Oxis Turbohaler Lab Report

Oxis Turbohaler
1.0 Generic Drug Name; Preparation/Formulation
Oxis (Formoterol); Oxis Turbuhaler; Oxis (Eformoterol fumarate dihydrate for inhalation)
1.1 Oxis Turbohaler 6, inhalation powder
• Each delivered dose of Oxis Turbohaler 6 (i.e. the dose leaving the mouthpiece) contains 4.5 micrograms formoterol fumarate dihydrate which is derived from a metered dose of 6 micrograms.
• Diluents: Lactose Monohydrate 895 micrograms per delivered dose, corresponding to 1005 micrograms per metered dose.
1.2 Oxis Turbohaler 12, inhalation powder
• Each delivered dose of Oxis Turbohaler 12 (i.e. the dose leaving the mouthpiece) contains 9 micrograms formoterol fumarate dihydrate which is derived from a metered dose of 12 micrograms.
• Diluents: Lactose

How to administer Oxis Turbohaler
1. Unscrew the white cover and lift it off.
2. Hold the Turbohaler upright with the turquoise grip at the bottom.
3. To load the Turbohaler with a dose, turn the turquoise grip as far as it will go in one direction. Then turn it as far as it will go in the other direction. A click sound should be heard. The Turbohaler is now loaded and ready to use.
4. Hold the Turbohaler away from mouth. Breathe out gently (as far as is comfortable). Do not breathe out through the Turbohaler.
5. Place the mouthpiece gently between teeth. Close lips. Breathe in as deeply and as hard as possible through the mouth. Do not chew or bite on the mouthpiece.
6. Remove Turbohaler from mouth. Then breathe out gently.
7. If you are to take a second inhalation, repeat steps 2 to 6
8. Replace the cover tightly after use.
There is only a small amount of the drug delivered during each dose, so the patient may not taste it. However if used correctly it can be assumed the drug has been adequately delivered.

5.0

6.3 Metabolism
Formoterol is metabolized by direct Glucuronidation and O-demethylation followed by glucuronide conjugation (Phase II metabolism).
6.4 Excretion
The majority of the formoterol dose is eliminated via metabolism. After inhalation, 59%-62% is eliminated in the urine and 32%-34% in faeces. About 8%-13% is excreted unmetabolised in the urine, and about 15% to 18% is excreted in the urine as conjugates. The terminal half-life after inhalation is estimated to be 17 hours.
7.0 Contraindications/Adverse Side Effects
7.1
 Contraindications for Formoterol include hypersensitivity to Formoterol or to Lactose Monohydrate; may cause anaphylaxis, severe hypotension and angioedema.
 It should not be used as a first line treatment for asthma, and patients on long acting β2 agonists should also receive anti-inflammatory treatment with inhaled corticosteroids.
 Oxis Turbohaler may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, however patients should not be given Oxis Turbohaler during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
 Daily Dose should not be