Beclometasone Dipropionate + Formoterol Fumarate

Beclomethasone + Formoterol is a combination of Beclomethasone Dipropionate (an inhaled corticosteroid with potent anti-inflammatory activity) and Formoterol Fumarate Dihydrate (a long-acting selective beta2-adrenergic agonist with rapid onset of action). When used as an inhaler, the medication goes directly into the lungs and very little enters the rest of the body.

It is indicated for the regular treatment of asthma where a combination of inhaled corticosteroid and long-acting beta2-agonist is appropriate, and for symptomatic treatment of severe COPD with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators.

Common side effects include hypokalemia, headache, tremor, palpitations, cough, muscle spasms, and QTc interval prolongation.

• Asthma - where use of a combination of inhaled corticosteroid and long-acting beta2-agonist is appropriate
• COPD - symptomatic treatment of severe COPD with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators

Beclomethasone Dipropionate is a synthetic halogenated corticosteroid with potent anti-inflammatory activity. When given by inhalation, it exerts 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 beta2-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.

Beclomethasone reduces airway inflammation and swelling by inhibiting inflammatory cells and mediators in the lungs. Formoterol stimulates beta2-adrenergic receptors, relaxing bronchial smooth muscle and widening airways. This combination helps control asthma and COPD symptoms.

Asthma: Dosage should be adjusted according to disease severity. When control has been achieved, titrate to the lowest effective dose.

Maintenance Therapy (Adults & Adolescents ≥18 years): 1-2 inhalations twice daily. Maximum daily dose: 4 inhalations.

Maintenance and Reliever Therapy: 1 inhalation twice daily. If symptoms persist after a few minutes, take an additional inhalation. Maximum daily dose: 8 inhalations.

COPD: 2 inhalations twice daily.

Correct inhaler technique:

1. Remove the cap
2. Shake the inhaler vigorously (at least 6 times)
3. If new or unused for ≥1 week, release one puff into the air
4. Breathe out fully and hold the inhaler upright
5. Place mouthpiece between teeth and close lips
6. While breathing in deeply and slowly, press down firmly on the canister
7. Remove inhaler and hold breath for at least 10 seconds
8. If multiple puffs, wait 1 minute between puffs
9. Replace cap and rinse mouth with water

Clean the inhaler at least once a week.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

• Hypokalemia
• Headache
• Tremor
• Palpitations
• Cough
• Muscle spasms
• QTc interval prolongation

Rare: Rash, urticaria, pruritus, erythema, edema of the eyes, face, lips, and throat.

• Do not initiate treatment for severe exacerbation or acutely deteriorating asthma
• Monitor potassium levels regularly during treatment
• Caution when driving or operating machinery (may cause dizziness or tremor)
• Caution during pregnancy and lactation

• Hypersensitivity to beclomethasone, formoterol, or any constituent

• Beta-adrenergic drugs, quinidine, disopyramide, procainamides, phenothiazines, antihistamines, MAO inhibitors, tricyclic antidepressants: Avoid concomitant administration

No data is found on interaction with food.

[CONSULT YOUR DOCTOR] Use during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

[CONSULT YOUR DOCTOR] Use during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Safety and efficacy in pediatric patients under 18 years have not been established.

No dose adjustment needed for elderly patients.

No dose adjustment needed for renal or hepatic impairment (minimal systemic absorption with inhalation).

Overdose may cause hypokalemia, hyperglycemia, tachycardia, palpitations, tremor, headache. Symptomatic treatment should be provided.

Store below 30°C, in a dry place, protected from light. Do not puncture, break, or incinerate the pressurized canister. Keep out of reach of children.

Beclomethasone Dipropionate + Formoterol Fumarate Dihydrate