Budesonide / Formoterol Fumarate Dihydrate

Budesonide and Formoterol Fumarate Dihydrate are prescription medications used for the long-term control of asthma and chronic obstructive pulmonary disease (COPD). It combines two medications: Budesonide, an inhaled corticosteroid that reduces inflammation in the airways, and Formoterol Fumarate Dihydrate, a long-acting bronchodilator that relaxes airway muscles and improves airflow.

This combination inhaler helps reduce symptoms such as wheezing, coughing, and shortness of breath. It is intended for maintenance treatment and is not used to relieve sudden breathing problems or acute asthma attacks.

Below is a quick overview of important facts for patients and caregivers:

This medication is prescribed for the long-term control of asthma and chronic obstructive pulmonary disease (COPD). The usage is as follows:

• Asthma: It is used for the maintenance treatment of asthma in patients 6 years of age and older, particularly when symptoms are not adequately controlled with inhaled corticosteroids alone.
• Chronic obstructive pulmonary disease (COPD): This medication is also used for the maintenance treatment of airflow obstruction in adults with COPD, including chronic bronchitis and emphysema. The 160 mcg / 4.5 mcg strength is the formulation indicated for COPD.

It is not indicated for the relief of acute bronchospasm or sudden asthma attacks. A rescue inhaler should be used for immediate relief of symptoms.

The Budesonide and Formoterol inhalation aerosol combines two medicines that work together to improve breathing and control airway inflammation. Each active ingredient works in a different way:

Budesonide:

• An inhaled corticosteroid
• Reduces inflammation and swelling in the airways
• Helps prevent asthma and COPD symptoms over time

Formoterol:

• A long-acting beta2-agonist bronchodilator
• Relaxes airway muscles
• Helps keep the airways open for easier breathing

Together, these medications provide both anti-inflammatory and bronchodilating effects, helping improve airflow and maintain long-term control of asthma and COPD symptoms.

Always follow your healthcare provider’s instructions. General guidelines include:

• Shake the inhaler well before each use.
• Exhale fully before inserting the mouthpiece in your mouth.
• Press the inhaler while inhaling slowly and deeply.
• Hold your breath for about 10 seconds after inhalation.
• Use the inhaler twice daily (morning and evening), about 12 hours apart.
• Rinse your mouth with water after each use and spit it out.

The recommended dosage depends on the patient’s condition and the inhaler strength prescribed by a healthcare provider. This medication is typically used twice daily, approximately 12 hours apart.

Asthma dosage (adults and adolescents 12 years and older):

Asthma dosage (children 6-11 years):

COPD dosage (adults):

Important information:

• Do not exceed two inhalations twice daily.
• Do not use additional LABA medications while using this inhaler unless directed by a healthcare provider.
• If breathing symptoms occur between doses, a short-acting rescue inhaler may be used for immediate relief.

Using more than the recommended amount of this inhalation aerosol may increase the risk of adverse effects related to its components, particularly the bronchodilator formoterol. Symptoms of overdose may include:

• Chest pain or angina
• Rapid or irregular heartbeat
• Tremor or muscle cramps
• Headache
• Nervousness or agitation
• Dizziness
• Nausea or vomiting
• Changes in blood pressure

Excessive exposure to corticosteroids such as budesonide over long periods may also lead to systemic steroid effects. If an overdose is suspected, seek immediate emergency medical help or contact a poison control center. Treatment typically involves discontinuing the medication and providing supportive medical care with appropriate monitoring.

Like all medications, this inhalation aerosol may cause side effects. Most are mild and manageable, but some reactions may require medical attention.

Common Side Effects

Commonly reported Budesonide and Formoterol Fumarate Dihydrate side effects are listed below:

• Throat irritation
• Headache
• Upper respiratory tract infection
• Sinusitis
• Nasal congestion
• Oral thrush (fungal infection in the mouth or throat)
• Stomach discomfort
• Vomiting
• Flu-like symptoms

Rinsing the mouth with water after using the inhaler may help reduce the risk of oral thrush.

