Seretide drug Uses, Dosage, Side Effects, Precautions & Warnings

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seretide drug class >>Generic drug of the therapeutic class: Pulmonology
active ingredients: Fluticasone , Salmeterol

Important to know about Seretide ?

Asthma.

You must use Seretide every day as directed by your doctor. This will properly control your asthma.

Seretide prevents the occurrence of shortness and hissing. It does not work when you already have a shortness of breath or hissing sound. In these cases, you should use your fast-acting, short-acting bronchodilator, such as salbutamol.

What is Seretide used for and indication ?

What is Seretide used for

Seretide and Seretide Diskus:

Asthma:

1. Continuous treatment of asthma, in situations where the inhaled administration of a combination corticosteroid and long-acting ß-2 agonist bronchodilator is warranted:
2. in patients inadequately controlled by inhaled corticosteroid therapy and a short-acting ß-2 agonist bronchodilator by inhalation “on demand”,
   or
3. in patients controlled by the administration of inhaled corticosteroids associated with continuous therapy with inhaled long-acting ß-2 agonist.

Note :

• Seretide Inhalation Suspension 50 μg / 25 μg / dose and Seretide Diskus 100 μg / 50 μg / dose are not suitable for the treatment of severe adult and pediatric asthma.

Seretide Diskus at 500 μg / 50 μg / dose:

Chronic Obstructive Pulmonary Disease (COPD):

• Symptomatic treatment of COPD in patients whose FEV1 (measured before bronchodilator administration) is less than 60% of the theoretical value, and who has a history of repeated exacerbations and significant symptoms despite continuous bronchodilator therapy.

seretide dosage 250/50/25

Inhaled route only.

• The patient should be informed that to observe an optimal treatment effect, Seretide should be administered daily even when symptoms are improved.
• The doctor should regularly check that the prescribed dosage of Seretide is well adapted to the clinical condition of the patient. It will only be changed with medical advice.
• The minimum effective dosage should always be sought. When symptoms are controlled by the lowest recommended dose twice daily, then inhaled corticosteroid alone will be considered.
• It may also be considered to reduce the dosage of Seretide once a day, if the physician considers it necessary to maintain a long-acting beta-2 mimetic treatment for symptom control.
• The time of taking Seretide will then depend on the frequency of appearance of symptoms. If the predominance of symptoms is nocturnal, Seretide will be given in the evening; if it is diurnal,

The dosage of Seretide that will be prescribed to the patient should correspond to the dose of fluticasone propionate adapted to the severity of his asthma. It should be emphasized that Seretide 50 micrograms / 25 micrograms / dose is not suitable for the treatment of severe adult and pediatric asthma. In asthmatics, fluticasone propionate (FP) is as effective as other inhaled corticosteroids at approximately half the daily dose. For example, administered by inhalation, 100 micrograms of fluticasone propionate are approximately equivalent to 200 micrograms of beclometasone dipropionate (BDP) (CFC formulation) or budesonide.

Recommended dosage:

Asthma

seretide dosage Adults and Teens 12 years and older:

• Two inhalations of 50 μg of fluticasone propionate and 25 μg of salmeterol twice daily..or
• Two inhalations of 125 μg fluticasone propionate and 25 μg salmeterol 2 times daily..or
• Two inhalations of 250 μg of fluticasone propionate and 25 μg of salmeterol twice daily..or

Seretide may be considered as an initiation therapy for a short trial period in adults and adolescents with moderate persistent asthma (defined by the presence of daytime symptoms, daily use of a short-term bronchodilator).

action in symptomatic relief treatment and moderate to severe bronchial obstruction) and in whom it appears essential to obtain a rapid control of asthma. In these cases, the recommended initial dose is two inhalations of 25 micrograms of salmeterol and 50 micrograms of fluticasone propionate, twice daily.

When control of asthma is achieved, treatment should be re-evaluated to consider reducing treatment to inhaled corticosteroid alone. It is important that patients are followed regularly during the treatment reduction period.

