SALTROL Salmeterol / Fluticasone Propionate 25mcg / 250mcg Pressurized Liquid for Inhalation 120actuations
RXDRUG-DR-XY47462
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Asthma (Reversible Obstructive Airways Disease): Salmeterol + Fluticasone propionate (Saltrol) is indicated in the regular treatment of asthma (Reversible Obstructive Airways Disease). This may include: Patients on effective maintenance doses of long-acting β agonists and inhaled corticosteroids.
Patients who are symptomatic on current inhaled corticosteroid therapy.
Patients on regular bronchodilator therapy who require inhaled corticosteroids.
Chronic Obstructive Pulmonary Disease (COPD): Salmeterol + Fluticasone propionate (Saltrol) is indicated in the regular treatment of Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and emphysema.
Patients who are symptomatic on current inhaled corticosteroid therapy.
Patients on regular bronchodilator therapy who require inhaled corticosteroids.
Chronic Obstructive Pulmonary Disease (COPD): Salmeterol + Fluticasone propionate (Saltrol) is indicated in the regular treatment of Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and emphysema.
Dosage/Direction for Use
Salmeterol + Fluticasone propionate (Saltrol) inhaler is for inhalation only.
Patients should be made aware that Salmeterol + Fluticasone propionate (Saltrol) must be used regularly for optimum benefit, even when asymptomatic.
Patients should be regularly re-assessed by a doctor, so that the strength of Salmeterol + Fluticasone propionate (Saltrol) they are receiving remains optimal and is only changed on medical advice.
Asthma (Reversible Obstructive Airways Disease): The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with twice daily Salmeterol + Fluticasone propionate (Saltrol), titration to the lowest effective dose could include Salmeterol + Fluticasone propionate (Saltrol) given once daily.
Patients should be given the strength of Salmeterol + Fluticasone propionate (Saltrol) containing the appropriate Fluticasone propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Saltrol) at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control. For patients whose asthma control is acceptable on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Saltrol) may permit a reduction in corticosteroid dose while maintaining asthma control.
Adults and adolescents 12 years and older: Two inhalations of 25mcg salmeterol and 125mcg Fluticasone propionate twice daily. or Two inhalations of 25mcg salmeterol and 250mcg Fluticasone propionate twice daily.
Chronic Obstructive Pulmonary Disease (COPD): For adult patients the recommended dose is two inhalation 25mcg / 125mcg to 25mcg / 250mcg Salmeterol + Fluticasone propionate (Saltrol) twice daily.
Special population: There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.
Patients should be made aware that Salmeterol + Fluticasone propionate (Saltrol) must be used regularly for optimum benefit, even when asymptomatic.
Patients should be regularly re-assessed by a doctor, so that the strength of Salmeterol + Fluticasone propionate (Saltrol) they are receiving remains optimal and is only changed on medical advice.
Asthma (Reversible Obstructive Airways Disease): The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with twice daily Salmeterol + Fluticasone propionate (Saltrol), titration to the lowest effective dose could include Salmeterol + Fluticasone propionate (Saltrol) given once daily.
Patients should be given the strength of Salmeterol + Fluticasone propionate (Saltrol) containing the appropriate Fluticasone propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Saltrol) at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control. For patients whose asthma control is acceptable on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Saltrol) may permit a reduction in corticosteroid dose while maintaining asthma control.
Adults and adolescents 12 years and older: Two inhalations of 25mcg salmeterol and 125mcg Fluticasone propionate twice daily. or Two inhalations of 25mcg salmeterol and 250mcg Fluticasone propionate twice daily.
Chronic Obstructive Pulmonary Disease (COPD): For adult patients the recommended dose is two inhalation 25mcg / 125mcg to 25mcg / 250mcg Salmeterol + Fluticasone propionate (Saltrol) twice daily.
Special population: There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.
Overdosage
Salmeterol: The signs and symptoms of Salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. If Salmeterol + Fluticasone propionate therapy has to be withdrawn due to overdose of the β agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Additionally, hypokalemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.
Fluticasone propionate: Acute: Acute inhalation of Fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Chronic overdose of inhaled Fluticasone propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilized, treatment should be continued with an inhaled corticosteroid at the recommended dose.
In cases of both acute and chronic Fluticasone propionate overdose, therapy should be continued at a suitable dosage for symptom control.
Fluticasone propionate: Acute: Acute inhalation of Fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Chronic overdose of inhaled Fluticasone propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilized, treatment should be continued with an inhaled corticosteroid at the recommended dose.
In cases of both acute and chronic Fluticasone propionate overdose, therapy should be continued at a suitable dosage for symptom control.
