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

Do not exceed recommended dosage.

Hypertensive crises can occur with concurrent use of pseudoephedrine or phenylephrine and MAOI, and for 14 days after stopping M.O. therapy, indomethacin, or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling.

General

Use with caution in patients with diabetes, hypertension, cardiovascular disease and intolerance to ephedrine.

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

Information for the Patient

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

Pediatric Use

This product is not recommended for use in pediatric patients under 2 years of age.

Use in Elderly

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

Drug/Laboratory Interactions

Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic 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 drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or or humans.

Pregnancy

Category C: Animal reproduction studies have not been conducted with pseudoephedrine HCl w/ guaifenesin tablets. It is also not known whether pseudoephedrine HCl w/ guaifenesin tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pseudoephedrine HCl w/ guaifenesin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Pseudoephedrine is excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines.

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