REGLAN- metoclopramide hydrochloride tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46)

Dostupné z:

ANI Pharmaceuticals, Inc.

INN (Medzinárodný Name):

METOCLOPRAMIDE HYDROCHLORIDE

Zloženie:

METOCLOPRAMIDE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Reglan tablets are indicated for the: Limitations of Use : Reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4)]. Reglan is contraindicated: Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see Clinical Considerations] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) [see Data] . The estimated background risk of major birth defects and miscarriage for the indic

Prehľad produktov:

Each green, elliptical-shaped Reglan tablet contains 5 mg metoclopramide. The tablet is debossed “REGLAN” over “5” on one side and “ANI” on the opposite side. Available in bottles of 100 tablets (NDC 62559-165-01) Each white, double edge scored, capsule-shaped Reglan tablet contains 10 mg metoclopramide. The tablet is debossed “REGLAN” on one side and “ANI 10” on the opposite side. Available in bottles of 100 tablets (NDC 62559-166-01) Dispense tablets in tight, light-resistant container. Store tablets at controlled room temperature between 20°C and 25°C (68°F and 77°F).

Stav Autorizácia:

New Drug Application

Príbalový leták

ANI Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
REGLAN® (REG-lan)
(metoclopramide) tablets, oral use
Read this Medication Guide before you start taking REGLAN and each
time you get a refill. There may
be new information. If you take another product that contains
metoclopramide (such as REGLAN
injection, metoclopramide orally disintegrating tablets, or
metoclopramide oral solution), you should read
the Medication Guide that comes with that product. Some of the
information may be different. This
information does not take the place of talking with your healthcare
provider about your medical
condition or your treatment.
What is the most important information I should know about REGLAN?
REGLAN can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements). These movements happen
mostly in the face muscles.
You cannot control these movements. They may not go away even after
stopping REGLAN. There is no
treatment for tardive dyskinesia, but symptoms may lessen or go away
over time after you stop taking
REGLAN.
Your chances for getting tardive dyskinesia increase:
•
the longer you take REGLAN and the more REGLAN you take. You should
not take REGLAN for
more than 12 weeks.
•
if you are older, especially if you are an older woman.
•
if you have diabetes.
It is not possible for your healthcare provider to know if you will
get tardive dyskinesia if you take
REGLAN.
Call your healthcare provider right away if you get movements you
cannot stop or control, such as:
•
lip smacking, chewing, or puckering up your mouth
•
frowning or scowling
•
sticking out your tongue
•
blinking and moving your eyes
•
shaking of your arms and legs
See the section "What are the possible side effects of REGLAN?" for
more information about side
effects.
What is REGLAN?
REGLAN is a prescription medicine used in adults:
•
for 4 to 12 weeks to relieve heartburn symptoms with gastroesophageal
reflux when certain other
treatments do not work.
•
to relieve the symptoms of slow stomach emptying in people

Súhrn charakteristických

REGLAN- METOCLOPRAMIDE HYDROCHLORIDE TABLET
ANI PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REGLAN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR REGLAN TABLETS.
REGLAN (METOCLOPRAMIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1979
WARNING: TARDIVE DYSKINESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 8/2017
Indications and Usage (1) 8/2017
Dosage and Administration, Dosage for Gastroesophageal Reflux (2.2)
8/2017
Dosage and Administration, Dosage for Acute and Recurrent Diabetic
Gastroparesis (2.3) 8/2017
Contraindications (4) 8/2017
Warnings and Precautions, Tardive Dyskinesia (5.1) 8/2017
Warnings and Precautions, Other Extrapyramidal Symptoms (5.2) 8/2017
Warnings and Precautions, Neuroleptic Malignant Syndrome (5.3) 8/2017
Warnings and Precautions, Hyperprolactinemia (5.7) 8/2017
INDICATIONS AND USAGE
Reglan tablets are indicated for the:
•
•
Limitations of Use:
Reglan tablets are not recommended for use in pediatric patients due
to the risk of tardive dyskinesia (TD) and other
extrapyramidal symptoms as well as the risk of methemoglobinemia in
neonates (1, 8.4)
DOSAGE AND ADMINISTRATION
Gastroesophageal Reflux (2.2)
•
○ Continuous: Administer 10 to 15 mg, 30 minutes before each meal
and at bedtime (maximum of 60 mg per day) for
4 to 12 weeks.
○ Intermittent: Single doses up to 20 mg prior to provoking
situation.
Acute and Recurrent Diabetic Gastroparesis (2.3)
•
Dosage Adjustment in Specific Populations (2.2, 2.3)
•
®
REGLAN CAN CAUSE TARDIVE DYSKINESIA (TD), A SERIOUS MOVEMENT DISORDER
THAT IS OFTEN IRREVERSIBLE.
THERE IS NO KNOWN TREATMENT FOR TD. THE RISK OF DEVELOPING TD
INCREASES WITH DURATION OF TREATMENT
AND TOTAL CUMULATIVE DOSAGE (5.1)
DISCONTINUE REGLAN IN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS OF TD
(5.1)
AVOID TREATMENT WITH REGLAN FOR LONGER THAN 12 WEEKS BECAUSE OF THE
RISK OF DEVELOPING TD WITH