Inhalex Forte

Inhalex Forte

ipratropium + fenoterol

Manufacturer:

Teva Pharma

Distributor:

DKLL
Full Prescribing Info
Contents
Ipratropium bromide, fenoterol hydrobromide.
Description
1 unit dose (4 mL) solution for inhalation contains ipratropium bromide 0.5 mg and fenoterol hydrobromide 1.25 mg.
Indications/Uses
Inhalex Forte is a bronchodilator for the acute treatment and prevention of symptoms in chronic obstructive airway disorders with reversible bronchospasm such as bronchial asthma and chronic bronchitis with or without emphysema.
Dosage/Direction for Use
The solution is ready for use and requires no dilution. Pour the contents of the unit dose tube into the nebuliser reservoir and the contents are used soon after opening. The dosage should be given under medical supervisor. Unless otherwise prescribed, the following dose are recommended: Adults and Children over 12 years: Treatment of attacks: 1-2 unit dose tubes are required for symptom relief but administered under medical supervision.
Intermittent and long-term treatment: 1 unit dose tube for each administration, up to 4 times daily. Where wall oxygen is available the solution should be administered at a flow rate of 6-8 litres per minute.
Children under 12 years: Not recommended in this age group.
Overdosage
Symptoms: Flushing, tremor of the fingers, nausea, restlessness, tachycardia, palpitation, dizziness, headache, increase in systolic blood pressure, fall in diastolic blood pressure, a feeling of pressure in the chest, excitation and possibly extrasystoles.
Treatment: In severe cases intensive therapy, should give sedatives or tranquilizers and ß-receptor blockers, preferably β1-selective are suitable as specific antidotes. However, the dose should be adjusted carefully to prevent the increase of bronchial obstruction caused by β-receptor.
Contraindications
Hypersensitivity to Fenoterol hydrobromide or Atropine like substances or other ingredients of the drug, tachyarrhythmia and hypertrophic cardiomyopathy.
Special Precautions
Use of Inhalex Forte with other sympathomimetic bronchodilators is recommended to be given under medical supervision only. In insufficiently controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, Inhalex Forte should be used by medical advise. In the case of prolonged use, on demand treatment may be preferable to regular use. The use of high amounts of Inhalex Forte on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this situation, the physician should review the patient's therapy plan, and the adequacy of anti-inflammatory therapy. Concomitant treatment with β2-agonist, xanthine derivatives, steroids and diuretics may cause serious hypokalemia. In such situations, it is recommended that serum potassium levels should be monitored.
Ocular complications: Not to allow the solution or mist to enter the eyes. Patients predisposed to glaucoma should be warned specifically to protect their eyes. If eye complications develop, treatment with miotic drops should be initiated and consult specialist immediately.
Use In Pregnancy & Lactation
The use of drugs at the first trimester should be use after careful risk/benefit assessment. Safety during lactation has not yet been established.
Side Effects
Fine tremor of skeletal muscles and nervousness, tachycardia, dizziness, palpitations or headache are frequent adverse effects. In some cases there may be local reactions such as dryness of the mouth, throat irritation, or allergic reactions, hypokalemia and cough. Use of anticholinergic agents (like e.g. ipratropium bromide) may precipitate urinary retention. Ocular side effects have been reported (see Precautions).
Drug Interactions
ß-adrenergics, anticholinergics, xanthine derivatives and corticosteroids may enhance the effect of Inhalex Forte, thus increasing the side effects of Inhalex Forte as well. Concomitant treatment of ß-blockers and Inhalex Forte may cause reduction in efficacy of Inhalex Forte.
Caution For Usage
Instructions for the use of Inhalex Forte: Tear off tube from the card. Twist the tip off to open. Keep un-opened tubes within pouches.
Storage
Store below 30°C and protect from light.
ATC Classification
R03AL01 - fenoterol and ipratropium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Inhalation soln 4 mL x 21's.
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