Last update of description by the manufacturer 01.08.2014
Filtered list
Active substance:
ATX
Pharmacological group
Nonological Classification (ICD-10)
Structure
pharmachologic effect
pharmachologic effect - anti-inflammatory, antimicrobial.Method of application and dose
Inside after meal.
Ulcerative colitis, Crohn's disease. Adults and children over 16 years old: in the 1st day - 500 mg 4 times a day; in the 2nd - 1 g 4 times a day; In the 3rd and subsequent days - 1.5-2 g 4 times a day. After anemia of sharp clinical symptoms ulcerative colitis Adults and adolescents and / or patients with a body weight of more than 65 kg are prescribed a supporting dose - 500 mg 3-4 times a day for several months.
Children from 10 to 16 years and / or with a body weight from 35 to 50 kg - 500 mg 4 times a day.
Supporting therapy for children and adolescents up to 16 years and / or with a body weight less than 65 kg is not recommended.
Maximum daily dose For adults - 8 g, for children - 2 g.
Sulfasalazine - medicine with antimicrobial action, as well as with anti-inflammatory effect, used when intestinal diseasesFor example, with the so-called Crohn disease. For readers "Popular about health" I will present this pharmaceutical education in detail.
So, the Sulfasalazine instruction:
Composition of sulfasalazine and release form
Pharmacestical Sulfasalazine is produced in yellowish brown pills, they are double-screwed, round, edge dosage form Several bevered, some splasions can be allowed. The active compound is represented by sulfaasin at a dose of 500 milligrams.
Sulfasalazine auxiliary substances are as follows: starch premaritalized, there is a magnesium stearate, anhydrous silicon oxide colloid, added hyprontellos, there is a propylene glycol. The medication is placed on the contour cellular packs of ten pieces.
Pharmacological effect Sulfasalazine
The sulfasalazine antimicrobial medicine refers to the so-called intestinal pharmaceutical ideas, has a bacteriostatic effect, in addition, the medication has an anti-inflammatory effect with a diagnosed non-specific colitis.
The absorption of the medication does not exceed 10%, the drug is cleavaged to the sulfopyridine of the intestinal microflora. Communication with blood proteins varies from 50 to 99 percent. Subjected to metabolism in hepatocytes, while inactive metabolites are formed. It is removed with the chair, as well as the kidneys.
Sulfasalazine testimony to use
The sulfasalazine pharmaceutic is shown to use with ulcerative colitis both in the exacerbation of this pathology and in the phase of squeezing the disease. In addition, the medication is prescribed during Crohn's disease, effectively medicine with rheumatoid arthritis in the ineffectiveness of funds from the NSAID group.
Contraindications Sulfasalazine to use
We list the situations under which the sulfasalazine medicine is contraindicated to use:
Sulfasalazine medicine is not used in hypersensitivity to the medicine;
In porphyry, the drug is not used;
With liver or renal failure;
Do not prescribe a means for aplastic anemia;
With diagnosed granulocyptopenia;
Up to five years;
With congenital shortage of glucose-6-phosphate dehydrogenase;
Lactation;
Defearance of the intestine or urinary tract The so-called obstructive process.
With caution, the sulfasalazine medicine is prescribed with bronchial asthma, during pregnancy, with atopic dermatitis.
Application Sulfasalazine and Dosage
The sulfasalazine medicine is taken after eating, with ulcerative colitis are usually prescribed on the first day of a tablet of 500 mg 4 times a day; in the second - 1 gram of medication 4 times a day; In the third and subsequent - from 1.5 to 2 grams. After the sickness of the so-called disease clinic, the supporting pharmaceutical dose is 500 mg 3-4 times a day for several months.
Side effects of sulfasalazine
Drug Sulfasalazine causes a number of negative reactions to pharmaceutically: a decrease in appetite is possible headache, peripheral neuropathy is joined, dizziness is observed, hallucinations are observed, convulsions, in addition, ataxia, diarrhea, as well as sleep disorders, may be vomiting and nausea, depressive condition, aseptic meningitis, as well as pancreatitis, stomatitis.
