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Pseudovent 400

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Pseudovent 400 Capsules

Warnings
Precautions

WARNINGS

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, peripheral vascular disease, renal impairment, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy (see CONTRAINDICATIONS). Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.

Hypertensive crisis can occur with concurrent use of pseudoephedrine and MAO inhibitors (and for 14 days after stopping MAOI 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.

Before prescribing medication to suppress or modify a 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.

PRECAUTIONS

General

Check with physician if cough persists after medication has been used for 7 days or if high fever, skin rash, or continued headache, or sore throat is present with cough. Hypertensive patients should use Pseudovent™ 400 (pseudoephedrine hcl extended-release and guaifenesin) Capsules only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no animal or in vitro studies on the combination product pseudoephedrine hydrochloride and guaifenesin to evaluate carcinogenesis, mutagenesis, and impairment of fertility.

Pregnancy Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if the potential benefit justifies risk to the fetus.

Nursing Mothers

Small amounts of pseudoephedrine are excreted in breast milk. Use of this product by nursing mothers is contraindicated because of the higher than usual risk for infants from sympathomimetic amines. It is not known if guaifenesin is excreted in breast milk.

Pediatric Use

Safety and effectiveness of Pseudovent™ 400 (pseudoephedrine hcl extended-release and guaifenesin) in pediatric patients below the age of 12 years have not been established.

Pseudovent™ 400 (pseudoephedrine hcl extended-release and guaifenesin) contains a fixed dose of pseudoephedrine hydrochloride in an extended release formulation. Very young children may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines like pseudoephedrine. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in pediatric patients. Appropriate studies on the relationship of age to the effects of guaifenesin have not been performed in the pediatric population.

Geriatric Use

Patients aged 60 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. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation in geriatric patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or drug therapy.

Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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