Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1275
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A-METHAPRED (Injection, Powder, Lyophilized, For Solution)
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When high dose therapy is desired, the recommended
dose of A-Methapred sterile powder is 30 mg/kg administered intravenously
over at least 30 minutes. This dose may be repeated every 4 to 6 hours
for 48 hours. In general, high
dose corticosteroid therapy should be continued only until the patient's
condition has stabilized; usually not beyond 48 to 72 hours. Although adverse effects associated with
high dose short-term corticoid therapy are uncommon, peptic ulceration
may occur. Prophylactic antacid therapy may be indicated. In other indications initial dosage will
vary from 10 to 40 mg of methylprednisolone depending on the clinical
problem being treated. The larger doses may be required for short-term
management of severe, acute conditions. The initial dose usually should
be given intravenously over a period of several minutes. Subsequent
doses may be given intravenously or intramuscularly at intervals dictated
by the patient's response and clinical condition. Corticoid
therapy is an adjunct to, and not replacement for conventional therapy. Dosage may be reduced for infants and children
but should be governed more by the severity of the condition and response
of the patient than by age or size. It should not be less than 0.5
mg/kg every 24 hours. Dosage must
be decreased or discontinued gradually when the drug has been administered
for more than a few days. If a period of spontaneous remission occurs
in a chronic condition, treatment should be discontinued. Routine
laboratory studies, such as urinalysis, two-hour postprandial blood
sugar, determination of blood pressure and body weight, and a chest
X-ray should be made at regular intervals during prolonged therapy.
Upper GI X-rays are desirable in patients with an ulcer history or
significant dyspepsia. A-Methapred
may be administered by intravenous or intramuscular injection or by
intravenous infusion, the preferred method for initial emergency use
being intravenous injection. To administer by intravenous (or intramuscular)
injection, prepare solution as directed. The desired dose may be administered
intravenously over a period of several minutes. To prepare solutions for intravenous infusion, first prepare
the solution for injection as directed. This solution may then be
added to indicated amounts of 5% dextrose in water, isotonic saline
solution or 5% dextrose in isotonic saline solution. Multiple Sclerosis In treatment of acute exacerbations of multiple sclerosis,
daily doses of 200 mg of prednisolone for a week followed by 80 mg
every other day for 1 month have been shown to be effective (4 mg
of methylprednisolone is equivalent to 5 mg of prednisolone). Directions for Reconstitution STORAGE CONDITIONS Protect from light. Store unreconstituted product at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] Store solution at 20 to 25��C (68 to
77��F). [See USP Controlled Room Temperature.] Use solution within 48 hours after mixing.
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| dailymed-instance:descripti... |
A-Methapred (methylprednisolone sodium succinate
for injection, USP) sterile powder contains methylprednisolone sodium
succinate as the active ingredient. Methylprednisolone sodium succinate,
USP, occurs as a white, or nearly white, odorless hygroscopic, amorphous
solid. It is very soluble in water and in alcohol; it is insoluble
in chloroform and is very slightly soluble in acetone. The chemical name for methylprednisolone
sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxo-propoxy)-11,17-dihydroxy-6-methyl-monosodium
salt, (6��, 11��), and the molecular weight is 496.53. The structural formula is represented below: Methylprednisolone
sodium succinate is so extremely soluble in water that it may be administered
in a small volume of diluent and is especially well suited for intravenous
use in situations in which high blood levels of methylprednisolone
are required rapidly. A-Methapred
is available in several strengths and packages for intravenous or
intramuscular administration. 40 mg Single-Dose Vial���Each mL
(when mixed) contains methylprednisolone sodium succinate equivalent
to 40 mg methylprednisolone; also 1.6 mg monobasic sodium phosphate
anhydrous; 17.46 mg dibasic sodium phosphate anhydrous; 25 mg lactose
anhydrous; 8.8 mg benzyl alcohol added as preservative. 125 mg Single-Dose Vial���Each 2 mL (when mixed) contains methylprednisolone sodium
succinate equivalent to 125 mg methylprednisolone; also 1.6 mg monobasic
sodium phosphate anhydrous; 17.4 mg dibasic sodium phosphate anhydrous;
17.6 mg benzyl alcohol added as preservative. When necessary, the pH of each formula was adjusted
with sodium hydroxide so that the pH of the reconstituted solution
is within the USP specified range of 7 to 8 and the tonicities are,
for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2
mL, 0.40 osmolar; (Isotonic saline = 0.28 osmolar). IMPORTANT���Use only Bacteriostatic
Water For Injection with Benzyl Alcohol when reconstituting A-Methapred. Use within 48 hours after mixing.
