Continuous treatment of asthma: persistent.

Inhaled exclusively.

Reserved for adults and adolescents from the age of 12.

The dosage will be adjusted according to the severity of asthma (see below)

Asthma persistent light to moderate

The recommended initial dosage for most patients is 400 micrograms once daily. Data suggest a better control of asthma when the daily dose is administered at night. Some patients will be better controlled by administration of 400 micrograms in two catches per day (200 micrograms morning and evening).
The dosage of Asmanex Twisthaler is individual and the minimum effective dose should always be sought. The dosage of 200 micrograms once a day administered at night may be a dose of adequate maintenance for some patients.
Persistent asthma, severe

The recommended starting dose is 400 micrograms twice daily and corresponds to the maximum recommended dose. When the symptoms are checked, it will be advisable to look for the minimum effective dose.

In patients with severe asthma and receiving oral corticosteroid therapy, Asmanex Twisthaler will be initiated in combination with ongoing corticosteroid therapy. After about a week, the progressive reduction in oral corticosteroid therapy may be considered by reducing the daily dose or by administering it only on alternate days. Depending on the patient's response, this dose will be maintained, one to two weeks before the next dose is considered In the majority of cases, each dose reduction should not exceed 2.5 mg of prednisone per day Or its equivalent. Any attempt to withdraw oral corticosteroids should be considered only very gradually. During the period of reduction in oral corticosteroids, attention should be paid to the risk of destabilization of asthma (possibly with objective measurements of functions, ventilatory) or adrenal insufficiency (see section 4.4). And, precautions for use).

The patient should be informed that Asmanex Twisthaler is not intended to be used "on demand" for the treatment of acute symptoms but should be administered continuously to ensure the maintenance of the benefit Therapeutic when the symptoms have regressed

Criteria

Asthma, persistent light

Symptoms more than once a week but less than once a day, seizures that can affect activity and sleep, nocturnal asthma symptoms more than twice a month, DEP or FEV1> 80% , Predicted, DEP variability between 20-30%.

Persistent asthma, moderate

Daily symptoms, seizures, activity and sleep, symptoms, nocturnal asthma more than once a week, daily use of a beta-2-mimetic action, brief, DEP or FEV 1> 60% And 30%.

Persistent asthma, severe

Symptoms of asthma, frequent, physical activity limited by asthma symptoms, DEP or FEV1 ≤ 60% of predicted values, variability> 30%

Populations, special

Children under 12 years of age

There is no adequate clinical data in this age group

Patients over 65 years of age

No dose adjustment is to be expected.

For correct use, the patient should be informed of the mode of operation of the inhaler (see below).

Mode of administration

Before removing the cap from the mouthpiece, make sure the meter and the cap pointer are aligned. The inhaler opens by unscrewing the white cap counterclockwise while the unit is held in an upright position (the base is burgundy at the bottom). The counter will count down one unit. It should be explained to the patient that he must first place the inhaler in the mouth, closing the lips on the mouthpiece and then inhale rapidly and deeply. After removing the inhaler from the mouth, the patient should hold his or her breath for about 10 seconds if possible. Do not exhale in the inhaler.

To close the device, immediately replace the cap on its base after each inhalation while holding the device in a vertical position, the next dose will be loaded by screwing the cap in a clockwise direction and holding a cap; Lightly press down until a snap is heard and the cap is fully closed. The arrow on the cap will be completely aligned on the counter's window.

It is advisable to rinse mouth after inhalation by spraying water to reduce the risk of oral candidiasis

The digital display indicates the time at which the last dose was delivered after dose 01, the counter indicates 00 and the cap is blocked, the inhaler can then be discarded. >

The inhaler must remain clean and dry permanently. The exterior of the mouthpiece will be cleaned with a dry cloth, do not wash the inhaler, avoid contact with water

For detailed instructions, see the package insert for the patient.

Agglomerates of white powder, off-white

GLUCOCORTICOIDES, ATC code R03BA07.

