Product Name

Inspirol
Inhaler
Composition


Each Inhaler Contains:


Salbutamol BP ......... 100 mcg.

Pack

1 Inhaler



INDICATION & USAGE


Inspirol is indicated in the treatment and prophylaxis of bronchial asthma, treatment of conditions associated with reversible airways obstruction e.g. bronchitis, emphysema, maintenance therapy in chronic asthma and chronic bronchitis, relief of acute bronchospasm, prevention of exercise induced asthma.


DOSAGE AND ADMINISTRATION


Method of Administration

Relief of acute bronchospasm:
  Adults: 100 or 200 micrograms
  Children: 100 micrograms

Chronic maintenance or prophylactic therapy:
  Adults: 200 micrograms three or four times daily
  Children: 100 micrograms three to four times daily

Prevention of exercise induced bronchospasm:
   Adults: 200 micrograms before exertion
   Children: 100 micrograms before exertion

Children’s doses may be increased to 200 micrograms if necessary.

Side Effects:
Mild tremors and headache have been reported. They usually disappear with continued treatment.

Hypersensitivity reactions including angiodema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. Potentially serious hypokalaemia may result from beta2 agonist therapy.

As with other beta2 agonist hyperactivity has been reported rarely in children.

Contra-indications:
Inspirol is contra-indicated in patients with a history of hypersensitivity to any of its components.
Inhaled Salbutamol preparations are not appropriate for managing premature labor. Salbutamol preparations should not be used for threatened abortion.

Drug interactions:
Inspirol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

Precautions:
Salbutamol and non-selective beta blocking drugs, such as propranolol, should not usually be prescribed together.

Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis. Potentially serious hypokalaemia may result from beta2 agonist therapy mainly from parenteral and nebulised administration. Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics, and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.

Pregnancy:
Administration of drug during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

Lactation:
Salbutamol is not recommended in nursing mothers. It is not known whether Salbutamol in breast milk has a harmful effect on the neonate.

Overdosage:
Hypokalaemia may occur following overdose with Salbutamol. Serum potassium level should be monitored. Instruction for use: Pharmaceutical Precautions / Storage: l Inspirol inhaler should be stored below 30oC. l The therapeutic effect of this medication may decrease when the canister is cold. l Protect from frost, direct sunlight and heat. l The canister should not be punctured, broken or burnt even when apparently empty. l Keep all medicines out of the reach of children.

Instruction for use:

Pharmaceutical Precautions / Storage:

  • Inspirol inhaler should be stored below 30oC.
  • The therapeutic effect of this medication may decrease when the canister is cold.
  • Protect from frost, direct sunlight and heat.
  • The canister should not be punctured, broken or burnt even when apparently empty.
  • Keep all medicines out of the reach of children.

Presentation:
Inspirol is available as a metered inhaler sufficient for 200 inhalations.

 
 
 
 
 
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