PREGABALIN tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MSN LABORATORIES PRIVATE LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pregabalin extended-release tablets are indicated for the management of: -  Neuropathic pain associated with diabetic peripheral neuropathy - Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets 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 (5.1, 5.2),Adverse Reactions (6)]. 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 extended-release tablets, physicians are advised to recommend that pregnant patients taking pregabalin extended-release tablets enroll in the Nort

Product summary:

Pregabalin extended-release tablets are supplied in the following strengths and package configurations: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) in the original package. (See USP Controlled Room Temperature).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MSN LABORATORIES PRIVATE LIMITED
----------
MEDICATION GUIDE
MEDICATION GUIDE
Pregabalin
(pree gab' a lin)
extended-release tablets, CV
Read this Medication Guide before you start taking pregabalin
extended-release tablets 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 extended-
release tablets, ask your healthcare provider or pharmacist.
What is the most important information I should know about pregabalin
extended-release tablets?
Pregabalin extended-release tablets 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 extended-release tablets 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
•
skin redness
•
Pregabalin extended-release tablets 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
extended-re

Summary of Product characteristics

PREGABALIN - PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE
MSN LABORATORIES PRIVATE LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREGABALIN EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PREGABALIN
EXTENDED- RELEASE TABLETS.
PREGABALIN EXTENDED-RELEASE TABLETS, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Respiratory Depression
(5.4) 4/2020
INDICATIONS AND USAGE
Pregabalin extended-release tablets are indicated for the management
of:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
(1)
Postherpetic neuralgia (PHN) (1)
Efficacy of pregabalin extended-release tablets has not been
established for the management of
fibromyalgia or as adjunctive therapy for adult patients with partial
onset seizures.
DOSAGE AND ADMINISTRATION
Pregabalin extended-release tablets should be administered once daily
after an evening meal. It should
be swallowed whole and should not be split, crushed, or chewed. (2.1)
Dosing recommendations for pregabalin extended-release tablets:
INDICATION
DOSING REGIMEN
INITIAL DOSE
MAXIMUM DOSE
DPN Pain (2.2)
Single dose per day
165 mg/day
330 mg/day within 1 week
PHN (2.3)
Single dose per day
165 mg/day
330 mg/day within 1 week.
Maximum dose of
660 mg/day
Conversion from Pregabalin Capsules or Oral Solution to pregabalin
extended-release tablets: See full
prescribing information. (2.4)
Dose modification recommended in patients with renal impairment. (2.5)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 82.5 mg, 165 mg, and 330 mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to pregabalin or any of its components.(4)
WARNINGS AND PRECAUTIONS
Angioedema: Angioedema [e.g., swelling of the face, mouth (tongue,
lips, and gums) and neck (throat
and larynx)] can occur and may be associated with life-threatening
respiratory compromise requiring
emergency treatment. Discontinue pregabalin extended-release tablets
immedi