Salflu

Instructions for use of the drug (for patients)

SALFLU 125  dosed aerosol for inhalation
SALFLU 125

SALFLU 250  dosed aerosol for inhalation
SALFLU 250  

International non-proprietary name:Salmeterol + Fluticasone propionate

Composition 
Active ingredient: 1 dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 mcg or 250 mcg of fluticasone propionate.
Auxiliary substances:sorbitan trioleate, ethanol (pure alcohol), propellant HFA 134a (1,1,1,2-Tetrafluoroethane).

Description
It is a white powder.

Pharmacotherapeutic group
Selective long-acting β-adrenoceptor stimulants, Respiratory corticosteroids.

ATC code:R03AK06.

Pharmacological properties
Salmeterol xinafoate is a selective, long-acting β2-agonist used in the treatment of asthma and other forms of diffuse airway obstruction. Fluticasone propionate is a corticosteroid with primarily glucocorticoid activity. Fluticasone propionate is said to act locally in the lungs without causing systemic effects at usual doses.
Salmeterol protects against symptoms, Fluticasone propionate improves lung function and prevents exacerbation of the disease. This drug may offer a more favorable regimen for patients receiving concomitant therapy with β-agonists and inhaled corticosteroids. The respective mechanisms of action of both drugs are discussed below:
Salmeterol
Salmeterol is a selective, long-acting (12 hours) β2-adrenergic receptor agonist with a long side chain that binds to the exosite of the receptor.
Fluticasone propionate
Inhaled fluticasone propionate at recommended doses has a potent anti-inflammatory glucocorticoid effect in the lungs, resulting in reduced asthma symptoms and exacerbations without the side effects seen with systemic corticosteroids.

Instructions for use
Salflu is used as a combination drug (a long-acting β2-agonist and an inhaled corticosteroid) for the regular treatment of asthma. 

Contraindications 
It is contraindicated in patients with sensitivity to any component of the preparation.

Special instructions and precautions
Consideration should be given to the use of adjunctive corticosteroid therapy and the inclusion of antibiotics when infection is present. As with all inhaled corticosteroids, this drug should be used with caution in patients with active or inactive pulmonary tuberculosis. This drug should be given with caution to patients with thyrotoxicosis 

Interaction with other drugs 
Both nonselective and selective beta-blockers should be avoided in asthmatic patients unless there is a compelling reason to use them. Due to the very low plasma concentrations achieved after inhalation, clinically significant drug interactions are unlikely. Caution should be exercised during concomitant use of known strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir), as there is a potential for increased systemic exposure to fluticasone propionate.

Use during pregnancy and lactation 
The use of drugs during pregnancy and lactation should be considered only if the expected benefit to the mother is higher than the possible risk to the fetus or child. There is insufficient human experience with the use of salmeterol xinafoate and fluticasone propionate during pregnancy and lactation.
Pregnancy
There are no adequate and well-controlled studies in pregnant women and lactating mothers.
Lactation
There is no information on breastfeeding. It should not be used during lactation.
Fertility
There is no information on the effect of this product on fertility in humans.

Effects on the ability to drive vehicles and other potentially dangerous mechanisms
Patients experiencing drowsiness should avoid driving, engaging in potentially hazardous activities, or operating machinery.
Patients who intend to drive, engage in potentially hazardous activities or operate machinery should not exceed the recommended dose and should take into account their reaction to the drug. Concomitant use with alcohol or other CNS depressants in susceptible patients may additionally cause decreased alertness and impaired performance, although cetirizine does not increase the effects of alcohol (blood level 0.5 g/l).
Be careful when driving a vehicle or working with machinery.

Method of use and dosages
Adults and adolescents 12 years of age and older: two inhalations of Salflu 125 HFA twice daily or two inhalations of Salflu 250 HFA twice daily
Elderly patients
Dose adjustment is not required.
Patients with kidney and liver failure:Patients with severe renal impairment were exempted from clinical trials. Experience with the use of Salflu in individuals with any degree of hepatic insufficiency is limited.
Or as directed by a doctor
Using an inhaler seems simple, but most patients do not know how to use it properly. If the inhaler is used incorrectly, less medicine can reach the lungs. Correct and regular use of your inhaler will prevent or reduce the severity of asthma attacks.
The following simple steps can help you use your inhaler effectively (according to the National Asthma Guidelines for Physicians, published by the Asthma Association).

Side effects
Because this drug contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each combination can be expected. No additional adverse events have been reported following simultaneous administration of the two compounds. Side effects associated with Salmeterol or Fluticasone Propionate are listed below.
Salmeterol
Pharmacological side effects of treatment with β2-agonists, such as tremors, subjective palpitations, and headache, have been reported, but they are transient and tend to subside with regular treatment. Cardiac arrhythmias (pulsatile arrhythmia, supraventricular tachycardia, and ecstasy) may occur in usually sensitive patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, purpura, and angioedema, as well as mouth and throat irritation. There is rare information about muscle spasms.
Fluticasone propionate
Some patients may have hoarseness and candidiasis (mucosal infection) in the mouth and throat. Skin sensitivity reactions have been observed. Rare cases of swelling of the face, mouth and throat have been reported. Both hoarseness and candidiasis can be relieved by gargling with water after using salmeterol/fluticasone propionate inhaler.

Overdose
There is no specific information on overdose of Salflu 125 HFA or 250 HFA inhalers.
Treatment
Medication overuse headache:Detoxification may be necessary.

Release form
120 doses in aluminum canister equipped with metering valve and transmitter. 1 canister is packed in a cardboard box with a leaflet.

Storage conditions
Store at a temperature below 25°C, protected from light and moisture and out of the reach of children.

Shelf life
2 years.
Do not use after the expiration date.

Condition of release from pharmacy
It is released on the basis of a prescription.

Manufacturer
The ACME Laboratories Ltd., Bangladesh.
Dhulivita, Dhamrai, Dhaka, Bangladesh.
Phone: +88-02-8091051-3.
Email: export@acmeglobal.com

Holder of registration card
LN company LLC, Republic of Azerbaijan.
Khirdalan city, Baku-Guba highway, 12th km, building 2, No. 3, Republic of Azerbaijan.