Medicinal Products

ASMANEX TWISTHALER 400 micrograms / dose

Generic drug of the therapeutic class: Pneumology
active ingredients: Mométasone
laboratory: Msd France

Inhalation powder
Inhaler device of 60 Doses
All forms

Indication

Continuous treatment of persistent asthma.

Dosage ASMANEX TWISTHALER 400 micrograms / dose Inhalation powder Inhalator device of 60 Doses

Inhaled route only.

Reserved for adults and teenagers from 12 years old.

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

Persistent mild to moderate asthma

The recommended starting dose for most patients is 400 micrograms once a day. Data suggest better control of asthma when the daily dose is administered in the evening. Some patients will be better controlled by administering 400 micrograms twice daily (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 in the evening may be an adequate maintenance dose for some patients.

Severe persistent asthma

The recommended starting dose is 400 micrograms twice daily and is the maximum recommended dose. When symptoms are controlled, the minimum effective dose should be sought.

In patients with severe asthma receiving oral corticosteroid therapy, Asmanex Twisthaler will be initiated in combination with ongoing corticosteroid therapy. After about a week, the gradual decrease in oral corticosteroid therapy may be considered by reducing the daily dose or by administering it every other day. Depending on the patient's response, this dose will be maintained for one to two weeks before considering the next level. In most cases, each dose reduction should not exceed 2.5 mg prednisone daily or its equivalent. Any attempt at weaning oral corticosteroid therapy should be considered only very gradually. During the period of reduction of oral corticosteroid therapy, caution should be exercised regarding the risk of destabilization of asthma (possibly with objective measures of ventilatory function), or adrenal insufficiency (see Warnings and Precautions section). employment ).

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

criteria

Light persistent asthma

Symptoms more than once a week but less than once a day; seizures that can affect activity and sleep nocturnal asthma symptoms more than 2 times per month; PEF or FEV1> 80% of the predicted values, variability of the DEP between 20-30%.

Moderate persistent asthma

Daily symptoms; resounding attacks on activity and sleep; nocturnal asthma symptoms more than once a week; daily use of a short acting beta-2-mimetic; PED or FEV1> 60% and 30%.

Severe persistent asthma

Permanent symptoms; frequent crises; frequent nocturnal asthma symptoms; physical activity limited by asthma symptoms; PEF or FEV1 ≤ 60% predicted values, variability> 30%.

Special populations

Children under 12 years

There is no sufficient clinical data in this age group.

Patients over 65

No dosage adjustment is to be expected.

For proper use, the patient should be informed of how the inhaler works (see below).

Administration mode

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

To close the device, immediately replace the cap on its base after each inhalation while keeping the device upright; the next dose will be loaded by screwing the cap in a clockwise direction and maintaining a slight downward pressure until a click is perceived and the cap is completely closed. The arrow on the cap will be fully aligned with the counter window.

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

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

The inhaler should be kept clean and dry at all times. The outside of the mouthpiece will be cleaned with a dry cloth; do not wash the inhaler; avoid contact with water.

For detailed instructions, see the patient instructions.

Against indications

Hypersensitivity (allergy) known to the active substance or to any of the excipients (see section Composition ).

Side effects Asmanex Twisthaler

In placebo-controlled clinical trials, oral candidiasis was frequently observed (> 10%) in patients treated with 400 micrograms twice daily; other common treatment-related adverse events (1-10%) were pharyngitis, headache, and dysphonia. Treatment-related adverse events observed in clinical trials and postmarketing reports of Asmanex Twisthaler Inhalation Powder are listed in Table 1 below:

Table 1: Clinical Trial Adverse Drug Reactions and Adverse Drug Reactions Reported Post-Marketed Asmanex Twisthaler Powder for Inhalation Based on Dose and Severity, MedDRA Organ System Classes and Terms conventional

(Very common (> 1cas / 10); Frequent (> 1cas / 100, 1cas / 1000, <1cas / 100) Frequency not known (can not be estimated from available data))

Category

Daily dose
(one dose per day)

Daily dose
(2 taken daily)

200 μg

400 μg

200 μg

400 μg

Infections and infestations

candida

frequent

frequent

frequent

very common

Immune system disorders

Hypersensitivity reaction including skin rash, pruritus, angioedema, and anaphylactic reaction

indefinite frequency

indefinite frequency

indefinite frequency

indefinite frequency

Psychiatric disorders

Psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders (especially in children).

Undetermined

Undetermined

Undetermined

Undetermined

Respiratory, thoracic and mediastinal disorders

Pharyngitis

frequent

frequent

frequent

frequent

Exacerbation of asthma symptoms such as cough, dyspnea, sibilants and bronchospasm

indefinite frequency

indefinite frequency

indefinite frequency

indefinite frequency

dysphonia

rare

frequent

frequent

frequent

General disorders and administration site conditions

Headache

frequent

frequent

frequent

frequent

With oral administration twice daily, oral candidiasis occurred in 6% and 15% of patients treated with 200 micrograms and 400 micrograms respectively, and in 2% of patients treated once daily.

With twice-daily dosing, treatment-related pharyngitis was reported in 4% (200 micrograms) and 8% (400 micrograms) patients. With once-daily administration, the incidence was 4% (200 micrograms) and 2% (400 micrograms).

In corticosteroid-dependent patients (oral corticosteroids) treated with Asmanex Twisthaler 400 micrograms twice daily for 12 weeks, oral candidiasis occurred in 20% of patients and dysphonia in 7%. These effects were considered to be treatment-related.

Side effects reported as rare were dry mouth and throat, dyspepsia, weight gain and palpitations.

As with other inhaled medications, bronchospasm may occur (see Warnings and Precautions for Special Warnings and Precautions). A quick-acting inhaled bronchodilator should be used immediately for treatment. Asmanex treatment will be discontinued immediately, and the therapeutic management will be re-evaluated after clinical examination to consider if necessary alternative treatment.

Systemic effects may occur with inhaled corticosteroids, particularly when prescribed in high doses or for prolonged periods. Potential systemic effects include adrenal insufficiency, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, psychological and behavioral disorders including psychomotor hyperactivity, sleep disorders, anxiety, depressive or aggressive (especially in children).

As with other inhaled corticosteroids, rare cases of glaucoma, increased intraocular pressure, and / or cataracts have been reported.

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

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