Doxofylline


Generic Medicine Info
Indications and Dosage
Oral
Bronchial asthma, Chronic obstructive pulmonary disease
Adult: Recommended dose: 400 mg bid-tid. Max: 1,200 mg daily.
Child: As syr: <12 years 6-9 mg/kg bid; ≥12 years 200 mg bid-tid. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Elderly: Reduce dose to 200 mg bid-tid.
Special Patient Group
Patient with CHF or concomitant infection: Dose reduction may be required.

Smokers: Dose adjustment may be necessary.
Renal Impairment
Dose reduction may be required.
Hepatic Impairment
Dose reduction may be required.
Contraindications
Acute MI, hypotension. Lactation.
Special Precautions
Patient with CV disease (e.g. cardiac arrhythmias, angina pectoris, chronic right ventricular failure, CHF, hypertension), COPD; active or history of peptic ulcer and/or GERD; hyperthyroidism, hypoxaemia, concomitant infection, inflammation, history of seizure disorder. Smokers (including after cessation of smoking). Hepatic and renal impairment. Children and elderly. Pregnancy.
Adverse Reactions
Cardiac disorders: Tachycardia, extrasystoles, palpitations.
Gastrointestinal disorders: Nausea, vomiting, epigastric pain.
Metabolism and nutrition disorders: Hyperglycaemia.
Nervous system disorders: Headache. Rarely, seizures.
Psychiatric disorders: Irritability, insomnia.
Renal and urinary disorders: Albuminuria.
Respiratory, thoracic and mediastinal disorders: Tachypnoea.
Monitoring Parameters
Monitor heart rate, respiratory rate, and CNS effects (e.g. irritability, insomnia).
Overdosage
Symptoms: Nausea, vomiting, gastrointestinal bleeding, hypotension, seizures, and severe arrhythmia. Management: Symptomatic and supportive treatment. May induce emesis or perform gastric lavage, followed by administration of activated charcoal or cathartic. In case of seizures, establish adequate airway and give IV diazepam and/or phenobarbital.
Drug Interactions
Increased half-life and decreased clearance with cimetidine, allopurinol, erythromycin, ciprofloxacin, troleandomycin, lincomycin, clindamycin, ranitidine, propranolol, and flu vaccines. Decreased half-life and increased clearance with phenytoin and other anticonvulsants. Increased risk of synergistic toxicity with ephedrine and other sympathomimetics. May potentiate hypokalaemia caused by hypoxia with β2-agonists, corticosteroids, and diuretics.
Food Interaction
Caffeine-containing products may enhance the adverse effect of doxofylline; avoid concomitant use.
Action
Description: Doxofylline, a theophylline derivative, is a bronchodilator. It inhibits phosphodiesterase enzymes which increase cyclic adenine monophosphate (cAMP), thereby causing bronchial smooth muscle relaxation leading to bronchodilation.
Pharmacokinetics:
Absorption: Rapidly absorbed. Absolute bioavailability: 62.6%. Time to peak plasma concentration: 1.19 hours.
Distribution: Volume of distribution: 1 L/kg. Plasma protein binding: Approx 48%.
Metabolism: Extensively metabolised in the liver (approx 90%) into the inactive metabolite, hydroxyethyltheophylline.
Excretion: Via urine (<4% as unchanged drug). Elimination half-life: 7-10 hours.
Chemical Structure

Chemical Structure Image
Doxofylline

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 50942, Doxofylline. https://pubchem.ncbi.nlm.nih.gov/compound/Doxofylline. Accessed Apr. 26, 2022.

Storage
Store below 30°C. Protect from light.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DA11 - doxofylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway diseases.
References
Cazzola M and Mactera MG. The Effect of Doxofylline in Asthma and COPD. Respiratory Medicine. 2020 Feb;164. https://doi.org/10.1016/j.rmed.2020.105904. Accessed 05/04/2022

Goldstein MF and Chervinsky P. Efficacy and Safety of Doxofylline Compared to Theophylline in Chronic Reversible Asthma - A Double-Blind Randomized Placebo-Controlled Multicentre Clinical Trial. Med Sci Monit. 2002;8(4):CR297-304. Accessed 05/04/2022. PMID: 11951074

Anon. Doxofylline. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/04/2022.

Buckingham R (ed). Doxofylline. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/04/2022.

Doxofix 400 mg Tablet (Amherst Laboratories, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 05/04/2022.

Doxofree 400 mg Tablet (Lloyd Laboratories, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 05/04/2022.

Fildox 400 mg Extended-release Tablet (Zydus Healthcare Philippines Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 05/04/2022.

Maxivent 200 mg Tablet, 400 mg Tablet, 100 mg/5 mL Syrup (Ajanta Pharma Limited). MIMS Philippines. http://www.mims.com/philippines. Accessed 05/04/2022.

Puroxan (Eurodrug). MIMS Thailand. http://www.mims.com/thailand. Accessed 05/04/2022.

Puroxan Tablet (Eurodrug Laboratories [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 25/04/2022.

Disclaimer: This information is independently developed by MIMS based on Doxofylline from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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