Contraindications
Salmeterol + Fluticasone propionate is contraindicated: In patients with known hypersensitivity to Salmeterol or Fluticasone propionate or to any excipient of the product.
In primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
In primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Warnings
The canister should not be broken, punctured or burnt even when apparently empty.
SHAKE WELL BEFORE USE.
For inhalation use only.
SHAKE WELL BEFORE USE.
For inhalation use only.
Special Precautions
General: Patients should be advised that this product contains small amount of ethanol. At normal doses, the amounts of ethanol are negligible and do not pose a risk to patients.
Asthma-Related Death: Long-acting β2 adrenergic agonists (LABA), such as salmeterol, increase the risk of asthma-related death. When treating patients with asthma, only prescribe Salmeterol + Fluticasone propionate inhaler for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Salmeterol + Fluticasone propionate inhaler) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Salmeterol + Fluticasone propionate inhaler for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
Deterioration of Disease and Acute Episodes: Salmeterol + Fluticasone propionate inhaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. It should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. When beginning treatment with Salmeterol + Fluticasone propionate inhaler, patients who have been taking oral or inhaled, short-acting β2 agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Excessive Use of Salmeterol + Fluticasone propionate inhaler and Use with Other Long-Acting β2 Agonists: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Salmeterol + Fluticasone propionate inhaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
Local Effects of Inhaled Corticosteroids: Candida albicans infection of the mouth and pharynx may occur in subjects treated with Salmeterol + Fluticasone propionate inhaler. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
Pneumonia: Lower respiratory tract infections, including pneumonia, have been reported in patients with chronic obstructive pulmonary disease (COPD) following the inhaled administration of corticosteroids, including fluticasone propionate. Monitor patients with signs and symptoms of pneumonia.
Immunosuppression: Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Salmeterol + Fluticasone propionate inhaler.
Hypercorticism and Adrenal Suppression: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear with very high dosages or at the regular dosage in susceptible individuals. If such effects occur, Salmeterol + Fluticasone propionate inhaler should be reduced slowly.
Paradoxical Bronchospasm and Upper Airway Symptoms: As with other inhaled medicines, Salmeterol + Fluticasone propionate inhaler can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs discontinue Salmeterol + Fluticasone propionate inhaler and institute alternative therapy.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Salmeterol + Fluticasone propionate inhaler.
Cardiovascular and Central Nervous System Effects: Salmeterol + Fluticasone propionate inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension because of β adrenergic stimulation.
Reduction in Bone Mineral Density: Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Patients should be assessed for decrease in bone mineral density initially and periodically thereafter.
Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Salmeterol + Fluticasone propionate inhaler routinely.
Glaucoma and Cataracts: Glaucoma and cataracts have been reported in patients with asthma following the long-term administration of inhaled corticosteroids, including fluticasone propionate. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Eosinophilic Conditions and Churg-Strauss Syndrome: In rare cases, patients on inhaled fluticasone propionate, may present with systemic eosinophilic conditions. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Coexisting Conditions: Salmeterol + Fluticasone propionate inhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, diabetes mellitus and ketoacidosis.
Hypokalemia: β adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.
Hyperglycemia: There have been very rare reports of increase in blood glucose level and this should be considered when prescribing to patients with a history of diabetes mellitus.
Asthma-Related Death: Long-acting β2 adrenergic agonists (LABA), such as salmeterol, increase the risk of asthma-related death. When treating patients with asthma, only prescribe Salmeterol + Fluticasone propionate inhaler for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Salmeterol + Fluticasone propionate inhaler) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Salmeterol + Fluticasone propionate inhaler for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
Deterioration of Disease and Acute Episodes: Salmeterol + Fluticasone propionate inhaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. It should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. When beginning treatment with Salmeterol + Fluticasone propionate inhaler, patients who have been taking oral or inhaled, short-acting β2 agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Excessive Use of Salmeterol + Fluticasone propionate inhaler and Use with Other Long-Acting β2 Agonists: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Salmeterol + Fluticasone propionate inhaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
Local Effects of Inhaled Corticosteroids: Candida albicans infection of the mouth and pharynx may occur in subjects treated with Salmeterol + Fluticasone propionate inhaler. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
Pneumonia: Lower respiratory tract infections, including pneumonia, have been reported in patients with chronic obstructive pulmonary disease (COPD) following the inhaled administration of corticosteroids, including fluticasone propionate. Monitor patients with signs and symptoms of pneumonia.
Immunosuppression: Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Salmeterol + Fluticasone propionate inhaler.
