PREGABALIN capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)

Διαθέσιμο από:

Bryant Ranch Prepack

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Pregabalin capsules are indicated for: - Management of neuropathic pain associated with diabetic peripheral neuropathy - Management of postherpetic neuralgia - Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older -  Management of fibromyalgia - Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsules are contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information reg

Περίληψη προϊόντος:

NDC: 71335-1300-1: 30 Capsules in a BOTTLE NDC: 71335-1300-2: 60 Capsules in a BOTTLE NDC: 71335-1300-3: 90 Capsules in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Bryant Ranch Prepack
----------
Medication Guide
Pregabalin (pre-GAB-a-lin)
Capsules, CV
Read this Medication Guide before you start taking pregabalin capsules
and each time you get a refill. There may be new
information. This information does not take the place of talking to
your healthcare provider about your medical condition or
treatment. If you have any questions about pregabalin capsules, ask
your healthcare provider or pharmacist.
What
is
the
most
important
information
I
should
know
about
pregabalin
capsules?
Pregabalin capsules may cause serious side effects including:
•
serious, even life-threatening, allergic reactions
•
suicidal thoughts or actions
•
serious breathing problems
•
swelling of your hands, legs and feet
•
dizziness and sleepiness
These serious side effects are described below:
•
Serious, even life-threatening, allergic reactions.
Stop taking pregabalin capsules and call your healthcare provider
right away if you have any of these signs of a serious allergic
reaction:
•
swelling of your face, mouth, lips, gums, tongue, throat or neck
•
trouble breathing
•
rash, hives (raised bumps) or blisters
•
Like other antiepileptic drugs, pregabalin capsules may cause suicidal
thoughts or actions in a very small number of people,
about 1 in 500. Call a healthcare provider right away if you have any
of these symptoms, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
If you have suicidal thoughts or actions, do not stop pregabalin
capsules without first talking to a healthcare provider.
•
Stopping pregabalin capsules suddenly can cause serious problems.
•
Suicidal thoughts

Αρχείο Π.Χ.Π.

PREGABALIN- PREGABALIN CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREGABALIN
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PREGABALIN
CAPSULES.
PREGABALIN CAPSULES, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression (5.4) 4/2020
INDICATIONS AND USAGE
PREGABALIN CAPSULES ARE INDICATED FOR:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
(1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in
patients 17 years of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
DOSAGE AND ADMINISTRATION
For adult indications, begin dosing at 150 mg/day. (2.2, 2.3, 2.4,
2.5, 2.6)
Dosing recommendations:
INDICATION
DOSING
REGIMEN
MAXIMUM DOSE
DPN Pain (2.2)
3 divided doses per day
300 mg/day within
1 week
PHN (2.3)
2 or 3 divided doses per day
300 mg/day within
1 week. Maximum dose of 600
mg/day.
Adjunctive Therapy for Partial-Onset
Seizures in Adult Patients 17 years
of Age and Older (2.4)
2 or 3 divided doses per day
Maximum dose of
600 mg/day.
Fibromyalgia (2.5)
2 divided doses per day
300 mg/day within
1 week. Maximum dose of 450
mg/day.
Neuropathic Pain Associated with
Spinal Cord Injury (2.6)
2 divided doses per day
300 mg/day within
1 week. Maximum dose of 600
mg/day.
Dose should be adjusted in adult patients with reduced renal function.
(2.7)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300
mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components. (4)
WARNINGS AND PRECAUTIONS
Angioedema (e.g., swelling of the throat, head and neck) can occur,
and may be associated with life-
threatening respiratory compromise requiring emergency treatment.
Discontinue pregabalin
immediately in these cases. (5.1)
Hypersensitivity reactions (e.g., hives, dyspnea, and whee