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Entex Pse

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Entex Pse

Warnings
Precautions

WARNINGS

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

PRECAUTIONS

General:   Hypertensive patients should use Entex PSE (pseudoephedrine and guaifenesin) tablets only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction.

Information for Patients:   Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash, or persistent headache, consult a physician.

 

Drug Interactions:   MAO inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects if methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids.

Drug/Laboratory Test Interactions:   Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

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

Nursing Mothers:   Entex PSE (pseudoephedrine and guaifenesin) tablets are contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents.

Usage in Elderly:   Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients.

Pediatric Use:   Safety and effectiveness of Entex PSE (pseudoephedrine and guaifenesin) tablets in pediatric patients below the age of 6 have not been established.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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