For Healthcare Professionals

Applies to methylprednisolone: compounding powder, injectable powder for injection, injectable

suspension, oral tablet

General
Adverse effects have occurred less frequently when minimum dosages have been administered.
Adverse effects of corticosteroid therapy may be subdivided into those associated with short-term
therapy (to three weeks) and those of long-term therapy (> three weeks).
Short-term effects have included sodium retention-related weight gain and fluid accumulation,
hyperglycemia and glucose intolerance, hypokalemia, gastrointestinal upset and ulceration,
reversible depression of the hypothalamic-pituitary-adrenal (HPA) axis, and mood changes
ranging from mild euphoria and insomnia to nervousness, restlessness, mania, catatonia,
depression, delusions, hallucinations, and violent behavior.
Long-term effects have included HPA suppression, Cushingoid appearance, hirsutism or virilism,
impotence, and menstrual irregularities, peptic ulcer disease, cataracts and increased intraocular
pressure/glaucoma, myopathy, osteoporosis, and vertebral compression fractures.[Ref]

Cardiovascular
Cardiovascular side effects have included hypertension and congestive heart failure due to longterm fluid retention as well as direct vascular effects. Bradycardia, cardiac arrest, cardiac
arrhythmias, cardiac enlargement, circulatory collapse, fat embolism, myocardial rupture
following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis,
and vasculitis have also been reported.[Ref]
Hypertension has been associated with long-term therapy with corticosteroids and is thought to
be due to fluid retention.[Ref]

Endocrine
Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in
tissues and increasing hepatic glucose output. Patients on alternate day therapy may exhibit
significantly higher serum glucose on the day methylprednisolone is taken. Diabetes mellitus
requiring diet modifications and hypoglycemic agents has developed in some patients.
Adrenal suppression can persist for up to twelve months after long-term corticosteroid therapy.
Adrenal suppression may be reduced by giving corticosteroids once a day or once every other
day. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during
times of physical stress may be required.[Ref]

Endocrine side effects have included decreased glucose tolerance and hyperglycemia resulting
in diabetes-like symptoms. Hypothalamic-pituitary-adrenal activity has been suppressed 12
months or more following long-term corticosteroid administration. Cushingoid appearance
commonly has occurred with chronic therapy. Hirsutism or virilism, impotence, and menstrual
irregularities may occur. Glycosuria, hirsutism, and hypertrichosis have also been reported. [Ref]

Gastrointestinal
Gastrointestinal effects most commonly occurring during corticosteroid therapy have included
nausea, vomiting, dyspepsia, and anorexia. Peptic ulcer disease has been associated with longterm corticosteroid therapy, but is relatively uncommon. Routine prophylactic therapy is not
warranted in all individuals. Aluminum/magnesium containing antacids generally have been used
to manage GI complaints without significant drug interactions.[Ref]
Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic
ulcer disease. Pancreatitis, ulcerative esophagitis, gastrointestinal perforation and hemorrhage
have also been reported. Additionally, abdominal distention, bowel/bladder dysfunction (after
intrathecal administration), increased appetite, and perforation of the small and large intestine
(particularly in patients with inflammatory bowel disease) have been reported. [Ref]

Metabolic
Metabolic side effects have included hypernatremia (rare), hypokalemia, fluid retention, negative
nitrogen balance and increase in blood urea nitrogen concentration. [Ref]

Musculoskeletal
Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression
fractures, tendon rupture (particularly the Achilles tendon), and aseptic necrosis of bone have
occurred during corticosteroid therapy. Aseptic necrosis most often has affected the femoral
head. Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic
fracture of long bones, and vertebral compression fractures has also been reported. [Ref]
Corticosteroid myopathy presenting as weakness and wasting of the proximal limb and girdle
muscles has occurred, but has generally resolved following cessation of therapy.
Corticosteroids inhibit intestinal absorption and increase urinary excretion of calcium leading to
bone resorption and bone loss. Bone loss of 3% over one year has been demonstrated with
prednisolone 10 mg per day. Postmenopausal females are at risk of loss of bone density. Up to
16% of elderly patients treated with corticosteroids for 5 years may experience vertebral
compression fractures. One author reported measurable bone loss over two years in women on
concomitant therapy with prednisone 7.5 mg per day and tamoxifen.[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia, lymphopenia, and platelet alterations
resulting in thrombolic events.[Ref]

