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Description
The instruction for medical use
of SULFASALAZINUM medicine
A trade name
Sulfasalazinum
The international unlicensed
name Sulfasalazinum Dosage Form
of the Tablet, film coated 500 mg
Structure
One tablet contains
active agent of Sulfasalazinum covered with povidone of 535 mg equivalent a sulfazalazina of 500 mg,
excipients: prezhelatinizirovanny starch, magnesium stearate, silicon dioxide colloidal anhydrous,
film cover: gipromelloza, propylene glycol.
The description
the Round, biconvex tablets with a facet, brownish-yellow color covered with a colourless film cover.
Pharmacotherapeutic group
Aminosalicylic acid and similar drugs.
A07EC01 code
the Pharmacological
Pharmacokinetics Later properties of administration of drug of 30% of Sulfasalazinum is soaked up by automatic telephone exchange in a small intestine, the remained 70% are split by indestinal flora in a large intestine to sulphapyridine and 5-aminosalicylic acid.
Differences in the maximum concentration of Sulfasalazinum and its metabolites in blood serum at different patients significantly differ: at patients at whom process of acetylation is slowed down the concentration of metabolites is overestimated and it causes more frequent emergence of undesirable effects.
Sulfasalazinum well contacts proteins of blood plasma and connective tissue. A considerable part of the soaked-up Sulfasalazinum returns to a gut gleam with bile, an insignificant part is excreted in not changed view with urine. It is metabolized in a liver by acetylation, oxidation and linking with glucuronic acid. A considerable part of the released sulphapyridine is soaked up and reaches the maximum concentration in blood serum in 12-24 hours after administration of drug. It is metabolized in a liver and a type of metabolites is removed by kidneys. Time of semi-removal is from 6 to 14 hours and depends on acetylation speed. Only about 30% of 5-aminosalicylic acid are soaked up in blood, acetylated in a liver and removed by kidneys. The rest is removed in not changed view with a stake.
The pharmacodynamics
Sulfasalazinum possesses immunosuppressive, anti-inflammatory and antibacterial action. Its effect, mainly, is connected with action of its two active metabolites operating both locally and is system. Sulphapyridine inhibits action of natural cells – killers and transformation of lymphocytes. Anti-inflammatory effect of 5-aminosalicylic acid is the most important for treatment of inflammatory bowel diseases as it inhibits cyclooxygenase and a lipoxygenase in an intestines wall, as prevents formation of prostaglandins, leukotrienes and other mediators of inflammation. Also there is a probability of binding of free oxygen radicals. Sulfasalazinum does not render boleutolyashchy effect.
Indications
– Crohn’s disease, nonspecific ulcer colitis and a proctitis (treatment and prevention of a recurrence)
– a pseudorheumatism and juvenile arthritis.
To accept a route of administration and doses of the Tablet entirely, without breaking and without chewing, at meal time it is washed down with a glass of water. If administration of drug was missed, then in the following reception accept only one dose.
Crohn’s disease, nonspecific ulcer colitis and a proctitis
to Adults and teenagers are more senior than 16 years in the 1st day on 500 mg (1 tablet)
4 times a day, in the 2nd day on 1 g (2 tablets) 4 times a day, in the 3rd and the next days on 1.5-2 g (3-4 tablets) 4 times a day.
Children are from 10 to 16 years old and/or with the body weight of 35-50 kg appoint 500 mg
4 times a day.
To children from 6 to 10 years the recommended dose makes 40-60 mg of Sulfasalazinum on kilogram of body weight a day.
Prevention of a recurrence of ulcer colitis and proctitis
After subsiding of acute clinical symptoms of ulcer colitis by the adult and to teenagers and/or with body weight more than 65 kg appoint a maintenance dose on 500 mg 3-4 times a day within several months.
Maintenance therapy for children and teenagers up to 16 years and/or with a body weight less than 65 kg is not recommended.
The pseudorheumatism and juvenile arthritis which is not responding to treatment by non-steroidal anti-inflammatory drugs.
To adults and children 16 years are more senior: within the first week – on 500 mg of 1 times a day, during the second – on 500 mg 2 times a day, during the third – on 500 mg 3 times a day, etc. The therapeutic dose can make 1.5-3 g a day. The clinical effect is shown after 6-10 weeks of therapy. A course of treatment – 6 months and more.
Children are from 6 to 8 years old and/or with the body weight of 20-29 kg: on 500 mg 2 times a day.
Children are from 8 to 12 years old and/or with the body weight of 30-39 kg: on 500 mg 2-3 times a day.
Children are from 12 to 16 years old and/or with the body weight of 40-50 kg: on 500 mg 3 times a day or 1 g 2 times a day.
To children 16 years and/or with a body weight more than 50 kg are more senior: 1 g 2 times a day.
The maximum daily dose for children – 2 g or 40-50 mg/kg of body weight.
