Tigan 300mg Capsules

Manufacturer PFIZER 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
Jan 1961
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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 calming the part of your brain that causes you to feel sick.
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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 the bathroom. Keep all medications in a secure location, out of the 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. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for safe and responsible disposal.

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, be sure not to exceed the frequency recommended by your doctor.
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Lifestyle & Tips

  • Avoid alcohol while taking this medication, as it can increase drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Stay hydrated, especially if experiencing vomiting.
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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: 900 - 1200 mg

Condition-Specific Dosing:

maximumDailyDose: 1.2 grams (1200 mg) per 24 hours
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Pediatric Dosing

Neonatal: Contraindicated
Infant: Not established; generally not recommended due to risk of Reye's syndrome and CNS effects.
Child: Not established; generally not recommended due to risk of Reye's syndrome and CNS effects.
Adolescent: Not established; generally not recommended due to risk of Reye's syndrome and CNS effects.
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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: Not available

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 primarily acts on the chemoreceptor trigger zone (CTZ) in the medulla oblongata. It blocks emetic impulses from reaching the vomiting center, thereby inhibiting nausea and vomiting. Its exact mechanism of action is not fully elucidated but is thought to involve antagonism of dopamine D2 receptors in the CTZ, although it is not a phenothiazine derivative.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well absorbed orally.
Tmax: Approximately 1 to 2 hours
FoodEffect: Not significantly affected by food; can be taken with or without food.

Distribution:

Vd: Not precisely quantified
ProteinBinding: Not precisely quantified
CnssPenetration: Limited, but sufficient to act on the CTZ which is outside the blood-brain barrier.

Elimination:

HalfLife: Approximately 7 to 9 hours
Clearance: Not precisely quantified
ExcretionRoute: Primarily renal excretion (urine), with a significant portion excreted unchanged.
Unchanged: Approximately 30-50% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Oral: 10 to 40 minutes
PeakEffect: Oral: 1 to 2 hours
DurationOfAction: Oral: 3 to 4 hours

Safety & Warnings

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BLACK BOX WARNING

Trimethobenzamide is contraindicated in pediatric patients and has been associated with Reye's syndrome in children and adolescents. The use of trimethobenzamide in pediatric patients should be avoided.
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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

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, changes in balance, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Diarrhea
Dizziness or drowsiness
Headache

This is not an exhaustive list of possible 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 dizziness or lightheadedness
  • Unusual or uncontrolled muscle movements (e.g., tremors, stiffness, difficulty speaking or swallowing)
  • Confusion or disorientation
  • Severe skin rash or itching
  • Yellowing of the skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., swelling of face/lips/tongue, difficulty breathing)
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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. Be sure to describe the allergic reaction and its symptoms.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you are taking any medications that may increase the risk of involuntary body movements. There are numerous medications that can cause this side effect, so consult 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 crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Never start, stop, or change the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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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.

To ensure your safety, avoid operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you. Additionally, refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.

Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions, consult with your doctor to discuss potential interactions.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to experiencing side effects.

If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

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 administering this medication to your child, discuss them with their doctor.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Coma
  • