budesonide and formoterol (inhalation)

Action and Spectrum

Actions and spectrum:

Budesonide is a type of corticosteroid, which is a type of steroid hormone that acts to reduce inflammation in the airways. It is often used as a preventive treatment for asthma, helping to reduce the frequency and severity of asthma attacks. Budesonide is inhaled directly into the lungs, and its effects are generally localized to the airways, reducing the risk of systemic side effects.

Formoterol, on the other hand, is a type of bronchodilator, which means it works to relax the muscles in the airways, making it easier to breathe. It is often used as a quick-relief medication for asthma, helping to relieve symptoms during an asthma attack. Formoterol is also inhaled directly into the lungs.

In terms of their spectrum of action, budesonide is generally considered to be a more broad-spectrum medication, as it acts to reduce inflammation in the airways, which is a key factor in many respiratory disorders, including asthma and COPD. Formoterol, on the other hand, is more targeted towards the specific symptom of airflow obstruction, and is therefore generally considered to have a more limited spectrum of action.

Drug Interaction

Adverse Reaction

Frequency defined:

10%

Nasopharyngitis (7-11%)

Headache (7-11%)

Upper respiratory tract infection (URTI) (8-11%)

1-10%

Vomiting (1- 3%)

Stomach discomfort (1-7%)

Oral candidiasis (1-6%)

Backache (2-3%)

Nasal congestion (2-3%)

Influenza (2-3%)

Viral URTI (4%)

Bronchitis (5%)

Sinusitis (5-6%)

Pharyngolaryngeal pain (6-9%)

Frequency undefined:

Angina pectoris

atrial fibrillation

Hypertension

Hypercorticism

Glaucoma

Oropharyngeal candidiasis

anaphylactic reaction

Angioedema

Dermatitis

Hyperglycemia

Muscle cramps

sleep disturbances

Behavior disturbances

Depression

Dizziness

Cough

Dysphonia

throat irritation

Black Box Warning

Black box warning:

The patients with COPD should not use Budesonide/Formoterol to treat sudden symptoms of bronchospasm, as it is not a rescue medication for this condition either.

Contraindication / Caution

Contraindication/Caution:

Contraindication

• Hypersensitivity: Budesonide/Formoterol is contraindicated in patients with a known hypersensitivity to budesonide, formoterol, or any other ingredients in the product.
• Cardiac conditions: Patients with serious cardiac disorders, such as severe heart failure or arrhythmias, should not use Budesonide/Formoterol.
• Severe liver disease: Budesonide/Formoterol is contraindicated in patients with severe liver disease.
• Paradoxical bronchospasm: Budesonide/Formoterol is contraindicated in patients with a history of paradoxical bronchospasm, as this medication may cause this condition to worsen.
• Children under 12 years of age: Budesonide/Formoterol should not be recommended in children under 12 years of age.
  Cautions
• Not a rescue medication: Budesonide/Formoterol is not intended for use as a rescue medication for sudden symptoms of asthma or bronchospasm. Patients should always have a fast-acting inhaled bronchodilator available for the treatment of sudden symptoms.
• Long-term control medication: Budesonide/Formoterol is meant to be used as a long-term control medication and should not be used to treat sudden symptoms of asthma or bronchospasm.
• Systemic effects: Budesonide, the steroid component of Budesonide/Formoterol, can cause systemic effects when inhaled, including decreased bone density and adrenal suppression.
• Infections: Budesonide/Formoterol can increase the risk of developing infections, such as pneumonia, especially in patients with COPD.
• Cardiac effects: Formoterol, the beta-2 agonist component of Budesonide/Formoterol, can cause cardiac effects, such as palpitations, tachycardia, and arrhythmias.
• Hyperglycemia: Budesonide/Formoterol can cause hyperglycemia and glucose intolerance, especially in patients with diabetes.

