Tudorza Pressair aclidinium bromide 400 ug Powder, Metered — NDC 70515-002-01 (Billing 70515-0002-01)
This is a package of Tudorza Pressair aclidinium bromide 400 ug Powder, Metered from Covis Pharma US, Inc, marketed since Jul 2015 and currently FDA-listed; retail pharmacies pay about $431.50 per unit (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 70515-002-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70515 labeler · 002 product · 01 package
- Package marketed since
- Jul 1, 2015
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7051500201 2
- Medicaid fills, this package
- 1,597 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 069855
- GCN: 33084
- GPI-14 (Medi-Span): 44100007108020
- HICL (First Databank): 039528
- AHFS class code: 12:08.08.00
- RxCUI (RxNorm): 1303102
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Tudorza Pressair (aclidinium) is a daily maintenance medicine for COPD. It helps keep your airways open over time. It is not meant to treat sudden breathing trouble.
- No. This is not a rescue inhaler. Use the quick-relief medicine your prescriber gave you for sudden symptoms, and ask us if you are unsure what that is.
- Can I use it when I'm short of breath suddenly?
- It is one inhalation in the morning and one in the evening, about 12 hours apart. It is for oral inhalation only. Follow your prescriber's directions and the instructions with your...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Aclidinium Bromide — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $431.500 | $25,890.00 / 60 powders |
| Medicaid paysCMS SDUD · 12 mo | $552.34 | $33,140.33 / 60 powders |
| Medicare drug plans payPart D · Q2 2026 | $405.81 | $24,348.76 / 60 powders |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 70515-0002-01 You're viewing this Main listing | 1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER | $431.50 / ea | $25,890.00 | 2015-07-01 | — | Active |
| 70515-0002-02 70515-002-02 | 1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER | $257.59 / ea | $7,727.79 | 2015-07-01 | — | Active |
| 70515-0002-03 70515-002-03 | 1 POUCH in 1 CARTON / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER Sample | — | — | 2015-07-01 | — | Active |
Per ea, this pack runs about 68% above the cheapest pack (NDC 70515-0002-02, $257.59 vs $431.50 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 86% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Tudorza Pressair aclidinium bromide 400 ug Powder, Metered?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tudorza Pressair 400 ugthis 70515-0002-01 | Covis | 1 pouch | $431.500 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10085974 ↗ | Method of use | U-2513 | Mar 13, 2029 |
| US 11000517 ↗ | Method of use | U-2513 | Mar 13, 2029 |
Is there a generic version of TUDORZA PRESSAIR 400 MCG INHAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Aclidinium Oral Inhalation inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Covis Pharma US, Inc labeler code 70515
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- LANOXIN digoxin 250 ug/mL Injection, Solution NDC 70515-261-10
- LANOXIN digoxin 100 ug/mL Injection, Solution NDC 70515-262-10
- LANOXIN digoxin 100 ug/mL Injection, Solution NDC 70515-263-10
- Sular nisoldipine 8.5 mg Tablet, Film Coated, Extended Release NDC 70515-500-10
- Sular nisoldipine 17 mg Tablet, Film Coated, Extended Release NDC 70515-501-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily (morning and evening approximately 12 hours apart). For oral inhalation only • One inhalation of TUDORZA PRESSAIR 400 mcg twice daily. (2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. • Inhalation powder; The multi-dose device is a dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of TUDORZA PRESSAIR is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions (5.5) ] • Hypersensitivity to aclidinium bromide or any of the excipients [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to milk proteins. (4) • Hypersensitivity to any ingredient. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Not for acute use: Not for use as a rescue medication. (5.1) • Paradoxical bronchospasm: Discontinue TUDORZA PRESSAIR and consider other treatments if paradoxical bronchospasm occurs. (5.2) • Worsening of narrow-angle glaucoma may occur.
Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. (5.3) • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs.
(5.4) • Immediate hypersensitivity reactions: Discontinue TUDORZA PRESSAIR at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis occur. (5.5)
5.1Not for Acute Use 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).
5.2Paradoxical Bronchospasm Inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If this occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered.
5.3Worsening of Narrow-Angle Glaucoma TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
5.4Worsening of Urinary Retention TUDORZA PRESSAIR should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of prostatic hyperplasia or bladder-neck obstruction (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
5.5Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching, have occurred after administration of TUDORZA PRESSAIR. If such a reaction occurs, therapy with TUDORZA PRESSAIR should be stopped at once and alternative treatments should be considered.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 3-Month and 6-Month Trials TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily.
