Trimethobenzamide

What is Trimethobenzamide?

• Trimethobenzamide (Tigan) an antiemetic used in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Trimethobenzamide

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What are the uses of this medicine?

• Trimethobenzamide (Tigan) is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Limitations of use:

• Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients.

How does this medicine work?

• Trimethobenzamide (trye meth” oh ben’ za mide) is a benzamide used to prevent nausea and vomiting.
• Although the mechanism of action is largely unknown, it inhibits the chemoreceptor trigger zone (CTZ), an area in the medulla oblongata through which emetic impulses are conveyed to the vomiting center, thereby suppressing nausea and vomiting.
• It has weak antihistaminic activity, but does not appear to act via serotonin or dopamine pathways.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to trimethobenzamide.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antidepressants
• antihistamines
• barbiturates such as phenobarbital (Luminal)
• belladonna alkaloids (Donnatal)
• medications for anxiety, mental illness, pain and seizures
• other medications for nausea and vomiting
• sedatives
• sleeping pills
• tranquilizers

Is this medicine FDA approved?

• Trimethobenzamide was approved for use in the United States in 1974 and is widely used in therapy of nausea, vomiting caused by gastroenteritis, medications and other illnesses.

How should this medicine be used?

Recommended dosage: Adult Dosage:

• The recommended adult dosage is 300 mg orally three or four times daily.
• Select the lowest effective daily dosage and adjust as needed based upon therapeutic response and tolerability.

Geriatric Patients and/or Patients with Renal Impairment:

• In geriatric patients and/or in patients with renal impairment (creatinine clearance 70 mL/min/1.73m2 or less), reduce the daily dosage of trimethobenzamide hydrochloride capsules by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability.

Administration:

• Trimethobenzamide comes as a capsule to take by mouth.
• Trimethobenzamide usually is taken three or four times a day.
• Take trimethobenzamide at around the same times every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsule: 300 mg of trimethobenzamide hydrochloride

This medicine is available in fallowing brand namesː

• Tigan

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypersensitivity reactions and Parkinson-like symptoms
• blood dyscrasias
• blurring of vision
• coma
• convulsions
• depression of mood
• diarrhea
• disorientation
• dizziness
• drowsiness
• headache
• jaundice
• muscle cramps
• opisthotonos

Trimethobenzamide may cause serious side effects include:

• rash
• backward arching of the head, neck, and back
• muscle cramps
• uncontrollable shaking of a part of the body
• blurred vision
• yellowing of the skin or eyes
• seizures
• coma
• slow, jerking movements
• shuffling walk
• slow speech
• confusion
• hypersensitivity reactions
• disorientation

What special precautions should I follow?

• Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, may occur with trimethobenzamide hydrochloride capsules. Depending on the severity of symptoms, reduce the dosage or discontinue the drug. Treat acute dystonic reactions with anticholinergics. Avoid trimethobenzamide hydrochloride capsules in patients receiving other drugs that are likely to cause EPS.
• EPS and other CNS symptoms in patients treated with trimethobenzamide hydrochloride capsules may be confused with CNS signs of undiagnosed primary disease (e.g., encephalopathy, metabolic imbalance, Reye’s Syndrome). If CNS symptoms occur, evaluate the risks and benefits of continuing trimethobenzamide hydrochloride tablets.
• Coma, depression of mood, disorientation, and seizures have been reported. The recent use of other drugs that cause CNS depression or EPS symptoms may also increase the risk; consider reducing the dosage or discontinuing the drug.
• Trimethobenzamide hydrochloride capsules are potentially hepatotoxic. Avoid use in patients whose signs and symptoms suggest the presence of hepatic impairment. Discontinue trimethobenzamide hydrochloride capsules in patients who develop impaired liver function while on treatment.
• Trimethobenzamide hydrochloride capsules can cause drowsiness and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery.
• Concomitant use of other drugs that cause CNS depression or EPS symptoms may increase this effect; either trimethobenzamide hydrochloride capsules or the other interacting drug should be chosen, depending on the importance of the drug to the patient.
• Trimethobenzamide has not been linked convincingly to elevations in serum enzymes during therapy or to cases of clinically apparent liver injury with jaundice.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of trimethobenzamide hydrochloride capsules in pediatric patients have not been established.
• Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of EPS and other serious CNS effects, and the risk of exacerbation of underlying disease in pediatric patients with Reye’s Syndrome, or other hepatic impairment.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• Trimethobenzamide Hydrochloride

Inactive Ingredients:

• ferric oxide red
• GELATIN, UNSPECIFIED
• magnesium stearate
• MICROCRYSTALLINE CELLULOSE
• titanium dioxide
• D&C yellow no. 10
• Aluminum oxide
• FD&C blue no. 1
• FD&C blue no. 2
• FD&C red no. 40
• ferrosoferric oxide
• propylene glycol
• shellac
• Sodium Starch Glycolate Type A Potato

Who manufactures and distributes this medicine?

