Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED METOCLOPRAMIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1367-1 METOCLOPRAMIDE INJECTION, USP 10 mg/2 Ml (5mg/mL) 2mL SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (as the monohydrochloride monohydrate) is available as: 10 mg/2 mL (5 mg/mL) in a pre-filled disposable single-use syringe Available in a carton of twenty-four (24) syringes. NDC 76045-101-20 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. 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. Discard unused portion. Benadryl® is a registered trademark of McNeil Consumer. Cogentin® is a registered trademark of MS&D. Do not place syringe on a sterile field. Instructions For Use: CAUTION: Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. This syringe has a larger internal syringe tip and an external collar (luer collar). The external collar must remain attached to the syringe. Data show that the syringe achieves acceptable connections with the BD Eclipse™ Needle and the Terumo SurGuard2™ Safety Needle and with the following non-center post NLADs: Alaris SMARTSITE™, B-Braun ULTRASITE™, BD-Q SYTE™, Maximum MAX PLUS™, and B-Braun SAFSITE™. The data also show acceptable connections are achieved to the center post ICU Medical CLAVE™. However, spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Visually inspect the glass syringe-needle or glass syringe –NLAD connection before and during drug administration. Do not remove the clear plastic wrap around the external collar. (See Figure 1) Figure 1 Inspect the outer packaging (blister pack) by verifying: - blister integrity - drug name - drug strength - dose volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability Do not use if package has been damaged. Peel open the paper (top web) of the outer packaging that displays the product information to access the syringe. Do not pop syringe through. Bend the plastic part of the outer packaging (thermoform) so as to present the plunger rod for syringe removal. (See Figure 2) Figure 2 Perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color - expiration date to be sure that the drug has not expired - drug name - drug strength - dose volume - route of administration - integrity of the plastic wrap around the external collar Do not remove plastic wrap around the external collar. Push plunger rod slightly to break the stopper loose while tip cap is still on. Do not remove plastic wrap around the external collar. Remove tip cap by twisting it off. (See Figure 3) Figure 3 Discard the tip cap. Expel air bubble. To use the syringe in pediatric patients or patients who need a dose less than 10 mg, adjust dose into sterile material. Connect the syringe to appropriate injection connection depending on route of administration. Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD). Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle. If delivering medication with a needle, to prevent needle stick injuries, do not recap needle. NOTES: - All steps must be done sequentially - Do not autoclave syringe - Do not use this product on a sterile field - Do not introduce any other fluid into the syringe at any time - This product is for single dose only. For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The brand names mentioned in this document are the trademarks of their respective owners. www.fresenius-kabi.us D1018P01 Rev: May 2016 HOW SUPPLIED 1 HOW SUPPLIED 2 HOW SUPPLIED 3 LOGO; PRINCIPAL DISPLAY PANEL - SYRINGE LABELING SYRINGE LABEL 2 SYRINGE LABEL 1; PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING BLISTER PACK SERIALIZED LABELING SYRINGE IN BLISTER PACK - BACK
- HOW SUPPLIED METOCLOPRAMIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1367-1 METOCLOPRAMIDE INJECTION, USP 10 mg/2 Ml (5mg/mL) 2mL SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Metoclopramide Injection, USP, 5 mg/mL metoclopramide base (as the monohydrochloride monohydrate) is available as: 10 mg/2 mL (5 mg/mL) in a pre-filled disposable single-use syringe Available in a carton of twenty-four (24) syringes. NDC 76045-101-20 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. 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. Discard unused portion. Benadryl® is a registered trademark of McNeil Consumer. Cogentin® is a registered trademark of MS&D. Do not place syringe on a sterile field. Instructions For Use: CAUTION: Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. This syringe has a larger internal syringe tip and an external collar (luer collar). The external collar must remain attached to the syringe. Data show that the syringe achieves acceptable connections with the BD Eclipse™ Needle and the Terumo SurGuard2™ Safety Needle and with the following non-center post NLADs: Alaris SMARTSITE™, B-Braun ULTRASITE™, BD-Q SYTE™, Maximum MAX PLUS™, and B-Braun SAFSITE™. The data also show acceptable connections are achieved to the center post ICU Medical CLAVE™. However, spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Visually inspect the glass syringe-needle or glass syringe –NLAD connection before and during drug administration. Do not remove the clear plastic wrap around the external collar. (See Figure 1) Figure 1 Inspect the outer packaging (blister pack) by verifying: - blister integrity - drug name - drug strength - dose volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability Do not use if package has been damaged. Peel open the paper (top web) of the outer packaging that displays the product information to access the syringe. Do not pop syringe through. Bend the plastic part of the outer packaging (thermoform) so as to present the plunger rod for syringe removal. (See Figure 2) Figure 2 Perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color - expiration date to be sure that the drug has not expired - drug name - drug strength - dose volume - route of administration - integrity of the plastic wrap around the external collar Do not remove plastic wrap around the external collar. Push plunger rod slightly to break the stopper loose while tip cap is still on. Do not remove plastic wrap around the external collar. Remove tip cap by twisting it off. (See Figure 3) Figure 3 Discard the tip cap. Expel air bubble. To use the syringe in pediatric patients or patients who need a dose less than 10 mg, adjust dose into sterile material. Connect the syringe to appropriate injection connection depending on route of administration. Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD). Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle. If delivering medication with a needle, to prevent needle stick injuries, do not recap needle. NOTES: - All steps must be done sequentially - Do not autoclave syringe - Do not use this product on a sterile field - Do not introduce any other fluid into the syringe at any time - This product is for single dose only. For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The brand names mentioned in this document are the trademarks of their respective owners. www.fresenius-kabi.us D1018P01 Rev: May 2016 HOW SUPPLIED 1 HOW SUPPLIED 2 HOW SUPPLIED 3 LOGO