The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV 1 ) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials. Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 1% in the TUDORZA PRESSAIR group in the two 3-month and one 6-month placebo-controlled trials where the rates in the TUDORZA PRESSAIR group exceeded placebo.
Table 1: Adverse Reactions (% Patients) in Placebo-Controlled Clinical Trials Treatment Adverse Reactions TUDORZA PRESSAIR Placebo Preferred Term (N=636) (N=640) n (%) n (%) Headache 42 (6.6) 32 (5.0) Nasopharyngitis 35 (5.5) 25 (3.9) Cough 19 (3.0) 14 (2.2) Diarrhea 17 (2.7) 9 (1.4) Sinusitis 11 (1.7) 5 (0.8) Rhinitis 10 (1.6) 8 (1.2) Toothache 7 (1.1) 5 (0.8) Fall 7 (1.1) 3 (0.5) Vomiting 7 (1.1) 3 (0.5) In addition, among the adverse reactions observed in the clinical trials with an incidence of less than 1% were diabetes mellitus, dry mouth, 1 st degree AV block, osteoarthritis, cardiac failure, and cardio-respiratory arrest.
Long-term Safety Trials TUDORZA PRESSAIR was studied in three long-term safety trials, two double blind and one open label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. Two of these trials were extensions of the 3-month trials, and one was a dedicated long-term safety trial. In these trials, 891 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily.
The demographic and baseline characteristics of the long-term safety trials were similar to those of the placebo-controlled trials. The adverse events reported in the long-term safety trials were similar to those occurring in the placebo-controlled trials of 3 to 6 months. No new safety findings were reported compared to the placebo-controlled trials.
Long-Term Trial of up to 3-Years In a long-term safety trial with 3630 moderate to very severe COPD patients with previous major cardiac events or cardiovascular risk factors at baseline, the adverse reactions reported with a frequency ≥2% in the TUDORZA PRESSAIR group in which the exposure-adjusted incidence rate exceeds the placebo group were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease.
No other new adverse reactions were identified.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of drug TUDORZA PRESSAIR. Because these reactions are reported volunt… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS In vitro studies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with TUDORZA PRESSAIR [see Clinical Pharmacology (12.3) ] . Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of TUDORZA PRESSAIR with other anticholinergic-containing drugs. ( 7.2 )
7.1Sympathomimetics, Methylxanthines, Steroids In clinical studies, concurrent administration of aclidinium bromide and other drugs commonly used in the treatment of COPD including sympathomimetics (short-acting beta 2 agonists), methylxanthines, and oral and inhaled steroids showed no increases in adverse drug reactions.
7.2Anticholinergics There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of TUDORZA PRESSAIR with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well controlled studies of TUDORZA PRESSAIR in pregnant women to inform drug associated risks. No adverse developmental effects were seen with inhalation administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID). However, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID of aclidinium bromide.
Adverse developmental effects occurred when rabbits were orally dosed with aclidinium bromide at approximately 1,400 times the MRHDID [ see Data ]. The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-17, no evidence of structural alterations was observed at approximately 15 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 5.0 mg/kg/day]. However, in a pre- and post-natal development study, decreased pup weights were observed when pregnant rats were exposed from gestation day 6 and continuing during the lactation period at approximately 5 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses greater than or equal to 0.2 mg/kg/day].
Maternal toxicity was also observed at inhaled doses greater than or equal to 0.2 mg/kg/day. In an embryo-fetal development study in pregnant Himalayan rabbits administered inhaled doses of aclidinium bromide during the period of organogenesis from gestation days 6-19, no evidence of structural alterations was observed at approximately 20 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 3.6 mg/kg/day]. However, in another embryo-fetal development study in pregnant Himalayan rabbits dosed orally from gestation days 6-19, increased incidences of additional liver lobes (3-5%), as compared to 0% in the control group, were observed at approximately 1,400 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 150 mg/kg/day], and decreased fetal body weights were observed at approximately 2,300 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 300 mg/kg/day].
These fetal findings were observed in the presence of maternal toxicity.
8.2Lactation Risk Summary There are no available data on the effects of TUDORZA PRESSAIR or aclidinium bromide on the breastfed child or on milk production or presence in human milk. Aclidinium bromide is present in milk of lactating female rats [ see Data ]. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TUDORZA PRESSAIR and any potential adverse effects on the breastfed child from TUDORZA PRESSAIR or from the underlying maternal condition. Data In a pharmacokinetic study, levels of radioactivity in milk and plasma in rats were measured after a single intravenous dose of 1 mg/kg of radiolabeled aclidinium bromide on approximately post-natal day 14 [see Use in Specific Populations (8.1) ] . The maximum concentration of radioactivity [ 14 C-aclidinium] in milk was measured at 6 hours post-dose and was found to be 10-14 times higher than in plasma.
