PREGABALIN capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Direct_Rx

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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)]. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding th

Přehled produktů:

Pregabalin capsules, 25 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1310” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 50 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1311” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 75 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1312” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 100 mg are supplied as orange, hard gelatin capsule printed with black ink “AN” on cap & “1313” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 150 mg are supplied as white, hard gelatin capsule printed with black ink “AN” on cap & “1314” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 200 mg are supplied as light orange, hard gelatin capsule printed with black ink “AN” on cap & “1315” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 225 mg are supplied as white/light orange, hard gelatin capsule printed with black ink “AN” on cap & “1316” on body. They are available as follows: Bottles of 90: Pregabalin capsules, 300 mg are supplied as white/orange, hard gelatin capsule printed with black ink “AN” on cap & “1317” on body. They are available as follows: Bottles of 90: Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Direct_Rx
----------
Pregabalin (pree gabʹ 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
swelling of your hands, legs and feet
suicidal thoughts or actions
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
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 thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthcare provider may check for other caus

Charakteristika produktu

PREGABALIN- PREGABALIN CAPSULE
DIRECT_RX
----------
PREGABALIN
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.
2.1 Important Administration Instructions
Pregabalin capsules are given orally with or without food.
When discontinuing pregabalin capsules, taper gradually over a minimum
of 1 week [see Warnings and
Precautions (5.3)].
Because pregabalin is eliminated primarily by renal excretion, adjust
the dose in adult patients with
reduced renal function [see Dosage and Administration (2.7)].
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in
Adults
The maximum recommended dose of pregabalin capsule is 100 mg three
times a day (300 mg/day) in
patients with creatinine clearance of at least 60 mL/min. Begin dosing
at 50 mg three times a day (150
mg/day). The dose may be increased to 300 mg/day within 1 week based
on efficacy and tolerability.
Although pregabalin capsule was also studied at 600 mg/day, there is
no evidence that this dose confers
additional significant benefit and this dose was less well tolerated.
In view of the dose-dependent
adverse reactions, treatment with doses above 300 mg/day is not
recommended [see Adverse Reactions
(6.1)].
2.3 Postherpetic Neuralgia in Adults
The recommended dose of pregabalin capsule is 75 mg to 150 mg two
times a day, or 50 mg to 100 mg
three times a day (150 to 300 mg/day) in patients with creatinine
clearance of at least 60 mL/min. Begin
dosing at 75 mg two times a day, or 50 mg three times a day (150
mg/day). The dose may be increased to
300 mg/day within