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Trinalin Repetabs Side Effects

Generic Name: azatadine / pseudoephedrine

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

Applies to azatadine/pseudoephedrine: oral tablet extended release

Nervous system

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]

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]

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

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]

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]

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

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

3. Joske DJ "Dystonic reaction to azatadine." Med J Aust 141 (1984): 449

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

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

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

7. "Product Information. Trinalin (pseudoephedrine-azatadine)." Schering Laboratories, Kenilworth, NJ.

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

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

10. 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 16 (1988): 420-7

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 11 (1983): 101-7

12. Covington TR, Lawson LC, Young LL, eds. "Handbook of Nonprescription Drugs. 10th ed." Washington, DC: American Pharmaceutical Association (1993):

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

14. 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 19 (1992): 287-90

15. Mariani PJ "Pseudoephedrine-induced hypertensive emergency: treatment with labetalol." Am J Emerg Med 4 (1986): 141-2

16. Rosen RA "Angina associated with pseudoephedrine ." Ann Emerg Med 10 (1981): 230-1

17. 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 20 (1990): 51-3

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 17 (1987): 403-7

19. Quan MB, Chow WC "Nonpigmenting fixed drug eruption after pseudoephedrine." Int J Dermatol 35 (1996): 367-70

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

21. Camisa C "Fixed drug eruption due to pseudoephedrine." Cutis 41 (1988): 339-40

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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