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aclidinium bromide

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Overview

What is Tudorza Pressair?

TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only.

Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-Azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3)-. The structural formula is:

Aclidinium bromide is a white powder with a molecular formula of CHNOSBr and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol.

TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide. This results in delivery of 375 mcg aclidinium bromide from the mouthpiece, based on testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time. The PRESSAIR inhaler delivers the target dose at flow rates as low as 35 L/min. Based on a study in adult patients with moderate (N=24) and severe (N=24) COPD the mean peak inspiratory flow (PIF) was 95.3 L/min (range: 54.6 to 129.4 L/min) and 88.7 L/min (range: 72.0 to 106.4 L/min) respectively.



What does Tudorza Pressair look like?



What are the available doses of Tudorza Pressair?

Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.

What should I talk to my health care provider before I take Tudorza Pressair?

How should I use Tudorza Pressair?

TUDORZA PRESSAIR (aclidinium bromide inhalation powder) is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily.


What interacts with Tudorza Pressair?

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What are the warnings of Tudorza Pressair?

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What are the precautions of Tudorza Pressair?

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What are the side effects of Tudorza Pressair?

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What should I look out for while using Tudorza Pressair?

The use of TUDORZA PRESSAIR is contraindicated in the following conditions:


What might happen if I take too much Tudorza Pressair?


How should I store and handle Tudorza Pressair?

Store TUDORZA PRESSAIR in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [].The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.Keep out of reach of children.Store TUDORZA PRESSAIR in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [].The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.Keep out of reach of children.Store TUDORZA PRESSAIR in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [].The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.Keep out of reach of children.Store TUDORZA PRESSAIR in a dry place at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [].The PRESSAIR inhaler should be stored inside the sealed pouch and only be opened immediately before use.Discard the PRESSAIR inhaler 45 days after opening the pouch, after the marking “0” with a red background shows in the middle of the dose indicator, or when the device locks out, whichever comes first.Keep out of reach of children.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Aclidinium bromide is a long-acting antimuscarinic agent, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M to M. In the airways, it exhibits pharmacological effects through inhibition of M receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical as well as studies, prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of aclidinium bromide is predominantly a site-specific effect.

Non-Clinical Toxicology
The use of TUDORZA PRESSAIR is contraindicated in the following conditions:

TUDORZA PRESSAIR is intended as a twice-daily maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).

The following adverse reactions are described in greater detail in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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