Solu-Medrol 500mg Pfizer injection powder treats endocrine disorders (1 bottle of dough x 1 bottle of solvent)
Dosage form Box
Specifications Methylprednisolone
Ingredient
| Composition information | Content |
| Methylprednisolone | 500mg |
Uses
Indications
Solu-Medrol 500mg drug are indicated in the following cases:
Endocrine disorders:
Rheumatoid disorders (short -term supplementary treatment to control acute phase or play):
Inflammation of the epidemic membrane in osteoarthritis. rheumatoid arthritis , including rheumatoid arthritis in teenagers. Non -specific acute tendonitis. Systemic disease and immune system disease (during the play or maintenance treatment in selective cases): Agent inflammation. Skin disease: Heavy psoriasis. Allergies (used to control severe or difficult allergies when failing with normal treatments): Allergic dermatitis . Serum disease. Seasonal or year -round allergic rhinitis. Infectious laryngeal edema. eye diseases (inflammatory and chronic and acute allergies in the eye): Vascular veins diffuse rear and vascular inflammation. Allergic conjunctivitis. Gastrointestinal diseases (helping patients through the crisis of the disease) Respiratory disease: Beryli poisoning. Inhalation pneumonia. Blood disorders: Secondary platelets in adults. Cancer (temporary treatment): Acute leukemia in children. Support: To help the urinary tract or reduce the proteinuria in the nephrotic syndrome without the urea of the spontaneous or erythematic lupus. Nervous system: Other indications: Organs. Methylprednisolon is an anti -inflammatory steroid that has an anti -inflammatory effect greater than prednisolon and is less likely to retain water and sodium than prednisolon. methylprednisolon sodium sucinat has the same metabolic and anti -inflammatory effect such as methylprednisolon. When using the injection and with the amount of molar copper, both of these substances are equivalent to biological activity. The potential is relatively when comparing methylprednisolon sodium sucinat with Hydrocortison sodium sucinat on the effect of reducing the amount of eosinophilus after intravenous injection, at least 4/1. This also coincides with relative potential when comparing these two preparations by oral. Cavalry Compatibility and stability when intravenous methylprednisolon sodium sucinat solution and when mixed with other intravenous solutions depend on the pH of mixed solution, concentration, time, temperature and solubility of methylprednisolon. Thus, to avoid the problem of taboos and stability, if possible, the methylprednisolon solution should be injected separately, not mixed with other drugs. Pharmacokinetic properties of methylprednisolon linear, regardless of the line. absorption After intramuscularly 40mg of methylprednisolon sodium sucinat for 14 healthy adult male volunteers, the average peak concentration is 454ng/ml achieved after 1 hour. By the 12th hour, the concentration of methylprednisolon in the blood statue drops to 31.9ng/ml. After 18 hours of injection, no longer found methylprednisolon. Based on the area under the curve (AUC), the expression of the total amount of drugs is absorbed, the intramuscular methylprednisolon sodium sucinat is equivalent to the same intravenous dose. The results of a study have shown that the methylprednisolon sodium ester ester is quickly and strongly converted into methylprednisolon that is active after use in every lane. The absorption level of free methylprednisolon after intravenous and intramuscular injection is equivalent and significantly greater than the level of absorption after taking methylprednisolon in solution and tablet form. Because the amount of methylprednisolon is absorbed after intramuscular injection and intravenous injection is the equivalent, although there is a larger amount of the ester hemisuccinat in the common circulation after intravenous injection, it can be assumed that the ester has been transformed in tissue after intramuscular injection and then absorbed in the form of methylprednisolone freely. Distribution Methylprednisolon is widely distributed into tissues, through the bloody barrier, and excreted through breast milk. The apparent distribution of the drug is about 1.4L/kg. The ability to attach to plasma proteins in humans is approximately 77%. Metabolism In humans, methylprednisolon is converted in the liver into non-active metabolites: most into 20α-hydroxymethylprednisolon and 20β-hydroxymethylprednisolon. Metabolism in the liver mainly through CYP3A4. Methylprednisolon, as well as many substrates of CYP3A4, can also be a substrate of P-Glycoprotein transport protein near ATP (ATP-Binding Cassette, ABC), affecting the distribution in tissue and interacting with other drugs. Era: The average selling time of methylprednisolon from 1.8 to 5.2 hours. The total clearance of approximately 5 - 6ml/minute/kg. Pharmacokology
Dynamic pharmacokinetics
Before taking Solu-Medrol 500mg Pfizer injection powder treats endocrine disorders (1 bottle of dough x 1 bottle of solvent)
How to use
methylprednisolon sodium sucinat can be injected or intravenous or intramuscularly. The priority method for the initial emergency is intravenously.
