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DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023

ACME Laboratories Ltd. · Metered-Dose Inhaler (MDI)
/ 200 metered doses
The information provided on All Samadhan is intended for general informational purposes only and is prepared based on our best practices. It is not a substitute for professional medical advice, diagnosis, or treatment. While we strive to keep the information accurate and up to date, we do not guarantee its completeness or accuracy. The absence of specific information or warnings about any medicine or service should not be considered as an assurance or endorsement by All Samadhan. All Samadhan shall not be held responsible for any consequences arising from the use of this information. We strongly recommend consulting a qualified healthcare professional or physician for any medical concerns, questions, or clarifications.
This preparation is indicated for the treatment of asthma and COPD.Asthma: This inhaler is indicated in the regular treatment of asthma where use of a combination of inhaled corticosteroid and long-acting P2 adrenergic agonist is appropriate.COPD: This inhaler is indicated for the symptomatic treatment of severe COPD and a history of repeated exacerbations despite regular therapy with long acting bronchodilators.
This preparation is a combination of Beclomethasone Dipropionate BP and Formoterol Fumarate Dihydrate BP. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion. Beclomethasone Dipropionate is a synthetic halogenated corticosteroid with potent anti-inflammatory activity. It given by inhalation has a potent glucocorticoid anti-inflammatory action within the lungs without the side effects observed when steroids are administered systemically. Formoterol Fumarate Dihydrate is a long acting selective P2 adrenergic agonist with a rapid onset of action. Inhaled Formoterol acts in the lung as a bronchodilator.When used as an inhaler, the medication goes directly into the lungs and very little finds its way into the rest of the body.
Asthma: Dosage should be adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose.Maintenance Therapy: Adults & Adolescents (18 years & above): One or two inhalations twice daily.The maximum daily dose is 4 inhalations.Maintenance and reliever therapy: Patients take a daily maintenance dose of this inhaler as needed in response to symptoms. Patients should be advised to always have this inhaler available for rescue use.Adults & Adolescents (18 years & above): One inhalation twice daily. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.COPD: 2 Inhalations twice daily.
With medicine: Concomitant treatment with beta-adrenergic drugs, quinidine, disopyramide, procainamides, phenothaizines, antihistamines, MAO inhibitors, tricyclic antidepressants should be avoided.With food & others: No data is found on interaction with food of this medicine.
Common side effects: Adverse events which have been associated with Beclomethasone and Formoterol arehypokalemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTs interval.Rear Side Effects: Rash, Urticaria pruritus, erhythema and oedema of the eyes, face,lips & throat may also occur.
Administration of this inhaler in pregnant women and lactating mother should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Treatment with Beclomethasone and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma.
Respiratory corticosteroids
Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight and heat. Store below 30° C temperature & dry place, protected from light. Keep away from children. Keep away from eyes.