Comorbidities

• Cardiovascular disease: Patients with cardiovascular disease, such as angina, heart failure, or arrhythmias, may be at increased risk for adverse effects when taking Budesonide/Formoterol.
• Diabetes: Budesonide, the steroid component of Budesonide/Formoterol, can cause hyperglycemia and glucose intolerance, especially in patients with diabetes.
• Osteoporosis: Budesonide, the steroid component of Budesonide/Formoterol, can cause decreased bone density and increase the risk of osteoporosis, especially with long-term use.
• Infections: Patients with weakened immune systems, such as (HIV) or (AIDS), may be at increased risk for infections when taking Budesonide/Formoterol.
• Adrenal insufficiency: Budesonide, the steroid component of Budesonide/Formoterol, can cause adrenal suppression, especially with long-term use.

Pregnancy / Lactation

Pregnancy consideration:

USFDA pregnancy category: not assigned

Lactation: safety and efficacy not established

Pregnancy category:

Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester.

Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women.

Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women

Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh risks over benefits These category drugs should be prohibited for pregnant women.

Category N: There is no data available for the drug under this category.

Pharmacology

Pharmacology:

Budesonide is a steroid that works by reducing inflammation in the airways, which helps to relieve airway narrowing and improve breathing. Formoterol is a beta-2 agonist that works by relaxing the smooth muscle in the airways, which helps to relieve airway narrowing and improve breathing.

When taken by inhalation, Budesonide/Formoterol is rapidly absorbed into the bloodstream and reaches the lungs, where it acts to control asthma and COPD symptoms. The medication is generally well tolerated, but some patients may experience side effects, such as headache, throat irritation, and hoarseness.

Pharmacodynamics

• Mechanism of action: Budesonide acts by binding to specific receptors in the body called glucocorticoid receptors. When these receptors are activated, they reduce the production of cytokines and other inflammatory mediators, thereby reducing inflammation.
• Anti-inflammatory effects: Budesonide has potent anti-inflammatory effects, which is why it is commonly used to treat conditions characterized by inflammation, such as asthma and COPD.
• Bronchodilation: In addition to its anti-inflammatory effects, Budesonide has also been shown to have bronchodilatory effects, can improve lung function in patients with asthma and COPD.
• Systemic effects: When Budesonide is taken orally, it can be absorbed into the bloodstream and have systemic effects, such as reducing inflammation throughout the body. However, when Budesonide is taken by inhalation, it primarily acts locally in the lungs, which reduces the risk of systemic side effects.

Pharmacokinetics

• Absorption: When Budesonide is taken by inhalation, it is rapidly absorbed into the bloodstream. When taken orally, Budesonide is absorbed more slowly and less efficiently.
• Distribution: After absorption, Budesonide is widely distributed throughout the body.
• Metabolism: Budesonide is metabolized in the liver by the cytochrome P450 system. The metabolism of Budesonide can be affected by other medications that are metabolized by the same enzyme system.
• Elimination: Budesonide is primarily eliminated from the body by the liver and the kidneys. The elimination half-life of Budesonide is approximately 2-3 hours.

Adminstartion

Administration

Metered-dose inhaler (MDI): Shake the inhaler well before each use. Remove the cap and breathe out fully. Breathe in deeply and steadily while pressing down on the canister to release the medication. If more than one dose is needed, wait a minute or two before taking the second dose.

Dry powder inhaler (DPI): Follow the instructions that come with the specific DPI you are using. In general, the DPI should be shaken well before each use. Breathe out fully and then place the mouthpiece in your mouth. Breathe in deeply and steadily to inhale the medication. If more than one dose is needed, wait a minute or two before taking the second dose.

Patient Information Leaflet

Patient information leaflet

Generic Name: budesonide and formoterol

Pronounced: (bue-des-oh-nide-and-for-moe-te-rol)

Why do we use budesonide?

The uses of Budesonide/Formoterol:

Asthma: Budesonide/Formoterol is used to control symptoms of asthma, such as wheezing, coughing, and shortness of breath. It is used in patients whose asthma is not well controlled with other medications or in patients who require a combination of a steroid and a bronchodilator to control their asthma.

Chronic Obstructive Pulmonary Disease (COPD): Budesonide/Formoterol is used to treat COPD. It is used to relieve symptoms, such as shortness of breath and wheezing, and to improve lung function.