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Exefen (Pseudoephedrine Hydrochloride / Guaifenesin) - Warnings and Precautions



Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension.

Do not exceed recommended dosage.

Hypertensive crises can occur with concurrent use of Pseudoephedrine and an MAO inhibitor, and for 14 days after stopping the MAO inhibitor therapy, indomethacin, or with beta blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy in lower blood pressure should be instituted. Fever should be managed by means of external cooling.



Use with caution in patients with: hypertension; coronary artery disease; any other cardiovascular disease; glaucoma; prostatic hypertrophy; hyperthyroidism, diabetes.

Before prescribing medication to suppress or modify cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Information for Patients

Patients should be instructed to check with physician if symptoms do not improve within 5 days or if fever is present.

Drug Interactions

MAO inhibitors and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkaloids. Care should be taken in administering EXEFEN-IR Tablets concomitantly with other sympathomimetic amines, since their combined effects on the cardiovascular system may be harmful to the patient.

Drug/Laboratory Test Interactions

Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindolacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this product should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term or reproduction studies in animals have been performed with EXEFEN-IR Tablets to evaluate its carcinogenic, mutagenic and impairment of fertility potential.


Pregnancy Category C

Animal reproduction studies have not been conducted with EXEFEN-IR Tablets. It is not known whether EXEFEN-IR Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. EXEFEN-IR Tablets should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Pseudoephedrine is contraindicated in nursing mothers because of the higher than usual risk for infants from sympathomimetic amines.

Use in the Elderly

The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.

Page last updated: 2009-12-21

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