Instructions for Decaris tablets 150 mg No. 1
Composition
active ingredient: levamisole;
1 tablet of 50 mg contains levamisole 50 mg (as 59 mg of levamisole hydrochloride);
excipients: corn starch, sodium saccharin, povidone, talc, apricot flavor, magnesium stearate, sunset yellow FCF (E 110);
1 tablet of 150 mg contains 150 mg of levamisole (as 177 mg of levamisole hydrochloride);
Excipients: corn starch, lactose monohydrate, sucrose, povidone, talc, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties:
50 mg tablets – round, flat, pale orange, with a faint apricot odor, with a bevel and with lines dividing the tablet into four parts on one side. The tablet is pale orange when broken. The diameter of the tablets is about 7 mm;
150 mg tablets are round, flat, almost white, with a bevel and engraving "DECARIS •150•" on one side, the other side is plain. The diameter of the tablets is about 9 mm.
Pharmacotherapeutic group
Anthelmintic agents. Agents used in nematodoses. Imidazothiazole derivatives. ATX code P02C E01.
Pharmacological properties
Pharmacodynamics.
Levamisole has a rapid anthelmintic effect. In the ganglion-like formations of nematodes, levamisole causes depolarizing neuromuscular paralysis. Thus, paralyzed nematodes are removed from the body due to normal intestinal peristalsis within 24 hours after taking the drug. Although levamisole primarily affects the neuromuscular system of nematodes, it is possible that in some helminths, inhibition of the fumarate reductase system also affects the anthelmintic efficacy of levamisole.
Pharmacokinetics.
A single dose of levamisole 50 mg is rapidly absorbed from the gastrointestinal tract. The maximum concentration of levamisole in the blood plasma of 0.13 μg/ml is observed on average 1.5-2 hours after administration of the drug. Levamisole is metabolized in the liver, its main metabolites are p-hydroxy-levamisole and its glucuronide derivative. The half-life is 3-6 hours. Levamisole is metabolized in the liver to many metabolites, which are excreted mainly by the kidneys (about 70% within 3 days) and to a lesser extent with feces (5%). Less than 5% of the administered dose is excreted unchanged in the urine, with feces - less than 0.2% of the administered dose. The main metabolite in the urine is p-hydroxylevamisole and its glucuronide conjugate (12% of the dose).
Indication
Ascariasis, necatoriasis, hookworm infection.
Contraindication
Hypersensitivity to levamisole or to any of the excipients included in the medicinal product.
Interaction with other medicinal products and other types of interactions
When taking Decaris simultaneously with alcoholic beverages, disulfiram-like symptoms are observed.
Use Dekaris with caution with drugs that affect hematopoiesis.
When taking Decaris simultaneously with coumarin-like anticoagulants, prothrombin time may increase, so it is necessary to adjust the dose of the oral anticoagulant.
Concomitant use of Decaris with albendazole significantly reduced the area under the curve (AUC) of albendazole sulfoxide. The safety and efficacy of levamisole have not been established when used concomitantly with albendazole.
Concomitant use of Decaris with ivermectin significantly increased the area under the curve (AUC) of ivermectin. The safety and efficacy of levamisole have not been established when used concomitantly with ivermectin.
Decaris increases the level of phenytoin in the blood, so when they are used simultaneously, it is necessary to monitor the level of phenytoin in the blood.
Application features
Alcoholic beverages are not allowed during and for 24 hours after taking the drug.
There is some evidence that repeated exposure to levamisole may be associated with allergic reactions, including hematological disorders such as leukopenia. Therefore, the recommended dose of the drug should not be exceeded. Caution is required when using Decaris in combination with drugs that may adversely affect hematopoiesis.
Leukocytoclastic vasculitis has been reported with the use of levamisole.
Stevens-Johnson syndrome. Cases of Stevens-Johnson syndrome have been reported in patients receiving the combination of 5-fluorouracil and levamisole, but a causal relationship has not been established. If symptoms of Stevens-Johnson syndrome appear, treatment with Decaris should be discontinued immediately. The best result in the treatment of Stevens-Johnson syndrome is achieved with early diagnosis.
Cirrhosis of the liver. In the presence of cirrhosis of the liver, Cmax of levamisole hydrochloride is slightly increased, but the area under the curve (AUC) increases 4-fold. Since the clinical significance of this interaction is uncertain, patients with cirrhosis of the liver should be carefully monitored for possible adverse reactions. If such reactions are observed, it may be necessary to reduce the dose or discontinue the drug.
