PULMODUAL Ipratropium Bromide / Salbutamol Sulfate 500mcg / 2.5mg per 2.5mL Solution for Inhalation 2.5mL 1's
RXDRUG-DR-XY44869-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Pulmodual: Ipratropium bromide + Salbutamol (Pulmodual) is indicated in the treatment of reversible airways obstruction, like: asthma and Chronic Obstructive Pulmonary Disease (COPD) for patients in need of more than a single bronchodilator or who require a second bronchodilator.
Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation is particularly suitable for the relief and prevention of asthma systems. It should relieve symptoms when they occur and to prevent them in circumstances recognized by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure).
Salbutamol Sulphate and Ipratropium Bromide Inhalation is particularly valuable as relief medication in mild, moderate or severe asthma, provide that reliance on it does not delay the introduction & use of regular inhaled corticosteroid therapy.
Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation is particularly suitable for the relief and prevention of asthma systems. It should relieve symptoms when they occur and to prevent them in circumstances recognized by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure).
Salbutamol Sulphate and Ipratropium Bromide Inhalation is particularly valuable as relief medication in mild, moderate or severe asthma, provide that reliance on it does not delay the introduction & use of regular inhaled corticosteroid therapy.
Dosage/Direction for Use
Pulmodual: Per 2.5 mL of Ipratropium bromide + Salbutamol contains 500 mcg of Ipratropium bromide and 2.5 mg of Salbutamol.
Dosage of Solution for Inhalation: Adult (Including Elderly Patients) and Adolescents over 12 years: One (1) ampoule (2.5 mL) every 6 to 8 hours.
For the Treatment of Acute Attacks: One (1) ampoule (2.5 mL) is sufficient for the prompt relief of symptom; in severe cases two (2) ampoules (5 mL) may be required if an attack has not been relieved by one (1) ampoule (2.5 mL).
Children 2 to 12 years: 3 drops/kg/dose (maximum dose 2.5 mg of salbutamol) every 6 to 8 hours.
Administration: Administer by oral inhalation via nebulization.
Prepare the nebulizer for use.
Remove the ampoule from the labeled strip by twisting and pulling. Hold the ampoule upright and twist off the cap, transfer the contents of the solution into the nebulizer reservoir.
Use the nebulizer according to the instruction provided by the manufacturer.
After use, discard any solution left in the reservoir and thoroughly clean the nebulizer.
Since the Ipratropium bromide + Salbutamol (Pulmodual) solution contains no preservatives, it is important to use the content immediately after opening. A new ampoule should be used for each administration to avoid microbial contamination. Discard partly used, opened or damaged ampoule.
Ipratropium bromide + Salbutamol (Pulmodual) solution for inhalation should not be mixed with other drugs in the same nebulizer.
Pulmodual MDI: Recommended Dose: Salbutamol Sulphate and Ipratropium Bromide Inhalation is for inhalation use only.
Patients should be made aware that Salbutamol Sulphate and Ipratropium Bromide Inhalation must be used daily for optimum benefit, even when asymptomatic.
Two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours.
Mode of Administration: For inhalation use only.
Instruction for Use: Patients should be instructed in the proper use of their Inhalation. During inhalation, the patient should preferably sit or stand. The Inhalation has been designed for use in a vertical position.
Testing the Inhalation: Before using for the first time, patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhalation well, hold the inhalation between the fingers and thumb with the thumb at the base, below the mouthpiece and release puffs into the air to make sure that it works. The inhalation should be shaken immediately before releasing each puff. If the inhalation has not been used for a week or more remove the mouthpiece cover, the patients should shake the inhalation well and release two puffs into the air.
Use of the Inhalation: 1. Patients should remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Patients should check inside and outside of the Inhalation including the mouthpiece for the presence of loose objects.
3. Patients should shake the Inhalation well to ensure that any loose objects are removed and that the contents of the Inhalation are evenly mixed.
4. Patients should hold the Inhalation upright between fingers and thumb with their thumb on the base, below the mouthpiece.
5. Patients should breathe out as far as it is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it. Patients should be instructed not to bite the mouthpiece.
6. Just after starting to breathe in through their mouth, patients should press firmly down on the top of the Inhalation to release Salbutamol Sulphate and Ipratropium Bromide Inhalation, while still breathing in steadily and deeply.
7. While holding their breath, patients should take the Inhalation from their mouth and take their finger from the top of the Inhalation. Patients should continue holding their breath for as long as it is comfortable.
8. To take a second inhalation, patients should keep the Inhalation upright and wait about half a minute before repeating steps 3 to 7.
9. Patients should immediately replace the mouthpiece cover in the correct orientation by firmly pushing and snapping the cap into position. The cover does not require excessive force and it will click into position.
Important: Patients should not rush stages 5, 6 and 7. It is important that patients start to breathe in as slowly as possible just before operating their Inhalation. Patients should practice in front of a mirror for the first few times. If they see "mist" coming from the top of their Inhalation or the sides of their mouth they should start again from stage 2.
Cleaning: The Inhalation should be cleaned at least once a week.
1. Remove the mouthpiece cover.
2. Do not remove the canister from the plastic casing.
3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
4. Replace the mouthpiece cover in the correct orientation. The cover does not require excessive force and it will click into position.
