Arofil Sr

Arofil Sr Tablet, Tablet (sustained Release)

Arofil Sr is a bronchodilator, structurally classified as a Methylxanthine. Arofil Sr has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation and suppression of the response of the airways to stimuli. Arofil Sr also increases the force of contraction of diaphragmatic muscles. The half-life of Arofil Sr is influenced by a number of known variables. In adult nonsmokers with uncomplicated asthma the half-life ranges from 3 to 9 hours

Uses

This is used for the symptomatic treatment of reversible bronchoconstriction associated with bronchial asthma, chronic obstructive pulmonary emphysema, chronic bronchitis and related bronchospastic disorders.

Arofil Sr is also used to associated treatment for these conditions: Asthma, Bronchitis, Bronchoconstriction, Bronchospasm, Chronic Obstructive Pulmonary Disease (COPD), Chronic bronchial inflammation, Airway secretion clearance therapy, Bronchodilation

Arofil Sr

Trade Name Arofil Sr
Generic Theophylline
Theophylline Other Names Teofilina, Theophyllin
Weight 300mg, 400mg, 200mg
Type Tablet, Tablet (sustained Release)
Formula C7H8N4O2
Weight Average: 180.164
Monoisotopic: 180.06472552
Protein binding

40%, primarily to albumin.

Therapeutic Class Theophylline & related drugs
Manufacturer Incepta Pharmaceuticals Ltd, Incepta Pharmaceuticals Limited
Available Country India, Bangladesh
Last Updated: June 23, 2021 at 9:00 am

Structure

Arofil Sr
Theophylline Structure

Dosage

Arofil Sr dosage

Dosages are adjusted to maintain serum theophylline concentrations that provide optimal relief of symptoms with minimal side effects. Most of the controlled release preparations may be administered every 12 hours in adults while administration every 8 hours may be necessary in some children with markedly rapid hepatic metabolism of theophylline. The recommended dosages for achieving serum theophylline concentrations within the accepted therapeutic range is as follow: 

  • 1-6 months: 10 mg/Kg/day
  • 6 months-1 year: 15 mg/Kg/day
  • 1-9 years: 24 mg/Kg/day
  • 10-16 years: 18 mg/Kg/day
  • Adults: 10-15 mg/Kg/day

Side Effects

The following side effects have been observed:

Gastrointestinal: Nausea, vomiting, epigastric pain and diarrhoea.

Central nervous system: Headache, irritability, restlessness, insomnia, muscles twitching.

Cardiovascular: Palpitation, tachycardia, hypotension. circulatory failure.

Respiratory: Tachypnoea.Renal: Potentiation of diuresis.

Others: Alopecia, hyperglycemia, rash etc.

Precaution

Careful consideration is needed for various interacting drugs and physiologic conditions that can alter Arofil Sr clearance. Dosage adjustment is required prior to initiation of Arofil Sr therapy, prior to increases in Arofil Sr dose, and during follow up. The dose of Arofil Sr selected for initiation of therapy should be low and, if tolerated, increased slowly over a period of time.

Interaction

Allopurinol, cimetidine, norfloxacin, ciprofloxacin, erythromycin, oral contraceptives and propranolol increase serum theophylline levels. Phenytoin, methotrexate and rifampicin lead to decreased serum theophylline levels

Food Interaction

  • Avoid excessive or chronic alcohol consumption. Ingesting alcohol may reduce the clearance, and therefore increase the serum concentrations of theophylline.
  • Avoid St. John's Wort.
  • Take with or without food. Take consistently with regard to food.

Volume of Distribution

  • 0.3 to 0.7 L/kg

Half Life

8 hours

Clearance

  • 0.29 mL/kg/min [Premature neonates, postnatal age 3-15 days]
  • 0.64 mL/kg/min [Premature neonates, postnatal age 25-57 days]
  • 1.7 mL/kg/min [Children 1-4 years]
  • 1.6 mL/kg/min [Children 4-12 years]
  • 0.9 mL/kg/min [Children 13-15 years]
  • 1.4 mL/kg/min [Children 16-17 years]
  • 0.65 mL/kg/min [Adults (16-60 years), otherwise healthy non-smoking asthmatics]
  • 0.41 mL/kg/min [Elderly (>60 years), non-smokers with normal cardiac, liver, and renal function]
  • 0.33 mL/kg/min [Acute pulmonary edema]
  • 0.54 mL/kg/min [COPD >60 years, stable, non-smoker >1 year]
  • 0.48 mL/kg/min [COPD with cor pulmonale]
  • 1.25 mL/kg/min [Cystic fibrosis (14-28 years)]
  • 0.31 mL/kg/min [Liver disease cirrhosis]
  • 0.35 mL/kg/min [acute hepatitis]
  • 0.65 mL/kg/min [cholestasis]
  • 0.47 mL/kg/min [Sepsis with multi-organ failure]
  • 0.38 mL/kg/min [hypothyroid]
  • 0.8 mL/kg/min [hyperthyroid]

Pregnancy & Breastfeeding use

Pregnancy: It is not known whether Arofil Sr can cause foetal harm when administered to pregnant woman.Xanthines should be given to a pregnant woman only if clearly needed.

Nursing mother: Arofil Sr is excreted into breast milk and may cause irritability or other signs of mild toxicity in nursing human infants. Serious adverse effects in the infant are unlikely unless the mother has toxic serum Arofil Sr concentrations.

Contraindication

Hypersensitivity to xanthine derivatives. It is also contraindicated in patients with active peptic ulcer disease and in individuals with underlying seizure disorders (unless receiving appropriate anti-convulsing medication).

Arofil Sr should not be administered concurrently with other xanthine. Use with caution in patients with hypoxemia, hypertension, or those with history of peptic ulcer. Do not attempt to maintain any dose that is not tolerated.

Acute Overdose

Symptoms may include nausea, vomiting, gastrointestinal irritation, cramps, convulsions, tachycardia & hypotension. The stomach contents should be emptied & supportive measures employed to maintain circulation, respiration & fluid & electrolyte balance. Electrocardiographic monitoring should be carried out & in severe poisoning charcoal haemoperfusion should be used.

Storage Condition

Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children

Innovators Monograph

Arofil Sr contains Theophylline see full prescribing information from innovator Monograph