Farmoks

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHARMOX

Composition:

Active substance: albendazole;

10 mL of oral suspension contain 400 mg of albendazole;

Excipients: fructose; glycerin; polysorbate 60; sodium carboxymethylcellulose; sodium methylparahydroxybenzoate (E 219); sodium propylparahydroxybenzoate (E 217); sodium benzoate (E 211); citric acid monohydrate; plum flavor MA/1 142 (containing propylene glycol); purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical properties: white or almost white suspension with a characteristic aromatic odor and sweet taste. Stratification may occur during storage, which is eliminated by shaking.

Pharmacotherapeutic group.
Anthelmintic agents. Agents used in nematode infections. Benzimidazole derivatives. ATC code P02CA03.

Pharmacological properties.

Pharmacodynamics.

Albendazole is an antiprotozoal and anthelmintic agent from the benzimidazole carbamate 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, Cutaneous Larva Migrans;
Cestodes – Hymenolepis nana, Taenia solium, Taenia saginata;
Trematodes – Opisthorchis viverrini, Clonorchis sinensis;
Protozoa – Giardia lamblia (intestinalis or duodenalis).

Albendazole is also active 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.

In patients with hydatid echinococcosis, albendazole destroys cysts or significantly reduces their size (by up to 80%). After albendazole treatment, the proportion of non-viable cysts increases to 90%, compared to 10% in untreated patients. Following albendazole treatment for cysts caused by Echinococcus multilocularis, complete recovery was observed in a minority of patients, while most showed improvement or stabilization of disease.

Pharmacokinetics.

After oral administration, albendazole is poorly absorbed (less than 5%). Systemic exposure increases when the drug is taken with fatty food, which enhances absorption by up to fivefold. Albendazole undergoes rapid hepatic metabolism during first-pass effect. The main metabolite, albendazole sulfoxide, is the primary active compound responsible for efficacy in tissue infections. The elimination half-life is 8.5 hours. Albendazole sulfoxide and its metabolites are primarily excreted via bile, with only a small fraction eliminated in urine. It has been established that with prolonged high-dose treatment, elimination of the drug from cysts may persist for several weeks.

Elderly patients.

Although pharmacokinetic studies of albendazole in elderly patients have not been conducted, data from treatment of 26 patients up to 79 years of age suggest that pharmacokinetics in this age group are similar to those in young healthy volunteers.

Renal impairment.

The pharmacokinetics of albendazole in this patient group have not been studied.

Hepatic impairment.

The pharmacokinetics of albendazole in this patient group have not been studied.

Clinical characteristics.

Indications.

Intestinal forms of helminthiases and cutaneous syndrome Larva Migrans (short-term treatment with low doses): enterobiasis, ancylostomiasis and necatoriasis, hymenolepiasis, taeniasis, strongyloidiasis, ascariasis, trichocephalosis, clonorchiasis, opisthorchiasis, cutaneous syndrome Larva Migrans, 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 parasitic dissemination 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 or to any other component of the medicinal product.

Pregnancy or breastfeeding.

Women planning to become pregnant. Women of childbearing potential must use effective non-hormonal contraception during and for 1 month after treatment with the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Albendazole induces enzymes of the cytochrome P450 system.

Medicinal products that may slightly reduce the efficacy of albendazole: anticonvulsants (e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, primidone), levamisole, ritonavir. The effectiveness of treatment should be monitored, and alternative dosing regimens or therapies may be required.

Cimetidine, praziquantel, and dexamethasone increase plasma levels of the albendazole metabolite responsible for systemic activity, which in turn may lead to an increased risk of adverse reactions.

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 the following drugs: oral contraceptives, anticoagulants, oral hypoglycemic agents, theophylline.

Special precautions for use.

Treatment of intestinal forms of helminthiases and cutaneous syndrome Larva Migrans.

To prevent administration of Pharmox during early pregnancy, women of childbearing potential should be treated during the first week of the menstrual cycle 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 Taenia solium strains. Neurological symptoms such as seizures, increased intracranial pressure, and focal neurological signs may occur due to inflammatory reactions caused by parasite death in the brain. Symptoms may appear rapidly after treatment; therefore, prompt initiation of appropriate therapy with corticosteroids and anticonvulsants is recommended.

Treatment of systemic helminthic infections.

Albendazole treatment may be associated with mild to moderate elevation of liver enzymes, which usually normalizes after discontinuation of treatment. Cases of hepatitis have been reported. Therefore, liver enzyme levels should be assessed before 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 tests should be performed at the beginning of treatment and every 2 weeks during a 28-day 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 blood count reductions occur, treatment should be discontinued (see sections "Dosage and administration" and "Adverse reactions").

