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Bihale 100 Rotacap
Vilanterol and Fluticasone Furoate-25 mcg+100 mcg
- Asthma: Treatment for patients aged 12 years and older.
- Chronic Obstructive Pulmonary Disease (COPD): Maintenance treatment for COPD.
Bihale Rotacap is not indicated for the immediate relief of acute bronchospasm. It is a maintenance medication meant for regular, scheduled use.
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✅ Description:
Composition:
- Bihale 25/100 Rotacap: Each capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) and Fluticasone Furoate BP 100 mcg.
- Bihale 25/200 Rotacap: Each capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) and Fluticasone Furoate BP 200 mcg.
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✔️ Bihale Rotacap Pharmacology and Usage
Active Ingredients:
- Vilanterol Trifenatate: A long-acting beta-2 agonist (LABA) that relaxes bronchial smooth muscle by stimulating intracellular adenyl cyclase, increasing cyclic AMP and smooth muscle relaxation.
- Fluticasone Furoate: A corticosteroid with glucocorticoid activity that reduces inflammation by acting on multiple cell types and mediators involved in inflammatory processes. However, the exact mechanism of COPD and asthma is not fully understood.
✔️ Indications: Bihale 100 Rotacap
- Asthma: Maintenance treatment for patients 12 years and older.
- COPD: Maintenance treatment; not for acute bronchospasm relief.
✔️ Dosage & Administration: Bihale 100 Rotacap
- Route: Oral inhalation only. Do not swallow the capsule.
- Device Usage: Insert the capsule into ACME’s Easyhaler device immediately before use to ensure it is pierced and ready for inhalation.
- Instructions: Rinse mouth with water post-inhalation to reduce the risk of oral candidiasis.
- Dosage for Maintenance:
- COPD: 1 inhalation of 25/100 mcg once daily.
- Asthma: 1 inhalation of 25/100 mcg or 25/200 mcg once daily.
✔️ Special Populations: Bihale 100 Rotacap
- Pediatric Use: Not indicated for children under 17 years.
- Hepatic Impairment: Increased risk of systemic corticosteroid effects in moderate to severe hepatic impairment.
✔️ Side Effects: Bihale 100 Rotacap
- COPD: Common side effects (≥3%) include nasopharyngitis, headache, pneumonia, sinusitis, bronchitis, back pain, and oral candidiasis.
- Asthma: Common side effects (≥2%) include nasopharyngitis, headache, bronchitis, sinusitis, and oral candidiasis.
✔️ Special Instructions: Bihale 100 Rotacap
- Use Bihale Rotacap at the same time each day to maintain effectiveness.
- Please do not use it more than once in 24 hours.
- Rinse mouth after each inhalation (without swallowing) to reduce the risk of oropharyngeal candidiasis (oral thrush).
✔️ Drug Interactions: Bihale 100 Rotacap
- CYP3A4 Inhibitors (e.g., ketoconazole): Use cautiously; may cause systemic effects.
- Monoamine Oxidase Inhibitors & Tricyclic Antidepressants: Can potentiate cardiovascular effects.
- Beta-blockers: May reduce bronchodilation and cause severe bronchospasm.
- Diuretics: Non-potassium-sparing diuretics may worsen hypokalemia with beta-agonists.
✔️ Use in Pregnancy & Lactation: Bihale 100 Rotacap
Limited data on safety; consult a physician if pregnant or breastfeeding.
✔️ Precautions & Warnings:
- LABA Warning: Increased risk of serious asthma-related events if used as monotherapy.
- Not for Acute Relief: Do not use in cases of acutely deteriorating COPD or asthma.
- Candidiasis Risk: Regularly monitor for oral thrush; rinse mouth with water post-use.
- Pneumonia Risk: Higher pneumonia risk in COPD patients; monitor for symptoms.
- Adrenal Suppression & Hypercorticism: Risk in susceptible individuals; taper corticosteroids carefully if transferring from systemic corticosteroids.
- Cardiovascular Effects: Use with caution in patients with cardiovascular disorders due to beta-adrenergic stimulation.
- Bone Mineral Density: Assess periodically due to corticosteroid effects on bone density.
- Ocular Risks: Long-term use may lead to cataracts and glaucoma; consider ophthalmology referral if ocular symptoms develop.
✔️ Storage Conditions:
Store in a cool, dry place, away from direct sunlight and heat. Keep out of reach of children.
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