Instructions for use ALLOPURINOL

Allopurinol

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

Contraindication: severe liver dysfunction. Allopurinol should be used with caution in case of liver dysfunction (dose reduction is necessary).

Use for renal impairment

Contraindication: severe renal dysfunction. Allopurinol should be used with caution in case of impaired renal function (dose reduction is necessary).

Use in children

In children, it is used only for malignant neoplasms (especially leukemia), as well as for certain enzyme disorders (Lesch-Nychen syndrome).
The dosage regimen is set individually, under the control of the concentration of urates and uric acid in the blood and urine: children under 15 years of age - 10-20 mg/kg/day or 100-400 mg/day.

special instructions

Allopurinol should be used with caution in case of impaired liver and/or kidney function (in both cases a dose reduction is necessary), hypothyroidism. During the initial period of allopurinol therapy, systematic assessment of liver function parameters is necessary.

During treatment with allopurinol, the daily amount of fluid consumed should be at least 2 liters (under the control of diuresis).

At the beginning of the course of treatment for gout, an exacerbation of the disease may occur. For prevention, you can use NSAIDs or colchicine (0.5 mg 3 times a day). It should be taken into account that with adequate therapy with allopurinol, large urate stones in the renal pelvis may dissolve and subsequently enter the ureter.

Asymptomatic hyperuricemia is not an indication for the use of allopurinol.

In children, it is used only for malignant neoplasms (especially leukemia), as well as for certain enzyme disorders (Lesch-Nychen syndrome).

To correct hyperuricemia in patients with tumor diseases, allopurinol is recommended before starting treatment with cytostatics. In such cases, the minimum effective dose should be used. In addition, in order to reduce the risk of xanthine deposition in the urinary tract, measures must be taken to maintain optimal diuresis and alkalinization of urine. With the simultaneous use of allopurinol and cytostatics, more frequent monitoring of peripheral blood patterns is necessary.

During the period of taking allopurinol, alcohol consumption is not allowed.

Impact on the ability to drive vehicles and operate machinery

Use with caution in patients whose activities require high concentration and rapid psychomotor reactions.

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Gout

Gout is a systemic tophi disease characterized by the deposition of monosodium urate crystals in various tissues and the resulting inflammation in individuals with hyperuricemia (increased levels of uric acid) caused by environmental and/or genetic factors.

Gout is a disease that, except in rare cases and unlike other chronic arthritis, is highly treatable. In the absence of advanced and irreversible cases of renal failure, with proper management of the patient and its adequacy, almost complete reverse development of the disease process is possible. If this does not happen, then there is reason to doubt the reliability of the diagnosis of gout. Therapy includes: treatment of arthritis (acute or chronic), therapy aimed at reducing uric acid levels, diet, lifestyle changes. What do doctors usually do to make a diagnosis? Typically, an X-ray of the inflamed joint and a serum uric acid (UA) level are performed. If a fracture is suspected or there is a history of trauma, an x-ray examination may be useful, but it will not be possible to diagnose early gout with its help, since its typical signs appear later and are x-ray-negative tophi, which are called the “piercer symptom.” Intraosseous tophi appear on average at the 7th–8th year of the disease, when their diagnostic value is lost due to the presence of tophi in visible localizations. Moreover, the percentage of discrepancies in the assessment of radiographs - whether they are tophi or pseudocysts in osteoarthritis - is high even at a late stage of the disease.

Determining the level of UA also does not help determine the diagnosis: hyperuricemia is a common symptom of other arthritis, the onset of which may be similar to the onset of gout (pyrophosphate arthropathy, osteoarthritis, psoriatic arthritis). It is also difficult to use these data for further selection of antihyperuricemic therapy, since urinary levels decrease during an attack of arthritis and it will be difficult to assess the effectiveness of allopurinol in the future. In this regard, the main task during this period is to quickly and safely relieve arthritis.

Arthritis treatment

Important! 1. Avoid alcohol during an attack (it helps to increase the duration of the attack, there is an undesirable interaction with medications). 2. Drink plenty of liquid: green tea, mineral water, unsweetened berry fruit drinks. 3. Home regimen (due to severe pain, blood pressure may rise, there is a risk of developing cardiovascular accidents). 4. Follow a strict diet. 5. Do not wait for the attack to resolve itself, start effective therapy. One of the drugs that has a rapid onset of anti-inflammatory effect is nimesulide. Drugs such as artrosilene and arcoxia have proven themselves well in the treatment of gouty arthritis. The use of glucocorticoids (GC) in acute gouty arthritis

Intra-articular administration of GC for gouty arthritis on an outpatient basis is a well-known approach recommended by the European League of Rheumatology. Colchicine Colchicine is prescribed mainly when there are contraindications to taking NSAIDs or when they are ineffective. High doses of colchicine lead to the development of side effects, while low doses (0.5 mg 1–3 times/day) are safe and can be prescribed to a number of patients with acute gouty arthritis. Unfortunately, colchicine is currently not available in the Russian Federation. However, patients can bring it from other countries.

