Trolamine Salicylate

Trolamine Salicylate
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: Kiran Singh, M.D. [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

Trolamine Salicylate is an analgesic that is FDA approved for the treatment of musculoskeletal pain and osteoarthritis. Common adverse reactions include erythema, skin irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Temporarily relieves minor pain associated with:

• Arthritis
• Simple backache
• Muscle strains
• Sprains
• Bruises

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• There is limited information regarding FDA-Labeled Use of Trolamine Salicylate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Trolamine Salicylate Contraindications in the drug label.

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

• Use only as directed
• Do not bandage tightly or use with a heating pad
• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds or damaged skin

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

• Redness is present

• Irritation develops

If pregnant or breast-feeding

• Ask a health professional before use.

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 Trolamine Salicylate in the drug label.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Trolamine Salicylate in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Topical

Adults and children over 12 years:

• Apply generously to affected area

• Massage into painful area until thoroughly absorbed into skin

• Repeat as necessary, but not more than 4 times daily

Monitoring

There is limited information regarding Monitoring of Trolamine Salicylate in the drug label

IV Compatibility

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

Overdosage

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

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

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

Structure

There is limited information regarding Structure of Trolamine Salicylate in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

There is limited information regarding Trolamine Salicylate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

• TROLAMINE SALICYLATE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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