® 300 Tablet: Each sustained release tablet contains Theophylline BP 300 mg.
® 400 Tablet: Each sustained release tablet contains Theophylline BP 400 mg.
Theophylline is a bronchodilator, structurally classified as a Methylxanthine. Theophylline
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. Theophylline
also increases the force of contraction of diaphragmatic muscles. The half-life of
Theophylline is influenced by a number of known variables. In adult nonsmokers with
uncomplicated asthma the half-life ranges from 3 to 9 hours.
® Tablet is indicated for the symptomatic treatment of reversible
bronchoconstriction associated with bronchial asthma, chronic obstructive pulmonary
emphysema, chronic bronchitis and related bronchospastic disorders.
DOSAGE & ADMINISTRATION
Adult: One Contifil ® 300 tablet every 12 hours or as directed by the physicians.
Recommended dose of Contifil
® 400 tablet is once daily in the evening.
Children: 9 mg / kg twice daily or as directed by the physicians.
Dosing initiation and titration (as anhydrous theophylline):
Side effects associated with Theophylline are generally mild when peak serum Theophylline
concentrations are < 20 mcg/ml and mainly consist of transient caffeine like adverse effects
such as nausea, vomiting, headache,restlessness and insomnia.
Serum Theophylline concentrations above 20 mcg/ml side effects such as vomiting, cardiac
arrhythmias and seizures have been reported.
Careful consideration is needed for various interacting drugs and physiologic conditions
that can alter Theophylline clearance. Dosage adjustment is required prior to initiation of
Theophylline therapy, prior to increases in Theophylline dose, and during follow up. The
dose of Theophylline selected for initiation of therapy should be low and, if tolerated,
increased slowly over a period of time.
Allopurinol, cimetidine, norfloxacin, ciprofloxacin, erythromycin, oral contraceptives and
propranolol increase serum theophylline levels.
Phenytoin, methotrexate and rifampicin lead to decreased serum theophylline levels.
It is not known whether Theophylline can cause foetal harm when administered to
pregnant woman.Xanthines should be given to a pregnant woman only if clearly needed.
Theophylline 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 Theophylline concentrations.
The clearance of Theophylline is very low in neonates. Careful attention to dosage selection
and monitoring of serum Theophylline concentrations are required in pediatric patients.
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).
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of
® 300 : Box containing 10x10 sustained release tablets in blister packs.
® 400 : Box containing 3x10 sustained release tablets in blister packs.
® Registered Trade Mark.
Manufactured by :
Titration step Children < 45 kg Children > 45 kg & adults
Starting dosage: 12-14 mg/kg/day up to a 300 - 400 mg/day
maximum of 300 mg/day
After 3 days, if tolerated, 16 mg/kg/day up to a maximum 400 - 600 mg/day
increase dose to: of 400 mg/day administration administration
After more days, if 20 mg/kg/day up to a Doses greater than 600 mg
tolerated, and if needed maximum of 600 mg/day should be titrated according
increase dose to: administration to blood level
Brand: Square Pharmaceuticals Ltd