Decaris (Tablets) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Manufactured By

Gedeon Richter Romania, S.A. (Romania)

Contact Information

GEDEON RICHTER Plc. (Hungary)

ATC Code

P02CE01 (Levamisole)

Active Substance

Levamisole (Rec.INN registered by WHO)

Dosage Forms

	Decaris	Tablets 50 mg: 2 pcs.
		Tablets 150 mg: 1 pc.

Dosage Form, Packaging, and Composition

Tablets light orange in color (inclusions of a darker color are possible) with a faint apricot odor, round, flat, with a bevel and with quartering scores on one side.

Excipients: corn starch, sodium saccharin, povidone K90, talc, apricot flavor, magnesium stearate, dye sunset yellow (E110).

2 pcs. – blisters (1) – cardboard packs.

Tablets almost white in color, round, flat, with a bevel and with the engraving “DECARIS 150” on one side.

Excipients: corn starch, lactose monohydrate, sucrose, talc, povidone K90, magnesium stearate.

1 pc. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Anthelmintic drug

Pharmacotherapeutic Group

Anthelmintic agents; agents for the treatment of nematode infections; imidazothiazole derivatives

Pharmacological Action

The active substance of Decaris – Levamisole is a fast-acting anthelmintic agent. By acting on the ganglion-like formations of nematodes, Levamisole paralyzes the musculature of the helminths within seconds of contact. Thus, the paralyzed nematodes are removed from the body by normal intestinal peristalsis, usually within 24 hours after taking the drug. Although it has been established that Levamisole affects the neuromuscular system of nematodes, it is also possible that in some helminths, the inhibition of the enzyme fumarate reductase also contributes to the anthelmintic effect of levamisole.

Pharmacokinetics

Absorption

Levamisole, when taken orally at a dose of 50 mg, is rapidly absorbed from the gastrointestinal tract.

Distribution

C_max in blood plasma is 0.13 µg/ml and is determined 1.5-2 hours after taking the drug.

Metabolism

Levamisole undergoes intensive metabolism in the liver, forming numerous metabolites. The main metabolite found in urine is p-hydroxylevamisole and its glucuronide conjugate (12% of the dose).

Elimination

T_1/2 from the body is 3-6 hours. Levamisole metabolites are excreted mainly by the kidneys (approximately 70% within 3 days) and to a lesser extent through the intestine (5%). Less than 5% of the levamisole dose is excreted unchanged in the urine and less than 0.2% is excreted in the feces.

Indications

• Diseases caused by the following types of gastrointestinal helminths: Ascaris lumbricoides, Necator americanus and Ancylostoma duodenale.

ICD codes

Dosage Regimen

Orally. The drug is advisable to take after a light snack with a small amount of water, in the evening. The use of laxatives or a special diet is not necessary.

Adults are prescribed one 150 mg tablet as a single dose.

Children over 3 years old are prescribed Decaris, 50 mg tablets, with the dose calculation depending on body weight.

If necessary, the course of treatment can be repeated after 7-14 days.

Decaris, 50 mg tablets, are not intended for use in children under 3 years of age.

Decaris, 150 mg tablets, are not intended for use in children under 18 years of age.

Adverse Reactions

The safety of levamisole was evaluated in 6799 patients who participated in 13 clinical studies of levamisole used as a treatment for parasitic diseases caused by the helminths Ancylostoma duodenale, Ascaris lumbricoides and Necator americanus.

Of the 13 clinical studies:

• 6 studies involved taking levamisole only;
• 4 studies were placebo- and active-controlled (pyrantel pamoate, piperazine, thiabendazole and mebendazole);
• 2 studies were active-controlled (piperazine);
• 1 study was placebo-controlled.

Adverse reactions (ARs) observed during the 13 clinical studies in patients who took at least one dose of levamisole and provided safety data are presented in Table 1.

The frequency of ARs is defined as follows: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000, including isolated reports); frequency unknown (cannot be estimated from the available data).

Table 1. Adverse reactions observed in patients taking Levamisole during 13 clinical studies of levamisole

Adverse reactions identified for the first time during the post-registration use of levamisole are presented in Table 2.

