Seretide Evohaler DC 25/125 GSK treatment for bronchial asthma, chronic pulmonary obstruction (120 doses)

Dosage form Bottle
Specifications Salmeterol, Fluticasone Propionate

Ingredient

Composition information	Content
Salmeterol	25mcg
Fluticasone Propionate	125mcg

Uses

indications

Evohaler DC Seretide DC is indicated in the following cases:

asthma (obstruction of a recovery gas path). Including:

Patients are not fully controlled by spray corticosteroids and Beta 2 shipping owners.

Patients still have symptoms during treatment with inhaled corticosteroids.

Patient is being effectively controlled with a spray corticosteroid maintenance dose and beta 2 -effect for prolonged effect.

Chronic obstructive pulmonary disease (COPD) . And Fluticasone Propionate has different mechanisms of action.

Salmeterol protects from symptoms, Fluticasone Propionate improves lung function and prevents the drama of the disease.

Patients who are treated simultaneously with beta and inhaled corticosteroids may have a more convenient regimen with Seretide. The mechanism of action of the two substances mentioned below:

salmeterol

Salmeterol is the beta 2 sympathetic receptor owner who has a selective and prolonged effect (12 hours) with a long chain that connects to the exterior (EXO-Site) of receptors.

Salmeterol's pharmacological characteristics bring more effective protection for bronchospasm of histamine and create longer bronchodilator effects, lasting for at least 12 hours, compared to the Beta 2 shipping owner with a short -term effect on the proposed dose.

In vitro test shows that Salmeterol is a strong inhibitor and prolonged the release of intermediate substances from moisturizers in the human lungs such as histamine, leukotrien and prostaglandin D2.

In Salmeterol people inhibit the early and late stages for inhaled allergens; The inhibition of this late period lasts more than 30 hours after taking a single dose when the bronchodilator is no longer clear.

A single dose of Salmeterol reduces the increased response of the bronchi. These characteristics indicate that Salmeterol has an additional impact that is not bronchodilator but its full clinical meaning is not clear. This mechanism is different from the anti -inflammatory effect of corticosteroids.

fluticasone propionate

At the recommended dose, Fluticasone Propionate inhaled with strong anti -inflammatory glucocorticoid activity at coordination, reducing the symptoms and drama of asthma, without any disadvantage, such as when using body corticosteroids.

Usually the daily hormone secretion of the adrenal shell remains in the normal range during long -term treatment with Fluticasone Propionate inhaled, even at the highest dose in children and adults.

After moving from other inhaled steroids, the ability to secret hormones daily gradually improves despite using oral steroid interruptions in the past and present, this shows that the adrenal gland function returns to normal when treated with Fluticasone Propionate inhaled.

The adrenal gland reserves also maintain at a normal level throughout the long -term treatment process, measured by the normal increase in stimulating test.

However, any decrease in the adrenal gland reserves remaining from previous treatment may still persist for a significant time and always need to remember this point.

Dynamic pharmacokinetics

There is no evidence in animals as well as humans that use the use of salmeterol along with Fluticasone Propionate inhaled form affecting the pharmacokinetics of each component. Therefore, it is possible to consider the pharmacokinetics of each component in a separate way.

In a cross -to -control study with placebo, to assess interactions between drugs on 15 healthy subjects, simultaneously use Salmeterol (50 microram 2 inhaled daily) and CYP3A4 inhibitors are ketoconazole (400 mg oral/ day) for 7 days, the result is significantly increasing the concentration of plasma salmeterol (CMAX increasing 1.4 times, AUC increases by 15 times).

Do not increase the accumulation of salmeterol when the dose is repeated. There are 3 subjects withdrawal from simultaneous use of salmeterol and ketoconazole due to extending the QTC interval or beating the chest with fast sinus rhythm.

Of the remaining 12 subjects, simultaneously using Salmeterol and Ketoconazole does not cause clinical significance on heart rate, blood potassium or QTC.

salmeterol

Salmeterol acts at the lungs so plasma concentration does not indicate the treatment effect.

In addition, the pharmacokinetic data of Salmeterol is also limited because of the technical difficulties in determining the drug in plasma due to the low inhaled plasma treatment concentration (about 200 picogam/ml or lower).

