Generic medicine

Formoterol Fumarate + Glycopyrrolate + Budesonide: Brands, Price & Uses in Bangladesh

Formoterol Fumarate + Glycopyrrolate + Budesonide is an FDA-approved, guideline-supported triple fixed-dose combination inhaler indicated for the long-term and more.

Forms:InhalerMetered-Dose Inhaler (MDI)

About Formoterol Fumarate + Glycopyrrolate + Budesonide

Indications of Formoterol Fumarate + Glycopyrrolate + Budesonide

Formoterol Fumarate + Glycopyrrolate + Budesonide is an FDA-approved, guideline-supported triple fixed-dose combination inhaler indicated for the long-term, twice-daily maintenance treatment of two chronic obstructive airway diseases. It is not a rescue inhaler and must not be used to relieve sudden breathing problems.

Established/Approved Indications

  • Maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis and/or emphysema, to reduce exacerbations and improve lung function and symptoms.
  • Maintenance treatment of asthma in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled on an inhaled corticosteroid and a long-acting bronchodilator, or whose disease severity warrants initiation of triple therapy.

Not Indicated For

  • Relief of acute bronchospasm or acute exacerbations (it is not a rescue/reliever medicine; a separate short-acting bronchodilator must be available for acute symptoms).
  • Primary treatment of status asthmaticus or other acute episodes requiring intensive measures.

Formoterol Fumarate + Glycopyrrolate + Budesonide is always used as maintenance/controller therapy and is prescribed by a physician after assessment of disease severity.

Dosage & Administration of Formoterol Fumarate + Glycopyrrolate + Budesonide

Formoterol Fumarate + Glycopyrrolate + Budesonide is administered by oral inhalation only, using the actuator provided. It must be used regularly, twice daily, approximately 12 hours apart, and not more often than prescribed.

IndicationRecommended Dose
COPD (adults)2 oral inhalations twice daily (morning and evening)
Asthma (adults and adolescents ≥12 years)2 oral inhalations twice daily (morning and evening)

The exact delivered strength of Formoterol Fumarate + Glycopyrrolate + Budesonide per actuation differs between the COPD-indicated product and the asthma-indicated product; patients should use only the specific inhaler strength prescribed for their condition and should not exceed 2 inhalations twice daily (maximum 4 inhalations per day).

Missed Dose

If a dose of Formoterol Fumarate + Glycopyrrolate + Budesonide is missed, it should be taken as soon as remembered; if it is almost time for the next dose, the missed dose should be skipped. Do not double the dose.

Formoterol Fumarate + Glycopyrrolate + Budesonide should never be used for sudden shortness of breath; a separate fast-acting rescue inhaler should always be available.

Side Effects of Formoterol Fumarate + Glycopyrrolate + Budesonide

Most people tolerate Formoterol Fumarate + Glycopyrrolate + Budesonide well, but side effects can occur.

Common Side Effects

  • Oral candidiasis (thrush), throat irritation, hoarseness/dysphonia
  • Nasopharyngitis and upper respiratory tract infections
  • Headache
  • Cough
  • Back pain
  • Urinary tract infection
  • Nausea
  • Tremor and palpitations (from the bronchodilator components)

Serious but Less Common Side Effects

Serious risks such as paradoxical bronchospasm, cardiovascular effects, pneumonia (in COPD patients), hypersensitivity reactions, and effects on the adrenal glands and bone density are discussed in detail under Precautions and Warnings.

Patients should contact their physician promptly if side effects are severe, persistent, or concerning.

Contraindications of Formoterol Fumarate + Glycopyrrolate + Budesonide

Formoterol Fumarate + Glycopyrrolate + Budesonide is contraindicated in:

  • Patients with a known hypersensitivity to formoterol fumarate, glycopyrrolate, budesonide, atropine or its derivatives, or any excipient of Formoterol Fumarate + Glycopyrrolate + Budesonide, as severe hypersensitivity reactions (including anaphylaxis, angioedema, urticaria, and bronchospasm) have occurred.
  • Primary treatment of acute bronchospasm, status asthmaticus, or acute exacerbations of asthma or COPD requiring intensive measures — Formoterol Fumarate + Glycopyrrolate + Budesonide is not a rescue therapy and must not be substituted for a fast-acting bronchodilator in this setting.

Frequently Asked Questions about Formoterol Fumarate + Glycopyrrolate + Budesonide

What is Formoterol Fumarate + Glycopyrrolate + Budesonide used for?

Formoterol Fumarate + Glycopyrrolate + Budesonide is used for the regular, twice-daily maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults and of asthma in adults and adolescents 12 years of age and older. It is not used to treat sudden breathing attacks.

Can Formoterol Fumarate + Glycopyrrolate + Budesonide be used as a rescue inhaler for a sudden asthma or COPD attack?

No. Formoterol Fumarate + Glycopyrrolate + Budesonide is a long-acting maintenance medicine and is not indicated for the primary treatment of acute bronchospasm or status asthmaticus. Patients should always keep a separate fast-acting rescue inhaler on hand for sudden symptoms, and should seek medical help if they need their rescue inhaler more often than usual.

What are the main side effects of Formoterol Fumarate + Glycopyrrolate + Budesonide?

Common side effects of Formoterol Fumarate + Glycopyrrolate + Budesonide include oral thrush (candidiasis), throat irritation, hoarseness, headache, upper respiratory tract infection, cough, and tremor or palpitations. Rinsing the mouth with water after each dose reduces the risk of oral thrush.

Is Formoterol Fumarate + Glycopyrrolate + Budesonide safe to use during pregnancy or while breastfeeding?

Formoterol Fumarate + Glycopyrrolate + Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and while breastfeeding only if clearly needed, since safety data in humans are limited. A physician should always be consulted before using Formoterol Fumarate + Glycopyrrolate + Budesonide during pregnancy or breastfeeding.

Who should not use Formoterol Fumarate + Glycopyrrolate + Budesonide?

Formoterol Fumarate + Glycopyrrolate + Budesonide should not be used by anyone with a known hypersensitivity to formoterol fumarate, glycopyrrolate, budesonide, atropine or its derivatives, or any ingredient of Formoterol Fumarate + Glycopyrrolate + Budesonide, and it should not be used as the primary treatment for an acute asthma attack or COPD exacerbation.

What should I do if I accidentally use more than my prescribed dose of Formoterol Fumarate + Glycopyrrolate + Budesonide?

If an overdose of Formoterol Fumarate + Glycopyrrolate + Budesonide is suspected, seek immediate medical attention or contact emergency services/a poison control center right away, as excessive use can cause a fast heart rate, tremor, and other serious effects.

Disclaimer

The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.

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