Aminophylline S.A.L.F 240 mg/10 ml

/ Raz Pharmaceutics

Adults:
The treatment is reserved to severe cases of bronchial asthma through a slow infusion of a solution obtained by diluting 480 mg of Aminophylline (equal to 2 ampoules of 240 mg/10 ml) in 50 ml of a compatible solution for infusion (e.g. saline solution, glucose solution, laevulose solutions).
The infusion rate of the solution should not exceed 3.6 ml/min (equal to 25 mg of Aminophylline/minute).
The total administered dose should not exceed 0.8 ml/kg (equal to 5.6 mg of
Aminophylline/kg).
This infusion can be followed by another maintenance infusion obtained by diluting 240 mg of Aminophylline (equal to 1 ampoule of 240 mg/10 ml) in 500 ml of a solution for infusion.
The infusion rate for the maintenance solution should be:
1.9 ml/kg/hour (equal to 0.9 mg of Aminophylline/kg/hour) in smoking adults
below 50 years;
0.9 ml/kg/hour (equal to 0.45 mg/kg/hour) in no smoking adults below 50 years;
0.5 ml/kg/hour (equal to 0.25 mg/kg/hour) in adults with heart failure or hepatic impairment.
In any case, the intravenous administration of the product should be carried out with the patient in supine position, at a controlled slow rate (15-20 minutes).
Children:
The dosage in children below 9 years is 1 mg/kg/hour.
Do not use the solution in presence of crystallization. Inject slowly.

Bronchial asthma;
Pulmonary affections with bronchial spastic component.

Known hypersensitivity to the active ingredients, to other xanthine derivatives or to any of the excipients.
Acute myocardial infarction
Hypotensive states
Lactation

The solution should be clear and colorless to slightly yellowish and free of visible particles.
It is intended for a single, uninterrupted administration and any residue should be discarded.
Aminophylline should not be administered simultaneously with other xanthine
preparations. Caution is also required when associating Aminophylline with ephedrine or other bronchodilating sympathomimetic drugs.
Phenytoin, other anticonvulsants and the smoke of cigarettes may increase the
clearance of Aminophylline thus reducing its plasmatic half-life. In such cases it may be necessary to increase the dosage of Aminophylline.
The product should be administered with caution in the elderly, in patients
with cardiopathies, hypertension, with severe hypoxemia, hyperthyroidism, chronic pulmonary heart disease, congestive heart failure, peptic ulcer and in patients with severe renal and hepatic affections.
Extreme caution is recommended when administering Aminophylline in children.
Various factors can reduce the hepatic clearance of Aminophylline with consequent increase of the plasmatic levels of the drug. Among these are included age (newborns and premature infants under 1 year of age, the elderly over sixty years who have a reduced clearance), congestive heart failure, chronic obstructive lung affections and related infections, fever (a temperature of 39°C or higher for 24 hours or more, or a lower temperature but for longer periods), hypothyroidism, liver disease (cirrhosis, acute hepatitis), acute pulmonary edema, sepsis, shock, and the concomitant administration of certain drugs. In the presence of these factors, it is recommended to monitor blood levels of Aminophylline considering that its therapeutic values are 10-15 μg/ml and the minimum toxic dose 20 μg/ml.

See prescribing information for full details.

Drugs that may decrease the hematic concentration of Aminophylline and
consequently reduce its effectiveness:
adenosine, barbiturates, butalbital, cannabis, carbamazepine, felodipine, phenytoin, phenobarbital, smoke of cigarette, furosemide, hypericum, isoniazid, nifedipine, pancuronium, primidone, rifampicin, rifapentine, ritonavir, sulfinpyrazone, terbutaline.
Drugs that may increase the hematic concentration of aminophylline and
consequently increase its toxicity:
pipemidic acid, albendazole, allopurinol, amiodarone, anagrelide, bupropion, cimetidine, clarithromicyn, clindamycin, oral contraceptives, diltiazem, disulfiram, enoxacin, erythromycin, fluoroquinolones, fluvoxamine, furosemide, imipenem, interferons (alpha-2a, alpha-2b), ipriflavone, isoniazid, josamycin, lincomycin, macrolides, metotrexate, mexiletine, nifedipine, paroxetine, peginterferon alpha-2a, pentoxifylline, propafenone, propanolol, ranitidine, riluzole, rofecoxib, telitromycin, oral anticoagulant therapy, ticlopidine, troleandomycin, anti-flu vaccine, verapamil.
The interaction between Isoproterenol (or Isoprenaline) and Aminophylline has not been clarified: in some cases it was observed that Isoproterenol increases the clearance of Aminophylline with a consequent decrease of Aminophylline plasmatic concentrations.
Aminophylline increases the excretion of lithium carbonate and reduces its hematic concentration; it may modify the sensitivity and toxicity of the digitalis derivatives and the sympathomimetic ammines. It increases the hematic levels of ropivacaine and tacrolimus.
The simultaneous administration of Aminophylline and the following drugs
increases toxicity: halothane (increase of cardiac toxicity), epinephrine (increase of toxicity in the central nervous system and gastrointestinal tract), ketamine (decrease of the seizure threshold).
Aminophylline decreases the effect of the benzodiazepines.
The plasmatic concentrations of Aminophylline may be reduced by the simultaneous administration of preparations with Hypericum perforatum that interfere with the enzymes responsible for the metabolism of the drugs and, consequently, should not be administered together with Aminophylline. The induction effect may persist for at least 2 weeks after suspension of the treatment with products containing Hypericum perforatum.
If a patient is treated contemporarily also with products containing Hypericum
perforatum, the plasmatic levels of Aminophylline should be monitored and the
therapy with Hypericum perforatum should be discontinued. In this case the plasmatic levels of Aminophylline may increase and the dosage of Aminophylline might require an adjustment.

Pregnancy:
Though no negative effects of Aminophylline on the development of the fetus have been reported, the use of Aminophylline during pregnancy should be limited to the cases in which asthma represents a serious danger for the mother.
Lactation:
Lactation is not compatible with administration of Aminophylline. inotropic effects, which result in an increase in the cardiac output. The increased cardiac work involves an increase in myocardial metabolic demands, usually offset by an increase in coronary flow. Aminophylline exerts a diuretic effect, due to the increase in the renal blood flow and the action in the renal tubule.

The first symptoms of overdose are represented by agitation, tremor, confusion, vomiting and tachycardia, followed by hematemesis, convulsions, cardiac arrhythmia and fever. First signs of intoxication are generalized tonic-clonic seizures and severe ventricular arrhythmia.
In case of overdose, diazepam should be administered against the toxic effects
on the central nervous system. An adequate respiratory assistance should
also be available and the patient should be hydrated and his blood pressure monitored.

Store in the original package to protect from light. Store below 25°C.