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Methylprednisolone Tablets, USP

Rx Only

DESCRIPTION

Methylprednisolone Tablets contain methylprednisolone hich is a !l"cocorticoid#$l"cocorticoids are adrenocortical steroids, both nat"rally occ"rrin! and synthetic, hich are

readily absorbed %rom the !astrointestinal tract# Methylprednisolone occ"rs as a hite to

practically hite, odorless, crystalline poder# It is sparin!ly sol"ble in alcohol, in dioxane, and

in methanol, sli!htly sol"ble in acetone, and in chloro%orm, and &ery sli!htly sol"ble in ether# It

is practically insol"ble in ater#

The chemical name %or methylprednisolone is pre!na'(,)'diene'*,+'dione, ((, (-, +('

trihydroxy'.' methyl',/.0,((12' and the molec"lar ei!ht is *-)#)3# The str"ct"ral %orm"la isrepresented belo4

C++5*O6

Methylprednisolone Tablets, %or oral administration, are a&ailable as scored tablets in the

%olloin! stren!th4 ) m!# In addition each tablet contains the %olloin! inacti&e in!redients4

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Psoriatic arthritis

Epicondylitis

;c"te !o"ty arthritis

3.Collagen Diseases

D"rin! an exacerbation or as maintenance therapy in selected cases o%4

Systemic l"p"s erythematos"s

Systemic dermatomyositis /polymyositis2

;c"te rhe"matic carditis

4.Dermatologic Diseases

>"llo"s dermatitis herpeti%ormis

Se&ere erythema m"lti%orme /Ste&ens'?ohnson syndrome2

Se&ere seborrheic dermatitis

Ex%oliati&e dermatitis

Mycosis %"n!oides

Pemphi!"s

Se&ere psoriasis

5.Allergic States

Control o% se&ere or incapacitatin! aller!ic conditions intractable to ade

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Se&ere ac"te and chronic aller!ic and in%lammatory processes in&ol&in! the eye and its adnexa

s"ch as4

;ller!ic corneal mar!inal "lcers

5erpes 7oster ophthalmic"s

;nterior se!ment in%lammation

Di%%"se posterior "&eitis and choroiditis

Sympathetic ophthalmia

@eratitis

Optic ne"ritis

;ller!ic con:"ncti&itis

Chorioretinitis

Iritis and iridocyclitis

.Respirator! Diseases

Symptomatic sarcoidosis

>erylliosis

Aoe%%lerBs syndrome not mana!eable by other means

"lminatin! or disseminated p"lmonary t"berc"losis hen "sed conc"rrently ith appropriate

antit"berc"lo"s chemotherapy

;spiration pne"monitis

".#ematologic Disorders

Idiopathic thrombocytopenic p"rp"ra in ad"lts

Secondary thrombocytopenia in ad"lts

;c

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or palliati&e mana!ement o%4

Ae"=emias and lymphomas in ad"lts

;c"te le"=emia o% childhood

1&.Edematous States

To ind"ce a di"resis or remission o% protein"ria in the nephrotic syndrome, itho"t "remia, o%

the idiopathic type or that d"e to l"p"s erythematos"s#

11.'astrointestinal Diseases

To tide the patient o&er a critical period o% the disease in4

Ulcerati&e colitis

Re!ional enteritis

12.%er(ous S!stem

;c"te exacerbations o% m"ltiple sclerosis

13.)iscellaneous

T"berc"lo"s menin!itis ith s"barachnoid bloc= or impendin! bloc= hen "sed conc"rrently

ith appropriate antit"berc"lo"s chemotherapy#

Trichinosis ith ne"rolo!ic or myocardial in&ol&ement#

Contraindications

Systemic %"n!al in%ections and =non hypersensiti&ity to components#

arnin!s

In patients on corticosteroid therapy s"b:ected to "n"s"al stress, increased dosa!e o% rapidly

actin! corticosteroids be%ore, d"rin!, and a%ter the stress%"l sit"ation is indicated#

Corticosteroids may mas= some si!ns o% in%ection, and ne in%ections may appear d"rin! their

"se# There may be decreased resistance and inability to locali7e in%ection hen corticosteroids

are "sed#

Prolon!ed "se o% corticosteroids may prod"ce posterior s"bcaps"lar cataracts, !la"coma ith

possible dama!e to the optic ner&es, and may enhance the establishment o% secondary oc"lar

in%ections d"e to %"n!i or &ir"ses#

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*sage in pregnanc!+Since ade

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There is an enhanced e%%ect o% corticosteroids on patients ith hypothyroidism and in those ith

cirrhosis#

Corticosteroids sho"ld be "sed ca"tio"sly in patients ith oc"lar herpes simplex beca"se o%

possible corneal per%oration#

The loest possible dose o% corticosteroid sho"ld be "sed to control the condition "nder

treatment, and hen red"ction in dosa!e is possible, the red"ction sho"ld be !rad"al#

