Beclomethasone Dipropionate + Formoterol Fumarate

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.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

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.

Beclomethasone Dipropionate BP and Formoterol Fumarate Dihydrate BP HFA Inhaler is contraindicated in patients with hypersensitivity to any of the constituents.

Common side effects: Adverse events which have been associated with Beclomethasone and Formoterol are
hypokalemia, 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.