Metilone 16mg Davipharm anti -inflammatory, endocrine disorders, arthritis (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Methylprednisolone

Ingredient

Composition information	Content
Methylprednisolone	16mg

Uses

Indications

Metilone drug are indicated for treatment for patients who need the effect of glucocorticoids such as:

Endocrine disorders: primary and secondary adrenal impairment, congenital adrenal glands.

rheumatism: rheumatoid arthritis , adolescence chronic arthritis, joint inflammation.

Collagen/artery disease: Systemic erythematosus lupus, body dermatitis, rheumatoid fever with severe heart inflammation, giant cell arteritis/muscle pain due to rheumatism.

Dermatological disease: pemphigus usual.

Allergic: Seasonal and long -lasting allergic rhinitis, drug -hypersensitivity reactions, serum disease, allergic contact dermatitis , bronchial asthma.

Eyes of ophthalmology: Ivanitis (iritis, iriditis), post-peach dug inflammation, optic neuritis.

Respiratory disease: pulmonary sarcoid , acute or spreading tuberculosis (with appropriate anti -tuberculosis chemotherapy), inhalation of gastric juice.

Hematological disorders: Obstal hemorrhagic hemorrhage (ITP), hemolytic anemia (autoimmune).

Cancer: leukemia (acute and lymphoma), malignant lymphoma.

Gastrointestinal disease: ulcerative colitis, Crohn disease.

Other conditions: tuberculosis, organs.

Pharmacokology

Methylprednisolone is a synthetic glucocorticoid, 6-alpha-methyl derivative of prednisolon. The drug is mainly used to prevent inflammation, or immunosuppressive. The drug is often used in the form of esterification or no esterification to treat diseases that corticosteroid has prescribed.

Due to Prednisolone methylation, methylprednisolone has only mineralocorticoid effect (very little salt metabolism), not suitable for treating adrenal insufficiency. If using methylprednisolone in this case, it must be used by mineralocorticoids.

Methylprednisolone has anti -inflammatory, immunosuppressive and anti -cell anti -proliferation effects. The anti -inflammatory effect is caused by methylprednisolone that reduces the production, release and activity of inflammatory intermediates (such as histamine, prostaglandin, leucotrien, etc.), due to reducing the initial manifestation of the inflammatory process.

methylprednisolone inhibits leukocytes to stick to the vascular wall of damage and immigration in damaged areas, rapidly reduces absorbent properties in that area, causing leukocytes to rarely come to this area. This effect reduces vessel escape, swelling, edema, pain.

The immunosuppressive properties reduce response to slow and instant reactions (tube III and tube IV), due to the toxic inhibition of the antigen complex - antibodies that cause allergic vasculitis in the skin. By inhibiting the effects of lymphokin, target cells and macrophages, corticosteroids have reduced contact dermatitis reactions due to allergies. In addition, corticosteroids also prevent T -cell lymphocytes and sensitive macrophages to target cells. Anti -cell proliferating effects reduces the characteristics of psoriasis.

Pharmacokinetics

absorption

Birth is approximately 80%. Plasma concentration reaches a maximum of 1-2 hours after oral medication, the time reaches about 30 hours.

Distribution

Methylprednisolone is heavily connected to plasma proteins. The distribution volume is about 1.4 l/kg.

Metabolism

Methylprednisolone metabolizes mainly in the liver through CYP 3A4, methylprednisolone may be a substrate of ABC (ATP-binding Cassette) P-Glycoprotein, which affects the distribution in tissue and other drug interactions.

Elimination

Excessive metabolites through urine. The sale time is approximately 3 hours, reduced for obese people. The total clearance of methylprednisolone is about 5 - 6 ml/hour.

Before taking Metilone 16mg Davipharm anti -inflammatory, endocrine disorders, arthritis (2 blisters x 14 tablets)

How to use

recommendations of daily daily daily dumps and are used as treatment instructions. Total daily dose recommended can be taken once or divided into several times (except Japanese insertion: Double daily minimum daily doses and daily drink at 8 am).

Unwanted effects can be reduced by using the lowest doses effectively in the shortest time.

The starting dose may vary depending on the condition being treated. This dose is continued until the clinical response is achieved, usually after 3-7 days for patients with rheumatism (except for acute rheumatitis), allergies affect skin or respiratory tract and ophthalmology. If not meet the response after 7 days, it is necessary to conduct a re -evaluation to confirm the initial diagnosis.

Immediately after the clinical response, should gradually reduce the daily dose to stop the lowest treatment effectively for chronic diseases (such as seasonal bronchial asthma, flaky dermatitis, acute inflammation in the eye), or gradually decreased daily daily doses to the lowest doses that are effective for chronic diseases (rheumatoid arthritis, systemic lupus erythematosus, bronchial asthma, atopic dermatitis).