There is no clear benefit of Seretide for initiation therapy compared with fluticasone propionate inhaled alone when 1 to 2 of the severity criteria discussed above are not present. In the majority of cases, the first-line treatment remains the administration of inhaled corticosteroids alone. Seretide is not intended for first-line treatment of mild asthma. The 50 microgram / 25 microgram Seretide is not suitable for adults and children with severe asthma; the appropriate dose of inhaled corticosteroids should be adjusted individually before

Children 4 years old and over:

• Two inhalations of 50 μg of fluticasone propionate and 25 μg of salmeterol twice daily.

In children, the recommended maximum dose of inhaled fluticasone propionate is 100 micrograms twice daily.

No data are available on the use of Seretide in children under 4 years of age.

Children under 12 may have difficulty coordinating the triggering of the inhalation device with their inspiration. The use of an inhalation chamber with Seretide suspension for inhalation in a pressurized bottle is recommended in patients who have or may have difficulty coordinating their inspiration with the triggering of the inhalation device. A recent clinical study showed that pediatric patients who used an inhalation chamber had similar exposure to adults who did not use an inhalation chamber and pediatric patients who had used a Diskus device. confirming that the inhalation chamber compensates for a poor technique of

Volumatic or AeroChamber Plus inhalation chambers can be used. Limited data has shown increased systemic exposure when inhaled using the AeroChamber Plus inhalation chamber compared to the Volumatic inhalation chamber (see Warnings and Precautions section ). .

Patients should be informed of the procedures for the use and maintenance of their inhalation device and their inhalation chamber. It should also be checked that the patient is using the inhalation chamber properly so that the product is delivered optimally to the lung. Whenever possible, patients should continue to use the same type of inhalation chamber, as switching from one chamber to another may vary the dose of inhaled product (see Warnings and Precautions section). employment ). When introducing or changing the inhalation chamber, the minimum effective dose should always be sought.

Populations at risk:

There is no need to adjust doses in elderly or renally impaired patients. No data are available on the use of Seretide in patients with hepatic impairment.

seretide how to use

1. Patients should be informed about how the metered dose inhaler works (see leaflet).
2. During inhalation, the patient should preferably sit or stand. The aerosol has been designed for use in a vertical position.

Verification of the operation of the device:

Before first use, in order to check the proper functioning of the device, release puffs of product in the air until the meter indicates 120 doses. For this, after having removed the cap of the mouthpiece by exerting a pressure on each side, shake the inhaler well, hold the device between the fingers by positioning the thumb at the base of the device under the mouthpiece, then press on the cartridge. Shake the device right before activating to release each puff. If the device has not been used for a week or more, remove the cap from the mouthpiece, the patient should shake the inhaler and release two puffs of product into the air. The number of doses released is counted each time the device is triggered.

Use of the aerosol:

1. The patient should remove the cap from the mouthpiece by exerting pressure on each side.
2. The patient should check that there is no foreign body inside or outside the device, including the mouthpiece, to ensure that it is clean.
3. The patient should shake the aerosol well to remove any foreign matter and ensure mixing of the suspension components in the vial.
4. The patient should hold the aerosol straight between the fingers and thumb with his thumb at the base, under the mouthpiece.
5. The patient should exhale as much as possible then place the mouthpiece in his mouth between the teeth and close the lips around. Tell the patient that they should not bite the mouthpiece.
6. Right after starting to inhale through the device through the device, the patient should firmly press down on the top of the metered dose inhaler to release the product, while inhaling regularly and deeply.
7.  While holding his breath, the patient will remove the inhaler from his mouth. The patient will hold his breath as much as possible.
8. If the patient is to take a second inhalation, he / she should keep the MDI straight and wait about 30 seconds before repeating steps 3 to 7.
9. The patient should replace the cap on the mouthpiece immediately afterwards by firmly pressing the cap, making sure that it is in the correct position .. There is no need to exert a significant force to replace the cap on the mouthpiece, a simple “click” is enough to ensure the closure of the mouthpiece by the cap.