In addition to the listed side effects, it can be noted: the pain in the abdomen, drug hepatitis develops, macrocytosis, leukopenia is joined, thrombocytopenia, neutropenia is noted, megaloblastic or aplastic anemia is possible, in addition, methemoglobinemia, as well as agranulocytosis, hypoprothrombinemia.
Others negative actions Drugs on the body: proteinuria, hematuria, it is possible to crystalluria, develops nephrotic syndrome, oligospermia, the man's infertility is not excluded, shortness of breath, cough, there is an interstitial pneumonite, noise in the ears, the fibrosent alveolite is characterized, infiltrates in the lungs are characterized.
Among other side effects, the patient may complain to the occurrence of itching and rash, which will talk about the development of the allergic process, the laboratory is noted to increase the hepatic transaminase, the urban, hyperthermia, erythema, exfoliative dermatitis, vapotitis, photosensibilization, epidermal necroliza, is observed, fever, Lymphadenopathy, eosinophilia, serum disease, anaphylactic shock, periorbital swelling, nodular periaryitis, staining contact lenses In an orange-yellowish color.
Overdose from sulfasalazine
With overdose, sulfasalazine tablets occurs nausea, vomiting, anouria, abdominal pain, cramps, dizziness, crystalluria, as well as hematuria. The patient provoke vomit, washed with the stomach and prescribed symptomatic treatment with forced diuresis.
special instructions
With long-term treatment of pharmaceutically, sulfasalazine is important to control the patient with a picture of blood, as well as general analysis urine, when changing the main indicators it is worth reviewing the dosage of the medication.
Analogs of sulfasalazine
Pharmaceutical S.A.S. Enterik 500, sulfasalazin-en, medicine S.A.S. 500 belong to the analogues medication Sulfasalazine.
Conclusion
Sulfasalazine's pharmaceutical assignment should only be appointed specialist.
Sulfasalazine refers to drugs with anti-inflammatory properties. In addition, the active substance of the preparation of sulfasalazine is able to destroy the pathogens of intestinal diseases.
As a result of therapy, it accumulates in the intestinal walls and gradually releases acids, which have anti-inflammatory qualities.
In this article, we will consider for what doctors are prescribed sulfasalazine, including instructions for use, analogues and prices for this medicinal product in pharmacies. Real Reviews People who have already used sulfasalazine can be found in the comments.
Composition and form of release
We produce sulfasalazine in the form of tablets covered with a colorless transparent film shell: slightly twofold, round, round, brownish yellow with possible lighter splashes (10 pcs. In cell contour packaging, 1 or 5 packs in a cardboard pack).
- One tablet with a film shell contains 535 mg of the active compound - sulfasalazine, covered with povidone 3% with water (in terms of 500 mg of sulfasalazine).
Clinical and Pharmacological Group: The drug with an anti-inflammatory effect used to treat Crohn's disease and niac.
Indications for use
Treatment with sulfasalazine is shown in such diseases:
- inflammatory bowel diseases (for example, Crohn's disease, nonspecific ulcerative colitis);
- acute attack or exacerbation of crown disease, ulcerative colitis;
- to support the remission period with ulcerative colitis.
- rheumatoid arthritis in adults, juvenile rheumatoid polyarthritis (as part of auxiliary therapy).
Pharmacological impact
The drug is an antibacterial and antimicrobial tool, which has an anti-inflammatory property. The substance begins to dissolve inside the colon, after which it is distributed over all connecting tissues.
The anti-inflammatory effect is possible due to the fact that sulfasalazine when accumulating in the connecting tissues began the process of excretion of 5-aminosalcyl acid. It carries all the necessary properties to assist in the disease.
Instructions for use
In accordance with the Sulfasalazine instruction, take this means Recommended after eating.
- Adults on the first day of treatment are prescribed at a dose of 500 mg 4 times / day; in the 2nd day - 1 g 4 times / day; In the 3rd and subsequent days - 1.5-2 g 4 times / day. After an element of acute clinical symptoms of ulcerative colitis, a drug is prescribed in a supporting dose of 500 mg 3-4 times / day for several months.