Hypercorticism and Adrenal Suppression: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear with very high dosages or at the regular dosage in susceptible individuals. If such effects occur, Salmeterol + Fluticasone propionate inhaler should be reduced slowly.
Paradoxical Bronchospasm and Upper Airway Symptoms: As with other inhaled medicines, Salmeterol + Fluticasone propionate inhaler can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs discontinue Salmeterol + Fluticasone propionate inhaler and institute alternative therapy.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Salmeterol + Fluticasone propionate inhaler.
Cardiovascular and Central Nervous System Effects: Salmeterol + Fluticasone propionate inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension because of β adrenergic stimulation.
Reduction in Bone Mineral Density: Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Patients should be assessed for decrease in bone mineral density initially and periodically thereafter.
Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Salmeterol + Fluticasone propionate inhaler routinely.
Glaucoma and Cataracts: Glaucoma and cataracts have been reported in patients with asthma following the long-term administration of inhaled corticosteroids, including fluticasone propionate. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Eosinophilic Conditions and Churg-Strauss Syndrome: In rare cases, patients on inhaled fluticasone propionate, may present with systemic eosinophilic conditions. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Coexisting Conditions: Salmeterol + Fluticasone propionate inhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, diabetes mellitus and ketoacidosis.
Hypokalemia: β adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.
Hyperglycemia: There have been very rare reports of increase in blood glucose level and this should be considered when prescribing to patients with a history of diabetes mellitus.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well controlled studies with Salmeterol + Fluticasone propionate in pregnant women. Salmeterol + Fluticasone propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking Salmeterol + Fluticasone propionate inhaler.
Nursing Mother: It is not known whether Salmeterol and Fluticasone propionate / metabolites are excreted in human milk. A risk to breastfed newborns / infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Salmeterol + Fluticasone propionate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
Nursing Mother: It is not known whether Salmeterol and Fluticasone propionate / metabolites are excreted in human milk. A risk to breastfed newborns / infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Salmeterol + Fluticasone propionate therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
Adverse Reactions
Infections and infestations: Common: Candidiasis of the mouth and throat, bronchitis, pneumonia (in COPD patients).
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, respiratory symptoms (dyspnoea).
Rare: Anaphylactic reactions including anaphylactic shock, angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (bronchospasm).
Endocrine Disorders: Uncommon: Cataract.
Rare: Glaucoma, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density.
Metabolism and nutrition disorders: Common: Hypokalemia.
Uncommon: Hyperglycemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children).
Nervous system disorders: Very common: Headache.
Uncommon: Tremor.
Cardiac disorders: Uncommon: Palpitations, tachycardia, atrial fibrillation, angina pectoris.
Rare: Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Respiratory, thoracic and mediastinal disorders: Very common: Nasopharyngitis.
Common: Hoarseness/dysphonia, sinusitis.
Uncommon: Throat irritation.
Rare: Paradoxical bronchospasm.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia, traumatic fractures, myalgia.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, respiratory symptoms (dyspnoea).
Rare: Anaphylactic reactions including anaphylactic shock, angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (bronchospasm).
Endocrine Disorders: Uncommon: Cataract.
Rare: Glaucoma, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density.
Metabolism and nutrition disorders: Common: Hypokalemia.
Uncommon: Hyperglycemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children).
Nervous system disorders: Very common: Headache.
Uncommon: Tremor.
Cardiac disorders: Uncommon: Palpitations, tachycardia, atrial fibrillation, angina pectoris.
Rare: Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Respiratory, thoracic and mediastinal disorders: Very common: Nasopharyngitis.
Common: Hoarseness/dysphonia, sinusitis.
Uncommon: Throat irritation.
Rare: Paradoxical bronchospasm.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia, traumatic fractures, myalgia.
Drug Interactions
Inhibitors of Cytochrome P450 3A4: Salmeterol and Fluticasone propionate are substrates of CYP3A4. The use of strong CYP3A4 inhibitors is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Salmeterol and Fluticasone propionate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, because the action of Salmeterol on the vascular system may be potentiated by these agents.
β Adrenergic Receptor Blocking Agents: β adrenergic blockers may weaken or antagonize the effect of Salmeterol. Both non-selective and selective β blockers should be avoided in patients with asthma. Potentially serious hypokalemia may result from β2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Non-Potassium-Sparing Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β agonists, such as salmeterol, especially when the recommended dose of the β agonist is exceeded. Caution is advised in the co-administration of Salmeterol + Fluticasone propionate with non-potassium-sparing diuretics.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Salmeterol and Fluticasone propionate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, because the action of Salmeterol on the vascular system may be potentiated by these agents.
