Seretide Evohaler DC 50/500 GSK Seretide Dosage Treatment Treatment of Bronchial Asthma, Chronic Pulmonary Block (60 Doses)

Patients still have symptoms while inhaled corticosteroids.

Patients are not fully controlled with spray corticosteroids and agonized drugs β2 short -acting "when needed".

Chronic Obstructive Pulmonary Disease (COPD).

Seretide Accuhaler is indicated in the treatment of gas congestion and reduced drama in patients with chronic obstructive pulmonary disease (COPD) and has been shown to reduce the death rate due to all causes.

Pharmacokology

Mechanism of action

Seretide contains salmeterol and fluticasone propionate have different mechanisms. Salmeterol protects from symptoms, Fluticasone Propionate improves lung function and prevents the disease of the disease. The patient is treating simultaneously with the owner of the beta and corticosteroids inhaled may have a more convenient regimen with Seretide. The mechanism of action of the two substances mentioned below:

salmeterol

Salmeterol is the owner of the beta sympathetic receptor, which has a selective and prolonged effect (12 hours) with a long chain structure connected to the exterior (EXO - site) of the receptor.

fluticasone propionate

At the recommended dose, Fluticasone Propionate inhaled with anti -inflammatory activity of a powerful glucocorticoid in coordination, reducing symptoms and drama of asthma, without any unwanted effects are observed when using corticosteroids.

pharmacokinetics

There is no evidence in animals as well as humans that use the use of salmeterol along with Fluticasone Propionate inhaled, affecting the pharmacokinetics of each component. Therefore, in terms of pharmacokinetics, each component can be considered.

salmeterol

salmeterol acts at the lungs, so the concentration of plasma does not predict the treatment effect. In addition, there is only a limited data on pharmacokinetics of salmeterol because it is difficult to determine the concentration of drugs in plasma due to plasma concentrations in the hemorrhage at the dosage after low inhalation (approximately 200 picograms/ml or lower).

When using Salmeterol regularly, it is possible to detect hydrogen acid in the circulatory system, reaching concentrations in a stable state of about 100 nanogram/ml. These concentrations are 1000 times lower than the concentrations 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 showed that salmeterol was converted quite a lot into α - hydroxysalmeterol (alphatic oxidation) by cytochrome P450 3A4.

fluticasone propionate

absolute bioavailability offluticasone propionate for each existing inhalation device is estimated from comparisons of inhaled and intravenous dynamic data. In healthy adults, absolute bioavailability for FluticasonePropionafe Accuhaler (7.8%), FluticasonePropionate Diskhaler (9.0%), Fluticasone Propionate Evohaler (10.9%), Almeterolfluticasonepropionate Evohaler (5.3%) and Salmeterol - and Salmeterol - FluticasonePropionate Accuhaier (5.6%).

In asthma patients or COPD, observing the body's body concentration of the lower inhaled form. The whole body absorption occurs mainly through the lungs at first quickly 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, leading to oral use less than 1%. When increasing the dose of inhalation, the body absorption also increases linear.

FluticasonePropionate has high plasma clearance coefficient (1150 ml/minute), large distribution volume at a stable stage (about 300 l) and half -life eliminated at the end of about 8 hours. The attachment to plasma protein is relatively high (91%). Fluticasone propionate excreted very quickly from the circulatory system, the owner is converted into a carboxylic acid conversion that is no longer active, because Cytochrome P450 enzyme CYP3A4. The renal removal of Fluticasone Propionate is negligible (less than 0.2%) and less than 5% in the form of metabolites. Should be cautious when used in combination with CYP3A4 inhibitors already know because of the risk of increasing the body level of Fluticasone Propionate.

Main treatment of asthma or exacerbations of bronchial asthma, or COPD when needed actively treatment.

Be cautious when using

deterioration and exacerbations

Seretide Accuhaler should not be started in patients who are in the period of deteriorating quickly or exacerbations of asthma or COPD risks threatening life. Seretide Accuhaler has not been studied in patients in exacerbations of asthma or COPD. Start using Seretide Accuhaler in these cases is inappropriate.

Use too many Seretide Accuhaler and use simultaneously with other Beta 2 receptor anti -receptors.

Seretide Accuhaler should not be used more than the recommended level, at a higher dose than the recommended dose or simultaneous use with other drugs containing laba, as it can lead to overdose. Cardiovascular significance impacts and deaths have been reported related to overdose of drugs that are similar to inhaled sympathetic effects. Patients who are using Seretide Accuhaler should not use other drugs containing laba (for example, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol ) for any reason.

The on -site effect of inhaled corticosteroids

In clinical trials, the development of infections in the mouth and throat by Candida Albicans occurred in patients treated with Seretide Accuhaler. Advice for patients with mouth rinse with water and spit out after inhalation can help reduce the risk of candidiasis in the pharyngeal.

pneumonia

There has been an increase in pneumonia reports in solemnity in patients with COPD using Seretide Accuhaler Seretide doctors should be alert with the likelihood of progressive pneumonia in COPD patients because of the clinical characteristics of pneumonia and COPD's plays that are overlapping.

Patient transfer from body corticosteroid therapy

Because of the ability to decline in adrenal response, patients transferred from oral steroids to Fluticasone Propionate inhaled form, should be treated with special care and regular monitoring of the adrenal skin function regularly.