8.4Pediatric Use TUDORZA PRESSAIR is approved for use in the maintenance treatment of bronchospasm associated with COPD. COPD do… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well controlled studies of TUDORZA PRESSAIR in pregnant women to inform drug associated risks. No adverse developmental effects were seen with inhalation administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID). However, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID of aclidinium bromide.
Adverse developmental effects occurred when rabbits were orally dosed with aclidinium bromide at approximately 1,400 times the MRHDID [ see Data ]. The estimated background risk of major birth defects and miscarriage of the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-17, no evidence of structural alterations was observed at approximately 15 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 5.0 mg/kg/day]. However, in a pre- and post-natal development study, decreased pup weights were observed when pregnant rats were exposed from gestation day 6 and continuing during the lactation period at approximately 5 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses greater than or equal to 0.2 mg/kg/day].
Maternal toxicity was also observed at inhaled doses greater than or equal to 0.2 mg/kg/day. In an embryo-fetal development study in pregnant Himalayan rabbits administered inhaled doses of aclidinium bromide during the period of organogenesis from gestation days 6-19, no evidence of structural alterations was observed at approximately 20 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 3.6 mg/kg/day]. However, in another embryo-fetal development study in pregnant Himalayan rabbits dosed orally from gestation days 6-19, increased incidences of additional liver lobes (3-5%), as compared to 0% in the control group, were observed at approximately 1,400 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 150 mg/kg/day], and decreased fetal body weights were observed at approximately 2,300 times the MRHDID [based on summed AUCs of aclidinium bromide and its metabolites at oral doses greater than or equal to 300 mg/kg/day].
These fetal findings were observed in the presence of maternal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use TUDORZA PRESSAIR is approved for use in the maintenance treatment of bronchospasm associated with COPD. COPD does not normally occur in children. The safety and effectiveness of TUDORZA PRESSAIR in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 636 COPD patients exposed to TUDORZA PRESSAIR 400 mcg twice daily for up to 24 weeks in three placebo-controlled clinical trials, 197 were less than 60 years, 272 were greater than or equal to 60 to less than 70 years, and 167 were greater than or equal to 70 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Based on available data for TUDORZA PRESSAIR, no adjustment of dosage in geriatric patients is warranted [see Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Human Experience No case of overdose has been reported in clinical studies with TUDORZA PRESSAIR. There were no systemic anticholinergic or other adverse effects following a single inhaled dose of up to 6,000 mcg aclidinium bromide (7.5 times the RHDD) in 16 healthy volunteers.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 1 to M 5 . In the airways, it exhibits pharmacological effects through inhibition of M 3 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 in vitro as well as in vivo 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.
12.2Pharmacodynamics Cardiovascular Effects In a thorough QT Study, 200 mcg and 800 mcg TUDORZA PRESSAIR was administered to healthy volunteers once daily for 3 days; no effects on prolongation of QT interval were observed using QTcF heart-rate correction methods. Additionally, the effect of TUDORZA PRESSAIR on cardiac rhythm was assessed in 336 COPD patients, 164 patients received aclidinium bromide 400 mcg twice daily and 172 patients received placebo, using 24-hr Holter monitoring. No clinically significant effects on cardiac rhythm were observed.
12.3Pharmacokinetics Absorption The absolute bioavailability of aclidinium bromide is approximately 6% in healthy volunteers. Following twice-daily oral inhalation administration of 400 mcg aclidinium bromide in healthy subjects, peak steady state plasma levels were observed within 10 minutes after inhalation. Distribution Aclidinium bromide shows a volume of distribution of approximately 300 L following intravenous administration of 400 mcg in humans.
Metabolism Clinical pharmacokinetics studies, including a mass balance study, indicate that the major route of metabolism of aclidinium bromide is hydrolysis, which occurs both chemically and enzymatically by esterases. Aclidinium bromide is rapidly and extensively hydrolyzed to its alcohol and dithienylglycolic acid derivatives, neither of which binds to muscarinic receptors and are devoid of pharmacologic activity. Therefore, due to the low plasma levels achieved at the clinically relevant doses, aclidinium bromide and its metabolites are not expected to alter the disposition of drugs metabolized by the human CYP450 enzymes.
Elimination Total clearance was approximately 170 L/h after an intravenous dose of aclidinium bromide in young healthy volunteers with an inter-individual variability of 36%. Intravenously administered radiolabeled aclidinium bromide was administered to healthy volunteers and was extensively metabolized with 1% excreted as unchanged aclidinium. Approximately 54% to 65% of the radioactivity was excreted in urine and 20% to 33% of the dose was excreted in feces.
The combined results indicated that almost the entire aclidinium bromide dose was eliminated by hydrolysis. After dry powder inhalation, urinary excretion of aclidinium is about 0.09% of the dose and the estimated effective half-life is 5 to 8 hours. Drug Interactions Formal drug interaction studies were not performed.
In vitro studies using human liver microsomes indicated that aclidinium bromide and its major metabolites do not inhibit CYP450, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11 at concentrations up to 1,000-fold higher than the maximum plasma concentration that would be expected to be achieved at the therapeutic dose. Therefore, it is unlikely that aclidinium bromide causes CYP450 related drug interactions [see Drug Interactions (7) ] . Specific Populations Elderly Patients The pharmacokinetic profile of aclidinium bromide and its main metabolites was assessed in 12 elderly COPD patients (aged 70 years or older) compared to a younger cohort of 12 COPD patients (40-59 years) that were administered 400 mcg aclidiniu… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 1 to M 5 . In the airways, it exhibits pharmacological effects through inhibition of M 3 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 in vitro as well as in vivo 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING TUDORZA ® PRESSAIR ® (aclidinium bromide inhalation powder) 400 mcg is supplied in a sealed bag and is available in 60 metered doses (NDC 0310-0800-60) and 30 metered doses (NDC 0310-0800-39). The active ingredient is administered using a multi-dose dry powder inhaler, PRESSAIR ® , which delivers 60 doses or 30 doses of aclidinium bromide powder for oral inhalation. The PRESSAIR inhaler is a white and green colored device and is comprised of an assembled plastic dosing mechanism with a dose indicator, a drug-product storage unit containing the drug-product formulation, and a mouthpiece covered by a green protective cap.
Store TUDORZA PRESSAIR in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] . Do not store the inhaler on a vibrating surface. The PRESSAIR inhaler should be stored inside the sealed bag and only be opened immediately before use.
Throw away the bag. Throw away (dispose of) the PRESSAIR inhaler after the marking “0” with a red background shows in the middle of the dose indicator, when the device is empty and locks out, or 45 days after the date you opened the sealed bag that the inhaler comes in, whichever comes first. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION 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 R )-.
The structural formula is: Aclidinium bromide is a white powder with a molecular formula of C 26 H 30 NO 4 S 2 Br 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 (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on in 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.
Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved Patient Labeling (Patient Information and Instructions for Use) • Acute Bronchospasm Instruct patients that TUDORZA PRESSAIR is a twice daily maintenance bronchodilator and should not be used for immediate relief of breathing problems (i.e., as a rescue medication) [see Warnings and Precautions (5.1) ] . • Paradoxical Bronchospasm Inform patients that TUDORZA PRESSAIR can cause paradoxical bronchospasm. Advise patients that if paradoxical bronchospasm occurs, patients should discontinue TUDORZA PRESSAIR [see Warnings and Precautions (5.2) ]. • Visual Effects Eye pain or discomfort, blurred vision, visual halos, or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma.
Inform patients to consult a physician immediately should any of these signs and symptoms develop. Advise patients that miotic eyedrops alone are not considered to be effective treatment [see Warnings and Precautions (5.3) ] . Inform patients that care must be taken not to allow the powder to enter into the eyes as this may cause blurring of vision and pupil dilation. • Urinary Retention Difficulty passing urine and dysuria may be symptoms of new or worsening prostatic hyperplasia or bladder outlet obstruction.
Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop [see Warnings and Precautions (5.4) ] . • Immediate Hypersensitivity Reactions Inform patients that anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching, may occur after administration of TUDORZA PRESSAIR. Advise patient to immediately discontinue treatment and consult a physician should any of these signs or symptoms develop [see Contraindications (4) and Warnings and Precautions (5.5) ]. • Instructions for Administering TUDORZA PRESSAIR It is important for patients to understand how to correctly use TUDORZA PRESSAIR.
Inform patients that if they miss a dose, they should take their next dose at the usual time; they should not take 2 doses at one time. Manufactured for: Covis Pharma, Zug, 6300 Switzerland Under license of ALMIRALL, S.A. TUDORZA® and the logo are registered trademarks of Almirall, S.A., used under license by Covis Pharma.
PRESSAIR® is a registered trademark of the AstraZeneca group of companies, used under license by Covis Pharma. © 2022 Covis Pharma
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The absolute bioavailability of aclidinium bromide is approximately 6% in healthy volunteers. Following twice-daily oral inhalation administration of 400 mcg aclidinium bromide in healthy subjects, peak steady state plasma levels were observed within 10 minutes after inhalation. Distribution Aclidinium bromide shows a volume of distribution of approximately 300 L following intravenous administration of 400 mcg in humans.
Metabolism Clinical pharmacokinetics studies, including a mass balance study, indicate that the major route of metabolism of aclidinium bromide is hydrolysis, which occurs both chemically and enzymatically by esterases. Aclidinium bromide is rapidly and extensively hydrolyzed to its alcohol and dithienylglycolic acid derivatives, neither of which binds to muscarinic receptors and are devoid of pharmacologic activity. Therefore, due to the low plasma levels achieved at the clinically relevant doses, aclidinium bromide and its metabolites are not expected to alter the disposition of drugs metabolized by the human CYP450 enzymes.
Elimination Total clearance was approximately 170 L/h after an intravenous dose of aclidinium bromide in young healthy volunteers with an inter-individual variability of 36%. Intravenously administered radiolabeled aclidinium bromide was administered to healthy volunteers and was extensively metabolized with 1% excreted as unchanged aclidinium. Approximately 54% to 65% of the radioactivity was excreted in urine and 20% to 33% of the dose was excreted in feces.
The combined results indicated that almost the entire aclidinium bromide dose was eliminated by hydrolysis. After dry powder inhalation, urinary excretion of aclidinium is about 0.09% of the dose and the estimated effective half-life is 5 to 8 hours. Drug Interactions Formal drug interaction studies were not performed.
In vitro studies using human liver microsomes indicated that aclidinium bromide and its major metabolites do not inhibit CYP450, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11 at concentrations up to 1,000-fold higher than the maximum plasma concentration that would be expected to be achieved at the therapeutic dose. Therefore, it is unlikely that aclidinium bromide causes CYP450 related drug interactions [see Drug Interactions (7) ] . Specific Populations Elderly Patients The pharmacokinetic profile of aclidinium bromide and its main metabolites was assessed in 12 elderly COPD patients (aged 70 years or older) compared to a younger cohort of 12 COPD patients (40-59 years) that were administered 400 mcg aclidinium bromide once daily for 3 days via inhalation.
No clinically significant differences in systemic exposure (AUC and C max ) were observed when the two groups were compared. No dosage adjustment is necessary in elderly patients [see Use in Specific Populations (8.5) ] . Renal Impairment The impact of renal disease upon the pharmacokinetics of aclidinium bromide was studied in 18 subjects with mild, moderate, or severe renal impairment.
Systemic exposure (AUC and C max ) to aclidinium bromide and its main metabolites following single doses of 400 mcg aclidinium bromide was similar in renally impaired patients compared with 6 matched healthy control subjects. No dose adjustment is necessary in renally impaired patients [see Use in Specific Populations (8.6) ] . Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of aclidinium bromide were not studied.
However, hepatic insufficiency is not expected to have relevant influence on aclidinium bromide pharmacokinetics, since it is predominantly metabolized by chemical and enzymatic hydrolysis to products that do not bind to muscarinic receptors [see Use in Specific Populations (8.7) ].
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Cardiovascular Effects In a thorough QT Study, 200 mcg and 800 mcg TUDORZA PRESSAIR was administered to healthy volunteers once daily for 3 days; no effects on prolongation of QT interval were observed using QTcF heart-rate correction methods. Additionally, the effect of TUDORZA PRESSAIR on cardiac rhythm was assessed in 336 COPD patients, 164 patients received aclidinium bromide 400 mcg twice daily and 172 patients received placebo, using 24-hr Holter monitoring. No clinically significant effects on cardiac rhythm were observed.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Chronic Obstructive Pulmonary Disease (COPD) The TUDORZA PRESSAIR clinical development program included a dose-ranging trial (Trial A) for nominal dose selection and three confirmatory lung function trials (Trials B, C, and D). Two additional lung function trials (Trials E and F) of aclidinium bromide alone and as part of a fixed-dose combination product also provided information on the effect of TUDORZA PRESSAIR on the St. George’s Respiratory Questionnaire (SGRQ) total score compared to placebo.
