PREGABALIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 regarding the effects of i

Product summary:

Pregabalin Capsules 225 mg: Hard gelatin capsules with white, opaque body and light orange, opaque cap. Imprinted ‘’APO’’ and ‘’P225’’ in black ink. White to off-white powder fill. Bottles of 90: NDC 72162-2028-9 Store pregabalin capsules at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PREGABALIN- PREGABALIN CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Pregabalin Capsules CV
(pree gab’ a lin)
25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
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
•
swelling of your hands, legs and feet
•
suicidal thoughts or actions
•
dizziness and sleepiness
•
serious breathing problems
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
•
trouble sleeping (insomnia)
•
attempts to commit suicide
•
new or worse irritability
•
new or worse depression
•
acting aggressive, being angry, or violent
•
new or worse anxiety
•
acting on dangerous impulses
•
feeling agitated or restless
•
an extreme increase in activity and talking (mania)
•
panic attacks
•
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 prov

Summary of Product characteristics

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 _CV_
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage (1) 5/2019
Warnings and Precautions, Respiratory Depression (5.4) 4/2020
Warnings and Precautions, Dizziness and Somnolence (5.5) 5/2019 ​
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
immed