Psychic deran!ements may appear hen corticosteroids are "sed, ran!in! %rom e"phoria,

insomnia, mood sin!s, personality chan!es, and se&ere depression, to %ran= psychotic

mani%estations# ;lso, existin! emotional instability or psychotic tendencies may be a!!ra&ated

by corticosteroids#

;spirin sho"ld be "sed ca"tio"sly in con:"nction ith corticosteroids in hypoprothrombinemia#

Steroids sho"ld be "sed ith ca"tion in nonspeci%ic "lcerati&e colitis, i% there is a probability o%

impendin! per%oration, abscess or other pyo!enic in%ection9 di&ertic"litis9 %resh intestinal

anastomoses9 acti&e or latent peptic "lcer9 renal ins"%%iciency9 hypertension9 osteoporosis9 and

myasthenia !ra&is#

$roth and de&elopment o% in%ants and children on prolon!ed corticosteroid therapy sho"ld be

care%"lly obser&ed#

;ltho"!h controlled clinical trials ha&e shon corticosteroids to be e%%ecti&e in speedin! the

resol"tion o% ac"te exacerbations o% m"ltiple sclerosis, they do not sho that corticosteroids

a%%ect the "ltimate o"tcome or nat"ral history o% the disease# The st"dies do sho that relati&elyhi!h doses o% corticosteroids are necessary to demonstrate a si!ni%icant e%%ect# /see DOSA'E

A%D AD)%SRAO%.

Since complications o% treatment ith !l"cocorticoids are dependent on the si7e o% the dose and

the d"ration o% treatment, a ris=Gbene%it decision m"st be made in each indi&id"al case as to dose

and d"ration o% treatment and as to hether daily or intermittent therapy sho"ld be "sed#

Con&"lsions ha&e been reported ith conc"rrent "se o% methylprednisolone and cyclosporine#

Since conc"rrent "se o% these a!ents res"lts in a m"t"al inhibition o% metabolism, it is possible

that ad&erse e&ents associated ith the indi&id"al "se o% either dr"! may be more apt to occ"r#

In%ormation %or the Patient

Persons ho are on imm"nos"ppressant doses o% corticosteroids sho"ld be arned to a&oid

expos"re to chic=enpox or measles and, i% exposed, to obtain medical ad&ice#

;d&erse Reactions

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7luid and Electrol!te Distur-ances

Sodi"m retention

Con!esti&e heart %ail"re in s"sceptible patients

5ypertension

l"id retention

Potassi"m loss

5ypo=alemic al=alosis

)usculos0eletal

M"scle ea=ness

Aoss o% m"scle mass

Steroid myopathy

Osteoporosis

ertebral compression %ract"res

;septic necrosis o% %emoral and h"meral heads

Patholo!ic %ract"re o% lon! bones

'astrointestinal

Peptic "lcer ith possible per%oration and hemorrha!e

Pancreatitis

;bdominal distention

Ulcerati&e esopha!itis

Dermatologic

Impaired o"nd healin!

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Petechiae and ecchymoses

May s"ppress reactions to s=in tests

Thin %ra!ile s=in

acial erythema

Increased seatin!

%eurological

Increased intracranial press"re ith papilledema /pse"do't"mor cerebri2 "s"ally a%ter treatment

Con&"lsions

erti!o

5eadache

Endocrine

De&elopment o% C"shin!oid state

S"ppression o% !roth in children

Secondary adrenocortical and pit"itary "nresponsi&eness, partic"larly in times o% stress, as in

tra"ma, s"r!ery or illness

Menstr"al irre!"larities

Decreased carbohydrate tolerance

Mani%estations o% latent diabetes mellit"s

Increased re

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Exophthalmos

)eta-olic

Ne!ati&e nitro!en balance d"e to protein catabolism

The %olloin! additional reactions ha&e been reported %olloin! oral as ell as parenteral

therapy4

Urticaria and other aller!ic, anaphylactic or hypersensiti&ity reactions#

Methylprednisolone Tablets Dosa!e and ;dministration

The initial dosa!e o% Methylprednisolone Tablets may &ary %rom ) m! to )3 m! o%

methylprednisolone per day dependin! on the speci%ic disease entity bein! treated# In sit"ations

o% less se&erity loer doses ill !enerally s"%%ice hile in selected patients hi!her initial doses

may be reAlternati(e Da! herap!+;lternati&e day therapy is a corticosteroid dosin! re!imen in

hich tice the "s"al daily dose o% corticoid is administered e&ery other mornin!# The p"rpose

o% this mode o% therapy is to pro&ide the patient re

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treatment ith the bene%icial e%%ects o% corticoids hile minimi7in! certain "ndesirable e%%ects,

incl"din! pit"itary'adrenal s"ppression, the C"shin!oid state, Corticoid ithdraal symptoms,

and !roth s"ppression in children#

The rationale %or this treatment sched"le is based on to ma:or premises4 /a2 the anti'

in%lammatory or therape"tic e%%ect o% corticoids persists lon!er than their physical presence andmetabolic e%%ects and /b2 administration o% the corticosteroid e&ery other mornin! allos %or

reestablishment o% more nearly normal hypothalamic'pit"itary'adrenal /5P;2 acti&ity on the o%%'

steroid day#

; brie% re&ie o% the 5P; physiolo!y may be help%"l in "nderstandin! this rationale# ;ctin!

