Medicine Information

Formocort

Name: Formocort
Brand: Formocort

Dry Powder Inhaler (DPI)Budesonide 160 mcg + Formoterol 4.5 mcg per actuationCombined inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA)ATC: 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 160 mcg inhaler	৳ 500.00	N/A

Description

Overview of the medicine

Formocort 160 mcg Inhaler is a combination medicine containing Budesonide (an inhaled corticosteroid) and Formoterol Fumarate Dihydrate (a long-acting beta2-agonist). It is used to prevent and control the symptoms of asthma and chronic obstructive pulmonary disease (COPD) by reducing inflammation and relaxing the airways.

Uses & Indications

Maintenance treatment of asthma in adults and adolescents (12 years and older) where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate.

Symptomatic treatment of severe chronic obstructive pulmonary disease (COPD) in adults (18 years and older) with a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy.

Dosage

Adults

Asthma: Usually 1-2 inhalations twice daily. COPD: 2 inhalations twice daily.

Elderly

No dosage adjustment specifically required for the elderly, but caution is advised, especially in those with comorbidities.

Renal_impairment

No specific dosage adjustment recommendations for renal impairment, as budesonide and formoterol are primarily metabolized by the liver.

How to Take

For inhalation use only. Shake well before use if it's a pMDI. For DPI, load the dose as per device instructions. Inhale slowly and deeply through the mouthpiece. Rinse mouth with water and spit out after each use to minimize the risk of oral candidiasis.

Mechanism of Action

Budesonide is an anti-inflammatory corticosteroid that works by decreasing the inflammation in the airways, thereby reducing swelling and mucus production. Formoterol is a selective long-acting beta2-adrenergic agonist that acts locally in the lung as a bronchodilator by relaxing the smooth muscles of the airways, making it easier to breathe.

Pharmacokinetics

Onset

Bronchodilation with Formoterol typically occurs within 1-3 minutes, while the full anti-inflammatory effect of Budesonide may take several days to weeks.

Excretion

Budesonide and its metabolites are primarily excreted via urine and feces. Formoterol is mainly excreted via urine.

Half life

Budesonide: approximately 2-2.8 hours. Formoterol: approximately 10 hours.

Absorption

Budesonide is well absorbed after inhalation, with systemic bioavailability of approximately 15%. Formoterol is rapidly absorbed after inhalation, with peak plasma concentrations reached within minutes. Systemic bioavailability is approximately 21%.

Metabolism

Budesonide undergoes extensive first-pass metabolism in the liver via CYP3A4. Formoterol is primarily metabolized via direct glucuronidation and O-demethylation.

Side Effects

Contraindications

Hypersensitivity to budesonide, formoterol, or any excipients.
Not for the relief of acute bronchospasm; a rapid-acting bronchodilator should be used for this purpose.
Patients with active pulmonary tuberculosis.

Drug Interactions

Beta-blockers

May reduce the effect of formoterol. Non-cardioselective beta-blockers should generally be avoided.

Diuretics (thiazide or loop)

May exacerbate hypokalemia when used with high doses of beta2-agonists.

CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)

May increase systemic exposure to budesonide.

Quinidine, Disopyramide, Procainamide, Phenothiazines, Antihistamines (non-sedating), TCAs

May prolong QTc interval and increase the risk of ventricular arrhythmias with formoterol.

Storage

Store below 30°C in a dry place, away from direct sunlight and heat. Do not freeze. Keep out of reach of children.

Overdose

Symptoms of budesonide overdose include adrenal suppression. Symptoms of formoterol overdose include tremor, headache, palpitations, and tachycardia. Treatment is supportive; discontinue the drug and monitor cardiac function and serum potassium levels.

Pregnancy & Lactation

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is considered safe in pregnancy, but formoterol's data is more limited. Consult a doctor. Avoid during lactation unless deemed essential by a physician.

Side Effects

Contraindications

Hypersensitivity to budesonide, formoterol, or any excipients.
Not for the relief of acute bronchospasm; a rapid-acting bronchodilator should be used for this purpose.
Patients with active pulmonary tuberculosis.

Drug Interactions

Beta-blockers

May reduce the effect of formoterol. Non-cardioselective beta-blockers should generally be avoided.

Diuretics (thiazide or loop)

May exacerbate hypokalemia when used with high doses of beta2-agonists.

CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)

May increase systemic exposure to budesonide.

Quinidine, Disopyramide, Procainamide, Phenothiazines, Antihistamines (non-sedating), TCAs

May prolong QTc interval and increase the risk of ventricular arrhythmias with formoterol.

Storage

Store below 30°C in a dry place, away from direct sunlight and heat. Do not freeze. Keep out of reach of children.

Overdose

Pregnancy & Lactation

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

Inhaler with 120 actuationsInhaler with 60 actuations

Shelf Life

Typically 24 months from manufacturing date when stored correctly. Refer to package for exact expiry date.

Availability

Pharmacies, hospitals

Approval Status

Approved by relevant regulatory authorities (e.g., DGDA, FDA for similar combinations)

Patent Status

Generic available, original patent expired for combination

WHO Essential Medicine

Yes

Clinical Trials

The combination of Budesonide and Formoterol has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in the management of asthma and COPD. These trials have shown improvements in lung function, reduction in exacerbations, and symptom control compared to monotherapy.

Lab Monitoring

Monitor lung function (e.g., FEV1).
Regular height and growth monitoring in children/adolescents receiving long-term treatment.
Monitor for signs of adrenal suppression, especially with high doses or prolonged use.
Periodically monitor serum potassium and glucose levels, especially in patients at risk.

Doctor Notes

Emphasize the importance of consistent daily use and not as a rescue inhaler.
Educate patients on proper inhaler technique and mouth rinsing to prevent oral candidiasis.
Assess for potential drug interactions, especially with beta-blockers and strong CYP3A4 inhibitors.
Monitor for systemic corticosteroid effects with high doses or prolonged use.

Patient Guidelines

Use regularly as prescribed, even when feeling well, for optimal control of asthma/COPD.
This inhaler is for maintenance therapy, not for sudden breathing problems. Use a separate rescue inhaler (e.g., salbutamol) for acute symptoms.
Rinse your mouth with water and spit it out after each dose to help prevent oral thrush.
Do not exceed the prescribed dose.

Missed Dose Advice

If a dose is missed, take the next dose at the regular scheduled time. Do not take a double dose to make up for a missed one.

Driving Precautions

Generally, Formocort does not affect the ability to drive or operate machinery. However, if side effects like dizziness or tremor occur, avoid these activities.

Lifestyle Advice

Avoid smoking, as it can worsen asthma/COPD symptoms and reduce medication effectiveness.
Maintain a healthy lifestyle, including regular exercise and a balanced diet.
Identify and avoid asthma triggers.