Sulfasalazin tabs 500mg #50

Sulfasalazin user manual

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Composition

One film-coated tablet contains 535 mg of active compound-Sulfasalazin, 3% povidone coated with water (equivalent to 500 mg of Sulfasalazin).
Pregelatinized starch, magnesium stearate and colloidal anhydrous silicon dioxide are auxiliary substances, and hypromellose, propylene glycol is a film coat.

Form of issue

Sulfasalazin can be found in the form of a powder, in polyethylene bags of various weights, ranging from 50 g. Usually, it is a film-coated tablet, with a dosage of 500 mg, which is sealed in blisters of 10 tab. and cardboard boxes, packs are on 10 or 50 tablets.

pharmachologic effect

Anti-inflammatory and antimicrobial.

Pharmacodynamics and pharmacokinetics

Sulfasalazin is an anti-inflammatory drug. Has immunosuppressive effect in connective tissue, in the thickness of the intestinal wall and serous fluid (its highest concentration). Due to intestinal flora the drug disintegrates:
    up to sulfapyridine, suppressing proliferation of T-killer cells and transformation of lymphocytes;
    up to 5-aminosalicylic acid (Mesalazine) - the most significant compound for the treatment of inflammatory diseases of the large intestine. Mechanism of action: binding of free oxygen radicals, local inhibition of cyclooxygenase and lipoxygenase in the intestinal wall, which is necessary to prevent the formation of prostaglandins, leukotrienes and other mediators of inflammation.

Pharmacokinetics

Approximately 30% of the dose is absorbed in the wall of the small intestine, the remaining 70% - disintegrate under the influence of intestinal flora of the large intestine. In the future, the active substance is taken together with bile in the intestine, and also in small amounts is excreted unchanged in the urine. The half-life is 5-10 hours.
Metabolised liberated sulfapyridine in the liver (along the way of acetylation, hydroxylation, conjugation together with glucuronic acid), excretion occurs through the kidneys. Approximately 30% of mesalazine is absorbed and acetylated by the liver, excretion by kidneys with urine or in unchanged form with feces.

Indications for use

The drug is effective for the treatment of exacerbations and maintenance therapy during the remission phase:
    with (NNC) nonspecific ulcerative colitis and Crohn's disease;
    with rheumatoid arthritis, incl. juvenile.

Contraindications

    blood diseases;
    marked violations of the liver or kidneys;
    porphyria;
    deficiency of glucose-6-phosphate dehydrogenase;
    children under 5 years;
    III trimester of pregnancy, lactation;
    overreaction to the components of the drug, sulfonamides, as well as derivatives of salicylic acid.
    With caution appoint for bronchial asthma and risk of allergic reactions.

Side effects of Sulfasalazin

On the part of the following systems, organs of the human body during therapy with Sulfasalazin, unwanted side effects may occur:
    Peripheral and CNS: attacks of headache, dizziness, hallucinations, sensation of noise in the ears, ataxia, convulsions, various sleep disorders, development of peripheral neuropathy.
    Urinary system: impaired renal function, interstitial nephritis possible.
    Digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, the development of hepatitis, pancreatitis.
    Respiratory system: may cause damage to lung tissue, interstitial pneumonitis.
    The system of hematopoiesis: agranulocytosis, anemia, thrombocytopenia, and leukopenia.
    Reproductive system: infertility, transitory phenomenon of oligospermia.
    Allergic reactions: fever, skin rash, anaphylactic shock is possible.
    Among others: jaundice of skin, contact lenses, urine.