5. Do not put the metal canister in water.
Dosage of Solution for Inhalation: Adult (Including Elderly Patients) and Adolescents over 12 years: One (1) ampoule (2.5 mL) every 6 to 8 hours.
For the Treatment of Acute Attacks: One (1) ampoule (2.5 mL) is sufficient for the prompt relief of symptom; in severe cases two (2) ampoules (5 mL) may be required if an attack has not been relieved by one (1) ampoule (2.5 mL).
Children 2 to 12 years: 3 drops/kg/dose (maximum dose 2.5 mg of salbutamol) every 6 to 8 hours.
Administration: Administer by oral inhalation via nebulization.
Prepare the nebulizer for use.
Remove the ampoule from the labeled strip by twisting and pulling. Hold the ampoule upright and twist off the cap, transfer the contents of the solution into the nebulizer reservoir.
Use the nebulizer according to the instruction provided by the manufacturer.
After use, discard any solution left in the reservoir and thoroughly clean the nebulizer.
Since the Ipratropium bromide + Salbutamol (Pulmodual) solution contains no preservatives, it is important to use the content immediately after opening. A new ampoule should be used for each administration to avoid microbial contamination. Discard partly used, opened or damaged ampoule.
Ipratropium bromide + Salbutamol (Pulmodual) solution for inhalation should not be mixed with other drugs in the same nebulizer.
Pulmodual MDI: Recommended Dose: Salbutamol Sulphate and Ipratropium Bromide Inhalation is for inhalation use only.
Patients should be made aware that Salbutamol Sulphate and Ipratropium Bromide Inhalation must be used daily for optimum benefit, even when asymptomatic.
Two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours.
Mode of Administration: For inhalation use only.
Instruction for Use: Patients should be instructed in the proper use of their Inhalation. During inhalation, the patient should preferably sit or stand. The Inhalation has been designed for use in a vertical position.
Testing the Inhalation: Before using for the first time, patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhalation well, hold the inhalation between the fingers and thumb with the thumb at the base, below the mouthpiece and release puffs into the air to make sure that it works. The inhalation should be shaken immediately before releasing each puff. If the inhalation has not been used for a week or more remove the mouthpiece cover, the patients should shake the inhalation well and release two puffs into the air.
Use of the Inhalation: 1. Patients should remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Patients should check inside and outside of the Inhalation including the mouthpiece for the presence of loose objects.
3. Patients should shake the Inhalation well to ensure that any loose objects are removed and that the contents of the Inhalation are evenly mixed.
4. Patients should hold the Inhalation upright between fingers and thumb with their thumb on the base, below the mouthpiece.
5. Patients should breathe out as far as it is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it. Patients should be instructed not to bite the mouthpiece.
6. Just after starting to breathe in through their mouth, patients should press firmly down on the top of the Inhalation to release Salbutamol Sulphate and Ipratropium Bromide Inhalation, while still breathing in steadily and deeply.
7. While holding their breath, patients should take the Inhalation from their mouth and take their finger from the top of the Inhalation. Patients should continue holding their breath for as long as it is comfortable.
8. To take a second inhalation, patients should keep the Inhalation upright and wait about half a minute before repeating steps 3 to 7.
9. Patients should immediately replace the mouthpiece cover in the correct orientation by firmly pushing and snapping the cap into position. The cover does not require excessive force and it will click into position.
Important: Patients should not rush stages 5, 6 and 7. It is important that patients start to breathe in as slowly as possible just before operating their Inhalation. Patients should practice in front of a mirror for the first few times. If they see "mist" coming from the top of their Inhalation or the sides of their mouth they should start again from stage 2.
Cleaning: The Inhalation should be cleaned at least once a week.
1. Remove the mouthpiece cover.
2. Do not remove the canister from the plastic casing.
3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
4. Replace the mouthpiece cover in the correct orientation. The cover does not require excessive force and it will click into position.
5. Do not put the metal canister in water.
Overdosage
Pulmodual: Reports of overdosage are more likely with Salbutamol. The expected symptoms of overdosage are tachycardia, CNS stimulation, tremor, hypokalaemia, and hyperglycaemia.
Symptomatic treatment of the adverse effects has proved successful. The plasma-potassium concentration and pulse rate have been found to correlate with the plasma concentration of salbutamol.
Pulmodual MDI: There are no data available from clinical trials on overdose with Salbutamol Sulphate and Ipratropium Bromide Inhalation, however data on overdose with both drugs are given as follows: The signs and symptoms of salbutamol overdose are chest pain, high blood pressure (hypertension) or low blood pressure (hypotension), fast heart rate (tachycardia), nervousness, headaches, shakiness (tremor), dry mouth, feelings of a rapidly or forcefully beating heart (heart palpitations), nausea, dizziness, insomnia, seizures, irregular heart rhythm (arrhythmia), fatigue, low potassium in the blood (hypokalemia) cardiac arrest, loss of life.
If the patient happens to overdose on this, seek immediate medical attention.
