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APTENSIO XR

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Overview

What is APTENSIO XR?

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 (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is CHNO●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.

Inactive Ingredients:

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



What does APTENSIO XR look like?



What are the available doses of APTENSIO XR?

What should I talk to my health care provider before I take APTENSIO XR?

How should I use APTENSIO XR?

APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) 

The recommended starting dose of APTENSIO XR for patients 6 years and above is 10 mg once daily in the morning with or without food. Advise patients to establish a routine pattern with regard to meals. The dose should be individualized according to the needs and response of the patient.

The dose may be titrated weekly in increments of 10 mg. Daily doses above 60 mg have not been studied and are not recommended.

APTENSIO XR may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of APTENSIO XR, and adjust dosage as needed.


What interacts with APTENSIO XR?

Sorry No Records found


What are the warnings of APTENSIO XR?

Sorry No Records found


What are the precautions of APTENSIO XR?

Sorry No Records found


What are the side effects of APTENSIO XR?

Sorry No records found


What should I look out for while using APTENSIO XR?

Known hypersensitivity to methylphenidate or product components ()

Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ()

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 Warning and Precautions (), Drug Abuse and Dependence ( )]


What might happen if I take too much APTENSIO XR?


How should I store and handle APTENSIO XR?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.APTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg CapsulesAPTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows:10 mg Capsules15 mg Capsules20 mg Capsules30 mg Capsules40 mg Capsules50 mg Capsules60 mg Capsules


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Methylphenidate HCl is a central nervous system (CNS) stimulant.

Non-Clinical Toxicology
Known hypersensitivity to methylphenidate or product components ()

Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ()

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 Warning and Precautions (), Drug Abuse and Dependence ( )]

Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients.

Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs.

Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.

A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).

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 .

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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