Special note when using and other operations
Prepare solutions
To prepare intravenous solution, first of all the methylprednisolon sodium sucinat solution as instructed. Methylprednisolon sodium sucinat can be started for at least 5 minutes (for example, up to 250mg doses) until at least 30 minutes (for example, with doses of 250mg or higher). The next dose can be taken and used similarly. When needed, it can be diluted to use by mixing with solvents such as 5% dextrose in water, 0.9% NaCl, 5% Dextrose in NaCl 0.45% or 0.9%. The solution after mixing will be chemical and physical stability for 48 hours.
Dosage
See table 1 on recommended doses. The dose may be reduced for babies and children, but it is necessary to choose based on the severity of the disease and the patient's response rather than based on the age and condition of the patient. The dosage for children should not be lower than 0.5mg/kg every 24 hours.
Table 1: Recommended dose for methylprednisolon sodium sucinat
1g/1 day, for 1-4 days, or 1g/1 month, for 6 months. This dose may be repeated if there is no improvement after 1 week of treatment, or due to the patient's condition. This dosage may be repeated if there is no improvement after 1 week of treatment, or due to the patient's condition. This dose may be repeated if there is no improvement after 1 week of treatment, or due to the patient's condition:
30mg/kg is used for 4 days or 1g/day for 3, 5 or 7 days.
Need to reserve an intravenous line for transmission pump. Pneumocystis
A mode that can be done is intravenously 40mg/6 - 12 hours at a maximum of 21 days or until the end of the Pneumocystis treatment process. It is also necessary to monitor patients with the possibility of other potential infections. gradually. The total treatment time should be at least 2 weeks. It may need higher doses to treat short -term and serious conditions. The starting dose is up to 250mg, which is an intravenous injection for at least 5 minutes, and if the dose is higher, the injection for at least 30 minutes. The next dose can be intramuscularly or veins according to the distance depending on the response of the patient and the clinical condition. Other if possible. Can be injected by types: intravenous pump, through the injection chamber (chamber) or using intravenous solution according to the "Piggy-back" technique (see the cautious part when used).
Note:
Some preparations of methylprednisolon sodium sucinat contain alcohol benzylic (see the cautious part when used, used in children).
The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Report on acute toxicity or death after corticosteroid overdose is very rare.
In case of overdose, no specific antidote but only treatment support and symptomatic treatment. Methylprednisolon can be separated.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Solu-Medrol 500mg , you may experience unwanted effects (ADR).