No symptoms specific to overdosage of ipratropium bromide have been encountered. In view of the wide therapeutic window and topical administration of ipratropium bromide, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
Symptomatic treatment of the adverse effects has proved successful. The plasma-potassium concentration and pulse rate have been found to correlate with the plasma concentration of salbutamol.
Pulmodual MDI: There are no data available from clinical trials on overdose with Salbutamol Sulphate and Ipratropium Bromide Inhalation, however data on overdose with both drugs are given as follows: The signs and symptoms of salbutamol overdose are chest pain, high blood pressure (hypertension) or low blood pressure (hypotension), fast heart rate (tachycardia), nervousness, headaches, shakiness (tremor), dry mouth, feelings of a rapidly or forcefully beating heart (heart palpitations), nausea, dizziness, insomnia, seizures, irregular heart rhythm (arrhythmia), fatigue, low potassium in the blood (hypokalemia) cardiac arrest, loss of life.
If the patient happens to overdose on this, seek immediate medical attention.
No symptoms specific to overdosage of ipratropium bromide have been encountered. In view of the wide therapeutic window and topical administration of ipratropium bromide, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
Contraindications
Pulmodual: Known hypersensitivity to the drug or any other component of Ipratropium bromide + Salbutamol (Pulmodual) or to atropine or its derivatives. Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.
Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation is contraindicated in patients with hypersensitivity to any of the active substances or to the excipient.
Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation is contraindicated in patients with hypersensitivity to any of the active substances or to the excipient.
Warnings
Pulmodual MDI: Salbutamol Sulphate and Ipratropium Bromide Inhalation can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. The Salbutamol Sulphate contained in Salbutamol Sulphate and Ipratropium Bromide Inhalation, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. If these symptoms occur, discontinuation of the drug may be indicated. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with salbutamol. In addition, beta-adrenergic agents have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, Salbutamol Sulphate and Ipratropium Bromide Inhalation should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension. 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 may occur after administration of ipratropium bromide or salbutamol sulphate, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Salbutamol Sulphate and Ipratropium Bromide Inhalation should be stopped at once and alternative treatment should be considered.
Salbutamol Sulphate and Ipratropium Bromide Inhalation contains ipratropium bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.
Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders. Hyperthyroidism, or diabetes mellitus and in patients who are usually 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.
Salbutamol Sulphate and Ipratropium Bromide Inhalation has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Immediate hypersensitivity reactions may occur after administration of ipratropium bromide or salbutamol sulphate, as demonstrated by urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. If such a reaction occurs, therapy with Salbutamol Sulphate and Ipratropium Bromide Inhalation should be stopped at once and alternative treatment should be considered.
Salbutamol Sulphate and Ipratropium Bromide Inhalation contains ipratropium bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.
Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders. Hyperthyroidism, or diabetes mellitus and in patients who are usually 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.
Salbutamol Sulphate and Ipratropium Bromide Inhalation has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Special Precautions
Pulmodual: Ipratropium bromide + Salbutamol (Pulmodual) should be used with caution in patients with prostatic hypertrophy, bladder neck obstruction, narrow angle glaucoma; risk of paradoxical bronchospasm usually occurs with the first dose of nebulized solution, it should be inhaled under medical supervision; hyperthyroidism, cardiovascular disease, arrhythmias, susceptibility to QT-interval prolongation, hypertension and diabetes mellitus.
Potentially serious hypokalaemia may result from beta2 agonist therapy, possibly through intracellular shunting, which can produce adverse cardiovascular effects. The decrease in serum potassium levels is usually transient, not requiring supplementation.
Pulmodual MDI: The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.
Information for Patients: Patients should be cautioned to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately.
The action of Salbutamol Sulphate and Ipratropium Bromide Inhalation should last 4 to 5 hours or longer. Salbutamol Sulphate and Ipratropium Bromide Inhalation should not be used more frequently than recommended. Do not increase the dose or frequency of Salbutamol Sulphate and Ipratropium Bromide Inhalation without consulting the physician. If the patient finds that treatment with Salbutamol Sulphate and Ipratropium Bromide Inhalation becomes less effective for symptomatic relief, the symptoms become worse, and/or the patient needs to use the product more frequently than usual, medical attention should be sought immediately. While the patient is taking Salbutamol Sulphate and Ipratropium Bromide Inhalation, other inhaled drugs should be taken only as directed by the physician. If the patient is pregnant or nursing, contact the physician about use of Salbutamol Sulphate and Ipratropium Bromide Inhalation. Appropriate use of Salbutamol Sulphate and Ipratropium Bromide Inhalation includes an understanding of the way it should be administered. Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Salbutamol Sulphate and Ipratropium Bromide Inhalation, patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.
Precautions: Before using this product, tell the doctor or the pharmacist if the patient is allergic to salbutamol or Ipratropium or if the patient has any other allergies.
Before using this product, tell the doctor the patient's medical history, especially of: diabetes, heart disease (e.g., irregular heartbeat, coronary insufficiency), high blood pressure, glaucoma, low potassium blood level (hypokalemia), seizure, overactive thyroid (hyperthyroidism), urination problems (e.g., due to enlarged prostate, urinary retention).
This drug may make the patient dizzy. If accidentally sprayed into the eyes, it may also cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until the patient is sure the patient can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell the doctor or dentist that the patient is using this medication.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with the doctor.
