Indications

Asthma:
Sinatide is indicated for the regular treatment of asthma where the use of a combination product (a long-acting β2-agonist and an inhaled corticosteroid) is appropriate in:

Patients who are not adequately controlled with inhaled corticosteroids and an "as needed" inhaled short-acting β2-agonist, or
Patients who are already adequately controlled with both an inhaled corticosteroid and a long-acting β2-agonist.

Pharmacology

Sinatide contains Salmeterol Xinafoate and Fluticasone Propionate.

Salmeterol Xinafoate is a selective, long-acting β2-adrenergic agonist used for the treatment of asthma and other obstructive airway diseases.

Fluticasone Propionate is an inhaled corticosteroid with potent anti-inflammatory activity in the lungs and minimal systemic effects at recommended doses.

Salmeterol helps prevent symptoms, while Fluticasone Propionate improves lung function and reduces asthma exacerbations. The combination provides a convenient treatment option for patients requiring both therapies.

Mechanism of Action

Salmeterol

A selective long-acting (approximately 12-hour) β2-adrenoceptor agonist.
Possesses a long side chain that binds to the exo-site of the receptor, resulting in prolonged bronchodilation.

Fluticasone Propionate

Produces a potent glucocorticoid anti-inflammatory effect within the lungs.
Reduces asthma symptoms and exacerbations without the systemic adverse effects commonly associated with oral corticosteroids.

Dosage

Inhaler

Adults and Adolescents (12 years and older):

2 puffs of Salmeterol 25 mcg + Fluticasone 50 mcg twice daily, or
2 puffs of Salmeterol 25 mcg + Fluticasone 125 mcg twice daily, or
2 puffs of Salmeterol 25 mcg + Fluticasone 250 mcg twice daily.

Children (4-12 years):

2 puffs of Salmeterol 25 mcg + Fluticasone 50 mcg twice daily.

Inhalation Capsule for Asthma

Adults and Adolescents (12 years and older):

50 mcg + 100 mcg twice daily, or
50 mcg + 250 mcg twice daily (morning and evening, approximately 12 hours apart).

The starting dose should be selected according to asthma severity.

Maximum Recommended Dose:

50 mcg + 500 mcg twice daily.

Pediatric Patients (4-11 years):

50 mcg + 100 mcg twice daily (morning and evening, approximately 12 hours apart).

Inhalation Capsule for COPD

Adults:

50 mcg + 250 mcg twice daily (morning and evening, approximately 12 hours apart).

Note: Rinse the mouth with water after each inhalation.

Special Patient Groups

No dosage adjustment is required in elderly patients.
No dosage adjustment is required in patients with renal impairment.
No data are currently available regarding use in patients with hepatic impairment.

Using the Inhaler

This inhaler is a patient-friendly, ready-to-use, and easy-to-grip device. Use according to the instructions provided.

Administration

Correct inhaler technique is essential to ensure adequate drug delivery to the lungs and achieve optimal asthma control.

Steps for Proper Inhaler Use

Remove the cap.
Shake the inhaler vigorously at least six times before each use.
If the inhaler is new or has not been used for one week or longer, shake well and release one test puff into the air.
Exhale fully and comfortably.
Hold the inhaler upright.
Place the mouthpiece between the teeth and close the lips around it.
Begin a slow, deep inhalation through the mouth and simultaneously press the canister firmly to release the medication.
Remove the inhaler from the mouth.
Hold your breath for at least 10 seconds or for as long as comfortable.
If a second puff is prescribed, wait one minute and repeat steps 4 through 9.
Replace the cap after use.
Rinse the mouth thoroughly with water after each treatment.

Checking Technique

Use a mirror periodically while inhaling.
If a white mist is observed escaping from the mouth or inhaler, the technique may be incorrect.
Repeat the procedure carefully if this occurs.

Cleaning Instructions

Clean the inhaler at least once weekly.

Remove the metal canister.
Wash the plastic actuator and cap with warm water.
Do not immerse the metal canister in water.
Allow all parts to dry thoroughly.
Reinsert the canister gently using a twisting motion.
Replace the cap.

Drug Interactions

Both selective and non-selective beta-blockers should generally be avoided in patients with asthma unless their use is essential.
Clinically significant interactions are unlikely because plasma concentrations following inhalation are very low.
Caution should be exercised when administering strong CYP3A4 inhibitors, such as:
- Ketoconazole
- Ritonavir

These agents may increase systemic exposure to Fluticasone Propionate.