Ipratropium bromide, fenoterol hydrobromide.
Each mL vial contains Ipratropium bromide 250 microgram; Fenoterol hydrobromide 500 microgram.
PUNOL INHALATION SOLUTION contains two active bronchodilating ingredients: ipratropium bromide, exhibiting an anticholinergic effect, and fenoterol hydrobromide, a beta2-adrenergic agent.
Pharmacology: Pharmacodynamics: lpratropium bromide is an anticholinergic agent. It inhibits vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from vagus nerve. The bronchodilation following inhibition of ipratropium bromide is primarily a local effect, not a systemic one.
Fenoterol hydrobromide is a sympathomimetic agent, selective stimulating beta-2 receptors in the therapeutic dose range. The stimulation of beta-1 receptor comes into effect at higher dose range. Concurrent use of two bronchodilators affect different pharmacological sites of action.
Pharmacokinetics: Ipratropium bromide: Following oral inhalation, ipratropium bromide is only minimally absorbed into systemic circulation from the surface of the lungs or from the GI tract. Following oral inhalation via nebulization of 400 - 600 mcg of ipratropium bromide, bronchodilation usually is evident within 15 - 30 minutes with peak effect in approximately 1-2 hours. Following concomitant administration via nebulization of a β2-adrenergic agonist and ipratropium in patients with chronic obstructive pulmonary disease (COPD), bronchodilalion persists for 5 - 7 hours compared with 3 - 4 hours in patients given a β2-adrenergic agonist alone. Distribution of ipratropium bromide into human tissues and body fluids has not been elucidated. Quaternary ammonium antimuscarinics arc completely ionized and possess poor lipid solubility; accordingly, they do not readily penetrate the CNS. Ipratropium bromide reportedly is 0 - 9% bound to plasma albumin and α1-acid glycoproteins in vitro.
It is not known whether ipratropium bromide crosses the placenta or is distributed into milk. An elimination half-life of about 2 - 4 hours. The drug is partially metabolized to at least 8 metabolites. The main metabolites appear to be N-isopropylnortropium rnethobromide, α-phenylacrylic acid-N-isopropylnortropine-ester methobromide and phenylacetic acid-N-isopropylnortropine-ester methobromide. In vitro, these metabolites have minimal or no antimuscarinic activity. After oral inhalation of ipratropium bromide, most of the dose is excreted in feces, principally as unchanged drugs.
Fenoterol hydrobromide: When drug is administered by inhalation, as much as 90% of the dose is swallowed. Fenoterol undergoes extensive first-pass metabolism. The half-life is 7 hours. Although maximum effect of inhaled fenoterol is not achieved for 1 to 2 hours, 60% of the maximal response is seen within the first few minutes. The duration of action is about 4 - 6 hours. Less than 2% of the dose is eliminated unchanged in the urine. The balance is excreted as acid conjugates in the urine and feces (40%).
PUNOL INHALATION SOLUTION is a bronchodilator for prevention and treatment of symptoms in chronic obstructive airway disorders with reversible bronchospasm such as bronchial asthma and especially chronic bronchitis with or without emphysema. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease.
Adults and adolescents over 12 years of age: Acute asthma treatment: 1 mL is sufficient for prompt symptom relief in many cases of mild to moderate exacerbations. In severe cases 2.5 - 4 mL may be administered under medical supervision.
Intermittent and long term treatment: 1 - 2 mL for each administration, up to 4 times daily.
Children 6 -12 years: Acute asthma treatment: 0.5 - 1 mL is sufficient for prompt symptom relief in many cases of mild to moderate exacerbations. In severe cases 3 mL may be administered under medical supervision.
Intermittent and long term treatment: 0.5 - 1 mL for each administration, up to 4 times daily.
Children under 6 years (below 22 kg body weight): There is limited information in this age group, the following dose is recommended to be under medical supervision; about 25 mcg Ipratropium bromide and 50 mcg Fenoterol hydrobromide per kg body weight per dose up to 3 times a day.
Symptoms: The effect of overdosage are expected to be primarily related to fenoterol hydrobromide.
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, angina pain, arrhythmias, seizures, hypokalemia and hyperglycemia.
Acute overdosage of ipratropium bromide is unlikely following oral inhalation because of topical administration and poor absorption of ipratropium bromide. The overdosage of ipratropium bromide may expected to produce effects associated with antimuscarinic administration such as dry mouth, visual accommodation disturbances.
Treatment: The drug should be discontinued and appropriate symptomatic and supportive therapy should be initiated. Monitor blood pressure and ECG. The judicious use of a cardioselective β-receptor blocker (i.e., metroprolol, atenolol) is suggested, bearing in mind the danger of inducing an asthmatic attack. Dialysis is not appropriate.
Hypertrophic obstructive cardiomyopathy, tachycardia. Hypersensitivity to ipratropium bromide or fenoterol hydrobromide, or atropine or its derivatives or other inactive ingredients.
In case of acute rapidly worsening dyspnea, consult the physician immediately.
Use with caution in patients with cardiovascular disease (especially coronary insufficiency, cardiac arrhythmias, or hypertension), seizure disorder, hyperthyroidism, diabetes mellitus, and in those who are unusually responsive to β-adrenergic agents.
Temporary blurred vision, mydriasis, occular pain, or precipitation or worsening of angle-closure glaucoma has occurred following inadvertent contact of ipratropium bromide with the eyes; therefore, when the drug is administered via a nebulizer, procedures to minimize ocular exposure should be employed (e.g., using a mouthpiece rather than a face mask to deliver the drug). In addition, the patients should be instructed to close their eyes during administration.
Immediate hypersensitivity reactions may occur after administration of ipratropium bromide as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction, particularly if they are receiving an anticholinergic by another route.
Pregnancy: PUNOL INHALATION SOLUTION should be used during pregnancy only if the possible benefits outweigh the potential risks.
Lactation: It is not known whether ipratropium bromide are excreted in human milk. Exercise caution when PUNOL INHALATION SOLUTION is administered to a breast-feeding woman.
Cardiovascular: Chest pain, hypertension, hypertension aggravated, tachycardia, palpitation.
Central nervous system: Dizziness, headache, insomnia, nervousness, tremor.
Gastrointestinal tract: Constipation, dry mouth, nausea.
Musculoskeletal: Arthritis, skeletal muscle tremor.
Respiratory: Bronchitis, bronchospasm, coughing, dyspnea, pharyngitis, rhinitis, sputum increased, upper respiratory tract infection.
Miscellaneous: Back pain, influenza-like syndrome, pain, eye pain, urinary retention, urinary tract infection, urticaria.
Anticholinergic drug: Concomitant use may potentiate anticholinergic effect.
Beta blockers: Concomitant use may inhibit bronchodilating effects. Severe bronchospasms may be produced in asthmatic patients.
Methyldopa: Concurrent administralion may result in an increased pressor response.
MAO inhibitors: Coadministration may result in severe headache, hypertension, and hyperpyrexia, resulting in hypertensive crisis. MAO inhibitors also potentiate the actions of beta-adrenergic agonists on the vascular system. Avoid coadministration with sympathomimetics or within 2 weeks.
Tricyclic antidepressants (TCAs): TCAs potentiate the pressor response of direct-acting sympathomimetics; dysrhythmias have occurred.
Theophylline: Enhanced toxicity, particularly cardiotoxicity, has been noted. Decreased theophylline levels may occur.
Store at temperature not exceeding 30°C.
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.
Punol inhalation soln
20 mL x 1's
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