Milurite tablets 300mg Egis Pharma treat gout, prevent uric acid stones (30 tablets)

Dosage form Box of 30 tablets
Specifications Allopurinol

Ingredient

Composition information	Content
Allopurinol	300mg

Uses

indications

Milurut drugs are indicated in the following cases:

Treatment of gout, hyperuricemiaemia, prevention and treatment of kidney disease caused by uric acid, hyperuricemia. Secondary hyperuricemia is accompanied by blood diseases.

Pharmacology

allopurinol is similar to hypoxanthine in terms of structure. Allopurinol as well as its main metabolites, oxipurinol, Xanthin inhibitors - oxidase are enzymes that convert hypoxanthine to xanthine and from this substance to uric acid. Allopurinol reduces the concentration of uric acid in serum and urine, thereby preventing the deposition of urate crystals in tissue and/or promoting their solubility.

Uric acid concentration begins from the fourth day and the maximum effect is achieved within about 2 weeks.

can combine millurite with drugs that increase uric doxic acid, especially when there are many urate grit.

Milurit is especially effective in preventing the creation and recurrence of uric acid stones.

Dynamic pharmacokinetics

about 79 - 90% of the treatment dose is absorbed in the digestive system. The drug reaches a maximum plasma concentration within 0.5 - 2 hours after drinking. Semi -cancellation time changes in about 1 to 3 hours.

Allopurinol is converted into oxipurinol mainly in the liver, this is also a Xanthine - oxidase inhibitor. The maximum oxipurinol concentration in plasma is reached within 2-5 hours and the half -life is 12 - 27 hours if the function of the kidneys is normal, but if there is kidney failure, it will be longer.

Allopurinol and oxipurinol are not attached to plasma proteins.

About 10% of the daily dose is eliminated by glomerular filtration in the form of Allopurinol in the form of constant and about 70% in the form of oxipurinol. Rehabilitation in the renal tubules may extend the half -life. The remaining 20% of the daily dose is discharged through constant form.

When kidney failure, allurinol and oxipurinol's clearance may be greatly reduced, as a result, the concentration of plasma increases. Therefore, it is necessary to reduce the dose appropriately when kidney failure.

In elderly patients, Allopurinol's pharmacokinetics does not change much for age, unless the kidney function is poor.

Before taking Milurite tablets 300mg Egis Pharma treat gout, prevent uric acid stones (30 tablets)

How to use

use orally, drink after meals with plenty of water.

Dosage

Adults

To reduce the risk of side effects, the recommended starting dose is 150 mg once a day. If necessary, the daily dose is increased to 150 mg per one until the desired effect, with the test of uric acid in serum every 1 to 3 weeks.

The usual maintenance dose is 300 - 600 mg per day. Sometimes it may be necessary to increase the dose in a day up to 900 mg. When the daily dose exceeds 300 mg, 2-4 doses must be divided.

If calculated by weight, the dose of 2 - 10 mg/kg/day can be used.

If used in cancer diseases, it must start for millurite 1-2 days before the anti -cancer treatment. The daily dose of 600 mg per day for 2-3 days, then select the maintenance dose based on serum acid levels.

Children

In hyperuricemia, secondary blood uric acid is accompanied by blood malignant or other cancer diseases and in some enzyme disorders, the usual dosage of 10 - 20mg/kg of weight depending on the size of the tumor, the number of peripheral embryos, or the level of intensive infection of the bone marrow.

Elderly patients, kidney failure and liver

always treat elderly patients with the lowest doses and still have clinical effects and always think about the ability to reduce kidney function and/or liver.

Depending on the degree of renal and liver failure, the risk of increased toxicity must be reduced in these cases.

The dose must be reduced when renal failure and must not exceed 150 mg per day if the clearance is less than 20 ml/min. It may also be necessary to consider the ability to use 150 mg at a distance between doses longer than 1 day. It is necessary to monitor Allopurinol levels in plasma; The plasma concentration should not exceed 100 mcmol/l (15.2 mg/l).

Allopurinol and its metabolites can be removed by hemolysis. In patients who are appraised 2 to 3 times a week, a single dose should be 300 - 450 mg right after being appraised and not for the drug on the day of non -appraisal days.

Note: 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?

Symptoms

The most common when overdose is nausea, vomiting, diarrhea.

Handling

There is no specific antidote. Overdose can be treated by water and ensure the appropriate urinary tract to increase the speed of erolopurinol and its metabolites. Can be clinically fertilized if necessary.

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 Milurit, you may experience unwanted effects (ADR).

Unwanted effects are often rare (ADR

Skin and hypersensitivity reactions

These are the most common and can occur at any time during treatment. The reactions can occur in the form of itching, lumpy, sometimes scales or hemorrhage and rarer than peeling skin. If these reactions occur, it must be stopped immediately. If the skin reactions are mild, after the end, it can be reused with low doses (5 mg/kg of weight), and then gradually increasing the dose. If the skin reactions occur again, stop allurinol and never use again.

