Combivair Rotacaps Capsules 400/6mcg

Combivair Rotacaps – Product Specification Sheet
1. Basic Information
 Prescription Required: ✅ Yes
 Generic Components: Formoterol Fumarate, Budesonide
 Used For:
o Asthma
o Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
2. Mechanism of Action
 Budesonide:
A glucocorticosteroid with a dose-dependent anti-inflammatory effect in the airways.
Reduces symptoms and exacerbations. Inhaled use results in fewer systemic side effects
compared to oral corticosteroids.
 Formoterol:
A selective β2-adrenoceptor agonist. Provides rapid (within 1–3 minutes) and longlasting (≥12 hours) bronchodilation by relaxing bronchial smooth muscle.
3. Dosage
 Contains both Formoterol Fumarate and Budesonide in fixed-dose combination
(individual dosages per capsule depend on the strength prescribed).
4. Side Effects
 Common:
o Oral thrush (Candida), headache, tremor
o Palpitations, hoarseness, coughing, throat irritation
 Uncommon:
o Anxiety, aggression, sleep disturbances
o Dizziness, nausea, bruising, muscle cramps
 Rare:
o Allergic reactions (rash, urticaria, anaphylaxis)
o Cardiac arrhythmias, bronchospasm, hypokalemia
 Very Rare:
o Cushing's syndrome, adrenal suppression
o Growth retardation, osteoporosis, hyperglycemia
o Glaucoma, cataracts, depression, QTc prolongation
5. Drug Interactions
Avoid concurrent use with:
 CYP3A4 inhibitors: (e.g., ketoconazole, itraconazole, HIV protease inhibitors)
 Beta-blockers: (including eye drops)
 Antiarrhythmics: (quinidine, procainamide)
 Antidepressants: (TCAs, MAOIs)
 Others: L-Dopa, L-thyroxine, oxytocin, alcohol, loop/thiazide diuretics
6. Contraindications
 Known hypersensitivity to Budesonide, Formoterol, or excipients
 Not for primary treatment of status asthmaticus or acute exacerbations requiring
intensive intervention
7. Precautions
 Long-term use of inhaled corticosteroids may increase risk of glaucoma and cataracts
 Monitor patients with a history of ocular hypertension
8. Warnings
1. Not for acute asthma/COPD episodes – do not use as a rescue inhaler
2. Avoid additional LABA use – risk of serious cardiovascular side effects
3. Systemic steroid effects may occur at high or prolonged doses; taper slowly if
discontinuing
9. Additional Information
 Pregnancy Category: Consult your physician before use
 Storage: ✅ Yes
o Store at room temperature
o Keep away from direct heat and light