PREGABALIN capsule PREGABALIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pregabalin is indicated for: Pregabalin is 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 in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate and well-controlled studies with pregabalin in pregnant women. However, in animal reproduction studies, increased incidences

Product summary:

25 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in: Bottles of 90: NDC 59762-1342-1 50 mg capsules: White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in: Bottles of 90: NDC 59762-1344-1 75 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in: Bottles of 90: NDC 59762-1346-1 100 mg capsules: Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in: Bottles of 90: NDC 59762-1348-1 150 mg capsules: White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in: Bottles of 90: NDC 59762-1351-1 200 mg capsules: Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in: Bottles of 90: NDC 59762-1354-1 225 mg capsules: White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in: Bottles of 90: NDC 59762-1360-1 300 mg capsules: White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in: Bottles of 90: NDC 59762-1364-1 20 mg/mL oral solution: 16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure: 16 fluid ounce bottle NDC 59762-1576-1 Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

PREGABALIN- PREGABALIN SOLUTION
Greenstone LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 4/2020
MEDICATION GUIDE
Pregabalin
Capsules, CV
Pregabalin
Oral Solution, CV
Read this Medication Guide before you start taking pregabalin 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, ask your healthcare
provider or pharmacist.
What is the most important information I should know about pregabalin?
Pregabalin 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 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 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
without first talking to a healthcare
provider.
•
Stopping prega

Summary of Product characteristics

PREGABALIN- PREGABALIN CAPSULE
PREGABALIN- PREGABALIN SOLUTION
GREENSTONE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREGABALIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREGABALIN.
PREGABALIN CAPSULES, CV
PREGABALIN ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression (5.4)
4/2020
INDICATIONS AND USAGE
Pregabalin is 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 1 month 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. For partial-onset
seizure dosing in pediatric patients 1 month of age
and older, refer to section 2.4. (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 Pediatric and Adult Patients
Weighing 30 kg or More (2.4)
2 or 3 divided doses per day
Maximum dose of 600 mg/day.
Adjunctive Therapy for Partial-Onset
Seizures in Pediatric Patients Weighing
Less than 30 kg (2.4)
_1 month to less than 4 years:_
3 divided doses per day
_4 years and older:_
2 or 3 divided doses per day
14 mg/kg/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)
Oral Solution: 20 mg/mL. (3)
CONTRAINDICATIONS