Medicine Information

Formocort

Name: Formocort
Brand: Formocort

Pressurized Metered Dose Inhaler (pMDI)Budesonide 80 mcg + Formoterol Fumarate Dihydrate 4.5 mcg per actuationAnti-asthmatic, COPD preparations; Corticosteroid & Long-acting Beta-2 AgonistATC: R03AK07

Generic Name

Budesonide + Formoterol Fumarate Dihydrate

Manufacturer

Cipla Ltd.

Country

India

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
formocort 80 mcg inhaler	৳ 400.00	N/A

Description

Overview of the medicine

Formocort 80 mcg Inhaler is a combination medicine containing Budesonide (an inhaled corticosteroid) and Formoterol (a long-acting beta2-agonist). It is used for the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) to improve breathing and reduce flare-ups. It is not intended for acute relief of bronchospasm.

Uses & Indications

Regular treatment of asthma where a combination of an inhaled corticosteroid and a long-acting beta2-agonist is appropriate.

Symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) who have a history of repeated exacerbations and who have significant symptoms despite regular therapy with long-acting bronchodilators.

Dosage

Adults

Asthma: Typically 1-2 inhalations twice daily. COPD: Typically 2 inhalations twice daily. The dose should be titrated to the lowest effective dose.

Elderly

No specific dose adjustment is required, but caution should be exercised due to potential comorbidities and concomitant medications.

Renal_impairment

No specific dose adjustment is considered necessary for patients with renal impairment, but clinical judgment is advised.

How to Take

For oral inhalation only. Shake the inhaler well before each use. Inhale slowly and deeply through the mouth while pressing down on the canister. Hold breath for 5-10 seconds, then exhale slowly. Rinse mouth with water after use to minimize the risk of oral candidiasis (thrush).

Mechanism of Action

Budesonide works as an anti-inflammatory agent, reducing swelling and irritation in the airways. Formoterol acts as a bronchodilator, relaxing the muscles in the airways and widening them, making breathing easier. The combination provides both anti-inflammatory and bronchodilatory effects.

Pharmacokinetics

Onset

Bronchodilatory effect of Formoterol typically occurs within 1-3 minutes. Anti-inflammatory effects of Budesonide develop gradually over days to weeks.

Excretion

Budesonide metabolites are primarily excreted via urine (60%) and feces. Formoterol metabolites are primarily excreted via urine (60%) and feces (30-40%).

Half life

Budesonide: approximately 2-3 hours. Formoterol: approximately 10 hours.

Absorption

Budesonide has approximately 39% systemic availability after inhalation, with peak plasma concentration occurring within 10-30 minutes. Formoterol has approximately 28% systemic availability after inhalation, with peak plasma concentration occurring within 10 minutes.

Metabolism

Both Budesonide and Formoterol are extensively metabolized in the liver, primarily via CYP3A4 enzymes.

Side Effects

Contraindications

Hypersensitivity to Budesonide, Formoterol, or any excipients.
Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Not indicated for acute bronchospasm.

Drug Interactions

Diuretics (thiazide or loop)

May potentiate hypokalemia associated with beta2-agonists.

Beta-adrenergic blockers (non-cardioselective)

May antagonize the effect of Formoterol and should generally be avoided.

Tricyclic antidepressants (TCAs) and Monoamine oxidase inhibitors (MAOIs)

May potentiate the effect of Formoterol on the cardiovascular system.

Ketoconazole, Itraconazole, Ritonavir, Atazanavir, Indinavir, Nelfinavir, Saquinavir (CYP3A4 inhibitors)

May increase systemic exposure to Budesonide, potentially leading to systemic corticosteroid effects.

Storage

Store below 30°C. Do not freeze. Protect from direct sunlight, heat, and moisture. Keep out of reach of children.

Overdose

Symptoms of Budesonide overdose include adrenal suppression. Symptoms of Formoterol overdose include tachycardia, tremors, palpitations, headache, and hypokalemia. Treatment is largely supportive. Discontinuation of the drug may be necessary, and monitoring of serum potassium levels is recommended.

Pregnancy & Lactation

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide and Formoterol are excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Side Effects

Contraindications

Hypersensitivity to Budesonide, Formoterol, or any excipients.
Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
Not indicated for acute bronchospasm.

Drug Interactions

Diuretics (thiazide or loop)

May potentiate hypokalemia associated with beta2-agonists.

Beta-adrenergic blockers (non-cardioselective)

May antagonize the effect of Formoterol and should generally be avoided.

Tricyclic antidepressants (TCAs) and Monoamine oxidase inhibitors (MAOIs)

May potentiate the effect of Formoterol on the cardiovascular system.

Ketoconazole, Itraconazole, Ritonavir, Atazanavir, Indinavir, Nelfinavir, Saquinavir (CYP3A4 inhibitors)

May increase systemic exposure to Budesonide, potentially leading to systemic corticosteroid effects.

Storage

Store below 30°C. Do not freeze. Protect from direct sunlight, heat, and moisture. Keep out of reach of children.

Overdose

Pregnancy & Lactation

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 Inhaler containing 120 actuations

Shelf Life

Typically 2-3 years from the date of manufacture. Check the expiry date on the packaging.

Availability

Available in pharmacies and hospitals.

Approval Status

Approved globally for asthma and COPD management.

Patent Status

Generically available in many countries; specific formulations may have patents.

WHO Essential Medicine

Yes

Clinical Trials

Extensive clinical trials have demonstrated the efficacy and safety of Budesonide/Formoterol combination therapy in both asthma and COPD management, leading to its widespread approval and use.

Lab Monitoring

Regular monitoring of growth in children and adolescents receiving long-term ICS therapy.
Periodic ophthalmological examinations for patients with glaucoma or cataracts, or a family history of same.
Serum potassium levels in patients at risk of hypokalemia (e.g., concomitant diuretic use).

Doctor Notes

Emphasize correct inhaler technique and mouth rinsing to patients.
Distinguish clearly between maintenance inhaler (Formocort) and rescue inhaler.
Monitor for signs of oral candidiasis or systemic corticosteroid effects, especially with long-term high-dose use.

Patient Guidelines

Always use the inhaler exactly as prescribed by your doctor.
Ensure proper inhaler technique as demonstrated by your healthcare provider.
Rinse your mouth with water after each use to prevent oral candidiasis (thrush). Do not swallow the water.
Do not use this inhaler for sudden breathing problems. Always carry a separate rescue inhaler (e.g., salbutamol) for acute symptoms.
Do not stop using the inhaler suddenly, even if you feel better, without consulting your doctor.

Missed Dose Advice

If a dose is missed, take the next scheduled dose at the usual time. Do not take a double dose to compensate for the missed one. Consult a doctor if you miss multiple doses.

Driving Precautions

Formocort 80 mcg Inhaler is unlikely to affect your ability to drive or operate machinery. However, if you experience side effects like dizziness or tremor, avoid driving or operating machinery until these symptoms subside.

Lifestyle Advice

Avoid smoking and exposure to smoke, as it can worsen respiratory conditions.
Identify and avoid environmental triggers that may worsen your asthma or COPD (e.g., pollen, dust mites, pet dander).
Maintain a healthy lifestyle, including regular exercise and a balanced diet, as advised by your doctor.