- Children at the age of 5-7 are prescribed 250-500 mg 3-6 times / day, children over 7 years old - 500 mg 3-6 times / day.
The pronounced clinical effect of the use of sulfasalazine is noted, as a rule, after several months of treatment.
Contraindications
Absolute contraindications for reception of drug diarrhea (diarrhea) and arthritis are such conditions:
- Anemia;
- Children's age up to five years;
- Lactation;
- Granulocyptopenia;
- Increased sensitivity to the components of the medication;
- Severe liver and / or renal failure;
- The lack of enzyme glucose-6-phosphitdehydehydrogenase (due to reception is possible the occurrence of jaundice).
With caution, it is important to take the drug to pregnant women and patients who have a history of:
- Bronchial asthma;
- Frequent allergic manifestations;
- Atopic dermatitis.
Side effects
The effect of the drug may adversely affect the following systems:
- Nervous System: Dizziness, Sleep Disruption, Headache, Ataxia, Peripheral Neuropathy, Hallucinations, Aseptic Meningitis, Causes, Depression;
- Urinary system: interstitial nephritis, impaired kidney function;
- Respiratory system: lesions of the pulmonary fabric, incl. interstitial pneumonitis;
- Gastrointestinal tract: nausea, diarrhea, vomiting, decreased appetite, abdominal pain, stomatitis, pancreatitis, medicinal hepatitis;
- Blood formation system: thrombocytopenia, leukopenia, agranulocytosis, anemia;
- Reproductive system: transient oligospermia and infertility;
- Allergic reactions: fever, rash on the skin, anaphylactic shock;
- Others: Staining in yellow urine, skin and soft contact lenses.
The above adverse reactions Depend on the level of concentration in the plasma of sulfapyridine (formed by the decay of sulfasalazine), especially in persons with slow acetylation. The most often unwanted effects are observed in patients with rheumatoid arthritis.
Analogs of sulfasalazine
Analogues, where the active substance coincides - Salazopin EN and Sulfasalazine EN. There are generics similar to pharmacological action, but the active substance is - Mesalazin, among them are most famous:
- Asaca;
- Mealac;
- Pentas;
- Samiel.
ATTENTION: The use of analogs should be coordinated with the doctor.
Sulfasalazine - antimicrobial, anti-inflammatory medication produced in Slovenia (Krka). Available in tablet form. One unit contains 500 mg active substancewhich serves sulfasalazine, and auxiliary components.
Round tablets, convex on both sides, the edge is beveled. Covered with a shell, as part of which hyromellos and propyllenglyol. The color of the shell is yellow or slightly brownish, intrinsic, smell of specific, bitter taste are possible.
Pupils in blisters for 10 units. In the corporate box 5 blisters and instructions for applying with books with recommendations, for which the medicine is prescribed and how to take it properly. Either in banks for 10-60 or 100 pieces, one in a cardboard box.
The manufacturer decides the shelf life of the drug 5 years from the date of release. Keep sulfasalazine at a temperature not exceeding 25 ° C.
From pharmacies, medicine is released only on a medical recipe.
pharmachologic effect
Approximately a third of the drug is absorbed from the intestinal lumen and is distributed in nearby connecting tissues. The remaining part is exposed to intestinal microflora, which releases from sulfasalazine mesalazine (5-aminoalcyl acid) as well as sulfapyridine. The first component has an anti-inflammatory effect, the second is antimicrobial. To the action of sulfapyridine is sensitive:
- Streptococci;
- Intestinal chopsticks;
- Diplococci;
- Gonococci.
Mesalazine is poorly adsorbed, because an explicit anti-inflammatory effect is manifested in a thick intestine, which allows you to stop diarrhea (diarrhea) and liquid chair with inflammatory processes in this part digestive tract.
Sulfasalazine is subject to intestinal and liver circulation for some time, because it returns to the intestines along with her yeast. Maximum concentration reaches after a period of time from three to twelve hours from the moment of reception. The half-life of the medicine is from five to ten hours.