- PRINCIPAL DISPLAY PANEL - SYRINGE LABELING SYRINGE LABEL 2 SYRINGE LABEL 1
- PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING BLISTER PACK SERIALIZED LABELING SYRINGE IN BLISTER PACK - BACK
Overview
Metoclopramide hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Molecular weight: 354.3. C14H22ClN3O2⋅HCl⋅H2O Metoclopramide Injection, USP is a clear, colorless, sterile solution with a pH of 4.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration. This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Each mL contains: metoclopramide base 5 mg (as the monohydrochloride monohydrate), sodium chloride, USP 8.5 mg, Water for Injection, USP q.s. pH adjusted, when necessary with hydrochloric acid and/or sodium hydroxide. STRUCTURE
Indications & Usage
INDICATIONS & USAGE Diabetic Gastroparesis (Diabetic Gastric Stasis) Metoclopramide Injection (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 Metoclopramide Injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. The Prevention of Postoperative Nausea and Vomiting Metoclopramide Injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. Small Bowel Intubation 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 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 & Administration
DOSAGE & 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 (intramuscular or intravenous). 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. 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, Metoclopramide Injection, USP should be diluted in 50 mL of a parenteral solution. 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. 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 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 to 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 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.
Warnings & Precautions
WARNINGS Neuroleptic Malignant Syndrome (NMS) There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g. pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS ). Extrapyramidal Symptoms (EPS) Acute Dystonic Reactions Acute dystonic reactions occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses used in prophylaxis of vomiting due to cancer chemotherapy. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and they usually will subside. Cogentin® (benztropine mesylate), 1 to 2 mg intramuscularly, may also be used to reverse these reactions. Tardive Dyskinesia (see BOXED WARNING ) Treatment with Metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20% of patients who used Metoclopramide took it for longer than 12 weeks. Treatment with Metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD. Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop Metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose. Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after Metoclopramide is withdrawn. Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, Metoclopramide should not be used for the symptomatic control of TD. Parkinsonian-like Symptoms Parkinsonian-like symptoms, including bradykinesia, tremor, cogwheel rigidity, or mask-like facies, have occurred more commonly within the first 6 months after beginning treatment with Metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuation of Metoclopramide. Patients with preexisting Parkinson's disease should be given Metoclopramide cautiously, if at all, since such patients may experience exacerbation of Parkinsonian symptoms when taking Metoclopramide. Depression Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
Boxed Warning
BOXED WARNING BOXED WARNING
Contraindications
Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g. in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine. Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs, which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.
Adverse Reactions
In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency: CNS Effects Restlessness, drowsiness, fatigue and lassitude may occur in patients receiving the recommended prescribed dosage of Metoclopramide Injection. Insomnia, headache, confusion, dizziness or mental depression with suicidal ideation also may occur (see WARNINGS). In cancer chemotherapy patients being treated with 1 to 2 mg/kg per dose, incidence of drowsiness is about 70%. There are isolated reports of convulsive seizures without clear-cut relationship to metoclopramide. Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. In cancer, chemotherapy patients receiving 1 to 2 mg/kg per dose, the incidence is 2% in patients over the ages of 30 to 35, and 25% or higher in pediatric patients and adult patients less than 30 years of age who have not had prophylactic administration of diphenhydramine. Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ). Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS ). Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage. Neuroleptic Malignant Syndrome Rare occurrences of Neuroleptic malignant syndrome (NMS) have been reported. This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, muscular rigidity, altered consciousness, and autonomic instability (see WARNINGS ). Endocrine Disturbances Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS ). Fluid retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY ). Cardiovascular Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure and possible atrioventricular (AVA) block (see CONTRAINDICATIONS and PRECAUTIONS ). Gastrointestinal Nausea and bowel disturbances, primary diarrhea. Hepatic Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential. Renal Urinary frequency and incontinence. Hematologic A few cases of neutropenia, leucopenia, or agranulocytosis, generally without clear-cut relationship to metoclopramide. Methemoglobinemia in adults and especially with overdosage in neonates (see OVERDOSAGE ). Sulfhemoglobinemia in adults. Allergic Reactions A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema. Miscellaneous Visual disturbances, Porphyria. Transient flushing of the face and upper body, without alterations in vital signs, following high doses intravenously.
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