Description
The Cathay Drug Co., Inc.
FORMULATION
Each tablet contains:
Doxofylline …………………………………………………………………………. 200 mg
Doxofylline …………………………………………………………………………. 400 mg
MECHANISM OF ACTION
Doxofylline is chemically designated as 7-(1, 3-dioxolan-2-ylmethyl)-theophylline. It differs from theophylline by the presence of a dioxolone group in position 7. The mechanism of action is similar to that of theophylline. However, unlike theophylline, Doxofylline has greatly decreased affinity towards adenosine A1 and A2 receptors which explain its better safety profile. Moreover, it does not interfere with calcium influx into the cells nor antagonize calcium channel blockers. In experimental studies, Doxofylline has been shown to be a more potent bronchodilator with fewer side effects than theophylline. In mechanically ventilated patients with acute respiratory failure, it results in rapid and efficient bronchodilation, thus decreasing the airway resistance.
PHARMACOKINETICS
After oral administration, peak plasma levels were reached after one hour. Absolute bioavailability is about 62.6%; at pH 7.4 plasma protein binding the compound is about 48%. Less than 4% of an orally administered dose is excreted unchanged in the urine.
Doxofylline is almost completely metabolized in the liver (90% of the total drug clearance). Hydroxyethyltheophylline is the only detectable circulating metabolite of Doxofylline.
After repeated administrations Doxofylline reaches the steady-state in about 4 days; the elimination half-life during long-term treatment is 8-10 hours: this allows a twice daily dose regimen. No accumulation of the drug was noted after one week of treatment.
INDICATIONS
Doxofylline is indicated for the treatment of bronchial asthma, pulmonary disease with spastic bronchial component and Chronic Obstructive Pulmonary Disease (COPD).
CONTRAINDICATIONS
This product is contraindicated in individuals who have shown hypersensitivity to its components. It is also contraindicated in patients with acute myocardial infarction, gipotensia arterial (hypotension), arrhythmia, duodenal ulcer, epilepsy, convulsion and in lactating/ pregnant women.
ADVERSE EFFECTS
After xanthine administration, nausea, vomiting, epigastric pain, headache, cephalgia, irritability, insomnia, tachycardia, extrasystole, tachypnea and occasionally hyperglycemia and albuminuria, may occur. If a potential oral overdose is established, the patient may present with severe arrhythmias and seizures; these symptoms could be the first sign of intoxication. Adverse reactions may cause the withdrawal from treatment; a lower dose re-challenge may start only after the advice of physician.
WARNINGS & PRECAUTIONS
Use with caution in patients with hypertension, heart disease, hypoxemia, hyperthyroidism, chrome right ventricular failure, congestive heart failure, liver disease, renal disease, in those with history of peptic ulcer and in elderly. Frequently, patients with congestive heart failure have markedly prolonged drug serum levels following discontinuation of the drug.
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver diseases, in patients with congestive heart failure, in those affected with chronic obstructive lung disease or concomitant infections, and in those patients taking certain other drugs (erythromycin, troleandomycin, lincomycin and other antibiotics of the same group, allopurinol, cimetidine, propranolol and anti-flu vaccine). In these cases, a lower dose of Doxofylline may be needed. Phenytoins, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life: in these cases higher doses of Doxofylline may be needed.
USE IN PREGNANCY AND LACTATION
Animal reproduction studies indicate that Doxofylline does not cause fetal harm when administered to pregnant animals nor can affect reproduction capacity. However, since there is limited experiences innhumans during pregnancy, xanthines should be given to a pregnant women only if clearly needed. Doxofylline is contraindicated in nursing mothers.
DOSAGE AND ADMINISTRATION
Tablet
Elderly Patients: 200 mg tablet two or three times daily.
Adults: 400 mg tablet two or three times daily.
Or as prescribed by the physicians.
DRUG INTERACTIONS
Doxofylline should not be administered together with other xanthine derivatives, including beverages and foods containing caffeine.
Toxic synergism with ephedrine has been documented for xanthines.
Concomitant therapy with erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels.
OVERDOSAGE
Although no major arrhythmias have been documented with Doxofylline tablets the occurrence of major cardiac rhythm disturbances cannot be excluded in case of overdosage of xanthine compounds. If a potential oral overdose is established the patient may present with seizures; these symptoms could be the first sign of intoxication. Adverse reactions may cause the withdrawal from treatment. A lower dose re-challenge may start only after the advice of the physician.
There is no specific antidote. It is suggested that the management principle should be instituted according to a symptomatic relief of cardio circulatory shock. Doxofylline tablets does not cause any risk of tolerance or addiction.
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription
STORE AT TEMPERATURES NOT EXCEEDING 30°C.
PROTECT FROM LIGHT.
AVAILABILITY
Doxofylline (Dilatair) 200 mg Tablet x Alu PVC blister pack of 10’s, box of 30 tablets
Doxofylline (Dilatair) 400 mg Tablet x Alu PVC blister pack of 10’s, box of 30 tablets
Manufactured by
AJANTA PHARMA LIMITED
B-4/5/6, MIDC Industrial Area Paithan – 431 128,
Dist-Aurangabad, India
Distributed by
THE CATHAY DRUG CO., INC.
2/F Vernida 1 Condominium
120 Amosolo St., Legaspi Village, Makati City
Date of revision: July 2016
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