trolamine salicylate

Trolamine salicylate is a medication used for temporary relief from mild to moderate aches and pains of muscles and joints, associated with conditions such as arthritis, rheumatism, lower back pain, muscle sprains and strains, muscle soreness from exercise, cramps, bruises, and tendon or ligament pains. Trolamine salicylate is a topical pain-relief (analgesic) cream available over the counter (OTC). Trolamine salicylate relieves pain by reducing inflammation in the treatment region, however, it does not cure the underlying condition.

Trolamine salicylate works by inhibiting the activity of cyclo-oxygenase (COX) enzymes, which are responsible for initiating inflammatory responses in muscle and joint disorders. COX enzymes initiate the synthesis and release of pro-inflammatory substances such as prostaglandins and thromboxane when there is an injury or inflammation in the joints or muscles, which results in pain, swelling and other inflammation symptoms. Trolamine salicylate inhibits the inflammatory process and temporarily prevents pain generation.

• Do not use if you are hypersensitive to salicylates, aspirin, trolamine salicylate, or any of its components. Use with caution if you are prone to allergic reactions.
• Do not use trolamine salicylate to treat children younger than 2 years of age.
• Avoid applying trolamine salicylate over a large area or for prolonged periods, particularly in young children.
• Do not apply on wounds or damaged skin.
• Do not cover tightly with a bandage.
• Do not apply external heat, including a heat pad, after topical application.
• Avoid contact with eyes and mucous membranes.
• Stop using trolamine salicylate and consult with your physician if
  • Your condition worsens
  • Redness of the skin occurs
  • You develop skin irritation
  • Symptoms persist for more than 7 days or clear up and reoccur within a few days

Common side effects of trolamine salicylate include:

• Application site reactions such as:
• Blistering
• Peeling
• Redness
• Irritation
• Nausea
• Diarrhea
• Vomiting
• Fast breathing (hyperventilation)
• Ringing in the ears (tinnitus)
• Confusion
• Drowsiness

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Topical Cream

• 10%

Analgesia for Minor Muscle/Joint Pain

Adult:

• Apply liberal amount topically to affected area and massage three/four times daily

Pediatric:

• Children below 2 years: Safety and efficacy not established
• Children above 2 years: Apply liberal amount topically to affected area and massage three/four times daily

Overdose

• Topical use of trolamine salicylate is unlikely to result in overdose. Oral ingestion of trolamine salicylate can be harmful.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Trolamine salicylate has no listed severe or serious interactions with other drugs.
• Moderate interactions of trolamine salicylate include:
  • warfarin
• Trolamine salicylate has no listed mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the safety of trolamine salicylate use during pregnancy. Up to 20 weeks of pregnancy, trolamine salicylate may be used with caution in pregnant women, only if clearly needed. Trolamine salicylate is not recommended for use from 20 weeks of pregnancy until delivery.
• It is not known if trolamine salicylate is present in breast milk.
• If you are pregnant or breastfeeding, do not use any OTC products, including trolamine salicylate, without first checking with your healthcare provider.

• Use trolamine salicylate exactly as per label directions.
• Trolamine salicylate is for external use only.
• Avoid taking a bath or shower within 1 hour before or after application of trolamine salicylate.
• Store safely away from the reach of children.
• In case of oral ingestion of trolamine salicylate, seek immediate medical help or contact Poison Control.