VERMOX 500 mg/1
mebendazole · TABLET, CHEWABLE · Janssen Pharmaceuticals, Inc.
VERMOX is a tablet, chewable containing mebendazole at 500 mg/1, taken oral. Manufactured by Janssen Pharmaceuticals, Inc..
Key Facts
- Brand Name
- VERMOX
- Generic Name
- mebendazole
- NDC Code (Product)
50458-675- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Strength
- 500 mg/1
- Dosage Form
- TABLET, CHEWABLE
- Route
- ORAL
- Marketing Status
- Application #
- NDA208398
- Drug Class
- Anthelmintic [EPC]
- Marketing Start
- 10/20/2016
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & Administration
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 )
Contraindications
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 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of mebendazole and metronidazole should be avoided [see Warnings and Precautions (5.3) ] .
Adverse Reactions
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. 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. Table 1: Adverse Reactions Reported in Mebendazole-Treated Subjects from 39 Clinical Trials Includes mebendazole formulations, dosages and treatment duration other than…
Frequently Asked Questions
What is VERMOX used for?
VERMOX contains mebendazole. It is a tablet, chewable taken oral. Consult your doctor for specific uses.
Is VERMOX a controlled substance?
VERMOX is not classified as a controlled substance by the DEA.
What is the generic name for VERMOX?
The generic name for VERMOX is mebendazole. There are no other listed brand versions of mebendazole.
What is the NDC code for VERMOX 500 mg/1?
The NDC (National Drug Code) for VERMOX 500 mg/1 is 50458-675, listed by Janssen Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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