Otitis

Salazopyridazine instructions for use. Drug: Salazopyridazine

The price of the drug in different pharmacies may vary.

International name

Mesalazine

Pharmacological group

Antimicrobial and anti-inflammatory intestinal agent (12)

Active ingredients

Mesalazine

Dosage form

rectal suppositories, oral suspension, rectal suspension, tablets, enteric-coated tablets, extended-release tablets

Pharm.Action

It has local anti-inflammatory properties (due to inhibition of the activity of neutrophil lipoxygenase and the synthesis of Pg and leukotrienes). Inhibits migration, degranulation, phagocytosis of neutrophils, as well as secretion of Ig by lymphocytes. It has an antibacterial effect against E. coli and some cocci (manifests in the large intestine). It has an antioxidant effect (due to the ability to bind to free oxygen radicals and destroy them). It is well tolerated and reduces the risk of relapse in Crohn's disease, especially in patients with ileitis and a long duration of the disease.

Usage

Nonspecific ulcerative colitis, Crohn's disease (prevention and treatment of exacerbations).

Contraindications for use

Hypersensitivity (when using enemas, including to methyl and propylparaben), blood diseases, peptic ulcer of the stomach and duodenum, deficiency of glucose-6-phosphate dehydrogenase, hemorrhagic diathesis, severe renal/liver failure, lactation period, the latter 2-4 weeks of pregnancy, children (up to 2 years). With caution. Pregnancy (first trimester), liver and/or kidney failure.

Possible side effects

From the digestive system: nausea, vomiting, heartburn, diarrhea, loss of appetite, abdominal pain, dry mouth, stomatitis, increased activity of liver transaminases, hepatitis, pancreatitis. From the cardiovascular system: palpitations, tachycardia, increased or decreased blood pressure, chest pain, shortness of breath. From the nervous system: headache, tinnitus, dizziness, polyneuropathy, tremor, depression. From the urinary system: proteinuria, hematuria, oliguria, anuria, crystalluria, nephrotic syndrome. Allergic reactions: skin rash, itching, dermatoses (pseudoerythromatosis), bronchospasm. From the hematopoietic organs: eosinophilia, anemia (hemolytic, megaloblastic, aplastic), leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia. Other: weakness, mumps, photosensitivity, lupus-like syndrome, oligospermia, alopecia, decreased tear production. Overdose. Symptoms: nausea, vomiting, gastralgia, weakness, drowsiness. Treatment: gastric lavage, laxative administration, symptomatic therapy.

Doses and method of administration

The choice of dosage form is determined by the location and extent of intestinal damage. For common forms, tablets are used, for distal forms (proctitis, proctosigmoiditis) - rectal forms. In case of exacerbation of the disease - 400-800 mg 3 times a day, for 8-12 weeks. To prevent relapses - 400-500 mg 3 times a day for nonspecific ulcerative colitis and 1 g 4 times a day for Crohn's disease; children over 2 years old - 20-30 mg/kg/day in several doses for several years. In severe cases of the disease, the daily dose can be increased to 3-4 g, but not more than for 8-12 weeks. The tablets should be taken whole, without chewing, after meals, with plenty of liquid. Suppositories - 500 mg 3 times a day, and suspension - 60 g of suspension (4 g of mesalazine) 1 time per day at night, in the form of a medicinal microenema (it is recommended to cleanse the intestines in advance). For children, suppositories are prescribed at the following rate: for exacerbation - 40-60 mg/kg/day; for maintenance therapy - 20-30 mg/kg/day.

Other instructions

It is advisable to regularly conduct a general blood test (before, during, and after treatment) and urine, and monitor the excretory function of the kidneys. Patients who are “slow acetylators” have an increased risk of developing side effects. There may be a yellow-orange coloration of urine and tears, and staining of soft contact lenses. If you miss a dose, the missed dose should be taken at any time or with the next dose. If several doses are missed, then consult a doctor without stopping treatment. If the development of acute intolerance syndrome is suspected, mesalazine should be discontinued.

