Seroflo Inhaler

Instruction for Use

Tradename: Seroflo Inhaler

Dosage Form

Aerosol for inhalation dose
25/50 mcg / dose, 25/125 mg / dose, 25 / 250mkg / dose

Composition

One dose of Seroflo Inhaler contains:
Active substance:

• Salmeterol 0.025 mg 0.025 mg 0.025 mg;
• Fluticasone propionate 0.050 mg 0.125 mg 0.250 mg;
• Additive agents: ethanol, lecithin, tetrafluoroethane (HFA – 134a).

Description

White homogeneous suspension in liquefied propellant placed in aerosol pressurized tube.

Pharmacotherapeutic Group

Sympathomimetics in combination with other preparations for asthma and obstructive airway diseases treatment.
ATC code R03AK06

Pharmacokinetics

Simultaneous salmeterol introduction and inhaled fluticasone propionate do not affect pharmacokinetics of each mentioned substances.
Salmeterol
Data on salmeterol pharmacokinetics is limited because it is technically difficult to determine preparation concentration in plasma (200 mg / ml or less) after inhalation in therapeutical doses. With regular use of inhaled salmeterol xinafoate in systemic circulation it is determined hydroxide isonaphthoic acid in concentrations of 100 ng / mL. These concentrations are about 1000 times low that steady state concentrations identified during toxicological studies.
Fluticasone Propionate
After inhalation absolute fluticasone propionate bioavailability is 10-30% depending on drug delivery system. In patients with reversible obstructive and chronic obstructive pulmonary disease (COPD) and asthma are observed considerably lower systemic exposure of fluticasone propionate inhalation administration.

Systemic absorption is carried out preferably in lungs. Part of inhaled dose may be swallowed but its systemic effect is minimal due to intensive metabolism at first penetration in liver. Fluticasone propionate bioavailability at oral administration is less than 1%. There is a direct relationship between quantity of inhaled dose and systemic action of fluticasone propionate.

Fluticasone propionate has plasmatic clearance (1150 ml / min) and the largest volume of distribution (about 300 l). Grade of proteins’ binding with high blood plasma is high (91%).

Fluticasone propionate is rapidly eliminated from systemic blood flow, mainly due to biotransformation of non-active derivative using cytochrome CYP3A4 enzyme system R450. It is required to be careful while appointing fluticasone propionate and CYP3A4 enzyme inhibitors, as a systemic action of fluticasone propionate may be increased.

The half-life lasts 8 hours. Renal clearance of fluticasone propionate is negligible (less than 0,2%), and less than 5% metabolites are excreted with urine.

Pharmacodynamics

It is combined preparation for inhalation. Seroflo inhaler composition comprises of two active components: salmeterol fluticasone propionate which have different mechanisms of action. Seroflo inhalers provide more convenient regimen for patients who simultaneously receive medications of b-agonists adrenergic receptors and inhaled glucocorticosteroids (GCS) groups.

Salmeterol

Salmeterol is selective b2-adrenergic receptor agonist with long action duration (12 hours). Salmeterol molecule has a long side chain, which binds to outer receptor area. Salmeterol is effective in preventing histamine-induced bronchospasm caused by hyperreactivity bronchodilation. It inhibits mediators release from lung tissue of mast cells, such as histamine, leukotriene and prostaglandin D2.
It suppresses early and late stage of inhaled allergens reactions. After a single dose suppression is happened after 30 hours.

Fluticasone Propionate

Fluticasone propionate related to corticosteroids group of topical inhalation administration of recommended doses provides anti-inflammatory effects in lungs that leads to expressed symptoms reduction and decreasing asthma and COPD exacerbations accompanied by airway obstruction. Fluticasone propionatane action is accompanied by side effects, characteristic for Valium of systemic action.

With prolonged use of Seroflo Inhaler maximum inhaled dose, daily secretion of adrenal glands hormones remains within normal range for adults and children. After patients transplantation receiving other inhaled corticosteroids, secretion of adrenal glands hormones is gradually restored by donators despite previous GCS. This indicates renewal of adrenal function on inhaled background fluticasone propionate application. With prolonged use of fluticasone propionate adrenal cortex function also remained within normal range, test results are confirmed stimulus. However, it should be borne in mind that residual adrenal reserve reduction may persist during long after therapy.

