Dalfampridine: Difference between revisions

Dalfampridine
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 16:02, 31 March 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Overview

Dalfampridine is a potassium channel blocker that is FDA approved for the treatment of multiple sclerosis. Common adverse reactions include urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

AMPYRA (dalfampridine) is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed

Dosage

The maximum recommended dose of AMPYRA is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. Tablets should only be taken whole; do not divide, crush, chew, or dissolve. Patients should not take double or extra doses if a dose is missed.

Estimated creatinine clearance (CrCl) should be known before initiating treatment with AMPYRA, and monitored at least annually during treatment with AMPYRA. CrCl can be estimated using the following equation (multiply by 0.85 for women):

CrCl = (140 - age) × weight(kg) SerumCr(mg/dl)× 72 In patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of AMPYRA should be carefully considered against the risk of seizures in these patients [see WARNINGS AND PRECAUTIONS (5.2) and CLINICAL PHARMACOLOGY (12.4)].

No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses

DOSAGE FORMS AND STRENGTHS

AMPYRA is available in a 10 mg strength and is a film-coated, white to off-white, biconvex, oval shaped, non-scored tablet with flat edge, debossed with "A10" on one side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dalfampridine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dalfampridine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Dalfampridine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dalfampridine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dalfampridine in pediatric patients.

Contraindications

Condition1

Warnings

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dalfampridine 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 Dalfampridine 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 (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dalfampridine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dalfampridine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dalfampridine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dalfampridine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dalfampridine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dalfampridine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dalfampridine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dalfampridine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dalfampridine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dalfampridine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dalfampridine in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Dalfampridine in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Dalfampridine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Dalfampridine in the drug label.

Pharmacology

There is limited information regarding Dalfampridine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dalfampridine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dalfampridine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dalfampridine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dalfampridine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dalfampridine in the drug label.

How Supplied

Storage

There is limited information regarding Dalfampridine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Dalfampridine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dalfampridine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dalfampridine in the drug label.

Precautions with Alcohol

Alcohol-Dalfampridine 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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[1] Empty citation (help)

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[1]

[2]

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+* AMPYRA (dalfampridine) is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed
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+* The maximum recommended dose of AMPYRA is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. Tablets should only be taken whole; do not divide, crush, chew, or dissolve. Patients should not take double or extra doses if a dose is missed.
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+In patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of AMPYRA should be carefully considered against the risk of seizures in these patients [see WARNINGS AND PRECAUTIONS (5.2) and CLINICAL PHARMACOLOGY (12.4)].
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+====DOSAGE FORMS AND STRENGTHS====
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