Interaction

It enhances the hypoglycemic effect of sulfonylurea derivatives, the ulcerogenicity of GCS, the toxicity of methotrexate, weakens the activity of furosemide, spironolactone, sulfonamides, rifampicin, enhances the effect of anticoagulants, increases the effectiveness of uricosuric drugs (tubular secretion blockers). Slows down the absorption of cyanocobalamin.

Please note! Before using any medications, you should always consult your doctor!

Indications for use:
Nonspecific ulcerative colitis (chronic inflammation of the colon with the formation of ulcers, caused by unclear reasons), also in diseases occurring with autoimmune disorders (disorders based on allergic reactions to the body’s own tissues or waste products), including as a basic remedy in the treatment of rheumatoid arthritis (an infectious-allergic disease from the group of collagenoses, characterized by chronic progressive inflammation of the joints).

Pharmacological action:
Sulfanilamyl product. It has an anti-inflammatory and immunosuppressive (suppressing the body's defenses) effect.

Salazopyridazine method of administration and dosage:
For nonspecific ulcerative colitis, salazopyridazine is prescribed to adults orally (after meals) in tablets of 0.5 g 4 times every day for 3-4 weeks. If during this period a therapeutic effect appears, the daily dose is reduced to 1.0-1.5 g (0.5 g 2-3 times every day) and treatment is continued for another 2-3 weeks. If there is no effect, stop taking the product. For patients with mild forms of the disease, the product is first prescribed at a daily dose of 1.5 g, and if there is no effect, the dose is increased to 2 g per day.
For children aged 3 to 5 years, salazopyridazine is prescribed starting with a dose of 0.5 g per day (2-3 doses). If there is no effect within 2 weeks. the product is discontinued, and if there is a therapeutic effect, treatment is continued at this dose for 5-7 days, then the dose is reduced by 2 times and treatment is continued for another 2 weeks. In case of clinical remission (temporary weakening or disappearance of the manifestations of the disease), the daily dose is again reduced by half and prescribed until the 40-50th day, counting from the start of treatment.
Children aged 5 to 7 years are prescribed the product starting from 0.75-1.0 g per day; from 7 to 15 years - with a dose of 1.0-1.2-1.5 g per day. Treatment and dose reduction are carried out according to the same scheme as for children from 3 to 5 years old.
The use of salazopyridazine is combined with general treatment methods and diet recommended for nonspecific ulcerative colitis.
Salazopyridazine can also be used for ulcerative colitis and Crohn's disease (a disease of unknown cause characterized by inflammation and narrowing of the lumen of certain parts of the intestine) rectally (into the rectum) in the form of suspensions (a suspension of solid particles in a liquid) and suppositories.
Salazopyridazine suspension 5% is used for rectal administration in cases of damage to the rectum and sieve, in the preoperative period and after subtotal colectomy (after removal of part of the colon), with poor tolerability of the product in tablet form. The suspension is slightly heated and administered as an enema into the rectum or intestinal stump, 20-40 ml 1-2 times a day. Children are administered 10-20 ml (depending on age). Rectal administration can be combined with oral administration of the substance.
Suppositories are used rectally. In the acute stage of the disease, 1 suppository is prescribed 2-4 times every day for 2 weeks. up to 3 months The duration of the course depends on the effectiveness of treatment and tolerability of the product. The maximum daily dose is 4 suppositories (2 g). At the same time, you can take salazopyridazine tablets (not exceeding a total daily dose of 3 g) and other drugs for the treatment of ulcerative colitis.
In order to prevent relapses (reappearance of signs of the disease), 1-2 suppositories are prescribed per day for 2-3 months.
The dosage and regimen of the product for other forms of colitis with ulcerative lesions are the same as for nonspecific ulcerative colitis.

Salazopyridazine contraindications:
The drug is contraindicated if there is a history (medical history) of toxic-allergic reactions during treatment with sulfonamides and salicylates.