IMPORTANT

1. Steps 5, 6 and 7 should not be performed in a hurry. It is important for the patient to start breathing as slowly as possible before triggering the device. The patient will have to train the first time in front of a mirror. If he sees a bit of “smoke” coming out of the top of the metered dose inhaler or at the corner of his mouth, he must start again from step 2.
2. Patients should consider replacing the metered dose inhaler when the dose counter reads 020. When all available doses in the device have been dispensed, the meter displays 000. The metered aerosol must be replaced when the meter reads 000 .
3. Patients should never try to change the numbers on the meter or detach it from the metal cartridge. The counter can not be reset and remains permanently attached to the cartridge.

Cleaning :

The device should be cleaned at least once a week.

1. Remove the cap from the mouthpiece.
2. Do not remove the cartridge from its plastic adapter.
3. Wipe the inside and outside of the mouthpiece and plastic adapter with a clean, dry tissue or tissue.
4. Replace the mouthpiece cap, making sure that it is correctly positioned in the correct direction. There is no need to exert a significant force to replace the cap on the mouthpiece, a simple “click” is enough to ensure the closure of the mouthpiece by the cap.

DO NOT PUT THE METAL CARTRIDGE IN WATER.

how does seretide works

Pharmacotherapeutic group: Adrenergic and other drugs for obstructive airways syndromes

ATC Code: R03AK06

Clinical studies conducted with the propionate combination of fluticasone / salmeterol in asthma:

A 12-month study (Gaining Optimal Asthma controL, GOAL) in 3416 adult and adolescent patients with persistent asthma compared the safety and efficacy of Seretide with inhaled corticosteroid alone (fluticasone propionate) to evaluate the possibility of achieving the goals of asthma management. The dosage of treatment was increased every 12 weeks until full control ** was obtained or the highest dose in the study was reached. GOAL showed that there were more patients achieving asthma control when treated with Seretide than with inhaled corticosteroids alone, with lower doses of corticosteroids.

“Good Control” of asthma was achieved more rapidly in patients treated with Seretide than in patients treated with inhaled corticosteroids alone. The time required for 50% of subjects in the study to reach their first week of “good control” was 16 days for subjects treated with Seretide and 37 days for those treated with inhaled corticosteroids (ICS). In the subgroup of asthmatic patients not previously treated with inhaled corticosteroids, this time was 16 days (Seretide) and 23 days (CSI), respectively.

The overall results of the study were as follows:

Percentage of patients achieving * Good Control (BC) and ** Total Control (CT) of asthma over 12 months
Treatment before inclusion in the study	FP 4 / Salmeterol		FP 4
	BC	CT	BC	CT
No CSI 1 (ß2 CDA 2 alone)	78%	50%	70%	40%
Low dose ICS (≤ 500 μg BDP 3 or equivalent per day)	75%	44%	60%	28%
Medium dose ICS (> 500-1000 μg BDP 3 or equivalent per day)	62%	29%	47%	16%
Overall results (regardless of previous treatment)	71%	41%	59%	28%

1. CSI: inhaled corticosteroids
2.  ß2 CDA: Beta-2 short-acting agonist
3.  BDP: beclometasone dipropionate
4. FP: Fluticasone Propionate

* Good asthma control: occasional symptoms or occasional use of a short-acting beta-2 agonist bronchodilator, or pulmonary function less than 80% of the theoretical values, without nocturnal awakening, exacerbation or adverse effect a modification of treatment.

** Total control of asthma: no symptoms, no use of a short-acting beta-2 agonist bronchodilator, pulmonary function greater than or equal to 80% of the theoretical values, no nocturnal awakening, no exacerbation no adverse effect leading to a change in treatment.

The results of this study suggest that Seretide 100 micrograms / 50 micrograms / dose, twice a day, may be considered for initiation of DMARD therapy in patients with moderate persistent asthma who experience essential control. asthma (see Dosage and administration section ).

