Components:
Mebendazole
Method of action:
Anthelmintic
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy Last updated on 2019.06.26

Name of the medicinal product

Gavox

Qualitative and quantitative composition

Mebendazole

Therapeutic indications

The information provided in Therapeutic indications of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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For the treatment of Trichuris trichuria (whipworm), Enterobius vermicularis (pinworm or threadworm), Ascaris lumbricoides (roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed gastrointestinal infestations.

There is no evidence that Gavox Tablets are effective in the treatment of cysticercosis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Adults and children over 2 years:

For the control of trichuriasis, ascariasis and hookworm infections, one tablet twice a day for three consecutive days.

For the control of enterobiasis a single tablet is administered. It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected.

Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.

Method of Administration

Oral use.

Contraindications

The information provided in Contraindications of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Gavox is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Not recommended in the treatment of children under 2 years.

A case-control study of a single outbreak of Stevens-Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Gavox has no influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Gavox based on the comprehensive assessment of the available adverse event information. A causal relationship with Gavox cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Gavox was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in >1% of Gavox-treated subjects.

ADRs identified from clinical trials and post-marketing experience with Gavox are included in Table 1. The displayed frequency categories use the following convention:

Very common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1000 to <1/100); Rare (>1/10,000 to <1/1000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1: Adverse Drug Reactions Reported in Clinical Trials and Post-marketing Experience for Gavox

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(> 1/100 to < 1/10)

Uncommon

(> 1/1000 to < 1/100)

Rare

(>1/10,000 to <1/1000)

Blood and lymphatic system disorders

Neutropeniab

Immune system disorders

Hypersensitivity including anaphylactic reaction and anaphylactoid reactionb

Nervous system disorders

Convulsionsb

Dizzinessa

Gastrointestinal disorders

Abdominal paina

Abdominal discomforta;

Diarrhoeaa;

Flatulencea

Hepatobiliary disorders

Hepatitisb;

Abnormal liver function testsb

Skin and subcutaneous tissue disorders

Rasha

Toxic epidermal necrolysisb;

Stevens-Johnson syndromeb;

Exanthemab;

Angioedemab;

Urticariab;

Alopeciab

a ADR frequency data derived from Clinical Trials or Epidemiological Studies

b ADRs not observed in clinical trials and frequency calculated using “Rule of 3”, as detailed in SmPC guideline 2009. 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092). Note: frequencies differ from those reported in the August 2009 CCDS, as these were not calculated using the formula detailed in the SmPC guideline 2009.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages.

Signs and symptoms

In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment

There is no specific antidote. Activated charcoal may be given if considered appropriate.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: anthelmintic for oral administration, benzimidazole derivatives; ATC code: P02CA01.

In vitro and in vivo work suggests that mebendazole blocks the uptake of glucose by adult and larval forms of helminths, in a selective and irreversible manner. Inhibition of glucose uptake appears to lead to endogenous depletion of glycogen stores within the helminth. Lack of glycogen leads to decreased formation of ATP and ultrastructural changes in the cells.

There is no evidence that Gavox is effective in the treatment of cysticercosis.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Absorption

Following oral administration, < 10% of the dose reaches the systemic circulation, due to incomplete absorption and to extensive pre-systemic metabolism (first-pass effect). Maximum plasma concentrations are generally seen 2 to 4 hours after administration. Dosing with a high fat meal leads to a modest increase in the bioavailability of mebendazole.

Distribution

The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that mebendazole penetrates areas outside the vascular space. This is supported by data in patients on chronic mebendazole therapy (e.g., 40 mg/kg/day for 3-21 months) that show drug levels in tissue.

Metabolism

Orally administered mebendazole is extensively metabolised primarily by the liver. Plasma concentrations of its major metabolites (amino and hydroxylated amino forms of mebendazole) are substantially higher than those of mebendazole. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.

Elimination

Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation and are excreted in the urine and bile. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients.

Steady-state pharmacokinetics

During chronic dosing (e.g., 40 mg/kg/day for 3-21 months), plasma concentrations of mebendazole and its major metabolites increase, resulting in approximately 3-fold higher exposure at steady-state compared to single dosing.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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anthelmintic for oral administration, benzimidazole derivatives; ATC code: P02CA01.

Preclinical safety data

The information provided in Preclinical safety data of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Incompatibilities

The information provided in Incompatibilities of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Gavox is based on data of another medicine with exactly the same composition as the Gavox of the medicine (Mebendazole). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Gavox directly from the package or from the pharmacist at the pharmacy.
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No special requirements.