Salazopyridazine side effects:
When taking salazopyridazine tablets orally, the same adverse reactions are possible as when using sulfonamides and salicylates: allergic phenomena, leukopenia (decrease in the level of leukocytes in the blood), dyspeptic disorders (digestive disorders), sometimes a slight decrease in the level of hemoglobin (the functional structure of the red blood cell that ensures its interaction with oxygen). In such cases, the dose should be reduced or the product discontinued. After administration of the suspension, a burning sensation in the rectum and the urge to defecate (bowel movement) may appear, especially with rapid administration. When using salazopyridazine in suppositories, there may be a burning sensation and pain in the rectum, and sometimes increased bowel movements. In case of severe pain during rectal administration of salazopyridazine in suppositories, it is recommended to administer the product rectally in the form of a 5% suspension and orally in tablets.

For nonspecific ulcerative colitis, salazopyridazine is prescribed to adults orally (after meals) in tablets of 0.5 g 4 times every day for 3-4 weeks. If during this period a therapeutic effect appears, the daily dose is reduced to 1.0-1.5 g (0.5 g 2-3 times every day) and treatment is continued for another 2-3 weeks. If there is no effect, stop taking the product. For patients with mild forms of the disease, the product is first prescribed at a daily dose of 1.5 g, and if there is no effect, the dose is increased to 2 g per day. For children aged 3 to 5 years, salazopyridazine is prescribed starting with a dose of 0.5 g per day (2-3 doses). If there is no effect within 2 weeks. The product is canceled, and when... If there is a therapeutic effect, continue treatment at this dose for 5-7 days, then reduce the dose by 2 times and continue treatment for another 2 weeks. In case of clinical remission (temporary weakening or disappearance of the manifestations of the disease), the daily dose is again reduced by half and prescribed until the 40-50th day, counting from the start of treatment. Children aged 5 to 7 years are prescribed the product starting from 0.75-1.0 g per day; from 7 to 15 years - with a dose of 1.0-1.2-1.5 g per day. Treatment and dose reduction are carried out according to the same scheme as for children from 3 to 5 years old. The use of salazopyridazine is combined with general treatment methods and diet recommended for nonspecific ulcerative colitis. Salazopyridazine can also be used for ulcerative colitis and Crohn's disease (a disease of unknown cause characterized by inflammation and narrowing of the lumen of certain parts of the intestine) rectally (into the rectum) in the form of suspensions (a suspension of solid particles in a liquid) and suppositories. Salazopyridazine suspension 5% is used for rectal administration in cases of damage to the rectum and sieve, in the preoperative period and after subtotal colectomy (after removal of part of the colon), with poor tolerability of the product in tablet form. The suspension is slightly heated and administered as an enema into the rectum or intestinal stump, 20-40 ml 1-2 times a day. Children are administered 10-20 ml (depending on age). Rectal administration can be combined with oral administration of the substance. Suppositories are used rectally. In the acute stage of the disease, 1 suppository is prescribed 2-4 times every day for 2 weeks. Up to 3 months The duration of the course depends on the effectiveness of treatment and tolerability of the product. The maximum daily dose is 4 suppositories (2 g). At the same time, you can take salazopyridazine tablets (not exceeding a total daily dose of 3 g) and other drugs for the treatment of ulcerative colitis. In order to prevent relapses (reappearance of signs of the disease), 1-2 suppositories are prescribed per day for 2-3 months. The dosage and regimen of the product for other forms of colitis with ulcerative lesions are the same as for nonspecific ulcerative colitis.

Mesalazine

Salazopyridazine:: Dosage form

rectal suppositories, oral suspension, rectal suspension, tablets, enteric-coated tablets, extended-release tablets

Salazopyridazine:: Pharmacological action

Salazopyridazine:: Indications

Nonspecific ulcerative colitis, Crohn's disease (prevention and treatment of exacerbations).

Salazopyridazine:: Contraindications

Salazopyridazine:: Side effects

Salazopyridazine:: Method of administration and dosage

Salazopyridazine:: Special instructions

Salazopyridazine:: Interactions

non-pharmacopoeial drug 5-(p-phenylazo)-salicylic acid

Description: orange powder, odorless.

