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Daliresp

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Overview

What is Daliresp?

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 160°C. 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 “D” on one side and “250” or “500” 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.



What does Daliresp look like?



What are the available doses of Daliresp?

Tablets: 250 mcg, 500 mcg ()

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

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. (2)

How should I use Daliresp?

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.

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.


What interacts with Daliresp?

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What are the warnings of Daliresp?

Sorry No Records found


What are the precautions of Daliresp?

Sorry No Records found


What are the side effects of Daliresp?

Sorry No records found


What should I look out for while using Daliresp?

The use of DALIRESP is contraindicated in the following condition:

Moderate to severe liver impairment (Child-Pugh B or C) .


What might happen if I take too much Daliresp?


How should I store and handle Daliresp?

Store DALIRESP tablets at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Product: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLEProduct: 71335-0450NDC: 71335-0450-8 28 CAPSULE in a BOTTLENDC: 71335-0450-5 20 CAPSULE in a BOTTLENDC: 71335-0450-6 10 CAPSULE in a BOTTLENDC: 71335-0450-9 56 CAPSULE in a BOTTLENDC: 71335-0450-3 90 CAPSULE in a BOTTLENDC: 71335-0450-4 14 CAPSULE in a BOTTLENDC: 71335-0450-7 180 CAPSULE in a BOTTLENDC: 71335-0450-1 30 CAPSULE in a BOTTLENDC: 71335-0450-2 60 CAPSULE in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While the specific mechanism(s) by which DALIRESP exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

Non-Clinical Toxicology
The use of DALIRESP is contraindicated in the following condition:

Moderate to severe liver impairment (Child-Pugh B or C) .

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.

In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.

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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