Asakol
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Asakol is an anti-inflammatory intestinal agent with antimicrobial action.
Release form and composition
Dosage forms:
- enteric coated tablets (10 pcs. in a blister strip: 400 mg - in a cardboard box 10 packs, 800 mg - in a cardboard box 1 or 5 packs);
- rectal suppositories: No. 20 (10 pcs. in a blister, 2 blisters in a cardboard box);
- rectal suspension (100 ml or 50 ml in plastic vials, 7 vials in a cardboard box).
1 tablet contains:
- active substance: mesalazine (5-ASA) - 0.4 g or 0.8 g;
- auxiliary components: sodium starch glyconate, lactose monohydrate, povidone, talc, magnesium stearate;
- shell composition: methacrylic acid, methacrylate copolymer, dibutyl phthalate, macrogol 6000, dye iron oxide yellow and red, talc.
1 suppository contains:
- active substance: mesalazine - 0.5 g;
- excipients: solid fat.
In 100 ml of suspension, the active substance content of mesalazine is 4 g.
Indications for use
The use of Asakol is indicated for the treatment of inflammatory bowel diseases (Crohn's disease, ulcerative colitis) and the prevention of their recurrence.
Contraindications
- severe forms of impaired renal and / or liver function;
- age up to 2 years;
- peptic ulcer of the stomach and duodenum;
- hemorrhagic diathesis;
- last 4 weeks of pregnancy;
- breast-feeding;
- individual intolerance to the components of the drug.
With caution, Asakol should be prescribed for hepatic and / or renal failure, deficiency of glucose-6-phosphate dehydrogenase, in the first trimester of pregnancy.
Suppositories should not be prescribed to patients with confirmed hypersensitivity to salicylates.
It is contraindicated to use the suspension in patients with hypersensitivity to methylparaben, propylparaben.
Method of administration and dosage
The dosage form and dosage regimen is prescribed by the doctor, taking into account the localization and length of the affected intestine.
For the treatment of common forms of diseases, tablets are used, for distal sections (proctosigmoiditis, proctitis) - rectal forms of the drug.
Enteric-coated tablets
The tablets are taken orally, after meals, swallowing whole and drinking plenty of liquid.
Recommended dosage for adults:
- acute form of the disease: 0.4-0.8 g 3 times a day, for the treatment of severe diseases, the daily dose can be increased to 3-4 g, the duration of treatment is 8-12 weeks;
- relapse prevention: ulcerative colitis - 0.4–0.5 g 3 times a day, Crohn's disease - 1 g 4 times a day.
For children over 2 years old, the daily dose is determined at the rate of 0.02-0.03 g per 1 kg of the child's weight and divided into several doses, the course of treatment is long - up to several years.
Rectal suppositories
Suppositories are used rectally, after preliminary bowel cleansing.
Recommended dosing regimen for adults:
- monotherapy: 0.5 g 3 times a day;
- combination therapy: severe forms of total ulcerative colitis (damage to the rectum or rectosigmoid part) or slow response to treatment with tablets - 0.5 g each morning and evening in addition to the use of tablets.
In the stage of remission, the dosage is determined individually, depending on the severity of the disease.
The duration of therapy is up to 1 year.
Elderly patients without impaired renal function do not require dosage adjustment.
The experience of using suppositories in pediatric practice is limited.
Recommended dosage for children:
- period of exacerbation: at the rate of 0.04–0.06 g per 1 kg of body weight per day;
- supportive therapy: 0.02–0.03 g per 1 kg of body weight per day.
Rectal suspension
The suspension is intended for rectal administration in the form of medicinal microclysters at night. The drug is used after preliminary cleaning of the intestine.
Adults are prescribed 60 g of suspension 1 time per day.
Side effects
Enteric-coated tablets
- digestive system: heartburn, nausea, vomiting, abdominal pain, diarrhea, decreased appetite, increased activity of liver enzymes, pancreatitis, hepatitis;
- cardiovascular system: shortness of breath, increase or decrease in blood pressure (BP), tachycardia, palpitations, chest pain;
- nervous system: tinnitus, headache, dizziness, depression, polyneuropathy, tremor;
- urinary system: hematuria, oliguria, proteinuria, anuria, nephrotic syndrome, crystalluria;
- allergic reactions: bronchospasm, pruritus, rash, dermatosis;
- hematopoietic organs: leukopenia, anemia (hemolytic, aplastic, megaloblastic), agranulocytosis, hypoprothrombinemia, thrombocytopenia;
- others: weakness, photosensitivity, mumps, lupus-like syndrome, alopecia, oligospermia, decreased production of tear fluid.
Rectal suppositories, rectal suspension
- cardiovascular system: rarely - pericarditis, myocarditis;
- blood system and lymphatic system: very rarely - leukopenia, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, thrombocytopenia;
- nervous system: rarely - dizziness, headache; very rarely - peripheral neuropathy;
- immune system: very rarely - hypersensitivity reactions (allergic rashes, drug fever, pancolitis, lupus erythematosus);
- gastrointestinal tract: rarely - flatulence, nausea, vomiting, abdominal pain, diarrhea; very rarely - acute pancreatitis;
- hepatobiliary system: very rarely - hepatitis, increased cholestasis parameters and transaminase levels, cholestatic hepatitis;
- respiratory system, chest and mediastinal organs: very rarely - bronchospasm, shortness of breath, cough, alveolitis, pulmonary infiltration, pulmonary eosinophilia, pneumonitis, other reactions of fibrous and allergic genesis from the lungs;
- dermatological reactions: very rarely - alopecia;
- reproductive system and mammary gland: very rarely - transient oligospermia;
- musculoskeletal system and connective tissue: very rarely - arthralgia, myalgia;
- urinary system: very rarely - impaired renal function (including acute or chronic interstitial nephritis, renal failure);
- systemic disorders: infrequently - lack of a therapeutic effect.
special instructions
The appointment of Asakol should be based on the results of blood tests, kidney and liver function of the patient. Long-term use of the drug provides for regular general blood and urine tests, hematological studies, monitoring of kidney and liver function. If signs of a functional disorder of the kidneys or liver appear, you should immediately stop using the drug and consult a doctor.
If symptoms of acute intolerance syndrome appear (acute abdominal pain, rash, fever, abdominal colic, severe headache), therapy should be canceled.
When signs of blood dyscrasia appear against the background of the use of suppositories (in the form of bruises, bleeding of unknown origin, purpura, sore throat, anemia, persistent fever), immediate discontinuation of the drug is required.
With caution, Asakol should be prescribed to patients with a history of myocarditis or pericarditis of allergic genesis.
When pills are taken, urine and tears (including soft contact lenses) may turn yellow-orange.
With asthma and other pulmonary pathologies, patients need close medical supervision.
If you accidentally skip the next dose of the drug, the missed dose must be taken immediately, as soon as you remember, or at the same time as the next dose. If you miss several doses, you should consult your doctor.
Since the use of Asakol can cause dizziness, care must be taken when driving vehicles and mechanisms.
Drug interactions
With the simultaneous use of Asakol:
- sulfonylurea derivatives - enhance the hypoglycemic effect;
- glucocorticosteroids - increase side effects that cause disruption of the mucous membrane of the gastrointestinal tract;
- anticoagulants - enhance their effect;
- cyanocobalamin - slows down its absorption;
- methotrexate - increases toxicity;
- sulfonamides, spironolactone, rifampicin, furosemide - weaken their therapeutic effect;
- tubular secretion blockers (uricosuric drugs) - increase their effectiveness.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, suppositories - in a dark place.
Do not freeze suppositories and suspensions.
The shelf life is 3 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