To prevent administration of Pharmox during early pregnancy, women of childbearing potential should:

• initiate treatment only after a negative pregnancy test;
• be advised to use effective contraceptive methods during treatment and for one month after discontinuation.

In patients with neurocysticercosis treated with albendazole, symptoms (e.g., seizures, increased intracranial pressure, focal signs) related to inflammatory reactions due to parasite death may occur. Such adverse reactions should be managed with corticosteroids and anticonvulsants. To prevent increased intracranial pressure during the first week of treatment, oral or intravenous corticosteroids are recommended.

Albendazole treatment may also reveal pre-existing neurocysticercosis, especially in areas with high prevalence of Taenia solium infection. Neurological symptoms such as seizures, increased intracranial pressure, and focal signs may occur rapidly after treatment due to inflammatory reactions from parasite death in the brain. Prompt initiation of appropriate therapy with corticosteroids and anticonvulsants is therefore necessary.

The medicinal product contains fructose. In patients with diagnosed intolerance to certain sugars, consultation with a physician is recommended before taking this medicinal product. May be harmful to teeth.

Pharmox contains sodium methylparahydroxybenzoate (E 219) and sodium propylparahydroxybenzoate (E 217), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated in women during pregnancy or breastfeeding, or in women planning to become pregnant.

Ability to affect reaction speed when driving or operating machinery.

Given the potential adverse reaction of dizziness, it is recommended to refrain from driving or operating machinery during treatment with albendazole.

Method of administration and dosage.

Intestinal forms and cutaneous syndrome Larva Migrans

The medication should be taken with food. Shake well before use. It is advisable to take it at the same time each day. If there is no recovery within 3 weeks, the physician should prescribe a second course 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 minimal amounts by the kidneys, dose adjustment is not required for this patient group. 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 altered liver function parameters (elevated transaminase levels) should be closely monitored at the start of albendazole therapy.

Systemic helminthic infections (prolonged high-dose treatment)

The drug should be taken with food.

For use in adults and children aged 6 years and older.

Administration of high doses of the drug is not recommended in children under 6 years of age.

The dosage regimen should be individually determined based on age, body weight, and the severity of infection.

The dose for patients with body weight over 60 kg is 400 mg (10 ml of suspension) twice daily. For patients with body weight below 60 kg, the dose should be 15 mg/kg/day, divided into two doses. Maximum daily dose – 800 mg.

* When treating patients with neurocysticercosis, appropriate corticosteroid and anticonvulsant therapy should be administered. Oral and intravenous corticosteroids are recommended to prevent episodes of cerebral hypertension during the first week of treatment.

**Usually, a single course of treatment is required, but additional courses may be necessary if the results of parasitological examination remain positive.

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 by the kidneys only to a very small extent, dose adjustment is not required for treating this patient group. However, patients with signs of renal impairment should be closely monitored.

Hepatic impairment

Since albendazole is extensively metabolized in the liver to its pharmacologically active metabolite, impaired liver function may have a significant effect on its pharmacokinetics. Therefore, patients with abnormal liver function tests (elevated transaminase levels) should be carefully evaluated before initiating albendazole therapy. Treatment should be discontinued in case of significant elevation of transaminase levels or clinically significant reduction in blood parameters (see sections "Special precautions" and "Adverse reactions").

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

In case of overdose, treatment is symptomatic and based on the clinical condition.

Adverse Reactions.

Adverse effects occurring during short-term treatment of intestinal infections and cutaneous Larva Migrans syndrome.

Immune system disorders: hypersensitivity reactions, including rash, pruritus, and urticaria.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, and diarrhea.

Hepatobiliary disorders: elevated liver enzymes.

Skin disorders: polymorphic erythema, Stevens-Johnson syndrome.

Adverse effects occurring during long-term treatment of systemic helminthic infections.

Blood and lymphatic system disorders: leukopenia, pancytopenia, aplastic anemia, agranulocytosis.

Patients with liver disease, including hepatic echinococcosis, are more susceptible to bone marrow suppression (see sections "Dosage and Administration" and "Special Warnings and Precautions for Use").

Immune system disorders: hypersensitivity reactions, including rash, pruritus, and urticaria.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: abdominal pain, nausea, vomiting, and diarrhea. These events are associated with albendazole treatment in patients with echinococcosis.

Hepatobiliary disorders: mild to moderate elevation of liver enzymes, hepatitis.

Skin disorders: reversible alopecia (thinning and mild hair loss), polymorphic erythema, Stevens-Johnson syndrome.

General disorders: fever.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging.

10 mL in a vial, 1 vial per carton.

Prescription category. Prescription only.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4 Korolyova St., Stanishivka, Zhytomyr District, Zhytomyr Oblast, 12430, Ukraine.