PREGABALIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pregabalin capsules are indicated for: 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 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 b

Product summary:

Pregabalin Capsules 100 mg:   Hard gelatin capsules with light orange, opaque body and light orange, opaque cap. Imprinted ‘’APO’’ and ‘’P100’’ in black ink. Bottles of 30: NDC 68788-8359-3 Bottles of 60: NDC 68788-8359-6 Bottles of 90: NDC 68788-8359-9 Bottles of 10: NDC 68788-8359-1 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
Preferred Pharmaceuticals Inc.
----------
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:
1.
serious, even life-threatening, allergic reactions
2.
swelling of your hands, legs and feet
3.
suicidal thoughts or actions
4.
dizziness and sleepiness
5.
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:
1.
swelling of your face, mouth, lips, gums, tongue, throat or neck
2.
trouble breathing
3.
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:
1.
thoughts about suicide or dying
2.
trouble sleeping (insomnia)
3.
attempts to commit suicide
4.
new or worse irritability
5.
new or worse depression
6.
acting aggressive, being angry, or violent
7.
new or worse anxiety
8.
acting on dangerous impulses
9.
feeling agitated or restless
10.
an extreme increase in activity and talking (mania)
11.
panic attacks
12.
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.
1

Summary of Product characteristics

PREGABALIN- PREGABALIN CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
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:
6.
7.
8.
9.
10.
DOSAGE AND ADMINISTRATION
3.
4.
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.
2.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
2.
WARNINGS AND PRECAUTIONS
8.
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)
For adult indications, begin dosing at 150 mg/day. (2.2, 2.3, 2.4,
2.5, 2.6)
Dosing recommendations:
Dose should be adjusted in adult patients with reduced renal
function.(2.7)
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300
mg. (3)
Known hypersensitivity to pregabalin or any of its components. (4)
Angioedema (e.g., swelling of the throat, head and neck) can occur,
and may be associated with life-
8.
9.
10.
11.
12.
13.
14.
ADVERSE REACTIONS
Most c