METHYLPREDNISOLONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Boleh didapati daripada:

BluePoint Laboratories

INN (Nama Antarabangsa):

Methylprednisolone

Komposisi:

Methylprednisolone 4 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Methylprednisolone Tablets are indicated in the following conditions: 1.Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3.Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4.Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7.Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler’s syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11.Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.Nervous System Acute exacerbations of multiple sclerosis 13.Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. Systemic fungal infections and known hypersensitivity to components.

Ringkasan produk:

Methylprednisolone Tablets, USP are available in the following strength and package size: 4 mg (White, oval-shaped tablets debossed with “TL 001” on one side and quadrisected on the other side.) Bottles of 100 tablets with Child Resistant Closure, NDC 68001-557-00 Unit of use pack (21 tablets) NDC 68001-005-01 8 mg (White, oval shaped tablets debossed with “TL” and “002” on either side of score line on one side and plain on other side.) Bottles of 25 tablets with Child Resistant Closure, NDC 68001-558-55 16 mg (White, oval shaped tablets debossed with “TL 003” on one side and quadrisected on the other side.) Bottles of 50 tablets with Child Resistant Closure, NDC 68001-559-69 32 mg (White, oval shaped tablets debossed with “TL 015” on one side and bisected on the other side.) Bottles of 25 tablets with Child Resistant Closure, NDC 68001-560-55 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: JUBILANT CADISTA PHARMACEUTICALS INC . Salisbury, MD 21801, USA For BluePoint Laboratories. Rev. 01/2024

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MET H YLP RED NIS O LO NE- m eth ylp re dnis o lo ne t a b le t
Blu eP oin t L ab ora to rie s
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MET H YLP RED NIS O LO NE T A BLET S, U SP
Rx O nly
DES C RIP TIO N
Meth ylp re d nis o lo ne T ab le ts , U SP c o nta in m eth ylp re d nis o lo ne w hic h is a g lu co co rtic o id .
Glu co co rtic o id s a re a d re n oco rtic al s te ro id s, b oth n atu ra lly o ccu rrin g a n d s yn th etic ,
whic h a re r e ad ily a b so rb ed f r o m t h e g astr o in te stin al t r a ct. M eth ylp re d nis o lo ne o ccu rs a s
a w hit e t o p ra ctic ally w hit e , o dorle ss, c ry sta llin e p ow der. It is s p arin gly s o lu ble in a lc o hol,
in d io xan e, a n d in m eth an ol, s lig htly s o lu ble in a ceto ne, a n d in c h lo ro fo rm , a n d v ery
slig htly s o lu ble in e th er. It is p ra ctic ally in so lu ble in w ate r.
Th e c h em ic al n am e f o r m eth ylp re d nis o lo ne is p re g na-1 ,4 -d ie n e-3 ,2 0-d io ne, 1 1, 1 7, 2 1-
tr ih yd ro xy-6 - m eth yl- ,( 6 α ,1 1β)- a n d t h e m ole cu la r w eig ht is 3 74.4 8. T h e s tr u ctu ra l
fo rm ula is r e p re sen te d b elo w :
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Meth ylp re d nis o lo ne T ab le ts , U SP f o r o ra l a d m in is tr a tio n, a re a vaila b le a s s co re d t a b le ts in
th e f o llo w in g s tr e n gth : 4 m g, 8 m g, 1 6 m g, a n d 3 2 m g. In a d dit io n e ach t a b le t c o nta in s
th e f o llo w in g in activ e in gre d ie n ts : c o llo id al s ilic o n d io xid e, la cto se a n hyd ro us ( 4 m g a n d 8
mg), la cto se m onohyd ra te ( 1 6 m g a n d 3 2 m g), m ag nesiu m s te ara te , m ic ro cry sta llin e
cellu lo se, p re g ela tin iz ed s ta rc h , s o diu m la u ry l s u lf a te a n d s o diu m s ta rc h g ly co la te .
CLIN IC AL P HARM ACO LO GY
Natu ra lly o ccu rrin g g lu co co rtic o id s ( h yd ro co rtis o ne a n d c o rtis o ne), w hic h a ls o h ave s alt -
re ta in in g p ro pertie s, a re u sed a s r e p la cem en t t h era p y in a d re n oco rtic al d efic ie n cy
sta te s. T h eir s yn th etic a n alo gs a re p rim arily u s