Dexmethylphenidate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
DRUG DEPENDENCE:
See full prescribing information for complete Boxed Warning.
Dexmethylphenidate hydrochloride tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- Dosing Information
- Dosage
Condition2
- Dosing Information
- Dosage
Condition3
- Dosing Information
- Dosage
Condition4
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Dexmethylphenidate in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexmethylphenidate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Dexmethylphenidate in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Dexmethylphenidate in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexmethylphenidate in pediatric patients.
Contraindications
- Condition1
Warnings
DRUG DEPENDENCE:
See full prescribing information for complete Boxed Warning.
Dexmethylphenidate hydrochloride tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
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- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Dexmethylphenidate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dexmethylphenidate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dexmethylphenidate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dexmethylphenidate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dexmethylphenidate with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Dexmethylphenidate with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Dexmethylphenidate with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dexmethylphenidate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dexmethylphenidate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dexmethylphenidate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dexmethylphenidate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dexmethylphenidate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dexmethylphenidate in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Dexmethylphenidate in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Dexmethylphenidate in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Dexmethylphenidate in the drug label.
Pharmacology
There is limited information regarding Dexmethylphenidate Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dexmethylphenidate in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Dexmethylphenidate in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dexmethylphenidate in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Dexmethylphenidate in the drug label.
How Supplied
Storage
There is limited information regarding Dexmethylphenidate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dexmethylphenidate in the drug label.
Precautions with Alcohol
- Alcohol-Dexmethylphenidate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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