Table 2. Adverse reactions identified during the post-registration use of levamisole

Decaris, 50 mg tablets, contains the dye sunset yellow, E110. The dye may cause allergic reactions.

Contraindications

• Hypersensitivity to the active substance or any of the components of the drug;
• Drug-induced agranulocytosis (in history).

Decaris, 150 mg tablets

• Childhood (for 150 mg tablets);
• Lactose intolerance, fructose intolerance, lactase deficiency, sucrase/isomaltase deficiency, glucose-galactose malabsorption syndrome (contains lactose monohydrate and sucrose).

With caution

In case of bone marrow hematopoiesis suppression. Concomitant use of Decaris and drugs that may negatively affect hematopoiesis requires caution.

Concomitant use with coumarin derivatives is not recommended; with alcoholic beverages.

Use in Pregnancy and Lactation

Pregnancy

The use of levamisole did not lead to the development of teratogenic effects in animals, however, Levamisole has an embryotoxic effect if the mother receives Levamisole in toxic doses. Adequately planned controlled studies of the use of levamisole in pregnant women have not been conducted, therefore, during pregnancy, the drug is recommended to be taken only if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

There are no data on whether Levamisole is excreted in human breast milk. However, it is known that Levamisole is excreted in cow’s milk. Due to possible adverse reactions in breastfed newborns, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Decaris, 50 mg tablets, are not intended for use in children under 3 years of age.

Decaris, 150 mg tablets, are not intended for use in children under 18 years of age.

Special Precautions

Hematological disorders

There is evidence that repeated use of levamisole can cause allergic reactions and hematological disorders, such as leukopenia. Therefore, the recommended dose should not be exceeded. Concomitant use of Decaris and drugs that may negatively affect hematopoiesis requires caution.

Off-label use

There are reports of cases of leukopenia, neutropenia/agranulocytosis associated with the use of high doses of levamisole, as well as with its use for a prolonged period of time. A case of necrotizing vasculitis with off-label use of levamisole has also been noted.

Alcohol

Alcoholic beverages should not be consumed during and for 24 hours after taking the drug.

Excipients

Decaris, 50 mg tablets, contains the dye sunset yellow, E110. The dye may cause allergic reactions.

Decaris, 150 mg tablets, contains lactose (as lactose monohydrate) and sucrose. Patients with rare hereditary diseases such as lactose intolerance, fructose intolerance, lactase deficiency, sucrase/isomaltase deficiency, glucose-galactose malabsorption syndrome should not take this drug.

Effect on ability to drive vehicles and operate machinery

Since transient, mild dizziness may occur when taking the drug, caution should be exercised when driving vehicles or operating machinery during the entire course of treatment.

Overdose

Symptoms when taking a large dose of levamisole (over 600 mg) the following signs of intoxication were described: nausea, vomiting, drowsiness, muscle cramps, diarrhea, headache, dizziness and confusion.

Cases of convulsions, leukopenia, neutropenia/agranulocytosis have been reported.

Treatment: monitoring of vital body functions and symptomatic therapy are necessary. If signs of anticholinesterase action are present, atropine can be administered.

Drug Interactions

Alcohol

Disulfiram-like reactions were observed with the simultaneous use of the drug with alcoholic beverages. It is not recommended to take Decaris simultaneously with alcoholic beverages.

Drugs affecting hematopoiesis

Caution is required when using Decaris with drugs that affect hematopoiesis.

Anticoagulants

Levamisole may enhance the effect of coumarin derivatives. The dose of anticoagulants must be carefully titrated and their effect monitored.

Phenytoin

Decaris increases the concentration of phenytoin in the blood, so when used concomitantly, the concentration of phenytoin in the blood should be monitored.

Other anthelmintic drugs

The AUC of albendazole sulfoxide is significantly decreased with the simultaneous use of Decaris and albendazole. The safety and efficacy of the simultaneous use of Decaris and albendazole have not been established.

The AUC of ivermectin is significantly increased with the simultaneous use of Decaris and ivermectin. The safety and efficacy of the simultaneous use of Decaris and ivermectin have not been established.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 5 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.