Pulmicort-F(160 mcg+4.5 mcg)/puff

Pulmicort-F is a fixed-dose combination inhaler containing an inhaled corticosteroid (budesonide) and a long-acting beta2-agonist (formoterol fumarate), indicated for the following:

Established / Approved Uses

• Maintenance treatment of asthma in patients (typically 6 years of age and older, depending on the specific product strength and local labeling) who require regular treatment with both an inhaled corticosteroid and a long-acting bronchodilator, including patients whose asthma is not adequately controlled on an inhaled corticosteroid alone.
• Maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce the frequency of COPD exacerbations in adult patients.

Guideline-Supported Additional Use

• In some countries, under specific asthma treatment guidelines (e.g., GINA), certain strengths of Pulmicort-F are used as combined maintenance-and-reliever therapy in adults; this specific reliever role is not part of every national label and should only be followed under a physician's explicit instruction.

Not Indicated For

• Pulmicort-F is not a rescue/quick-relief inhaler for acute bronchospasm or a first-line treatment for status asthmaticus or other acute episodes of asthma/COPD requiring intensive intervention (see Contraindications).

Each actuation/dose of Budesonide + Formoterol Fumarate delivers a fixed combination of two active ingredients: budesonide (an inhaled corticosteroid, micronized) and formoterol fumarate dihydrate (a long-acting beta2-adrenergic agonist), formulated as a pressurized metered-dose inhaler (pMDI) or a dry powder inhaler (DPI), depending on the marketed brand. Available strengths vary by product and market (for example, lower-strength and higher-strength combinations per actuation), and the correct strength should be selected by the prescribing physician based on disease severity.

Pulmicort-F is a combination respiratory medicine that pairs an inhaled corticosteroid (budesonide) with a long-acting beta2-agonist, or LABA (formoterol fumarate), in a single inhaler device.

Budesonide reduces airway inflammation, while formoterol fumarate relaxes the smooth muscle of the airways to keep them open for an extended period. Together, they provide combined anti-inflammatory and bronchodilator action for the long-term maintenance management of asthma and chronic obstructive pulmonary disease (COPD). Pulmicort-F is delivered by oral inhalation and is intended for regular, scheduled use rather than as an as-needed rescue treatment.

Pulmicort-F belongs to the therapeutic class of combination inhaled corticosteroid (ICS) / long-acting beta2-agonist (LABA) bronchodilator-anti-inflammatory agents, used in the management of obstructive airway diseases (asthma and COPD).

Mechanism of Action

Budesonide + Formoterol Fumarate combines two complementary mechanisms:

• Budesonide is a glucocorticosteroid that, after inhalation, exerts a locally acting anti-inflammatory effect in the airways, reducing mucosal edema, mucus secretion, and airway hyperresponsiveness by binding to glucocorticoid receptors and suppressing multiple inflammatory cell types and mediators.
• Formoterol fumarate is a selective long-acting beta2-adrenergic agonist that relaxes bronchial smooth muscle by stimulating beta2-receptors, increasing intracellular cyclic AMP. Bronchodilation occurs within minutes of inhalation and persists for approximately 12 hours.

Pharmacokinetics (brief)

Both components are absorbed from the lungs and, to a lesser extent, the gastrointestinal tract after swallowing the inhaled portion. Budesonide undergoes extensive first-pass hepatic metabolism primarily via CYP3A4 to metabolites with low corticosteroid activity. Formoterol is metabolized mainly by direct glucuronidation and O-demethylation. Elimination of both components occurs chiefly via the kidneys and feces as metabolites.

Pulmicort-F is for oral inhalation only and must never be swallowed as a tablet, injected, or used in a nebulizer unless the specific product is a nebulizer suspension explicitly labeled as such. Proper inhaler technique (correct priming, inhalation timing, and breath-holding) is essential for the medicine to reach the lungs effectively; patients should be trained by a pharmacist or physician on the specific device dispensed. Mouth rinsing after each dose is required (see Dosage and Administration).

The following clinically significant interactions have been reported with the components of Pulmicort-F:

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): may substantially increase systemic exposure to the budesonide component, raising the risk of corticosteroid-related side effects; concurrent use should be avoided or undertaken with caution and monitoring.
• Beta-blockers (including cardioselective agents and ophthalmic beta-blocker eye drops): may blunt or antagonize the bronchodilator effect of the formoterol component and can, in some patients, provoke severe bronchospasm; concurrent use should generally be avoided in patients with obstructive airway disease unless there is a compelling reason and close monitoring.
• Other long-acting beta2-agonists or sympathomimetic amines: should not be used concurrently with Pulmicort-F, as additive cardiovascular effects (tachycardia, arrhythmia) may occur.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: may potentiate the cardiovascular effects of the formoterol component (e.g., effects on the QT interval and heart rate); use with caution.
• Non-potassium-sparing diuretics (e.g., loop or thiazide diuretics): formoterol may worsen diuretic-induced ECG changes and/or hypokalemia; monitor potassium levels when used together.

Side effects of Pulmicort-F may involve either the inhaled corticosteroid component, the long-acting beta2-agonist component, or both.

