Rhea Doxofylline

Rhea Doxofylline

doxofylline

Manufacturer:

ABC Farmaceutici

Distributor:

Philusa
Full Prescribing Info
Contents
Doxofylline.
Description
Each tablet contains 400 mg Doxofylline.
Action
Pharmacology: Pharmacodynamics: Clinical Trials: Chronic Obstructive Pulmonary Disease: In an open-label, non-comparative, multi-center clinical study in 169 Filipino patients, Doxofylline (ANSIMAR) administered as 400 mg tablet twice daily for eight (8) weeks, was better tolerated by elderly COPD patients while providing the same effective bronchodilatory effect as other methylxanthine preparations.
The results of this study indicate that Doxofylline (ANSIMAR) is an effective and well-tolerated agent for Filipino patients with stable chronic obstructive pulmonary disease.
Indications/Uses
Doxofylline is indicated for the treatment of COPD, bronchial asthma and pulmonary disease with spastic bronchial component.
Dosage/Direction for Use
Tablet: Elderly Patients: 1/2 tablet two or three times daily.
Adults: 1 tablet two or three times daily.
Or as prescribed by a physician.
Contraindications
This product is contraindicated in individuals who have shown hypersensitivity to its components. It is also contraindicated in patients with acute myocardial infarction, hypotension and in lactating women.
Special Precautions
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, 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. Phenytoin, 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 with caution in patients with hypoxemia, hyperthyroidism, liver disease, renal disease, in those with history of peptic ulcer and in elderly.
Frequently, patients with congestive heart failures have markedly prolonged drug serum levels following discontinuation of the drug.
Use In Pregnancy & 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 experience in humans during pregnancy, xanthines should be given to a pregnant woman only if clearly needed. Doxofylline is contraindicated in nursing mothers.
Adverse Reactions
After xanthine administration, nausea, vomiting, epigastric pain, cephalalgia, 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 seizure; these symptoms could be the first sign of intoxication. Adverse reactions may cause the withdrawal from treatment; a lower dose rechallenge may start only after the advice of physician.
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.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DA11 - doxofylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway diseases.
Presentation/Packing
Form
Rhea Doxofylline tab 400 mg
Packing/Price
50's (P937.5/box)
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