Unknown frequency
Blood disorders and lymphatic systems: leukemia. Immune system disorders: Hypersensitivity reaction, anaphylactic reaction, anaphylactic reaction. Endocrine disorders : Cushing syndrome, pituitary failure, steroid stop syndrome. Metabolic and nutrient disorders: Metabolic acidosis, sodium stasis, fluid retention, metabolic alkaline reduction due to hypokalemia, blood lipid disorders, reduced glucose tolerance, increased insulin demand (or oral hypoglycemic drugs in diabetes patients), Fat accumulation, increased cravings (may lead to weight gain). Mental disorders: emotional disorders (including depression, excitement, unstable emotions, drug dependence, suicide intentions), mental disorders (including Hung Cam, Ho Chi Minh, illusion and schizophrenia), Change of personality, confusion state, anxiety, erratic temperament, abnormal behavior, ominous behavior. Heart disorders: Heartbreaking heart failure (in sensitive patients), arrhythmia. Respiratory disorders, chest and mediastinum: pulmonary embolism, hiccups. Hepatitis: Hepatitis. Skin disorders and subcutaneous tissues: angioedema, hemorrhoids, hemorrhagic spots, bruises, skin atrophy, congestion, increased sweating, floating skin, rash, itching, urticaria, acne, reducing skin pigmentation. musculoskeletal disorders and connective tissues: muscle weakness, muscle pain, muscle disease, muscle atrophy, osteoporosis, bone necrosis, pathological fracture, neurological joint disease, joint pain, growth slowly. Complications due to tricks, trauma and poisoning: spinal fracture due to compression, tendon rupture. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Solu-Medrol 500mg medicine contraindicated in the following cases:
Precautions when using
The effect of immunosuppressure/Increased risk of infection
corticosteroids may increase the risk of infection, cover some signs of infection and some new infections may occur while using corticosteroids. There may be a phenomenon of reducing resistance and losing local infections when using corticosteroids. Pathogenic microorganisms include: viral infection, bacteria, fungus, single cells or helminths in any position of the body may be related to the use of corticosteroids separately or in combination with other immunosuppressive drugs that have an impact on cell immune or immune immunity or the function of neutrophils. These infections may be mild, but may also be serious and sometimes death. When increasing the dose of corticosteroids, the incidence of infection complications also increases.
Patients are using immunosuppressive drugs that are more susceptible to infections than other healthy people. For example, in children or adults without immunity using corticosteroids when suffering from chickenpox and measles may be worse and even death.
contraindicated use of live vaccines or live vaccines has reduced poisoning in patients who are taking immunosuppressant corticosteroids. Dead vaccines or inactivated vaccines can be used for patients taking corticosteroids to inhibit immunosuppression, however, the patient's response to these vaccines may be reduced. Vacculation may be indicated for patients who are taking corticosteroid doses that do not cause immunosuppressive.
Use of corticosteroids in labor is limited to only cases of pervasive or acute outbreaks in which corticosteroids are used to control diseases in combination with appropriate tuberculosis regimen.
If corticosteroid is indicated in patients with tuberculosis or reacting with tuberculin, it is necessary to closely monitor because the disease may recur. If used for long -term corticosteroids, patients need to be treated with anti -tuberculosis drugs. U Sarcom Kaposi (Kaposis’s Sarcoma) has been reported in patients treated with corticosteroids. Stop using corticosteroids may relieve clinical symptoms.
The role of corticosteroids in bacterial shock is still being debated, recent studies show that both beneficial effects as well as adverse effects. Recently, the use of supplemented corticosteroids has shown that the patient is determined to be infection shock and have a decline in adrenal gland function. However, this therapy should not be used regularly in bacterial shock. A systematic overview concluded that high -dose corticosteroid treatment in a short time did not work. However, gross analysis and an overview showed that the use of low -dose corticosteroids for a longer period of time (5 - 11 days) may reduce the mortality rate, especially patients with bacterial shock, they have to use vasoconstrictor drugs.
Effects on the immune system
may occur allergic reactions. Because some rare cases of skin allergies and anaphylaxis have occurred in patients with corticosteroids, it is necessary to take appropriate preventive measures before using corticosteroids, especially when the patient has a history of allergies to any drug.
Hormonal effects
Patients who are using corticosteroids must suffer abnormal stresses, need to be indicated to use corticosteroids faster than the dose higher than before, during and after stress.
Use of corticosteroids at the doses with pharmacological effects in a long time can lead to inhibition of hypothalamus axis - pituitary - adrenal gland (HPA) (secondary adrenal insufficiency). The degree of adrenal insufficiency is different from the patient and depends on the dose, frequency, time of drug use and the duration of treatment with glucocorticoid. This effect can be minimized by Japanese treatment therapy.
In addition, acute adrenal insufficiency also leads to death if the glucocorticoid stops suddenly.
