ZENHALE Inhalation aerosol Ref.[27835] Active ingredients: Eformoterol Mometasone

Dosing Considerations

ZENHALE should not be used in patients whose asthma can be managed by occasional use of short-acting, inhaled beta2-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists. Once asthma control has been achieved and maintained, assess the patient at regular intervals and do not use ZENHALE for patients whose asthma can be adequately controlled on low or medium dose inhaled corticosteroids.

Patients should be made aware that for optimum benefit, ZENHALE should be taken regularly, even when they are asymptomatic. Rescue inhalations only need to be taken to relieve acute asthma symptoms (see WARNINGS AND PRECAUTIONS). A reassessment of asthma therapy should be considered in patients using an increasing number of rescue inhalations for symptom relief without achieving improved asthma control.

ZENHALE therapy should not be initiated to treat an asthma exacerbation.

Patients should be instructed to not use more than two inhalations twice daily of the prescribed strength of ZENHALE as some patients are more likely to experience adverse effects with higher doses of formoterol. If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

Recommended Dose and Dosage Adjustment

ZENHALE is available in three strengths, 50/5, 100/5 and 200/5; delivering 50 mcg, 100 mcg and 200 mcg of mometasone furoate (MF), respectively and 5 mcg of formoterol fumarate dihydrate (F) per actuation.

Adult and Adolescent Patients aged 12 years and older

ZENHALE should be administered as two inhalations twice daily (morning and evening) by oral inhalation.

When choosing the starting dosage strength of ZENHALE, consider the patient’s disease severity, based on their previous asthma therapy, including the inhaled corticosteroid dosage (Table 4), as well as the patient’s current control of asthma symptoms and risk of future exacerbation.

Table 4. Recommended dose for ZENHALE treatment based on prior asthma therapy:

For patients who have not previously received inhaled corticosteroids, but whose disease severity warrants initiation of treatment with two maintenance therapies, depending upon asthma severity, the recommended starting dose must be decided by the physician.

The maximum daily recommended dose is 800 mcg MF / 20 mcg F (given as two inhalations of ZENHALE 200/5 twice daily) for patients 12 years of age and older. In the event of an acute attack or if symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

Pediatric Patients aged 5 to less than 12 years

For patients aged 5 to less than 12 years, the dosage is two (2) inhalations of ZENHALE 50/5 twice daily (morning and evening) by oral inhalation. The maximum recommended daily dosage is 200/20 microgram.

If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

All Patients aged 5 years and older

Patients should be regularly assessed by a doctor.

If a previously effective dosage regimen of ZENHALE fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ZENHALE with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage.

Missed Dose

If a dose is missed, the patient should be instructed to take the next dose as soon as they remember unless it is near to the time for the next dose, at which time they should wait until the next dose is due. The patient should be instructed not to double the dose.

Administration

ZENHALE should be administered by oral inhalation only.

Patients should be made aware that ZENHALE must be used daily for optimum benefit, even when asymptomatic.

As a general rule, rinsing the mouth and gargling with water after each inhalation can help in preventing the occurrence of candidiasis. Cleansing dentures has the same effect.

Priming and Use

Patients should be instructed to properly use the inhaler, as described in PART III: CONSUMER INFORMATION and to read the Product Insert contained in their package.

ZENHALE should be administered only by orally inhaled routes. After each dose, the patients should be advised to rinse their mouths out with water and spit out the contents without swallowing.

The cap from the mouthpiece of the actuator should be removed before using ZENHALE.

The inhaler must be shaken prior to each inhalation.

ZENHALE should be primed before using for the first time by removing the cap and releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, the inhaler should be primed again as described above.

The canister should not be removed from the actuator because the correct amount of medication may not be discharged; the dose counter may not function properly; reinsertion may cause the dose counter to count down by 1 and discharge a puff.

The ZENHALE canister should only be used with the ZENHALE actuator. The ZENHALE actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ZENHALE canister.

The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of actuations has been used (the dose counter will read “0”). The canister should never be immersed into water to determine the amount remaining in the canister (“float test”).

Use with a spacer device

Use of the AeroChamber Plus Anti-Static valved holding chamber is recommended with ZENHALE, in patients who find it difficult to synchronize aerosol actuation with inspiration of breath. Pediatric patients may use Zenhale with or without a spacer device.

The risks associated with overdosage for the individual components apply to ZENHALE.

• Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
• Excessive formoterol fumarate is likely to lead to effects that are typical of beta₂-adrenergic stimulants: nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, hypertension.

Treatment

Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. Use of cardioselective beta-blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Adrenal function monitoring should be included as part of management.

For management of suspected drug overdose, contact your regional Poison Control Centre.

Store at controlled room temperature 15°-30°C. Do not freeze. For best results, the inhaler should be warmed to room temperature before use (e.g. by warming in the hands) if it is exposed to low temperatures.

For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children. Avoid spraying in eyes.

The 120-inhalation inhaler does not require specific storage orientation. For the 60-inhalation inhaler, after priming, store the inhaler with the mouthpiece down or in a horizontal position.

Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.