METOCLOPRAMIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

AvKARE

INN (Mezinárodní Name):

METOCLOPRAMIDE HYDROCHLORIDE

Složení:

METOCLOPRAMIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Metoclopramide tablets are indicated for the:Metoclopramide tablets are indicated for the: - Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. - Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : Metoclopramide 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) ]. Metoclopramide is contraindicated:Metoclopramide is contraindicated: - In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [ see Warnings and Precautions ( 5.1, 5.2) ]. - When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). - In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [ see Warnings and Precautions ( 5.5) ]. - In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [ see Adverse Reactions ( 6) ]. - In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [ see Adverse Reactions ( 6) ]. 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 indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [ see Warnings and Precautions ( 5.1, 5.2), Use in Specific Populations ( 8.4) ]. Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area. No evidence of adverse developmental effects due to metoclopramide were observed. Risk Summary Limited published data report the presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation [ see Data ]. Metoclopramide elevates prolactin levels [ see Warnings and Precautions ( 5.7) ]; however, the published data are not adequate to support drug effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metoclopramide and any potential adverse effects on the breastfed child from metoclopramide or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [ see Warnings and Precautions ( 5.1, 5.2), Use in Specific Populations ( 8.4) ]. Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum. Metoclopramide is 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. The safety and effectiveness of metoclopramide in pediatric patients have not been established. Dystonias and other extrapyramidal symptoms associated with metoclopramide are more common in pediatric patients than in adults [ see Warnings and Precautions ( 5.1, 5.2) ]. In addition, neonates have reduced levels of NADH-cytochrome b 5 reductase, making them more susceptible to methemoglobinemia, a possible adverse reaction of metoclopramide use in neonates [ see Use in Specific Populations ( 8.8) ]. Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [ see Use in Specific Populations ( 8.6), Clinical Pharmacology ( 12.3) ]. Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of metoclopramide in elderly patients [ see Boxed Warning, Dosage and Administration ( 2.2, 2.3), Warnings and Precautions ( 5.1) ]. The clearance of metoclopramide is decreased and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. Reduce the metoclopramide dosage in patients with moderate and severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), including those receiving hemodialysis and continuous ambulatory peritoneal dialysis [ see Dosage and Administration ( 2.2, 2.3), Clinical Pharmacology ( 12.3) ]. Patients with severe hepatic impairment (Child-Pugh C) have reduced systemic metoclopramide clearance (by approximately 50%) compared to patients with normal hepatic function. The resulting increase in metoclopramide blood concentrations increases the risk of adverse reactions. There is no pharmacokinetic data in patients with moderate hepatic impairment (Child-Pugh B). Reduce metoclopramide dosage in patients with moderate or severe (Child-Pugh B or C) hepatic impairment [ see Dosage and Administration ( 2.2, 2.3) ]. There is no dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A). In addition, metoclopramide, by producing a transient increase in plasma aldosterone, may increase the risk of fluid retention in patients with hepatic impairment [ see Warnings and Precautions ( 5.6) ]. Monitor patients with hepatic impairment for the occurrence of fluid retention and volume overload. Metoclopramide-treated patients with NADH-cytochrome b 5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. For patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with metoclopramide-induced methemoglobinemia, methylene blue treatment is not recommended. Methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal [ see Overdosage ( 10)] . Metoclopramide is a substrate of CYP2D6. The elimination of metoclopramide may be slowed in patients who are CYP2D6 poor metabolizers (compared to patients who are CYP2D6 intermediate, extensive, or ultra-rapid metabolizers); possibly increasing the risk of dystonic and other adverse reactions to metoclopramide [ see Clinical Pharmacology ( 12.3) ]. Reduce the metoclopramide dosage in patients who are poor CYP2D6 metabolizers [ see Dosage and Administration ( 2.2, 2.3) ].

Přehled produktů:

Each white, round, unscored, debossed “TV” on one side and “2204” on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 5 mg metoclopramide. Available in bottles of 100 (NDC 0093-2204-01) and 500 (NDC 0093-2204-05). Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 100 (NDC 0093-2203-01), 500 (NDC 0093-2203-05), and 1000 (NDC 0093-2203-10). Dispense in a tight, light-resistant container. Store tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

AvKARE
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MEDICATION GUIDE
METOCLOPRAMIDE TABLETS, USP
(MET-oh-KLOE-pra-mide), oral use
Read this Medication Guide before you start taking metoclopramide
tablets and each time you get a
refill. There may be new information. If you take another product that
contains metoclopramide (such as
metoclopramide 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
metoclopramide tablets?
Metoclopramide tablets 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 metoclopramide
tablets. There is no treatment for tardive dyskinesia, but symptoms
may decrease or go away over time
after you stop taking metoclopramide tablets.
Your chances for getting tardive dyskinesia increase:
•
the longer you take metoclopramide tablets and the more metoclopramide
tablets you take. You
should not take metoclopramide tablets 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
metoclopramide tablets.
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
metoclopramide tablets?” for more information
about side effects.
What are metoclopramide tablets?
Metoclopramide tablets are a prescription medicine used

Charakteristika produktu

METOCLOPRAMIDE- METOCLOPRAMIDE TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
METOCLOPRAMIDE TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METOCLOPRAMIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METOCLOPRAMIDE
TABLETS.
METOCLOPRAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1979
WARNING: TARDIVE DYSKINESIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METOCLOPRAMIDE 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 METOCLOPRAMIDE IN PATIENTS WHO DEVELOP SIGNS OR SYMPTOMS
OF TD ( 5.1)
AVOID TREATMENT WITH METOCLOPRAMIDE FOR LONGER THAN 12 WEEKS BECAUSE
OF THE RISK
OF DEVELOPING TD WITH LONGER-TERM USE ( 5.1, 2.1, 2.2, 2.3)
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
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented
gastroesophageal reflux in adults who fail to
respond to conventional therapy. ( 1)
Relief of symptoms in adults with acute and recurrent diabetic
gastroparesis. ( 1)
Limitations of Use:
Metoclopramide 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)
Administer metoc