PREGABALIN capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Exelan Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 capsules during pregnancy. To provide info

Produkt oppsummering:

Pregabalin capsules are supplied as follows: 25 mg Capsules: Hard Gelatin Capsules Size “4” with White Opaque cap and White Opaque body imprinted with 25 mg on cap and IG568 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-568-90) and 500’s count (NDC 76282-568-05). 50 mg Capsules: Hard Gelatin Capsules Size “3” with White Opaque cap and White Opaque body imprinted with 50 mg on cap and IG569 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-569-90) and 500’s count (NDC 76282-569-05). 75 mg Capsules: Hard Gelatin Capsules Size “4” with Orange Opaque cap and White Opaque body imprinted with 75 mg on cap and IG570 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-570-90) and 500’s count (NDC 76282-570-05). 100 mg Capsules: Hard Gelatin Capsules Size “3” with Orange Opaque cap and Orange Opaque body imprinted with 100 mg on cap and IG571 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-571-90) and 500’s count (NDC 76282-571-05). 150 mg Capsules: Hard Gelatin Capsules Size “2” with White Opaque cap and White Opaque body imprinted with 150 mg on cap and IG572 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-572-90) and 500’s count (NDC 76282-572-05). 200 mg Capsules: Hard Gelatin Capsules Size “1” with Light Orange Opaque cap and Light Orange Opaque body imprinted with 200 mg on cap and IG573 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-573-90) and 500’s count (NDC 76282-573-05). 225 mg Capsules: Hard Gelatin Capsules Size “1” with Light Orange Opaque cap and White Opaque body imprinted with 225 mg on cap and IG574 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-574-90) and 500’s count (NDC 76282-574-05). 300 mg Capsules: Hard Gelatin Capsules Size “0” with Orange Opaque cap and White Opaque body imprinted with 300 mg on cap and IG575 on body with black ink and filled with White to Off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 76282-575-90) and 500’s count (NDC 76282-575-05). Storage and Handling Store pregabalin capsules at room temperature between 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Exelan Pharmaceuticals Inc.
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MEDICATION GUIDE
Pregabalin Capsules, CV
[pree gab’ a lin]
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
•
Swelling of your hands, legs and feet
•
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 provider.
•
Stopping pregabalin capsules suddenly can cause serious problems.
•
Suicidal

Preparatomtale

PREGABALIN- PREGABALIN CAPSULE
EXELAN 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, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage (1)
5/2019
Warnings and Precautions, Respiratory Depression (5.4)
4/2020
Warning 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