Immunologic
Immunologic side effects have included impairment in cell-mediated immunity and increased
susceptibility to bacterial, viral, fungal and parasitic infections. Immune response to skin tests
may be suppressed.[Ref]

Hepatic
Hepatic side effects have included reversible increases in serum transaminase and alkaline
phosphatase concentrations. Hepatomegaly has also bee reported. [Ref]

Ocular
Ocular side effects have included increased intraocular pressure, glaucoma, and posterior
subcapsular cataracts.[Ref]
In renal transplant patients maintained on prednisone 10 mg per day, 33% developed posterior
subcapsular cataracts. Mean time to cataract development was 26 months. Increased intraocular
pressure has occurred in 5% of patients.[Ref]

Psychiatric
Psychiatric side effects have included psychoses, personality or behavioral changes, depression,
emotional instability, euphoria, mood swings, and psychic disorders.[Ref]

Dermatologic
Dermatologic side effects have included bruising, ecchymosis, petechiae striae, delayed wound
healing, and acne. Allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin,
erythema, hyperpigmentation, hypopigmentation, increase sweating, rash, sterile abscess, striae,
thin fragile skin, and thinning scalp hair, and urticaria have also been reported. [Ref]

Other
Pseudorheumatism, or glucocorticoid-withdrawal syndrome not related to adrenal insufficiency
has occurred on withdrawal of corticosteroids. Patients experienced anorexia, nausea, vomiting,
lethargy, headache, fever, arthralgias, myalgias and postural hypotension. Symptoms resolved
when corticosteroid therapy was reinstated.[Ref]
Other side effects have included a glucocorticoid withdrawal syndrome seen upon abrupt
discontinuation of corticosteroid therapy that was not associated with adrenal suppression. [Ref]

Oncologic
Oncologic side effects have included Kaposi's sarcoma. Clinical remission may occur with
discontinuation of therapy.[Ref]

Hypersensitivity
Hypersensitivity side effects have included anaphylaxis with or without circulatory collapse,
cardiac arrest, or bronchospasm with parenteral administration of methylprednisolone.
Anaphylactoid reactions and angioedema have also been reported.[Ref]

Local
Local side effects have included hyperpigmentation, hypopigmentation, subcutaneous and
cutaneous atrophy, and sterile abscess at injection sites following parenteral administration. [Ref]

Respiratory
Respiratory side effects have included pulmonary edema. [Ref]

Nervous system
Nervous system side effects have included convulsions, headache, increased intracranial
pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment,
insomnia, neuritis, neuropathy, paresthesia, and vertigo. [Ref]

Methylprednisolone dosing information

Usual Adult Dose of Methylprednisolone for Allergic Rhinitis:
acetate: 80 to 120 mg intramuscular only.
Usual Adult Dose of Methylprednisolone for Dermatologic Lesion:
acetate: 40 to 120 mg intramuscular weekly for 1 to 4 weeks.
Usual Adult Dose for Rheumatoid Arthritis:
Acetate: 40 to 120 mg intramuscular weekly
Large joints: 20 to 80 mg intraarticular
Medium joints: 10 to 40 mg intraarticular
Small joints: 4 to 10 mg intraarticular
Usual Adult Dose of Methylprednisolone for Adrenogenital Syndrome:

Acetate: 40 mg intramuscular every 2 weeks.