Side effects
Side effects are connected, mainly, with high concentrations of sulphapyridine in blood, especially at patients with the slowed-down metabolism (with the slowed-down acetylation), at patients with a pseudorheumatism:
Often (& ge, 1/100 to & lt, 1/10):
– a leukopenia, a neutropenia, a macrocytosis
– a headache
– nausea, vomiting
– anorexia
– Infrequently (& ge, 1/1000 to & lt, 1/100):
– increase in level of amylase and bilirubin, alkaline phosphatase
and hepatic transaminases
– megaloblastny anemia, hemolytic anemia, an agranulocytosis, trombotsi-
a topeniya
– a ring in ears
– diarrhea, stomatitis, parotitis
– aggravation of a porphyria
– a depression, insomnia
– a reversible oligospermatism, reversible male infertility
Is rare (& ge, 1/10,000 to & lt, 1/1000):
– a peripheral neuropathy, dizziness, convulsions, an ataxy, gallyu-
tsination, spasms
– pancreatitis
– pulmonary infiltrate, short wind, cough
– a nephrotic syndrome, a hamaturia, a proteinuria, a crystalluria
– hepatitis, coloring in orange-yellow color of urine, skin or soft
contact lenses
Very seldom (& lt, 1/10,000):
– aplastic anemia, including hemolytic anemia with
Heinz-Ehrlich’s little bodies, a methemoglobinemia, an eosinophilia
– a prothrombinopenia
– a hyperadenosis
– aseptic meningitis
– a fibroziruyushchy alveolitis
– a toxic epidermal necrolysis, Stephens-Johnson’s syndrome,
a serum disease, skin rash, a dieback multiformny, an eksfolia
tivny dermatitis, reactions of photosensitivity, medicinal fever,
periorbital hypostasis, nodular arteritis of scleras and conjunctiva or
cornea, urticaria, an itching and a dermahemia
of the Contraindication
– hypersensitivity to sulfonamide, ethers of salicylic acid or any of drug components
– a liver and/or renal failure
– a porphyria
– a granulocytopenia, anemia
– the lactation period
– congenital deficit glyukozo-6-fosfatdegidrogenazy
– children’s age up to 6 years
Medicinal interactions
Sulfasalazinum reduces absorption of folic acid and digoxin.
Sulfasalazinum strengthens effect of anticoagulants and oral hypoglycemic means (sulphonylurea derivatives), antiepileptic means and also side effects of tsitostatik, immunodepressants, gepato- and nefrotoksichny means.
Simultaneous use with the drugs oppressing a marrowy hemopoiesis increases risk of myelosuppression.
Antibiotics can reduce efficiency of Sulfasalazinum.
Sulfasalazinum can be applied along with corticosteroids and metronidazole.
Special instructions
With care appoint Sulfasalazinum sick with a renal failure and a liver, bronchial asthma, an allergy and deficit glyukozo-6-fosfatdegidrogenazy.
Before an initiation of treatment (to intake of Sulfasalazinum) and during treatment by Sulfasalazinum (the first two months monthly and subsequently every 3-6 months) it is necessary to carry out blood test (control of level of liver enzymes, the general of blood test). Patients with a renal failure need to carry out the general analysis of urine.
During treatment the good hydration of patients has to be carried out. The cross hypersensitivity with the furosemide, thiazide diuretics derivative of sulfanylurea, karboangidraza inhibitors is possible.
Drug is not recommended at system forms of a juvenile pseudorheumatism as often causes the undesirable phenomenon reminding a serum disease. Typical symptoms of this state are fever, nausea, vomiting, a headache, rash, deterioration in function of a liver.
Pregnancy and a lactation
Prescribing of drug to pregnant women is possible only according to strict indications and in minimum effective dose. Administration of drug in the last trimester of pregnancy should be stopped.
Breastfeeding during treatment by Sulfasalazinum is not recommended.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
was not reported about negative influence of Sulfasalazinum on ability to run vehicles or potentially dangerous mechanisms. Nevertheless, it is necessary to be careful at vypolneniye of the actions demanding concentration of attention.
Overdose Symptoms: nausea, vomiting and abdominal pain. At administration of drug in very high doses an anury, a crystalluria and symptoms of intoxication of the central nervous system (convulsion). The toxicity is proportional to concentration of sulphapyridine in blood serum.
Treatment: calling of vomiting, gastric lavage, purgation, artificial diuresis, urine alkalization, symptomatic therapy.
In case of an anury and/or a renal failure intake of liquid and electrolytes has to be limited. The efficiency of the taken measures can monitorirovatsya by definition of concentration of sulphapyridine in blood serum.
The form of release and packing
On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 5 blister strip packagings together with the instruction for use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25C. To store in original packing.
To store out of children’s reach!
Not to apply a period of storage of 5 years after a period of storage
Prescription status
According to the prescription
Producer
of KRK, of, the place, Slovenia
the Owner of the registration certificate
of KRK, of Is new, the Place, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representation of KRKA, tovarna zdravil, d.d., Novo mesto in PK
PK, 050059, Almaty, Al-Farabi Ave., 5/1, section 3 A, the 4th floor Is new.
ph. 8 (727) 311-08-09
fax 8 (727) 311-08-12
www.krka.si
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