For Healthcare Professionals
Applies to Metlazel: compounding powder, injectable solution, oral concentrate, oral syrup, oral tablet, oral tablet disintegrating
What brand names are available for Metlazel?
Reglan, Metozolv ODT, (Reglan ODT, Octamide, and Maxolon are discontinued)
Is Metlazel safe to take when pregnant or breastfeeding?
The safety of Metlazel in pregnancy has not been established.
Metlazel is excreted in human breast milk. Nursing mothers should avoid Metlazel during pregnancy.
COMMON BRAND(S): Reglan
GENERIC NAME(S): Metlazel Hcl
OTHER NAME(S): Metlazel Hcl ODTMetlazel Hcl Tablet
This medication may cause a serious movement disorder called tardive dyskinesia. In some cases, this condition may be permanent. The risk of tardive dyskinesia is increased with the longer use of the medication and the more medication that you take. The risk is also increased in older adults (especially women) and in people with diabetes. Do not use Metlazel for longer than 12 weeks. Talk to your doctor about the risks and benefits of this medication.
Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs). There is no treatment for tardive dyskinesia, but in some cases the symptoms may lessen or stop once Metlazel is stopped.
This medication is used to treat certain conditions of the stomach and intestines. Metlazel is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing.
Metlazel is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metlazel works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines.
This drug is not recommended for use in children due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.
Metlazel is a dopamine antagonist that stimulates motility of the upper gastrointestinal tract and increases lower esophageal sphincter tone.
For the Consumer
Applies to Metlazel: oral solution, oral tablet, oral tablet disintegrating
Other dosage forms:
Use In Patients With Renal Or Hepatic Impairment
Since Metlazel 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.
Metlazel 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.
Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Stearic Acid.
reglan ® tablets (Metlazel 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:
Metlazel base 5 mg (as the monohydrochloride monohydrate)
25.1.4 Promotility agents
Metlazel (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 Metlazel 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.