Respimax Pro 100

Indications

This medication is prescribed for:

• Chronic Obstructive Pulmonary Disease (COPD): For the ongoing management of COPD in adults.
• Asthma: For the maintenance treatment of asthma in patients aged 18 years and older.

Important Note: This medication is not intended for the immediate relief of acute bronchospasm.
Always follow the advice of a registered healthcare professional when using this medication.

Composition

Each dry powder inhaler capsule contains the following active ingredients:

• Vilanterol: 25 mcg (as Vilanterol Trifenatate INN)
• Fluticasone Furoate: 100 mcg / 200 mcg (INN)
• Umeclidinium: 62.5 mcg (as Umeclidinium Bromide INN)

Pharmacology

This inhaler delivers a combination of Fluticasone Furoate (an inhaled corticosteroid or ICS), Umeclidinium (an anticholinergic), and Vilanterol (a long-acting beta-agonist or LABA) for oral inhalation.

• Vilanterol works by stimulating beta-2 adrenergic receptors, increasing cyclic AMP levels, which relaxes bronchial smooth muscles and inhibits the release of histamine and other inflammatory mediators from mast cells.
• Fluticasone Furoate targets inflammation, a key factor in asthma and COPD, acting on various immune cells like eosinophils and mast cells to reduce symptoms.
• Umeclidinium, an anticholinergic, inhibits the M3 muscarinic receptors in the airway smooth muscles, promoting bronchodilation.

Dosage & Administration

This inhaler is to be used with a designated inhalation device. Do not swallow the capsule. Only remove the capsule from the blister pack immediately before use. After inhaling, rinse your mouth with water (do not swallow) to minimize the risk of oropharyngeal candidiasis.

Adults (18 years and older):

• For COPD treatment: 1 inhalation capsule per day.
• For Asthma treatment: 1 inhalation capsule per day.

Note: Always use this medication at the same time every day, no more than once every 24 hours. If asthma symptoms or shortness of breath occur between doses, use a Short-Acting Beta-Agonist (SABA) for immediate relief.
Always follow the guidance of a registered healthcare provider.

Interactions

• Cytochrome P450 3A4 Inhibitors (e.g., ketoconazole): May increase systemic corticosteroid and cardiovascular side effects.
• Monoamine oxidase inhibitors & Tricyclic antidepressants: May enhance the vascular effects of Vilanterol.
• Beta-blockers: May block the bronchodilatory effect of beta-agonists, possibly leading to severe bronchospasm.
• Diuretics: May exacerbate the risk of hypokalemia when combined with beta-agonists.
• Anticholinergics: Avoid concurrent use with other anticholinergic-containing drugs to prevent additive effects.

Contraindications

• Not recommended for treating acute episodes of asthma or COPD.
• Contraindicated in patients with a known severe allergy to milk proteins or any of the ingredients.

Side Effects

Common Side Effects in COPD:

• Upper respiratory infections, pneumonia, bronchitis, oral candidiasis, headaches, sinusitis, and more.

Common Side Effects in Asthma:

• Pharyngitis, upper respiratory tract infections, bronchitis, sinusitis, headache, and back pain.

Pregnancy & Lactation

There is limited information on the use of this medication during pregnancy and lactation. Consult your healthcare provider for personalized advice.

Warnings & Precautions

• Risk of severe asthma-related events when used as monotherapy.
• Not for use in acute COPD or asthma episodes.
• Monitor for signs of oral fungal infections (Candida albicans) and rinse mouth after use to reduce risk.
• Patients with cardiovascular conditions should use with caution due to beta-adrenergic stimulation effects.
• Caution is advised in individuals with urinary retention, convulsive disorders, diabetes, and thyrotoxicosis.

Use in Special Populations

• Children and Adolescents: Not indicated for patients under 18 years of age.
• Elderly: No specific dosage adjustments required for geriatric patients, though individual sensitivity may vary.
• Renal & Hepatic Impairment: Safety in patients with renal or hepatic impairment has not been established.

Overdose

There is limited data regarding overdose effects. Follow the instructions carefully to avoid overuse.

Therapeutic Class

Combined bronchodilators.

Storage Conditions

• Store in a cool, dry place away from direct sunlight or heat.
• Keep out of reach of children and away from the eyes.