A long-term study of up to 3 years (Trial G) evaluated the effect of TUDORZA PRESSAIR on major adverse cardiovascular events and on COPD exacerbations. Dose-ranging trial Trial A (NCT01120093) was a randomized, double-blind, placebo-controlled, active-controlled, crossover trial with 7-day treatment periods separated by 5-day washout periods. Trial A enrolled 79 patients who had a clinical diagnosis of COPD were 40 years of age or older, had a history of smoking at least 10 pack-years, had a forced expiratory volume in one second (FEV 1 ) of at least 30% and less than 80% of predicted normal value, and a ratio of FEV 1 over forced vital capacity (FEV 1 /FVC) of less than 0.7.
Trial A included TUDORZA PRESSAIR doses of 400 mcg, 200 mcg, and 100 mcg twice daily, formoterol active control, and placebo. Trial A demonstrated that the effect on trough FEV 1 and serial FEV 1 in patients treated with the TUDORZA PRESSAIR 100 mcg twice daily and 200 mcg twice daily doses was lower compared to patients treated with the TUDORZA PRESSAIR 400 mcg twice daily dose ( Figure 1 ). Figure 1: Change from baseline in FEV 1 Over Time (prior to and after administration of study drug) at Week 1 in Trial A Confirmatory trials Trials B (NCT00891462), C (NCT01045161), and D (NCT01001494) were three randomized, double-blind, placebo-controlled trials in patients with COPD.
Trials B and C were 3 months in duration, and Trial D was 6 months in duration. These trials enrolled 1,276 patients who had a clinical diagnosis of COPD, including chronic bronchitis and emphysema, were 40 years of age or older, had a history of smoking at least 10 pack-years, had an FEV 1 of at least 30% and less than 80% of predicted normal value, and a ratio of FEV 1 /FVC of less than 0.7; 59% were male, and 93% were Caucasian. These clinical trials evaluated TUDORZA PRESSAIR 400 mcg twice daily (636 patients) and placebo (640 patients).
TUDORZA PRESSAIR 400 mcg resulted in statistically significantly greater bronchodilation as measured by change from baseline in morning pre-dose FEV 1 at 12 weeks (the primary efficacy endpoint) compared to placebo in all three trials ( Table 2 ). Table 2: Change from Baseline in Trough FEV 1 (L) at Week 12 Treatment Arm Baseline Change from Baseline LS Mean (SE) Treatment Difference LS Mean (95% CI) Trial B (N=375) Aclidinium 400 mcg 1.33 0.10 (0.01) 0.12 (0.08, 0.16) Placebo 1.38 -0.02 (0.02) Trial C (N=359) Aclidinium 400 mcg 1.25 0.06 (0.02) 0.07 (0.03, 0.12) Placebo 1.46 -0.01 (0.02) Trial D In the 6-month Trial D, placebo adjusted change from baseline in Trough FEV 1 at 24 weeks was 0.13 (0.09, 0.17).
(N=542) Aclidinium 400 mcg 1.51 0.06 (0.02) 0.11 (0.07, 0.14) Placebo 1.50 -0.05 (0.02) SE=standard error, and LS mean=least square mean. LS mean, and 95% confidence interval were obtained from an ANCOVA model with change from baseline in trough FEV 1 as response, with treatment group and sex as factors and baseline trough FEV 1 and age as covariates. Serial spirometric evaluations were performed throughout daytime hours in a subset of patients in the three trials.
The serial FEV 1 values over 12 hours for one of the 3-month trials (Trial B) are displayed in Figure 2 . Results for the other two placebo-controlled trials were similar to the results for Trial B. Improvement of lung function was maintained for 12 hours after a single dose and was consistent over the 3- or 6-month treatment period.
Figure 2: Mean FEV 1 Over Time (… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year inhalation studies were conducted in mice and rats to assess the carcinogenic potential of aclidinium bromide. No evidence of tumorigenicity was observed in rats and mice at aclidinium doses up to 0.20 and 2.4 mg/kg/day, respectively [approximately 10 and 80 times the Maximum Recommended Human Daily Inhalation Dose (MRHDID), respectively, based on summed AUCs of aclidinium bromide and its metabolites]. Aclidinium bromide was positive in the in vitro bacterial gene mutation assay and the in vitro thymidine locus mouse lymphoma assay.
However, aclidinium bromide was negative in the in vivo mouse micronucleus assay and the in vivo/in vitro unscheduled DNA synthesis assay with rat liver. Aclidinium bromide impaired several fertility and reproductive performance indices (increased number of days to mate, decreased conception rate, decreased number of corpora lutea, increased pre-implantation loss with consequent decreased number of implantations, and live embryos) in both male and female rats administered inhaled doses greater than or equal to 0.8 mg/kg/day [approximately 15 times the MRHDID based on summed AUCs of aclidinium bromide and its metabolites].