Usual Adult Dose for Anti-inflammatory:
4 to 48 mg/day orally.
Sodium succinate: 10 to 40 mg Intravenous over 1 to several minutes. Give subsequent doses IV
or IM.
Usual Adult Dose of Methylprednisolone for Shock:
30 mg/kg IV repeated every 4 to 6 hours or 100 to 250 mg IV repeated every 2 to 6 hours.
Usual Adult Dose for Immunosuppression:
4 to 48 mg orally per day.
2 to 2.5 mg/kg per day IV or IM, tapered slowly over 2 to 3 weeks or 250 to 1,000 mg IV once
daily or on alternate days for 3 to 5 doses.
Usual Adult Dose of Methylprednisolone for Asthma -- Acute:
Asthma exacerbations (emergency medical care or hospital doses):
Oral or IV: 40 to 80 mg/day in divided doses 1 to 2 times/day until peak expiratory flow is 70% of
predicted or personal best
Short-course "burst" (acute asthma):
Oral: 40 to 60 mg/day in divided doses 1 to 2 times/day for 3 to 10 days; Note: Burst should be
continued until symptoms resolve and peak expiratory flow is at least 80% of personal best;
usually requires 3 to 10 days of treatment (approximately 5 days on average); longer treatment
may be required
IM (acetate): 240 mg as a one-time dose (Note: This may be given in place of short-course
"burst" of oral steroids in patients who are vomiting or if compliance is a problem)
Usual Adult Dose of Methylprednisolone for Asthma -- Maintenance:
Oral: 7.5 to 60 mg daily given as a single dose in the morning or every other day as needed for
asthma control
Usual Pediatric Dose for Anti-inflammatory:
Sodium succinate: not less than 0.5 mg/kg/24 hours intravenous or intramuscular.
High dose therapy: 30 mg/kg intravenous over 10 to 20 minutes. May repeat every 4 to 6 hours,
but not beyond 48 to 72 hours.
Usual Pediatric Dose for Asthma -- Acute:

Up to 11 years:
Asthma exacerbations (emergency medical care or hospital doses):
Oral or IV: 1 to 2 mg/kg/day in 2 divided doses (maximum: 60 mg/day) until peak expiratory flow
is 70% of predicted or personal best.
Short-course "burst" (acute asthma):
Oral: 1 to 2 mg/kg/day in divided doses 1 to 2 times/day for 3 to 10 days; maximum dose: 60
mg/day; Note: Burst should be continued until symptoms resolve or patient achieves peak
expiratory flow 80% of personal best; usually requires 3 to 10 days of treatment (approximately 5
days on average); longer treatment may be required
IM (acetate) : Note: This may be given in place of short-course "burst" of oral steroids in patients
who are vomiting or if compliance is a problem:
Children up to 4 years: 7.5 mg/kg as a one-time dose; maximum dose: 240 mg
Children 5 to 11 years: 240 mg as a one-time dose.
11 years or older:
Asthma exacerbations (emergency medical care or hospital doses):
Oral or IV: 40 to 80 mg/day in divided doses 1 to 2 times/day until peak expiratory flow is 70% of
predicted or personal best
Short-course "burst" (acute asthma):
Oral: 40 to 60 mg/day in divided doses 1 to 2 times/day for 3 to 10 days; Note: Burst should be
continued until symptoms resolve and peak expiratory flow is at least 80% of personal best;
usually requires 3 to 10 days of treatment (approximately 5 days on average); longer treatment
may be required
IM (acetate): 240 mg as a one-time dose (Note: This may be given in place of short-course
"burst" of oral steroids in patients who are vomiting or if compliance is a problem)
Usual Pediatric Dose of of Methylprednisolone for Asthma -- Maintenance:
Up to 11 years:
0.25 to 2 mg/kg/day given as a single dose in the morning or every other day as needed for
asthma control; maximum dose: 60 mg/day.
11 years or older:
Oral: 7.5 to 60 mg orally daily given as a single dose in the morning or every other day as needed
for asthma control

umum
Efek samping terjadi lebih jarang ketika dosis minimal telah diberikan.