Instructions for use of Sulfasalazin (Method and dosage)

Tablets should be taken orally, after eating.
With ulcerative colitis and granulomatous enteritis (Crohn's disease)
The scheme of treatment for adults and children over 16: the first daily dose - 2 g, divided into 4 doses, the second - 4 g divided into 4 doses; the third and all subsequent - for 6-8 g, divided into 4 receptions. When there is a subsidence of acute clinical manifestations with a sufficient maintenance dose of 1.5-2 g, divided into 3-4 doses. Supportive therapy may last several months, but children under 16 years of age with a body weight of up to 65 kg are not recommended.
The maximum daily dose, depending on the age of the patients: adults - 8 g, children - 2 g.
With the left-sided distal location of the focus, microclysters and suppositories can be applied - 2 times a day, 1 g of Sulfasalazin with 1.6 g of cocoa butter is injected into the rectum.
With rheumatoid arthritis, incl. juvenile
The standard treatment regimen for adults and children over 16: during the first week of treatment, the recommended daily dose is 500 mg, the second - 1000 mg (divided into 2 doses), the third - 1500 mg (divided into 3 doses).
The therapeutic dose ranges from 1.5 to 3 g per day. To achieve a clinical effect, it takes 6-10 weeks, the treatment can last more than 6 months.

Instructions on Sulfasalazin and dosage when used in pediatrics:

    children 6-8 years, with a weight of 20-29 kg - 1 tablet 2 times a day;
    8- 12 years, weight 30-39 kg - 1 tablet up to 3 times a day;
    12 - 16 years, weight - 40-45 kg - 1 tablet 3 times a day or 2 tablets 2 times a day;
    starting at age 16 and weighing over 50 kg - 2 tablets 2 times a day.

With Bekhterev's disease

When it turns out that the treatment of NSAIDs and hormones is ineffective, Sulfasalazin is used as a basic drug that can inhibit the inflammatory process in the joints. Take it for a long time - 3-6 months. before the healing effect and ease the patient's condition, then they use the maximum doses and start the abolition of other drugs, further reduce the dosage and cancel the anti-inflammatory agent itself.
Sulfasalazin is not able to stop the pathological process with Bechterew's disease, but the effect can last for a couple of months (NSAIDs are required in small doses) and then a renewal of therapy is required.

Overdose

Symptomatology
Abdominal pain, nausea, vomiting, dizziness.
Purpose of treatment
Gastric lavage, symptomatic therapy, forced diuresis.

Interaction

    Simultaneous reception of Sulfasalazin with folic acid and digoxin reduces the level of their absorption.
    With anticoagulants and derivatives of sulfonylureas - there is an intensification of their action.
    With antibiotics, the effectiveness of the active substance of this drug decreases, as the intestinal flora is suppressed.

Terms of sale

To buy Sulfasalazin you don't need a prescription.

Storage conditions

The temperature should not exceed + 25 ° C.
Keep out of reach of children and pets.
Shelf life is not more than five years.

special instructions

During therapy, patients are advised to use a large (3-4 liters) amount of fluid.

With alcohol

Despite the fact that alcohol is not a contraindication in the use of the drug, it is believed that Sulfasalazin and alcohol are incompatible, since there is a risk of liver damage, and regular or one-time alcohol intake may lead to a more rapid development of complications.

Which is better: Sulfasalazin or Sulfasalazin-EN?

The main difference between Sulfasalazin-EN and Sulfasalazin is the chemical structure of the film coating of tablets. In Sulfasalazin-EN is a film membrane, a special enterosoluble, which gives better bioavailability and absorption of the active substance, for example, with the intake of Sulfasalazin-EN 90% dose reaches the large intestine, and the "simple" - only 70%. However, Sulfasalazin EN is produced by the American firm Pfizer and therefore costs about a third more.

Reviews of Sulfasalazin

Reviews of patients - only positive, but in 2015 the issue of the lack of a drug in Russian pharmacies became acute. The forums agree on the possibility of sending by mail the drug from the neighboring countries of the former CIS.
Reviews of Sulfasalazin in rheumatoid arthritis indicate its effectiveness, and what is important - the possibility of treating the juvenile form of the disease. However, the course is quite long and some note side reactions in the form of rashes, worry about the negative impact on the work of the liver and kidneys.