Roflumilast (Daliresp)

Trade Name : Daliresp

AstraZeneca Pharmaceuticals LP

TABLET

Strength 250 ug/1

ROFLUMILAST Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Roflumilast (Daliresp) which is also known as Daliresp and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 250 ug/1 per ml. Read more

Roflumilast (Daliresp) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Limitations of Use
DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
DALIRESP 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (, )
Limitations of Usen

1,n- 14
2,n- 14

The maintenance dose of DALIRESP is one 500 micrograms (mcg) tablet per day, with or without food.
Starting treatment with a dose of DALIRESP 250 mcg once daily for 4 weeks and increasing to DALIRESP 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients . However, 250 mcg per day is not the effective (therapeutic) dose.
The maintenance dose for patients with COPD is one 500 mcg tablet per day, with or without food. Starting treatment with a dose of DALIRESP 250 mcg once daily for 4 weeks and increasing to DALIRESP 500 mcg once daily thereafter may reduce the rate of treatment discontinuation in some patients. ()

Tablets: 250 mcg, 500 mcg ()

The use of DALIRESP is contraindicated in the following condition:
Moderate to severe liver impairment (Child-Pugh B or C) n n .
Moderate to severe liver impairment (Child-Pugh B or C) ()

No data

The following adverse reactions are described in greater detail in other sections:
Most common adverse reactions (u22652%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite. ()
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .

A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2 .
Use with inhibitors of CYP3A4 or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) will increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit. ()

Nursing Mothers: DALIRESP should not be used by women who are nursing as excretion of roflumilast and/or its metabolites into human milk is probable and there are no human studies that have investigated effects of DALIRESP on breast-fed infants. ()

No data

The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is CHClFNO and the molecular weight is 403.22.
The chemical structure is:
The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160u00b0C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone.
DALIRESP is supplied as white to off-white, round tablets, embossed with u201cDu201d on one side and u201c250u201d or u201c500u201d on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast.
Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.

No data

Long-term studies were conducted in hamsters and mice with roflumilast to evaluate its carcinogenic potential. In 2-year oral gavage carcinogenicity studies, roflumilast treatment resulted in dose-related, statistically significant increases in the incidence of undifferentiated carcinomas of nasal epithelium in hamsters at u22658 mg/kg/day (approximately 11 times the MRHD based on summed AUCs of roflumilast and its metabolites). The tumorigenicity of roflumilast appears to be attributed to a reactive metabolite of 4-amino-3,5-dichloro-pyridine N-oxide (ADCP N-oxide). No evidence of tumorigenicity was observed in mice at roflumilast oral doses up to 12 and 18 mg/kg/day in females and males, respectively (approximately 10 and 15 times the MRHD, respectively, based on summed AUCs of roflumilast and its metabolites).
Roflumilast tested positive in an mouse micronucleus test, but negative in the following assays: Ames test for bacterial gene mutation, chromosome aberration assay in human lymphocytes, HPRT test with V79 cells, an micronucleus test with V79 cells, DNA adduct formation assay in rat nasal mucosa, liver and testes, and mouse bone marrow chromosome aberration assay. Roflumilast N-oxide was negative in the Ames test and in vitro micronucleus test with V79 cells.
In a human spermatogenesis study, roflumilast 500 mcg had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period. In a fertility study, roflumilast decreased fertility rates in male rats at 1.8 mg/kg/day (approximately 29 times the MRHD on a mg/m basis). The male rats also showed increases in the incidence of tubular atrophy, degeneration in the testis and spermiogenic granuloma in the epididymides. No effect on rat fertility rate or male reproductive organ morphology was observed at 0.6 mg/kg/day (approximately 10 times the MRHD on a mg/m basis). In a female fertility study, no effect on fertility was observed up to the highest roflumilast dose of 1.5 mg/kg/day in rats (approximately 24 times the MRHD on a mg/m basis).

