EMVERM- mebendazole tablet, chewable

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

MEBENDAZOLE (UNII: 81G6I5V05I) (MEBENDAZOLE - UNII:81G6I5V05I)

זמין מ:

Amneal Pharmaceuticals LLC

INN (שם בינלאומי):

MEBENDAZOLE

הרכב:

MEBENDAZOLE 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

EMVERM® 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). EMVERM® 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 doses as low as 10 mg/kg (approximately 0.5-fold the total daily maximum recommended human dose [MRHD]). Maternal toxicity was present at the highest of these doses [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risks Untreated soil transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death. Data Human Data Several published studies, including prospective pregnancy registries, case-control, retrospective cohort, and randomized controlled studies, have reported no association between mebendazole use and a potential risk of major birth defects or miscarriage. Overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use. However, these studies cannot definitely establish the absence of any mebendazole-associated risk because of methodological limitations, including recall bias, confounding factors and, in some cases, small sample size or exclusion of first trimester mebendazole exposures. Animal Data Embryo-fetal developmental toxicity studies in rats revealed no adverse effects on dams or their progeny at doses up to 2.5 mg/kg/day on gestation days 6–15 (the period of organogenesis). Dosing at ≥10 mg/kg/day resulted in a lowered body weight gain and a decreased pregnancy rate. Maternal toxicity, including body weight loss in one animal and maternal death in 11 of 20 animals, was seen at 40 mg/kg/day. At 10 mg/kg/day, increased embryo-fetal resorption (100% were resorbed at 40 mg/kg/day), decreased pup weight and increased incidence of malformations (primarily skeletal) were observed. Mebendazole was also embryotoxic and teratogenic in pregnant rats at single oral doses during organogenesis as low as 10 mg/kg (approximately 0.5-fold the total daily MRHD, based on mg/m2 ). In embryo-fetal developmental toxicity studies in mice dosed on gestation days 6–15, doses of 10 mg/kg/day and higher resulted in decreased body weight gain at 10 and 40 mg/kg/day and a higher mortality rate at 40 mg/kg/day. At doses of 10 mg/kg/day (approximately 0.2-fold the total daily MRHD, based on mg/m2 ) and higher, embryo-fetal resorption increased (100% at 40 mg/kg) and fetal malformations, including skeletal, cranial, and soft tissue anomalies, were present. Dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity at doses up to 40 mg/kg/day (1.6 to 3.9-fold the total daily MRHD, based on mg/m2 ). In a peri- and post-natal toxicity study in rats, mebendazole did not adversely affect dams or their progeny at 20 mg/kg/day. At 40 mg/kg (1.9-fold the total daily MRHD, based on mg/m2 ), a reduction of the number of live pups was observed and there was no survival at weaning. No abnormalities were found on gross and radiographic examination of pups at birth. Risk Summary Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. There are no reports of effects on the breastfed infant, and the limited reports on the effects on milk production are inconsistent. The limited clinical data during lactation precludes a clear determination of the risk of EMVERM® to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EMVERM® and any potential adverse effects on the breastfed infant from EMVERM® or from the underlying maternal condition. The safety and effectiveness of EMVERM® 100 mg chewable tablets has not been established in pediatric patients less than two years of age. Convulsions have been reported with mebendazole use in children less than one year of age [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

leaflet_short:

EMVERM® (mebendazole) Chewable Tablet, USP is available as a 100 mg, round, light peach-colored, unscored, debossed “ap” above “107” on one side and plain on the other side. They are supplied as follows: Blister package of 1 tablet                     NDC 64896-669-30 Store at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

EMVERM- MEBENDAZOLE TABLET, CHEWABLE
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMVERM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EMVERM .
EMVERM (MEBENDAZOLE) CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
EMVERM 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).
Pinworm
(enterobiasis)
Whipworm (trichuriasis)
Roundworm (ascariasis)
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 AMNEAL PHARMACEUTICALS
AT 1-877-835-
5472 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWA