Brand Information

Strength	Rate	Packing Style
mg	0.00	unit

Drug Interaction:

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.

Indication:

DALIRESP® (roflumilast) tablets

Initial U.S. Approval: 2011

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 Name- Dalirep

Active Ingredient - Roflumilast

To decrease the frequency of flare-ups (exacerbations) or worsening

of symptoms from severe chronic obstructive pulmonary disease(COPD)

Indication-

To decrease the frequency of flare-ups (exacerbations) or worsening

of symptoms from severe chronic obstructive pulmonary disease(COPD)

Approved by FDA on 28-2-2011 (Ref- FDA approved List- 2011)

Roflumilast Tab 500mcg

Indication-

In the treatment of severe chronic obstructive pulmonary disease

(COPD) (FEVI post bronchodilator less than 50% predicted)

associated with chronic bronchitis in adult patients with a history

of frequent exacerbations as add on to bronchodilator treatment

Approved by FDA on 07-07--2014 (Ref- FDA approved List- 2014)

Repiratory ailment

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Roflumilast Respiratory Altana/Byk/Gulden 27-10-2015

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

Roflumilast Tablets 500mcg 17-07-2014

For the treatment of severe chronic obstuctive pulomonary disease (COPD)

(FEV1 post bronchodilator less than 50% predicted) associated with a

History of frequent exacerbations as add on to bronchodilator treatment

Adverse Reaction:

Most common adverse reactions (2%) are diarrhea, weight decrease,

nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

Contra-Indications:

CONTRAINDICATIONS

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

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.

Dosages/ Overdosage Etc:

Indication-

To decrease the frequency of flare-ups (exacerbations) or worsening

of symptoms from severe chronic obstructive pulmonary disease(COPD)

INDICATIONS AND USAGE

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 Use: DALIRESP is not a bronchodilator and is not indicated

for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

The recommended dosage for patients with COPD is one 500 mcg tablet per day,

with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 500 mcg

Patient Information:

PATIENT COUNSELING INFORMATION

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

1.Bronchospasm

DALIRESP is not a bronchodilator and should not be used for immediate relief of breathing

problems (i.e., as a rescue medication).

2.Psychiatric Events including Suicidality

Treatment with DALIRESP is associated with an increase in psychiatric adverse

reactions. Cases of suicidal ideation and behavior, including completed suicide,

have been observed in the post-marketing setting in patients with or without

a history of depression.

The risks and benefits of treatment with DALIRESP in patients with a history of

depression and/or suicidal thoughts or behavior should be carefully considered.

Advise patients, caregivers, and families to be alert for the emergence or

worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes,

and if such change continuing treatment with DALIRESP may be considered

3. Weight Decrease

Weight loss was a common adverse reaction in DALIRESP clinical trials

During follow-up after treatment discontinuation, the majority of patients

with weight loss regained some of the weight they had lost while receiving

DALIRESP.

Advise patients treated with DALIRESP to have their weight monitored regularly.

If unexplained weight loss occurs, patients should inform their healthcare provider

so that the weight loss can be evaluated, as discontinuation of DALIRESP may need

to be considered.

4.Drug Interactions

The use of cytochrome P450 enzyme inducers resulted in a reduction in exposure

which may result in decreased therapeutic effectiveness of DALIRESP.

The use of strong cytochrome P450 enzyme inducers (e.g., rifampicin,

phenobarbital, carbamazepine, phenytoin) with DALIRESP is not recommended

Pharmacology/ Pharmacokinetics:

1. 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-3Œ,5Œ-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

2. Pharmacokinetics

Absorption

The absolute bioavailability of roflumilast following a 500 mcg oral dose is

approximately 80%. Maximum plasma concentrations (Cmax) of roflumilast

typically occur approximately one hour after dosing (ranging from

0.5 to 2 hours) in the fasted state while plateau-like maximum concentration

of the N-oxide metabolite are reached in approximately eight hours

(ranging from 4 to 13 hours).

Food has no effect on total drug absorption, but delays time to maximum

concentration (Tmax) of roflumilast by one hour and reduces Cmax by

approximately 40%, however, Cmax and Tmax of roflumilast N-oxide

did not inhibit P-gp transporter

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1. Pregnancy

Teratogenic effects:

Pregnancy Category C:

There are no adequate and well controlled studies of DALIRESP in pregnant women.

DALIRESP was not teratogenic in mice, rats, or rabbits. DALIRESP should be used

during pregnancy only if the potential benefit justifies the potential risk to the fetus.

2. Nursing Mothers

Roflumilast and/or its metabolites are excreted into the milk of lactating rats.

Excretion of roflumilast and/or its metabolites into human milk is probable.

There are no human studies that have investigated effects of DALIRESP

on breast-fed infants. DALIRESP should not be used by women who are nursing.

3. Pediatric Use

COPD does not normally occur in children. The safety and effectiveness of

DALIRESP in pediatric patients have not been established.

4. Geriatric Use

Of the 4438 COPD subjects exposed to DALIRESP for up to 12 months in 8

controlled clinical trials, 2022 were >65 years of age and 471 were >75 years of age.

No overall differences in safety or effectiveness were observed between these

subjects and younger subjects and 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 roflumilast, no adjustment of dosage in geriatric

patients is warranted

DALIRESP*

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

Patient Information:

Pharmacology/ Pharmacokinetics:

Pregnancy and lactation:

Search

Quick Links

Free Mobile App

	Starts With		Contains