Allopurinol

Allopurinol (Milurit) does not have a direct analgesic effect, so during an exacerbation of gout it is useless for pain relief. BUT: regular use of this drug helps eliminate pain in the future

Allopurinol tablets are taken orally after meals. The daily dose of the medicine is calculated by the doctor, taking into account the severity of the disease and the concentration of uric acid in the blood.

Treatment is usually started with minimal doses, gradually increasing them to the required level under the control of a blood test.

If you take Allopurinol, strictly following the doctor’s recommendations, then after six months or a year you can notice significant progress: the intensity and frequency of attacks of gouty arthritis becomes less and less frequent, tophi begin to resolve and soften (nodules limited by connective tissue - deposits of uric acid salts).

Treatment with Allopurinol is a long-term and continuous process. It is possible, although not advisable, to take a break for 2-3 weeks, but subject to normal blood and urine counts and only with the permission of a doctor.

It is not recommended to interrupt the medication on your own, since when Allopurinol is discontinued, the level of uric acid begins to increase already on the 3-4th day.

You cannot start treatment with these drugs during an acute attack; treatment is carried out only in the interictal period!!!

Treatment of associated conditions For patients with gout and arterial hypertension It is important to know: 1. All diuretics increase the level of sUA. 2. Diuretics prescribed for health reasons (heart failure) to patients with gout must be compensated by taking allopurinol, which requires observation by a rheumatologist in order to titrate the dose. 3. If the patient has uncomplicated hypertension, it is advisable to discontinue diuretics. The tactics of patient management should be almost the same when prescribing anticoagulants, which also help increase the level of sUA. The prescription of drugs “friendly” to MK - losartan, metformin, fenofibrate, vitamin C - is carried out in accordance with the indications for the use of these drugs.

Purina Diet Patients should avoid eating foods high in purines, which include seafood and offal (offal). Meat has a relatively high purine content, but this depends on how it is prepared. Thus, patients with gout are not recommended to consume rich soups, as well as jelly, jellied meat, sausages, etc., but they can eat meat boiled in several waters. Mushrooms and plant foods such as asparagus, cauliflower, spinach, lentils and soy are also rich in purines, but recent studies have shown that consuming plant purines does not increase blood levels of uric acid and does not lead to the development of gout. The production of endogenous purines increases with the consumption of large amounts of protein, so the diet of a patient with gout should limit proteins of animal origin. On the other hand, the amount of protein should be at least 1.5 g per 1 kg of weight to prevent and reduce the effects of fatty liver disease. Recent large studies have shown that consuming low-fat dairy products leads to lower UA levels and a reduced incidence of gout. This is due to the fact that the proteins casein and lactalbumin contained in dairy products increase the excretion of sUA in the urine. Alcohol. One of the main risk factors for developing gout is alcohol. It is necessary to exclude the consumption of beer, port wine, strong alcoholic drinks (whisky, cognac, etc.). As the results of recent studies have shown, drinking a glass (250 ml) of wine per day did not lead to an increase in the level of sUA in the blood. However, the grapes from which dry wine is produced contain a lot of fructose, which contributes to hyperuricemia, so drinking more wine per day is fraught with an increase in uric acid levels and an exacerbation of the disease. At least three days a week should be alcohol-free. Alcohol may increase sUA levels by not only increasing urate production but also decreasing renal clearance. In particular, acute alcoholic excess causes a decrease in urate excretion. Chronic alcohol consumption stimulates the production of purines. The nature of the alcohol also matters. Thus, the purine components of beer cause hyperproduction of urates. The components of whiskey, port wine and other strong alcoholic drinks include lead, which reduces the excretion of sUA. Alcohol can affect the metabolism of drugs. Alcohol consumption reduces the effect of allopurinol due to suppression of the formation of its active metabolite, oxypurinol, which is associated with the low effect of allopurinol in patients with gout who continue to drink alcohol. To prevent stone formation, patients with gout should receive enough fluid to produce at least 2 liters of urine per day. It is allowed to drink water, including mineral water, skim milk, citrus juices and berry fruit drinks, tea and coffee. Green tea has a powerful uricosuric effect. Drinking 5 or more cups of coffee per day has also been shown to have a moderate but significant uricosuric effect. Long-term coffee consumption is associated with a reduced risk of developing gout. Carbohydrates. Currently, the negative effects of fructose contained in drinks and foods are known, which, unlike other sugars, increases sUA levels. Thus, it was shown that in people who ate 5 apples at the same time, the level of UA increased by 35% (due to fructose). Recent studies have demonstrated a direct link between fructose intake and the development of gout in men. On the contrary, taking vitamin C leads to a decrease in the level of sUA in the blood due to increased excretion of sUA in the urine. In general, studies have shown that weight loss caused by reducing carbohydrate intake and increasing the amount of protein and unsaturated fats leads to a decrease in sUA levels and the incidence of gout attacks.

