Sudatex DM

Generic Name: pseudoephedrine hydrochloride, guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

SUDATEX – DM

Sudatex DM Description

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, (-[1-(methylamino) ethyl]-, [S-(R*,R*)]-, hydrochloride. The structural formula is:

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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-9(, 13(, 14(-morphinan. Its structure is as follows:

C18H25NO • HBr • H2O             M.W. 370.32

INACTIVE INGREDIENT

Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyvinylpyrrolidone, Silica and Stearic Acid.

Sudatex DM - Clinical Pharmacology

Pseudoephedrine:
Pseudoephedrine acts as an indirect sympathomimetic agent by stimulating sympathetic (adrenergic) nerve endings to release norepinephrine. Norepinephrine in turn stimulates alpha and beta receptors throughout the body. The action of pseudoephedrine is apparently more specific for the blood vessels of the upper respiratory tract and less specific for the blood vessels of the systemic circulation. The vasoconstriction elicited at these sites results in the shrinkage of swollen tissues in the sinuses and nasal passages. Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. Considerable variation in half-life has been observed (from about 4 1/2 to 10 hours), which is attributed to individual differences in absorption and excretion. Excretion rates are also altered by urine pH, increasing with acidification and decreasing with alkalinization. As a result, mean half-life falls to about 4 hours at pH 5 and increases to 12 to 13 hours at pH 8.

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.

Guaifenesin:
Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, Guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is readily metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is β-(2-methoxyphenoxy) lactic acid.

Dextromethorphan:
Dextromethorphan Hydrobromide is an antitussive agent which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, Dextromethorphan Hydrobromide does not inhibit ciliary activity. Dextromethorphan Hydrobromide is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine.

Indications and Usage for Sudatex DM

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.

Contraindications

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.

Warnings

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.
Do not exceed recommended dosage.

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.

Precautions

General

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.

Drug Interactions

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

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.

Nursing Mothers

Pseudoephedrine is contraindicated in nursing mothers because of the higher than usual risk for infants from sympathomimetic amines.

Geriatric Use

The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.

Adverse Reactions

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

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.

Sudatex DM 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.

How is Sudatex DM Supplied

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.

Rx Only

Report Adverse Reactions to:

Distributed by:


276 Nissan Parkway, Suite B
Canton, MS 39046

Or Call Toll Free: 1-888-527-5522

Manufactured by:

Contract Pharmacal Corp.
135 Adams Ave.
Hauppauge, NY 11788 USA

Rev. 09/08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Container Label

SUDATEX - DM 
pseudoephedrine hcl, guaifenesin, and dextromethorphan hbr tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68047-242
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 40 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
CROSPOVIDONE  
SILICON DIOXIDE  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code LL242
Contains         
Packaging
# Item Code Package Description
1 NDC:68047-242-01 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/07/2009 01/31/2013
Labeler - Larken Laboratories Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corp. 968334974 MANUFACTURE
Revised: 02/2010
 
Larken Laboratories Inc.

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