Dicsep Medisun treat ulcerative colitis, bleeding rectal (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Sulfasalazine
Ingredient Medisun Pharmaceutical Joint Stock Company

Ingredient

Composition information	Content
Sulfasalazine	500mg

Uses

indications

Dicseep drugs are indicated in the following cases:

ulcerative colitis, bleeding rectal.

Pharmacological group: Anti -inflammatory drugs.

Sulfasalazin is synthetic sulfonamid with sulfapyridine diazo and diazoni salt pair with salicylic acid. Sulfasalazin is considered to be a pharmaceutical substance, due to the Diazo bond when the body is cut to form sulfapyridine and acid 5 - aminosalicylic (Mesalamin). The mechanism of action of the drug may be due to the metabolites of sulfasalazin that reaches higher intestinal concentration when taking these metabolites itself. The effect of intestinal treatment may be due to antibacterial effects of sulfapyridine or anti -inflammatory effects of acid 5 - aminosalicylic when these substances come to the colon.

In addition, the effect of the drug may also be due to the effects of sulfasalazin: changing the organization style in the intestinal microorganism system, reducing Clostridium and E. coli in the feces, inhibiting Prostaglandin synthesis is a diarrhea and impacts on the transport of mucus, changing the secretion and absorption of fluids and electrolytes in the colon and/or immunosuppression.

sulfasalazin contributes to reducing inflammatory activity in rheumatoid arthritis, but the role of drugs and metabolites in this effect is not well known; Sulfasalazin is often used alone or in combination with corticosteroids to treat ulcerative colon.

Sulfasalazin is also used as a dmard to treat severe or progressive rheumatoid arthritis. Sulfasalazin does not recommend the treatment of arthritis in adolescents because it can cause serious ADR.

Pharmacokinetics

absorption

After taking about 10-15% of the sulfasalazin dose is absorbed in the form of non -metabolic drugs from the small intestine. A small percentage of sulfasalazin absorbed is excreted through bile into the intestine (gut -liver circulation). The rest of the oral dose of Sulfasalazin transferred intact into the colon, where the diazo link was cut by the bacteria in the colon, cut into sulfapyridine and mesalamin.

sulfapyridine is quickly absorbed in the colon. Only a small amount of mesalamine is absorbed in the colon, in the colon cutting, 60 - 90% of the total dose is transformed in this way, but the level of metabolism depends on both the intestinal bacteria in the intestine and the shipping speed of the drug. The metabolism in the colon decreases in people with diarrhea.

Distribution

Small amount of Sulfasalazin is absorbed strongly attached to plasma proteins and eventually eliminates non -metabolized into the urine. The drug through the placenta and found in breast milk.

Metabolism

After the sulfasalazin molecule is broken in the colon, 60 - 80% of sulfapyridine is absorbed and strongly metabolized in the liver thanks to acetylation, hydroxylation, and in conjugate with glucuronic acid.

Elimination

Half of the lifetime excreted the average of serum sulfasalazin is 5.7 hours after 1 single dose and 7.6 hours after many doses. Half -life sulfapyridine is 8.4 hours after 1 single dose and 10.4 hours after many doses.

Before taking Dicsep Medisun treat ulcerative colitis, bleeding rectal (3 blisters x 10 tablets)

How to use

Take oral, should take medicine after meals or food. Take medicine with 1 cup of full water and drink more water during the day.

Dosage

Total daily dose should be divided into small doses.

Children

Treatment of severe and medium -severe colic ulcer, Corhn's disease:

Children from 2 - 12 years old: Take 10 - 15 mg/kg (maximum 1 g), 4-6 times/day, drink until the remission; If the maximum increase is needed 60 mg/ kg/ day, divided into several times.

From 12 - 18 years old: Drink 1 - 2 g, 4 times/day, take it to release.

Maintain mild, medium and severe ulcerative treatment:

Children from 2 - 12 years old: Take 5 - 7.5 mg/kg (maximum 500 mg), 4 times/day.

From 12 - 18 years old: Take 500 mg, 4 times/day.

Treatment of Crohn's disease is active:

Take 1 - 2 g, divide 3-4 times.

Teenagic rheumatoid arthritis:

The disease does not respond to salicylat or NSAID

Children> 6 years old: Take 30 - 50 mg/kg/day divided into 2 times until maximum 2 g/day.

To reduce the gastrointestinal adr, use a tablet to dissolve in the intestine and the first dose must be 1/4 - 1/3 of the expected maintenance dose, then increase weekly until the maintenance dose after 1 month.

Adults

rheumatoid arthritis:

Start using 500 mg/day for a week, then increase to 500 mg per week, to a maximum dose of 2-3 g/day, divided into 2-4 times to take medication and response.

ulcerative colitis, Corhn disease:

Acute treatment, taking 1-2 g, 4 times/day, until the remission, combined with corticosteroids if necessary, follow the maintenance dose of 500 mg, 4 times/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Overdose

Drowsy, dizziness, anorexia, abdominal pain, nausea, vomiting, fever, hemolytic anemia.

