Combitide Starhaler
Combitide Starhaler
Sun Pharma
Sun Pharma

Prescribing Information

Salmeterol and Fluticasone Propionate Powder for Inhalation IP

ABOUT COMBITIDE STARHALER

Combitide Starhaler 125 and Combitide Starhaler 250 are novel reduced-dose combination products of the long-acting inhaled beta 2 agonist (LABA), salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate compared to currently available fixed dose combination products with similar action.

Combitide Starhaler 125 and Combitide Starhaler 250 are specially designed plastic devices containing a disk of foil-sealed 60 blisters. Each blister contains 1 complete dose of both medications.

Indications

Combitide Starhaler is indicated in the maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD) in patients aged 4 years and older.

Dosage Form

Powder for Inhalation

Composition

Combitide Starhaler 125,

Each dose contains:
Salmeterol Xinafoate IP equivalent to Salmeterol 25 mcg
Fluticasone Propionate IP 125 mcg
Excipient q.s.

Combitide Starhaler 250,

Each dose contains:
Salmeterol Xinafoate IP equivalent to Salmeterol 25 mcg
Fluticasone Propionate IP 250 mcg
Excipient q.s.

Dosage and Administration

Combitide Starhaler should be administered twice daily (morning and evening approximately 12 hours apart) by the orally inhaled route only. After inhalation, the mouth should be rinsed with water without swallowing.

More frequent administration or a higher number of inhalations (more than 1 inhalation twice daily) of the prescribed strength of Combitide Starhaler is not recommended as some patients are more likely to experience adverse effects with higher doses of salmeterol. Patients using Combitide Starhaler should not use additional long acting beta2 agonists for any reason.

Asthma: If asthma symptoms arise in the period between doses, an inhaled, short acting beta2 agonist should be taken for immediate relief.

For patients aged 12 years and older, the dosage is 1 inhalation twice daily (morning and evening, approximately 12 hours apart). The recommended starting dosages for Combitide Starhaler for patients aged 12 years and older are based upon patientsí asthma severity. For patients not currently on inhaled corticosteroids whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, or patients inadequately controlled on an inhaled corticosteroid, the recommended starting dosage is Combitide Starhaler 125 twice daily. The maximum recommended dosage is Combitide Starhaler 250twice daily.

For all patients it is desirable to titrate to the lowest effective strength after adequate asthma stability is achieved.

Improvement in asthma control following inhaled administration of Combitide Starhaler can occur within 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of Combitide Starhaler with a higher strength may provide additional improvement in asthma control.

If a previously effective dosage regimen of Combitide Starhaler fails to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the current strength of Combitide Starhaler with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.

Chronic Obstructive Pulmonary Disease: The recommended dosage for patients with COPD is 1 inhalation of Combitide Starhaler 125 twice daily (morning and evening, approximately 12 hours apart). If shortness of breath occurs in the period between doses, an inhaled, short acting beta2 agonist should be taken for immediate relief.

Elderly: Clinical studies of salmeterol and fluticasone powder for inhalation for asthma did not include sufficient numbers of patients aged 65 years and older to determine whether older patients with asthma respond differently than younger patients.

As with other products containing beta2 agonists, special caution should be observed when using Combitide Starhaler in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta2-agonists.

Pediatric use: For patients with asthma aged 4 to 11 years who are symptomatic on an inhaled corticosteroid, the dosage is 1 inhalation of Combitide Starhaler 50 twice daily (morning and evening, approximately 12 hours apart). The safety and effectiveness of salmeterol and fluticasone powder for inhalation in children with asthma less than 4 years of age have not been established.

Inhaled corticosteroids, including fluticasone propionate may cause a reduction in growth velocity in children and adolescents. The growth of pediatric patients receiving orally inhaled corticosteroids, including Combitide Starhaler, should be monitored.

If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including Combitide Starhaler, each patient should be titrated to the lowest strength that effectively controls his/her asthma.

Hepatic impairment: Formal pharmacokinetic studies using salmeterol and fluticasone powder for inhalation have not been conducted in patients with hepatic impairment. However, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. Therefore, patients with hepatic disease should be closely monitored.

Renal impairment: Formal pharmacokinetic studies using salmeterol and fluticasone powder for inhalation have not been conducted in patients with renal impairment.

Contra-indications:

Warnings and Precautions

Long acting beta2 adrenergic agonists, such as salmeterol, may increase the risk of asthma related death. Therefore, when treating patients with asthma, physicians should only prescribe salmeterol and fluticasone powder for inhalation for patients not adequately controlled on other asthma controller medications (e.g., low to medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies.

Salmeterol and fluticasone powder for inhalation should not be initiated in patients during rapidly deteriorating or potentially life threatening episodes of asthma or COPD. Salmeterol and fluticasone powder for inhalation has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of salmeterol and fluticasone powder for inhalation in this setting is not appropriate.

Serious acute respiratory events, including fatalities, have been reported when salmeterol, a component of salmeterol and fluticasone powder for inhalation, has been initiated in patients with significantly worsening or acutely deteriorating asthma. In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low pulmonary function, intubation, mechanical ventilation, frequent hospitalizations, previous life threatening acute asthma exacerbations) and in some patients with acutely deteriorating asthma (e.g., patients with significantly increasing symptoms; increasing need for inhaled, short acting beta2 agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function). However, these events have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether salmeterol contributed to these events.

Increasing use of inhaled, short acting beta2 agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of salmeterol and fluticasone powder for inhalation with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 1 inhalation twice daily (morning and evening) of salmeterol and fluticasone powder for inhalation.

Salmeterol and fluticasone powder for inhalation should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short acting beta2 agonist, not salmeterol and fluticasone powder for inhalation, should be used to relieve acute symptoms such as shortness of breath. When prescribing salmeterol and fluticasone powder for inhalation, the physician must also provide the patient with an inhaled, short-acting beta2 agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of salmeterol and fluticasone powder for inhalation.

When beginning treatment with salmeterol and fluticasone powder for inhalation, patients who have been taking oral or inhaled, short acting beta2 agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.

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