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Reglan Injection

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Reglan Injection

Indications
Dosage
How Supplied

INDICATIONS

Diabetic Gastroparesis (Diabetic Gastric Stasis)

REGLAN (metoclopramide hydrochloride, USP) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis.

The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy

REGLAN Injection (metoclopramide injection) is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy.

The Prevention of Postoperative Nausea and Vomiting

REGLAN Injection (metoclopramide injection) is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Small Bowel Intubation

REGLAN Injection (metoclopramide injection) may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers.

Radiological Examination

REGLAN Injection (metoclopramide injection) may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

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 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 Chemotherapy

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.

Admixtures Compatibilities

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).

HOW SUPPLIED

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).

Container Total Contents # Concentration # Administration
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.

Last reviewed on RxList: 8/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Additional Reglan Injection Information

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