These adverse fertility effects were observed in the presence of paternal toxicity as evidenced by mortality and decreased body weight gain. However, there were no effects on mating index and sperm number and morphology. In the separate fertility assessments (treated males mated with untreated females; treated females mated with untreated males), no effect was observed in male and female rats at inhaled doses of 1.9 and 0.8 mg/kg/day, respectively [approximately 30 and 15 times the MRHDID, respectively, based on summed AUCs of aclidinium bromide and its metabolites].
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year inhalation studies were conducted in mice and rats to assess the carcinogenic potential of aclidinium bromide. No evidence of tumorigenicity was observed in rats and mice at aclidinium doses up to 0.20 and 2.4 mg/kg/day, respectively [approximately 10 and 80 times the Maximum Recommended Human Daily Inhalation Dose (MRHDID), respectively, based on summed AUCs of aclidinium bromide and its metabolites]. Aclidinium bromide was positive in the in vitro bacterial gene mutation assay and the in vitro thymidine locus mouse lymphoma assay.
However, aclidinium bromide was negative in the in vivo mouse micronucleus assay and the in vivo/in vitro unscheduled DNA synthesis assay with rat liver. Aclidinium bromide impaired several fertility and reproductive performance indices (increased number of days to mate, decreased conception rate, decreased number of corpora lutea, increased pre-implantation loss with consequent decreased number of implantations, and live embryos) in both male and female rats administered inhaled doses greater than or equal to 0.8 mg/kg/day [approximately 15 times the MRHDID based on summed AUCs of aclidinium bromide and its metabolites].
These adverse fertility effects were observed in the presence of paternal toxicity as evidenced by mortality and decreased body weight gain. However, there were no effects on mating index and sperm number and morphology. In the separate fertility assessments (treated males mated with untreated females; treated females mated with untreated males), no effect was observed in male and female rats at inhaled doses of 1.9 and 0.8 mg/kg/day, respectively [approximately 30 and 15 times the MRHDID, respectively, based on summed AUCs of aclidinium bromide and its metabolites].
📄 Patient Package Insert ▾
Patient Information TUDORZA ® PRESSAIR ® (TU-door-za PRESS-air) (aclidinium bromide inhalation powder) Important: For oral inhalation only. Do not get TUDORZA PRESSAIR in your eyes. What is TUDORZA PRESSAIR? • TUDORZA PRESSAIR is a prescription medicine to treat chronic obstructive pulmonary disease (COPD).
COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both. • TUDORZA PRESSAIR is an anticholinergic medicine. Anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. • TUDORZA PRESSAIR is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor should give you other medicine to use for sudden breathing problems.
It is not known if TUDORZA PRESSAIR is safe and effective in children. Who should not use TUDORZA PRESSAIR? Do not use TUDORZA PRESSAIR if you: • have a severe allergy to milk proteins.
Ask your doctor if you are not sure. • are allergic to aclidinium bromide or any of the ingredients in TUDORZA PRESSAIR. See “What are the ingredients in TUDORZA PRESSAIR?” below for a complete list of ingredients. What should I tell my doctor before using TUDORZA PRESSAIR?
Before you use TUDORZA PRESSAIR, tell your doctor about all your medical conditions, including if you: • have eye problems, especially glaucoma. TUDORZA PRESSAIR may make your glaucoma worse. • have prostate or bladder problems, or problems passing urine. TUDORZA PRESSAIR may make these problems worse. • are pregnant or plan to become pregnant.
It is not known if TUDORZA PRESSAIR can harm your unborn baby. • are breast-feeding or plan to breast-feed. TUDORZA PRESSAIR may pass into your breast milk. You and your doctor should decide if you will take TUDORZA PRESSAIR.
Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines and eyedrops, vitamins, and herbal supplements. TUDORZA PRESSAIR and certain other medicines may interact with each other causing serious side effects. Especially tell your doctor if you take: • other anticholinergic medicines (including tiotropium, ipratropium, umeclidinium, glycopyrrolate). • atropine.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine. How should I use TUDORZA PRESSAIR? • See the “Instructions for Use” for information on how to use TUDORZA PRESSAIR at the end of this Patient Information. • Use TUDORZA PRESSAIR exactly as prescribed.
