Product Name

Salmicort
Inhaler
Composition

Each Inhaler Contains:

Salmicort 25/50 mcg.

Salmeterol as xinafoate ............ 25 mcg.
Fluticasone propionate ............ 50 mcg.

Salmicort 25/125 mcg.
Salmeterol as xinafoate ............ 25 mcg.
Fluticasone propionate ........... 125 mcg.

Salmicort 25/250 mcg.
Salmeterol as xinafoate ............ 25 mcg.
Fluticasone propionate .......... 250 mcg.



Pack
1 Inhaler


INDICATION & USAGE

Salmicort is indicated in the regular treatment of asthma where use of a combination product (long-acting beta2 agonist and inhaled corticosteroid) is appropriate:

  • Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2 agonists.
  • Patients already adequately controlled on both inhaled corticosteroids and long acting beta2 agonists.

Note: Salmicort 25/50 mcg strength is not appropriate in adults with severe asthma.


DOSAGE AND ADMINISTRATION

Method of Administration
Salmicort is for oral inhalation only.
Patients should be made aware that Salmicort must be used regularly for optimum benefit, even when asymptomatic.

Recommended Doses:
Adults and adolescents 12 years and older:-
- Two inhalations of 25 mcg Salmeterol and 50 mcg Fluticasone propionate twice daily or

- Two inhalations of 25 mcg Salmeterol and 125 mcg Fluticasone propionate twice daily or

- Two inhalations of 25 mcg Salmeterol and 250 mcg fluticasone propionate twice daily.

Special patient groups:-
There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.

Contra-indications

Salmicort is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Special Warnings and Special Precautions for Use

l As with all inhaled medication containing corticosteroids, Salmicort should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Salmicort should be administered with caution in patients with thyrotoxicosis. Systemic effects may occur with any inhaled corticosteroid particularly, at high doses prescribed for long periods; these effects are less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important; therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained.
l Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A casual relationship between fluticasone propionate and these underlying conditions has not been established.

Interaction with Other Medicinal Products and Other Forms of Interaction

Due to very low plasma concentrations achieved after inhaled dosing, clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) as there is potential for increased systemic exposure to fluticasone propionate.

Use during Pregnancy and Lactation

Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.

There is insufficient expericnce of the use of salmeterol xinafoate and fluticasone propionate in human pregnancy and lactation.

Undesirable Effects

  • As Salmicort contains Salmeterol xinafoate and Fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.
  • Adverse events which have been associated with salmeterol or fluticasone propionate are given below.
  • Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.
  • There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema.There have been reports of oropharyngeal irritation.
  • There have been rare reports of muscle cramps.

Fluticasone propionate:-

  • Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients.
  • Cutaneous hypersensitivity reactions have been reported.
  • Rare cases of facial and oropharyngeal oedema have been reported.
  • Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol / Fluticasone propionate inhaler.
  • As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast and short-acting inhaled bronchodilator. Salmeterol / Fluticasone propionate inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Over dosage:

  • l There is no data available from clinical trials on over dosage with Salmicort; however data on over dosage with both drugs are given below;
  • The sign and symptoms of Salmeterol over dosage are tremor, headache and tachycardia. The preferred antidotes are cardio – selective beta blocking agents, which should be used with cautions in patients with a history of bronchospasm.

Special Precautions for Storage:

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

Instruction for Use / Handling:

Presentation:
Salmicort is available as a metered inhaler sufficient for 120 inhalations

 
 
 
 
 
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