For chronic diseases such as rheumatoid arthritis, reducing the initial dose to the maintenance dose, it should be done appropriately. Dose reduction should not exceed 2 mg every 7-10 days. In rheumatoid arthritis, steroid maintenance should be at the lowest possible.

When using methylprednisolone for a long time, we must consider taking Japan. After long -term treatment must stop gradually.

In Japan, the minimum daily corticoid dose is doubled and drink once a day single at 8 am. Dosage depends on the patient's condition and response.

Elderly: For a long time, it is necessary to pay attention to the serious consequences than unwanted side effects, especially when osteoporosis, diabetes, hypertension, sensitive infections, thin skin.

Children: The dosage is based on the severity of the disease and the patient's response, according to age, weight, skin surface area, minimum doses effectively in the shortest time. Use Japanese -doseed therapy if possible.

Dosage

recommended dose:

Disease recommended starting dose.

Very heavy

Heavy

Average

Children

12 - 16 mg

8 - 12 mg

4 - 8 mg

Systemic dermatitis 48 mg Application 12 - 40 mg Mg

malignant lymphoma

16 - 100 mg Quan up to 3.6 mg/kg/day. Usually. 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?

Symptoms

Expression of Cushing syndrome, muscle weakness (body), and osteoporosis (systemic), all occur when using long -term glucocorticoids.

When taking high doses for a long time, increasing adrenal gland energy and adrenal inhibition may occur, it is necessary to suspend or stop using glucocorticoids.

Symptomatic treatment and supportive treatment in the case of overseas methylprednisolon, there is no specific antidote. Methylprednisolon is separated.

What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using Metilone, you may experience unwanted effects (ADR), often occurs when high doses, long -term doses.

Common, ADR> 1/100

Parasite and infection.

Endocrine: Cushing syndrome .

Metabolism and nutrition: Keeping sodium, water retention.

Mental: emotional disorders, depression, excitement.

eyes: cataracts .

Hypertension: Hypertension.

digestive: stomach ulcers.

Skin and subcutaneous tissue: Skin atrophy, Acne . muscle - bone and connective tissue: muscle weakness, developmental retardation.

Body and place of use: impaired self -healing ability.

Testing: Reducing potassium.

Unknown frequency

Infections and parasites: opportunistic infections, Potential TB recurrence , peritonitis.

benign and unknown: Sarcom Kaposi.

Hematology: white blood cells. immunity: The hypersensitivity reaction due to drugs.

Endocrine: adrenal insufficiency, Steroid suspension syndrome.

metabolism and nutrition: Hypotension alkaline infection, metabolic acidosis, reducing glucose tolerance, increasing insulin demand or oral diabetes, increasing appetite.

Psychiatric: Psychosis, mental behavior, emotional disorders, mental disorders, personality changes, confusion, abnormal behaviors, anxiety, insomnia, irritability.

Neurology: convulsions, increased intracranial pressure, dementia, cognitive disorder, dizziness, headache.

eyes: glaucom, convex eyes, thin cornea, thin worshiping, veins - retina.

heart: congestive heart failure, cardiac muscle rupture after myocardial infarction. vascular blood: Hypotension, arterial thrombosis, thrombosis.
respiratory - chest - mediastinum: pulmonary embolism, hiccup.
Digestive: Perforation of the intestine, gastric hemorrhage, pancreatitis, esophageal ulcer, bloating, esophagitis, abdominal pain, diarrhea, digestive disorders, nausea. liver - bile: increase liver enzyme.
Skin and mucous membranes: Red rash, angioedema, itching, urticaria, bruising, hemorrhage, rash, hairy, sweating, stretch marks, capillaries under the skin.
muscle - bone - joints: pathological fractures, bone necrosis, muscle atrophy, neurological joint disease, muscle disease, joint pain, tendon pain.
Reproduction system and mammary gland: irregular acupuncture points.

Systemic and place of use: fatigue, discomfort, symptoms of drug condensation, decreased dose of corticosteroids too quickly leading to acute adrenal insufficiency, lowering blood pressure, death.

Instructions on how to handle ADR
Methylprednisolon reduction step by step instead of sudden stop.
The only dose of the day is less than the subdivision of the dosage than the daily dose, a good measure is a good measure to minimize the inhibition of adrenal glands and other ADRs. In daily therapy, use only every 2 days, in the morning.
Monitoring the parameters of osteoporosis, hemorrhage, glucose tolerance, effects on eyes, blood pressure.
Preventia gastric ulcer, duodenum with H2 - histamine anti -receptor drugs when high doses.
All patients using long -term methylprednisolone need additional calcium to avoid osteoporosis.
Those who are likely to be inhibited immunosuppressants need to evaluate infections.
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

Metilone drug Contraindicated in the following cases:

Hypersensitivity to methylprednisolone or any other ingredient of the drug.

Severe infections, except for bacterial shock and meningitis.

Viral, mushroom or tuberculosis skin lesions.

is using a living virus vaccine.

