Ipratropium bromide, salbutamol sulphate.
Each puff delivers ipratropium bromide 20 mcg and salbutamol (as salbutamol sulphate) 100 mcg.
Pharmacology: Ipralin hydrofluoroalkane (HFA) inhaler contains ipratropium bromide and salbutamol. lpratropium bromide is an anticholinergic (parasympatholytic) agent, which inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cGMP), which are caused by the interaction of acetylcholine with the muscarinic receptors on bronchial smooth muscle. This opens bronchi and causes bronchodilation. Salbutamol is a selective β2-adrenoceptor agonist. At therapeutic doses, it acts on the β2-adrenoceptors of bronchial smooth muscle, with little or no action on the β1-adrenoceptors of cardiac muscle. Salbutamol provides short acting (4-6 hrs) bronchodilatation with a fast onset (within 5 min) in reversible airways obstruction.
Patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a 2nd bronchodilator.
Two (2) puffs, 4 times daily.
Patients may take additional puffs as required; however, the total number of puffs should not exceed 12 in 24 hrs.
Hypersensitivity to soya lecithin or related food products eg, soybean and peanut; to atropine or its derivatives, or any components of Ipralin.
Paradoxical Bronchospasm: Ipralin inhaler can produce paradoxical bronchospasm that can be life-threatening. If it occurs, Ipralin should be discontinued immediately and an alternative therapy may be instituted.
Cardiovascular Effect: The salbutamol sulphate contained in Ipralin HFA inhaler, like other β-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. Although such effects are uncommon after administration of Ipralin HFA inhaler at recommended doses, if they occur, discontinuation of Ipralin may be indicated. In addition, β-adrenergic agents have been reported to produce electrocardiogram (ECG) changes eg, flattening of the T-wave, prolongation of the QTc interval and ST segment depression. Therefore, Ipralin HFA inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.
Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of ipratropium bromide or salbutamol sulphate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema.
Ipratropium bromide containing inhaler should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Salbutamol sulphate containing inhaler should be used with caution in patients with convulsive disorders, hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines.
Beta-adrenergic agents may also produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. Combination of ipratropium and salbutamol inhaler has not been studied in patients with hepatic or renal insufficiency. it should be used with caution in those patient populations.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies of ipratropium bromide or salbutamol sulphate in pregnant women. Ipralin HFA inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether the components of Ipralin HFA inhaler are excreted in human milk. Ipralin HFA inhaler should not be used by breastfeeding mothers, unless the expected benefit is thought to outweigh the risks.
Use in children: Safety and effectiveness in the pediatric population have not been established.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies of ipratropium bromide or salbutamol sulphate in pregnant women. Ipralin HFA inhaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether the components of Ipralin HFA inhaler are excreted in human milk. Ipralin HFA inhaler should not be used by breastfeeding mothers, unless the expected benefit is thought to outweigh the risks.
Headache, pain, influenza, bronchitis, dyspnea, coughing, respiratory disorders, pneumonia, upper respiratory tract infection, pharyngitis, sinusitis, rhinitis have been reported. Additional adverse reactions reported include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion and urinary tract infection/dysuria.
Ipratropium bromide and salbutamol sulphate inhaler has been used concomitantly with other drugs including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids, commonly used in the treatment of COPD. With the exception of salbutamol, there are no formal studies fully evaluating the interaction effects of ipratropium bromide and salbutamol sulphate inhaler and these drugs with respect to effectiveness.
Anticholinergic Agents: Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of Ipralin with other anticholinergic-containing drugs.
Beta-Adrenergic Agents: Caution is advised in the co-administration of Ipralin and other sympathomimetic agents due to increased risk of adverse cardiovascular effects. Beta-receptor blocking agents and salbutamol inhibit the effect of each other. Beta-receptor blocking agents should be used with caution in patients with hyperreactive airways.
Diuretics: The ECG changes and/or hypokalemia which may result from the administration of non-potassium sparing diuretics (eg, loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of β-agonist-containing drugs eg, ipratropium bromide and salbutamol sulphate inhaler, with non-potassium sparing diuretics.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Ipratropium bromide and salbutamol sulphate inhaler should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents because the action of salbutamol on the cardiovascular system may be potentiated.
Instructions for Use and Handling: Testing the Inhaler: Before using the inhaler for the first time or if it has not been used for ≥1 week, shake the inhaler well and perform a "test fire" ie, release 1 puff into the air.
Using The Inhaler: 1. Remove the cap from the mouthpiece of the actuator. Make sure there is nothing in the mouthpiece before use.
2. Hold canister upright. Shake vigorously for at least 10 sec.
3. Breathe out gently and immediately place the mouthpiece in the mouth between the teeth. Do not bite.
4. Tilt head slightly backward. Start breathing slowly through the mouth. At the same time, press down firmly at the top of the canister to release medicine. Continue to breathe in steadily and deeply.
5. Remove the inhaler from the mouth and hold breath for 10 sec or as long as it is comfortable. Then, breath out gently. If the patient takes a 2nd inhalation, wait for at least 1 min before repeating steps 3 and 4.
6. Replace mouthpiece cap after use.
Important: Do not rush steps 4 and 5. It is important to start breathing in as slowly as possible just before releasing the dose. Practice in front of a mirror for the 1st few times. If a mist is seen coming from the top of the inhaler or the sides of mouth, start again from step 2. This escaping mist indicates incorrect technique.
Cleaning The Inhaler: 1. Remove the metal canister from the actuator (plastic casing) of the inhaler and remove the mouthpiece cap.
2. Immerse the actuator (plastic casing) and the mouthpiece cap in warm water for few minutes and then rinse under running water. But do not put the metal canister into water.
3. Leave actuator and mouthpiece cap to dry in warm place. Avoid excessive heat.
4. Replace the canister and the mouthpiece cap correctly.
Clean the inhaler at least once a week.
Tips for Children: Children and others who have weaker hands may have difficulty pressing down on the top of the canister with just 1 hand. Patients can use both hands to make the inhaler work.
Store below 30°C. Do not freeze.
Pressured canister. Do not puncture, break or burn even when apparently seemed empty. Keep away from sunlight and heat.
R03AL02 - salbutamol 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.
Inhaler (canister) 20 mcg/100 mcg/puff x 200 puffs.
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