Une étude en double aveugle, randomisée en groupes parallèles, conduite chez 318 patients d’au moins 18 ans, atteints d’asthme persistant, a évalué la sécurité et la tolérance de l’administration de deux inhalations deux fois par jour (double dose) de Seretide pendant deux semaines. Cette étude a montré que le doublement de la dose de Seretide (quel que soit le dosage), sur une durée allant jusqu’à 14 jours, entraîne par rapport à l’administration d’une inhalation deux fois par jour, une légère augmentation des effets indésirables liés à l’activité bêta-mimétique (tremblements : 1 patient [1 %] vs 0, palpitations : 6 [3 %] vs 1 [<1 %], crampes musculaires : 6 [3 %] vs 1 [<1 %]) et une incidence similaire des effets indésirables liés au corticoïde inhalé (candidose orale : 6 [6 %] vs 16 [8 %], raucité de la voix : 2 [2 %] vs 4 [2 %]). La faible augmentation des effets indésirables liés à l’activité bêta-mimétique doit être prise en considération, s’il est envisagé de doubler la dose prescrite de Seretide chez des patients adultes qui nécessiteraient une augmentation de la corticothérapie inhalée pendant une courte période (jusqu’à 14 jours).

Multicenter trial in asthma with salmeterol  (“Salmeterol Multi-Center Asthma Research Trial, SMART”)

The SMART study was a multi-center, randomized, double-blind, parallel group, placebo-controlled study conducted in the United States over 28 weeks. 13176 patients received salmeterol (50 micrograms twice daily) and 13179 patients received placebo administered in addition to their usual anti-asthmatic treatment. To be included in the study, patients had to be at least 12 years old, be asthmatic and have ongoing anti-asthmatic treatment (excluding long-acting beta-2 agonist therapy). action). Inhaled corticosteroid therapy was not mandatory during the study, although the use of corticosteroids was nevertheless recorded at study entry. The main criterion of judgment of the

Results of the SMART study on the primary endpoint:

Patient groups	Main criterion: Number of events / number of patients		Relative risk (95% Confidence Interval)
	salmeterol	placebo
Overall population included	50/13176	36/13179	1.40 (0.91, 2.14)
Patients using inhaled corticosteroids	23/6127	19/6138	1.21 (0.66, 2.23)
Patients not using inhaled corticosteroids	27/7049	17/7041	1.60 (0.87, 2.93)
Subgroup of African-American patients	20/2366	5/2319	4.10 (1.54, 10.90) **

** statistically significant at 95%

Other results of the SMART study according to whether or not inhaled corticosteroids were taken at baseline:

	Secondary criteria: Number of events / number of patients		Relative risk (95% Confidence Interval)
	salmeterol	placebo
Number of deaths related to a respiratory cause
Patients using inhaled corticosteroids	10/6127	5/6138	2.01 (0.69, 5.86)
Patients not using inhaled corticosteroids	14/7049	6/7041	2.28 (0.88, 5.94)
Combined criterion combining asthma episodes that have led to death or life-threatening
Patients using inhaled corticosteroids	16/6127	13/6138	1.24 (0.60; 2.58)
Patients not using inhaled corticosteroids	21/7049	9/7041	2.39 (1.10, 5.22) **
Number of deaths related to asthma
Patients using inhaled corticosteroids	4/6127	3/6138	1.35 (0.30, 6.04)
Patients not using inhaled corticosteroids	9/7049	0/7041	*

* = relative risk could not be calculated due to no event in the placebo group.

** The results are statistically significant at 95%. The secondary criteria in the table above reached statistical significance in the entire study population.

The secondary criteria of “death or vital threats from all causes”, “all-cause death” or “all-cause hospitalization” did not reach statistical significance for the entire study population.

Action mechanism

Seretide contains salmeterol and fluticasone propionate which have different modes of action:

salmeterol

Salmeterol is a selective long-acting agonist (12 hours) for beta-2 adrenergic receptors. It has a long side chain that links it to the receiver’s exo-site.

Salmeterol produces bronchodilation which persists for about 12 hours. This duration is greater than that generally observed with short-acting beta-2 mimetics administered at the usual dosages.

Fluticasone propionate

Fluticasone propionate administered by the inhaled route at the recommended doses exerts a glucocorticoid activity causing a local anti-inflammatory effect at the level of the bronchial mucosa. As a result, asthma symptoms and exacerbations are reduced while systemic effects are limited compared to systemic corticosteroid use.

Does Seretide have side effects?

yes it’s and this’s Description of adverse effects

Like all medicines, SERETIDE 50 micrograms / 25 micrograms / dose, suspension for inhalation in a pressurized bottle can cause side effects, but they do not occur systematically in everyone.

