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SUDATEX - DM
dextromethorphan hydrobromide tablet
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----------SUDATEX – DM
Each immediate-release tablet for oral administration contains:
Pseudoephedrine HCl ……..…. 40 mg
Guaifenesin ……………………... 400 mg
Dextromethorphan HBr …..…. 20 mg
Pseudoephedrine hydrochloride is an adrenergic (vasoconstrictor) which occurs as fine, white to off white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol and sparingly soluble in chloroform. The chemical name is benzenemethanol, α-[1-(methylamino) ethyl]-, [S-(R*,R*)]-, hydrochloride. The structural formula is:
C10H15NO • HCl M.W. 201.70
Guaifenesin is an expectorant and occurs as a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, in alcohol, in chloroform, in glycerin and in propylene glycol. Chemically, Guaifenesin is 1,2-Propanediol, 3-(2-methoxyphenoxy)-,(+) and has the following structural formula:
C10H14O4 M.W. 198.22
Dextromethorphan Hydrobromide is an antitussive with the chemical name 3-Methoxy-17-methyl-9α, 13α, 14α-morphinan. Its structure is as follows:
C18H25NO • HBr • H2O M.W. 370.32
Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyvinylpyrrolidone, Silica and Stearic Acid.
After administration of a 60 mg tablet, 87 to 96% of the Pseudoephedrine is cleared from the body within 24 hours. The drug is distributed to body tissues and fluids, including fetal tissue, breast milk, and the central nervous system (CNS). About 55 to 75% of an 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.
INDICATIONS AND USAGE
SUDATEX - DM 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, particularly when these conditions are complicated with tenacious mucus and/or mucus plugs and congestion. SUDATEX - DM is effective in productive as well as nonproductive cough, but it is of particular value in dry nonproductive cough which tends to injure the mucous membrane of the air passages.
SUDATEX - DM is contraindicated in patients with hypersensitivity to Guaifenesin, Dextromethorphan Hydrobromide, or with hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and in patients on monoamine oxidase (MAO) inhibitor therapy.
Nursing Mothers: Contraindicated because of the higher than usual risk for infants from sympathomimetic amines.
Geriatric patients may be more sensitive to the effects of this medication.
Newborn or Premature Infants: SUDATEX - DM Tablets should not be administered to premature or full-term infants.
Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension.
Hypertensive crises can occur with concurrent use of Pseudoephedrine and an MAO inhibitor, and for 14 days after stopping the MAO inhibitor 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.
Pseudoephedrine Hydrochloride-containing preparations should be used with caution in the presence of: hypertension; coronary artery disease; any other cardiovascular disease; glaucoma; prostatic hypertrophy; hyperthyroidism, diabetes. Dextromethorphan Hydrobromide should be used with caution in sedated or debilitated patients, and in patients confined to the supine position.
Administration of Dextromethorphan Hydrobromide may be accompanied by histamine release and should be used with caution in atopic children. Before prescribing medication to suppress or modify 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.
Information for Patients
Patients should be instructed to check with their physician if symptoms do not improve within 5 days or if fever is present.
Do not take SUDATEX - DM if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure or depression without first consulting your physician.
MAO inhibitors and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkaloids. Care should be taken in administering SUDATEX - DM Tablets concomitantly with other sympathomimetic amines, since their combined effects on the cardiovascular system may be harmful to the patient.
DRUG & OR LABORATORY TEST INTERACTIONS
Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindolacetic 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 product should be discontinued 48 hours prior to the collection of urine specimens for such tests.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term or reproduction studies in animals have been performed with SUDATEX - DM Tablets to evaluate its carcinogenic, mutagenic and impairment of fertility potential.
Pregnancy Category C: Animal reproduction studies have not been conducted with SUDATEX - DM. It is not known whether SUDATEX - DM Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SUDATEX - DM should be given to a pregnant woman only if clearly needed.
Pseudoephedrine is contraindicated in nursing mothers because of the higher than usual risk for infants from sympathomimetic amines.
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 or Dextromethorphan.
Overdosage with Guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion.
Overdosage with dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of dextromethorphan has been reported.
Toxicity with pseudoephedrine may be manifest as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propranolol, which is indicated when there are signs of cardiac toxicity. Theoretically, pseudoephedrine is dialyzable but procedures have not been clinically established. In severe cases of overdosage, it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes, and to give intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used.
DOSAGE AND ADMINISTRATION
Adults and Children over 12 years of age: 1 tablet by mouth every 4-6 hours not to exceed 6 tablets in 24 hours. Children 6 to under 12 years: 1/2 tablet by mouth every 4-6 hours not to exceed 3 tablets in 24 hours.
SUDATEX - DM Tablets are supplied as a white, capsule- shaped tablet, debossed “LL 242”; in bottles of 100 tablets. NDC 68047-242-01
Storage and Handling
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
Protect from light and moisture. Store at room temperature, USP
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Report Adverse Reactions to:
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Contract Pharmacal Corp.
Revised: 02/2010 Larken Laboratories Inc.
Reproduced with permission of U.S. National Library of Medicine
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