Do not use TUDORZA PRESSAIR more often than prescribed or take more medicine than prescribed for you. • The usual dose of TUDORZA PRESSAIR is 1 oral inhalation 2 times a day. Each dose should be about 12 hours apart. • If you miss a dose of TUDORZA PRESSAIR, skip the missed dose. Take your next dose at your usual time.
Do not take 2 doses at one time. • Do not use other medicines that contain an anticholinergic for any reason . Ask your doctor or pharmacist if any of your other medicines are anticholinergic medicines. • TUDORZA PRESSAIR does not relieve sudden symptoms of COPD and you should not use extra doses of TUDORZA PRESSAIR to relieve these sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
If you do not have a rescue inhaler medicine, call your doctor to have one prescribed for you. • Call your doctor or get emergency medical care right away if: • your breathing problems worsen with TUDORZA PRESSAIR • you need to use your rescue inhaler medicine more often than usual • your rescue inhaler medicine does not work as well for you at relieving symptoms What are the possible side effects of TUDORZA PRESSAIR? TUDORZA PRESSAIR can cause serious side effects including: • sudden breathing problems immediately after use of TUDORZA PRESSAIR.
If you have sudden breathing problems immediately after inhaling TUDORZA PRESSAIR, stop using TUDORZA PRESSAIR and c… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use TUDORZA ® PRESSAIR ® (TU-door-za PRESS-air) (aclidinium bromide inhalation powder) For oral inhalation only This Instructions for Use contains information on how to use your TUDORZA PRESSAIR inhaler. It is important that you read this information as the TUDORZA PRESSAIR inhaler may work differently from inhalers you have used before. Read this Instructions for Use before you start using TUDORZA PRESSAIR and each time you get a refill.
There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. If you have any questions about how to use your inhaler, ask your doctor, pharmacist, or nurse for help.
The Instructions for Use is divided into the following sections: • Getting started • Before use • Step 1: Prepare your dose • Step 2: Inhale your medicine • Additional information • Questions and Answers about your TUDORZA PRESSAIR Inhaler Getting Started Become familiar with the parts of TUDORZA PRESSAIR inhaler (Figure A). Before use: 1. Right before first use, open the sealed bag at the arrow marking and remove the inhaler.
Throw away the bag. 2. Write the date that you open the sealed bag on the label of the inhaler.
3. Do not press the green button until you are ready to take a dose. 4.
Remove the protective cap by lightly squeezing the arrows marked on each side of the protective cap and pulling straight off (Figure B). Step 1: Prepare your dose
1.1Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).
1.2Look at the control window. The control window should be red (Figure C).
1.3Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).
1.4Press the green button all the way down to load your dose (Figure E). When you press the green button all the way down, the control window changes from red to green. Make sure the green button is on top. Do not tilt the inhaler .
1.5Release the green button (Figure F). Make sure you release the green button, so the inhaler can work correctly. Stop and Check:
1.6Make sure the control window is now green (Figure G). This means your medicine is ready to be inhaled. Go to “Step 2: Inhale your medicine”. What to do if the control window is still red after pressing the button (Figure H). The dose is not prepared. Go back to “Step 1: Prepare your dose” and repeat steps 1.1 to 1.6. Step 2: Inhale your medicine Read steps 2.1 to 2.7 fully before use. Do not tilt the inhaler.
2.1Hold the inhaler away from your mouth, and breathe out completely . Never breathe out into the inhaler (Figure I).
2.2Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around the mouthpiece (Figure J). Do not hold the green button down while inhaling
2.3Take a strong, deep breath through your mouth. Keep breathing in for as long as possible. A “click” will let you know that you are inhaling correctly. Keep breathing in as long as possible after you hear the “click”. Some people may not hear the “click”. Use the control window to make sure you have inhaled correctly.
2.4Take the inhaler out of your mouth.
2.5Hold your breath for as long as possible.
2.6Slowly breathe out, away from the inhaler. Some people may have a grainy sensation in their mouth, or a slightly sweet or bitter taste. Do not take an extra-dose if you do not taste or feel anything after inhaling. Stop and Check:
2.7Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly. What to do if the control window is still green after inhalation (Figure L).
This means you have not inhaled your medicine correctly. Go back to “Step 2: Inhale your medicine” and repeat steps 2.1 to 2.7. If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough.
If this happens, try again. Make sure you have releas… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 60 Metered Doses Carton Carton - 60 Metered Doses NDC 70515-002-01 R x only Tudorza ® Pressair ® (aclidinium bromide inhalation powder) 400 mcg per actuation For Oral Inhalation 60 Metered Doses COVIS 60 metered doses carton