DailyMed Label: Dexmethylphenidate Hydrochloride

DailyMed Label: Dexmethylphenidate Hydrochloride

2024

DailyMed Prescription

Dexmethylphenidate Hydrochloride

Dexmethylphenidate Hydrochloride

Bryant Ranch Prepack

NDC: 63629-2171

NDC: 63629-2171

NDC: 63629-2171

NDC: 63629-2171

Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is intended for oral administration and is is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note* = asymmetric carbon center Dexmethylphenidate hydrochloride 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 g/mol. Inactive ingredients methacrylic acid copolymer, amino methacrylate copolymer, triethyl citrate, talc, sugar spheres, polyethylene glycol, gelatin, titanium dioxide and black ink. The black ink contains shellac glaze, iron oxide black, n-butyl alcohol, propylene glycol, FD&C blue #1, FD&C Blue #2, FD&C Red # 40 and D&C Yellow #10. The 5 mg also contains FD& C Blue #1 and FD&C Red #3. The 10 mg contains FD&C Yellow #6. The 15 mg contains FD&C Blue #1and FD&C Yellow #6. The 25 mg, 30 mg, 35 mg and 40 mg contains yellow iron oxide.

Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )].

5 mg, extended-release capsule, light blue opaque body and light blue opaque capsule, imprinted in black ink “par” on capsule and 048 on body. 10 mg, extended-release capsule, beige opaque body and beige opaque capsule, imprinted in black ink “par” on capsule and 049 on body. 15 mg, extended-release capsule, spring green opaque body and spring green opaque capsule, imprinted in black ink “par” on capsule and 090 on body. 20 mg, extended-release capsule, white opaque body and white opaque capsule, imprinted in black ink “par” on capsule and 248 on body. 25 mg, extended-release capsule, white opaque body and yellow transparent capsule, imprinted in black ink “par” on capsule and 333 on body. 30 mg, extended-release capsule, white opaque body and yellow transparent capsule, imprinted in black ink “par” on capsule and 539 on body. 35 mg, extended-release capsule, white opaque body and yellow transparent capsule, imprinted in black ink “par” on capsule and 339 on body. 40 mg, extended-release capsule, white opaque body and yellow transparent  capsule, imprinted in black ink “par” on capsule and 546 on body.

Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )]. 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 )].

The following are discussed in more detail in other sections of the labeling:

Dexmethylphenidate hydrochloride extended-release capsules are available as follows: 10 mg Extended Release Capsules (NDC 63629-2171-1) beige opaque body with a beige opaque cap printed with “par” on capsule and 049 on body in black ink supplied in bottles of 100. Store dexmethylphenidate hydrochloride extended-release capsules at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° C to 30°C (59°F to 86°F)[See USP Controlled Room Temperature.] Dispense in tight container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride extended-release 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 dexmethylphenidate hydrochloride extended-release with an undesirable, non-toxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard dexmethylphenidate hydrochloride extended-release in the household trash. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Dexmethylphenidate hydrochloride is a (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

Carcinogenesis Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg/day of racemic methylphenidate given to children on a mg/m 2 basis. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 4 times the MRHD (children) of 60mg/day racemic methylphenidate in children on a mg/m 2 basis. In a 24-week carcinogenicity study with racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60 to 74 mg/kg/day of racemic methylphenidate. Mutagenesis Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vivo mouse bone marrow micronucleus test. In an in vitro assay using cultured Chinese Hamster Ovary cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response. Impairment of Fertility No human data on the effect of methylphenidate on fertility are available. Fertility studies have not been conducted with dexmethylphenidate. Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses of up to 160 mg/kg/day, approximately 10 times the MRHD of 60 mg/day of racemic methylphenidate given to adolescents on a mg/m 2 basis.

Dexmethylphenidate Hcl 10 mg Cap, #100