ABRIDGED PRESCRIBING INFORMATION

COMPOSITION: Doxocontin™ 400 : Each tablet contains Doxophylline INN 400 mg (in a Controlled release system).

INDICATION: Doxophylline is indicated for the treatment of bronchial asthma, pulmonary disease with spastic bronchial component and Chronic Obstructive Pulmonary Disease (COPD).

DOSAGE & ADMINISTRATION:

Adults: Doxocontin ™ 400 tablet incorporates Doxophylline in a Controlled release system and is recommended once a day. Administration of single dose in the evening reduces nocturnal symptoms and helps the patients feel more comfortable during the day. The tablets must be swallowed whole and not chewed.

SIDE-EFFECTS: Nausea, vomiting, epigastric pain, cephalalgia, irritability, insomnia, tachycardia , extrasystole, tachypnea and occasionally, hyperglycemia and albuminuria may occur.

CONTRAINDICATIONS: This is contraindicated for individuals who have shown hypersensitivity to Doxophylline and its components . It is also contraindicated in patients with acute myocardial infarction, hypotension, and in lactating women.

DRUG INTERACTIONS: Doxophylline should not be administered together with other xanthine derivatives, including beverages and foods containing caffeine.

PREGNANCY & LACTATION: However, since there is limited experience in humans during pregnancy, xanthines should be given to a pregnant woman only if clearly needed. Doxophylline is contraindicated in nursing mothers.

STORAGE CONDITION: Store at a temperature not exceeding 30°C, protected from light and moisture. Keep out of reach of children.

PRESENTATION: Doxocontin™ 400: Box of 30 tablets (3 x 10’s blister strip)

 

COMPOSITION: Doxonorm™ 200: Each tablet contains Doxophylline INN 200 mg.

INDICATION: Doxophylline is indicated for the treatment of bronchial asthma, pulmonary disease with spastic bronchial component and Chronic Obstructive Pulmonary Disease (COPD).

DOSAGE & ADMINISTRATION: • Adults: 400 mg tablet two or three times daily or as prescribed by a physician. • Elderly: 200 mg tablet two or three times daily • Maximum Daily Dose: 1,200 mg. • <12 yr: 6-9 mg/kg body wt bid. Doxofylline may be taken with or without food.

CONTRAINDICATIONS: This is contraindicated for individuals who have shown hypersensitivity to Doxophylline and its components. It is also contraindicated in patients with acute myocardial infarction, hypotension, and in lactating women.

SIDE EFFECTS: Nausea, vomiting, epigastric pain, cephalalgia, irritability, insomnia, tachycardia, extrasystole, tachypnea and occasionally hyperglycemia and albuminuria, may occur.

USE IN PREGNANCY & LACTATION: Since there is limited experience in humans during pregnancy, xanthines should be given to a pregnant woman only if clearly needed. Doxophylline is contraindicated in nursing mothers.

DRUG INTERACTIONS: Doxophylline should not be administered together with other xanthine derivatives, including beverages and foods containing caffeine.

STORAGE CONDITION: Store at a temperature not exceeding 30°C, protected from light and moisture. Keep out of reach of children.

PRESENTATION: Doxonorm™ 200: Each box containing 100 tablets in Alu-PVDC blister pack.