Vormil
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VORMIL (VORMIL)
Composition:
Active substance: albendazole;
5 ml of suspension contain 200 mg of albendazole;
Excipients: sodium benzoate (E 211), xanthan gum, sucrose, sodium methylparaben (E 219), sodium propylparaben (E 217), glycerin, polysorbate 80, disodium edetate, erythrosine dye (E 127), aspartame (E 951), citric acid monohydrate, flavor "Raspberry flavor", flavor "Fruit flavor", purified water.
Pharmaceutical form. Oral suspension.
Main physicochemical properties: pink-colored suspension in glass bottles.
Pharmacotherapeutic group. Anthelmintics. Agents used in nematode infections. Benzimidazole derivatives. ATC code P02CA03.
Pharmacological properties.
Pharmacodynamics.
Albendazole is a broad-spectrum anthelmintic and antiprotozoal agent belonging to the carbamate benzimidazole group. The drug is active against both intestinal and tissue parasites in the form of eggs, larvae, and adult helminths. The anthelmintic effect of albendazole is due to inhibition of tubulin polymerization, leading to disruption of parasite metabolism and subsequent death.
Albendazole is active against the following intestinal parasites:
Nematodes – Ascaris lumbricoides, Trichuris trichiura, Enterobius vermicularis, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Cutaneus Larva Migrans;
Cestodes – Hymenolepsis nana, Taenia solium, Taenia saginata;
Trematodes – Opisthorchis viverrini, Clonorchis sinensis;
Protozoa – Giardia lamblia (intestinalis or duodenalis).
Albendazole is also effective against tissue parasites, including cystic and alveolar echinococcosis caused by Echinococcus granulosus and Echinococcus multilocularis, respectively. Albendazole is an effective treatment for neurocysticercosis caused by larval invasion of Taenia solium, capillariasis caused by Capillaria philippinensis, and gnathostomiasis caused by Gnathostoma spinigerum.
Albendazole destroys cysts or significantly reduces their size (by up to 80%) in patients with cystic echinococcosis. After treatment with albendazole, the number of non-viable cysts increases to 90%, compared to 10% in untreated patients. In patients with Echinococcus multilocularis-induced cysts, complete recovery after albendazole treatment occurs in a minority of cases, while most patients experience improvement or stabilization of their condition.
Pharmacokinetics.
After oral administration, the drug is poorly absorbed (up to 5%) from the gastrointestinal tract. Concomitant intake with fatty food increases absorption approximately fivefold.
Albendazole is rapidly metabolized in the liver during the first pass. The main metabolite, albendazole sulfoxide, retains about half of the pharmacological activity of the parent compound.
The elimination half-life of albendazole sulfoxide in plasma is approximately 8.5 hours. Albendazole sulfoxide and other metabolites are excreted predominantly in bile, with only a small fraction eliminated in urine. After prolonged administration of high doses, elimination of the drug from cysts may continue for several weeks.
Clinical characteristics.
Indications.
Intestinal forms of helminthiases and cutaneous Larva Migrans syndrome (short-term treatment with low doses): enterobiasis, ancylostomiasis and necatoriasis, hymenolepiasis, teniasis, strongyloidiasis, ascariasis, trichocephalosis, clonorchiasis, opisthorchiasis, cutaneous Larva Migrans syndrome, giardiasis in children.
Systemic helminthic infections (long-term treatment with high doses):
cystic echinococcosis (caused by Echinococcus granulosus):
- when surgical intervention is not possible;
- prior to surgery;
- after surgery, if preoperative treatment was short, if widespread helminth infestation is observed, or if live forms were found during surgery;
- after percutaneous drainage of cysts for diagnostic or therapeutic purposes;
alveolar echinococcosis (caused by Echinococcus multilocularis):
- in inoperable cases, particularly with local or distant metastases;
- after palliative surgical intervention;
- after radical surgical intervention or liver transplantation;
neurocysticercosis (caused by larvae of Taenia solium):
- in the presence of single or multiple cysts or granulomatous brain lesions;
- in arachnoid or intraventricular cysts;
- in racemose cysts;
capillariasis (caused by Capillaria philippinensis), gnathostomiasis (caused by Gnathostoma spinigerum and related species), trichinellosis (caused by Trichinella spiralis and T. pseudospiralis), toxocariasis (caused by Toxocara canis and related species).
Contraindications.
Hypersensitivity to albendazole, other benzimidazole derivatives, or any other component of the drug. Retinal disease. Women planning pregnancy. Women of reproductive age should use effective non-hormonal contraceptive methods during treatment and for 1 month after completion of therapy.
Interaction with other medicinal products and other types of interactions.
Albendazole induces enzymes of the cytochrome P450 system.
Concomitant use with cimetidine, praziquantel, and dexamethasone may increase plasma levels of albendazole metabolites responsible for systemic activity, which in turn may lead to drug overdose.
Medicinal products that may slightly reduce albendazole efficacy: anticonvulsants (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levamisole, ritonavir.
Treatment efficacy should be monitored in patients; alternative dosing regimens or therapies may be required.
