{"abuse":["Abuse"],"adverse_reactions":["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."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exhorts a decongestant action on the nasal mucosa. It does this by vasoconstriction which result in reduction of tissue hyperemia, edema, nasal congestion, and an increase in nasal potency. The vasoconstrictive 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. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids, including the fetal tissue, breast milk and 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 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 rapidly 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."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with hypersenditivity to guaifenesin, 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 patients on monoamine oxidase (MAO) inhibitor therapy."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each scored, white, dye-free DEFEN ® LA tablet provides 60 mg pseudoephedrine hydrochloride and 600 mg guaifenesin in a sustained release formulation intended for oral administration. Pseudoephedrine hydrochloride is a nasal decongestant."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One or two tablets every 12 hours not to exceed 4 tablets in 24 hours. Children 6 to 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."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Guaifenesin may increase renal clearance for urale and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary S-hydroxy-indoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of psudoephedrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathominetics may reduce the hypertensive effects of guanethidine, mecamylamine, methyldopa, reserphe and veratrum alkaloids. Concurrent use of tryciclic antidepressants may antagonize the effects of pseudoephedrine. It may also falsely elevate the VMA test for catechois. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug/Laboratory Test Interactions","Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of psudoephedrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathominetics may reduce the hypertensive effects of guanethidine, mecamylamine, methyldopa, reserphe and veratrum alkaloids. Concurrent use of tryciclic antidepressants may antagonize the effects of pseudoephedrine. It may also falsely elevate the VMA test for catechois. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests."],"effective_time":"20110311","general_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 ascentain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physologic complications, and that appropriate therapy for the primary disease is instituted."],"geriatric_use":["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."],"how_supplied":["HOW SUPPLIED Bottles of 100 tablets (NDC 59630-110-10). Scored, while, dye-free tablets are embossed with \"DEFEN\". Store at controlled room temperature between 15 o C - 30 o C (59 o F - 86 o F). Dispense in tight, light- resistant containers."],"id":"d4ae13e7-82d3-49fe-b782-505ff8283b95","indications_and_usage":["INDICATIONS AND USAGE DEFEN ® LA Tablets are indicated for the temporary relief of nasal cong4estion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these con6tions are complicated by tenacious mucus plugs and congestion. The product is effective in productive as well as non-productive cough, but is of particular value in dry, non productive cough which tends to injure the mucous membrane of the air passages."],"information_for_patients":["Information for Patients Patients should be instructed to check with physician if symptoms do not improve within 5 days or if fever is present."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["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 to infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE Since DEFEN ® LA Tablets contain two pharmacologically different compounds, treatment of overdosage should be based upon the symptomatology of the patient as it relates to the individual ingredients. Treatment of acute overdosage would probably be based upon treating the patient for pseudoephedrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness and insomnia. Other effects may include lachycardia, 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. Severe hypokalenia can occur probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with pseudoephedrine overdosage. Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is much lower than that of pseudoephedrine. The LD 50 of pseudoephedrine (single oral dose) has been reported to be 726 mg/kg in the mouse, 2206 mg/kg in the rat and 1177 mg/kg in the rabbit. The toxic and lethal concentrations in human biologic fluids are not known. Urinary excretion increases with acidification and decreases with alkanization of the urine. There are few published reports of toxicity due to pseudoephedrine and no case of fatal overdosage has been reported. Guaifenesin, when adminstered by stomach tube to test animals in doses up to 5 grams/kg produced no signs of toxicity. Since the action of sustained release products may continue for as long as 12 hours, treatment of overdosage should be directed toward reducing further absorption and supporting the patient for at least the length of time. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. Either isolonic or half-isotonic saline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than 4 hours have passed since ingestion. Saline cathartics, such as Milk of Magnesia, are useful for hastening the evacuation of unreleased medication. Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the et-blocker propanotal 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 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."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6298 CL"],"pediatric_use":["Pediatric Use This product is not recommended for use in children under 2 years of age."],"precautions":["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 ascentain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physologic complications, and that appropriate therapy for the primary disease is instituted. Information for Patients Patients should be instructed to check with physician if symptoms do not improve within 5 days or if fever is present. Laboratory Tests Interactions Guaifenesin may increase renal clearance for urale and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary S-hydroxy-indoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. Drug Interactions Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of psudoephedrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathominetics may reduce the hypertensive effects of guanethidine, mecamylamine, methyldopa, reserphe and veratrum alkaloids. Concurrent use of tryciclic antidepressants may antagonize the effects of pseudoephedrine. It may also falsely elevate the VMA test for catechois. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Drug/Laboratory Test Interactions 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 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. Teratogenic Effects Nonteratogenic Effects Labor and Delivery 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 to infants from sympathomimetic amines. Pediatric Use This product is not recommended for use in children 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."],"pregnancy":["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. Teratogenic Effects Nonteratogenic Effects"],"set_id":"d4ae13e7-82d3-49fe-b782-505ff8283b95","spl_product_data_elements":["DEFEN LA Pseudoephedrine, Guaifenesin PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE GUAIFENESIN GUAIFENESIN HYDROGENATED COTTONSEED OIL HYPROMELLOSE 2208 (100 MPA.S) MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID DEFEN"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}