DOSAGE AND ADMINISTRATION
For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic
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 REGLAN Injection (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 REGLAN Injection (metoclopramide injection, USP) up to 10
days may be required before symptoms subside, at which time oral administration
of metoclopramide may be instituted. The physician should make a thorough assessment
of the risks and benefits prior to prescribing further metoclopramide treatment.
For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer
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.
For doses in excess of 10 mg, REGLAN Injection (metoclopramide injection) should be diluted in 50 mL of a parenteral solution.
The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with REGLAN Injection (metoclopramide injection) , can be stored frozen for up to 4 weeks. REGLAN Injection (metoclopramide injection) is degraded when admixed and frozen with Dextrose-5% in Water. REGLAN Injection (metoclopramide injection) 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.
If acute dystonic reactions should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside.
For the Prevention of Postoperative Nausea and Vomiting
REGLAN Injection (metoclopramide injection) 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 clearance is 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 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.
REGLAN Injection (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 (Abbott), Potassium Acetate, USP (Invenex), Potassium Phosphate, USP (Invenex).
Physically Compatible Up to 48 Hours
Ascorbic Acid, USP (Abbott), Benztropine Mesylate, USP (MS&D), Cytarabine, USP (Upjohn), Dexamethasone Sodium Phosphate, USP (ESI, MS&D), Diphenhydramine Hydrochloride, USP (Parke-Davis), Doxorubicin Hydrochloride, USP (Adria), Heparin Sodium, USP (ESI), Hydrocortisone Sodium Phosphate (MS&D), Lidocaine Hydrochloride, USP (ESI), 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 IV line)
Ampicillin Sodium, USP (Bristol), Cisplatin (Bristol), Erythromycin Lactobionate, USP (Abbott), 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 (Abbott).
REGLAN Injection (metoclopramide injection, USP) 5 mg metoclopramide base (as the monohydrochloride monohydrate) per mL; available in:
2 mL single dose vials in cartons of 25 (NDC 60977-451-01),
10 mL single dose vials in cartons of 25 (NDC 60977-451-02),
30 mL single dose vials in cartons of 25 (NDC 60977-451-03).
|| Total Contents #
|| Concentration #
| 2 mL single dose vial
|| 10 mg
|| 5 mg/mL
|| FOR IV or IM ADMINISTRATION
| 10 mL single dose vial
|| 50 mg
|| 5 mg/mL
|| FOR IV INFUSION ONLY; DILUTE BEFORE USING
| 30 mL single dose vial
|| 150 mg
|| 5 mg/mL
|| FOR IV INFUSION ONLY; DILUTE BEFORE USING
|# Metoclopramide base (as the monohydrochloride monohydrate)
Store vials in carton until used. Do not store open single dose vials for later use, as they contain no preservative.
This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.
Dilutions may be stored unprotected from light under normal light conditions
up to 24 hours after preparation.
REGLAN Injection (metoclopramide injection) should be stored at Controlled Room Temperature, 20°-25°C
(68° 77°F) [see USP Controlled Room Temperature].
Manufactured by: Baxter Healthcare Corporation. Deerfield, IL
60015 USA. For Product Inquiry 1 800 933 3030.