{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Sympathomimetic amines may cause tachycardia, palpitations, nervousness, insomnia, restlessness, headache, gastric irritation, and irritability, Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty. dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision and excessive dryness of the nose, throat, and mouth."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pseudoephedrine HCI is rapidly and almost completely absorbed from the gastrointestinaltract.It has a plasma half-life of 6 to 8 hours Acidic urine is associated with faster elimination 01 the drug. The drug is distributed to body tissues and fluids including the fetal tissues, 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. Chlorpheniramine maleate is an alkylamine-type antihistamine that possesses anticholinergic and sedative effects. Antihistamines competitively antagonize histamine at the H, receptor site. Thus, activation of H 1 receptors by released histamine, which results in increased vascular permeability, increased mucus production, pruritis and sneezing, is prevented. Methscopolamine nitrate is a Quaternary ammonium derivative of the anticholinergic scopolamine, which possesses the peripheral actions 01 the belladonna alkaloids, but does not exhibit the central actions because 01 its lack of ability to cross the blood-brain barrier. Its antimuscarinic effect causes drying of mucus secretions."],"contraindications":["CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines and anticholinergics are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer and during an asthma attack."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each sustained -release tablet contains: Pseudoephedrine HCI .............................. 60 mg Chlorpheniramine Maleate ....................... 8 mg Methscopolamine Nitrate ......................... 1.25 mg Durahist TM is formulated in a special base to provide a prolonged therapeutic effect. This product contains ingredients of the following therapeutic classes: decongestant, antihistamine, and antisecretory. Durahist™ also contains the following inactive ingredients: dicalcium phosphate, hydrogenated vegetable oil, hydroxypropyl methylcellulose, stearic acid, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose, water."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One tablet twice daily (every 12 hours) not to exceed 2 tablets in 24 hours. Children 6 -12 years: One-half (112) tablet every 12 hours not to exceed 1 tablet in 24 hours. Durahist TM is not recommended for children under 6 years of age. Tablets may be broken in half for ease of administration without affecting release of medication, but should not be crushed or chewed prior to swallowing."],"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 Drug Interactions (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpme (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhy1hmias. 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. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. Drug/Laboratory Test Interactions","Drug Interactions (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpme (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhy1hmias. 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. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect."],"effective_time":"20110314","general_precautions":["General Use with caution in patients with diabetes, hypertension, cardiovascular diseases and hyperreactivity to sympathomimetic amines. Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Durahist TM is available as a white oval-shaped tablet with 'PE/424' embossed on the scored side and plain on the other Bottles of 100s (NDC 66869-42410). Store at room temperature, 15· -30·C (59· -8S·F). Dispense In light, light-resistant containers (USP/NFI. Caution: Federal law prohibits dispensing without prescription."],"id":"37aef3f9-3ebf-4033-be5f-0504e1572b19","indications_and_usage":["INDICATIONS AND USAGE For symptomatic relief of seasonal and perennial allergic rhinitis and vasomotor rhinitis."],"information_for_patients":["Information for Patients Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Do not crush or chew Durahist TM Tablets prior to swallowing. The antihistamine in this product may have additive effects with alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers)."],"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 for infants from sympathomimetic amines"],"openfda":{},"overdosage":["OVERDOSAGE The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Either isotonic 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. Stimulants should not be used because they may precipitate convulsions. Use of a short-acting barbiturate is recommended if convulsions or marked CNS excitement occur. Since the effects of Durahist TM may last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary. 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 alkalinization of the urine. There are few published reports of toxicity due to pseudoephedrine and no case of fatal overdosage has been reported. 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. Slimulants should not be used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6996 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of Durahist TM in children below the age of 6 have not been established."],"precautions":["PRECAUTIONS General Use with caution in patients with diabetes, hypertension, cardiovascular diseases and hyperreactivity to sympathomimetic amines. Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Information for Patients Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Do not crush or chew Durahist TM Tablets prior to swallowing. The antihistamine in this product may have additive effects with alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers). Laboratory Tests Interactions Drug Interactions (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, mecamylamine and reserpme (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhy1hmias. 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. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with Durahist TM , It is also not known whether Durahist TM can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Durahist TM 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 for infants from sympathomimetic amines Pediatric Use Safety and effectiveness of Durahist TM in children below the age of 6 have not been established. Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with Durahist TM , It is also not known whether Durahist TM can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Durahist TM should be given to a pregnant woman only if clearly needed Teratogenic Effects Nonteratogenic Effects"],"set_id":"37aef3f9-3ebf-4033-be5f-0504e1572b19","spl_product_data_elements":["DURAHIST D PSEUDOEPHEDRINE, DEXCHLORPHENIRAMINE, AND METHSCOPOLAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE CROSPOVIDONE HYPROMELLOSE 2910 (15000 MPA.S) CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUS SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE PE;426"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease. hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension, The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage."]}