Aprodine

Name: Aprodine

What is pseudoephedrine and triprolidine?

Triprolidine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of pseudoephedrine and triprolidine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Pseudoephedrine and triprolidine may also be used for purposes not listed in this medication guide.

How should I take pseudoephedrine and triprolidine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

For the Consumer

Applies to pseudoephedrine / triprolidine: oral liquid, oral tablet

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to pseudoephedrine / triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported with the use of pseudoephedrine. Antihistamines such as triprolidine have been reported to cause drowsiness.[Ref]

Gastrointestinal

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine. Antihistamines such as triprolidine have also been reported to cause dry mouth. Pseudoephedrine-triprolidine may cause diarrhea.[Ref]

Hypersensitivity

Hypersensitivity side effects with the use of pseudoephedrine have included fixed drug eruptions.[Ref]

Some side effects of Aprodine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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