To prevent the occurrence of side effects, your doctor will prescribe the lowest possible dose to control your asthma.

Allergic Reactions: You may find that your breathlessness worsens suddenly after you use Seretide. You can perceive bronchial wheezing and coughing. You may also experience itching and swelling (usually on the face, lips, tongue, or throat). If you experience these symptoms or if they suddenly appear after using Seretide, tell your doctor immediately. Allergic reactions to Seretide are very rare (they affect less than 1 in 10,000 people).

Other side effects are described below:

Very common effects (affects more than 1 in 10 people):

• · Headache usually decreases with further treatment.
• · An increase in colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with Seretide.

Common effects (affect less than 1 in 10 people):

• · Candidiasis of the mouth and throat (sometimes painful). Also tongue and throat irritated, and hoarse voice. Rinse your mouth with water and spit it out immediately after each shot can help prevent these effects. Your doctor may prescribe antifungal therapy to treat candidiasis.
• · Tremors and fast or irregular heartbeat (palpitations). This is usually not serious and decreases with further treatment.
• · Muscle cramps.

The following side effects have also been reported with Seretide in patients with Chronic Obstructive Pulmonary Disease (COPD):

• · Pneumonia and bronchitis (respiratory infection). Tell your doctor if you experience any of the following: increased sputum, changes in sputum, fever, chills, increased cough, increased breathing difficulty.
• · Bruising (blue on the skin) and fractures
• · Inflammation of the sinuses (feeling of tension or heaviness in the face, cheeks and behind the eyes, sometimes accompanied by pulsating pain).
• · Decrease in the amount of potassium in your blood (which can be manifested by palpitations, muscle weakness, cramps).

Infrequent effects (affect less than 1 in 100 people):

• · Rashes of the urticaria type.
• · Rapid acceleration of heart rate (tachycardia).

Very rare effects (affects less than 1 in 10,000 people):

• · Sudden difficulty with breathing or wheezing immediately after inhaling the drug. In this case, stop using Seretide. Use your bronchodilator medication called “rescue” to help you breathe and tell your doctor immediately.
• · Seretide can affect the normal production of steroid hormones by the body (produced by the adrenal glands), especially if you have taken it at high doses and over long periods. The effects include:

1. o a slowdown in the growth of the child and the teenager,
2. o a thinning of the bone structure,
3. o a cataract (opacification of the lens of the eye generally causing visual discomfort), and glaucoma (an eye condition related to an increase in intraocular pressure),
4. o weight gain,
5. o a rounding (moon-shaped appearance) of the face (Cushing’s syndrome).

• · Your doctor will regularly check that you do not have these side effects and that you are using Seretide at the lowest dose to control your asthma.
• · Irregular heart rhythm (arrhythmias). Tell your doctor, but there is no need to stop your treatment unless your doctor tells you to stop.
• · Increased sugar (glucose) in your blood (hyperglycemia). If you have diabetes, more frequent checks of your blood sugar level and a possible adjustment to your anti-diabetic treatment may be necessary. Feelings of worry, sleep disturbances and behavioral changes, such as unusual activity and irritability (these effects occur mainly in children).
• · Pain and inflammation of the joints, muscle pain.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

seretide drug interactions

Beta-blockers, selective or not, should be avoided in patients with asthma unless absolutely necessary.

Concomitant administration of other beta-adrenergic agents may potentiate beta-2-mimetic effects.

Fluticasone propionate

Under normal conditions of use, fluticasone propionate plasma concentrations achieved after inhaled administration are low due to a significant presystemic first-pass effect (hepatic and intestinal) and high plasma clearance by extensive metabolism. mediated by cytochrome P450 3A4. As a result, the risk of clinically significant interactions with fluticasone propionate appears to be low.