primarily thro"!h the hypothalam"s a %all in %ree cortisol stim"lates the pit"itary !land to

prod"ce increasin! amo"nts o% corticotropin /;CT52 hile a rise in %ree cortisol inhibits ;CT5

secretion# Normally the 5P; system is characteri7ed by di"rnal /circadian2 rhythm# Ser"m le&els

o% ;CT5 rise %rom a lo point abo"t ( pm to a pea= le&el abo"t . am# Increasin! le&els o%

;CT5 stim"late adrenal cortical acti&ity res"ltin! in a rise in plasma cortisol ith maximalle&els occ"rrin! beteen + am and 3 am# This rise in cortisol dampens ;CT5 prod"ction and in

t"rn adrenal cortical acti&ity# There is a !rad"al %all in plasma corticoids d"rin! the day ith

loest le&els occ"rrin! abo"t midni!ht#

The di"rnal rhythm o% the 5P; axis is lost in C"shin!8s disease, a syndrome o% adrenal cortical

hyper%"nction characteri7ed by obesity ith centripetal %at distrib"tion, thinnin! o% the s=in ith

easy br"isability, m"scle astin! ith ea=ness, hypertension, latent diabetes, osteoporosis,

electrolyte imbalance, etc# The same clinical %indin!s o% hyperadrenocorticism may be noted

d"rin! lon!'term pharmacolo!ic dose corticoid therapy administered in con&entional daily

di&ided doses# It o"ld appear, then, that a dist"rbance in the di"rnal cycle ith maintenance o%ele&ated corticoid &al"es d"rin! the ni!ht may play a si!ni%icant role in the de&elopment o%

"ndesirable corticoid e%%ects# Escape %rom these constantly ele&ated plasma le&els %or e&en short

periods o% time may be instr"mental in protectin! a!ainst "ndesirable pharmacolo!ic e%%ects#

D"rin! con&entional pharmacolo!ic dose corticosteroid therapy, ;CT5 prod"ction is inhibited

ith s"bse

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The %olloin! sho"ld be =ept in mind hen considerin! alternate day therapy4

(#

>asic principles and indications %or corticosteroid therapy sho"ld apply# The bene%its o%

;DT sho"ld not enco"ra!e the indiscriminate "se o% steroids#

+#;DT is a therape"tic techni

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In "sin! ;DT it is important, as in all therape"tic sit"ations to indi&id"ali7e and tailor the

therapy to each patient# Complete control o% symptoms ill not be possible in all patients#

;n explanation o% the bene%its o% ;DT ill help the patient to "nderstand and tolerate the

possible %lare'"p in symptoms hich may occ"r in the latter part o% the o%%'steroid day#

Other symptomatic therapy may be added or increased at this time i% needed#

3#

In the e&ent o% an ac"te %lare'"p o% the disease process, it may be necessary to ret"rn to a

%"ll s"ppressi&e daily di&ided corticoid dose %or control# Once control is a!ain established

alternate day therapy may be reinstit"ted#

H#

;ltho"!h many o% the "ndesirable %eat"res o% corticosteroid therapy can be minimi7ed by

;DT, as in any therape"tic sit"ation, the physician m"st care%"lly ei!h the bene%it'ris=

ratio %or each patient in hom corticoid therapy is bein! considered#

5o is Methylprednisolone Tablets S"pplied

Methylprednisolone Tablets are a&ailable in the %olloin! stren!th and pac=a!e si7e4

4mg/hite, o&al, l"ePoint Aaboratories#

Re&ised4 -G(*

Pac=a!eGAabel Display Panel

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Package/Label Display Panel

Package/Label Display Panel

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)E#?8:RED%SO8O%Emethylprednisolone tablet

:roduct normation:roduct !pe 5UM;N PRESCRIPTION DRU$

A;>EAtem Code >Source NDC4.3('

Route o Administration OR;A DEA Schedule

Acti(e ngredient@Acti(e )oiet!

ngredient %ame 9asis o Strength Strength)eth!lprednisolone/Methylprednisolone2 Methylprednisolone ) m!

nacti(e ngredientsngredient %ame Strength

Silicon Dioide

Anh!drous 8actose

)agnesium stearate

Cellulose )icrocr!stalline

Sodium laur!l sulate

Starch Corn

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Sodium Starch 'l!colate !pe A :otato

:roduct CharacteristicsColor 5ITE Score ) pieces

Shape O;A /O&al2 Si/e 3mm

7la(or mprint Code TA(

Contains

:ac0agingtem Code :ac0age Description

1NDC4.3('6'( +( T;>AET in ( >AISTER P;C@

)ar0eting normation)ar0eting Categor! Application %um-er or )onograph Citation )ar0eting Start Date )ar0eting End Date;ND; ;ND;)(3H 3G+G+(*

8a-eler B >l"ePoint Aaboratories /H+H6.(H2

Esta-lishment%ame Address D@7E Operations?U>IA;NT C;DIST; P5;RM;CEUTIC;AS, INC# ++)H6(6 M;NU;CTURE/.3('62

Revised: 08/2013