Therefore, the risk of secondary adrenal insufficiency can be reduced by the drug by slowly reducing the dose. This type of adrenal insufficiency may exist for months after stopping treatment, so during this time, if any stress occurs, it is advisable to start using hormone therapy.
Steroid cessation syndrome "is not related to adrenal insufficiency, which may be encountered after a sudden stop of glucocorticoid. This syndrome includes symptoms such as anorexia, nausea, vomiting, coma, headache, fever, joint pain, peeling, muscle aches, weight loss and or hypotension. These effects are thought to be due to a sudden change in glucocorticoid levels rather than low corticosteroid concentration.
Because glucocorticoid can cause or worsen the Cushing syndrome, it is advisable to avoid using glucocorticoids in Cushing patients.
The effect of corticosteroids increases above patients with thyroid disabilities.
Effects on metabolism and nutrition
corticosteroids, including methylprednisolon, can increase blood sugar, worse the existing diabetes, and can lead to diabetes on prolonged corticosteroids.
Mental effect
Mental disturbances may appear when using corticosteroids, from refreshment, insomnia, mood change, erratic temperament and severe depression to real mental manifestations. In addition, emotional instability or mental trend may be worse by corticosteroids.
The ability to experience unwanted mental effects that can occur when using steroids by systemic lines. Symptoms usually appear in a few days or weeks from the beginning of treatment. Most symptoms are lost after decrease or use of corticosteroids, although it may require special treatment. The mental effects have been reported when stopping corticosteroids, but the frequency is unknown. Patients/caregivers should be noted if mental symptoms progress in patients, especially if they suspect depression or suicide intent. Patients with caregivers should be warned of mental disorders that may appear during treatment or immediately after reducing the dose/ stop use of systemic steroids.
Effects on the nervous system
Should be cautious when taking corticosteroids on epilepsy patients. Caution should be used when using corticosteroids in severe myasthenia patients. Although controlled clinical trials have shown that corticosteroids have a rapid reduction in acute severity during the exacerbation of multiple sclerosis, those tests do not prove that corticosteroids affect the final treatment results or natural evolution of the disease. Studies show that the relatively high corticosteroid dose is needed. Heavy medical events have been reported to be related to epidural internal medulla (see the side effects).
There have been reports on epidural fat accumulation in patients with corticosteroids, typically when using high doses.
Effects on the eyes
Caution should be used with corticosteroids in patients with herpes Simplex in the eye because it can cause corneal perforation. Using prolonged corticosteroids can cause cataracts under the following bags and cataracts in the center (especially in children), convex or increased intraocular pressure, which can lead to glaucoma with visual nerve damage. The risk of fungal and secondary viruses may be increased in the eye in patients using glucocorticoids.
Corticosteroid therapy has been determined to be related to the central retinopathy, a disease that can lead to retinal detachment.
Effects on the heart
The undesirable effect of glucocorticoids on the cardiovascular system, such as lipid disorders and hypertension, can cause patients who have a cardiovascular risk to suffer from other cardiovascular effects, if high doses and prolonged doses. Therefore, corticosteroids should be used carefully in these patients, which should be monitored for changes in risk factors and extra heart function monitoring if necessary. Complications in corticosteroid treatment may be reduced when using Japanese treatment therapy and low doses.
After quick injection of high doses of methylprednisolon sodium sucinat (more than 0.5gam for less than 10 minutes), there is a report on arrhythmia or pulse and cardiac arrest. Slow heart rate has been reported during or after high doses of methylprednisolon sodium sucinat, and may not be related to the speed and time of injection.
Be cautious when using systemic corticosteroids, and only use when really necessary, in case of congestive heart failure.
Effects on the circuit
thrombosis, including venous thrombosis, has been reported when using corticosteroids. Therefore, corticosteroids need to be used carefully for patients who are or may be at risk of thrombosis. Corticosteroid caution should be used in patients with high blood pressure.
Effects on the gastrointestinal tract
Corticosteroid high doses can cause acute pancreatitis.