Be cautious when using

Effect of immunosuppressive effects/increase sensitivity to infections

Hide signs of infection and new infection may appear when taking the drug. Inhibiting inflammatory response and immune function increases sensitivity to fungal, virus, bacteria infections. Clinical manifestations may not be typical, can reach the stage of progress before being detected.

People who are taking more sensitive drugs than normal people such as measles or chickenpox may be more serious.

corticosteroids need to be used cautiously in infected patients or suspected parasitic infections such as Strongyloides (eelworms), which can cause increased infection and spreading Strongyloides with widespread larvae movement, often accompanied by severe intestinal inflammation and gram -negative infections, can die.

Contraindications for living vaccines in patients who are taking corticosteroids because it can reduce antibody antigen response.

Infection shock: Low doses in 5 - 11 days may reduce mortality.

immune system

Due to the skin reaction and anaphylactic reaction, anaphoid shock when using corticosteroids, it is necessary to take appropriate preventive measures before use, especially in patients with a history of allergies to any drug.

Hormonal effects

Prolonged treatment: adrenal atrophy may occur and exist for months after stopping use, patients taking drugs higher than physiological doses (6 mg methylprednisolone) for more than 3 weeks should not stop the drug suddenly. It is necessary to assess the clinical condition in the process of stopping the drug. If the disease is not likely to recur when stopping the body corticosteroids but not sure about the inhibition of HPA (hypothalamus axis - pituitary - adrenal gland), corticosteroid dose can be reduced to physiological dose. When reaching a dose of 6 mg/day, the dose reduction should be slower to restore HPA.

Sudden stopping corticosteroids after use continuously ≤ 3 weeks, only when determining the patient is not likely to recur. Stop suddenly after using the dose up to 32 mg/day for 3 weeks cannot cause HPA inhibition. The following patients should stop the drug slowly when used ≤ 3 weeks:

has used many body corticosteroids, especially when used over 3 weeks.

Use a short term within 1 year after prolonged treatment.

There is a risk of adrenal impairment in addition to external corticosteroid treatment. Also acute adrenal failure can be fatal if corticosteroid sudden stop.

Patients taking drugs in the evening and repeating many times.

Methylprednisolone> 32 mg.

When adrenal failure due to drugs can reduce the secretion of mineralocorticoids, add salt or mineralocorticoids.

Condensation syndrome can occur: anorexia, nausea, coma, headache, fever, joint pain, peeling, weight loss, muscle pain, hypotension.

Add worsening Cushing syndrome, should be avoided in this patient.

Metabolic and nutrition disorders

Hyperglycemia increases, causing diabetes during prolonged treatment.

Mental effect

Depression, excitement.

Symptoms usually appear after a few days of treatment and usually go away when stopping the drug. However, if the symptoms are worrying immediately.

Effects on the eyes

Causes cataract, retinal peeling when used for prolonged use, the risk of fungal infection and increased virus.

Cardiovascular events

Disorders of blood lipid and hypertension during prolonged treatment. Therefore, it is necessary to be very careful and only use the drug when really necessary in patients with congestion heart failure.

Monitor the effects on corticosteroid liver, musculoskeletal muscle in patients with liver problems, or osteoporosis patients.

Children

corticosteroids can cause embryo development, young and minor children.

Babies and young children treated for prolonged corticosteroids are at risk of increased intracranial pressure.

The ability to drive and operate machinery

Due to unwanted effects such as dizziness, dizziness, visual disorders, fatigue, should be cautious when driving and operating machinery.

pregnancy

only used when really necessary. Using this medication when it has evaluated the benefits greater than the risk for the fetus.

breastfeeding period

corticosteroids excreted in small amounts of breast milk. However, methylprednisolon 40 mg/day is not harmful to children, if higher doses may cause adrenal inhibition of the child. Therefore only used when really necessary and benefits are superior to the risk.

Drug interaction

interactive through CYP 3A4

CYP 3A4 inhibitors

Macrolid antibacterial, grapefruit juice, antihistamine H1, Isoniazid increases the concentration of methylprednisolone in the blood increased effect, increased toxicity.

CYP 3A4 induction

Antibiotics, rifampicin antibiotics, anti -convulsions such as carbamazepin, anti -vomiting drugs, oral contraceptives, antiviral drugs ... reduce methylprednisolone levels, reduce the treatment effect of methylprednisolone.

not through CYP 3A4

NSAIDS: Increased risk of stomach ulcers.

anti -cholinergic drugs, nerve maple medications, muscles.

anti -cholinininusterase: Increases the effects of myasthenia gravis.

Diabetes treatment: corticosteroids increase blood sugar, so it is necessary to increase the dose of diabetes.

Medications that cause hypokalemia: The risk of increased hypokalemia.

Storage

In a dry place, avoid light, the temperature does not exceed 30ºC.

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