OSMOHALE Inhalation powder, hard capsule Ref.[27640] Active ingredients: Mannitol

Posology

Adults

The capsules are supplied in kit form containing sufficient number of capsules to complete one maximum dose challenge, and an inhaler.

The airway response to Osmohale is measured using the FEV₁.

Paediatric population

The Osmohale test should not be used in children aged under 6 years because of their inability to provide reproducible spirometric measurements (see section 5.1).

There is limited information on the use of Osmohale in patients 6-18 years of age therefore Osmohale is not recommended in this population.

Method of administration

Prior to the challenge, spirometry should be performed and the reproducibility of the baseline FEV₁ established.

The patient should be seated comfortably and encouraged to maintain good posture to assist the effective delivery of Osmohale to the lungs. The test should proceed as follows:

1. Apply a nose clip. The patient should be directed to breathe through the mouth.
2. Insert the 0 mg capsule into the inhalation device. Puncture the capsule by depressing the buttons on the sides of the device carefully, and once only (a second puncture may shatter the capsules).
3. The patient should exhale completely, before inhaling from the device in a controlled rapid deep inhalation.
4. At the end of the deep inspiration, start a 60 second timer. The patient should hold his/her breath for 5 seconds and exhale through the mouth before removal of the nose clip.
5. At the end of the 60 seconds, measure the FEV₁ at least in duplicate to obtain two reproducible measurements. The highest reading becomes baseline FEV₁. The target FEV₁ is calculated by multiplying the baseline FEV₁ by 0.85.
6. Insert the 5 mg capsule into the inhalation device, and proceed as above.
7. Repeat steps 1–5 following the dose steps in the table below until the patient has a positive response or 635 mg have been administered.

A positive response is achieved when the patient experiences either of the following:

15% fall in FEV₁ from baseline (0 mg dose)

or

10% incremental fall in FEV₁ between doses

Examples of positive tests:

1. FEV₁ fall following dose step 2: 3%

FEV₁ fall following dose step 3: 8%

FEV₁ fall following dose step 4: 16%

• as the total fall is 16% (≥15%), the test is positive.

2. FEV₁ fall following dose step 2: 3%FEV₁ fall following dose step 3: 14%

• although the total fall is <15%, the incremental fall is 11% (≥10%) and the test is positive.

Points to remember:

1. There should be minimal delay between FEV₁ measurement and the next dose so that the osmotic effect in the airway is cumulative.
2. At least 2 acceptable FEV₁ measures should be obtained after each dose. More than 2 measurements may be required, for example in the case of variability between readings or improper manoeuvres during measurement (such as the occurrence of cough).
3. The 80 and 160 mg doses are administered in multiples of 40 mg capsules (i.e., 2 × 40 mg and 4 × 40 mg, respectively). There is no interval between administering multiple capsules for these doses. One capsule should be followed immediately by the next until the total dose has been inhaled.

3 After inhalation of each dose, the capsule should be checked to ensure it is empty. A second inhalation from the same capsule may be required if the dose has not been entirely dispersed from the capsule.

Most patients recover spontaneously after the challenge test, however those with a positive challenge or who experience aggravation of asthma should receive a standard dose of a beta2 agonist to expedite recovery. Those with a negative challenge may also receive a standard dose of a beta2 agonist to expedite recovery. Following administration of a beta2 agonist, FEV₁ usually returns to baseline within 10 – 20 minutes. Patients should be monitored until their FEV₁ has returned to within 5% of baseline levels.

Susceptible persons may suffer a hyperresponsiveness reaction from an overdose. The reaction can be treated with a bronchodilator. There is some experience with Osmohale in clinical studies where patients experienced a 15% fall in FEV1 and inhaled a further dose (these studies used 20-25% as the target FEV₁ fall). The maximum fall measured was 50.2%. If excessive bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary.

3 years.

Do not store above 25°C.

Capsules are packed in Aluminium/Aluminium blisters.

1 diagnostic kit consists of:

1 empty capsule
1 capsule containing 5 mg mannitol
1 capsule containing 10 mg mannitol
1 capsule containing 20 mg mannitol
15 capsules containing 40 mg mannitol
1 inhaler made of styrene plastics

No special requirements.