It is not known whether this drug passes into breast milk. Consult the doctor before breast-feeding.
Potentially serious hypokalaemia may result from beta2 agonist therapy, possibly through intracellular shunting, which can produce adverse cardiovascular effects. The decrease in serum potassium levels is usually transient, not requiring supplementation.
Pulmodual MDI: The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests.
Information for Patients: Patients should be cautioned to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately.
The action of Salbutamol Sulphate and Ipratropium Bromide Inhalation should last 4 to 5 hours or longer. Salbutamol Sulphate and Ipratropium Bromide Inhalation should not be used more frequently than recommended. Do not increase the dose or frequency of Salbutamol Sulphate and Ipratropium Bromide Inhalation without consulting the physician. If the patient finds that treatment with Salbutamol Sulphate and Ipratropium Bromide Inhalation becomes less effective for symptomatic relief, the symptoms become worse, and/or the patient needs to use the product more frequently than usual, medical attention should be sought immediately. While the patient is taking Salbutamol Sulphate and Ipratropium Bromide Inhalation, other inhaled drugs should be taken only as directed by the physician. If the patient is pregnant or nursing, contact the physician about use of Salbutamol Sulphate and Ipratropium Bromide Inhalation. Appropriate use of Salbutamol Sulphate and Ipratropium Bromide Inhalation includes an understanding of the way it should be administered. Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Salbutamol Sulphate and Ipratropium Bromide Inhalation, patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.
Precautions: Before using this product, tell the doctor or the pharmacist if the patient is allergic to salbutamol or Ipratropium or if the patient has any other allergies.
Before using this product, tell the doctor the patient's medical history, especially of: diabetes, heart disease (e.g., irregular heartbeat, coronary insufficiency), high blood pressure, glaucoma, low potassium blood level (hypokalemia), seizure, overactive thyroid (hyperthyroidism), urination problems (e.g., due to enlarged prostate, urinary retention).
This drug may make the patient dizzy. If accidentally sprayed into the eyes, it may also cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until the patient is sure the patient can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell the doctor or dentist that the patient is using this medication.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with the doctor.
It is not known whether this drug passes into breast milk. Consult the doctor before breast-feeding.
Use In Pregnancy & Lactation
Pulmodual: Pregnancy: Teratogenic Effects: Pregnancy Category C.
Ipratropium bromide + Salbutamol (Pulmodual) safety during pregnancy (human) has not been established. However, the use of drugs during pregnancy should be observed only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The use of Ipratropium bromide + Salbutamol (Pulmodual) for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh the risk because of the potential for beta-agonist interference with uterine contractility.
Nursing Mothers: The components of Ipratropium bromide and Salbutamol are excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipratropium bromide would reach the infant to an important extent, especially when taken by inhalation as a nebulized solution. However, caution should be exercised when administering to a nursing mother.
Pulmodual MDI: Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies of Salbutamol Sulphate and Ipratropium Bromide Inhalation in pregnant women. Animal reproduction studies have not been conducted with Salbutamol Sulphate and Ipratropium Bromide Inhalation. However, Salbutamol Sulphate has been shown to be teratogenic in mice and rabbits.
Salbutamol Sulphate and Ipratropium Bromide Inhalation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal studies with salbutamol have demonstrated a teratogenic effect. No evidence of abnormalities have been reported in women receiving salbutamol during pregnancy. Salbutamol has been given systemically to inhibit preterm labor. Use of salbutamol in pregnant women for relief of bronchospasm may interfere with uterine contractility.
Pulmonary edema has been associated with intravenous use of salbutamol in pregnant women. Metered dose Inhalations employ lower doses and result in lower plasma concentrations following administration, thereby producing fewer adverse effects for the mother and fetus. Ipratropium has failed to reveal evidence of teratogenicity in animal studies. There are no controlled data in human pregnancy. Salbutamol Sulphate and Ipratropium Bromide Inhalation is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Lactation: It is not known whether Salbutamol Sulphate and Ipratropium Bromide Inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling the doctor if the patient is breast-feeding a baby.
Ipratropium bromide + Salbutamol (Pulmodual) safety during pregnancy (human) has not been established. However, the use of drugs during pregnancy should be observed only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The use of Ipratropium bromide + Salbutamol (Pulmodual) for the treatment of COPD during labor should be restricted to those patients in whom the benefits clearly outweigh the risk because of the potential for beta-agonist interference with uterine contractility.
Nursing Mothers: The components of Ipratropium bromide and Salbutamol are excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Ipratropium bromide would reach the infant to an important extent, especially when taken by inhalation as a nebulized solution. However, caution should be exercised when administering to a nursing mother.
Pulmodual MDI: Pregnancy: Pregnancy Category C.
There are no adequate and well-controlled studies of Salbutamol Sulphate and Ipratropium Bromide Inhalation in pregnant women. Animal reproduction studies have not been conducted with Salbutamol Sulphate and Ipratropium Bromide Inhalation. However, Salbutamol Sulphate has been shown to be teratogenic in mice and rabbits.