Indications

Basic therapy of diseases is accompanied by reversible airway obstruction (including asthma in children and adults), when it is necessary appointment of combination therapy (bronchodilator and glucocorticosteroids preparation for inhalation):

• In patients receiving maintenance therapy β2-agonists and long-acting inhaled glucocorticosteroids;
• In patients which were observed persisting on background of glucocorticosteroids symptoms;
• In patients who regularly apply bronchodilators, which shows additional therapy for inhaled corticosteroids;
• Maintenance therapy in case of asthma and chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Dosing and Administration

SerofloInhaler online is intended only for inhalation.
Patients should be made aware that for maximum effect Seroflo should be used regularly, even in the absence of symptoms. Buy Seroflo via Asthma Inhalers Online and be sure this is the most reasonable way to purchase medication because you will save money and get high quality inhaler online.
Patients should be regularly examined by doctor in order to maintain optimum dose of Seroflo inhaler.

Reversible Airway Obstruction

The initial dose of Seroflo should be defined on basis of fluticasone propionate dose, which is recommended for this disorder treatment.
Then, initial dose should be reduced gradually to minimum effective dose.
Adults and adolescents aged 12 years and over:

1. two inhalations of 25 and 50 micrograms salmeterol twice daily;
2. or two inhalations of 25 micrograms salmeterol and 125mkg fluticasone propionate twice a day;
3. or two inhalations of 25 micrograms of salmeterol and 250mkg fluticasone propionate twice daily.

Children from 4 years to 12 years:
two inhalations 25 and 50 micrograms salmeterol twice daily.

No data on Seroflo use in children up to 4 years was presented.
Chronic obstructive pulmonary disease:
For adult patients maximal dose is 2 inhalations (25 micrograms and 250 micrograms of salmeterol) twice a day.
Certain groups of patients: there is no necessity for adjust or elderly patients to adhere dose or people with renal and hepatic function should not adjust the dose.

Instructions for Use

Seroflo is considered as inhaler.

Testing Seroflo Inhaler Online
Before the first use or after long (week or more) inhaler suspension remove mouthpiece cap by lightly pressing on cap side, carefully shake inhaler and make one spray in air to ensure its adequate operation.

How to Use the Inhaler:

• Remove cap on mouthpiece by lightly pressing on cap sides and check mouthpiece inside and outside.
• Carefully shake inhaler.
• Take inhaler upright between your thumb and other fingers, placing your thumb on the base, below mouthpiece.
• Exhale as deeply as possible, then place mouthpiece in your mouth between your teeth, having closed lips around, but not biting.
• Immediately after start of inhalation through mouth, press top of inhaler to carry out spraying and breathing deeply and slowly.
• Holding your breath, take inhaler out and release your finger from top of inhaler. Continue to detain breathing as deeply as possible.
• For implementation of second spraying it is necessary to turn inhaler upright and after about 30 seconds, repeat steps 2 – 6.
• The cap is placed on mouthpiece clicking into position.

Important: Do not rush when performing steps 4, 5 and 6. It is important to start to breathe as slowly as possible just before spraying product. The first few times you may test in front of a mirror.
If your doctor has given other instructions inhalation operation should be guided by them. If there are any troubles please inform your doctor.

Children

Young children may need adult assistance when using Seroflo inhaler or some other. You should ask child to breathe inhaled spray immediately after child starts to breathe in. You may practice this technique together with him. Older children or people with weak hands should hold inhaler with both hands. Place two pointer fingers to top of inhaler and both thumbs – to base beneath mouthpiece.

Cleaning

• The inhaler should be cleaned at least once a week.
• Take off the cap of the mouthpiece.
• Do not remove canister from plastic case.
• Rub inside and outside of mouthpiece, plastic casing with a dry cloth or tissue.
• Put mouthpiece cap in place.
• Do not place metal cans into water.

Seroflo Side Effects

• hoarseness;
• irritation of oral, cavity and pharynx mucous membrane;
• candidiasis of oral cavity and pharynx;
• cutaneous hypersensitivity reactions;
• rash;
• angioedema;
• edema (swelling of face, and especially oropharynx);
• anaphylactic reactions;
• paradoxical bronchospasm;
• dyspnea;
• cushing’s syndrome;
• decrease in adrenal glands functions;
• growth retardation in children;
• decrease in bone mineralization;
• cataract;
• glaucoma;
• hyperglycemia;
• headache;
• tremor;
• palpitations;
• cardiac arrhythmias;
• atrial fibrillation;
• supraventricular tachycardia;
• anxiety;
• sleep disturbance, including hyperactivity and irritability (especially in children);
• muscle cramps;
• arthralgia.

Contraindications

• Hypersensitivity to any drug components;
• Children under 4 years.

Drug Interactions

Avoid the use of non-selective beta-blockers, except when it is really necessary and justified.

Since inhalation contain fluticasone propionate concentration in plasma is very low, adverse interactions with other drugs.

