Symbion (100 mcg+6 mcg)/puff (Inhaler)

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Medicine Details

Title

Budesonide and Formoterol Inhalation Capsule

Category

  • Medicine
  • Respiratory Health
  • Inhaler

Description

This inhalation capsule is used for dry powder inhaler. It is intended for oral inhalation only. It is a combination of Formoterol Fumarate Dihydrate BP and Budesonide BP. Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. Inhaled Budesonide has less severe adverse effects than systemic corticosteroids.The exact mechanism responsible for the anti-inflammatory effect of glucocorticosteroids is unknown. Formoterol is a selective β2 adrenoceptor agonist that when inhaled results in rapid and long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect is dose-dependent, with an onset of effect within 1-3 minutes. The duration of effect is at least 12 hours after a single dose.

Indications

  • Treatment of Asthma in patients 12 years of age and older
  • Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD)

Pharmacology

  • Budesonide: Anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity
  • Formoterol Fumarate Dihydrate: Long-acting, selective β2 - adrenergic agonist with rapid onset of action

Dosage

  • Inhaler (For Asthma):
    • Adults and Adolescents: 1 puff twice daily or 2 puffs once daily
    • Children: 1 - 2 puffs once or twice daily
  • Inhalation Capsule (For Asthma):
    • Adults and Adolescents: Maintenance dose: Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily; Reliever dose: 1 additional Inhalation Capsule as needed

Administration

  • Steps:
    • Take off the cap
    • Shake the inhaler vigorously before each use
    • Breathe out fully and hold the inhaler upright
    • Place the actuator into the mouth between the teeth and close lips around the mouthpiece
    • While breathing deeply and slowly through the mouth, press down firmly and fully on the canister to release medicine
    • Remove the inhaler from the mouth and continue holding breath for at least for 10 seconds
    • Wait 1 minute between puffs if prescribed for more than one inhalation
    • Rinse mouth with water after each treatment
    • Check technique in front of a mirror
  • Cleaning Instructions: Clean Inhaler at least once a week. Rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Interaction

Co-administration with strong cytochrome P450 3A4 inhibitors (e.g., ritonavir) should be avoided. Co-administration with Monoamine oxidase inhibitors, tricyclic antidepressants, and beta-blockers should be with caution.

Contraindications

  • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD
  • Hypersensitivity to any of the ingredients in this preparation

Side Effects

  • Formoterol Fumarate:
    • Tremor
    • Palpitations
    • Headache
  • Budesonide:
    • Hoarseness
    • Candida infection in the oropharynx
    • Throat irritation

Pregnancy & Lactation

No clinical data on exposed pregnancies is available for this combination. Caution advised during pregnancy and lactation.

Precautions & Warnings

Caution should be taken in patients with diabetes mellitus, thyrotoxicosis, untreated hypokalaemia, severe hypertension and severe cardiovascular disorders.

Use in Special Populations

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. Consideration should be given to referring the patient to a paediatric respiratory specialist.

Overdose Effects

An overdose of Formoterol may lead to typical effects for β2 adrenoceptor agonists. Acute overdosage with Budesonide, even in excessive doses, is not expected to be a clinical problem.

Storage Conditions

Inhalation capsules must not be swallowed, keep away from light and wet place, store at or below 25°C temperature, keep out of reach of children

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