When using Salmeterol regularly, it is possible to detect hydrogen hydrogen acid in the circulatory system, reaching concentrations in a stable state of about 100 nanogam/ml.

These concentrations are 1000 times lower than those in stable state in toxic studies. No harmful effects when used regularly for a long time (more than 12 months) in patients with respiratory obstruction.

A In vitro study has shown that salmeterol has been converted quite a lot into a-hyperroxysalmeterol (alphatic oxidation) by Cytochrome P450 3A4 (CYP3A4). A study using the repeated dose of salmeterol and erythromycin on healthy volunteers has shown that there are no clinical changes on the pharmacological effect at erythromycin dose of 500 mg, 3 times daily.

However, in a Salmeterol interactive study - ketoconazole has a significant increase in plasma salmeterol levels.

fluticasone propionate

Fluticasone Propionate's absolute bioavailability for each inhaler device is estimated by comparisons of inhaled and intravenous dynamic data.

In healthy adults, absolute estimates for Fluticasone Propionate Accuhaler/Diskus (7.8%), Fluticasone Propionate Diskhaler (9.0%), Fluticasone Propionate Evohaler (10.9%), Salmeterol - Fluticasone Propionate Evohaler (5.3%) and Salmeterol - Fluticasone Propionate Accuhaler/Diskus (5.5%).

In asthma patients or COPD, the body concentration of Fluticasone Propionate is inhaled lower.

The whole body absorption occurs mainly through the lungs at first quickly and then prolonged. The remaining inhalation dose will be swallowed but only contributes to the absorption of the whole body because of the poor water soluble and metabolic ability before being absorbed to oral use under 1%.

When increasing the inhaled dose, the body absorption also increases linear. Fluticasone Propionate has a high plasma clearance coefficient (1150 ml/minute), a large distribution volume at a stable stage (about 300 l) and half -life eliminates the final stage of about 8 hours.

The attachment to a relatively high plasma protein (91%).

Fluticasone propionate excreted very quickly from the circulatory system, mainly converted into carboxylic acid metabolites no longer active, because Cytochrome P450 enzyme CYP3A4.

The renal clearance of Fluticasone Propionate is negligible (less than 0.2%) and less than 5% in the form of metabolites.

Be careful when used in combination with CYP3A4 inhibitors that have known because of the risk of increasing the whole body concentration of Fluticasone Propionate.

Before taking Seretide Evohaler DC 25/125 GSK treatment for bronchial asthma, chronic pulmonary obstruction (120 doses)

How to use

Seretide Evohaler DC only used for inhalation.

It is necessary to tell patients that Evohaler DC seretide must be used regularly to achieve optimal benefits, even without symptoms. Patients need to be examined regularly to the seretide content that the patient is taking is always optimal and only changes according to the doctor's advice.

Instructions for using Seretide Evohaler DC:

Check the spray bottle:

Before using the first time, remove the lid of the tube by gently squeeze the sides of the lid, shake the spray bottle well, keep the spray bottle between the thumb and other fingers with the thumb at the bottom of the bottle, under the suck tube and spray into the air until the index counting is sure that the spray bottle works. If you do not use a spray bottle for 1 week or longer, remove the lid of the tube, shake the spray bottle carefully and spray one into the air. Each time the spray starts, the number on the counter will decrease by 1.

1. Remove the lid of the tube by squeezing the sides of the lid.

2. Check the inner and outside spray, including the tube in the mouth to see if there is any place.

3. Shake the spray bottle carefully to make sure the objects have been removed and the drug ingredients in the spray are mixed.

4. Hold the vertical spray between the thumb and the other fingers, with the position of the thumb at the bottom, the bottom of the suck tube.

5. Breathing out as long as you feel comfortable and then put the tube into your mouth between the teeth and close your lips but do not bite the tube.

6. Immediately after starting inhaled through the mouth, pressing down the top of the spray bottle to release Salmeterol and Fluticasone Propionate while still inhaled and deep.

7. While holding your breath, remove the spray bottle from the mouth and relax your fingers on the top of the spray bottle. Continue to hold your breath until you still feel comfortable.

8. If you continue to spray the second dose, hold the vertical spray and wait about half a minute before repeating the steps from 3 to 7.

9. Then, rinse your mouth with water and spit.

10. Immediately, cover the lid of the spray bottle in the right position. When installed properly, the lid will match the right position. If the lid does not match the right position, rotate the lid in the opposite direction and try again. Do not use too strong force.

