Description

Combivair Forte is a prescription dry-powder inhalation medicine containing budesonide and formoterol. It helps reduce airway inflammation and relax bronchial muscles for maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD).

• Manufacturer Name: Highnoon
• Drug Class: Inhaled corticosteroid and long-acting beta2-adrenergic bronchodilator combination
• Dosage Form: Rotacapsule for inhalation (dry-powder inhalation capsule)
• Storage: Store at room temperature in a dry place, protected from heat, direct light, and moisture. Keep capsules in their original blister packaging until use and keep out of reach of children.
• Pack Size: Pack of 30 Capsules

Ingredients

• Budesonide 400 mcg
• Formoterol fumarate 12 mcg

Benefits

• Maintenance treatment of asthma in patients requiring both an inhaled corticosteroid and a long-acting bronchodilator.
• Maintenance treatment of COPD with persistent airflow limitation and recurrent respiratory symptoms.
• Helps reduce airway inflammation, wheezing, chest tightness, and shortness of breath when used regularly.

Usage & Safety

For Adult

• Use only as prescribed by a healthcare professional; a commonly prescribed regimen is one rotacapsule inhaled twice daily.
• Load the capsule into the recommended Rotahaler or compatible dry-powder inhaler, pierce it, and inhale the powder deeply through the device.
• Do not swallow the capsule and do not place it directly in the mouth.
• Rinse the mouth with water and spit it out after each dose to reduce the risk of oral fungal infection and hoarseness.
• This product is for regular maintenance treatment and is not intended for immediate relief of an acute asthma attack or sudden severe breathlessness.

For Children

• Use in children and adolescents only when specifically prescribed and supervised by a qualified clinician.
• The 400 mcg/12 mcg strength may not be appropriate for younger children; the suitable strength and dose depend on age, diagnosis, inhaler technique, and response.
• No general weight-based dose or weight limit applies; do not adjust the dose according to body weight without medical advice.

Side Effects

• Common effects may include oral or throat fungal infection, hoarseness, throat irritation, cough, headache, tremor, nervousness, nausea, muscle cramps, or palpitations.
• Formoterol may cause fast heartbeat, dizziness, changes in blood pressure, or low blood potassium.
• Seek urgent medical care for paradoxical bronchospasm, severe wheezing immediately after inhalation, facial or throat swelling, rash, fainting, chest pain, or severe irregular heartbeat.
• Long-term or high-dose use may rarely contribute to adrenal suppression, reduced bone density, cataracts, glaucoma, growth suppression in children, or increased blood glucose.

Contraindications

• Do not use in patients with known allergy to budesonide, formoterol, lactose or any component of the product.
• Do not use as the primary treatment for status asthmaticus or other rapidly worsening, life-threatening asthma or COPD episodes.
• Do not use as a rescue medicine for sudden bronchospasm; a separately prescribed rapid-acting reliever may be required.
• Use cautiously in patients with heart disease, abnormal heart rhythm, high blood pressure, diabetes, thyroid disease, low potassium, glaucoma, cataracts, osteoporosis, liver disease, tuberculosis, or other untreated infections.
• Do not combine with another long-acting beta2 agonist unless specifically directed by a clinician.

Precautions & Warnings

• Tell the doctor about ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, HIV protease inhibitors, or other strong CYP3A4 inhibitors.
• Use caution with beta-blockers, including ophthalmic beta-blocker drops, because they may reduce bronchodilator effectiveness or trigger bronchospasm.
• Use caution with monoamine oxidase inhibitors, tricyclic antidepressants, quinidine, disopyramide, procainamide, phenothiazines, or other medicines that may affect heart rhythm.
• Diuretics, systemic corticosteroids, digoxin, and other medicines that lower potassium may increase the risk of hypokalemia or heart rhythm problems.
• Do not use additional formoterol, salmeterol, arformoterol, or another long-acting beta2 agonist unless prescribed.
• There are no specific food restrictions, but excessive alcohol may worsen dizziness or other steroid-related effects.

Pregnancy

• Use during pregnancy only when clearly needed and under medical supervision; uncontrolled asthma can also pose risks to the mother and fetus.
• Available human data for inhaled budesonide are generally reassuring, but the combination should still be used at the lowest effective prescribed dose.
• Consult a healthcare professional before use during breastfeeding. Budesonide and formoterol exposure in breastfed infants is expected to be low, but monitoring and individualized advice are recommended.