There is no unified view of corticoteroids that cause gastrointestinal ulcer during treatment or not, however, using glucocorticoid can cover the symptoms of gastrointestinal ulcers, causing perforation or gastrointestinal bleeding without obvious pain. Glucocorticoid therapy can hide peritonitis or other signs or symptoms related to gastrointestinal disorders such as perforation, intestinal obstruction or pancreatitis. The risk of gastrointestinal ulcers increases when combined with nonsteroidal anti -inflammatory drugs (NSAID).
Be cautious when using corticosteroids in nausical ulcerative ulcer if there is a puncture, abscess or other pus infections, excess bag inflammation, new small intestinal connectivity, or a history of gastrointestinal ulcer.
Effects on the liver
Liver damage caused by drugs, such as acute hepatitis, may occur due to methylprednisolon transmission by cyclic vein (usually at a dose of 1g/day). The time for acute hepatitis can be many weeks or longer. Observed, these events disappeared after stopping treatment.
Effects on skeletal system
There have been a report on acute muscle disease when using high doses of corticosteroids, which often occurs in patients with neurotrotomic disorders (for example, severe muscle weakness) or on patients who are taking cholinergic drugs such as neurotransmitter (e.g. pancuronium). This acute disease spreads, may be related to facial muscles, respiratory muscles and can lead to paralysis. The increase in creatinine kinase may occur. In order to have clinical or recovery progress, it is necessary to stop the drug within a few weeks to a few years.
Osteoporosis is unwanted effect, but is less detected when using high doses of glucocorticoids.
Kidney and urinary disorders
Should be cautious when taking corticosteroids in patients with renal failure.
Research
The average or high dose of hydrocortison or cortison may cause hypertension, salt and water to keep potassium elimination. These effects are less common with synthetic derivatives unless high doses. The diet that limits salt and potassium supplements may be necessary. All corticosteroids increase calcium excretion.Trauma, poisoning and surgical complications
corticosteroids are not indicated, and therefore should not be used to treat traumatic brain injury. A multi -central study showed an increase in mortality rate at 2 weeks and 6 months after injury in patients using methylprednisolon sodium sucinat compared to patients with placebo. The causal relationship with methylprednisolon sodium sucinat treatment has not been established.
Other warnings
Due to complications when using glucocorticoid depends on the dosage and duration of treatment, it is necessary to consider the benefits/risks on each patient about dosage and daily dosage treatment or Japanese method.
Should take the lowest dose effectively with corticosteroids to control the treatment situation and when the dose can be reduced, it should be slowly reduced.
Be careful when using aspirin and nonsteroidal anti -inflammatory drugs in combination with corticosteroids. Chrome -loving cell tumor can be reported after using systemic corticosteroids. For patients suspected or have identified as chrome cell tumors, only corticosteroids should only be used after evaluating the appropriate benefits/risks.
used in children
Alcohol Benzylic is used to preserve drugs related to serious unwanted effects, including "breathing syndrome" and death in pediatric patients. Although the normal treatment dose of this product often contains significantly lower amount of alcohol Benzylic than the reporting dose related to the "shortness of breath syndrome", the minimum amount of benzylic alcohol is not known. The risk of Benzylic alcohol poisoning depends on the dose and ability to detoxify this substance of the liver and the kidneys. Premature and light weightborn babies are more likely to be poisoned. It is necessary to closely monitor the growth and development of newborns and children using prolonged corticosteroids.
Growth can be encountered in children using prolonged, daily glucocorticoids, with daily doses of split and this use should be limited, should only be used with the most urgent indications. Glucocorticoid therapy uses Japanese ways to avoid and minimize this unwanted effect.
Babies and children using long corticosteroids have a special risk of increased intracranial pressure.
Corticosteroid high doses can cause pancreatitis in children.
The ability to drive and operate machinery
has not systematically evaluated the influence of corticosteroids on the ability to drive and operate machinery. Unwanted effects such as dizziness, dizziness, visual disorders and fatigue may be encountered after corticosteroid treatment. If affected, patients should stop driving or operating machines.