Part of the drug is excreted from the body with a feet, part - by renal with urine. Complete excretion occurs throughout the three days.
Indications for use
Treatment with sulfasalazine is shown in such diseases:
- Ulcerative colitis accompanied by diarrhea (diarrhea), painful sensations, in acute form and as a warning of exacerbations during remission;
- Rheumatoid arthritis;
- The aggravation of Crohn's disease.
Reception of the drug is also shown by pets. For dogs and cats applied when inflammatory processes In the intestine, accompanied by diarrhea (diarrhea), a liquid chair, pain and other symptoms.
Contraindications
Absolute contraindications for reception of drug diarrhea (diarrhea) and arthritis are such conditions:
- Increased sensitivity to the components of the medication;
- Anemia;
- Children's age up to five years;
- Severe liver and / or renal failure;
- The lack of enzyme glucose-6-phosphitdehydehydrogenase (due to reception possible, the occurrence of jaundice);
- Lactation;
- Granulocytopenia.
With caution, it is important to take the drug to pregnant women and patients who have a history of:
- Bronchial asthma;
- Frequent allergic manifestations;
- Atopic dermatitis.
Rules of reception and dosage
How to take tablets, before eating or after, does not have significant. But it is advisable to drink a medicine after feeding, and drink a glass of water. Throughout the period of therapy, regular monitoring of blood and urine indicators is required, level liver enzymes and increased use of fluid.
With ulcerative colitis and exacerbation of Crohn's disease
To relieve the symptoms accompanying colitis and Crohn's disease, adult patients are shown by receiving a drug 4 times a day with an increasing one-time dose, until the symptoms are faded. Reception scheme Next:
- 1st day: one tablet;
- 2nd day: two tablets (1 g);
- 3 and subsequent days: 1.5 g or 2 g, but not exceeding daily rate in 16 tablets (8 g).
When acute period passed, the drug is taken over several months with a prophylactic goal in the dosage of 0.5 g to 4x times daily.
With rheumatoid arthritis
Adult patients and adolescents, which are more than 16 years old, prescribe the following treatment scheme:
- 1st week: 0.5 g daily;
- 2nd week: one tablet twice within a day;
- 3rd week: one tablet three times during the day.
The daily rate can be increased to three grams. Symptom relief occurs, after six to ten weeks. The duration of therapy is up to six months or more.
In case of Bekhtereva (only peripheral form)
Reception of sulfasalazine, like any other drugs, does not treat Bekhterev's disease, but slows down its development and facilitates the symptoms. When the course of treatment is completed, positive effect Save up to several months.
The medicine is prescribed only if therapy does not help with non-steroidal and glucocorticosteroid drugs.
The daily rate is up to three grams, the duration of therapy - from three to six months, is calculated by the attending physician. After facilitating the symptoms, the daily dose begins to evenly reduce.
Childcare
Reception of sulfasalazine Children under the five-year-old age is prohibited.
With colitis and crown disease
- From 5 to 7 years: 0.25-0.5 g from three to six times daily;
- From 79 to 16 years old: on one tablet with the same frequency.
- From 16 years old: adult dosage.
The daily rate for children cannot exceed 2 grams (4 tablets). As supportive therapy described drug Treatment Children are not appointed.
With rheumatoid and juvenile rheumatoid arthritis
Dosage and treatment scheme defines a doctor. The dose is calculated, based on the age and weight of a small patient.
- From 6 and 8 years or at a weight of 20 to 29 kg: on one tablet twice daily;
- From 8 to 12 years or a weight from 30 to 39 kg: you can increase the variety of techniques to three times;
- From 12th to 16 years or a weight from 40 to 49 kg: three times a day on one tablet or two tablets twice a day.
If necessary, the daily rate can be increased, but not more than 2 grams (or 40-50 mg per 1 kg of the weight of the child).
According to reviews, children drink the medicine is easy, but if you do not swallow the tablet immediately, there is a slightly bitter taste.
