22 Nov 2011

VERMOX Suspension (Mebendazole) - United Kingdom

Updated: 22 Nov 2011

VERMOX Suspension

Broad spectrum gastrointestinal anthelmintic indicated for the treatment of: Enterobius vermicularis (threadworm/pinworm) Oxyuris vermicularis Trichuris trichuria (whipworm) Ascaris lumbricoides (large roundworm) Ancylostoma duodenale (common hookworm) Necator americanus (American hookworm) There is no evidence that Vermox Suspension is effective in the treatment of cysticercosis.

VERMOX Suspension Description, Presentation and Dosage

VERMOX Suspension Description

VERMOX Suspension Drug Class Description

Anthelmintics

VERMOX Suspension Drug Description

Each 5 ml of suspension contains mebendazole PhEur 100 mg.

VERMOX Suspension Generic Name

Mebendazole

VERMOX Suspension Presentation

VERMOX Suspension Presentation

White homogeneous oral suspension.

VERMOX Suspension Manufacturer

Janssen-Cilag

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VERMOX Suspension Dosage

VERMOX Suspension Adult Dosage

Method of administration.

Oral Use

Adults and children over 2 years:

Enterobiasis:

1 x 5 ml (1 dosing cup).

It is highly recommended that a second dose is taken after two weeks, if reinfection is suspected.

Ascariasis, trichuriasis, ancylostomiasis, necatoriasis and mixed infections:

1 x 5 ml (1 dosing cup) bd for three days.

VERMOX Suspension Child Dosage

Children over 2 years see Adult Dosage

VERMOX Suspension Precautions, Reactions and Contraindications

VERMOX Suspension Special Precautions

VERMOX Suspension Special Precautions

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.

VERMOX Suspension Adverse Reactions

VERMOX Suspension Adverse Reactions

Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Vermox based on the comprehensive assessment of the available adverse event information. A causal relationship with Vermox 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 Vermox 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 GREATER-THAN OR EQUAL TO (8805)1% of Vermox-treated subjects.

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

Very common (GREATER-THAN OR EQUAL TO (8805)1/10); Common (GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10); Uncommon (GREATER-THAN OR EQUAL TO (8805)1/1000 to <1/100); Rare (GREATER-THAN OR EQUAL TO (8805)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 Vermox

 

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(GREATER-THAN OR EQUAL TO (8805) 1/100 to < 1/10)

Uncommon

(GREATER-THAN OR EQUAL TO (8805) 1/1000 to < 1/100)

Rare

(GREATER-THAN OR EQUAL TO (8805)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

   

Hepatitis; b

Abnormal liver function testsb

Skin and subcutaneous tissue disorders

   

Rasha

Toxic epidermal necrolysisb;

Stevens-Johnson syndrome b;

Exanthema b;

Angioedema b;

Urticaria b;

Alopecia b

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.

VERMOX Suspension Contraindications

VERMOX Suspension Contraindications

Vermox is contra-indicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.

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