Common Side Effects

• Oral candidiasis (thrush) and throat irritation
• Hoarseness or voice changes (dysphonia)
• Headache
• Nasopharyngitis, upper respiratory tract infection, sinusitis
• Nausea
• Back pain, muscle cramps
• Tremor and palpitations (related to the beta-agonist component)

Less Common but Serious Side Effects

• Paradoxical bronchospasm (worsening of wheeze immediately after use) — discontinue and seek medical advice if this occurs
• Increased risk of pneumonia in COPD patients
• Cardiovascular effects: increased heart rate, palpitations, arrhythmias, and rarely QT prolongation
• Hypokalemia (low blood potassium) and hyperglycemia
• Adrenal suppression and Cushingoid features with long-term, high-dose use (see Precautions)
• Reduced bone mineral density with long-term use
• Slowing of growth velocity in children (see Pediatric Use)
• Vision changes, glaucoma, or cataracts with long-term use
• Hypersensitivity reactions, including rash, urticaria, angioedema, and rarely anaphylaxis

Pregnancy: Data on the use of Pulmicort-F in pregnant women are limited. As with other corticosteroid/LABA combination inhalers, Pulmicort-F should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Uncontrolled asthma during pregnancy itself carries risks to both mother and fetus, so treatment should not be stopped without medical advice; any change in therapy should be made only under a physician's guidance.

Lactation: It is not known with certainty whether formoterol is excreted in human milk; budesonide is excreted in breast milk in small amounts. Because many drugs are excreted in human milk, caution should be exercised, and Pulmicort-F should be used during breastfeeding only if clearly needed and after consulting a physician, who can weigh the benefits of treatment against any potential risk to the infant.

Boxed Warning (Class Warning for LABA-Containing Medicines)

Long-acting beta2-agonists (LABAs), such as the formoterol component of Pulmicort-F, have been shown to increase the risk of asthma-related death when used as monotherapy (without an inhaled corticosteroid) for asthma. Because Pulmicort-F contains an inhaled corticosteroid in addition to a LABA, this specific risk is mitigated when used as directed for its approved combination indications; however, Pulmicort-F should not be used to treat asthma without additional, physician-directed monitoring, and should never be used in place of, or to replace, an inhaled corticosteroid that has been separately prescribed if this combination is discontinued.

Not a Rescue Medicine

Pulmicort-F is not intended to relieve acute symptoms; patients should have a separate fast-acting rescue inhaler available at all times (see Contraindications).

Local and Systemic Corticosteroid Effects

• Infections: Because of the local immunosuppressive effect of the corticosteroid component, Pulmicort-F should be used with caution in patients with active or quiescent tuberculosis, and untreated systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex, as it may mask or worsen these conditions.
• Adrenal function: Long-term use, especially at higher doses, or transfer from oral/systemic corticosteroids, may lead to adrenal insufficiency; monitor for signs such as fatigue, weakness, nausea, and low blood pressure, particularly during periods of stress or surgery.
• Bone density: Long-term use may be associated with decreased bone mineral density; consider monitoring in patients with additional osteoporosis risk factors.
• Growth in children: Long-term use of inhaled corticosteroids may slow growth velocity in children; growth should be monitored routinely.

Cardiovascular Precautions

Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension, as the beta-agonist component can produce clinically significant cardiovascular effects (increased heart rate, blood pressure changes, ECG changes).

Other Precautions

Use with caution in patients with convulsive disorders, thyrotoxicosis, or diabetes mellitus (beta-agonists may raise blood glucose), and in patients unusually responsive to sympathomimetic amines. Discontinue immediately if paradoxical bronchospasm occurs.

Overdose of Pulmicort-F may cause exaggerated effects of its two components: signs of excess beta-agonist effect (formoterol) may include tremor, headache, palpitations, tachycardia, muscle cramps, dry mouth, nausea, hypokalemia, hyperglycemia, and, rarely, arrhythmias, seizures, or QT prolongation; excessive or prolonged corticosteroid (budesonide) exposure may cause suppression of the body's own cortisol production.

If an overdose of Pulmicort-F is suspected, seek immediate medical attention or contact emergency services / a poison control center. Do not attempt to manage a suspected overdose at home; supportive care and cardiac monitoring in a medical facility may be required.

Store at room temperature (below 30°C), away from direct light, heat, and moisture. Do not puncture, break, or burn the canister/device, even when it appears empty, and avoid exposure to temperatures above 120°F (49°C). Keep out of reach and sight of children.

Hepatic Impairment

Budesonide is metabolized primarily by the liver; patients with hepatic impairment may have increased systemic exposure to Pulmicort-F's corticosteroid component and should be monitored for corticosteroid-related adverse effects.

Renal Impairment

No well-established dose adjustment is required for renal impairment; however, caution and clinical monitoring are advised, as specific studies in this population are limited.

Elderly Patients

No overall differences in effectiveness have been established between elderly and younger patients, but elderly patients may be more susceptible to cardiovascular effects of the beta-agonist component and should be monitored accordingly.

Pediatric Patients

See Pediatric Use.

Pregnancy and Lactation

See Pregnancy and Lactation section above.

Pulmicort-F is intended for long-term, regular maintenance therapy of asthma and COPD rather than short-term or as-needed use. Treatment duration should be determined by the treating physician based on symptom control, lung function, and exacerbation history, with periodic review to step down to the lowest effective dose once control is achieved, in line with standard asthma/COPD management guidelines. Do not stop treatment abruptly without medical advice, even if symptoms improve.

Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA); Fixed-dose combination bronchodilator/anti-inflammatory respiratory agent.

Budesonide + Formoterol Fumarate works through two complementary actions: the budesonide component suppresses airway inflammation by acting on glucocorticoid receptors in airway tissue, while the formoterol fumarate component relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors, producing bronchodilation that begins within minutes and lasts about 12 hours. Combined, these actions reduce airway inflammation and keep the airways open for sustained symptom control.

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Pulmicort-F is approved for asthma maintenance treatment in pediatric patients from an age that depends on the specific product strength and national labeling (commonly 6 years of age and older); it is not approved for use in children below the labeled age, and safety and efficacy in COPD have not been established in the pediatric population, since COPD does not typically occur in children. Long-term use of the corticosteroid component in children should include regular monitoring of growth velocity, and the lowest effective dose should be used.