Efek samping dari terapi kortikosteroid dapat dibagi menjadi Efek samping
dengan terapi jangka pendek (sampai tiga minggu) Efek samping terapi jangka
panjang (> tiga minggu).

Efek jangka pendek seperti retensi natrium yang menyebabkan peningkatan

berat badan dan akumulasi cairan, hiperglikemia dan intoleransi glukosa,
hipokalemia, gangguan pencernaan dan ulserasi, depresi reversibel dari
hipotalamus-hipofisis-adrenal (HPA), dan suasana hati berubah mulai dari euforia
ringan dan insomnia gugup, gelisah, mania, catatonia, depresi, delusi, halusinasi,
dan perilaku kekerasan.

Efek jangka panjang depresi HPA, chusing sindrome, hirsutisme atau virilism,
impotensi, dan ketidakteraturan menstruasi, penyakit ulkus peptikum, katarak
dan peningkatan tekanan intraokular / glaukoma, miopati, osteoporosis, dan
fraktur kompresi vertebral.
kardiovaskular
Efek samping kardiovaskular antara lain hipertensi dan gagal jantung kongestif
akibat retensi cairan jangka panjang serta efek vaskular langsung. Bradikardia,
serangan jantung, aritmia jantung, pembesaran jantung, kolaps sirkulasi, emboli
lemak, infark miokard, sinkop, takikardia, tromboemboli, tromboflebitis, dan
vaskulitis.
Kelenjar endokrin

Terapi kortikosteroid dapat menyebabkan intoleransi glukosa dengan mengurangi

pemanfaatan glukosa pada jaringan dan meningkatkan output glukosa hepatik.
Supresi adrenal dapat bertahan sampai dua belas bulan setelah terapi
kortikosteroid jangka panjang. Efek samping endokrin telah memasukkan
penurunan toleransi glukosa dan hiperglikemia mengakibatkan gejala diabetes
seperti. Kegiatan hipotalamus-hipofisis-adrenal telah ditekan 12 bulan atau lebih
setelah pemberian kortikosteroid jangka panjang. Penampilan cushing biasanya
terjadi dengan terapi kronis. Hirsutisme atau virilism, impotensi, dan
ketidakteraturan menstruasi dapat terjadi. Glikosuria, hirsutisme, dan
hipertrikosis.

Gastrointestinal
Efek gastrointestinal yang paling sering terjadi selama terapi kortikosteroid
adalah mual, muntah, dispepsia, dan anoreksia. Ulkus peptikum telah dikaitkan
dengan terapi kortikosteroid jangka panjang, tetapi relatif jarang. Pankreatitis,
esofagitis ulseratif, perforasi gastrointestinal dan perdarahan juga telah
dilaporkan. Selain itu, distensi perut, disfungsi usus / kandung kemih (setelah
pemberian intratekal), nafsu makan meningkat, dan perforasi dari usus kecil dan
besar (terutama pada pasien dengan penyakit inflamasi usus)

musculoskeletal
Efek samping muskuloskeletal seperti miopati, osteoporosis, fraktur kompresi
vertebral, ruptur tendon (terutama tendon Achilles), dan nekrosis aseptik tulang
bisa terjadi selama terapi kortikosteroid. Aseptic necrosis paling sering
mempengaruhi kepala femoral. Charcot-seperti arthropathy, kehilangan massa
otot, kelemahan otot, osteoporosis, fraktur patologis tulang panjang, dan fraktur
kompresi vertebral juga telah dilaporkan.
Kortikosteroid miopati menyajikan sebagai kelemahan dan pengecilan
ekstremitas dan korset otot proksimal telah terjadi, namun secara umum
diselesaikan setelah penghentian terapi.
Kortikosteroid menghambat penyerapan usus dan meningkatkan ekskresi
kalsium menyebabkan resorpsi tulang dan keropos tulang. Keropos tulang dari
3% lebih satu tahun telah dibuktikan dengan prednisolon 10 mg per hari.
Menopause perempuan berisiko kehilangan kepadatan tulang. Sampai dengan
16% dari pasien usia lanjut yang diobati dengan kortikosteroid selama 5 tahun
dapat mengalami fraktur kompresi vertebral.
hematologi
Efek samping hematologi telah memasukkan trombositopenia, limfopenia, dan
perubahan trombosit sehingga peristiwa tromboemboli.
imunologi
Efek samping imunologi seperti penurunan imunitas yang diperantarai sel dan
meningkatkan kerentanan terhadap bakteri, virus, jamur dan infeksi parasit.
Respon imun terhadap tes kulit dapat ditekan.

