Aminophylline Injection 250mg/10ml GMP Certificated

• Application: Internal Medicine
• Usage Mode: Intramuscular Injection
• Suitable for: Adult
• State: Liquid
• Shape: Liquid Injection
• Type: Biological Products
• Model NO.: 250mg/10ml
• Pharmaceutical Technology: Chemical Synthesis
• Transport Package: 10ampoules/Box, 50ampoules/Box
• Specification: Aminophylline injection 250mg
• Trademark: OEM
• Origin: China
• HS Code: 3004909099
• Production Capacity: 10000000AMP

Product Description

1. Name of the medicinal product

Aminophylline Hydrate 25mg/ml Solution for Injection

2. Qualitative and quantitative composition

Each 10ml of solution contains aminophylline hydrate B.P. 250mg.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Clear, sterile solution for injection, intended for parenteral administration to human beings.

4. Clinical particulars

4.1 Therapeutic indications

Aminophylline is a complex of theophylline and ethylenediamine and is given for its theophylline activity to relax smooth muscle and to relieve bronchial spasm.

Aminophylline Injection is indicated for relief of bronchospasm associated with asthma and in chronic obstructive pulmonary disease.

4.2 Posology and method of administration

Posology:

Aminophylline Injection B.P. 250mg/10ml is for slow intravenous administration. The solution may be injected very slowly, or it may be infused in a small volume of either 5% dextrose or 0.9% sodium chloride injection.

Maintenance therapy can be administered via larger volume infusion solutions, rate-regulated to deliver the required amount of drug each hour.

Therapeutic plasma concentrations of theophylline are considered to be in the range of 5 to 20mcg/ml and levels above 20mcg/ml are more likely to be associated with toxic effects. There is marked interpatient variation in the dosage required to achieve plasma levels of theophylline that are within the desired therapeutic range.

During therapy, patients should be monitored carefully for signs of toxicity and, where possible, the serum theophylline levels should also be monitored.

In the following dosage guidelines for the intravenous administration of aminophylline, doses should be calculated on the basis of lean (ideal) body weight; the drug is not recommended for infants under 6 months of age due to the marked variation in theophylline metabolism in infants;

1. PATIENTS NOT ALREADY RECEIVING THEOPHYILINE PRODUCTS

(a)	A loading dose of 6mg/kg body weight of aminophylline may be given by slow intravenous injection at a rate not exceeding 25mg/min.
(b)	Depending on the status of the patient, the maintenance dose for the next 12 hours may be considered as follows:

Children aged 6 months to 9 years:	1 .2mg/kg/hour (reducing to lmg/kg/hour beyond 12 hours).
Children aged 9 years to 16 years and young adult smokers:	1mg/kg/hour (reducing to 0.8mg/kg/hour beyond 12 hours).
Otherwise healthy non-smoking adults:	0.7mg/kg/hour (reducing to 0.5mg/kg/hour beyond 12 hours).
Older patients and those with cor pulmonale:	0.6mg/kg/hour (reducing to 0.3mg/kg/ hour beyond 12 hours).
Patients with congestive cardiac failure	0.5mg/kg/hour (reducing to 0.1 -
or hepatic disease:	0.2mg/kg/hour beyond 12 hours).

2. PATIENTS ALREADY RECEIVING THEOPHYLLINE PRODUCTS

The loading dose should be adjusted on the basis that each 0.5mg/kg of theophylline administered as a loading dose will result in a 1 mcg/ml increase in serum theophylline concentration.

Ideally, the loading dose should be deferred until serum theophylline levels can be determined. If this is not possible and if the clinical situation requires that the drug be administered, a dose of 3.1 mg/kg of aminophylline (equivalent to 2.5mg/kg of anhydrous theophylline) may be considered on the basis that it is likely to increase the serum theophylline concentration by approximately 5mcg/ml when administered as a loading dose.

Subsequently, the maintenance dosage recommendations are the same as those described above.