Nevertheless, an interaction study in healthy volunteers receiving nasal fluticasone propionate showed that ritonavir (a very potent inhibitor of cytochrome P450 3A4) at a dose of 100 mg twice daily increased several hundred times plasma concentrations of fluticasone propionate, resulting in a marked decrease in plasma cortisol levels. There is no data documenting the interaction with fluticasone propionate administered by inhalation, but a significant increase in plasma concentrations is expected; cases of Cushing’s syndrome and inhibition of adrenal function have been reported. The concomitant administration of fluticasone propionate and ritonavir should therefore be avoided,

A low-dose study conducted in healthy volunteers showed that ketoconazole, a somewhat less potent inhibitor of cytochrome P450 3A4, increased the systemic exposure of a dose of inhaled fluticasone propionate by 150%. The reduction in plasma cortisol was greater than that observed after administration of fluticasone propionate alone. An increase in systemic exposure and the risk of systemic adverse reactions is expected when concomitant administration of other potent cytochrome P450 3A4 inhibitors (eg, itraconazole). Caution is advised and long-term combination therapy should be avoided as much as possible.

salmeterol

·Strong inhibitors of cytochrome P450 3A4

Concomitant administration of ketoconazole (400 mg orally once daily) and salmeterol (50 μg inhaled twice daily) in 15 healthy volunteers for 7 days resulted in a significant increase in plasma concentrations of salmeterol (Concentration maximum (Cmax) increased by a factor of 1.4 and area under the curve (AUC) increased by a factor of 15). This observation therefore suggests an increased risk of systemic effects of salmeterol, such as QT prolongation and palpitations, compared with salmeterol or ketoconazole alone (see Warnings and Precautions section). ).

There was no clinically significant effect on blood pressure, heart rate, blood glucose, and serum potassium. Concomitant administration of ketoconazole did not result in an extension of the half-life of salmeterol elimination or its accumulation after repeated dosing.

The combination of ketoconazole with salmeterol should be avoided unless the expected benefits outweigh the potential risk of systemic effects of salmeterol. A similar risk of interaction is expected with other potent cytochrome P450 3A4 inhibitors (eg with itraconazole, telithromycin, ritonavir).

· Moderate inhibitors of cytochrome P450 3A4

Concomitant administration of erythromycin (500 mg orally three times a day) and salmeterol (50 μg twice daily) in 15 healthy volunteers for 6 days resulted in a small but not statistically significant increase. plasma concentrations of salmeterol (Cmax increased by a factor of 1.4 and AUC increased by a factor of 1.2). No serious adverse events were associated with concomitant administration with erythromycin.

Seretide Warnings and Precautions

The adaptation of an anti-asthmatic treatment is done in stages according to the clinical state of the patient who will be regularly reassessed by a medical follow-up and the control of the respiratory function.

Seretide is not suitable for the treatment of asthma attacks and episodes of paroxysmal dyspnea. In these situations, the patient should use a short-acting, fast-acting bronchodilator to treat acute symptoms. The patient will be informed that he must therefore have at his disposal a fast-acting, short-acting bronchodilator for use in an asthma attack.

Treatment with Seretide should not be initiated during an exacerbation phase, or when there is a significant worsening or deterioration of asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with Seretide. Patients should be advised that if symptoms of asthma persist or worsen during treatment with Seretide, they should continue their treatment but seek advice from their doctor.

An increase in short-acting, fast-acting bronchodilator use to treat symptoms is a sign of destabilization of the disease. In this case, the patient will have to consult his doctor. A more or less rapid deterioration in symptom control should raise the risk of progression to severe acute asthma that may be life-threatening and therefore require urgent medical consultation. It will be advisable then to consider an increase of the corticotherapy. Similarly, if symptom control is still insufficient following treatment with Seretide, medical consultation is necessary and the prescription of additional corticosteroids should be considered.

As soon as the symptoms of asthma are controlled, a gradual decrease in the dose of Seretide should be considered. It is important that patients are followed regularly during the treatment reduction period. The minimum effective dose of Seretide should be used  .

Seretide treatment should not be interrupted abruptly.

Like other corticosteroids for inhaled administration, Seretide should be used with caution in patients with pulmonary tuberculosis.

Rarely, Seretide can cause heart rhythm disorders such as supraventricular tachycardia, extrasystoles and atrial fibrillation, as well as a moderate and transient decrease in serum potassium at high therapeutic doses. Therefore, Seretide should be used with caution in cases of severe cardiovascular disease, cardiac arrhythmias, diabetes, hyperthyroidism, uncorrected hypokalaemia, or in patients at risk of hypokalemia.