Pregnancy and lactation
According to the instructions for use, in the first trimesters of pregnancy, sulfasalazine therapy is permissible in extreme cases and in the minimum recommended dose. In the last trimester, the drug is better not to take for the treatment of arthritis and colitis accompanied by diarrhea (diarrhea) and a liquid chair, due to the high risk of development in a newborn nuclear jaundice.
If there is a need to receive a medicament during lactation, it is required to stop it.
Side effects and overdose
The side effects after the sulfasalazine admission are usually observed in the event of a slowdown of sulfapyridine acetylation process due to liver diseases and other digestive organs, as a result of which it accumulates in the body. As a result of the increased concentration of this substance, such adverse reactions are manifested:
- Failures in the work of the digestive tract (diarrhea (diarrhea), vomiting, stomach colic, liquid chair);
- Headaches, noise, sleep disorders and hallucinations, dizziness;
- Feverish states, anaphylactic shock;
- Dermatological reactions (itching, Stephen-Johnson syndromes and Leila).
In the case of treating diseases of doses over 4 grams per day, such negative manifestations are possible:
- Jaundice;
- Leukopenia;
- Proteinuria;
- Violations in the work of the central nervous system (convulsions, ataxia);
- Hematuria;
- Hemolytic anemia.
The adverse reactions that he do not depend on the adopted dose of medication and occur even in the case of acceptance in accordance with the instructions for use:
- Hepatitis and pancreatitis;
- Shortness of breath, cough, alveolit, pneumonite and other lesions of lightweight fabric;
- Peripheral neuropathy;
- Violation of the kidney activities, jade;
- Agranulocytosis;
- Dermatitis, urticaria;
- Oligospermia (reversible) and infertility.
In the case of an overdose, urgent washing of the stomach, the acceleration of the diurea and the removal of the manifested symptoms is shown.
In some cases, urine, leather, contact lenses and soft fabrics Acquire a yellowish tint.
It is necessary to save caution when driving a car and complex mechanisms During the treatment of arthritis and diarrhea (diarrhea) with colitis due to the likelihood of dizziness.
Compatibility with other substances
Simultaneous reception Sulfasalazine with preparations containing foliic acid and digoxin reduces their absorption of the gastrointestinal tract. Compatibility with antibiotics is dubious, since the latter oppress the activity of intestinal microflora, which reduces the effectiveness of sulfasalazine in the treatment of colitis.
The described drug enhances the effect rendered by anticoagulants, hypoglycemic and antiepileptic means. Also increases side effects From the reception of immunosuppressants, nephrotoxic drugs, cytostatics and hepatotoxic agents.
Since therapy of arthritis and intestinal inflammations, provoking diarrhea, takes a long period, the question arises whether it is possible to take alcohol at this time. There is no direct response in the instructions, because it is desirable, if necessary, use alcohol, take a break between drugs and alcoholic beverages.
Price
You can buy the drug in Moscow pharmacies at a price of 276 to 444 rubles for 50 tablets. In other regions of Russia, the cost of the drug fluctuates in such limits:
- Rostov-on-Don: from 346 to 408 rubles;
- St. Petersburg: from 395 to 428 rubles;
- Krasnodar: from 339 to 427 rubles;
- Irkutsk: from 395 to 435 rubles;
- Ekaterinburg: from 349 to 441 rubles.
Analogs
The absolute synonym for the described drug is Sulfasalazine EN. The only difference between them is a shell. Sulfasalazine pills are coated with an intestinal-soluble shell with a different composition than a film casing of conventional sulfasalazine. According to reviews, sometimes arise allergic reactions The components included in its composition.
Among the preparations, in the composition of which the existing substance performs Mesalazin, salofalc is isolated, which is produced in the form of candles, tablets, suspensions, foam. In any form, it is released from pharmacies for the recipe. How much is the means:
- Tablets: from 2420 rubles for 50 tablets of 500 mg;
- Candles: from 1233 rubles for 10 candles of 500 mg;
- Granules: from 2845 rubles for 50 packs of 500 mg.
It is used to treat colitis and crown disease, which are accompanied by digestion disorders, including diarrhea (diarrhea) and liquid chair.
