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(methylphenidate hydrochloride) Extended-release Capsules
ABUSE AND DEPENDENCE
CNS stimulants, including APTENSIO XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence].
APTENSIO XR is a central nervous system (CNS) stimulant. APTENSIO XR capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. APTENSIO XR is available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2piperidineacetate hydrochloride. Its molecular formula is C14H19NO2•HCl. Its structural formula is:
Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline 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.
sugar spheres, hypromelloses, polyethylene glycol, ammonio methacrylate copolymer, type B; methacrylic acid copolymer, type C; triethyl citrate, talc, colloidal silicon dioxide (added if necessary), titanium oxide, and gelatin.
Each strength capsule also contains colorant ingredients in the capsule shell as follows:
10 mg: FD&C Blue No. 1
15 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 20 mg: D&C Red No. 33, D&C Yellow No. 10
30 mg: FD&C Blue No. 1, FD&C Red No. 3
40 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40
50 mg: D&C Yellow No. 10, FD&C Green No. 3
60 mg: Black Iron Oxide
Last reviewed on RxList: 1/23/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Aptensio XR Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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