Serious Side Effects

Seek immediate medical attention if you experience any of the following:

• Chest pain or rapid heartbeat
• Tremor or nervousness
• Pneumonia or lung infections (especially in COPD patients)
• Severe allergic reactions such as swelling, breathing problems, or rash
• Paradoxical bronchospasm (sudden worsening of breathing after inhalation)
• Decreased bone mineral density with long-term use
• Eye problems such as glaucoma or cataracts
• Adrenal insufficiency
• Low potassium levels (hypokalemia)
• Increased blood sugar levels (hyperglycemia)
• Slowed growth in children

This is not a complete list of side effects. Contact your healthcare provider for medical advice about adverse reactions. You may report side effects to the FDA at 1-800-FDA-1088 or visit MedWatch.

While taking this medication, the following warnings and precautions should be considered:

• Eye problems: Long-term use may increase the risk of glaucoma or cataracts.
• Bone mineral density: Prolonged use may reduce bone strength in some patients.
• Adrenal suppression: Long-term or high-dose use may affect adrenal gland function.
• Excessive LABA use: Do not exceed the prescribed dose or use other long-acting beta-agonist (LABA) medications at the same time.
• Growth effects in children: Inhaled corticosteroids may slow growth in pediatric patients.
• Cardiovascular effects: Use cautiously in patients with heart disease, hypertension, or arrhythmias.
• Immune system effects: Corticosteroids may weaken the immune system and increase susceptibility to infections.
• Not for sudden breathing problems: This medication should not be used as a rescue inhaler for acute bronchospasm.
• Oral fungal infections: Inhaled corticosteroids may cause thrush in the mouth or throat. Rinse the mouth with water after each use.
• Paradoxical bronchospasm: In rare cases, breathing may worsen immediately after inhalation. Discontinue use and seek medical care if this occurs.
• Pneumonia risk in COPD: Patients with COPD who use inhaled corticosteroids may be at increased risk of pneumonia or other respiratory infections.
• Electrolyte and metabolic changes: Beta-agonists may cause low potassium levels (hypokalemia) or increased blood sugar levels (hyperglycemia).

Pregnancy and Breastfeeding

Limited human data are available on the use of Budesonide and Formoterol Fumarate Dihydrate during pregnancy. Studies of inhaled Budesonide alone have not shown an increased risk of congenital disabilities. However, this medication should be used during pregnancy only if clearly needed and prescribed by a healthcare provider.

Budesonide is present in human breast milk, while data for Formoterol are limited. The benefits of breastfeeding should be weighed against the mother’s need for treatment. Consult a healthcare provider before using this medication while breastfeeding.

This medication may interact with certain drugs that affect how it is processed in the body or enhance beta-agonist effects. Examples of medications that may interact include:

• Strong CYP3A4 inhibitors (such as clarithromycin, ritonavir, ketoconazole, itraconazole)
• Beta-blockers, including some eye drops used for glaucoma
• Non-potassium-sparing diuretics (such as thiazide or loop diuretics)
• Monoamine oxidase inhibitors (MAOIs)
• Tricyclic antidepressants

Patients should inform their healthcare provider about all supplements, over-the-counter drugs, and prescription medications they use before starting this inhaler.

Several inhaled medications may be prescribed as alternatives depending on the patient’s condition and treatment response.

These medications contain different active ingredients and should not be substituted without medical guidance. Brand availability may vary depending on location and pharmacy supply. A healthcare provider will determine the most appropriate option based on the patient’s condition and treatment response.

Prescription inhaler medications for asthma and COPD may be costly at many U.S. retail pharmacies. Ordering Budesonide / Formoterol Fumarate Dihydrate online from Polar Bear Meds may help reduce overall costs while maintaining safety, quality, and reliability.

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All Budesonide / Formoterol Fumarate Dihydrate orders require a valid prescription. Medications are dispensed by licensed pharmacies that comply with applicable pharmacy regulations and safety standards.

• https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b974bab9-c6d2-41ad-b930-28f2904c5f9d#williamsonbk1208543094532