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Methylprednisolone is a potent anti-inflammatory
steroid with greater anti-inflammatory potency than prednisolone and
even less tendency than prednisolone to induce sodium and water retention. Methylprednisolone sodium succinate has the
same metabolic and anti-inflammatory actions as methylprednisolone.
When given parenterally and in equimolar quantities, the two compounds
are equivalent in biologic activity. The relative potency of A-Methapred
sterile powder and hydrocortisone sodium succinate, as indicated by
depression of eosinophil count, following intravenous administration,
is at least four to one. This is in good agreement with the relative
oral potency of methylprednisolone and hydrocortisone.
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The use of A-Methapred sterile powder is contraindicated
in premature infants because the reconstitution diluent contains benzyl
alcohol. Benzyl alcohol has been reported to be associated with a
fatal���Gasping Syndrome���in premature infants. A-Methapred
sterile powder is also contraindicated in systemic fungal infections
and patients with known hypersensitivity to the product and its constituents.
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A-Methapred sterile powder is available in the following
packages: Rev: October, 2005 ��Hospira
2005EN-1059Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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General Precautions: Drug-induced secondary adrenocortical insufficiency
may be minimized by gradual reduction of dosage. This type of relative
insufficiency may persist for months after discontinuation of therapy;
therefore, in any situation of stress occurring during that period,
hormone therapy should be reinstituted. Since mineralocorticoid secretion
may be impaired, salt and/or a mineralocorticoid should be administered
concurrently. There is an enhanced
effect of corticosteroids on patients with hypothyroidism and in those
with cirrhosis. Corticosteroids
should be used cautiously in patients with ocular herpes simplex because
of possible corneal perforation. The
lowest possible dose of corticosteroid should be used to control the
condition under treatment, and when reduction in dosage is possible,
the reduction should be gradual. Psychic
derangements may appear when corticosteroids are used, ranging from
euphoria, insomnia, mood swings, personality changes, and severe depression,
to frank psychotic manifestations. Also, existing emotional instability
or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with
corticosteroids in hypoprothrombinemia. Steroids
should be used with caution in nonspecific ulcerative colitis, if
there is a probability of impending perforation, abscess or other
pyogenic infection; diverticulitis; fresh intestinal anastomoses;
active or latent peptic ulcer; renal insufficiency; hypertension;
osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid
therapy should be carefully observed. Although
controlled clinical trials have shown corticosteroids to be effective
in speeding the resolution of acute exacerbations of multiple sclerosis,
they do not show that corticosteroids affect the ultimate outcome
or natural history of the disease. The studies do show that relatively
high doses of corticosteroids are necessary to demonstrate a significant
effect. (See DOSAGE AND ADMINISTRATION.) Since complications of treatment with glucocorticoids are dependent
on the size of the dose and duration of treatment, a risk/benefit
decision must be made in each individual case as to dose and duration
of treatment and as to whether daily or intermittent therapy should
be used.<br/>DRUG INTERACTIONS: The pharmacokinetic interactions listed below are
potentially clinically important. Mutual inhibition of metabolism
occurs with concurrent use of cyclosporin and methylprednisolone;
therefore, it is possible that adverse events associated with the
individual use of either drug may be more apt to occur. Convulsions
have been reported with concurrent use of methylprednisolone and cyclosporin.<br/>Information for the Patient: Persons who are on immunosuppressant doses of corticosteroids
should be warned to avoid exposure to chicken pox or measles. Patients
should also be advised that if they are exposed, medical advice should
be sought without delay.
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Methylprednisolone Sodium Succinate
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A-METHAPRED (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
Fluid and Electrolyte Disturbances Sodium retention, Fluid retention,
Congestive heart failure in susceptible patients, Potassium loss,
Hypokalemic alkalosis, Hypertension Musculoskeletal Muscle weakness, Steroid myopathy, Loss of muscle mass, Severe arthralgia,
Vertebral compression fractures, Aseptic necrosis of femoral and humeral
heads, Pathologic fracture of long bones, Osteoporosis Gastrointestinal Peptic ulcer with possible perforation and hemorrhage,
Pancreatitis, Abdominal distention, and Ulcerative esophagitis Dermatologic Impaired wound healing, Thin fragile skin, Petechiae and
ecchymoses, Facial erythema, Increased sweating, May suppress reactions
to skin tests Neurological Increased intracranial pressure
with papilledema (pseudo-tumor cerebri) usually after treatment, Convulsions,
Vertigo, Headache Endocrine Development of Cushingoid
state, Suppression of growth in children, Secondary adrenocortical
and pituitary unresponsiveness, particularly in times of stress, as
in trauma, surgery or illness, Menstrual irregularities, Decreased
carbohydrate tolerance, Manifestations of latent diabetes mellitus,
Increased requirements for insulin or oral hypoglycemic agents in
diabetics Ophthalmic Posterior subcapsular cataracts,
Increased intraocular pressure, Glaucoma, Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism The following additional adverse reactions are related to parenteral corticosteroid therapy:
Hyperpigmentation or hypopigmentation, Subcutaneous and cutaneous
atrophy, Sterile abscess, Anaphylactic reaction with or without circulatory
collapse, cardiac arrest, bronchospasm, Urticaria, Nausea and vomiting,
Cardiac arrhythmias; hypotension or hypertension
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| dailymed-instance:warning |
While on corticosteroid
therapy patients should not be vaccinated against smallpox. Other
immunization procedures should not be undertaken in patients who are
on corticosteroids, especially on high dose, because of possible hazards
of neurological complications and a lack of antibody response. In patients on corticosteroid therapy subjected
to any unusual stress, increased dosage of rapidly acting corticosteroids
before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of
infection, and new infections may appear during their use. There may
be decreased resistance and inability to localize infection when corticosteroids
are used. A study has failed
to establish the efficacy of Methylprednisolone Sodium Succinate for
Injection, USP in the treatment of sepsis syndrome and septic shock.