Another drug containing Mesalazin - Mealica. Available in 400 mg tablets. He is cheaper than a salofalca, for 50 tablets in Moscow will have to give away from 765 rubles.
A few more analogues used to relieve diarrhea (diarrhea) for ulcerative colitis:
- Asol: from 2495 rubles for 60 tablets (800 mg);
- Pentas: from 2282 for 50 tablets (500 mg). Also available in the form of candles and granules.
The composition of the means of the same, choose that it is better for the treatment of inflammation in the intestine, accompanied by diarrhea, can after individual use.
Description
Round, brownish yellow, slightly twofolding tablets, with beveled edges, covered with a transparent colorless film.
The heterogeneity of staining in the form of brighter inclusions and / or spots is allowed.
Structure
One tablet covered with film shell contains 500 mg of sulfasalazine (salazosulfapyridine).
Excipients: Povidone, starch premaritalized, magnesium stearate, silicon dioxide colloidal, hypimon, propylene glycol.
Pharmacotherapeutic group
Anti-diagracial, intestinal anti-inflammatory / anti-infectious drugs. Aminosalcyl acid and its derivatives. ATX code: A07ES01.
Pharmacological properties
Pharmacodynamics
Sulfasalazine (Salazosulfapyridine) has an immunosuppressive, anti-inflammatory and bactericidal action.
Its action is the result of the influence of two metabolites, which local affect the intestinal wall, while at the same time, providing a systematic action.
Sulfapyridine inhibits the effect of natural killer cells (NK cells) and the transformation of lymphocytes.
Anti-inflammatory effect of 5-aminosalcyl acid, possibly the most important property in the treatment of inflammatory bowel diseases, since it inhibits cyclooxygenase and lipoxygenase in the intestinal wall and thereby prevents the formation of prostaglandins, leukotrienes and other inflammation mediators, and also probably binds free oxygen radicals.
Sulfasalazine does not have an anesthetic effect.
Pharmacokinetics
Suction
About 30% of the accepted sulfasalazine is absorbed from fine intestine; The remaining 70% is metabolized by intestinal intestinal bacteria with the formation of sulfapyridine and 5-aminosalcyl acid. Distribution
There are large differences in the maximum serum concentration of sulfasalazine and its metabolites; Slow acetylants are much higher and associated with more frequent occurrence Side Effects. Sulfasalazine reaches the maximum serum concentration within 3-12 hours after taking the drug. Connection with plasma proteins and connective tissue very high. Most of absorbed sulfasalazine returns with bile in the intestines; A small part is removed unchanged with urine. The half-life of sulfasalazine - 5-10 hours.
Most of the formed sulfapyridine is absorbed and reaches the maximum concentration in serum 12-24 hours after receiving the drug.
Metabolism and elimination
Sulfapyridine is subjected to metabolism in the liver (acetylation, hydroxylation and conjugation with glucuronic acid) and is excreted by the kidneys. The half-life period is 6-14 hours, depending on the speed of acetylation.
Only about 30% of 5-aminosalcyl acid is absorbed and acetylated in the liver, and then excreted by the kidneys. The rest is removed unchanged with the feces.
Indications for application
For treatment acute manifestations and exacerbations of Crohn's disease, ulcerative colitis and proctitis, for supporting therapy in the phase of remission of ulcerative colitis and proctitis, for treatment rheumatoid arthritis and juvenile idiopathic chronic polyarthritis, resistant to non-steroidal anti-inflammatory drugs.
Sulfasalazine can be used in combination with corticosteroids and metronidazole.
Method of application and dosage
The dosage must be established depending on the severity of the disease and possible unwanted effects. Tablets should be taken while eating, drinking liquid.
The missed dose should be taken as soon as possible, if the time of the next reception is not coming. Otherwise, only another dose should be adopted, in accordance with the treatment scheme.
Acute seizures of ulcerative colitis and proctitis, crown disease
Adults and children over 16 should take 2-4 tablets (1-2 g) 4 times a day.
Children over two years old can give 40 - 60 mg of drug per kilogram body weight per day.