Increase the adrenal function and inhibit the adrenal glands

There may be effects of systemic corticosteroids such as increased adrenal function and adrenal inhibition (including adrenal gland crisis) may appear in a small amount of patients sensitive to these effects. If such effects occur, Accuhaler seretide should be slowly reduced the dose, in accordance with the accepted process of reducing the dose of systemic corticosteroids, and other treatments to control asthma symptoms should be considered.

Interaction with strong Cytochrome P450 3A4 inhibitors

observed in a drug interactive study when used with Ketoconazole, the body caused an increase in exposure to Serevent. This can lead to extending the QTC range. Caution should be careful when combining strong CYP 3A4 inhibitors (such as ketoconazole) with SEREVENT.

paradoxical bronchospasm and upper respiratory symptoms

Like other inhalers, paradoxical bronchospasms can occur with wheezing immediately after taking the drug. In this case, patients should be treated immediately with a quick and short -acting bronchodilator. Salmeterol - FP Accuhaler should be stopped immediately, patients need to be evaluated and replaced if necessary.

Instant hypersensitivity reactions

Instant hypersensitivity reactions (for example, urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylactic reaction, may occur after using Accuhaler seretide. There have been reports on anaphylactic reaction in patients with serious allergies to milk protein after using inhaled powder containing lactose; Therefore, for patients with severe allergies to milk protein should not use Seretide Accuhaler.

Effects on cardiovascular and central nervous system

excessive Beta - adrenergic stimulation is vowed to cause seizures, angina, hypertension or lower blood pressure, fast heart rate with speed up to 200 beats/minute, arrhythmia, restlessness, headache, tremor, chest drum, nausea, fatigue, fatigue, discomfort and insomnia (see overdose). Therefore, Seretide Accuhaler, like all products containing other sympathetic amines, should be used cautiously in patients with cardiovascular disorders, especially coronary artery failure, arrhythmia, and hypertension.Bone mineral density (Bone Mineral Density (BMD)

Reducing bone density (BMD) is observed in the long -term use of the drug containing inhaled corticosteroids. Because COPD patients often have many risk factors for reducing BMD, BMD evaluation is recommended before starting using Accuhaler seretide and periodic.

Effects on growth

Corticosteroids inhaled inhalation vow to reduce growth rate when used for children. It is necessary to monitor the patient's patients using regular accuhaler seretide (e.g. through height measurement). To minimize the systemic effects of corticosteroids inhaled in the mouth, including Accuhaler seretide, need to adjust the dose of each patient to the lowest dose to effectively control trieu.

Obmtrophy and cataracts

Intrained intrained intraocular pressure, and cataracts that have been reported in asthma and COPD patients after prolonged use of inhaled corticosteroids, including fluticasone propionate, a component of Accuhaler seretide. Therefore, closely monitoring should be guaranteed in patients with vision changes or a history of internal hypertension, glaucoma, and/or cataract.

other warnings and caution

Sudden and increasing deterioration of asthma control is life -threatening and patients need to be examined by a doctor. Corticosteroid dose should be considered. Patients should also be examined again when the seretide Accuhaler dose is using asthma.

Do not stop using Seretide Accuhaler suddenly in asthma patients due to the risk of drama, should reduce the dose slowly under the supervision of the doctor. For patients with COPD, stop treatment may cause symptoms and should be monitored by a doctor.

Should use Seretide Accuhaler cautious in patients with toxic armor.

A decrease in transient serum potassium can occur with all sympathetic medications at a higher dose than the treatment dose. Therefore, caution should be used with seretide accuhaler in patients who can easily lower serum potassium levels.

The ability to drive and operate machinery

There is no specialized research on the effects of Seretide Accuhaler on the above activities, but the pharmacological pharmacology of both pharmacies does not show any effect. Seretide Accuhaler does not affect or affect the ability to drive and operate machinery.

Pregnancy

data in pregnant women is limited. Seretide accuhaler should only be considered for pregnant women if the benefit for mothers is greater than any risk that can be built for the fetus.

Breastfeeding period

Salmeterol and Fluticasone propionate concentrations in plasma after inhaling the treatment dose are very low and so the concentration in human milk is likely to be low. This is proved in nursing animal studies, which determine the concentration of drugs in milk is low. There is no data in human milk.

Should only consider using the drug during breastfeeding if the benefit gives the mother superior to any risk that can be given to the child.

Drug interaction

should avoid using selective beta blockers and not selective in patients unless there is a mandatory reason.

Under normal conditions, due to the strong initial metabolism and high body clearance through cytochrome P450 3A4 intermediaries in the intestine and the liver, the plasma fluticasone propionate concentration is low after inhalation. Therefore, there is little significant drug interactions via Fluticasone Propionate intermediaries.

Should avoid simultaneous use of fluticasone propionate and ritonavir unless the benefits are superior to the risk of corticosteroid side effects.

Be cautious when using strongly strong inhibitors of Cytochrome P450 3A4 (such as ketoconazole) due to the ability to increase systemic exposure to Fluticasone Propionate.

Simultaneous use ketoconazole and Serevent (salmeterol) significantly increases the salmeterol levels in plasma (cmax increases 1.4 times and AUC increases 15 times) and this can cause QT extension.