Renafor-B 100 mcg+6 mcg (Inhalation Capsule)

Title

• Combination Dry Powder Inhalation Capsule
• Asthma and COPD Inhaler

Categories

• Medicine
• Healthcare
• Respiratory Care
• Pharmaceuticals

Description

• Combination of Formoterol Fumarate Dihydrate and Budesonide BP
• Used for the treatment of asthma in patients 12 years and older
• For maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)
• Formoterol is a selective β2 adrenoceptor agonist
• Budesonide is a glucocorticosteroid with anti-inflammatory action
• Intended for oral inhalation only
• Long-acting relaxation of bronchial smooth muscle
• Rapid onset of action within 1-3 minutes
• Duration of effect is at least 12 hours after a single dose

Dosage

• Recommended maintenance dose for adults and adolescents (12 years and older)
• Alternative dosage regimens for the treatment of asthma and COPD
• Usual maintenance dose for children
• Instructions for using the inhaler effectively
• Instructions for cleaning the inhaler
• Dosage for adults (40 years and older) with COPD

Administration

• Steps for correct and regular use of the inhaler
• Importance of technique and the impact of incorrect use
• Instructions for cleaning the inhaler
• Recommendation to check the technique in front of a mirror
• Importance of rinsing mouth with water after each treatment

Interaction

• Avoid co-administration with strong cytochrome P450 3A4 inhibitors
• Caution with Monoamine oxidase inhibitors and tricyclic antidepressants
• Caution with beta-blockers
• Potential interaction with diuretics

Contraindications

• Contraindicated for primary treatment of acute episodes of asthma or COPD
• Contraindicated in case of hypersensitivity to any ingredients

Side Effects

• Common and uncommon adverse events associated with Formoterol Fumarate
• Adverse events associated with Budesonide
• Possibility of side effects due to concurrent administration of the two compounds

Pregnancy & Lactation

• No clinical data on exposed pregnancies available
• Caution advised for pregnant and breastfeeding women
• No adequate data from use of Formoterol in pregnant women
• Caution advised for women who are breastfeeding

Precautions & Warnings

• Caution in patients with specific medical conditions
• Warning about the possibility of paradoxical bronchospasm
• Immediate discontinuation in case of paradoxical bronchospasm

Use in Special Populations

• Recommendation to monitor the height of children receiving prolonged treatment with inhaled corticosteroids
• Consideration for referral to a paediatric respiratory specialist

Overdose Effects

• Typical effects of an overdose of Formoterol
• Possibility of hypercorticism and adrenal suppression with chronic excessive doses of Budesonide

Storage Conditions

• Must not be swallowed, only to be used with inhalation device
• Importance of keeping away from light and wet place
• Storage at or below 25°C temperature
• Importance of keeping out of reach of children
• Recommendation to remove Inhalation capsule from the blister pack only immediately before use

Related Brands

• Renafor-B 200 mcg+6 mcg (Inhalation Capsule) - renata-limited
• Renafor-B 400 mcg+12 mcg (Inhalation Capsule) - renata-limited