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Guaifenesin and Pseudoephedrine
Please note the brand names, Deconsal II Tablets and Deconsal L.A. Tablets have been used in this monograph where noted to avoid confusion. Deconsal II: Each scored, dark blue Deconsal II Tablet provides 60 mg pseudoephedrine hydrochloride and 600 mg guaifenesin in a sustained-release formulation intended for oral administration. Inactive ingredients: Stearic acid, dibasic calcium phosphate, FD&C Blue #1 Lake, sodium lauryl sulfate, ethylcellulose, magnesium stearate. Deconsal L.A.: Each scored, light blue Deconsal L.A. Tablet provides 120 mg pseudoephedrine hydrochloride and 400 mg guaifenesin in a sustained-release formulation intended for oral administration. Pseudoephedrine hydrochloride is a nasal decongestant. Chemically, it is [S-(R*,R*)]-alpha-[1-(methylamino)ethyl]-, benzenemethanol hydrochloride and has the following formula: C10H15NO°HCl and a molecular weight of 201.70. Guaifenesin is an expectorant. Chemically it is, 3-(2-methoxyphenoxy)-1,2
propanediol and has the following chemical
formula: C10H14O4 and a molecular weight
of 198.22.
Pseudoephedrine hydrochloride is an orally indirect acting sympathomimetic amine and exerts a decongestant action on the nasal mucosa. It does this by vasoconstriction which results in reduction of tissue hyperemia, edema, nasal congestion, and an increase in nasal airway patency. The vasoconstriction action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours. Alkaline urine is associated with slower elimination of the drug. The drug is distributed to body tissues and fluids, including the central nervous system (CNS). Approximately 50% to 75% of the administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation and oxidative deamination. Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid.
Pseudoephedrine HCl w/ guaifenesin tablets are indicated for the temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. The product is effective in productive as well as non-productive cough which tends to injure the mucus membrane of the air passages.
Adults and adolescents over 12 years of age: One or two tablets every 12 hours not to exceed 4 tablets in 24 hours. Children 6 to under 12 years: 1 tablet every 12 hours not to exceed 2 tablets in 24 hours. Children 2 to 6 years: 1/2 tablet every 12 hours not to exceed 1 tablet in 24 hours. Store at controlled room temperature between 15° C and 30° C (59°F and 86°F). Dispense in tight, light- resistant containers. HOW SUPPLIED No information provided.
Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. No serious side effects have been reported with the use of guaifenesin.
Do not prescribe this product for use in patients that are now taking a prescription M.O. (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 14 days after stopping the MAOI drug therapy. Beta-adrenergic blockers and M.O. may potentiate the pressor effect of pseudoephedrine. (see WARNINGS.) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine.
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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