Hati
Efek samping hati seperti peningkatan reversibel dalam transaminase serum dan
konsentrasi alkali fosfatase. Hepatomegali juga lebah dilaporkan. [Ref]
ocular
Efek samping okular seperti peningkatan tekanan intraokular, glaukoma, dan
katarak subkapsular posterior. [Ref]
Psikiatrik
Efek samping kejiwaan seperti psikosis, kepribadian atau perubahan perilaku,
depresi, ketidakstabilan emosional, euforia, perubahan suasana hati, dan
gangguan psikis. [Ref]
Dermatologi
Efek samping dermatologi seperti memar, ecchymosis, striae petechiae,
penyembuhan luka tertunda, dan jerawat. Dermatitis alergi, kulit dan subkutan
atrofi, kulit kering bersisik, eritema, hiperpigmentasi, hipopigmentasi,
meningkatkan berkeringat, ruam, abses steril, striae, kulit rapuh tipis, dan
rambut menipis kulit kepala, dan urtikaria juga telah dilaporkan. [Ref]
Methylprednisolone informasi dosis
Dosis Dewasa biasa dari Methylprednisolone untuk Rhinitis alergi:
asetat: 80 sampai 120 mg hanya intramuskular.
Dosis Dewasa biasa dari Methylprednisolone untuk Dermatologic Lesi:
asetat: 40-120 mg mingguan intramuskular selama 1 sampai 4 minggu.
Dosis Dewasa biasa untuk Rheumatoid Arthritis:
Asetat: 40-120 mg mingguan intramuskular
Besar sendi: 20 sampai 80 mg artikular intra
Sedang sendi: 10 sampai 40 mg artikular intra
Sendi kecil: 4 sampai 10 mg intraartikular
Dosis Dewasa biasa dari Methylprednisolone untuk adrenogenital Syndrome:
Asetat: 40 mg intramuskular setiap 2 minggu.
Dosis Dewasa biasa untuk Anti-inflamasi:
4-48 mg / hari secara oral.
Natrium suksinat: 10 sampai 40 mg intravena selama 1 sampai beberapa menit.
Berikan dosis berikutnya IV atau IM.
Dosis Dewasa biasa dari Methylprednisolone untuk Syok:
30 mg / kg IV diulang setiap 4 sampai 6 jam atau 100-250 mg IV diulang setiap 2
sampai 6 jam.
Biasa Dosis Dewasa untuk Imunosupresi:

4-48 mg oral per hari.

2 sampai 2,5 mg / kg per hari IV atau IM, meruncing perlahan selama 2 sampai 3
minggu atau 250 sampai 1.000 mg IV sekali sehari atau pada hari alternatif
selama 3 sampai 5 dosis.
Dosis Dewasa biasa dari Methylprednisolone untuk Asma - Akut:
Eksaserbasi asma (perawatan medis darurat atau rumah sakit dosis):
Oral atau IV: 40 sampai 80 mg / hari dalam dosis terbagi 1-2 kali / hari sampai
aliran ekspirasi puncak 70% dari prediksi atau pribadi terbaik
Jangka pendek "meledak" (asma akut):
Oral: 40 sampai 60 mg / hari dalam dosis terbagi 1-2 kali / hari selama 3 sampai
10 hari; Catatan: Burst harus dilanjutkan sampai gejala menyelesaikan dan arus
puncak ekspirasi setidaknya 80% dari pribadi terbaik; biasanya membutuhkan 3
sampai 10 hari pengobatan (sekitar 5 hari rata-rata); pengobatan yang lebih
lama mungkin diperlukan
IM (asetat): 240 mg sebagai dosis satu kali (Catatan: Ini dapat diberikan di
tempat jangka pendek "meledak" steroid oral pada pasien yang muntah atau jika
kepatuhan masalah)
Dosis Dewasa biasa dari Methylprednisolone untuk Asma - Pemeliharaan:
Oral: 7,5-60 mg sehari diberikan sebagai dosis tunggal pada pagi atau setiap hari
lainnya yang diperlukan untuk mengontrol asma
Dosis Pediatric biasa untuk Anti-inflamasi:
Natrium suksinat: tidak kurang dari 0,5 mg / kg / 24 jam intravena atau
intramuskular.

