Sulfasalazine-EN

Active material: Sulfasalazine
When ATH: A07EC01
CCF: The drug with anti-inflammatory action, used to treat Crohn's disease and ulcerative colitis
When CSF: 11.13.01
Manufacturer: KRKA d.d. (Slovenia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills, enteric coated from yellow to brownish-yellow, round, lenticular, with a beveled edge, with a characteristic odor; of presentations – from orange to brownish orange.

povidone, pre-gelatinized starch, magnesium stearate, Colloidal anhydrous silica.

The composition of the shell: Titanium dioxide, dye iron oxide yellow 10 (E172), talc, triэtiltsitrat, macrogol 6000, carmellose sodium, a copolymer of methacrylic acid and ethyl acrylate (1:1).

10 PC. – blisters (5) – packs cardboard.

Pharmacological action

Drug for the treatment of Crohn's disease and ulcerative colitis. Sulfasalazine is selectively accumulated in the connective tissue of intestines to release 5-aminosalicylic acid, having anti-inflammatory activity, and sulfapyridine, has antimicrobial activity against diplokokkov, streptococci, gonokokkov, E. coli.

Testimony

- Nespetsificheskiy yazvennыy colitis (treatment exacerbations and maintenance therapy in remission);
- Crohn's disease (mild and moderate exacerbations);
- Rheumatoid arthritis;
- Juvenile rheumatoid arthritis.

Dosage regimen

At NYAK and sorrows Krona adult on the first day of treatment prescribed by 500 mg 4 times / day; 2-Dyen its – by 1 g 4 times / day; in the third and following days – by 1.5-2 g 4 times / day. After calming down of acute clinical symptoms prescribed drug in the maintenance dose of 500 mg 3-4 times / day for several months.
For children 5-7 years appoint 250-500 mg 3-6 time / day, older children 7 years – by 500 mg 3-6 time / day.
At revmatoidnom ARTHRO adult during the first week of drug prescribed 500 mg 1 time / day; during 2 of the week – by 500 mg 2 times / day; during 3 of the week – by 500 mg 3 times / day, etc.. The therapeutic daily dose of sulfasalazine-EN may range from 1.5 to 3 g. A course of treatment – 6 months or more.
Children under the age of 6 years the drug is prescribed in a dose 30-50 mg / kg body weight / day, razdelennoy of 2-4 admission; to older children 16 years – The maximum daily dose is 2 g.
The drug should be taken after meals.

Side effect

From the central and peripheral nervous system: headache, dizziness, noise in ears, ataxia, convulsions, sleep disorders, hallucinations, perifericheskaya neuropathy.
From the urinary system: renal dysfunction, interstitial nephritis.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, anorexia, hepatitis, pancreatitis.
The respiratory system: interstitial pneumonitis and other lesions of the lung tissue.
From the hematopoietic system: anemia, leukopenia, thrombocytopenia, agranulocytosis.
Reproductive system: transient oligospermia, infertility.
Allergic reactions: skin rash, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome), fever, anaphylactic shock.
Other: possible yellowing of the skin, Urine, soft contact lenses.

Contraindications

- Porphyria;
- Anemia;
- Expressed human liver;
- Expressed by the human kidney;
- Deficit ferment glucose-6-fosfatdegidrogenazы;
- Children up to age 5 years;
- Lactation;
- Hypersensitivity to sulfonamides and salicylic acid derivatives.

Pregnancy and lactation

The use of sulfasalazine-EN during pregnancy is possible only under strict indications in the minimum effective dose. If you allow the disease, It recommended to remove the drug in the III trimester of pregnancy.
If necessary, use during lactation should decide the issue of termination of breastfeeding.

Cautions

Precautions should be prescribed to patients with impaired liver function and / or kidneys, patients with bronchial asthma, allergic reactions.
During the period of the drug is recommended to use an increased amount of fluid.
During the period of use of the drug should be monitored liver enzymes, general analysis of blood and urine.

Overdose

Symptoms: nausea, vomiting, stomach ache, dizziness.
Treatment: gastric lavage, diurez; simptomaticheskaya therapy.

Drug Interactions

With simultaneous use of sulfasalazine-EN reduces the absorption of folic acid, and digoxin.
With simultaneous use of sulfasalazine-EN increases the effects of anticoagulants, antiepileptics and oral hypoglycemic drugs.
With simultaneous use of sulfasalazine-EN increases the side effects of cytostatics, immunosuppressants, scarp- and nephrotoxic agents.
With simultaneous use of sulfasalazine-EN and antibiotics may reduce the effectiveness of sulfasalazine-EN in ulcerative colitis, because antibiotics have a depressing effect on the intestinal flora.

Conditions and terms

The drug should be stored at temperatures above 25 ° C, out of reach of children. Shelf life – 5 years.
Conditions of supply of pharmacies
The drug is released under the prescription.