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Guaifenex PSE 60

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Guaifenex PSE 60

Warnings
Precautions

WARNINGS

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 crisis can occur with concurrent use of pseudoephedrine or phenylephrine and monoamine oxidase (MAO) inhibitors, indomethacin, or with beta-blockers and methyl-dopa. 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.

PRECAUTIONS

General: Use with caution in patients with diabetes, hypertension, cardiovascular disease and hyper-reactivity to ephedrine.

Before prescribing medication to suppress or modify cough, it is important to 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.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years has not been established. This product is not recommended for use in pediatric patients under 2 years of age.

Geriatric Use: 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. Clinical studies of Guaifenex® PSE 60 (guaifenesin pseudoephedrine extended-release tablets) Extended-release Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger 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 other drug therapy.

Carcinogenesis, Mutagenesis, 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 humans.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Accordingly, this product 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.

Last reviewed on RxList: 8/5/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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