Salbutamol Sulphate and Ipratropium Bromide Inhalation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal studies with salbutamol have demonstrated a teratogenic effect. No evidence of abnormalities have been reported in women receiving salbutamol during pregnancy. Salbutamol has been given systemically to inhibit preterm labor. Use of salbutamol in pregnant women for relief of bronchospasm may interfere with uterine contractility.
Pulmonary edema has been associated with intravenous use of salbutamol in pregnant women. Metered dose Inhalations employ lower doses and result in lower plasma concentrations following administration, thereby producing fewer adverse effects for the mother and fetus. Ipratropium has failed to reveal evidence of teratogenicity in animal studies. There are no controlled data in human pregnancy. Salbutamol Sulphate and Ipratropium Bromide Inhalation is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Lactation: It is not known whether Salbutamol Sulphate and Ipratropium Bromide Inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling the doctor if the patient is breast-feeding a baby.
Adverse Reactions
Pulmodual: The side effects of Ipratropium bromide + Salbutamol (Pulmodual) includes: dry mouth, nausea, constipation, headache, fine tremor (particularly in the hands), nervous tension, muscle cramps, and palpitation.
Other adverse effects include: tachycardia, atrial fibrillation, arrhythmias, peripheral vasodilation, and disturbances of sleep and behaviour.
Paradoxical bronchospasm, urticaria, angioedema, hypotension, and collapse have also been reported.
Potentially serious hypokalaemia may occur from beta2 agonist therapy.
Pulmodual MDI: Headache, nausea, nervousness, trouble sleeping, dizziness, dry mouth/throat, coughing, or runny nose may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.
Remember that the doctor has prescribed this medication because he or she has judged that the benefit to the patient is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell the doctor immediately if any of these unlikely but serious side effects occur: eye pain, fast/pounding heartbeat, muscle cramps, trouble urinating, vision changes, weakness.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, irregular heartbeat.
Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If the patient has trouble breathing or experience sudden wheezing, seek immediate medical attention.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if the patient notices any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If the patient notices other effects not previously listed, contact the doctor or pharmacist.
Other adverse effects include: tachycardia, atrial fibrillation, arrhythmias, peripheral vasodilation, and disturbances of sleep and behaviour.
Paradoxical bronchospasm, urticaria, angioedema, hypotension, and collapse have also been reported.
Potentially serious hypokalaemia may occur from beta2 agonist therapy.
Pulmodual MDI: Headache, nausea, nervousness, trouble sleeping, dizziness, dry mouth/throat, coughing, or runny nose may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.
Remember that the doctor has prescribed this medication because he or she has judged that the benefit to the patient is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell the doctor immediately if any of these unlikely but serious side effects occur: eye pain, fast/pounding heartbeat, muscle cramps, trouble urinating, vision changes, weakness.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, irregular heartbeat.
Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If the patient has trouble breathing or experience sudden wheezing, seek immediate medical attention.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if the patient notices any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If the patient notices other effects not previously listed, contact the doctor or pharmacist.
Drug Interactions
Pulmodual: Anticholinergic agents: Co-administration of other anticholinergic containing drugs must be avoided. It can cause an additive interaction upon concomitant use of anticholinergic medications.
Beta-adrenergic agents: Caution is advised in the co-administration of Ipratropium bromide + Salbutamol and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.
Beta-receptor blocking agents: Beta-receptor blocking agents and Salbutamol inhibit the effect of each other, it should be used with caution in patients with hyper reactive airways.
Cardiac glycosides: Salbutamol possibly reduces plasma concentration of digoxin.
Diuretics: Increased risk of hypokalemia when high doses of beta2 sympathomimetics is given with diuretics (e.g. loop or thiazide diuretics).
Monoamine oxidase inhibitors or tricyclic antidepressants: It should be administered with extreme caution to patients treated with monoamine oxidase inhibitors or tricyclic antidepressants or within two weeks of discontinuation of such agents because the action of salbutamol sulfate on the cardiovascular system may be potentiated.
Theophylline: Increased risk of hypokalemia when high doses of beta2 sympathomimetics is given with theophylline.
Pulmodual MDI: The healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring the patient for it. Do not start, stop or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur. Before using this medication, tell the doctor or pharmacist of all prescription and non-prescription/herbal product the patient may be using, especially of: anticholinergic drugs (e.g., atropine, scopolamine), certain antihistamine (e.g., diphenhydramine, meclizine), antispasmodic drugs (e.g., dicyclomine, hyoscyamine), certain anti-Parkinson's drugs (e.g., benztropine, trihexyphenidyl), some beta-blockers (such as propranolol), bladder control drugs (e.g., oxybutynin, tolterodine), pramlintide, stimulant-like drugs (e.g., ephedrine, epinephrine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), certain "water pills" (diuretics that cause potassium loss from the body such as furosemide, hydrochlorothiazide). Check the labels on all the patient's medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase the patient's heart rate or blood pressure. Ask the pharmacist about the safe use of those products. This monograph does not contain all the possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products the patient uses. Keep a list of all the patient's medications with the patient, and share the list with the doctor and pharmacist.
Beta-adrenergic agents: Caution is advised in the co-administration of Ipratropium bromide + Salbutamol and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.
