Formoterol Fumarate Dihydrate + Budesonide

Prescribing Information
To be sold on retail on the prescription of a Registered Medical Practitioner only.

1. Qualitative and Quantitative Composition

PULMOCURE-100 Capsules

Formoterol fumarate dihydrate IP — 6 mcg

Budesonide IP — 100 mcg

Excipients — q.s.

PULMOCURE-200 Capsules

Formoterol fumarate dihydrate IP — 6 mcg

Budesonide IP — 200 mcg

Excipients — q.s.

PULMOCURE-400 Capsules

Formoterol fumarate dihydrate IP — 6 mcg

Budesonide IP — 400 mcg

Excipients — q.s.

2. Dosage Form and Strength

Dry Powder for Inhalation (DPI Capsules).

3. Clinical Particulars

3.1 Therapeutic Indications

Asthma: Treatment of asthma where the combination of an inhaled corticosteroid and a long-acting β2 agonist is appropriate.

COPD: Regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease with frequent symptoms and a history of exacerbations.

3.2 Posology and Method of Administration

Dosage should be individualized according to disease severity. Once asthma control is achieved, the dose should be titrated to the lowest effective dose. Patients should be reassessed regularly by healthcare providers to ensure optimal dosing.

Maintenance Therapy

Pulmocure Capsules are used as regular maintenance treatment with a separate rapid acting bronchodilator for rescue.

Single Maintenance and Reliever Therapy

Pulmocure Capsules are used both for maintenance treatment and as needed for relief of symptoms.

3.3 Recommended Dosage

Adults (18 years and older)

PULMOCURE-100: 1–2 capsules twice daily (Maximum: 4 capsules twice daily).

PULMOCURE-200: 1–2 capsules twice daily (Maximum: 4 capsules twice daily).

PULMOCURE-400: 1 capsule twice daily (Maximum: 2 capsules twice daily).

Adolescents (12–17 years)

PULMOCURE-100: 1–2 capsules twice daily.

PULMOCURE-200: 1–2 capsules twice daily.

PULMOCURE-400: 1 capsule twice daily.

Children (6–11 years)

PULMOCURE-100: 2 capsules twice daily.

COPD

PULMOCURE-200: 2 capsules twice daily.

Method of Administration

Pulmocure Capsules should be used only for inhalation through DPI devices such as Rotahaler or Revolizer. The capsules must not be swallowed.

4. Contraindications

• Hypersensitivity to formoterol, budesonide, or any excipients.
• Primary treatment of status asthmaticus.
• Acute episodes of asthma or COPD requiring intensive therapy.
• Relief of acute bronchospasm.

5. Special Warnings and Precautions

Patients should always keep a rescue inhaler available. Sudden worsening of asthma requires immediate medical attention. Mouth rinsing after inhalation is recommended to reduce the risk of oral candidiasis.

6. Drug Interactions

Caution with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, and clarithromycin, as they may increase systemic exposure to budesonide.

7. Use in Special Populations

Pregnancy: Use only if the benefit outweighs the potential risk.

Lactation: Budesonide may pass into breast milk; use with caution.

Pediatric Use: Established for asthma patients aged 6 years and older.

Geriatric Use: Use with caution in patients with cardiovascular disease.

8. Undesirable Effects

Common adverse effects include tremor, palpitations, headache, nasopharyngitis, oral candidiasis, upper respiratory tract infection, and throat irritation.

9. Overdose

Symptoms of overdose may include tremor, tachycardia, palpitations, hypokalemia, and hyperglycemia. Management should be supportive and symptomatic.

10. Pharmacological Properties

Mechanism of Action

Pulmocure Capsules combine budesonide, an inhaled corticosteroid with potent anti-inflammatory activity, and formoterol, a long-acting β2 agonist bronchodilator with rapid onset of action. Together they provide additive effects in improving lung function and reducing asthma exacerbations.

11. Pharmaceutical Particulars

Shelf Life: See pack.

Packaging: Each sales pack contains 30 capsules.

12. Storage

Store below 30°C. Protect from moisture. Do not freeze.

13. Patient Counselling Information

Use exactly as prescribed. Do not exceed recommended dosage. Always keep a rescue inhaler available and consult a doctor if symptoms worsen.