{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Sympathomimetic amines may cause tachycardia, palpitations, nervousness, insomnia, restlessness, headache, dizziness, 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 drying of the nose, throat and mouth. Carbinoxamine maleate commonly causes CNS depression."],"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 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 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. Carbinoxamine maleate is a first generation antihistamine. Carbinoxamine blocks H1 receptors, thereby preventing histamine actions on the cell. Carbinoxamine maleate possesses H1 antihistaminic activity and mild anticholinergic and sedative effects. Serum half-life for carbinoxamine is estimated to be 10-20 hours. Virtually no intact drug is excreted in the urine. Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. Its antimuscarinic effect causes drying of mucous secretions."],"contraindications":["CONTRAINDICATIONS Patients with hypersensitivity 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, and peptic ulcer and during an asthma"],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each light green speckled scored tablet contains: Pseudoephedrine HCI...................................... 90 mg Carbinoxamine Maleate .................................. 8 mg Methscopolamine Nitrate ............................... 2.5 mg in a special base to provide a prolonged therapeutic effect. Pseudoephedrine hydrochloride is a nasal decongestant. Chemically, it is Benzenemethanol, α-[1-(methylamino)ethyl)]-, [S-(R*, R*)]-, hydrochloride. The empirical formula for pseudoephedrine hydrochloride is C 10 H 15 NO-HCI. Its molecular weight is 201.70 Carbinoxamine Maleate is an antihistamine having the chemical name: 2-[p-Chloro-α-[2-(dimethylamino)ethoxy)benzyl]pyridine maleate (1:1). The empirical formula for carbinoxamine maleate is C 16 H 19 CIN 2 O C 4 H 4 O 4 . It's molecular weight is 406.86 Methscopolamine Nitrate is an anticholinergic having the chemical name: 3-0xa-9-azoniatricyclo [3.3.1.0] nopane, 7-(3-hydrocy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-nitrate, [7(S)-1α, 2ß,4ß,5α, 7ß] Other ingredients: Dicalcium phosphate, hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, silica, magnesium stearate, D&C yellow #10, FD&C Blue #1, and FD&C Red #40."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: one tablet twice daily (every 12hours) not to exceed 2 tablets in 24 hours. Children 6 to under 12 years: one-half (1/2) tablet twice daily (every 12 hours) not to exceed 1 tablet in 24 hours. PANNAZ ® 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 reserpine. (2) 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. 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 reserpine. (2) 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. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect."],"effective_time":"20110317","general_precautions":["General Use with caution in patients with diabetes, hypertension, cardiovascular diseases and hyperactivity 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 PANNAZ ® is available in a light green, scored tablet imprinted with \"PAL\" on one side and \"88\" on the other. Bottles of 100s (NDC 0525-0880-01). Store at room temperature, 15° -30°C (59° -86°F). Dispense in tight, light-resistant containers (USP/NF)."],"id":"588b0bdb-1b76-4e5f-9120-4a12d14433dc","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 PANNAZ ® 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 PANNAZ ® 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. Stimulants should not be used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6337 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of PANNAZ ® 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 hyperactivity 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 PANNAZ ® 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 reserpine. (2) 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. 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 PANNAZ ® . It is also not known whether PANNAZ ® can cause fetal harm when administered to apregnant woman or can affect reproductive capacity. PANNAZ ® 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 PANNAZ ® 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 PANNAZ ® . It is also not known whether PANNAZ ® can cause fetal harm when administered to apregnant woman or can affect reproductive capacity. PANNAZ ® should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"588b0bdb-1b76-4e5f-9120-4a12d14433dc","spl_product_data_elements":["PANNAZ PSEUDOEPHEDRINE, CARINOXAMINE, and METHSCOPOLAMINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE METHSCOPOLAMINE NITRATE NITRATE ION FD&C RED NO. 40 FD&C BLUE NO. 1 HYPROMELLOSE 2910 (15000 MPA.S) HYDROGENATED COTTONSEED OIL STEARIC ACID SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE LIGHT GREEN 8;8;PAL"],"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 excitabili1y, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do Not Exceed Recommended Dosage."]}