Azinox (Tablets) Instructions for Use

Marketing Authorization Holder

Ecochimtech, LLC (Russia)

ATC Code

P02BA01 (Praziquantel)

Active Substance

Praziquantel (Rec.INN registered by WHO)

Dosage Form

Azinox

Tablets 300 mg: 10, 12, 20, 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
12 pcs. – polymer jars (1) – cardboard packs.
12 pcs. – dark glass jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

Anthelmintic drug

Pharmacotherapeutic Group

Anthelmintic agent

Pharmacological Action

Anthelmintic agent, a derivative of pyrazinoisoquinoline. It has a broad spectrum of activity, which includes many trematodes and cestodes.

Praziquantel is highly active against all human pathogenic agents of schistosomiasis, clonorchiasis, paragonimiasis, opisthorchiasis, as well as against Fasciolopsis buski, Heterophyes heterophyes and Metagonimus yokogawai (intestinal flukes).

Among trematodes, Fasciola hepatica is resistant to praziquantel; the mechanism of resistance is not clear.

Praziquantel is highly effective against agents of intestinal cestodiasis: hymenolepiasis (Hymenolepis nana), diphyllobothriasis (Diphyllobothrium latum), taeniarhynchosis (Taeniarhynchus saginatus), taeniasis (Taenia solium), and also acts on cysticerci.

Praziquantel is characterized by two main effects on sensitive helminths.

In low doses, it causes an increase in muscle activity, followed by contraction of the musculature and spastic paralysis.

In slightly higher doses, it causes damage to the tegument (the outer covering of flatworms).

The mechanism of action is not fully understood.

It is believed that the effect of praziquantel is due to its ability to increase membrane permeability to calcium ions (and some other mono- and divalent cations).

Pharmacokinetics

Rapidly and completely absorbed from the gastrointestinal tract.

C_max is reached in 1-3 hours.

Plasma protein binding is 80%.

Metabolized in the liver to form inactive mono- and polyhydroxylated metabolites.

T_1/2 is 0.8-1.5 hours for praziquantel and 4-6 hours for its metabolites.

It is mainly excreted by the kidneys (80% within 4 days), predominantly as metabolites: 90% is excreted within 24 hours.

A small amount is excreted in the feces.

It passes into breast milk in small amounts.

In case of renal impairment, excretion is slowed; in case of liver damage, the intensity of metabolism decreases, which is accompanied by a longer presence of unchanged praziquantel in the body, creating high concentrations.

Indications

Schistosomiasis, including intestinal schistosomiasis and genitourinary schistosomiasis; opisthorchiasis, clonorchiasis, paragonimiasis, metagonimiasis, fasciolopsiasis and other trematodoses caused by sensitive helminths. Intestinal cestodiasis: hymenolepiasis, diphyllobothriasis, taeniarhynchosis, taeniasis. Neurocysticercosis.

ICD codes

Dosage Regimen

Administer a single dose of 10-50 mg/kg. Determine the exact dosage and regimen based on the specific pathogen and patient weight.

For schistosomiasis, use 40 mg/kg as a single dose or 20 mg/kg twice daily for one day. For clonorchiasis, opisthorchiasis, and other liver fluke infections, administer 25 mg/kg three times daily for one or two days.

For intestinal cestodiasis (taeniasis, diphyllobothriasis), use 10-25 mg/kg as a single dose. For hymenolepiasis, administer 25 mg/kg, repeated after 7-10 days.

For neurocysticercosis, use 50 mg/kg per day in three divided doses for 14 days; concomitant corticosteroid therapy is often required.

Take tablets during or immediately after a meal with water. Do not chew the tablets. Swallow them whole to avoid the bitter taste.

For patients requiring multiple doses, space doses 4-6 hours apart. Adjust the regimen in patients with hepatic impairment; avoid use in severe impairment.

Re-evaluate the patient post-treatment to confirm parasite eradication. Repeat the course if necessary based on follow-up examinations.

Adverse Reactions

From the central nervous system and peripheral nervous system headache, dizziness, drowsiness, myalgia; when treating neurocysticercosis, meningism, thinking disorders, increased intracranial pressure, hyperthermia are possible.

From the digestive system abdominal pain, nausea, vomiting; rarely – transient increase in liver transaminase levels.

Allergic reactions rarely – fever, skin rashes.

Contraindications

Hypersensitivity to praziquantel, ocular cysticercosis, first trimester of pregnancy, lactation, children under 4 years of age, hepatic insufficiency, hepatic cysticercosis.

Use in Pregnancy and Lactation

Praziquantel is contraindicated for use in the first trimester of pregnancy and during lactation (breastfeeding).

In the second and third trimesters of pregnancy, Praziquantel is used only for strict indications.

If it is necessary to use during lactation, it is recommended to interrupt breastfeeding on the day of praziquantel intake and for the next 72 hours.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency, hepatic cysticercosis.

Pediatric Use

Contraindicated in children under 4 years of age.

Special Precautions

Praziquantel is not used for ocular cysticercosis due to the danger of developing eye tissue lesions during the death of cysticerci.

Effect on ability to drive vehicles and mechanisms

During the intake of praziquantel and for the following 24 hours, it is necessary to refrain from driving vehicles and other potentially hazardous activities.

Drug Interactions

Dexamethasone reduces the plasma concentration of praziquantel.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.