Pregnancy
Animal research shows that corticosteroids when taking high doses for mothers can cause malformations to the fetus. However, corticosteroid does not seem to cause birth defects when used for pregnant women. Because human reproductive studies have not been fully conducted with methylprednisolon sodium sucinat, this drug should only be used during pregnancy after being careful in terms of risk benefits for mother and fetus.
A few corticosteroids through the placenta fence. A rescue study shows that an increase in the proportion of infant infants born from mothers using corticosteroids. In humans, the risk of babies born mild weight seems to be related to the dose and can be reduced by lowering lower corticosteroids. Babies of mothers who have used corticosteroid dose significantly during pregnancy must be carefully monitored and evaluated about signs of adrenal functional impairment, although rarely cases of adrenal insufficiency in infants are exposed to corticosteroids in the uterus.
Unknown effects of corticosteroids on labor and childbirth. The cataract is observed in the newborns that mothers use corticosteroids during pregnancy. Benzylic alcohol can pass through the placenta (see the cautious part when used).
Breastfeeding period
corticosteroids excreted through breast milk.
corticosteroids excreted through breast milk can inhibit growth and affect endogenous glucocorticoid production in infant breastfeeding. This preparation should only be used during breastfeeding after careful evaluation of the benefit-mechanical benefits for mothers and babies.
Drug interaction
methylprednisolon is the substrate of the enzyme cytochrom P450 (CYP) and is mainly metabolized by the CYP3A4, CYP3A4 enzyme as the main enzyme of most CYP fertilizers in the liver of adults. It catalyzes the process of 6β - hydroxylation steroid, phase I is essential in the metabolism for both endogenous and synthetic corticosteroids. There are also many other substances that are also the substrate of CYP3A4, some of these substances (as well as other drugs) that change the metabolism of glucocorticoid by causing increased air -conditioning) or CYP3A4 enzyme inhibitors.
CYP3A4 inhibitors - CYP3A4 activated inhibitors generally reduce the clearance of the liver and increase the concentration of the drugs that are the substrate of CYP3A4 such as methylprednisolon in plasma. If there are CYP3A4 inhibitors, methylprednisolon should be standard to avoid steroid poisoning.
CYP3A4 induction substances - CYP3A4 induction drugs generally increase the clearance of the liver, leading to a reduction in the concentration of the drugs that are the substrate of CYP3A4. Methylprednisolon may be increased when used with these drugs to achieve the desired treatment results.
substances that are substrate of CYP3A4 - When there is another substrate of CYP3A4, the liver clearance process of methylprednisolon may be affected, so the corresponding adjustment of the dose of methylprednisolon. It is possible that unwanted effects when used separately each drug will be more likely to occur when used simultaneously.
Medicines without intermediaries CYP3A4 - Interactions and other influences occur with methylprednisolon presented in Table 2.
Table 2 includes common or important drug interactions with methylprednisolon.
Table 2: Important interactions/ effects of drugs or active ingredients with methylprednisolon.
2 CYP3A4. CYP3A4. High -dose aspirin, which can lead to reduced serum salicylate levels. Stop treatment with methylprednisolon can lead to increased serum salicylate levels, which can lead to an increased risk of salicylate poisoning. Sharing corticosteroids with amphotericin b, xanthin or beta 2 blockers also increases the risk of hypokalemia.
Cavalry
To avoid the problem when combining drugs and ensuring the stability of the drug, methylprednisolon sodium sucinat is recommended to use intravenous tract with drugs or other substances using intravenous tract. Physical drugs with methylprednisolon sodium sucinat in the solution include, but not limited to: allopurinol sodium, doxapram hydrochloride, tigecyclin, diltiazem hydrochloride, calcium gluconate, vecuronium bromid, rocuronium bromid, cisate glycopyrrolat, propofol.
Storage
Products have not been prepared: Storage below 30 ° C.
Products prepared: Store mixed solution at temperatures below 25 ° C. Use the mixed solution within 48 hours after mixing.
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