When remission reach, the dose should be gradually reduced. Supporting therapy in the phase of the remission of ulcerative colitis and proctitisRecommended supporting dose for adults and children over 16 years old - 1 tablet (500 mg) 4 times a day.
Children over 2 years old can give 20-30 mg of sulfasalazine per kilogram of body weight per day.
The duration of supporting therapy is not limited.
Rheumatoid arthritis and juvenile idiopathic chronic polyarthritis
Recommended dose for adults and children over 16 years old: 2-3 g per day. Start therapy follows from 1 tablet (500 mg) sulfasalazine per day. The dosage should be increased gradually, from weekly intervals, so that after 4 weeks the dose was 2 tablets (1 g) 2-3 times a day. The clinical effect becomes apparent to 6-10 week of therapy. The drug should be taken at least 6 months.
Children over 6 years old can give 30-50 mg of the drug per kilogram of body weight per day in 2-3 receptions. Begin treatment follows from 1/3 or 1/4 recommended dose, for example, from one tablet for the night. Dosage should be increased gradually, from weekly intervals, until the recommended dose is achieved. The maximum daily dose should not exceed 2 g (4 tablets).
Special groups of patients
Elderly people
Dose correction is not required
Patients with renal failure
It should be used in patients with renal failure in patients (creatinine clearance less than 60 ml / min). Such patients do not require a dose correction. Recommended before, and sometimes during treatment to monitor urine analysis. During treatment, patients should use a sufficient amount of fluid.
Patients with hepatic insufficiency
It should be used in patients with hepatic insufficiency in patients. Such patients do not require a dose correction.
Side effect
Sulfasalazine side effects are mainly associated with a high concentration of sulphapyridine in the blood, especially among people who have its decay occurs slower (slow acetylars). Side effects are more common in patients with rheumatoid arthritis.
Side effects that may occur in the process of sulfasalazine treatment are divided into the following groups in the frequency of occurrence:
Very frequent (≥ 1/10), frequent (≥ 1/100 to each group side effects Presented in descending order of their gravity. The frequency of side effects is listed for individual system systems.
Research
Infrequent: Enhance the serum concentration of amylase, bilirubin, alkaline phosphatase and hepatic levels Transaminase
Blood violations and lymphatic system
Frequent: leukopenia, neutropenia, macrocytosis are infrequent: Megaloblastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia Very rare: aplastic anemia, methemoglobinemia, anemia with Heinz, Hypoprothrombinemia, Limphadenopathy, Eosinophilia Disorders nervous system Frequent: Headache Rare: peripheral neuropathy, dizziness, cramps, Ataxia Very rare: Aseptic meningitis
Violation of hearing and equilibrium
Infrequent: ringing in the ears
Respiratory, thoracic disorders and violations by the mediastinal
Rare: pulmonary infiltration, dysnae, cough very rare: fibrous alveolo
Gastrointestinal disorders
Frequent: nausea, vomiting are infrequent: diarrhea, stomatitis, rare paotes: pancreatitis
Disorders from the kidneys and the urogenital system
Rare: nephrotic syndrome, hematuria, proteinuria, crystalluria
Violations of metabolism and nutritional disorders
Frequent: anorexia is infrequent: in patients with porphyria, sulfasalazine can lead to exacerbation of the disease
Disorders of the immune system
Very rare: serum disease, generalized skin rash, multiform examination, exfoliative dermatitis, photosensibilization, drug-induced fever, periorebital swelling, nodule polyarterite conjunctiva or cornea, urticaria, itching, redness.
Disturbing from the skin and subcutaneous fiber
Very rare: Stevens-Johnson syndrome, toxic epidermal necroliz
Hepatobiliary violations
Rare: hepatitis; Staining urine, leather or soft contact lenses in yellow-orange color.
Disorders of the reproductive system and breast disorders
Infrequent: reversible oligospermia, reversible male infertility
Mental violations
Infrequent: Depression, insomnia Rare: Hallucinations
If serious side effects are observed, the treatment must be stopped.
Contraindications
Hypersensitivity K. active substance, sulfonamidam, salicylate or any of the aids.
