VERMOX- mebendazole tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

mebendazole (UNII: 81G6I5V05I) (mebendazole - UNII:81G6I5V05I)

Available from:

Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division

INN (International Name):

mebendazole

Composition:

mebendazole 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VERMOX™ is indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Enterobius vermicularis (pinworm), Necator americanus (hookworm), and Trichuris trichiura (whipworm). VERMOX™ is contraindicated in persons with a known hypersensitivity to the drug or its excipients. 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] . In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral dose

Product summary:

VERMOX™ (mebendazole) is available as 100 mg, round, flat radius-edged white to yellowish chewable tablets that are debossed with "M/100" on one side and "J" on the other side. They are supplied as follows: Store at controlled room temperature 59°–77°F (15°–25°C).

Authorization status:

New Drug Application

Summary of Product characteristics

VERMOX- MEBENDAZOLE TABLET, CHEWABLE
JOHNSON & JOHNSON CONSUMER INC, MCNEIL CONSUMER HEALTHCARE DIVISION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERMOX™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VERMOX™.
VERMOX™ (MEBENDAZOLE) CHEWABLE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
VERMOX™ is an anthelmintic indicated for the treatment of patients
two years of age and older with gastrointestinal
infections caused by:
_Ancylostoma duodenale_ (hookworm),
_Ascaris lumbricoides _(roundworm),
_Enterobius vermicularis_ (pinworm),
_Necator americanus _(hookworm), and
_Trichuris trichiura_ (whipworm), (1).
DOSAGE AND ADMINISTRATION
_Adults and Pediatrics_: The tablet may be chewed, swallowed, or
crushed and mixed with food (2).
PINWO RM
(E NTE RO BIASIS)
WHIPWORM
(TRIC HURIASIS)
RO UNDWO RM
(ASC ARIASIS)
HOOKWORM
Dose
1 tablet once
1 tablet morning and
evening for 3
consecutive days
1 tablet morning and
evening for 3
consecutive days
1 tablet morning and
evening for 3
consecutive days
DOSAGE FORMS AND STRENGTHS
Chewable Tablet: 100 mg (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to the drug or its excipients
(4).
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).
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