Methylphenidate Hydrochloride Tablet, Extended Release
Product Images NDC 72865-133

This is a description of a medication called Methylphenidate Hydrochloride in the form of extended release tablets. The package contains 100 tablets with each tablet having 18mg of methylphenidate hydrochloride in a controlled-release formulation. The usual dosage is once daily and there is dosage information provided in the package insert. The medication guide enclosed should be given to each patient. The medication should be stored at a temperature of 20° to 25°C and protected from humidity. The drug was manufactured for XLCare Pharmaceuticals, Inc. by Ascent Pharmaceuticals, Inc.*

This is a medication guide for Methylphenidate Hydrochloride Extended-Release Tablets, USP. It is recommended to dispense this medication to patients once daily according to package instructions. Each tablet contains 27mg of controlled release formulation of methylphenidate. The medication is to be stored at 20°C to 25°C (68°F to 77°F) and protected from humidity. Manufacturing is done by Ascent Pharmaceuticals, Inc and it is a product by XL Care Pharmaceuticals, Inc.*

This is a description of a medication in tablet form called "Methylphenidate Hydrochloride," which is made by a pharmaceutical company called "broscromany." The tablet contains 36 mg of the medication and is considered an extended-release formulation. The usual dosage is provided in a package insert. The medication should be stored at 68°F to 77°F. The tablets are manufactured by Ascent Pharmaceuticals, Inc. and the medication guide should be given to each patient by the pharmacist. The text also provides the manufacturer's address and the product's RxOnly status.*

XLcare Pharmaceuticals, Inc. is a pharmaceutical company that produces and distributes Methylphenidate Hydrochloride Extended-Release Tablets, USP. Each tablet contains 54mg of Methylphenidate hydrochloride in a controlled-release formulation, and is packaged with an enclosed Medication Guide to be dispensed to each patient. The usual dosage for this medication is once daily, and more detailed dosage information can be found in the package insert. The tablets should be stored at a temperature between 20°C to 25°C (68°F to 77°F), and should be protected from humidity. The tablets are manufactured by Ascent Pharmaceuticals, Inc. and distributed by XLCare Pharmaceuticals, Inc.*

The text provides a graph (Figure 1) showing the mean plasma concentrations of methylphenidate in 36 adults after taking a single dose of extended-release methylphenidate hydrochloride tablets 18 mg once daily and immediate-release methylphenidate 5 mg three times daily every 4 hours.*

The text provides a figure (Figure 2) that shows the mean scores on the IOWA Conners Inattention/Overactivity Scale for community school teachers who were given different doses of methylphenidate hydrochloride extended-release tablets (18, 36, or 54 mg) or a placebo. There were three studies involved in this analysis. Studies 1 and 2 were crossover studies with one week per treatment arm while Study 3 involved 4 weeks of parallel-group treatments. The Last Observation Carried Forward analysis was utilized at week four for Study 3. The error bars in the figure represent the standard error of the mean.*

This is a graph displaying the mean (SEM) of Combined Attention ratings for a study involving Laboratory School Teachers, comparing the effects of Methylphenidate hydrochloride extended-release tablets taken once daily versus a placebo. The X-axis represents the hours post initial dose.*

This text provides a table containing recommended starting doses and dose ranges for Methylphenidate Hydrochloride Extended-Release Tablets based on the patient's age. The starting dose varies between 18 to 36 mg/day, and the dose range varies between 18 to 72 mg/day, depending on the age of the patient. For children aged between 6-12 years, the starting dose is 18 mg/day, while for adolescents aged between 13-17 years, it is also 18 mg/day (but not to exceed 2 mg/kg/day). For adults aged between 18-85 years, the starting dose could be either 18 mg/day or 36 mg/day.*

This is a table displaying the recommended dosage conversion from methylphenidate to methylphenidate hydrochloride extended-release tablets. It suggests the starting dosage of methylphenidate hydrochloride extended-release tablets for patients who were previously prescribed 5 mg, 10 mg, 15 mg, or 20 mg of methylphenidate twice or three times daily. The table recommends 18 mg, 36 mg, 54 mg, and 72 mg of methylphenidate hydrochloride extended-release tablets once every morning for the respective previous doses of methylphenidate.*

This is a table providing information on the exposure of Methylphenidate Hydrochloride Extended-Release Tablets in various clinical studies with different patient populations categorized into Children, Adolescents, and Adults. The table provides the number of patients and the dose range in mg for each category.*

Table 4 shows the adverse reactions reported in clinical trials of Methylphenidate Hydrochloride Extended-Release Tablets in children and adolescents. The table compares the incidence of adverse reactions between subjects treated with the tablets and those treated with a placebo. The most common adverse reactions reported were vomiting, nasopharyngitis, and insomnia.*

This text presents pharmacokinetic parameters for methylphenidate hydrochloride extended-release tablets in healthy adults. The parameters include Cmax, Trnax, and AUC, measured in ng/mL, hours, and ngeh/mL, respectively, after a single dose of either 5 mg three times daily or 18 mg once daily. There were 35 and 36 participants in each group, respectively. Mean and standard deviation values are reported for each parameter.*