Manufactured by:

• ALKALOIDA Chemical Company Zrt
• Tiszavasvári,
• Kabay János u. 29.
• Hungary

Distributed by:

• Sun Pharmaceutical Industries, Inc.
• Cranbury, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Antidiarrheal agents

Antidiarrheal agents include bulk forming agents, hydroscopic agents, bile acid resins, bismuth, inhibitors of intestinal motility, non-absorbed antibiotics and hormones. Bulk forming agents include methylcellulose; hydroscopic agents include pectin and kaolin; bile acid resins are cholestyramine, colestipol and colesevalam; inhibitors of intestinal motility include opioids such as diphenoxylate and loperamide. Antibiotics include rifamycin and rifaximin which are non-absorbed and are used for travelers' diarrhea. Hormones with antidiarrheal activity include octretide and somatostatin. Most antidiarrheal agents are active locally in the small intestine and colon and are largely not absorbed. Some, however, have been implicated in rare causes of liver injury (senna, cascara, cholestyramine). Telotristat is a relatively new agent that inhibits the synthesis of serotonin and is used specifically for the diarrhea of carcinoid syndrome.

• Cholestyramine
• Colesevelam
• Colestipol
• Crofelemer
• Difenoxin
• Diphenoxylate
• Kaolin
• Loperamide
• Methylcellulose
• Octreotide
• Pectin
• Rifamycin
• Rifaximin
• Somatostatin
• Telotristat

Antiemetics are a diverse group of medications that act at different points in the pathways that regulate nausea and vomiting. These include antihistamines, anticholinergic agents, phenothiazines, serotonin type 3 receptor blockers, centrally acting benzamides, cannabinoid receptor agonists, substance P antagonists and miscellaneous.

Anticholinergic Agents

• Hyoscyamine, Methscopolamine, Scopolamine

Antihistamines

• Cyclizine, Dimenhydrinate, Hydroxyzine, Meclizine, and Promethazine

Cannabinoid Receptor Agonists

• Dronabinol, Nabilone, Tetrahydrocannabinol
• Phenothiazines [See Antipsychotic Agents]
• Chlorpromazine, Prochlorperazine

Serotonin 5-HT3 Receptor Antagonists

• Alosetron, Dolasetron, Granisetron, Ondansetron, Palonosetron

Substance P/Neurokinin 1 Receptor Antagonists

• Aprepitant, Fosaprepitant, Rolapitant

Miscellaneous

• Dexamethasone, Metoclopramide, Trimethobenzamide

Acid peptic disease/antiulcer agents that include antacids, the histamine type 2 receptor blockers (H2 blockers), and the proton pump inhibitors (PPIs). These agents are some of the most commonly taken medications and are very well tolerated, most being available both by prescription and over-the-counter. While many of these drugs are approved for use in duodenal and gastric ulcer disease, their major use is for acid reflux and indigestion.

Histamine H2 Receptor Antagonists (H2 Blockers) Cimetidine, Famotidine, Nizatidine, Ranitidine

Proton Pump Inhibitors

• Dexlansoprazole, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole

Cathartics, laxatives or agents for constipation include bulk forming agents, osmotic agents, stool wetting agents, nonspecific stimulants, prokinetic agents and agents that increase fluid secretion. Many of these therapies are not systemically absorbed and none are considered particularly hepatotoxic. Naldemedine and naloxegol are opioid antagonists and are used to treat the constipation associated with opioid use.

• Bisacodyl
• Cascara Sagrada
• Castor Oil
• Docusate
• Fiber, Bran
• Lactulose
• Magnesium Sulfate
• Methylcellulose
• Naldemedine (Opioid Antagonist)
• Naloxegol (Opioid Antagonist)
• Plecanatide (for Chronic Idiopathic Constipation)
• Prucalopride (for Chronic Idiopathic Constipation)
• Senna

Inflammatory bowel disease encompasses several disorders, most commonly ulcerative colitis and Crohn colitis. Agents can be classified as 5-aminosalicyclic acid (5-ASA) based agents, immunosuppressive drugs, antitumor necrosis factor agents, corticosteroids, antibiotics and miscellaneous.

5-Aminosalicyclic Acid (5-ASA) Derivatives

• Balsalazide, Mesalamine, Olsalazine, Sulfasalazine

Immunosuppressive Agents

• Azathioprine, Mercaptopurine, Methotrexate

Tumor Necrosis Factor Antagonists

• Adalimumab, Certolizumab, Golimumab, Infliximab

Miscellaneous

• Metronidazole, Natalizumab, Vedolizumab

Irritable Bowel Syndrome Agents Antimuscarinics/Antispasmodics [See Anticholinergic agents

• Dicyclomine, Glycopyrrolate, Hyoscyamine, Methscopolamine

Prokinetic Agents - See Serotonin 5-ht4 receptor agonists Alosetron, Cisapride, Domperidone, Linaclotide, Lubiprostone, Metoclopramide, Plecanatide, Prucalopride, Tegaserod

Other

• Eluxadoline

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