Dilution Reglan ® - Metoclopramide

Metoclopramide (Reglan ®)

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Usual Diluents

NS , D5W

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[All doses] [50 ml] [30 min]

Stability / Miscellaneous

DOSAGE AND ADMINISTRATION
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1 to 2 minute period.

Administration of Metoclopramide Injection, USP up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted.

For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: For doses in excess of 10 mg, Metoclopramide Injection, USP should be diluted in 50 mL of a parenteral solution.

Stability:
The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with Metoclopramide Injection, USP, can be stored frozen for up to 4 weeks. Metoclopramide Injection, USP is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide Injection, USP diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer's Injection, or Lactated Ringer's Injection may be stored up to 48 hours (without freezing) after preparation if protected from light.

All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation. Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate. If extrapyramidal symptoms should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and EPS usually will subside.

For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection, USP should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.

To Facilitate Small Bowel Intubation: If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1 to 2 minute period.

The recommended single dose is:
Pediatric patients above 14 years of age and adults - 10 mg metoclopramide base.
Pediatric patients (6 - 14 years of age) - 2.5 to 5 mg metoclopramide base;
(under 6 years of age) - 0.1 mg/kg metoclopramide base.

To Aid in Radiological Examinations: In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose may be administered slowly by the intravenous route over a 1 to 2 minute period.

For dosage, see intubation, above.

Use in Patients with Renal or Hepatic Impairment:
Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearanceis below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

See package insert OVERDOSAGE section for information regarding dialysis.

Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

ADMIXTURE COMPATIBILITIES
Metoclopramide Injection, USP is compatible for mixing and injection with the following dosage forms to the extent indicated below:

Physically and Chemically Compatible Up to 48 Hours
Cimetidine Hydrochloride (SK&F), Mannitol, USP (Hospira), Potassium Acetate, USP (Invenex), Potassium Phosphate, USP (Invenex).

Physically Compatible Up to 48 Hours
Ascorbic Acid, USP (Hospira), Benztropine Mesylate, USP (MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate, USP (Baxter, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis), Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (Baxter), Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride, USP (Baxter), Multi-Vitamin Infusion (must be refrigerated-USV), Vitamin B Complex with Ascorbic Acid (Roche).

Physically Compatible Up to 24 Hours (Do not use if precipitation occurs)
Clindamycin Phosphate, USP (Upjohn), Cyclophosphamide, USP (Mead-Johnson), Insulin, USP (Lilly).

Conditionally Compatible(Use within one hour after mixing or may be infused directly into the same running I.V. line)
Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol), Erythromycin Lactobionate, USP (Hospira), Methotrexate Sodium, USP (Lederle), Penicillin G Potassium, USP (Squibb), Tetracycline Hydrochloride, USP (Lederle).

Incompatible (Do Not Mix)
Cephalothin Sodium, USP (Lilly), Chloramphenicol Sodium, USP (Parke-Davis), Sodium Bicarbonate, USP (Hospira).

HOW SUPPLIED
PRESERVATIVE FREE.

Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (present as the monohydrochloride monohydrate) is supplied in the following:

NDC No. Container Concentration Size Quantity

0409-3413–01 Ampul 5 mg/mL 2 mL 25 per container
0409-3414–01 Fliptop Glass Vial 5 mg/mL 2 mL 25 per tray

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light by retaining in package until time of use.

This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

Do not store open single-dose vials or ampuls for later use, as they contain no preservative. Discard unused portion.
Revised: October, 2006

Source: [package insert]