Skin reactions are accompanied by peeling skin, fever, lymphadenopathy, joint pain and/or eosinophilia like Stevens - Johnson and/or Lyell syndrome may rarely occur. The accompanying vasculitis and tissue reactions can be manifested in many ways including hepatitis, kidney failure and rarely seemingly epilepsy. In these cases, all must stop allurinol and never use again.

In general, these reactions occur if there is simultaneous kidney disease and/or liver disease. Corticosteroids may be useful to treat symptoms.

Some very rare cases may also occur anaphylaxis.

joints and motor systems

When starting treatment with allopurinol can cause acute gout attacks.

Digestive system

Rarely get nausea and vomiting, however can be avoided by taking millurite after meals.

Sometimes there can be liver dysfunctions (alkaline and transaminase phosphatase levels in serum increased). Hepatitis may have no other signs of hypersensitivity.

Hematomas

Sometimes thrombocytopenia, grain leukemia, non -regenerated anemia, mainly in patients with kidney diseases and/or liver disease. The association between the following side effects and Milurit has not been proven: abdominal pain, diarrhea, hair loss, headache, drowsiness, fatigue, dizziness, neurological disease, cataract, visual disorders.

Instructions on how to handle ADR

Notice unwanted doctors when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Milurit drugs contraindicated in the following cases:

Severe liver disease.

Severe kidney disease (urea).

breastfeeding. pregnant.

Skilled iron tissue diseases (even in family history).

Children, except for cancer or enzyme disorders.

Do not start treating with Allopurinol during acute gout attacks.

Be cautious when using

stop immediately if there is a sign of hypersensitivity reactions.

Hyperglycemia hyperkemis without clinical signs is not necessary to use Milurit.

Never use millurite for children except for secondary hyperuricemia hyperuricemia accompanied by blood malignant or other cancer diseases in some enzyme disorders.

While taking the drug to drink plenty of water. The amount of urine per day must reach at least 2 liters with neutral or slightly alkaline pH.

When there are factors that lead to reduced kidney function (high age, diuretics, or acei medication), it is necessary to monitor patients closely if they use allopurinol.

Should monitor liver function in the early stages of treatment.

At the beginning of treatment with Allopurinol can lead to a acute gout. To prevent this gout occurs, it is advisable to coordinate millurite with an nonsteroidal anti -inflammatory drug, or with Colchicine 0.5 - 1 mg daily for at least 1 month when starting treatment.

If acute gout occurs during millurite, it is necessary to continue treating with constant doses and must treat gout attacks with NSAIDS or Colchicine anti -inflammatory drugs. In the case of very high concentration of uric acid (malignant diseases and when treating these diseases, Lesch - Nyhan syndrome), the use of millurite can lead to xanthine deposits at tissue. This risk will be reduced if fully water supply.

In case of hematoma changes, regular number of blood cells should be checked.

The ability to drive and operate machinery

Sometimes the drug has side effects such as drowsiness, dizziness and reducing the ability to focus. Therefore, the limit or prohibition of driving and operating machinery must be determined by the doctor in each case.

Pregnancy

Clinical data

When a maximum dose of 100 mg/kg/day for mice and 200 mg/kg/day for rabbits, there is no toxic effect on the fetus as well as teratogenic. There is no mouse -causing mouse -causing effect when drinking allopurinol. However, when injected in Allopurinol, 50 mg/kg/day and 100 mg/kg/day for mice to become pregnant on the 10th and 13th days of pregnancy, significantly increasing the rate of pregnancy and teratogenic changes. It is unclear the relationship of this finding for people.

Human data

In humans, there is no evidence that Allopurinol is abnormal for the fetus. However, do not use drugs for pregnant women unless prescribed by a doctor and only when there is no replacement treatment and the risk caused by the disease is higher than the drug for the mother and the fetus.

The period of breastfeeding

Do not use millurite when breastfeeding because both allopurinol and oxipurinol are discharged into breast milk.

Drug interaction

6 - Mercaptopurine or azathioprine - Allopurinol increases the toxicity of these drugs due to inhibition of their metabolism, so the dose must be reduced by 6 - Mercaptopurine or azathioprine to 1/4 - 1/3 of the normal dose.

vidarabin (adenine arabinoside): because of increasing the sale time of these drugs.

Cyclophosphamide, Doxorubixine, BleomaCin, Procarbazine, Mechloroethamine): due to increased hematoma risk.

chlorpropamide: Because of the prolonged risk of hypoglycemia when the renal function is impaired.

The drugs have the effect of increasing urinary uric acid, sulfinpyrazone, probenecid or high doses of salicylate: because these drugs increase the rate of oxipurinol excretion and this reduces the effectiveness of Milurit's treatment.

Theophyllline, aminophylline, because Allopurinol inhibits the metabolism of these drugs, maybe by inhibiting Xanthine Oxidase.

cyclosporin: Because this drug concentration in plasma and thereby toxicity may increase.

Coumarin derivatives: Because anticoagulant effects can increase in some cases.

ampicillin, amoxicillin: Because it may increase the risk of skin reactions.

Storage

Store drugs at temperatures below 300C, avoid direct light.

To stay safe, stay out of reach of children.

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