Grapefruit juice also increases plasma levels of albendazole sulfoxide.
Due to the potential effect on cytochrome P450 activity, there is a theoretical risk of interaction with oral contraceptives, anticoagulants, oral hypoglycemic agents, and theophylline.
When albendazole is used concomitantly with theophylline, serum theophylline levels should be monitored.
Systemic exposure increases when the drug is taken with food.
Special precautions for use.
Treatment of intestinal infections and cutaneous larva migrans (short-term therapy).
To prevent administration of Vermox during early pregnancy, women of childbearing age should be treated only during the first week after menstruation or after a negative pregnancy test. Reliable contraception is required during treatment.
Albendazole treatment may unmask pre-existing neurocysticercosis, particularly in areas with high prevalence of Tenia solium infection. Patients may develop neurological symptoms such as seizures, increased intracranial pressure, and focal neurological signs due to inflammatory reactions caused by the death of parasites in the brain. These symptoms may appear rapidly after treatment initiation; therefore, prompt therapy with corticosteroids and anticonvulsants should be started immediately.
Long-term treatment of systemic helminthic infections.
Albendazole treatment may be associated with mild to moderate elevations in liver enzymes, which usually return to normal after discontinuation of therapy. Cases of hepatitis have been reported. Therefore, liver enzyme levels should be assessed before starting each treatment course and at least every 2 weeks during treatment. If liver enzyme levels increase significantly (more than twice the upper limit of normal), albendazole treatment should be discontinued. Treatment may be resumed after normalization of enzyme levels, but the patient must be closely monitored.
Albendazole may cause bone marrow suppression; therefore, blood counts should be performed at the beginning of treatment and every 2 weeks during the 28-day treatment cycle. Patients with liver disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression, which may result in pancytopenia, aplastic anemia, agranulocytosis, and leukemia, necessitating careful monitoring of blood parameters. If significant hematological abnormalities occur, treatment should be discontinued (see sections "Dosage and administration" and "Side effects").
This medication may be used for mandatory deworming (i.e., prophylaxis) prior to vaccination, as well as for prophylactic treatment twice a year.
In patients with neurocysticercosis treated with albendazole, symptoms (e.g., seizures, increased intracranial pressure, focal neurological signs) related to inflammatory reactions caused by parasite death may occur. These should be managed with corticosteroids and anticonvulsant therapy. To prevent episodes of increased cerebral pressure during the first week of treatment, oral or intravenous corticosteroids are recommended.
To avoid administration of Vermox during early pregnancy in women of childbearing potential, the following measures should be taken:
- initiate treatment only after a negative pregnancy test;
- advise the use of effective contraceptive methods during treatment and for one month after discontinuation of the drug.
It should be noted that the formulation contains sucrose; therefore, patients with known sugar intolerances should consult their physician before taking this medicinal product.
The presence of sodium propylparaben and sodium methylparaben in the formulation may cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding. The drug is contraindicated during pregnancy or breastfeeding and in women planning to become pregnant. Breastfeeding must be discontinued during treatment.
Ability to affect reaction speed when driving or operating machinery.
Given the potential side effect of dizziness, it is recommended to avoid driving vehicles or operating machinery during treatment with albendazole.
Method of Administration and Dosage
The dose is determined individually by a physician.
Children aged 1 to 2 years
For enterobiasis, ancylostomiasis, necatoriasis, ascariasis, trichinellosis: administer 5 mL of suspension (200 mg) once daily as a single dose.
Adults and children aged 2 years and older
For enterobiasis, ancylostomiasis, necatoriasis, ascariasis, trichinellosis: administer 10 mL of suspension (400 mg) once daily as a single dose.
For confirmed diagnosis of strongyloidiasis, teniasis, and hymenolepiasis: administer 10 mL of suspension (400 mg) once daily for 3 consecutive days in adults and children aged 2 years and older. For hymenolepiasis, a repeat course of treatment is recommended from the 10th to the 21st day after completion of the previous course.
For opisthorchiasis and clonorchiasis: administer 10 mL of suspension (400 mg) twice daily for 3 days in adults and children aged 2 years and older. This regimen is also effective in mixed infestations with Opisthorchis viverrini and Clonorchis sinensis.
For giardiasis: administer 10 mL of suspension (400 mg) once daily for 5 days in children aged 2 to 12 years.
For cutaneous larva migrans: administer 10 mL of suspension once daily for 1–3 days in adults and children aged 2 years and older.
Systemic helminthic infections (prolonged high-dose treatment)
The medication should be taken with food. Shake well before use.
High-dose administration is not recommended for children under 6 years of age. The dosage regimen should be determined individually based on age, body weight, and severity of infection.
For patients with body weight over 60 kg: 400 mg (10 mL of suspension) twice daily.
For patients with body weight less than 60 kg: administer at a dose of 15 mg/kg/day, divided into two doses.