Increases in blood glucose have been reported very rarely . This must be taken into account when prescribing to diabetic patients.

As with other inhaled products, increased bronchial whistling indicating bronchospasm following inhalation of the powder should lead to discontinuation of Seretide treatment and clinical examination of the patient. Treatment should be re-evaluated to consider alternative therapy as appropriate.

Caution should be taken when releasing Seretide for systemic corticosteroids, particularly in patients who may have impaired adrenal function.

Inhaled corticosteroid therapy may have systemic effects, especially during long-term high-dose therapy. The occurrence of these effects remains less likely than during oral corticosteroid therapy. Cushing’s syndrome, a cushingoid picture, an inhibition of adrenal function, a decrease in bone mineral density, a cataract and glaucoma can be observed. As a result, the patient will be followed regularly and the minimum effective dosage should always be sought.

Prolonged administration of high doses of inhaled corticosteroids may result in inhibition of adrenal function by promoting the occurrence of acute adrenal insufficiency. Cases of inhibition of adrenal function and acute adrenal insufficiency have also been very rarely described with fluticasone propionate doses of between 500 and 1000 micrograms. Adrenal insufficiency attacks can be triggered by trauma, surgery, infection or any rapid decrease in dosage. The clinical picture is usually atypical and may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, hypotension, disturbance of consciousness, hypoglycemia and convulsions.

Fluticasone propionate and salmeterol are mainly absorbed by the pulmonary route. The use of an inhalation chamber associated with the metered dose inhaler may increase the dose of product delivered to the lung, thereby increasing the risk of systemic adverse reactions. Single-dose kinetic data showed twice as much systemic exposure when Seretide was administered using the AeroChamber Plus inhalation chamber compared to the Volumatic inhalation chamber.

The use of inhaled fluticasone propionate reduces the need for oral corticosteroids to treat asthma, but it does not prevent the risk of developing adrenal insufficiency when patients treated with long-term oral corticotherapy. This risk also exists in patients who have received high doses of emergency corticosteroids. The risk of persistence of adrenal suppression should be kept in mind in emergency situations and / or likely to trigger a state of stress. Appropriate corticosteroid replacement therapy should be considered. A specialized opinion may be required.

Ritonavir can dramatically increase plasma concentrations of fluticasone propionate. Therefore, unless the expected benefit to the patient outweighs the risk of systemic effects of corticosteroid therapy, concomitant administration should be avoided. The risk of systemic effects of corticosteroid therapy is also increased when concomitant administration of fluticasone propionate with other potent cytochrome P450 3A4 inhibitors .

An increase in cases of low respiratory infections (especially pneumonia and bronchitis) was observed in a 3-year study (TORCH study) in patients with COPD treated with Seretide, compared to those receiving placebo . In this study, the risk of developing pneumonia, regardless of treatment, was highest in elderly patients, patients with low body mass index (<25 kg / m2) and those with very severe disease (FEV 1 < 30% of the theoretical value). The possibility of pneumonia or other low respiratory infections in patients with chronic obstructive pulmonary disease (COPD) should be carefully monitored as the clinical manifestations of infection are often confused with a simple exacerbation. The occurrence of pneumonia in a patient with severe COPD should lead to re-evaluation of Seretide therapy.

Data from a large-scale clinical trial (“Salmeterol Multi-Center Asthma Research Trial, SMART”) suggested an increased risk of serious respiratory adverse events or respiratory-related death in African patients. treated with salmeterol compared to placebo . It could not be determined whether these observations were of pharmacogenetic origin or resulted from other intercurrent factors. If symptoms of asthma persist or worsen during treatment with Seretide, patients of African-African or Afro-Caribbean origin should continue Seretide treatment while promptly seeking medical attention.

Co-administration of systemic ketoconazole significantly increases systemic exposure to salmeterol, which may increase the risk of systemic effects (eg prolongation of QTc interval and palpitations). Therefore, concomitant administration of ketoconazole or other potent inhibitors of cytochrome P450 3A4 should be avoided unless the expected benefits outweigh the potential risk of systemic effects of salmeterol .

