Trimethobenzamide 300mg Capsules

Manufacturer GAVIS Active Ingredient Trimethobenzamide Capsules(trye meth oh BEN za mide) Pronunciation trye meth oh BEN za mide
It is used to treat upset stomach and throwing up.
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Drug Class
Antiemetic
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Pharmacologic Class
Antiemetic (Chemoreceptor Trigger Zone Inhibitor)
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Pregnancy Category
Category C
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FDA Approved
Jul 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Trimethobenzamide is a medicine used to help stop nausea and vomiting. It works by affecting a specific area in your brain that controls vomiting.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. It's essential to follow the dosage instructions carefully to ensure safe and effective treatment.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid driving or operating machinery until you know how this medicine affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other medications that can cause drowsiness, as this can worsen side effects.
  • Take with food or milk if it causes stomach upset.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 300 mg orally 3 or 4 times daily
Dose Range: 300 - 1200 mg

Condition-Specific Dosing:

postoperative_nausea_vomiting: 200 mg orally 3 or 4 times daily (if capsules are used, though often injectable for this indication)
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Pediatric Dosing

Neonatal: Not established (Contraindicated in neonates/premature infants)
Infant: Not established (Contraindicated in infants)
Child: Children 30-90 lbs (13.6-40.8 kg): 100-200 mg orally 3 or 4 times daily. Not for children under 42 lbs (19 kg) or under 1 year.
Adolescent: Same as adult dose (300 mg orally 3 or 4 times daily) for adolescents over 90 lbs (40.8 kg)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution
Moderate: No specific adjustment recommended, use with caution
Severe: No specific adjustment recommended, use with caution
Dialysis: Considerations: Unknown if dialyzable, use with caution

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution
Moderate: No specific adjustment recommended, use with caution
Severe: No specific adjustment recommended, use with caution

Pharmacology

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Mechanism of Action

Trimethobenzamide is an antiemetic agent that acts primarily on the chemoreceptor trigger zone (CTZ) in the medulla oblongata. It is thought to block emetic impulses by inhibiting dopamine receptors in the CTZ, thereby reducing the sensitivity of the CTZ to emetogenic stimuli. It has weak antihistaminic and anticholinergic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well absorbed orally
Tmax: Approximately 1 hour
FoodEffect: Not significantly affected by food, but may delay absorption slightly

Distribution:

Vd: Not widely reported
ProteinBinding: Not extensively reported
CnssPenetration: Limited (primarily acts on CTZ which is outside the blood-brain barrier)

Elimination:

HalfLife: Approximately 3 hours
Clearance: Not widely reported
ExcretionRoute: Renal (urine)
Unchanged: Approximately 50% excreted unchanged in urine
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Pharmacodynamics

OnsetOfAction: Approximately 15-30 minutes (oral)
PeakEffect: Approximately 1 hour
DurationOfAction: 3-4 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
Shakiness, difficulty moving, or stiffness
Trouble controlling body movements, twitching, balance problems, or difficulty swallowing or speaking
Muscle spasms
Muscle cramps
Restlessness
Blurred vision
Depression
Seizures
Confusion
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Diarrhea
Dizziness or drowsiness
Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Unusual muscle movements or spasms (e.g., stiff neck, difficulty speaking, tremors)
  • Rash or itching
  • Difficulty breathing or swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Persistent or worsening headache
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease, as this may affect how your body processes the medication.
If you are taking any medications that may increase the risk of involuntary body movements. There are numerous drugs that can cause this side effect, so it is crucial to ask your doctor or pharmacist if you are unsure.

Please note that this is not an exhaustive list of all potential interactions between this medication and other substances. To ensure your safety, it is vital to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share any health problems you have, as these may interact with the medication.
Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any drug. Always consult your doctor before making any changes to your medication regimen.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle and engaging in other activities that require alertness. Additionally, refrain from consuming alcohol while taking this medication.

Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) drugs that may cause drowsiness or slow your reactions, consult with your doctor. If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks to you and your baby with your doctor. This medication is not approved for use in children, as it may increase the risk of severe side effects. If your child has been prescribed this drug, consult with their doctor to understand the benefits and risks associated with its use. If you have any questions or concerns about giving this medication to your child, be sure to discuss them with their doctor.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Dizziness
  • Disorientation
  • Ataxia (loss of coordination)
  • Extrapyramidal symptoms (e.g., dystonia, akathisia)
  • Hypotension
  • Coma
  • Respiratory depression

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, sedatives, hypnotics, tranquilizers)
  • Phenothiazines (e.g., prochlorperazine, promethazine)
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Moderate Interactions

  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines with anticholinergic effects)

Monitoring

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Baseline Monitoring

Patient history (allergies, pre-existing conditions)

Rationale: To identify contraindications or risk factors for adverse effects

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in nausea/vomiting)

Frequency: As needed, based on patient symptoms

Target: Symptom relief

Action Threshold: Lack of efficacy may require alternative treatment or dose adjustment

Adverse effects (e.g., drowsiness, dizziness, headache, extrapyramidal symptoms, allergic reactions)

Frequency: Regularly during therapy, especially early on

Target: Absence or minimal side effects

Action Threshold: Presence of significant or intolerable side effects may require dose reduction or discontinuation

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Headache
  • Diarrhea
  • Constipation
  • Blurred vision
  • Muscle cramps/spasms
  • Tremors
  • Rash
  • Hives
  • Difficulty breathing or swallowing (signs of allergic reaction)

Special Patient Groups

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Pregnancy

Trimethobenzamide is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.

Trimester-Specific Risks:

First Trimester: Potential risk, use only if clearly needed.
Second Trimester: Potential risk, use only if clearly needed.
Third Trimester: Potential risk, use only if clearly needed.
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Lactation

It is not known whether trimethobenzamide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trimethobenzamide is administered to a nursing woman.

Infant Risk: Risk unknown; potential for drowsiness or other CNS effects in infant. Monitor infant for adverse effects.
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Pediatric Use

Contraindicated in neonates and premature infants due to potential for respiratory depression and CNS effects. Use with caution in children, especially those with acute illnesses (e.g., viral infections, dehydration) due to increased risk of extrapyramidal symptoms and CNS effects. Dosing is weight-based for children.

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Geriatric Use

Elderly patients may be more susceptible to the adverse effects of trimethobenzamide, particularly CNS effects (drowsiness, dizziness, confusion) and anticholinergic effects (e.g., urinary retention, constipation). Use with caution, and consider lower starting doses.

Clinical Information

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Clinical Pearls

  • Trimethobenzamide is generally considered a weaker antiemetic compared to some newer agents, but can be useful for mild to moderate nausea and vomiting.
  • It is primarily effective for nausea and vomiting due to its action on the CTZ, rather than direct action on the GI tract.
  • Avoid use in patients with known hypersensitivity to trimethobenzamide or any of its components.
  • Caution should be exercised in patients with acute febrile illness, encephalitis, gastroenteritis, or dehydration, especially in children, as these conditions may increase the risk of extrapyramidal symptoms.
  • Patients should be advised to avoid activities requiring mental alertness until the drug's effects are known.
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Alternative Therapies

  • Ondansetron (5-HT3 receptor antagonist)
  • Promethazine (Phenothiazine, H1-antihistamine)
  • Prochlorperazine (Phenothiazine, dopamine receptor antagonist)
  • Metoclopramide (Dopamine receptor antagonist, prokinetic)
  • Dimenhydrinate (Antihistamine)
  • Meclizine (Antihistamine)
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Cost & Coverage

Average Cost: Varies, typically low per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.