Mometasone furoate is a glucocorticoid that exerts an anti-inflammatory effect.


In vitro, there was demonstrated a binding affinity of mometasone furoate to the human glucocorticoid receptor approximately 12-fold greater than that observed with dexamethasone, 7-fold higher than that of acetonide; Triamcinolone, 5 times that of budesonide, and 1.5 times that of fluticasone.

In situations of stress such as the onset of trauma, surgery, infection, or severe asthma, patients, recently weaned from corticosteroid therapy, may require a; Supplementation with a short course of corticosteroids administered systemically. This will then be gradually decreased as a function of the reduction in symptoms.

Such patients should be provided with oral corticosteroids if necessary, and they should be provided with a personal card, specifying their possible need for corticosteroid supplementation and dosage, recommended under stress conditions. Regular monitoring of cortico-adrenal function with assay, specific for morning plasma cortisol, is recommended.

In patients previously treated systemically, transfer to inhaled corticosteroids may sometimes unmask allergies until then, controlled by systemic corticosteroid therapy. Symptomatic treatment is then recommended,

Mometasone furoate does not have the properties of a bronchodilator and is not indicated for emergency treatment to alleviate acute symptoms, therefore it should be made clear to the patient to always be available; A bronchodilator medication of short duration, action by inhalation when needed.

Patients should be advised that an immediate medical consultation is necessary if relief of asthma symptoms is not obtained with the usually effective dose of short-acting inhaled bronchodilator and / Or if the peak flow drops. This may be the sign of an exacerbation of asthma. Such episodes may require the use of systemic corticosteroid therapy. In these patients, an increase in the dosage of inhaled mometasone furoate to the maximum recommended dose should be considered.
The use of Asmanex Twisthaler will often control the symptoms of asthma with decreased hypothalamic-pituitary-adrenal axis compared with oral administration of oral prednisone at equivalent dose. Although its systemic inhalation bioavailability is low at the recommended dose, mometasone furoate is nevertheless absorbed and may exert a systemic effect when higher doses are administered. Thus, in order for the hypothalamic-pituitary-adrenal axis to remain low, it will be advisable not to exceed the recommended doses and always to seek the minimal, effective dose.
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As with other drugs administered by inhalation, bronchospasm may occur immediately after the administration of Asmanex. If bronchospasm occurs after administration of Asmanex Twisthaler, immediate use of an inhaled bronchodilator of action should be advised, the patient should always be advised to keep his / her bronchodilator medication Inhaled, to treat acute symptoms. In this case, treatment with Asmanex Twisthaler should be immediately discontinued and alternative treatment should be considered.


Patients who have received corticosteroids or other immunosuppressive drugs should be advised of the risks involved in the case of exposure to certain infections (eg chicken pox, measles) and the need for medical advice, They are confronted with such situations. This recommendation is all the more important for children.

Insufficient control of asthma, as well as corticosteroid therapy itself, may be the cause of slower growth in children or adolescents. It is recommended to regularly monitor the growth of adolescents treated with corticosteroids regardless of the route of administration. In addition, consideration should be given to the benefits of corticosteroid therapy and symptom control, given the uncertainty of stopping growth, and when there is a slowing down in an adolescent.
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It is recommended to regularly monitor the size of children and adolescents receiving prolonged inhaled corticosteroids. If a slowing of growth is observed, the treatment should be re-evaluated in order to determine the minimal effective dosage for the control of symptoms. The opinion of a pediatrician specializing in pneumology is recommended.

Clinically significant corticosteroid adrenal suppression is possible with corticosteroids administered by the inhaled route especially during prolonged treatment or at high doses, especially as the doses are greater than those recommended. Code>
This should be taken into account during periods of stress or optional surgery where additional systemic corticosteroids may be required. In clinical trials it has not been reported: axillary abnormalities, hypothalamic-pituitary-adrenal after treatment, prolonged by inhaled mometasone furoate, for doses ≤ 800 micrograms per day < Code>
In case of non-response to therapy, or in the event of severe asthma exacerbations, the maintenance dose of inhaled mometasone furoate should be increased. If necessary, systemic corticosteroid therapy and / or antibiotic therapy for suspected infection should be considered in combination with beta-2-mimetics.

