REGLAN Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

ANI Pharmaceuticals, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

Reglan 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 ...

2. Dosage and Administration

2.1 Important Administration Instructions Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration (2.2, ...

3. Dosage Forms and Strengths

Tablets: 5 mg metoclopramide: green, elliptical-shaped, debossed REGLAN over 5 on one side and ANI on the opposite side 10 mg metoclopramide: white, double edge scored, capsule-shaped, debossed ...

4. Contraindications

Reglan 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 ...

5. Warnings and Precautions

5.1 Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or ...

6. Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1)] Other ...

7. Drug Interactions

7.1 Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3. Effects of Other Drugs on Metoclopramide: Antipsychotics Clinical ...

8. Use in Specific Populations

8.8 NADH-Cytochrome b5 Reductase Deficiency Metoclopramide-treated patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia. ...

8.1. Pregnancy

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 ...

8.2. Lactation

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, ...

8.4. Pediatric Use

Reglan 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 ...

8.5. Geriatric Use

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 ...

8.6. Renal Impairment

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 ...

8.7. Hepatic Impairment

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 ...

10. Overdosage

Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), ...

11. Description

Metoclopramide hydrochloride, the active ingredient of Reglan, is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white crystalline, odorless ...

12.1. Mechanism of Action

Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of ...

12.2. Pharmacodynamics

Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of Reglan produced dose-related increases in LESP. Effects began at ...

12.3. Pharmacokinetics

Absorption Relative to an intravenous dose of 20 mg, the absolute bioavailability of oral metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occurred ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A 77-week study was conducted in rats with oral metoclopramide doses up to 40 mg/kg/day (about six times the maximum recommended human dose on body surface area basis). Metoclopramide elevated ...

16.1. How Supplied

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). ...

16.2. Storage and Handling

Dispense tablets in tight, light-resistant container. Store tablets at controlled room temperature between 20°C and 25°C (68°F and 77°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients or their caregivers that Reglan can cause serious adverse reactions. Instruct patients to discontinue Reglan ...