Important attention:

Do not perform steps 5, 6 and 7 in a hurry. It is important that you start breathing as slow as possible right before operating the spray. When the 000 counters, you have to replace the new bottle. The counter cannot be reinstalled and is fixed to the bottle. Tell your doctor if you still have any difficulty.

Children:

Children may need help and adults can help control the spray bottle for children. Practice used with children.

Should clean your spray at least once a week.

1. Remove the lid of the tube.

2. Do not take the metal bottle containing the drug from the outer plastic cover.

3. Wipe off the inside and outside of the suck tube and plastic cover with cloth or dry paper towels.

4. Cover the tube in the right position. When installed properly, the lid of the pipe will match the right position. If the lid does not match the right position, rotate the lid in the opposite direction and try again. Do not use too strong force. Do not put metal drugs in water.

Dosage

Dosage for asthma treatment (obstructive gas pathway recovery)

Should adjust to the lowest dose while maintaining the effective control of symptoms. When the symptom control is maintained at the doses of seretide twice daily, the adjustment to the lowest dose effectively may be Seretide 1 time daily.

Should give patients using Seretide form with Fluticasone Propionate content suitable to the severity of the disease.

If the patient is not fully controlled with inhaled corticosteroid therapy, the replacement treatment with seretide with the doses of corticosteroids is equivalent to treatment that can bring improvement in asthma control. In patients that inhaled corticosteroids are simply controlled, replacement treatment with seretide can reduce corticosteroid dose while maintaining asthma control.

Adults and teenagers aged 12 years and older:

Take a 1 -dose of 25/50 or 25/125 or 25/250 once, 2 times daily.

The maximum dose is 50/500, 2 times a day.

Using 1 dose 1 spray 25/50 once, 2 times a day.

Dose for adults is 2 sprays 25/125 to 25/250, 2 times/day.

With a dose of 50/500, 2 times/day, the drug has been shown to reduce the risk of death due to any cause.

Special patient groups

No dose adjustment for elderly patients or patients with renal impairment or liver failure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when using overdose?

Salmeterol overdose signs and symptoms are typical signs of excessive excitation beta 2 adrenergic, including tremor, headache , tachycardia, hypertension systolic and hypotension. In the overdose of the acute Fluticasone Propionate, it can lead to temporary inhibition of the hill - pituitary -adrenal gland.

often do not need emergency treatment due to the adrenal gland function returning to normal for a few days.

If inhaling seretide at higher doses than the allowed dose for a long time can significantly inhibit the adrenal gland shell.

Rarely reports on acute adrenal attacks, mainly occurring in children with higher doses than allowed for a long time (several months or several years), observations that include lower blood glucose associated with reduced consciousness and/ or seizures.

Situations that may cause acute adrenal attacks include trauma, surgery, bacterial infection or any rapid decrease in the inhaling dose of Fluticasone Propionate.

recommend that patients should not use seretide at higher doses than the allowed dose. Regular checking for treatment and reducing the dose to the lowest dose allowed to maintain the disease effectively is very important.

Treatment: There is no specific treatment for the overdose of Salmeterol and Fluticasone Propionate. If an overdose occurs, patients should be treated with appropriate monitoring if needed.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Evohaler DC Seretide DC 25/125 , you may experience unwanted effects (ADR).

Infections and parasites:

Common: mouth and throat candidiasis, pneumonia (in patients with chronic obstructive pulmonary disease - COPD), bronchitis .

Rare: Fungal infection Candida esophagus.

immune system disorders:

Uncommon: Hypersensitivity reactions on the skin, shortness of breath.

Rare: Anaphylaxis reaction, bronchospasm, angioedema (mainly face and mouth - pharyngeal).

Endocrine disorders:

Rare: Cushing syndrome , Cushing phenotype, adrenal failure, slow growth in children and young people, reduce bone mineral density.

Disorders of metabolism and nutrition:

Common: Hypotension.

Less: hyperglycemia.

Mental disorders:

Less: Anxiety, sleep disorders.

rare: Change behavior, including increased activity and stimulation (mainly in children).

Not known: depression , agitated (mainly in children).

Nervous system disorders:

Very common: headache.

less common: Run.

