pregabalin 200 mg
1 INDICATIONS AND USAGE Pregabalin capsule is indicated for: β’ Management of neuropathic pain associated with diabetic peripheral neuropathy β’ Management of postherpetic neuralgia β’ Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older β’ Management of fibromyalgia β’ Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizerβs LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizerβs marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pregabalin capsule is indicated for: β’ neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) β’ Postherpetic neuralgia (PHN) (1) β’ Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (1) β’ fibromyalgia (1) β’ neuropathic pain associated with spinal cord injury (1)
Alembic Pharmaceuticals Limited
CAPSULE ORANGE A 145
A 145 CAPSULE ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
PREGABALIN capsules are available containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of
PREGABALIN, USP. 25 mg capsules are opaque white/opaque white, size β4β, hard gelatin capsules, radially imprinted with βAβ on Cap and β140β on body with black ink, filled with white to off-white powder. NDC 46708-119-30 bottle of 30 capsules NDC 46708-119-90 bottle of 90 capsules NDC 46708-119-91 bottle of 1000 capsules NDC 46708-119-10 carton of 100 (10 x 10) unit-dose capsules 50 mg capsules are opaque white/opaque orange, size β2β, hard gelatin capsules, radially imprinted with βAβ on Cap and β141β on body with black ink, filled with white to off-white powder. NDC 46708-120-30 bottle of 30 capsules NDC 46708-120-90 bottle of 90 capsules NDC 46708-120-91 bottle of 1000 capsules NDC 46708-120-10 carton of 100 (10 x 10) unit-dose capsules 75 mg capsules are opaque white/orange opaque, size β4β, hard gelatin capsules, radially imprinted with βAβ on Cap and β142β on body with black ink, filled with white to off-white powder. NDC 46708-121-30 bottle of 30 capsules NDC 46708-121-90 bottle of 90 capsules NDC 46708-121-91 bottle of 1000 capsules NDC 46708-121-10 carton of 100 (10 x 10) unit-dose capsules 100 mg capsules are orange opaque/orange opaque, size β3β, hard gelatin capsules, radially imprinted with βAβ on Cap and β143β on body with black ink, filled with white to off-white powder. NDC 46708-122-30 bottle of 30 capsules NDC 46708-122-90 bottle of 90 capsules NDC 46708-122-91 bottle of 1000 capsules NDC 46708-122-10 carton of 100 (10 x 10) unit-dose capsules 150 mg capsules are opaque white/opaque white, size β2β, hard gelatin capsules, radially imprinted with βAβ on Cap and β144β on body with black ink, filled with white to off-white powder. NDC 46708-123-30 bottle of 30 capsules NDC 46708-123-90 bottle of 90 capsules NDC 46708-123-91 bottle of 1000 capsules NDC 46708-123-10 carton of 100 (10 x 10) unit-dose capsules 200 mg capsules are orange/orange, size β1β, hard gelatin capsules, radially imprinted with βAβ on Cap and β145β on body with black ink, filled with white to off-white powder. NDC 46708-124-30 bottle of 30 capsules NDC 46708-124-90 bottle of 90 capsules NDC 46708-124-91 bottle of 1000 capsules NDC 46708-124-10 carton of 100 (10 x 10) unit-dose capsules 225 mg capsules are opaque white/light orange, size β1β, hard gelatin capsules, radially imprinted with βAβ on Cap and β146β on body with black ink, filled with white to off-white powder. NDC 46708-125-30 bottle of 30 capsules NDC 46708-125-90 bottle of 90 capsules NDC 46708-125-91 bottle of 1000 capsules NDC 46708-125-10 carton of 100 (10 x 10) unit-dose capsules 300 mg capsules are opaque white/orange, size β0β, hard gelatin capsules, radially imprinted with βAβ on Cap and β147β on body with black ink, filled with white to off-white powder. NDC 46708-126-30 bottle of 30 capsules NDC 46708-126-90 bottle of 90 capsules NDC 46708-126-71 bottle of 500 capsules NDC 46708-126-10 carton of 100 (10 x 10) unit-dose capsules Storage and Handling Store at 25Β°C (77Β°F); excursions permitted to 15Β°C to 30Β°C (59Β°F to 86Β°F) (see USP Controlled Room Temperature).
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