The patient should be advised not to abruptly discontinue treatment with Asmanex, Twisthaler.

Patients intolerant to lactose: the maximum recommended daily dose, contains 4.64 mg lactose. This amount does not normally cause problems in people lactose intolerant.

Due to the very low plasma concentrations reached after inhalation of a dose, the occurrence of clinically significant drug interactions is unlikely. However, systemic exposure to mometasone furoate may be increased when co-administered with potent inhibitors of CYP3A4 (eg ketoconazole, itraconazole, nelfinavir, ritonavir). >

The combination of inhaled mometasone furoate and ketoconazole, a potent inhibitor of the CYP3A4 enzyme, led to small but slightly significant decreases in AUC (0-24) of Cortisol and an increase of approximately 2-fold in the plasma concentration of mometasone furoate.

Not applicable.

Due to the low systemic bioavailability of this product, overdosage does not lead to the initiation of a particular treatment but to simple clinical monitoring. Corticosteroids will then be taken up at the appropriate dosage. Excessive doses of corticosteroids, administered by inhalation or by oral route, may lead to braking of the axis, hypothalamic-pituitary-adrenal.
The management of overdosage of inhaled mometasone furoate includes monitoring of the adrenal function. Treatment with mometasone furoate at a dose sufficient to control asthma may then be resumed.

There is no reliable data in pregnant women. Studies in the animal with mometasone furoate, as with other glucocorticoids, have shown toxicity and reproductive function (see section Preclinical safety data). However, the potential risks in the human population are unknown.

Like other inhaled corticosteroids, mometasone furoate should not be used during pregnancy or lactation unless the potential benefit to the mother justifies the potential risk to the fetus or infant

Infants born to mothers who received corticosteroids during pregnancy should be closely monitored to predict the possibility of adrenal insufficiency

Mometasone furoate is excreted at low doses in the milk of lactating rats. In man the passage into milk is not known. Administration of Asmanex Twisthaler in breastfeeding women should only be considered if the expected benefit to the mother is greater than the potential risk to the child
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In oral trials, oral candidiasis was frequently observed (> 10%) in patients treated with 400 micrograms twice daily, other frequent adverse events (1-10%), Related to treatment were pharyngitis, headache and dysphonia. Treatment-related adverse events observed in clinical trials and those reported since marketing Asmanex Twisthaler Inhalation Powder are listed in Table 1 below
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Table 1: Treatment-related adverse events observed in clinical trials and adverse reactions reported from marketing Asmanex Twisthaler Inhalation Powder, listed according to dosage and severity, MedDRA bodies and Conventional terms

(Frequent (> 1 case / 10), Frequent (> 1 case / 100, 1 case / 1000,

With two-dose administration, treatment-related pharyngitis was reported in 4% (200 micrograms) and 8% (400 micrograms) of the patients. With one-dose administration per day, the incidence was 4% (200 micrograms) and 2% (400 micrograms).
In patients with corticosteroids (oral corticosteroids), Asmanex Twisthaler treated 400 micrograms twice daily for 12 weeks, oral candidiasis occurred in 20% of patients and dysphonia in 7%. These effects were considered to be related to the treatment

Adverse reactions reported as rare were dry mouth and throat, dyspepsia, weight gain and palpitations.


As with other corticosteroids administered by inhalation, rare cases of glaucoma, increased intraocular pressure and / or cataract have been reported.

As with other glucocorticoids, the risk of hypersensitivity reactions including skin rash, urticaria, pruritus, erythema and ocular edema, face, lips and throat are not excluded. Br>

Continuous treatment of asthma: persistent.