salbutamol

salbutamolMIMS Class : Antiasthmatic & COPD Preparations, Drugs Acting on the Uterus See available brands of salbutamol See related salbutamol information Indication & Dosage Oral Acute bronchospasm Adult: 2-4 mg (up to 8 mg) 3-4 times daily. As modified-release tablet: 8 mg bid. Child: 1 mth-2 yr: 100 mcg/kg (max: 2 mg), 2-6 yr: 1-2 mg, >6 yr: 2 mg. Doses to be taken 3-4 times daily. Elderly: Initially, 2 mg 3-4 times daily. Inhalation Acute bronchospasm Adult: As aerosol: 100 or 200 mcg (1-2 puffs) 3-4 times daily. 2 puffs may be given prior to exertion to prevent exercise-induced bronchospasm. Inhalation Acute severe asthma Adult: As MDI: 4-6 inhalations may be given every 10-20 min via a large volume spacer. Parenteral Severe bronchospasm Adult: 250 mcg (as a solution of 50 mcg/ml) via IV inj, or via IV infusion of a solution containing 5 mg in 500 ml at a rate of 3-20 mcg/min adjusted according to patient's need. Higher dosages may be used in respiratory failure. IM/SC: 500 mcg, repeated every 4 hr if necessary. Intravenous Uncomplicated premature labour Adult: For arrest of preterm labor between 24 and 33 wk of gestation: Initially, 10 mcg/min using a dilute solution of 20 mcg/ml in glucose 5% (200 mcg/ml of salbutamol if using a syringe pump), increase rate gradually at 10-min intervals until there is response; then increase slowly until contractions cease. Maintain rate for 1 hr after contractions have stopped, then gradually reduce rate by 50% at intervals of 6 hr. Usual dose: 10-45 mcg/min. Avoid prolonged therapy. Inhalation Severe bronchospasm Adult: Via nebuliser: 2.5-5 mg, may repeat up to 4 times daily. Alternatively, may be given continuously at a rate of 1-2 mg/hr. Patients with asthma may require supplemental oxygen. Child: >18 mth: Via nebuliser: 2.5-5 mg, may repeat up to 4 times daily. Alternatively, may be given continuously at a rate of 1-2 mg/hr. Patients

with asthma may require supplemental oxygen. Administration Overdosage Should be taken on an empty stomach. (Take 1 hr before or 2 hr after meals.) May lead to tachycardia, tremor, CNS stimulation, hypokalaemia and hyperglycaemia. Symptomatic treatment is recommended.

Contraindications Eclampsia and severe pre-eclampsia; intra-uterine infection, intra-uterine foetal death, antepartum haemorrhage, placenta praevia and cord compression, threatened miscarriage, cardiac disease. Special Precautions Pregnancy; mild to moderate pre-eclampsia. Arrhythmias, hyperthyroidism, hypertension, DM, myocardial insufficiency, susceptibility to QT-interval prolongation. Monitor serum potassium levels. In women treated for premature labour, monitor hydration status, cardiac and respiratory function. Minimise volume of infusion fluid. Discontinue treatment if patient develops signs of pulmonary oedema. Fine skeletal muscle tremor especially hands, tachycardia, palpitations, muscle cramps, headache, paradoxical bronchospasm, angioedema, urticaria, hypotension and collapse. Potentially Fatal: Potentially serious hypokalaemia after large doses.

Adverse Drug Reactions

Drug Interactions Diuretics, corticosteroids and xanthines may augment hypokalaemia. CV effects potentiated by MAOIs, TCAs, sympathomimetics. Increases absorption of sulfamethoxazole when used together. May markedly increase heart rate and BP when used with atomoxetine. Reduces serum levels of digoxin. Hypokalaemia induced by salbutamol increases the risk of digitalis toxicity. BP should be closely monitored if linezolid is used concurrently with salbutamol. Click to view more Drug Interactions Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Inhalation: Store between 2-25C (36-77F). Intravenous: Store below 30C. Protect from light. Oral: Store at 20-25C (68-77F). Parenteral: Store below 30C. Protect from light. Salbutamol is a direct-acting sympathomimetic with -adrenergic activity and selective action on 2 receptors, producing bronchodilating effects. It also decreases uterine contractility. Onset: Inhalation: 5-15 min; oral: 30 min. Duration: Inhalation: 3-6 hr; oral: 8 hr; modified-release preparation: 12 hr. Absorption: Readily absorbed from the GI tract. Metabolism: Hepatic and in the gut wall.

Storage

Mechanism of Action

Excretion: Via the urine as metabolites and unchanged drug. Some excretion in the faeces. MIMS Class ATC Classification Antiasthmatic & COPD Preparations / Drugs Acting on the Uterus R03AC02 - salbutamol; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases. R03CC02 - salbutamol; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.

Duavent [Metered-dose inhaler]UAP [ United Lab ] MIMS Class : Antiasthmatic & COPD Preparations

See related Duavent Metered-dose inhaler information Contents Indications Per 2.5 mL pulmoneb Ipratropium Br 500 mcg, salbutamol sulfate 2.5 mg. Per actuation Ipratropium Br 21 mcg, salbutamol sulfate 120 mcg Management of reversible bronchospasm associated with obstructive airway diseases (eg, bronchial asthma). For patients with chronic obstructive pulmonary disease (COPD) on a regular inhaled bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. Dosage Pulmoneb: Each pulmoneb of ipratropium bromide-salbutamol contains 2500 mcg (2.5 mg) of salbutamol base (with each drop containing 50 mcg). Adult (Including Elderly Patients) and Adolescents >12 years: Treatment of Acute Attacks: 1 pulmoneb (2.5 mL) is sufficient for prompt symptom relief in many cases; 2 pulmonebs (5 mL) may be required in severe cases where an attack has not been relieved by 1