Terapi dosis tinggi: 30 mg / kg intravena selama 10 sampai 20 menit. Dapat

mengulang setiap 4 sampai 6 jam, tetapi tidak melampaui 48 sampai 72 jam.
Dosis Pediatric biasa untuk Asma - Akut:
Sampai 11 tahun:
Eksaserbasi asma (perawatan medis darurat atau rumah sakit dosis):
Oral atau IV: 1 sampai 2 mg / kg / hari dalam 2 dosis terbagi (maksimum: 60
mg / hari) sampai aliran ekspirasi puncak 70% dari prediksi atau personal
terbaik.

Jangka pendek "meledak" (asma akut):

Oral: 1 sampai 2 mg / kg / hari dalam dosis terbagi 1-2 kali / hari selama 3
sampai 10 hari; Dosis maksimum: 60 mg / hari; Catatan: Burst harus dilanjutkan
sampai gejala menyelesaikan atau pasien mencapai aliran ekspirasi puncak 80%
dari pribadi terbaik; biasanya membutuhkan 3 sampai 10 hari pengobatan
(sekitar 5 hari rata-rata); pengobatan yang lebih lama mungkin diperlukan

IM (asetat): Catatan: Ini dapat diberikan di tempat jangka pendek "meledak"

steroid oral pada pasien yang muntah atau jika kepatuhan masalah:
Anak-anak sampai 4 tahun: 7,5 mg / kg sebagai dosis satu kali; Dosis maksimum:
240 mg
Anak 5 sampai 11 tahun: 240 mg sebagai dosis satu kali.

11 tahun atau lebih tua:

Eksaserbasi asma (perawatan medis darurat atau rumah sakit dosis):
Oral atau IV: 40 sampai 80 mg / hari dalam dosis terbagi 1-2 kali / hari sampai
aliran ekspirasi puncak 70% dari prediksi atau pribadi terbaik
Jangka pendek "meledak" (asma akut):
Oral: 40 sampai 60 mg / hari dalam dosis terbagi 1-2 kali / hari selama 3 sampai
10 hari; Catatan: Burst harus dilanjutkan sampai gejala menyelesaikan dan arus
puncak ekspirasi setidaknya 80% dari pribadi terbaik; biasanya membutuhkan 3
sampai 10 hari pengobatan (sekitar 5 hari rata-rata); pengobatan yang lebih
lama mungkin diperlukan
IM (asetat): 240 mg sebagai dosis satu kali (Catatan: Ini dapat diberikan di
tempat jangka pendek "meledak" steroid oral pada pasien yang muntah atau jika
kepatuhan masalah)
Dosis Biasa Pediatric dari dari Methylprednisolone untuk Asma - Pemeliharaan:
Sampai 11 tahun:
0,25-2 mg / kg / hari diberikan sebagai dosis tunggal pada pagi atau setiap hari
lainnya yang diperlukan untuk pengendalian asma; Dosis maksimum: 60 mg /
hari.

11 tahun atau lebih tua:

Oral: 7,5-60 mg oral sehari diberikan sebagai dosis tunggal pada pagi atau setiap
hari lainnya yang diperlukan untuk mengontrol asma