The study also suggests that treatment of these conditions with Methylprednisolone
Sodium Succinate for Injection, USP may increase the risk of mortality
in certain patients (ie, patients with elevated serum creatinine levels
or patients who develop secondary infections after Methylprednisolone
Sodium Succinate for Injection, USP. Prolonged
use of corticosteroids may produce posterior subcapsular cataracts,
glaucoma with possible damage to the optic nerves, and may enhance
the establishment of secondary ocular infections due to fungi or viruses. Usage in
pregnancy. Since adequate human reproduction studies have
not been done with corticosteroids, the use of these drugs in pregnancy,
nursing mothers, or women of child-bearing potential requires that
the possible benefits of the drug be weighed against the potential
hazards to the mother and embryo or fetus. Infants born of mothers
who have received substantial doses of corticosteroids during pregnancy
should be carefully observed for signs of hypoadrenalism. Average and large doses of cortisone or hydrocortisone
can cause elevation of blood pressure, salt and water retention, and
increased excretion of potassium. These effects are less likely to
occur with the synthetic derivatives except when used in large doses.
Dietary salt restriction and potassium supplementation may be necessary.
All corticosteroids increase calcium excretion. While on corticosteroid therapy patients should
not be vaccinated against smallpox. Other immunization procedures
should not be undertaken in patients who are on corticosteroids, especially
on high dose, because of possible hazards of neurological complications
and a lack of antibody response. The use of
Methylprednisolone Sodium Succinate for Injection, USP sterile powder
in active tuberculosis should be restricted to those cases of fulminatingor disseminated tuberculosis in which the corticosteroid is used for
the management of the disease in conjunction with appropriate antituberculous
regimen. If corticosteroids are
indicated in patients with latent tuberculosis or tuberculin reactivity,
close observation is necessary as reactivation of the disease may
occur. During prolonged corticosteroid therapy, these patients should
receive chemoprophylaxis. Because
rare instances of anaphylactic (eg, bronchospasm) reactions have occurred
in patients receiving parenteral corticosteroid therapy, appropriate
precautionary measures should be taken prior to administration, especially
when the patient has a history of allergy to any drug. There are reports of cardiac arrhythmias and/or circulatory
collapse and/or cardiac arrest following the rapid administration
of large IV doses of Methylprednisolone Sodium Succinate for Injection,
USP (greater than 0.5 gram administered over a period of less than
10 minutes). Bradycardia has been reported during or after the administration
of large doses of Methylprednisolone sodium succinate, and may be
unrelated to the speed or duration of infusion. Persons who are on drugs which suppress the immune system
are more susceptible to infections than healthy individuals. Chicken
pox and measles, for example, can have a more serious or even fatal
course in non-immune children or adults on corticosteroids. In such
children or adults who have not had these diseases, particular care
should be taken to avoid exposure. How the dose, route and duration
of corticosteroid administration affects the risk of developing a
disseminated infection is not known. The contribution of the underlying
disease and/or prior corticosteroid treatment to the risk is also
not known. If exposed to chicken pox, prophylaxis with varicella zoster
immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis
with pooled intramuscular immunoglobulin (IG) may be indicated. (See
the respective package inserts for complete VZIG and IG prescribing
information.) If chicken pox develops, treatment with antiviral agents
may be considered.
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| dailymed-instance:indicatio... |
When oral therapy is not feasible, and the strength,
dosage form and route of administration of the drug reasonably lend
the preparation to the treatment of the condition, A-Methapred sterile
powder is indicated for intravenous or intramuscular use in the following
conditions:
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A-METHAPRED
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