β Adrenergic Receptor Blocking Agents: β adrenergic blockers may weaken or antagonize the effect of Salmeterol. Both non-selective and selective β blockers should be avoided in patients with asthma. Potentially serious hypokalemia may result from β2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics.
Non-Potassium-Sparing Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β agonists, such as salmeterol, especially when the recommended dose of the β agonist is exceeded. Caution is advised in the co-administration of Salmeterol + Fluticasone propionate with non-potassium-sparing diuretics.
Caution For Usage
Instructions for Use: Patients should be instructed in the proper use of their inhaler. During inhalation, the patient should preferably sit or stand.
Testing the inhaler: Before using for the first time or if the inhaler has not been used for a week or more remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release one puff into the air to make sure that it works.
Cleaning: The inhaler should be cleaned at least once a week.
Remove the mouthpiece cover.
Do not remove the canister from the plastic casing.
Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth, tissue or cotton bud.
Replace the mouthpiece cover.
Do not put metal canister in water.
Testing the inhaler: Before using for the first time or if the inhaler has not been used for a week or more remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release one puff into the air to make sure that it works.
Cleaning: The inhaler should be cleaned at least once a week.
Remove the mouthpiece cover.
Do not remove the canister from the plastic casing.
Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth, tissue or cotton bud.
Replace the mouthpiece cover.
Do not put metal canister in water.
Storage
Store at temperatures not exceeding 30°C.
Protect from heat, frost and direct sunlight.
Protect from heat, frost and direct sunlight.
Action
Pharmacology: Pharmacodynamics: Salmeterol: Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptor. The pharmacologic effects of β2 adrenoceptor agonist drugs, including salmeterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Fluticasone propionate: Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
Pharmacokinetics: Salmeterol: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects. The percentage of salmeterol bound to human plasma proteins averages 96% in vitro over the concentration range of 8 to 7,722ng of salmeterol base per milliliter. Salmeterol is extensively metabolized by hydroxylation, with subsequent elimination predominantly in the feces. No significant amount of unchanged salmeterol base was detected in either urine or feces.
Fluticasone propionate: Fluticasone propionate acts locally in the lung therefore plasma levels do not predict therapeutic effects. Oral systemic bioavailability of Fluticasone propionate is negligible (less than 1%) primarily due to incomplete absorption and presystemic metabolism in the gut and liver. The disposition of Fluticasone propionate is characterized by high plasma clearance (1150mL/min), a large volume of distribution at steady-state (approximately 300L) and a terminal half-life of approximately 8 hours. Plasma protein binding is 91%. Fluticasone propionate is cleared very rapidly from the systemic circulation. The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. Other unidentified metabolites are also found in the feces. The renal clearance of Fluticasone propionate is negligible. Less than 5% of the dose is excreted in urine, mainly as metabolites. The main part of the dose is excreted in feces as metabolites and unchanged drug.
Fluticasone propionate: Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
Pharmacokinetics: Salmeterol: Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects. The percentage of salmeterol bound to human plasma proteins averages 96% in vitro over the concentration range of 8 to 7,722ng of salmeterol base per milliliter. Salmeterol is extensively metabolized by hydroxylation, with subsequent elimination predominantly in the feces. No significant amount of unchanged salmeterol base was detected in either urine or feces.
Fluticasone propionate: Fluticasone propionate acts locally in the lung therefore plasma levels do not predict therapeutic effects. Oral systemic bioavailability of Fluticasone propionate is negligible (less than 1%) primarily due to incomplete absorption and presystemic metabolism in the gut and liver. The disposition of Fluticasone propionate is characterized by high plasma clearance (1150mL/min), a large volume of distribution at steady-state (approximately 300L) and a terminal half-life of approximately 8 hours. Plasma protein binding is 91%. Fluticasone propionate is cleared very rapidly from the systemic circulation. The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. Other unidentified metabolites are also found in the feces. The renal clearance of Fluticasone propionate is negligible. Less than 5% of the dose is excreted in urine, mainly as metabolites. The main part of the dose is excreted in feces as metabolites and unchanged drug.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Saltrol
Full Details
Dosage Strength
25 mcg / 125 mcg per Actuation Metered Dose
Drug Ingredients
- Fluticasone
- Salmeterol
Drug Packaging
Pressurized Liquid for Inhalation 120act.
Generic Name
Salmeterol / Fluticasone Propionate
Dosage Form
Liquid For Inhalation
Registration Number
DR-XY47451
Drug Classification
Prescription Drug (RX)
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