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DALIRESP™ (roflumilast) tablet

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED  
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(DESCRIPTION) top of page

Initial U.S. Approval: 2011
DESCRIPTION
The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors.
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 '500' on the other side. Each tablet contains 500 mcg of roflumilast.

Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone and magnesium stearate.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
Mechanism of Action
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.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
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.

CONTRAINDICATIONS top of page

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

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS
  • Acute bronchospasm: Do not use for the relief of acute bronchospasm.
  • Psychiatric Events including Suicidality: Advise patients , their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior.
  • Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of DALIRESP.
  • Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended.

DRUG INTERACTIONS
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.


USE IN SPECIFIC POPULATIONS
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.

ADVERSE REACTIONS top of page

Most common adverse reactions (geq 2%) are diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

To report SUSPECTED ADVERSE REACTIONS, Contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS
DALIRESP is supplied as white to off-white, round tablets, embossed with 'D' on one side and '500' on the other side. Each tablet contains 500 mcg of roflumilast

REFERENCE

Package Insert data: 
Manufactured by:
Nycomed GmbH
Production Site Oranienburg
Lehnitzstrasse 70 – 98
16515 Oranienburg
Germany

Manufactured for:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045, USA

Component Code Number:
© 2010 Forest Laboratories, Inc
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