The efficacy and safety of DALIRESP (roflumilast) in COPD was evaluated in 8 randomized, double-blind, controlled, parallelu2011group clinical trials in 9394 adult patients (4425 receiving DALIRESP 500 mcg) 40 years of age and older with COPD. Of the 8 trials, two were placebo-controlled dose selection trials (Trials 1 and 2) of 6 monthsu2019 duration that evaluated the efficacy of DALIRESP 250 mcg and 500 mcg once daily, four were placebo-controlled 1-year trials (Trials 3, 4, 5, and 6) primarily designed to evaluate the efficacy of DALIRESP on COPD exacerbations, and two were 6-month efficacy trials (Trials 7 and 8) which assessed the effect of DALIRESP as add-on therapy to a long-acting beta agonist or long-acting anti-muscarinic. The 8 trials enrolled patients with nonreversible obstructive lung disease (FEV/FVC u226470% and u226412% or 200 mL improvement in FEV in response to 4 puffs of albuterol/salbutamol) but the severity of airflow obstruction at baseline was different among the trials. Patients enrolled in the dose selection trials had the full range of COPD severity (FEV 30-80% predicted); median age of 63 years, 73% male, and 99% Caucasian. Patients enrolled in the four exacerbation trials had severe COPD (FEV u226450% predicted); median age of 64 years, 74% male, and 90% Caucasian.
Patients enrolled in the two 6-month efficacy trials had moderate to severe COPD (FEV 40-70% predicted); median age of 65 years, 68% male, and 97% Caucasian. COPD exacerbations and lung function (FEV) were co-primary efficacy outcome measures in the four 1-year trials. In the two 6-month supportive efficacy trials, lung function (FEV) alone was the primary efficacy outcome measure.
The two 6-month dose-selection efficacy trials (Trials 1 and 2) explored doses of 250 mcg and 500 mcg once daily in a total of 1929 patients (751 and 724 on DALIRESP 250 and 500 mcg, respectively). The selection of the 500 mcg dose was primarily based on nominal improvements in lung function (FEV) over the 250 mcg dose. The onceu2011daily dosing regimen was primarily based on the determination of a plasma half-life of 17 hours for roflumilast and 30 hours for its active metabolite roflumilast N-oxide .
An additional placebo-controlled 1-year trial (Trial 9) evaluated the effect of DALIRESP 500 mcg on COPD exacerbations when added to a fixed-dose combination (FDC) product containing an inhaled corticosteroid and long-acting beta agonist (ICS/LABA). At screening, patients were required to have two or more exacerbations in the previous year. This trial randomized a total of 2354 patients (1178 randomized to DALIRESP, 1176 to placebo). Approximately 60% of the patients enrolled had severe COPD (postbronchodilator FEV 30%-50% of predicted) associated with chronic bronchitis and 39% had very severe COPD (postbronchodilator FEV u2264 30% of predicted) associated with chronic bronchitis; mean age of 64 years, 69% male, and 80% Caucasian. The use of long-acting muscarinic antagonists was allowed.

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

MEDICATION GUIDE
DALIRESP (da'-li-resp)
(roflumilast)
Tablets
Read this Medication Guide before you start taking DALIRESP and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about DALIRESP?
DALIRESP can cause serious side effects.
DALIRESP may affect the way other medicines work, and other medicines may affect how DALIRESP works.
What is DALIRESP?
DALIRESP is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).
DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems.
It is not known if DALIRESP is safe and effective in children.
Who should not take DALIRESP?
Do not take DALIRESP if you:
What should I tell my healthcare provider before taking DALIRESP?
Before you take DALIRESP, tell your healthcare provider if you:
How should I take DALIRESP?
What are the possible side effects of DALIRESP?
DALIRESP can cause serious side effects, including:
See u201cu201d
The most common side effects of DALIRESP include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of DALIRESP.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store DALIRESP Tablets?
Keep DALIRESP Tablets and all medicines out of the reach of children.
General information about DALIRESP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DALIRESP for a condition for which it was not prescribed. Do not give DALIRESP to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about DALIRESP. For more information about DALIRESP, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DALIRESP that is written for health professionals.
For more information about DALIRESP call 1-800-236-9933.
What are the ingredients in DALIRESP?
Active ingredient:n- Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 04/2017
Distributed by:AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Rx Onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a028 Tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0310-0088-28
Daliresp
(roflumilast) tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0250 mcg
28 Day Pack
CONTENTS:
AstraZeneca

Rx Onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0310-0095-30
Daliresp
(roflumilast) tablets
500 mcg per tablet
Dispense the accompanying
Medication Guide to each patient
30 Tablets
AstraZeneca

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Roflumilast (Daliresp)

Trade Name : Daliresp

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Roflumilast (Daliresp)

Trade Name : Daliresp

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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