Peripheral neuropathy: Cases of peripheral neuropathy have been reported with concomitant use of levamisole with 5-fluorouracil, but a causal relationship has not been established. If symptoms suggestive of peripheral neuropathy occur during use, the benefit/risk balance of continued treatment should be re-evaluated.
Excipients: Decaris 50 mg tablets contain yellow FCF (E 110), which may cause allergic reactions.
Dekaris 150 mg tablets contain lactose monohydrate and sucrose. Patients with rare hereditary problems of galactose intolerance, lactose intolerance, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use during pregnancy or breastfeeding
Pregnancy. No teratogenic effects were observed in animal studies. Well-controlled studies involving pregnant women have not been conducted, therefore, Decaris can be prescribed during pregnancy only if the expected benefit outweighs the possible risk of using the drug.
Breastfeeding. It is not known whether levamisole is excreted in human milk, but it has been detected in cow's milk. To prevent adverse effects on the infant, it is necessary to decide whether the drug should be administered to a nursing woman.
Fertility: Animal reproduction studies have shown no effects on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Levamisole has not been shown to affect the ability to drive or use machines, although encephalopathy has been reported as a very rare adverse reaction during treatment with levamisole.
Method of administration and doses
Adults are prescribed Decaris for the treatment of helminthiasis in a single dose of 150 mg (1 tablet).
Children are prescribed the drug in the form of tablets of 50 mg once (in the evening) in a dose of
2.5 mg/kg body weight:
| Child's age | Body weight | Drug dose, single dose |
| 3−6 years | 10−20 kg | 25–50 mg (1/2–1 tablet) |
| 7−10 years | 20−30 kg | 50-75 mg (1-1.5 tablets) |
| 11−18 years old | 30−60 kg | 75–100 mg (1.5–3 tablets) |
It is advisable to take the drug with a small amount of water after meals, in the evening.
There is no need to use laxatives or follow a special diet.
If necessary, treatment is repeated after a 7-14-day break.
Children. 150 mg tablets should not be given to children! 50 mg tablets should be used in children over 3 years of age as directed and under the supervision of a physician.
Overdose
The following signs of intoxication have been described after taking large doses of levamisole (over 600 mg): nausea, vomiting, lethargy, cramps, diarrhea, headache, dizziness, and confusion. Convulsions have been reported at doses higher than recommended.
Treatment: in case of accidental overdose, if a short time has passed after ingestion, gastric lavage should be performed. Vital signs should be monitored and symptomatic therapy should be administered.
If there are signs of anticholinesterase activity, atropine can be administered as an antidote.
Side effects
Cardiovascular system: palpitations1;
Blood and lymphatic system disorders: agranulocytosis2, leukopenia2;
mental disorders: insomnia1;
Central nervous system: convulsions1, dizziness1, encephalopathy3, headache1;
Gastrointestinal: abdominal pain1, diarrhea1, nausea1, vomiting1;
on the part of the immune system: possible hypersensitivity reactions, including skin rashes, itching and angioedema;
general disorders and local reactions: pyrexia4.
1In isolated cases, headache, insomnia, dizziness, palpitations, convulsions, dyspeptic phenomena such as nausea, vomiting, abdominal pain, diarrhea may occur. These effects are mild, short-lived and resolve on their own.
2Leucopenia and agranulocytosis may occur with high doses or prolonged therapy.
3Central nervous system reactions (encephalopathy) have been reported 2-5 weeks after drug administration. In most cases, these were reversible and improved with early corticosteroid treatment.
4Rare cases of pyrexia have been reported during post-marketing surveillance with levamisole treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions during post-marketing surveillance is very important. This allows monitoring of the benefit-risk balance of medicinal products. Healthcare professionals should report suspected adverse reactions.
Expiration date
5 years. Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep the drug out of the reach of children.
Packaging
Decaris, 50 mg, – 2 tablets in a blister; 1 blister in a cardboard box;
Decaris, 150 mg, – 1 tablet in a blister; 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Gedeon Richter Romania A.T.; JSC "Gedeon Richter".
Location of manufacturers and addresses of their place of business.
99-105 Cuza Vode Street, Târgu Mureș, Mureș County, 540306, Romania (full cycle of finished product production, packaging, batch control);
H-1103, Budapest, Demrei Str. 19-21, Hungary (series release, quality certificate issuance). Manufactured under license from JANSSEN PHARMACEUTICA, BELGIUM.
Applicant
JSC "Gedeon Richter".
Address
H-1103, Budapest, Demrei Street 19-21, Hungary.