Eye disorders:

Uncommon: cataracts.

rare: glaucoma.

Heart disorders:

Uncommon: beating chest drum, tachycardia, atrial fibrillation, angina.

rare: arrhythmia includes tachycardia on ventricular and outdoor collection.

Respiratory disorders, chest and mediastinum:

Very common: rhinitis.

Common: hoarseness/difficulty pronunciation, throat irritation, sinusitis. rare: paradoxical bronchospasm.

Skin and tissue disorders:

Uncommon: bruises.

Musculoskeletal and connective tissue disorders:

Common: cramps, joint pain, fractures due to trauma, muscle pain.

Data after circulation:

Cardiovascular: arrhythmia (including atrial fibrillation, extra systolic, ventricular tachycardia), hypertension, the fastest tachycardia.

ears, nose and throat: loss of sound, ear pain, face and mouth edema - pharyngeal, sinus nose aches, rhinitis, sore throat, tonsillitis.

Endocrine and metabolism: Cushing syndrome, Cushing phenotype, reducing growth rate in children and young people, osteoporosis.

eyes: cataracts, glaucoma. stomach - intestines: indigestion, dry mouth . liver and pancreatic: abnormalities for liver function tests.

The immune system: instant and slow hypersensitivity reaction, including rare and very rare angiography, bronchial spasms.

Infection and parasitic infection: esophagus Candida.

Bone muscles: back pain, muscle inflammation.

Nervous system: Perception, restlessness.

No classification of organ systems: fever, pale.

Mental: anxiety, excitement, depression. Change behavior, including increased activity and stimulation, has been reported very rare and mainly in children.

Respiratory: asthma, asthma play, angina, cough, shortness of breath, instant bronchospasm, flu, paradoxical bronchospasm, trachea, wheezing, pneumonia, reports on the upper respiratory symptoms of larynx spasm, throat itching, or breathing or suffocating.

Skin: contact dermatitis, bruises, bruises, sensitive dermatitis, itching.

Genital urinary: Dysmenorrhea, irregular menstrual cycle, pelvic inflammatory diseases, vaginal candidiasis, vaginitis, vulva - vaginal inflammation.

Instructions for handling ADR: notify the doctor unwanted effects when taking the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Contraindicated seretide for patients with a history of hypersensitivity to any ingredients of the drug.

Initial treatment of asthma or exacerbations of bronchial asthma, COPD when needed active treatment.

Be cautious when using

deterioration and exacerbations: Evohaler DC Seretide should not be started in patients who are in the period of deteriorating the disease quickly or acute asthma or COPD is life -threatening.

Seretide Evohaler DC is not a cutting drug used to reduce acute symptoms, but in this case, a quick and short -acting bronchodilator.

Use too much Evohaler DC seretide and use simultaneously with other prolonged beta 2 receptors: Evohaler DC seretide should not be used more than the recommendation level.

Patients who are using Evohaler Seretide DC should not use other drugs containing laba (for example: salmeterol, formsterol fumarate, arformsterol tartrate, indacaterol ) for any reason.

The on -site effect of inhaled corticosteroids:

Development of local infections in the mouth and throat caused by Candida Albicans occurred in patients treated with Evohaler DC Seretide. Can be stopped.

pneumonia:

There has been an increase in pneumonia reports in studies on COPD patients using seretide.

Convert from body corticosteroid treatment to seretide:

Because the ability to decrease in adrenal gland response may occur, patients who move from oral steroid to Fluticasone Propionate inhaled should be treated carefully and regularly monitor the adrenal function regularly. Steroid indicates that patients may need steroid supplements during stress.

Inhibition of adrenal glands and cushing status due to drugs:

Interaction with strong Cytochrome P450 3A4:

In a drug interactive study when used with the whole Ketoconazole, observing an increase in exposure to seretide. This can lead to the extension of QTC.

paradoxical bronchospasm and upper respiratory symptoms:

Like other inhalers, paradoxical bronchospasm can occur with increased wheezing symptoms immediately after taking the drug.

Instant hypersensitivity reactions:

Instant hypersensitivity reactions (for example: urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylactic reaction, may occur after using Evohaler DC seretide.

