Tudorza Pressair (aclidinium bromide, 400 mcg), Dosage, Cost, Side Effects, Prescribing Information for COPD | Timothy O'Shea, PharmD | RxEconsult

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Tudorza Pressair (aclidinium bromide), Dosage, Cost, Side Effects, Prescribing Information for COPD Category: Chronic obstructive pulmonary disease (COPD) and Asthma by - January 11, 2015 | Views: 27313 | Likes: 0 | Comment: 0  

Tudorza Pressair for COPD

Brand name: Tudorza Pressair 
Generic name: aclidinium bromide

Drug Class: Anticholinergics, Respiratory
Similar Drugs: Incruse Ellipta, Spiriva Respimat, Atrovent HFA
Manufacturer: Forest Pharmaceutics, Inc.
FDA Approval Date: July 23, 2012

What is Tudorza Pressair and its mechanism of action?

Tudorza Pressair is a breath-actuated multi-dose dry powder inhaler. Each actuation provides a metered dose of 13 mg of the formulation which contains 400 mcg of aclidinium bromide. Aclidinium bromide is a long-acting antimuscarinic agent, often referred to as an anticholinergic. In the airways, it exhibits pharmacological actions through inhibition of the muscarinic receptor M3 at smooth muscles, leading to bronchodilation.

What is Tudorza Pressair FDA indicated for?

Tudorza Pressair is used for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Tudorza Pressair is not indicated for the treatment of acute episodes of bronchospasm (for example, rescue therapy)

How often should Tudorza Pressair be used?

The recommended dose of Tudorza Pressair is one inhalation of 400 mcg twice daily. Each dose should be given about 12 hours apart.

How effective is Tudorza Pressair?

Three clinical trials concluded that Tudorza Pressair 400 mcg resulted in statistically significantly greater bronchodilation as measured by change from baseline in morning pre-dose FEV1 at 12 weeks compared to placebo.

What are warnings and precautions for Tudorza Pressair?

Paradoxical bronchospasm may occur. Discontinue Tudorza Pressair if this occurs and consider another treatment.

Worsening of narrow-angle glaucoma may also occur. Monitor for signs of eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema.

Tudorza Pressair may worsen urinary retention. Monitor for signs of difficulty passing urine or painful urination.

Immediate hypersensitivity reactions have been reported. Discontinue if this occurs and consider alternative treatment. Patients with documented hypersensitivity reaction to atropine or milk proteins may be at higher hypersensitivity risk and should be monitored more closely for symptoms.

How do you administer Tudorza Pressair?

After removing Tudorza Pressair inhaler from the protective pouch use the following steps to administer the medication.

1.     Step 1: Remove the protective cap by lightly squeezing the arrows marked on each side of the cap and pulling outwards.

2.     Step 2: Hold the Tudorza Pressair inhaler with the mouthpiece facing you. The green button should be facing straight up.

3.     Step 3: Before putting the inhaler in your mouth, press the green button all the way down and then release.

4.     Step 4: Check the control window to make sure your dose is ready for inhalation. The green control window tells you that your medicine is ready for inhalation while red indicates the inhaler is not ready for use. If the control window stays red, repeat step 3 until the control window is green.

5.     Step 5: Take a deep breath away from the inhaler and put your lips tightly around the mouthpiece of the inhaler. Breath in quick and deeply through your mouth until you hear a “click” sound. Keep breathing in after the “click” to ensure you get the full dose.

6.     Step 6: Remove the Tudorza pressair inhaler from your mouth and hold your breath for as long as is comfortable, then breath out slowly through your nose.

7.     Step 7: Check the control window to ensure you used the inhaler correctly. The window should have turned from green to red. If still green, repeat step 5

8.     Step 8: Replace the protective cap back onto the inhaler.

What are important patient counseling points for Tudorza Pressair?

Tudorza Pressair has a dose indicator that shows how many doses are left in the inhaler. Each inhaler has 60 doses of medicine. The dose indicator will decrease by intervals of 10.

Discard the inhaler 45 days after opening the pouch, after the marking “0” with a red background appears in the dose indicator, or when the device locks out, whichever comes first.

If you miss a dose, take your next dose at the usual time; do not take 2 doses at one time.

The inhaler does not need to be cleaned. If you wish to clean it, wipe the outside of the mouthpiece with a dry tissue or paper towel. Do not use water to clean the inhaler as this may damage the medication.

What are possible side effects of Tudorza Pressair?

Most common (>3% incidence): headache, nasopharyngitis, cough

Less common (<3%): diarrhea, sinusitis, rhinitis, toothache, fall, vomiting

Rare (<1%): diabetes mellitus, dry mouth, 1st degree heart block, osteoarthritis, cardiac failure, cardio-respiratory arrest

Are there any drug interactions with Tudorza Pressair?

Tudorza Pressair may result in additive anticholinergic effect when used concomitantly with other anticholinergic medications. Therefore, avoid combining Tudorza Pressair with other anticholinergic drugs.

Is Tudorza Pressair safe for use in pregnant and nursing women?

Tudorza Pressair is classified as pregnancy category C. Adverse effects on development were observed in rats and rabbits exposed to aclidinium bromide, however there are no adequate and well controlled studies in women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

This medication should be used with caution in nursing women. Aclidinium bromide was shown to be excreted into the milk of lactating female rats and decrease pup weights were observed. Excretion into human milk is probable, however no studies have investigated this effect.

Is Tudorza Pressair safe for use in geriatric patients?

In three clinical studies, no overall differences in safety or effectiveness were observed in older versus young patients

What is the cost of Tudorza Pressair? 

The average wholesale price (AWP) for a 60 metered dose of Tudorza Pressair inhaler is $307.


Tudorza Pressair Prescribing Information (package insert)

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