How to handle

Stop taking the drug as soon as a hypersensitive reaction occurs. Can be used for antihistamine or corticosteroids to limit allergies.

There is no specific antidote. The treatment is to wash the stomach, cause vomiting, or use the bleach when needed. Alkaline urine. Promoting diuretic benefits if normal kidney function.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.

Side Effects

When using DICSEP, you may experience unwanted effects (ADR).

In general, there are few unwanted effects caused by sulfasalazin, but mild reactions occur often. About 75% of harmful reactions occur within the first 3 months of treatment, especially when the dose exceeds 4 g/ day, or when sulfapyridine concentration in serum is higher than 50 micrograms/ ml. Reactions such as anorexia, nausea, vomiting, digestive disorders and headaches occur in 1/3 of the patients and related to serum sulfapyridine.

Common, ADR> 1/100

Systemic: headache, fever, anorexia.

blood: leukopenia, anemia, hemolytic, red blood cells.

digestive: abdominal pain, nausea, epigastric pain.

Skin: Ban, urticaria, itching, erythema.

Liver: Translation Transaminase.

Other reactions: Reduce sperm recovery.

Uncommon, 1/1000

Body: Fatigue.

Blood: Losing leukocytes. Mental: depression.

ears: tinnitus.

dangerous, ADR

Immune: serum, angioedema.

blood: reduces all bloody, granulocytes, thrombocytopenia, red blood cell anemia. digestive: pancreatitis. skin: Lupus erythematosus, epidermal necrosis (Lyell syndrome), Stevens - Johnson syndrome, flaky dermatitis, light sensitivity. liver: hepatitis.

Respiratory: Lemonaritis, respiratory failure, cough.

Muscle muscle: joint pain.

nerve: peripheral neuropathy, sterile meningitis.

urinary tract: Nephrotic syndrome, proteinuria, erythrocyte, urinary crystal. other reactions: Awareness of smell, taste changes.

Comment

Patients with a history of all -body lupus, a history of liver toxicity or blood related to sulfonamid are often at high risk of unwanted effects when treating with sulfonamid. Cases of sterile meningitis only see notifications in patients who have rheumatism.

Instructions on how to handle ADR

Need to stop the drug as soon as there is a sensitive reaction, and for antihistamine or corticoid drugs.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Dicseep drug contraindicated in the following cases:

Cases of hypersensitivity to sulfasalazin, sulfonamid or salicylate.

Porphyrin metabolism.

Liver or kidney failure; intestinal obstruction or urinary obstruction; Children under 2 years old (because the drug can cause jaundice).

Be cautious when using

Patients with a history of hematopoietic disorders such as granulocytes, non -regenerated anemia.

Patients with glucose deficiency - 6 phosphate dehydro - genase.

Patients with severe allergies.

Pregnant and lactating women.

Be cautious when used with other drugs: Cumarin anticoagulant or indandion derivatives, hemolytic drugs, toxic pills with liver and methotrexate.

Must check the formula of red blood cells, leukocytes and platelets, liver and kidney function when starting treatment, checking once a month in the first 3 months of treatment.

Patients with rare genetics about non -Galactose, Lapp Lactase deficiency, or Glucose - Galactose should not take this drug.

The ability to drive and operate machinery

A few possible side effects such as headache, fatigue, can affect the ability to drive and operate machinery. Therefore, need to be cautious when driving and operating machinery.

pregnancy

sulfasalazin and sulfapyridin passes through the placenta. There are no full research for pregnant women. Some studies show that sulfasalazin may cause fetal deformities, so it is necessary to be cautious when using sulfasalazin for pregnant women and must supplement folic acid (see more drug interaction).

Breastfeeding period

sulfasalazin excreted in breast milk in small amounts, concentrations equal to about 30-60% in mother serum.

However, low -dose sulfonamids also cause severe hemolytic anemia in infants with glucose deficiency - 6 phosphate dehydrogenase. Therefore, it must be extremely cautious when taking the drug for breastfeeding mothers.

Drug interaction

Digoxin's bioavailability is reduced when used simultaneously with sulfasalazin. Sulfasalazin inhibits the absorption, preventing the metabolism of folic acid, which can lead to a decrease in serum folic acid levels. When treating with sulfasalazin, Folic acid supplements are needed.

Anticoneal drugs, anti -convulsions or anti -diabetes drugs may be pushed out of the protein and/ or metabolic position of these drugs that can be inhibited by sulfonamides, resulting in an increase or prolonged effect or toxicity, which needs to adjust the dose during and after sulfasalazin treatment.

Concentrated with hemolysis medications can increase the ability of the drug.

Effect of methotrexate, phenylbutazon, sulfinpyrazon may increase when used simultaneously with sulfonamid because the drug may be pushed out of the location of the protein.

Storage

Storage in closed packaging, avoid moisture, light, at temperatures below 30 ° C.

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