Beta-receptor blocking agents: Beta-receptor blocking agents and Salbutamol inhibit the effect of each other, it should be used with caution in patients with hyper reactive airways.
Cardiac glycosides: Salbutamol possibly reduces plasma concentration of digoxin.
Diuretics: Increased risk of hypokalemia when high doses of beta2 sympathomimetics is given with diuretics (e.g. loop or thiazide diuretics).
Monoamine oxidase inhibitors or tricyclic antidepressants: It should be administered with extreme caution to patients treated with monoamine oxidase inhibitors or tricyclic antidepressants or within two weeks of discontinuation of such agents because the action of salbutamol sulfate on the cardiovascular system may be potentiated.
Theophylline: Increased risk of hypokalemia when high doses of beta2 sympathomimetics is given with theophylline.
Pulmodual MDI: The healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring the patient for it. Do not start, stop or change the dosage of any medicine before checking with them first. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur. Before using this medication, tell the doctor or pharmacist of all prescription and non-prescription/herbal product the patient may be using, especially of: anticholinergic drugs (e.g., atropine, scopolamine), certain antihistamine (e.g., diphenhydramine, meclizine), antispasmodic drugs (e.g., dicyclomine, hyoscyamine), certain anti-Parkinson's drugs (e.g., benztropine, trihexyphenidyl), some beta-blockers (such as propranolol), bladder control drugs (e.g., oxybutynin, tolterodine), pramlintide, stimulant-like drugs (e.g., ephedrine, epinephrine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), certain "water pills" (diuretics that cause potassium loss from the body such as furosemide, hydrochlorothiazide). Check the labels on all the patient's medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase the patient's heart rate or blood pressure. Ask the pharmacist about the safe use of those products. This monograph does not contain all the possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products the patient uses. Keep a list of all the patient's medications with the patient, and share the list with the doctor and pharmacist.
Caution For Usage
Pulmodual: NOT FOR INTRAVENOUS USE.
FOR ORAL INHALATION ONLY.
Ampoule: DISCARD UNUSED AMPOULES THREE (3) MONTHS AFTER OPENING FOIL POUCH.
FOR ORAL INHALATION ONLY.
Ampoule: DISCARD UNUSED AMPOULES THREE (3) MONTHS AFTER OPENING FOIL POUCH.
Storage
Store at temperatures not exceeding 30°C.
Pulmodual: Protect from light.
Ampoule: Place inside aluminum pouch.
Pulmodual MDI: Do not freeze.
Pressurized canister: Do not puncture or burn even when apparently empty.
Keep away from sunlight and heat.
Protect from moisture.
Keep away from eyes.
Salbutamol Sulphate and Ipratropium Bromide Inhalation should be stored horizontal or in an inverted position, with the mouthpiece pointing downwards.
Pulmodual: Protect from light.
Ampoule: Place inside aluminum pouch.
Pulmodual MDI: Do not freeze.
Pressurized canister: Do not puncture or burn even when apparently empty.
Keep away from sunlight and heat.
Protect from moisture.
Keep away from eyes.
Salbutamol Sulphate and Ipratropium Bromide Inhalation should be stored horizontal or in an inverted position, with the mouthpiece pointing downwards.
Action
Pharmacotherapeutic group: Selective beta-2-adrenoreceptor agonists and anticholinergics.
Pharmacology: Pulmodual: Ipratropium bromide is a synthetic quaternary anticholinergic (parasympatholytic) ammonium compound chemically related to atropine. It appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine. Anticholinergics prevent the increases in intracellular concentrations of cyclic guanosine monophosphate (cyclic GMP), which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation is primarily a local, site-specific effect. Salbutamol sulfate is a direct-acting sympathomimetic with mainly beta-adrenergic activity and a selective action on beta2 receptors (a beta2 agonist) used to produce bronchodilation. It relieves reversible bronchospasm by relaxing the smooth muscles of the bronchioles in conditions associated with asthma, bronchitis, emphysema, or bronchiectasis.
Pulmodual MDI: Pharmacodynamics: Mechanism of Action: Salbutamol Sulphate and Ipratropium Bromide Inhalation contains salbutamol sulphate and Ipratropium bromide which have differing modes of action.
The respective mechanisms of action of both drugs are discussed as follows.
Salbutamol: Salbutamol is a short-acting, selective beta-2-adrenergic receptor agonist used in the treatment of asthma and COPD. It is 29 times more selective for beta2 receptors than beta1 receptors giving it higher specificity for pulmonary beta receptors versus beta1-adrenergic receptors located in the heart. Salbutamol is formulated as a racemic mixture of the R- and S-isomers. The R-isomer has 150 times greater affinity for the beta-2-receptor than the S-isomer and the S-isomer has been associated with toxicity. This lead to the development of levalbuterol, the single R-isomer of salbutamol. However, the high cost of levalbuterol compared to salbutamol has deterred wide-spread use of this enantiomerically pure version of the drug. Salbutamol is generally used for acute episodes of bronchospasm caused by bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders such as chronic obstructive pulmonary disorder (COPD). It is also used prophylactically for exercise-induced asthma.
