AnthelminticPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Vermox
MEBENDAZOLE
1 INDICATIONS AND USAGE VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:VERMOX
Quick Reference
Medicine ClassAnthelmintic
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- MEBENDAZOLE
- Medicine class
- Anthelmintic
- Brand names
- VERMOX
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life after an oral dose ranges from 3 to 6 hours in most patients
- FDA approved
- Yes
What Is Vermox?
1 INDICATIONS AND USAGE VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
Vermox (MEBENDAZOLE) belongs to the Anthelmintic class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Vermox. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Vermox with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Vermox is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).
VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose. Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole. For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water. Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed. VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake [see Clinical Pharmacology (12.3) ]. The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing ( 2 ). See Full Prescribing Information for administration instructions for patients who have difficulty chewing the tablets ( 2 )
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash.
- To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc.
- at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Studies 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 practice.
- The safety of mebendazole was evaluated in 6276 adult and pediatric subjects one year of age and older who participated in 39 clinical trials for treatment of single or mixed parasitic infections of the gastrointestinal tract.
- In these trials, the formulations, dosages and duration of mebendazole treatment varied.
- Adverse reactions reported in mebendazole-treated subjects from the 39 clinical trials are shown in Table 1 below.
Serious
- 5 WARNINGS AND PRECAUTIONS Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported ( 5.1 ) Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration.
- Monitor blood counts in these patients ( 5.2 ) Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole.
- Avoid concomitant use of mebendazole and metronidazole ( 5.3 ) 5.1 Risk of Convulsions Convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole [see Adverse Reactions (6.2) ] .
- 5.2 Hematologic Effects Agranulocytosis and neutropenia have been reported with mebendazole use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections.
- Monitor blood counts if VERMOX™ CHEWABLE is used at higher doses or for prolonged duration.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported ( 5.1 ) Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients ( 5.2 ) Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epiderma
How Vermox Works
12.1 Mechanism of Action Mebendazole, a benzimidazole, is an anthelmintic [see Microbiology (12.4) ] .
Pharmacokinetics
Absorption
Absorption Following oral administration of VERMOX™ CHEWABLE 500 mg tablet, the majority of the dose remains in the gastrointestinal tract where it exerts an anthelmintic effect locally
Half-Life
half-life after an oral dose ranges from 3 to 6 hours in most patients
Metabolism
Metabolism Orally administered mebendazole is extensively metabolized primarily by the liver
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Vermoxwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store below 30°C. Keep container tightly closed. Unused tablets should be discarded 1 month after the bottle is first opened. When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.
Frequently Asked Questions
Related on MedCentralHub
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Vermox
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.