ROFLUMILAST tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U)

متاح من:

Strides Pharma Science Limited

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Roflumilast tablets are 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 Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. The use of roflumilast is contraindicated in the following condition: Moderate to severe liver impairment (Child-Pugh B or C) [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)] . Risk Summary There are no randomized clinical studies of Roflumilast in pregnant women. In animal reproductive toxicity studies, Roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest Roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (MRHD). Roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the MRHD

ملخص المنتج:

Roflumilast tablets are supplied as white to off-white, round tablets, debossed with "0.5" on one side, "R" on the other side. Each tablet contains 500 mcg of roflumilast. Roflumilast tablets are available in bottles of 30 (NDC 64380-786-01) and 90 (NDC 64380-786-05). Store roflumilast tablets, 500 mcg at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

ROFLUMILAST - ROFLUMILAST TABLET
Strides Pharma Science Limited
----------
MEDICATION GUIDE
Roflumilast Tablets
(roe flue' mi last)
Read this Medication Guide before you start taking roflumilast tablets
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 roflumilast
tablets?
Roflumilast tablets can cause serious side effects. Tell your
healthcare provider right away if you have
any of the symptoms listed below while taking roflumilast tablets.
1.
Roflumilast tablets may cause mental health problems including
suicidal thoughts and behavior.
Some people taking roflumilast tablets may develop mood or behavior
problems including:
•
thoughts of suicide or dying
•
attempt to commit suicide
•
trouble sleeping (insomnia)
•
new or worse anxiety
•
new or worse depression
•
acting on dangerous impulses
•
other unusual changes in your behavior or mood
2.
Weight loss. Roflumilast tablets can cause weight loss. You should
check your weight on a regular
basis. You will also need to see your healthcare provider regularly to
have your weight checked.
If you notice that you are losing weight, call your healthcare
provider. Your healthcare provider
may ask you to stop taking roflumilast tablets if you lose too much
weight.
Roflumilast tablets may affect the way other medicines work, and other
medicines may affect how
roflumilast tablets work. Tell your healthcare provider about all the
medicines you take, including
prescription and non-prescription medicines, vitamins, and herbal
supplements.
What are roflumilast tablets?
Roflumilast tablets are 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).
Roflumilast tablets are not a bronchodilator and should not be used
for treating sudden breathing
proble

خصائص المنتج

ROFLUMILAST - ROFLUMILAST TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROFLUMILAST TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ROFLUMILAST TABLETS.
ROFLUMILAST TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
Roflumilast tablet 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. (1, 14) (1)
Limitations of Use_:_ Roflumilast tablet is not a bronchodilator and
is not indicated for the relief of acute
bronchospasm. (1, 14) (1)
DOSAGE AND ADMINISTRATION
The maintenance dose for patients with COPD is one 500 mcg tablet per
day, with or without food. Starting
treatment with a dose of roflumilast tablet 250 mcg once daily for 4
weeks and increasing to roflumilast
tablet 500 mcg once daily thereafter may reduce the rate of treatment
discontinuation in some patients.
(2) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mcg (3) (3)
CONTRAINDICATIONS
Moderate to severe liver impairment (Child-Pugh B or C) (4) (4)
WARNINGS AND PRECAUTIONS
Acute Bronchospasm: Do not use for the relief of acute bronchospasm.
(5.1)
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 roflumilast in patients with a history of depression
and/or suicidal thoughts or behavior.
(5.2)
Weight Decrease: Monitor weight regularly. If unexplained or
clinically significant weight loss occurs,
evaluate weight loss and consider discontinuation of roflumilast.
(5.3)
Drug Interactions: Use with strong cytochrome P450 enzyme inducers
(e.g., rifampicin, phenobarbital,
carbamazepine, phenytoi