Possible side effects

Like all medicines, allopurinol can cause side effects, although not everyone gets them. These symptoms include:

Hypersensitivity

Uncommon side effects (may affect less than 1 in 100 people)

If you experience an allergic reaction, stop taking allopurinol immediately and contact your doctor or the nearest hospital.

These symptoms include:

• exfoliative dermatitis, furunculosis and stomatitis
• very rarely symptoms such as sudden wheezing, anxiety and chest tightness and collapse

Rare side effects ( may affect less than 1 in 1000 people )

• fever, chills, headache, muscle aches (flu-like symptoms) and general feeling unwell.
• Serious allergic reactions, including fever, skin rash, joint pain, abnormal blood counts and liver tests, which are signs of impaired sensitivity in multiple organs.
• Bleeding from the lips, eyes, mouth, nose and genitals.
• Any changes in the skin, such as ulcers of the mouth, larynx, nose, genitals, conjunctivitis (red and swollen eyes), the spread of blisters and desquamation of the epidermis throughout the body.

You should not take more allopurinol than prescribed by your doctor.

Other possible side effects

Common side effects ( may affect 1 in 10 people )

• skin rash

Uncommon side effects (may affect 1 in 100 people)

• nausea and vomiting
• abnormal liver tests

Rare side effects (may affect 1 in 1,000 people)

• liver problems such as liver inflammation

Very rare side effects ( may affect 1 in 10,000 people )

• disorders of the hematopoietic system, which can lead to bruising from minor impacts or a sore throat or other symptoms of infection. These symptoms often appear in patients with impaired liver or kidney function. In this case, you should immediately consult a doctor.
• lymph node damage
• heat
• presence of blood in the urine (hematuria)
• elevated blood cholesterol levels (hyperlipidemia)
• general unwellness or feeling of weakness
• weakness, numbness, unsteadiness in a standing position, a feeling of inability to make voluntary muscle movements (paralysis) or loss of consciousness
• headache, dizziness, drowsiness, or blurred vision
• chest pain (angina), high blood pressure, or weak pulse
• male infertility or erectile dysfunction
• breast enlargement in both men and women
• bowel dysfunction
• taste disturbances
• cataract
• hair loss or bleaching
• depression
• impairment of voluntary coordination of muscle movements (ataxia)
• tingling, tickling, and burning sensations (paresthesia)
• swelling of the lower extremities, especially in the ankle area.
• impaired glucose tolerance. If this occurs, your doctor will need to periodically measure your blood glucose levels.

If you have any serious side effects or side effects not listed in this leaflet, contact your doctor or pharmacist.

Reporting Adverse Events

If you notice any side effects, tell your doctor, pharmacist or pharmacist, including any side effects not listed in this leaflet. You can also report side effects by going to the website www.arpimed.com and filling out the appropriate form “Report a side effect or ineffectiveness of a drug” and to the Scientific Center for Expertise of Medicines and Medical Technologies named after. Academician E. Gabrielyan by going to the website www.pharm.am to the “Report a side effect of a drug” section and fill out the form “Card of reporting a side effect of a drug.” Scientific center hotline phone number: +37410237665; +37498773368

How to store Allopurinol

• Store out of reach of children, protected from moisture and light at a temperature of 150C-250C.
• Shelf life – 3 years. Do not take allopurinol after the expiration date indicated on the drug package. When indicating the expiration date, we mean the last day of the specified month.
• Medicines should not be disposed of in wastewater or sewer systems. Ask your pharmacist how to dispose of any medicine you no longer need. These measures are aimed at protecting the environment.

Package contents and additional information

What Allopurinol contains

One tablet contains:

active substance : allopurinol-300 mg;

excipients : microcrystalline cellulose, corn starch, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate.

What Allopurinol looks like and contents of the pack:

Round, biconvex, white tablets with a score line on one side.

Cardboard packaging containing 30 tablets (3 blisters of 10 tablets each) along with an insert.

Vacation conditions

Available with prescription