate Hydrochloride USP 10 mg.
AlaradateTM Oral Solution: Each 5 ml solution contains Methylphenidate Hydrochloride USP 5 mg.
Description
Methylphenidate is a central nervous system (CNS) stimulant.
Indications
Methylphenidate is indicated for treatment of Attention Deficit Hyperactivity Disorders (ADHD) and
Narcolepsy.
Dosage & Administration
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/day are not recommended.
Adults: 20 to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 pm.
Precautions
Methylphenidate have a high potential for abuse and dependence. Avoid use in patients with known serious structural cardiac abnormalities, hypertension and, tachycardia, psychosis, priapism and long-term suppression of growth.
Use in Pregnancy & Lactation
Pregnancy & Lactation: Pregnancy Category C. Adequate and well-controlled studies in pregnant women have not been conducted. It is not known whether Methylphenidate is excreted in human milk.
Pediatric use: The safety, efficacy, and pharmacokinetics of Methylphenidate in pediatric patients less than 6 years of age have not been evaluated.
Geriatric use: Methylphenidate in geriatric patients have not been evaluated.
Over Dose
Signs and symptoms of acute overdosage may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis and rhabdomyolysis.
Storage
Do not store above 30 ºC. Keep away from light and out of the reach of children.
Commercial Pack
AlaradateTM 10: Each tablet contains Methylphenidate Hydrochloride USP 10 mg.
AlaradateTM Oral Solution: Each 5 ml solution contains Methylphenidate Hydrochloride USP 5 mg.