Riaphyllin Bronchodilator Syrup- Theophylline

COMPOSITION

Syrup: Each 5 ml contains 60 mg Theophylline BP.

CLINICAL PHARMACOLOGY

Riaphyllin pharmacologically acts as a bronchodilator, pulmonary vasodilator and smooth muscle relaxant. Since it directly relaxes the smooth muscles of bronchial airways and  pulmonary blood vessels, its actions are believed to be mediated through inhibition of phosphodiesterase and a resultant increase in intracellular cyclic-AMP.

INDICATIONS

Riaphyllin is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

شراب ريافيللين by pharmacia1
شراب ريافيللين by pharmacia1

CONTRAINDICATIONS

Riaphyllin is contraindicated in patients with hypersensitivity (allergic) to theophylline or any of the other ingredients of this product.

Riaphyllin is contraindicated in children taking ephedrine (found in some cough medicines and decongestants).

PRECAUTIONS

  • Theophylline should be used with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury, congestive heart failure, hepatic impairment and epilepsy.
  • It should be used with caution in patients with peptic ulcer and in patients who are sensitive to Xanthine derivatives.
  • Smoking may increase theophylline clearance and increased doses of theophylline might therefore be required.

WARNING

  • Contains Sulphites: Can cause allergic type reactions including anaphylactic symptoms, or severe asthmatic episodes in susceptible persons.
  • The herbal remedy St. John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St.John’s wort, consult your doctor before stopping the St. Johns wort preparations.
  • Xanthines can potentiate hypokalemia resulting from Beta-2 agonist therapy, steroids, diuretics, and hypoxia. Particular caution is advised in severe asthma. It is recommended that serum potassium levels are monitored in such situations.

ADVERSE REACTIONS

The most common side effects with Theophylline are nausea, twitching and reflex hyper-excitability.

Drug interaction

  1. Cimetidine, Allopurinol, Corticosteroids or Steroids, Frusemide, Isoprenaline, oral Contraceptives, Thiabendazole, Ciprofloxacin, Erythromycin or other antibiotics and Calcium Channel Blockers, Diltiazem and Verapamil, Nizatidine, Norfloxacin, Isoniazid, Fluconazole, Carbimazoje, Mexiletine, Propafenone,Oxpentifylline, Disulfiram, Viloxazine, Interferon Alfa and Influenza vaccine increase plasma theophylline concentrations, A reduction of theophylline dosage is recommended.
  2. Rifampicin, Phenytoin, Carbamazepine, Barbiturates, Sulfinpyrazone, Ritonavir, Primidone and Aminogfutethimide may reduce plasma theophylline concentration and therefore, the theophylline dosage may need to be increased.
  3. Theophylline can increase Lithium excretion.
  4. The concomitant use of Theophylline and Fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and plasma  theophylline should be monitored closely.
  5. Theophylline should not be administered concurrently with other Xanthine medications.
  6. Plasma concentration of theophylline can be reduced by concomitant use of the herbal remedy St John’s wort (hypericum perforatum).

USE DURING PREGNANCY AND LACTATION

Use of Theophylline in pregnant women should be balanced against the risk of uncontrolled asthma. Excretion of Theophylline in breast milk may cause irritability in the infant. For both cases, Theophylline Should be prescribed only under doctor’s supervision.

DOSAGE

The following guidelines for oral theophylline (Maintenance, and  Acute Symptoms) dose, based on population group:

  • Premature infants newborn 6 weeks (for apnea/bradycardia): 4 mg oral theophylline/ kg/ day.
  • Newborn from 6 weeks to 6 months: 10 mg/ kg/ day.
  • Infants from 6 months to 1 year: 12 to 18 mg/ kg/ day.
  • Children from 1 to 9 years: 20 to 24 mg/ kg/ day.
  • Children from 9 to 12 years and adolescent daily smokers of cigarettes and otherwise healthy adults smokers 50 years: 16 mg/ kg/ day.
  • Adolescents from 12 to 16 years: 13 mg/ kg/ day.
  • Otherwise healthy nonsmoking adults (including elderly patients): 10 mg/ kg/ day( not to exceed 900 mg/ day).
  • Cardiac decompensation or Pulmonary and/or liver dysfunction: 5 mg/ kg/ day( not to exceed 400 mg/ day).

OVERDOSAGE

Overdose is characterised by nausea, vomiting (often severe), epigastric pain, haematemesis, restlessness, hypertonia, impaired consciousness, exaggerated limb reflexes and convulsions, and arrhythmias.

In addition, hypokalemia, hyperglycaemia, hypomagnesaemia and metabolic acidosis may occur.

Activated charcoal or gastric lavage should be considered if a significant overdose has been ingested within 1 to 2 hours.Management is followed by symptomatic relief.

STORAGE

  • Store below 25 °, protect from light.
  • Do not use the drug after the expiry date printed on the package.

Patient Information Leaflet

Patient_Information_Leaflet
ريافيللين- نشرة معلومات المريض
ENG - Patient Information Leaflet
Riaphyllin – Patient Information Leaflet

Categories and tags: R03DA04, Theophylline, Xanthines,SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, RESPIRATORY SYSTEM Medicines, Medicines for Bronchoconstriction.

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