Pramoxine

Pramoxine
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

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

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Pramoxine is a local anesthetic that is FDA approved for the treatment of for the temporary relief of itching associated with minor skin irritations. Common adverse reactions include contact dermatitis, eczema.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• For the temporary relief of itching associated with minor skin irritations

Dosing information

• To open, squeeze cap tightly and turn pump counter-clockwise.
• Adults and children 2 years of age and older:

• apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a doctor.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Pramoxine Contraindications in the drug label.

Warnings

• For external use only

• When using this product

• avoid contact with the eyes.

• Stop use and ask a doctor if

• condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days.

• Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.

• Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pramoxine in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Pramoxine in the drug label.

Drug Interactions

There is limited information regarding Pramoxine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C There is no FDA guidance on usage of Pramoxine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pramoxine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Topical

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Mechanism of Action

There is limited information regarding Pramoxine Mechanism of Action in the drug label.

Structure

There is limited information regarding Pramoxine Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Pramoxine How Supplied in the drug label.

Storage

There is limited information regarding Pramoxine 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 Pramoxine in the drug label.

Precautions with Alcohol

• Alcohol-Pramoxine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Curasore
• Prax
• Proctofoam-NS
• Tronolane
• Sarna Sensitive
• Proctofoam
• PramoxGel

Look-Alike Drug Names

There is limited information regarding Pramoxine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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