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Trinalin Repetabs Side Effects

Generic name: azatadine / pseudoephedrine

Note: This document contains side effect information about azatadine / pseudoephedrine. Some dosage forms listed on this page may not apply to the brand name Trinalin Repetabs.

Applies to azatadine/pseudoephedrine: oral tablet extended release.

Warning

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 use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

Keep using the medication and talk with your doctor if you have any of these less serious side effects:

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to azatadine / pseudoephedrine: oral tablet extended release.

Nervous system

Nervous system side effects have commonly occurred with azatadine administration, resulting in drowsiness in most patients. Azatadine has also caused dizziness and disrupted coordination.

Pseudoephedrine has produced nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also occurred in patients receiving pseudoephedrine.[Ref]

Nearly all patients treated with azatadine experience drowsiness. This drowsiness may subside in some patients with extended use. Patients should be warned against driving, as well as concomitant ingestion of alcohol and other sedative-hypnotic drugs, while taking azatadine.

At higher than normal doses of azatadine, dystonic reactions have occurred.[Ref]

Gastrointestinal

Gastrointestinal side effects from azatadine have included dry mouth and constipation due to its anticholinergic effects. Patients have also experienced epigastric distress and nausea. Increased appetite has been reported with azatadine use.

Pseudoephedrine has caused anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients.[Ref]

Cardiovascular

Cardiovascular side effects of pseudoephedrine have included significant increases in heart rate. Hypertension and arrhythmias have occurred in susceptible patients. Azatadine has rarely caused hypotension, tachycardia, and palpitations.[Ref]

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.[Ref]

Ocular

Ocular side effects of azatadine have included blurred vision, diplopia, and dry eyes due to its anticholinergic effect.[Ref]

Genitourinary

Genitourinary tract side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention. These effects may be due to azatadine's anticholinergic effect.[Ref]

Hematologic

Hematologic side effects have rarely been reported with azatadine use and include bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

Respiratory

Respiratory side effects have included thickening of bronchial secretions.[Ref]

Hypersensitivity

Hypersensitivity reactions to azatadine or pseudoephedrine have occurred. Fixed drug eruptions secondary to pseudoephedrine have been reported.[Ref]

References

1. Schuller DE, Turkewitz D. Adverse effects of antihistamines. Postgrad Med. 1986;79:75-86.

2. Azatadine (optimine)--a new antihistamine. Med Lett Drugs Ther. 1977;19:77-9.

3. Luscombe DK, Nicholls PJ, Spencer PS. Effect of azatadine on human performance. Br J Clin Pract. 1980;34:75-9.

4. Stroh JE, Jr Ayars GH, Bernstein IL, Kemp JP, Podleski WK, Prenner BM, Schoenwetter WF, Salzmann JK. A comparative tolerance study of terfenadine-pseudoephedrine combination tablets and pseudoephedrine tablets in patients with allergic or vasomotor rhinitis. J Int Med Res. 1988;16:420-7.

5. Loizou LA, Hamilton JG, Tsementzis SA. Intracranial haemorrhage in association with pseudoephedrine overdose. J Neurol Neurosurg Psychiatry. 1982;45:471-2.

6. Dickerson J, Perrier D, Mayersohn M, Bressler R. Dose tolerance and pharmacokinetic studies of L (+) pseudoephedrine capsules in man. Eur J Clin Pharmacol. 1978;14:253-9.

7. Covington TR, eds., Lawson LC, Young LL. Handbook of Nonprescription Drugs. Washington, DC: American Pharmaceutical Association. 1993.

8. Small P, Barrett D, Biskin N. Effects of azatadine, terfenadine, and astemizole on allergen-induced nasal provocation. Ann Allergy. 1990;64:129-31.

9. Joske DJ. Dystonic reaction to azatadine. Med J Aust. 1984;141:449.

10. Wilson JD, Hillas JL, Somerfield SD. Azatadine maleate (Zadine): evaluation in the management of allergic rhinitis. N Z Med J. 1981;94:79-81.

11. Kaminszczik I, Barbon L. Relieving symptoms of upper respiratory allergies and the common cold: azatadine maleate/pseudoephedrine sulfate syrup versus placebo. J Int Med Res. 1983;11:101-7.

12. Luscombe DK, Nicholls PJ, Parish PA. Comparison of the effects of azatadine maleate and terfenadine on human performance. Pharmatherapeutica. 1983;3:370-5.

13. Product Information. Trinalin Repetabs (azatadine-pseudoephedrine). Scherer Laboratories Inc.

14. Mariani PJ. Pseudoephedrine-induced hypertensive emergency: treatment with labetalol. Am J Emerg Med. 1986;4:141-2.

15. Rosen RA. Angina associated with pseudoephedrine . Ann Emerg Med. 1981;10:230-1.

16. Wiener I, Tilkian AG, Palazzolo M. Coronary artery spasm and myocardial infarction in a patient with normal coronary arteries: temporal relationship to pseudoephedrine ingestion. Cathet Cardiovasc Diagn. 1990;20:51-3.

17. Gordon RD, Ballantine DM, Bachmann AW. Effects of repeated doses of pseudoephedrine on blood pressure and plasma catecholamines in normal subjects and in patients with phaeochromocytoma. Clin Exp Pharmacol Physiol. 1992;19:287-90.

18. Shelley WB, Shelley ED. Nonpigmenting fixed drug eruption as a distinctive reaction pattern: examples caused by sensitivity to pseudoephedrine hydrochloride and tetrahydrozoline. J Am Acad Dermatol. 1987;17:403-7.

19. Tomb RR, Lepoittevin JP, Espinassouze F, Heid E, Foussereau J. Systemic contact dermatitis from pseudoephedrine. Contact Dermatitis. 1991;24:86-8.

20. Camisa C. Fixed drug eruption due to pseudoephedrine. Cutis. 1988;41:339-40.

21. Quan MB, Chow WC. Nonpigmenting fixed drug eruption after pseudoephedrine. Int J Dermatol. 1996;35:367-70.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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