Salbutamol stimulates beta(2)-adrenergic receptors. Binding of Salbutamol to beta(2)-receptors in the lungs results in relaxation of bronchial smooth muscles. It is believed that salbutamol increases cAMP production by activating adenyl cycles, and the actions of salbutamol are mediated by cAMP. Increased intracellular cyclic AMP increases the activity of cAMP-dependent protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular calcium concentrations. A lowered intracellular calcium concentration leads to a smooth muscle relaxation and bronchodilation. In addition to bronchodilation, salbutamol inhibits the release of bronchoconstricting agents from mast cells, inhibits microvascular leakage, and enhances mucociliary clearance.
Ipratropium bromide: Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
In humans, ipratropium bromide has anti-secretory properties and, when applied locally, inhibits secretions from the seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membrane and the blood-brain barrier, resulting in a reduction of the systemic anticholinergic effects (e.g., neurologic, opthalmic, cardiovascular, and gastrointestinal effects) that are seen with tertiary anticholinergic amines.
Pharmacokinetics: Salbutamol: Salbutamol is readily absorbed from the gastrointestinal tract. It is subjected to first-pass metabolism in the liver and possibly in the gut wall; the main metabolite is an inactive sulfate conjugate. It is rapidly excreted in the urine as metabolites and unchanged drug; there is some excretion in the faeces. Salbutamol does not appear to be metabolized in the lungs, therefore its ultimate metabolism and excretion following inhalation depends upon the delivery method used, which determines the proportion of inhaled salbutamol relative to the proportion inadvertently swallowed.
Pulmodual: It has been suggested that most of an inhaled dose is swallowed and absorbed from the gut. The plasma half-life of salbutamol is 4 to 6 hours.
Pulmodual MDI: The plasma half-life of salbutamol has been estimated as 2 to 7 hours.
Ipratropium Bromide: Ipratropium bromide is minimally bound (≤ 9% (Pulmodual) or 0 to 9% (Pulmodual MDI) in vitro) to plasma albumin and α1-acid glycoprotein. It is partially metabolized to inactive ester hydrolysis products.
Pulmodual: After inhalation, only a small amount of ipratropium reaches the systemic circulation from the nasal mucosa. Less than 20% of an 84 mcg per nostril dose is absorbed from the nasal mucosa, but the amount which is systemically absorbed from nasal administration exceeds the amount absorbed from inhalation solution (2% of a 500 mcg dose). Some ipratropium is advertently swallowed but it is poorly absorbed from the gastrointestinal tract. The elimination half-life is about 1.6 hours. Ipratropium and its metabolites are eliminated in the urine and faeces.
Pulmodual MDI: Ipratropium bromide is a quaternary amine. It is not readily absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract as confirmed by blood level and renal excretion studies.
Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. The half-life of elimination is about 2 hours after inhalation or intravenous administration. Following intravenous administration, approximately one-half of the dose is excreted unchanged in the urine. Single doses of ipratropium bromide were administered intravenously, orally and by slow inhalation to ten healthy male volunteers. The plasma level after oral administration followed a low but a broad plateau persisting for several hours. After I.V. administration the kinetic parameters were: Vc = 25.9 L, V alpha = 13.1 L, V beta = 3.38 L, t1/2 alpha = 3.85 min, t1/2 beta = 98.4 min, AUC = 15.0 h.ng/mL, kel=11.8 L/h and total clearance is 2325 mL/min. The bioavailability was 3.3% (range 0.9-6.1%) on comparing the plasma AUCs following I.V. and 20 mg oral administration. The cumulative renal excretion (0-24 h) after I.V. administration was compared with that after oral administration and inhalation. Following oral administration, the apparent systemic availability was around 2%, and after inhalation it was 6.9%. In comparison with oral placebo administration, only after I.V. administration was there a significant change in heart rate (from 63.7 to 90.2 beats/min). The systolic blood pressure rose from 115.1 to 119.6 mm Hg and the diastolic blood pressure from 68.3 to 78.3 mm Hg.
Pharmacology: Pulmodual: Ipratropium bromide is a synthetic quaternary anticholinergic (parasympatholytic) ammonium compound chemically related to atropine. It appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine. Anticholinergics prevent the increases in intracellular concentrations of cyclic guanosine monophosphate (cyclic GMP), which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation is primarily a local, site-specific effect. Salbutamol sulfate is a direct-acting sympathomimetic with mainly beta-adrenergic activity and a selective action on beta2 receptors (a beta2 agonist) used to produce bronchodilation. It relieves reversible bronchospasm by relaxing the smooth muscles of the bronchioles in conditions associated with asthma, bronchitis, emphysema, or bronchiectasis.
Pulmodual MDI: Pharmacodynamics: Mechanism of Action: Salbutamol Sulphate and Ipratropium Bromide Inhalation contains salbutamol sulphate and Ipratropium bromide which have differing modes of action.
The respective mechanisms of action of both drugs are discussed as follows.
