SOFAFILIN. 240 mg. / ml. 10 ml.5 ampules

An ampoule of 10 ml of solution for injection contains aminophylline 240 mg.
* Indications
Influence of bronchoconstriction in bronchial asthma , bronchitis , emphysema , COPD.
Treatment of neonatal apnea as a respiratory stimulant.
Overdose or poisoning dipyridamole as an antidote .
 
* Dosage
Slow intravenous injection or infusion .
The dosage can be individualized on the basis of the measured peak serum theophylline concentrations in order to achieve a dose that would be most beneficial to the patient with minimal side effects .
Mature - in patients who were not taking aminophylline or product of the same group , the recommended dose is 240 mg, diluted in 10-20 ml of solvent ( saline ) to a concentration of 24 mg / ml, administered i.v. slowly for about 20 minutes . In order to reduce the adverse effects of product ( tachycardia , dizziness , nausea ) rate of intravenous administration must not be greater than 25 mg per minute . Upon occurrence of such side effects is recommended passage of drip . For this purpose, 1-2 ampoules sofafilin diluted in 100-150 ml of physiological saline and administered at a rate of 30-50 drops per minute. The maintenance dose is usually 0,4-0,6 mg / kg body weight ( bw) per hour. In elderly patients (over 65 years) patients with lung , heart failure , liver disease maintenance dose is lower - 0,2 mg / kg bw per hour. Smokers back maintenance dose is higher - 0,7 mg / kg bw per hour. Sofafilin administered for not longer than 14 days.
Children - single dose 2-3 mg / kg body weight intravenously for 20-30 minutes.
Maintenance dose for children:
o from 6 months to 9 years - 1 mg / kg bw hourly
o 10 to 16 years old - 0,8 mg / kg bw per hour.
In premature infants to 24 days is administered in a dose of 1 mg / kg body weight per 12 hours, and in premature after the 24th day - 1,5 mg / kg bodyweight for 12 h .
Maximum doses (iv) - in adults : single 250 mg, days 500 mg; in children single 3 mg / kg body weight
As antidote for poisoning - intravenously at 50-100 mg ( maximum dose - 240 mg) for 30-60 seconds.
* Contraindications
Hypersensitivity to the active substance , other xanthines or ethylenediamine .
Coronary artery disease .
Bronchiolitis ( bronchopneumonia ) .
 
* Special warnings
Be used with extreme caution in patients receiving treatment with other xanthines - danger of serious intoxication increases. Monitoring of serum levels of other xanthines before administration (due to a decrease in the clearance of aminophylline and increasing its toxicity ) .
With caution in :
o the elderly (over 65 years);
o newborns ;
o congestive heart failure;
o chronic alcoholism ;
o acute febrile illness ;
o pulmonary heart ;
o renal or hepatic insufficiency ;
o hypothyroidism ;
o acute pulmonary edema
May lower the convulsion threshold - carefully and with possible dosage adjustment of the on anticonvulsant drugs in patients with these diseases.
With attention at : peptic ulcer, hyperthyroidism , hypertension , glaucoma , diabetes , tachyarrhythmia , gastro-oesophageal reflux - possible exacerbation .
With caution in cardiac or circulatory function , angina , acute myocardial injury .
Shortens coagulation - monitoring of clotting parameters .
May increase blood glucose , uric acid , free fatty acids, total cholesterol, high density lipoprotein .
 
* Drug Interactions
Aminophylline clearance can be decreased by : high doses of allopurinol , beta -blockers, cimetidine, estrogen - containing oral contraceptives, corticosteroids , calcium antagonists, disulfiram , diuretics , methotrexate, mexiletine , ritonavir, thyroid hormones, ticlopidine, macrolides and quinolones , alcohol.
Aminophylline clearance can be increased by : aminoglutethimide , barbiturates , carbamazepine, isoprenaline, phenytoin, rifampicin, sulfinpyrazone , smoking .
Accelerates the excretion of lithium products .
Potentiates the effect of furosemide .
Increases cardiovascular side effects of sympathomimetics .
May increase the sensitivity of the myocardium to cardiac glycosides .
With halothane can induce ventricular arrhythmia .
May antagonize the cardiovascular effects of adenosine .
 
Pregnancy and lactation
Pregnancy - when to expected benefit is greater than the potential risk to the fetus.
When used in late pregnancy are possible signs of tachycardia and increased excitability in the newborn .
Breastfeeding - passes into breast milk , which can cause increased excitability in the infant . In need of treatment is recommended termination of breastfeeding.
 

* Adverse Drug Reactions
Good tolerance . Side effects are rare and usually reversible.
Cardiovascular - Hypotension , tachycardia , palpitation , extrasystoles , circulatory failure, atrial and ventricular arrhythmias , peripheral vasoconstriction.
 
 * Formulation and packaging
Injection.
5 ampoules in blister, 1 or 10 blisters in a box.