Cloprame is a dopamine antagonist that stimulates motility of the upper gastrointestinal tract and increases lower esophageal sphincter tone.
Use In Patients With Renal Or Hepatic Impairment
Since Cloprame 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 OVERDOSE section for information regarding dialysis.
Cloprame 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.
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 Cloprame. 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 Cloprame 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).
Cloprame oral tablet is a prescription drug that’s available as the brand-name drugs Reglan and Metozolv ODT. It’s also available as a generic drug. Generic drugs usually cost less than brand-name versions. In some cases, they may not be available in all strengths or forms as a brand-name drug.
Cloprame also comes in an oral solution as well as injectable forms that are only given by a healthcare provider.
What other drugs will affect Cloprame:
Before giving Cloprame, tell your veterinarian if your pet is being given an MAOI such as selegiline or Anipryl (within the last 14 days), digoxin, cyclosporine, tetracycline, insulin, a narcotic pain reliever or anticholinergic or antispasmodic medications such as Bentyl (dicyclomine). Also tell your veterinarian of any other medications you are giving that may cause drowsiness such as pain relievers, anxiety medications, muscle relaxants or any other prescription or over the counter medications.
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Do not use a monoamine oxidase inhibitor (MAOI) such as Anipryl, Selegiline, or a Preventic Flea Collar on your pet while giving this medication. Stop giving Cloprame and contact your veterinarian immediately if your pet has an allergic reaction. Tell your veterinarian if your pet has kidney disease, diabetes, or high blood pressure, if your pet has had recent stomach surgery, or is pregnant or lactating.
Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Stearic Acid.
reglan ® tablets (Cloprame tablets, USP) 5 mg are green, elliptical-shaped tablets engraved “REGLAN” over “5” on one side and “ANI” on the opposite side.
Each tablet contains:
Cloprame base 5 mg (as the monohydrochloride monohydrate)
25.1.4 Promotility agents
Cloprame (FDA category B) is a prokinetic, dopamine agonist which may be useful in the treatment of GERD by increasing LES pressure, improving esophageal acid clearance, and promoting gastric emptying. Use of Cloprame is often limited by its poor tolerability and the risk for extra-pyramidal side effects. It has been associated in rare cases with tardive dyskinesia, causing the FDA to issue a black-box warning concerning the use of this drug in 2009. The risk of the development of this complication increases with high dose or long-term use of the drug and continues even after the drug has been discontinued.
Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions. Anticholinergic or antiparkinson drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. Symptoms are self-limiting and usually disappear within 24 hours.
Hemodialysis removes relatively little Cloprame, probably because of the small amount of the drug in blood relative to tissues. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of drug. It is unlikely that dosage would need to be adjusted to compensate for losses through dialysis. Dialysis is not likely to be an effective method of drug removal in overdose situations.
Unintentional overdose due to misadministration has been reported in infants and children with the use of Cloprame oral solution. While there was no consistent pattern to the reports associated with these overdoses, events included seizures, extrapyramidal reactions, and lethargy.
Methemoglobinemia has occurred in premature and full-term neonates who were given overdoses of Cloprame (1 to 4 mg/kg/day orally, intramuscularly or intravenously for 1 to 3 or more days). Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal (see PRECAUTIONS – Other Special Populations).
More common side effects
The more common side effects of Cloprame can include:
- trouble sleeping
If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.
What brand names are available for Cloprame?
Reglan, Metozolv ODT, (Reglan ODT, Octamide, and Maxolon are discontinued)
What are the uses for Cloprame?
Cloprame is a prescription medicine used in adults:
- to relieve heartburn symptoms with gastroesophageal reflux when certain other treatments do not work
- to relieve the symptoms of slow stomach emptying in people with diabetes
Before taking Cloprame,
- tell your doctor and pharmacist if you are allergic to Cloprame, any other medications, or any of the ingredients in Cloprame tablets or solution. Ask your doctor or pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol, others); antihistamines; aspirin; atropine (in Lonox, in Lomotil); cyclosporine (Gengraf, Neoral, Sandimmune); barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal); digoxin (Lanoxicaps, Lanoxin); haloperidol (Haldol);insulin; ipratropium (Atrovent); lithium (Eskalith, Lithobid); levodopa (in Sinemet, in Stalevo); medications for anxiety, blood pressure, irritable bowel disease, motion sickness, nausea, Parkinson's disease, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); narcotic medications for pain; sedatives; sleeping pills; tetracycline (Bristacycline, Sumycin); or tranquilizers. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
- tell your doctor if you have or have ever had blockage, bleeding, or a tear in your stomach or intestines; pheochromocytoma (tumor on a small gland near the kidneys); or seizures. Your doctor will probably tell you not to take Cloprame.
- tell your doctor if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); high blood pressure; depression; breast cancer; asthma;glucose-6-phosphate dehydrogenase (G-6PD) deficiency (an inherited blood disorder); NADH cytochrome B5 reductase deficiency (an inherited blood disorder); or heart, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Cloprame, call your doctor.
- talk to your doctor about the risks and benefits of taking Cloprame if you are 65 years of age or older. Older adults should not usually take Cloprame, unless it is used to treat slow stomach emptying, because it is not as safe or effective as other medications that can be used to treat those conditions.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Cloprame.
- you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects of Cloprame worse.
Where can I get more information:
Your pharmacist has additional information about Cloprame written for health professionals that you may read.
Call your veterinarian for medical advice about any side effects to your pet. You may report side effects to the FDA at 1-800-FDA-1088.