Salbutamol: Salbutamol is a short-acting, selective beta-2-adrenergic receptor agonist used in the treatment of asthma and COPD. It is 29 times more selective for beta2 receptors than beta1 receptors giving it higher specificity for pulmonary beta receptors versus beta1-adrenergic receptors located in the heart. Salbutamol is formulated as a racemic mixture of the R- and S-isomers. The R-isomer has 150 times greater affinity for the beta-2-receptor than the S-isomer and the S-isomer has been associated with toxicity. This lead to the development of levalbuterol, the single R-isomer of salbutamol. However, the high cost of levalbuterol compared to salbutamol has deterred wide-spread use of this enantiomerically pure version of the drug. Salbutamol is generally used for acute episodes of bronchospasm caused by bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders such as chronic obstructive pulmonary disorder (COPD). It is also used prophylactically for exercise-induced asthma.
Salbutamol stimulates beta(2)-adrenergic receptors. Binding of Salbutamol to beta(2)-receptors in the lungs results in relaxation of bronchial smooth muscles. It is believed that salbutamol increases cAMP production by activating adenyl cycles, and the actions of salbutamol are mediated by cAMP. Increased intracellular cyclic AMP increases the activity of cAMP-dependent protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular calcium concentrations. A lowered intracellular calcium concentration leads to a smooth muscle relaxation and bronchodilation. In addition to bronchodilation, salbutamol inhibits the release of bronchoconstricting agents from mast cells, inhibits microvascular leakage, and enhances mucociliary clearance.
Ipratropium bromide: Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
In humans, ipratropium bromide has anti-secretory properties and, when applied locally, inhibits secretions from the seromucous glands lining the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal mucosa. Ipratropium bromide is a quaternary amine that minimally crosses the nasal and gastrointestinal membrane and the blood-brain barrier, resulting in a reduction of the systemic anticholinergic effects (e.g., neurologic, opthalmic, cardiovascular, and gastrointestinal effects) that are seen with tertiary anticholinergic amines.
Pharmacokinetics: Salbutamol: Salbutamol is readily absorbed from the gastrointestinal tract. It is subjected to first-pass metabolism in the liver and possibly in the gut wall; the main metabolite is an inactive sulfate conjugate. It is rapidly excreted in the urine as metabolites and unchanged drug; there is some excretion in the faeces. Salbutamol does not appear to be metabolized in the lungs, therefore its ultimate metabolism and excretion following inhalation depends upon the delivery method used, which determines the proportion of inhaled salbutamol relative to the proportion inadvertently swallowed.
Pulmodual: It has been suggested that most of an inhaled dose is swallowed and absorbed from the gut. The plasma half-life of salbutamol is 4 to 6 hours.
Pulmodual MDI: The plasma half-life of salbutamol has been estimated as 2 to 7 hours.
Ipratropium Bromide: Ipratropium bromide is minimally bound (≤ 9% (Pulmodual) or 0 to 9% (Pulmodual MDI) in vitro) to plasma albumin and α1-acid glycoprotein. It is partially metabolized to inactive ester hydrolysis products.
Pulmodual: After inhalation, only a small amount of ipratropium reaches the systemic circulation from the nasal mucosa. Less than 20% of an 84 mcg per nostril dose is absorbed from the nasal mucosa, but the amount which is systemically absorbed from nasal administration exceeds the amount absorbed from inhalation solution (2% of a 500 mcg dose). Some ipratropium is advertently swallowed but it is poorly absorbed from the gastrointestinal tract. The elimination half-life is about 1.6 hours. Ipratropium and its metabolites are eliminated in the urine and faeces.
Pulmodual MDI: Ipratropium bromide is a quaternary amine. It is not readily absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract as confirmed by blood level and renal excretion studies.
Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. The half-life of elimination is about 2 hours after inhalation or intravenous administration. Following intravenous administration, approximately one-half of the dose is excreted unchanged in the urine. Single doses of ipratropium bromide were administered intravenously, orally and by slow inhalation to ten healthy male volunteers. The plasma level after oral administration followed a low but a broad plateau persisting for several hours. After I.V. administration the kinetic parameters were: Vc = 25.9 L, V alpha = 13.1 L, V beta = 3.38 L, t1/2 alpha = 3.85 min, t1/2 beta = 98.4 min, AUC = 15.0 h.ng/mL, kel=11.8 L/h and total clearance is 2325 mL/min. The bioavailability was 3.3% (range 0.9-6.1%) on comparing the plasma AUCs following I.V. and 20 mg oral administration. The cumulative renal excretion (0-24 h) after I.V. administration was compared with that after oral administration and inhalation. Following oral administration, the apparent systemic availability was around 2%, and after inhalation it was 6.9%. In comparison with oral placebo administration, only after I.V. administration was there a significant change in heart rate (from 63.7 to 90.2 beats/min). The systolic blood pressure rose from 115.1 to 119.6 mm Hg and the diastolic blood pressure from 68.3 to 78.3 mm Hg.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
PULMODUAL
Full Details
Dosage Strength
500 mcg / 2.5 mg per 2.5 ml
Drug Ingredients
- Ipratropium
- Salbutamol
Drug Packaging
Solution for Inhalation 2.5ml x 1's
Generic Name
Ipratropium Bromide / Salbutamol Sulfate
Dosage Form
Solution for Inhalation
Registration Number
DR-XY44869
Drug Classification
Prescription Drug (RX)
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