Effects on cardiovascular and central nervous system:

excessive beta-adrenergic stimulation can cause seizures, angina, hypertension or hypotension, tachycardia with a frequency of up to 200 beats/min, arrhythmia, restlessness, headache, tremor, chest drum, nausea, fatigue, uncomfortable and insomnia. Other, should be used carefully in patients with cardiovascular disorders, especially coronary artery failure, arrhythmia, and hypertension.

Salmeterol, a component of Evohaler DC seretide, can cause significant clinical significance on some cardiovascular patients expressed by heart rate, blood pressure, and/ or other symptoms. Although such effects are not common after using salmeterol at the recommended dose, if they occur, may need to stop using the drug.

Bone mineral density (Bone Mineral Density (BMD):

Reduce bone density (BMD) has been observed in patients using long -term drugs containing inhaled corticosteroids. Oral convulsions, corticosteroids) should be monitored and treated appropriately. If the BMD is significantly reduced, the Evohaler DC seretide is still considered an important medicine for patient COPD treatment, using the drug to treat or prevent osteoporosis, so it is carefully considered.

Effect on growth:

corticosteroid inhaled inhalation may cause reduction in children's growth when used for children. of each patient to the lowest dose effectively controlling million.

Obmtrophy and cataract:

has been reported in patients with asthma and COPD after prolonged use of inhaled corticosteroids, including Fluticasone Propionate, a component of Evohaler DC seretide.

The ability to drive and operate machinery

No research.

However, it should be noted that the unwanted effects of the drug include headache, cramps, joint pain, fractures due to trauma, muscle pain.

In addition, the drug may also have unwanted effects such as tremor, anxiety, sleep disorders, shortness of breath, face and mouth edema - pharyngeal, bronchospasm, bronchial bronze, tachycardia, atrial fibrillation and angina.

Pregnancy

There is no data on human fertility. Seretide should only be considered for pregnant women if the benefit for mothers is greater than any risk that may occur for the fetus.

The period of breastfeeding

should only consider using the drug during breastfeeding if the benefit gives the mother superior to any risk that may have for the child.

Drug interaction

drug interactions may affect the activity of the drug or cause side effects. Should notify the doctor or pharmacist a list of drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

Avoid using both selective and non -selective beta inhibitors unless there is a mandatory reason.

Under normal conditions, due to the initial metabolism and high body clearance through cytochrome P450 3A4 intermediaries in the intestine and liver, the concentration of fluticasone propionate in plasma is low after the inhalation. Therefore, it is less likely to have clinical drug interactions via Fluticasone Propionate.

A study of drug interaction in healthy people shows that Ritonavir (strong inhibitor of Cytochrome P450 3A4) can cause increased plasma fluticasone propionate levels, resulting in a significant reduction in serum cortisol levels.

During the use of the drug after the drug was circulated, there was a report on clinical drug interaction in patients using Fluticasone Propionate inhaled through the nose or mouth and Ritonavir leading to the systemic effect of corticosteroids including cushing syndrome and adrenal inhibition. Therefore, avoid simultaneous use of Fluticasone Propionate and Ritonavir unless the benefits of superior treatment have a whole body side effect of corticosteroids.

Studies show that other Cytochrome P450 3A4 inhibitors increase omromycin negligible and slightly increased (ketoconazole) fluticasone propionate body levels without significantly reducing the concentration of cortisol in serum. However, be cautious when using a combination of strong Cytochrome P450 3A4 inhibitors (such as ketoconazole) due to the ability to increase the level of fluticasone propionate.

Seretide Evohaler DC should be used very carefully in patients who are being treated with imaos or 3 -round antidepressants, or have just stopped using within 2 weeks of the above drugs, because of the impact of salmeterol, a component of Evohaler DC seretide, on the blood vessel system can increase sharply by these factors.

Change ECG and/ or reduce blood potassium due to the use of potassium diuretics (such as diuretics or thiazide) may become worse because beta -shunned drugs, such as salmeterol, should be cautious when using simultaneously Evohaler DC Seretide with potassium diuretics.

Storage

Close the lid of the tube definitely and push in the right position.

Seretide Evohaler DC should be stored no more than 30 ° C. Avoid freezing and direct sunlight.

Like most of the inhalers in other pressure tanks, the treatment effect of the drug may be reduced when the bottle is cold. Do not puncture, break or burn the jar even when the vessel is empty.

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