{"adverse_reactions":["Adverse Reactions: Note: Included in this listing which follows are a few adverse reactions which may not have been reported with this specific drug. However, pharmacological similarities among the xanthine drugs require that each of the reaction be considered when Dyphylline is administered. The most consistent adverse reactions are: nausea, vomiting, and epigastric pain, generally preceded by headache, hematemesis, diarrhea. Central nervous system stimulation: irritability, restlessness, insomnia, reflex hyperexcitability, muscle twitching, clonic and tonic generalized convulsions, agitation. Cardiovascular: palpitation, tachycardia, extra systoles, flushing, marked hypotension, and circulatory failure. Respiratory: tachypnea, respiratory arrest. Renal: albuminaria, increased excretion of renal tubule and red blood cells. Others: fever and dehydration."],"contraindications":["Contraindications: In individuals who have shown hypersensitivity to any of its components. Dyphylline should be administered concurrently with xanthine preparations."],"description":["Composition: Each orange mottled tablet contains: Dyphylline ............................................ 200mg Guaifenesin .......................................... 200mg Description: Dyphylline [7-(2,3-dihydroxypropyl) theophylline] [C 10 H 14 N 4 O 4 ] is a white extremely bitter amorphous solid, freely soluble in water and soluble to the extent of 2 g in 100 mL of alcohol. Dyphylline contains the equivalent of about 70 percent of anhydrous theophylline. Chemically, Guaifenesin is not an ester as its name would imply, but rather an ether. It is capable of being partially eliminated by way of the expired are and is therefore able to exert a local expectorant action in the respiratory passage. Guaifenesin makes expectoration freer and easier, because the respiratory tract secretions are made more fluid and thereby more easily expelled. Actions: As a xanthine derivative, dyphylline possesses the peripheral vasodilator and bronchodilator actions characteristic of theophylline. It has diuretic and myocardial stimulant effects and is effective orally. Dyphylline may show fewer side effects than aminophylline, but its blood levels and possibly its activity are also lower."],"dosage_and_administration":["Dosage and Administration: When administered orally it produces less nausea than aminophylline and other alkaline theophylline compounds. Absorption orally appears to be faster on an empty stomach; preferably the drug is to be given at six hour intervals. Adults: Usual adult dose 15mg/kg every six hours up to four times a day. The dosage should be individualized by titration to the condition and response of the patient. Therapeutic blood levels are considered to be between 10 micrograms/ml. and 20 mcg./ml. Levels above 20 mcg/ml may produce toxic effects. There is great variation from patient to patient in dosage needed in order to achieve a therapeutic blood level. Also, the duration of action of oral theophylline preparations varies widely from one patient to another. Because of this variation from patient to patient and the relative narrow therapeutic blood level range, dosage must be individualized with monitoring of theophylline blood levels, particularly when prolonged or repeated use is planned. Pulmonary function measurements before and after a period of treatment allow and objective assessment of whether or not therapy should be continued in patients with chronic bronchitis and emphysema."],"effective_time":"20100423","how_supplied":["Supplied in bottles of 500's only."],"id":"a33a31a4-ee79-41c6-ac4d-fef66adfa81e","indications_and_usage":["Indications: For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema."],"openfda":{},"package_label_principal_display_panel":["Theospect Label"],"precautions":["Precautions: Use with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, or acute myocardial injury. Particular caution in dose administration must be exercised in patients with peptic ulcers, since the condition may be exacerbated. Chronic oral administration in high doses, (500 to 1,000 mg) is usually associated with gastro-intestinal irritation. Great caution should be used in giving Dyphylline to patients in congestive heart failure. Such patients have shown markedly prolonged blood levels curves which have persisted for long periods following discontinuation of the drug."],"pregnancy":["Usage in Pregnancy: Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, Dyphylline should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards."],"set_id":"e8f79d62-6a62-4099-a282-1d33e9c2ea1b","spl_product_data_elements":["Theospect Improved Dyphylline and Guaifenesin DYPHYLLINE DYPHYLLINE GUAIFENESIN GUAIFENESIN NONE"],"version":"1","warnings":["Warnings: Status asthmaticus is a medical emergency. Excessive doses may be expected to be toxic."]}