The drug cannot be taken to patients with acute porphyria and / or granulocytopenia.
The drug is not recommended for children up to 2 years with chronic inflammatory diseases Colon and children under 6 years old with juvenile idiopathic chronic polyarthritis, since the safety and effectiveness of treatment has not been proven. In addition, the drug is not recommended for the systemic form of juvenile idiopathic chronic polyarthritis, since it often may entail unwanted consequences, including serum-like reactions.
Overdose
Too large doses cause nausea, vomiting and abdominal pain. At very high doses, Anururia, crystalluria, hematuria and symptoms of toxic damage to the central nervous system (seizures) can develop.
Toxicity is proportional to the concentration of sulfapyridine in serum.
Treatment: Preventing the absorption of the drug (vomiting, washing the stomach, intestinal emptying), urine sickness, forced diuresis. In the case of Anururia and / or renal failure, fluid consumption and electrolytes should be limited. The effectiveness of the measures taken may be monitored by determining the concentration of sulfapyridine in the blood plasma.
Precautions
It is recommended before the treatment of sulfasalazine and, if necessary, during treatment with the drug, to do blood tests (clinical blood test: at the beginning of treatment 1-2 times a month, then every 3-6 months) and urine.
During treatment, patients should use a sufficient amount of fluid.
In the treatment of sulfasalazine, special attention should be paid to patients with renal (creatinine clearance less than 60 ml / min) or hepatic insufficiency, bronchial asthma and allergies (it is possible to cross hypersensitivity to furosemide, thiazide diuretics, sulfonylurea derivatives and carbonic henching inhibitors).
With softer allergy forms on sulfasalazine, patients may be desensitized.
When using sulfasalazine, life-threatening skin reactions were recorded: Stevens-Johnson syndrome and toxic epidermal necrolis. The patient must be reported signs of Stevens-Johnson syndrome and toxic epidermal necrolis. The patient must closely monitor the skin reactions. The greatest risk of Stevens-Johnson's syndrome and toxic epidermal necrolize during the first week of treatment. If symptoms or signs of Stevens-Johnson syndrome and toxic epidermal necrolize are observed (for example: the progression of the skin rash is more often in the form of a bullous lesion or lesion of the mucous), the treatment of sulfasalazine should be discontinued.
For early diagnosis Stevens-Johnson syndrome and toxic epidermal necrolis are achieved nice results In the management of this disease. Early termination of the use of the drug is associated with best predictions. Patients, in the history of which were recorded signs of Stevens-Johnson syndrome and toxic epidermal necrolis, when taking sulfasalazine, should not receive this drug.
Pregnancy and lactation
Data collected with the participation of a limited number of pregnant patients does not demonstrate negative influence Sulfasalazine on the flow of pregnancy or on the health of the fetus and a newborn baby. To date, there are no other relevant epidemiological data. Pregnant women prescribe a drug with caution. Pregnant women can take sulfasalazine with the obvious necessity and in minimally effective doses. Sulfasalazine is not recommended in the last trimension of pregnancy, because It can exhibit bilirubin from plasma protein binding centers in newborns and be the cause of nuclear jaundice. In newborns with a deficiency of glucose-6-phosphate-dehydrogenase, this can lead to hemolytic anemia.
A very small amount of sulfasalazine stands out from breast milk; Thus, the probability of the development of nuclear jaundice in a healthy newborn is insignificant, which is also confirmed by experience. Difficulties may arise from premature babies or other newborns with risk. Sulfopyridine situation is different: its concentration in milk reaches 40% of the plasma concentration, but it, however, is moderately associated with plasma proteins. Since the consequences of taking sulfasalazine in children on breastfeedingwere not well understood quite well, then breastfeeding during treatment is not recommended.
Impact on the ability to drive a car or other mechanisms
Sulfasalazine does not either have a slight impact on the ability to control the car or other mechanisms.
Packaging
50 tablets covered with film shell, 500 mg (blister 10 pills, 5 blisters in a cardboard pack).
Information about the manufacturer
Krka, D.D., Novo, Schmariška Cesta, 6, 8501 Novo, Slovenia.
