Tudorza Pressair
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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, (3R)-. The structural formula is:
Aclidinium bromide is a white powder with a molecular formula of C26H30NO4S2Br 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 onin vitro 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.
Sources
Tudorza Pressair Manufacturers
- Astrazeneca Pharmaceuticals Lp
![Tudorza Pressair (Aclidinium Bromide) Inhalant [Astrazeneca Pharmaceuticals Lp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tudorza Pressair | Qualitest Pharmaceuticals
Dosing Information
The recommended dose is a single tablet of frovatriptan succinate tablets (frovatriptan 2.5 mg) taken orally with fluids.
If the migraine recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of frovatriptan succinate tablets should not exceed 3 tablets (3 x 2.5 mg per 24 hour period).
There is no evidence that a second dose of frovatriptan succinate tablets is effective in patients who do not respond to a first dose of the drug for the same headache.
The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
- Forest Laboratories, Inc.
Tudorza Pressair | Actavis Pharma, Inc.
Carefully consider the potential benefits and risks of naproxen sodium extended-release tablets and other treatment options before deciding to use naproxen sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with naproxen sodium extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of:
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing SpondylitisThe recommended starting dose of naproxen sodium extended-release tablets in adults is two naproxen sodium extended-release 375 mg tablets (750 mg) once daily, or two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg or 500 mg twice daily (morning and evening) may have their total daily dose replaced with naproxen sodium extended-release tablets as a single daily dose.
During long-term administration, the dose of naproxen sodium extended-release tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of naproxen sodium extended-release tablets well, the dose may be increased to three naproxen sodium extended-release 500 mg tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk. (See Clinical Pharmacology). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.
A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see Precautions). Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.
Management of Pain, Primary Dysmenorrhea, and Acute Tendinitis and BursitisThe recommended starting dose is two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily. For patients requiring greater analgesic benefit, three naproxen sodium extended-release 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two naproxen sodium extended-release 500 mg tablets (1000 mg).
Acute GoutThe recommended dose on the first day is two to three naproxen sodium extended-release 500 mg tablets (1000 - 1500 mg) once daily, followed by two naproxen sodium extended-release 500 mg tablets (1000 mg) once daily, until the attack has subsided.
![Tudorza Pressair (Aclidinium Bromide) Inhalant [Forest Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14496afb-a541-4b01-a672-fcd411292b8d&name=naproxen-sodium-extended-release-tablets-3.jpg)
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