pulmoneb. Maintenance Treatment: 1 pulmoneb (2.5 mL) every 6-8 hrs daily. Children 2-12 years: 3 drops/kg/dose, maximum dose 2500 mcg (2.5 mg) of salbutamol every 6-8 hrs. Administration: The solution is intended only for inhalation with suitable nebulizing devices and should not be taken orally. Prepare the nebulizer for use. Remove the pulmoneb from the labeled strip by twisting and pulling. Hold the pulmoneb upright and twist off the cap, transfer the contents to the reservoir of the nebulizer. (Note: In most studies, a volume fill of 4 mL in the nebulizer chamber, using sterile normal saline as diluent, is recommended to ensure high aerosol output, small respirable particle size and acceptably short treatment time.) Use the nebulizer as instructed by the manufacturer. After use, discard any remaining solution and thoroughly clean the nebulizer. Other Information: Since the solution contains no preservatives, it is important to use the content soon after opening. A new pulmoneb should be used for each administration to avoid microbial contamination. Discard partly used, opened or damaged pulmoneb. Do not mix the inhalation solution with other drugs in the same nebulizer. Metered-Dose Inhaler: Adults and children 12 years: 2 actuations every 6 hrs. Patients may have additional inhalations as required but should not exceed 12 actuations in 24 hrs. Directions for Use: 1. Before using the inhaler for the 1st time, or if it has not been used for a week or longer, shake it well and then "test fire" by releasing 1 actuation into the air. Avoid spraying in the eyes. 2. Shake the inhaler well before each use. 3. Remove the mouthpiece cover, and check if it is clean. 4. Hold the inhaler between the index and thumb. Breathe out deeply through the mouth and immediately place the mouthpiece in the mouth between the teeth and close lips around it.

5. Tilt head slightly backwards. Keep the eyes closed because ocular undesirable effects (ie, temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma, eye pain) may result after contact of the aerosol with the eyes. 6. Start breathing in slowly and deeply through the mouth. Press down the canister while breathing in to release 1 dose while continuing to breathe in steady and deeply. 7. Remove the inhaler from the mouth and hold breath for 10 seconds, or for as long as comfortable. Breathe out slowly. 8. For the 2nd dose, wait for at least 1 min and repeat steps 4-7. 9. After use, replace the mouthpiece cover. Cleaning Instructions: Clean inhaler at least once a week. 1. Gently pull the metal canister out of the inhaler's adapter. Remove the mouthpiece cover. 2. Rinse the adapter and the mouthpiece cover in warm water. Do not put the metal canister in water. 3. Shake well to remove excess water. 4. Leave to dry in warm place. Avoid excess heat. 5. Replace the canister and mouthpiece cover correctly. Overdosage Symptoms: Metered-Dose Inhaler: Signs and symptoms of overdose are associated with salbutamol since ipratropium bromide is not well absorbed after oral inhalation. These include extensions of salbutamol's common undesirable effects (eg, angina, hypertension or hypotension, arrhythmias, palpitation, tachycardia, nervousness, dizziness, tremor, headache, sleeplessness or insomnia, dry mouth and nausea). Hypokalemia has also been reported; thus, plasma potassium concentrations should be monitored. Treatment: Discontinue the use of Duavent and institute appropriate symptomatic therapy in cases of overdosage. Administration of a adrenergic blocking agent may be appropriate, but use with caution if the patient is asthmatic. There is no adequate evidence to support the use of dialysis in the treatment of salbutamol overdose. Contraindications Hypersensitivity to soya lecithin or related food products eg, soybeans or peanuts; and to any component of Duavent or to atropine and its

derivatives. Hypertrophic obstructive cardiomyopathy or tachyarrhythmia. Warnings Pulmoneb: Ipratropium bromide-salbutamol combination can produce paradoxical bronchospasm that can be life-threatening. If it occurs, discontinue the preparation immediately and institute alternative therapy. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new pulmoneb. Salbutamol sulfate contained in the formulation, like other -adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure and/or other symptoms. Such effects are uncommon after administration of the combination at recommended doses. Metered-Dose Inhaler: If a previously effective dose fails to provide the usual relief, symptoms become worse, or the usual duration of action is reduced, consult a physician for medicinal advice as this would require reassessment of therapy. Excessive use of sympathomimetic oral inhalations has been associated with fatalities in asthmatic patients. The exact cause of death in unknown but cardiac arrest following severe, acute asthmatic crisis and hypoxia is suspected. Paradoxical bronchospasm, a potentially life-threatening event, frequently occurs with the 1st use of a new canister. If it occurs, discontinue the use of Duavent immediately. Therapy with salbutamol and other 2-agonists may produce decrease in plasma potassium concentration possibly through intracellular shunting resulting in cardiovascular undesirable effects. Immediately hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema may occur rarely after administration of Duavent. Special Precautions Patients should avoid spraying the aerosol into the eyes since this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association of red eyes from conjunctival and corneal congestion. Consult a physician if any combination of these symptoms develops. Use with caution in patients with the following conditions: Prostatic hypertrophy or bladder-neck obstruction; convulsive disorders, hyperthyroidism or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines ( -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.); hepatic or renal disease, since use of Duavent in these patients has not been studied. Use in pregnancy & lactation: Safety and efficacy of Duavent during pregnancy has not yet been established. The inhibitory effect of Duavent on uterine contraction should be taken into account. It is not known whether the components (ipratropium bromide and salbutamol sulfate) of the FDC 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 as a nebulized solution. Because of the potential for tumorigenicity shown for salbutamol sulfate in some animals, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Labor and Delivery: Since 2-agonists may interfere with uterine contraction, Duavent should be used in labor only if the potential benefit justifies the potential risk. Use in children: The safety and efficacy of the FDC in patients