Solubility: practically insoluble in water, slightly soluble in alcohol, ether and chloroform, easily soluble in DMF (dimethylformamide) and sodium hydroxide solution.

Authenticity: 1) upon interaction with a solution of copper sulfate, a green precipitate is formed. 2) A particular reaction based on the presence of an azo group in the molecule is the hydrogenation reaction: zinc dust and concentrated hydrochloric acid are added to the salazopyridazine solution. The orange color of the solution gradually fades. FS recommends identification in the visible part of the spectrum 400-600 nm; Thus, the drug has a maximum at 457 nm when using a solvent of 0.1 M sodium hydroxide solution. Quantitative determination can also be carried out at this wavelength.

Purity: by FS by TLC method on “Silufol UV-254” plates in comparison with the witness substance. There should be one spot. The microbiological purity of the drug is established according to the State Pharmacopoeia of the 19th century. 2, p. 193.

Quantification: polarography method. Polarograph in DMF solution. I carry out the calculations according to the calibration schedule. It is possible to use bromatometry and the method of neutralization at the carboxyl group and phenolic hydroxyl in a DMF environment. Titrant is a non-aqueous solution of sodium hydroxide.

Storage:

Application: antibacterial effect in the intestine, where the molecule is split into sulfapyridazine and 5-aminosalicylic acid, which have an antibacterial effect in the treatment of nonspecific ulcerative colitis.

Release form: powder, tablets of 0.5 g, 5% suspension in 250 ml bottles, suppositories.

Co-Trimoxazole (Biseptol). Co-trimoxazole (Biseptol)

non-pharmacopoeial drug

Composition: in a tablet of sulfamethoxazole 0.4 g and trimethoprim 0.08 g:

Description: tablets are white with a creamy tint.

Authenticity: determination is carried out after shaking the powder of the crushed half of the tablet for 3 minutes with 5 ml of 0.1 M sodium hydroxide solution and 20 ml of purified water. 1) The suspension is filtered and a solution of copper (II) sulfate is added to the filtrate; a yellowish-greenish precipitate of the copper salt of sulfamethoxazole is formed. 2) The filtrate gives a pharmacopoeial reaction for the formation of an azo dye on primary aromatic amines (with β-naphthol). The sulfonamide component of the drug also gives other characteristic reactions to sulfonamides. For identification, you can use the UV spectrum, which has an absorption maximum at a wavelength of 246 nm.

Using TLC on Kieselgel plates, chromatograph in the mobile phase chloroform-methanol-concentrated ammonia solution (80:20:3); manifestation is carried out with Dragendorff's reagent - two spots should appear at the level of witness substances. The presence of impurities determined by this method should not exceed 1%; The presence of streptocide (no more than 0.5%) and sulfanilic acid (no more than 0.3%) is also determined.

Quantification: according to the FS, sulfamethoxazole is determined nitritometrically. The indicator is iodine starch paper (or potentiometrically). Trimethoprim is determined by non-aqueous titration in glacial acetic acid and acetic anhydride. Titrant – 0.1 M perchloric acid solution, indicator – crystal violet.

Storage: list B; in a place protected from light.

Application: antibacterial agent for the treatment of diseases of the respiratory tract, urinary tract and gastrointestinal tract.

Release form: tablets for adults called “Co-trimoxazole-480” and for children “Co-trimoxazole-240 (and 120)”; syrup for children.

Sulfatonum. Sulfatone

non-pharmacopoeial drug

A Soviet drug similar in pharmacological action to co-trimoxazole, but having 0.25 g of sulfamonomethoxine and 0.1 g of trimethoprim as a sulfonamide component. The higher antibacterial activity of sulfamonomethoxine allows the drug to be used in a lower dosage, which reduces possible side effects.

Benzothiadiazine derivatives

The fused benzothiadiazine system includes a benzo-1,3-diazine core, and the basis of the structure of drugs in this group is 1,2,4-benzothiadiazine-1,1-dioxide: