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Atuss-12 DM Side Effects

Generic Name: chlorpheniramine / dextromethorphan / pseudoephedrine

Note: This document contains side effect information about chlorpheniramine / dextromethorphan / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Atuss-12 DM.

For the Consumer

Applies to chlorpheniramine / dextromethorphan / pseudoephedrine: oral liquid, oral syrup

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

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 chlorpheniramine / dextromethorphan / pseudoephedrine: oral liquid, oral suspension extended release, oral tablet chewable

Nervous system

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.[Ref]

Nervous system side effects of chlorpheniramine have included drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine.

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation in up to one-third of treated patients.

Gastrointestinal side effects of dextromethorphan have included stomach upset.

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.[Ref]

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 (simulated) 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 chlorpheniramine have included hypotension, tachycardia, and palpitations.

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

Ocular

Ocular effects of chlorpheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects of chlorpheniramine have included dysuria, urinary hesitancy, and a decreased urine flow. In rare cases, the anticholinergic effect of chlorpheniramine has precipitated acute urinary retention.[Ref]

Hematologic

Hematologic side effects of chlorpheniramine have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[Ref]

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.

Hypersensitivity side effects of pseudoephedrine have included fixed-drug eruptions.[Ref]

References

1. Lyon CC, Turney JH "Pseudoephedrine toxicity in renal failure." Br J Clin Pract 50 (1996): 396-7

2. Bantz EW, Dolen WK, Chadwick EW, Nelson HS "Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance." Ann Allergy 59 (1987): 341-6

3. Bostwick JM "Dextromethorphan-induced manic symptoms in a bipolar patient on lithium." Psychosomatics 37 (1996): 571-2

4. Polles A, Griffith JL "Dextromethorphan-induced mania." Psychosomatics 37 (1996): 71-4

5. Krause LB, Shuster S "A comparison of astemizole and chlorpheniramine in dermographic urticaria." Br J Dermatol 112 (1985): 447-53

6. Schuller DE, Turkewitz D "Adverse effects of antihistamines." Postgrad Med 79 (1986): 75-86

7. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4

8. Taylor DM, O'Toole KS, Auble TE, Ryan CM, Sherman DR "The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment." Pharmacotherapy 20 (2000): 1045-50

9. "Product Information. Chlortrimeton (chlorpheniramine)." Schering-Plough, Liberty Corner, NJ.

10. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13

11. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10

12. Knowles SR, Weber E "Dextromethorphan anaphylaxis." J Allerg Clin Immunol 102 (1998): 316-7

Some side effects of Atuss-12 DM 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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