Maximum daily dose – 800 mg.
| Infection |
Duration of treatment |
| Cystic echinococcosis |
28 days. The 28-day cycle may be repeated (up to 3 times in total) after a 14-day break. |
| Inoperable and multiple cysts |
Up to 3 cycles of 28 days for treatment of liver, lung, and peritoneal cysts. For cysts at other sites (in bones or brain), longer treatment may be required. |
| Preoperative |
Two 28-day cycles are recommended before surgery; if surgery must be performed before completing these cycles, treatment should be continued as long as possible prior to surgery. |
| Postoperative After percutaneous drainage of cysts |
If a short course of treatment (less than 14 days) was administered before surgery or if emergency surgery was performed, two 28-day treatment cycles should be administered after surgery, separated by a 14-day drug-free interval. Similarly, if viable cysts are found or if helminth dissemination has occurred, two full treatment cycles should be administered. |
| Alveolar echinococcosis |
28 days. A second 28-day course should be repeated after a two-week drug-free interval. Treatment may be prolonged for several months or years. |
| Neurocysticercosis* |
Treatment duration ranges from 7 to 30 days, depending on response to therapy. A second course may be repeated after a two-week drug-free interval. |
| Cysts in parenchyma and granulomas |
Usual treatment duration is from 7 days (minimum) to 28 days. |
| Arachnoid and intraventricular cysts |
The usual treatment course is 28 days. |
| Racemose cysts |
The usual treatment course is 28 days and may last longer. Duration of treatment is determined by clinical and radiological response. |
| Capillariasis |
400 mg once daily for 10 days; Usually one course is sufficient, but additional courses may be needed if parasitological tests remain positive. |
| Gnathostomiasis |
400 mg once daily for 10–20 days (see above). |
| Trichinellosis, toxocariasis |
400 mg twice daily for 5–10 days (see above). |
** In the treatment of patients with neurocysticercosis, appropriate corticosteroid and anticonvulsant therapy should be prescribed. Oral and intravenous corticosteroids are recommended to prevent episodes of cerebral hypertension during the first week of treatment.
Elderly patients
Experience with the use of the drug in elderly patients is limited. Dose adjustment is not required; however, albendazole should be used with caution in elderly patients with impaired liver function.
Renal impairment
Since albendazole is excreted in very small amounts by the kidneys, dose adjustment in this patient group is not necessary. However, patients with signs of renal impairment should be closely monitored.
Hepatic impairment
Since albendazole is actively metabolized in the liver to its pharmacologically active metabolite, impaired liver function may significantly affect its pharmacokinetics. Therefore, patients with abnormal liver function tests (elevated transaminase levels) should be carefully evaluated before initiating albendazole treatment. Treatment should be discontinued if significant increases in transaminase levels or clinically significant reductions in blood parameters occur.
Children. The drug is contraindicated for use in children under 1 year of age.
Administer to children according to the information specified in the section "Dosage and Administration".
Overdose.
Symptoms: nausea, vomiting, diarrhea, tachycardia, drowsiness, visual disturbances, visual hallucinations, speech impairment, dizziness, loss of consciousness, hepatomegaly, elevated transaminase levels, jaundice; respiratory distress, brown-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces proportional to the administered dose of the drug.
Treatment: perform gastric lavage and administer symptomatic and supportive therapy.
Adverse Reactions.
Gastrointestinal and hepatic disorders: stomatitis, dry mouth, heartburn, nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation, transient increase in liver enzyme activity, jaundice, hepatitis, hepatocellular disorders.
Cardiovascular system disorders: increased blood pressure, tachycardia.
Central and peripheral nervous system disorders: insomnia or somnolence, headache, dizziness, confusion, disorientation, hallucinations, seizures, decreased visual acuity.
Blood and lymphatic system disorders: leukopenia; neutropenia; thrombocytopenia; anemia, including aplastic anemia; agranulocytosis; pancytopenia. Patients with liver disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression.
Skin and subcutaneous tissue disorders: skin rashes, erythema, polymorphic erythema, Stevens-Johnson syndrome, reversible alopecia, dermatitis, edema.
Renal and urinary system disorders: renal function impairment, acute renal failure, proteinuria.
Allergic reactions: hypersensitivity reactions, including rash; itching; urticaria; bullous eruption; dermatitis; fever.
General disorders: bone and throat pain; chills; weakness.
Patients with liver diseases, including hepatic echinococcosis, are more susceptible to bone marrow suppression.
Shelf life. 3 years.
Storage conditions.
Store at a temperature not exceeding 25 °C in the original packaging, in a place inaccessible to children.
Packaging.
10 ml of the preparation in a vial. 1 vial in a cardboard box together with the instruction for medical use.
Prescription category. Prescription only.
Manufacturer.
Gracure Pharmaceuticals Ltd.
Manufacturer's address and place of business.
E-1105, Industrial Area, Sector III, Bhivadi, Alwar District, Rajasthan, 301019, India.
Marketing Authorization Holder. Milley Healthcare Limited.
Address of the Marketing Authorization Holder. 2nd floor, office premises, 4 Charterfield House, Castle Street, Taunton, Somerset, England, TA1 4AS, United Kingdom.