Ritonavir (cytochrome P450 3A4 inhibitor) can significantly increase concentration of fluticasone propionate in blood plasma, resulting in markedly reduced cortisol concentrations in serum that’s why it is necessary exclude simultaneous use of ritonavir and Seroflo inhaler.

Other inhibitors of cytochrome P450 3A4 (erythromycin, ketoconazole) cause increase in systemic Seroflo use impact without significant reduction in serum cortisol concentrations.

Special Instructions

Treatment of reversible obstructive respiratory disease and asthma should be carried out sequentially; patient response should be estimated by clinical data and pulmonary function tests.

Seroflo of long action for diseases, but not for cupping. For relief it is necessary to apply short-acting bronchodilator (eg salbutamol) that patients are advised by doctors.

Increased use bronchodilator action relieves asthma symptoms and indicates asthma exacerbation.

Sudden and progressive asthma exacerbation may pose threat to patient’s life, in so similar situations it is necessary to review and decide about treatment plan as corticosteroids dose increase. Then if Seroflo administered dose is not provided sufficient diseases’ control treatment plan should be reviewed and, there is need to assign additional corticosteroids when infection development is observed.

Seroflo treatment should not be stopped abruptly at patients with asthma due to exacerbation risk, treatment should be supervised by your doctor. For patients with chronic obstructive pulmonary disease treatment withdrawal may be associated with systemic decompensation and should be conducted under medical supervision.

As with other inhaled medications containing corticosteroids, Seroflo inhaler is necessary to be prescribed with caution in case of active or latent pulmonary tuberculosis.

Seroflo inhalers online should be used with caution in case of thyrotoxicosis.

If you have voice hoarseness and oral cavity and pharynx candidiasis it is recommended after inhalation to rinse the mouth and throat.
In case of candidiasis anti-fungal local preparations application is possible, without stopping Seroflo application.

Inhaled medicines may cause reverse bronchospasm that needs to be arrested immediately by means of high-speed inhaled bronchodilator. Seroflo should be immediately withdrawn, patient survey is carried out and an alternative therapy should be appointed.

In sympathomimetic agents application, particularly at doses higher than those recommended systolic pressure may increase. Seroflo inhaler should be therefore used with caution by patients with cardiovascular system disorders.

Seroflo is prescribed with caution if there is predisposition to serum potassium levels decrease.
Any inhaled corticosteroids may cause systemic effects, especially when high doses long-acting bronhodilators are taken, but likelihood of their development is much lower than when GCS is applied. Possible systemic effects include Cushing’s syndrome, adrenal function decline, growth retardation in children and adolescents, bone mineralization decrease, cataract and glaucoma. It is therefore particularly important that to achieve therapeutic effect dose inhaled corticosteroids were reduced to minimal effective dose of controlling disease.

For some patients, it may be defined individual hypersensitivity to inhaled corticosteroids.
It is recommended to regularly monitor children growth receiving prolonged treatment with inhaled corticosteroids.
In connection with possible adrenal gland insufficiency you should be particularly careful and regular monitor indicators of adrenocortical function when transferring patients taking corticosteroids by mouth, for fluticasone propionate treatment for inhalation.

In appointment of inhaled fluticasone propionate abolition of systemic corticosteroids should be gradual and patients are recommended to carry a special card indicating that they may demand GCS under different stress situations.

Reported rarely glucose level increase in blood, so Seroflo inhaler should be used with caution in with diabetes.

Pregnancy and Lactation

Use of drug during pregnancy, lactation are justified only if expected benefit for mother exceeds any possible risk to fetus or infant.
There may be observed side effects. Make sure to be used with caution when driving a car or dangerous machinery.

Overdose

There is no information on overdose caused by Seroflo use.
There is data on overdose of separate cases of salmeterol and fluticasone propionate application.
Symptoms caused by Salmeterol: tremor, headache, tachycardia, decreased systolic pressure and hyperkalemia.
Inhaled fluticasone propionate in doses exceeding recommended may lead to temporary hypothalamo-pituitary-adrenal axis function worsening. This phenomenon is not required immediate intervention because adrenal function recovers during few days.
If excess of recommended doses is carried out for a long period, and adrenal function suppression can occur. It is recommended to monitor backup of adrenal gland function.
Treatment: Best antidotes are considered to be beta1-blockers, but they should be used with caution not to provoke bronchospasm in patients with such a predisposition. If Seroflo inhaler should be withdrawn because of salmeterol overdose, patient should be prescribed as replacement steroid therapy.

Storage Conditions

Keep out of the reach of children! Expiry data is 3 years. It may be bought via Asthma Inhalers Online.