Athletes’ attention will be drawn to the fact that this specialty contains two active ingredients that can induce a positive reaction of the tests performed during doping controls.

Pediatric population

Children and adolescents under 16 years of age receiving high doses of fluticasone propionate (usually ≥ 1000 micrograms daily) are at particular risk. Systemic effects may occur, especially during long-term high-dose treatments. Cushing’s syndrome, a cushingoid picture, an inhibition of adrenal function, acute adrenal insufficiency and stunting in children and adolescents can be observed.

The growth of children receiving long-term inhaled corticosteroid therapy should be monitored regularly. Inhaled corticosteroid therapy should be reduced to the lowest dose for effective asthma control.

Drive and use machines

There are no studies evaluating the effects of this drug on the ability to drive and use machines.

Seretide and PREGNANCY / BREAST FEEDING / FERTILITY:

Fertility:

• There is no data in humans. However, animal studies have shown no effect of salmeterol or fluticasone propionate on fertility.

Pregnancy :

• A moderate amount of data obtained in pregnant women (between 300 and 1000 cases of documented pregnancies) do not report the malformative or fetononatal toxicity of salmeterol and fluticasone propionate. Studies in animals on reproductive functions have shown a toxicity of ß-2-mimetics and glucocorticoids ( see Preclinical safety ).Use of Seretide during pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the fetus.
• In pregnant women, the minimum effective dose of fluticasone propionate should be sought for satisfactory control of the symptoms of asthma.

Breastfeeding:

• The passage of salmeterol and fluticasone propionate and their metabolites into breast milk is not known.Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted in the milk of lactating rats.
• A risk for breastfed newborns / infants can not be ruled out. The decision to discontinue breastfeeding or treatment with Seretide will be based on the expected benefit of breastfeeding for the child compared to the treatment for the breastfeeding woman.

What should I do if I miss a dose?

If you forget to take your medicine

• take the next dose at the usual time.
• Do not take a double dose to make up for the single dose you forgot to take.

What happens if I overdose from Seretide ?

• It is important to use the device as your doctor has shown you. If you accidentally take more than the recommended dose, tell your doctor or pharmacist. You may notice an increased heart rate and tremors. You may also experience headaches, muscle weakness and joint pain.
• If you have taken large doses for a long time, talk to your doctor or pharmacist. High doses administered in the long term may result in a decrease in the steroid hormones secreted by the adrenal glands.

What is  Forms and Composition Seretide?

FORMS and PRESENTATIONS

Seretide:
Inhalation suspension at 50 μg / 25 μg / dose, at 125 μg / 25 μg / dose and at 250 μg / 25 μg / dose (white to whitish):   Pressurized 8 ml (120 doses) vial with metering valve. The cartridge is inserted in a purple plastic applicator with a mouthpiece closed by a cap, with a dose counter to indicate the number of doses remaining. Seretide Diskus: Inhalation powder at 100 μg / 50 μg / dose, 250 μg / 50 μg / dose and 500 μg / 50 μg / dose:   Distributor (Diskus) of 60 single-dose containers (regularly spaced), under heat-sealed film. Hospital models: Distributor (Diskus) of 28 single-dose containers, under heat-sealed film.

COMPOSITION

Seretide:

	p dose *	p dose delivered
Fluticasone (DCI) propionate	50 μg	44 μg
or	125 μg	110 μg
or	250 μg	220 μg
Salmeterol (INN) xinafoate expressed as salmeterol	25 μg	21 μg

^*  Issued by the metering valve.
Excipient (common): norflurane (HFA 134a, propellant).

Seretide Diskus:

	p dose *	p dose delivered **
Fluticasone (DCI) propionate	100 μg	92 μg
or	250 μg	231 μg
or	500 μg	460 μg
Salmeterol (INN) xinafoate expressed as salmeterol	50 μg	47 μg

^*   Contained in each single-dose container.

^**   At the mouthpiece.
Excipient (common): lactose monohydrate (containing milk proteins).

Lactose content: up to 12.5 mg / dose.

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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