Mebendazole
Generic Name: mebendazole
Brand Names:
Vermox
11 DESCRIPTION VERMOX™ CHEWABLE (mebendazole chewable tablets) is an orally administered anthelmintic. Chemically, it is methyl 5-benzoylbenzimidazole-2-carbamate. Its molecular formula is C 16 H 13 N 3 O 3. Its molecular weight is 295.30. It has the following chemical structure: Mebendazole exhibits polymorphism. The polymorph used in VERMOX™ CHEWABLE is polymorph form C. Mebendazole is a white to almost white powder.
Overview
11 DESCRIPTION VERMOX™ CHEWABLE (mebendazole chewable tablets) is an orally administered anthelmintic. Chemically, it is methyl 5-benzoylbenzimidazole-2-carbamate. Its molecular formula is C 16 H 13 N 3 O 3. Its molecular weight is 295.30. It has the following chemical structure: Mebendazole exhibits polymorphism. The polymorph used in VERMOX™ CHEWABLE is polymorph form C. Mebendazole is a white to almost white powder.
Uses
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
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) ].
Side Effects
6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash. ( 6.1 ). 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.
Interactions
7 DRUG INTERACTIONS Concomitant use of mebendazole and metronidazole should be avoided [see Warnings and Precautions (5.3) ] .
Warnings
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) ] . 4 CONTRAINDICATIONS VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients. Patients with a known hypersensitivity to the drug or its excipients ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data ]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations ] .
Storage
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
What is Mebendazole used for?▼
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 ).
What are the side effects of Mebendazole?▼
6 ADVERSE REACTIONS Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash. ( 6.1 ). 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.
Can I take Mebendazole during pregnancy?▼
8.1 Pregnancy Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data ]. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations ] .
What are the important warnings for Mebendazole?▼
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) ] . 4 CONTRAINDICATIONS VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients. Patients with a known hypersensitivity to the drug or its excipients ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.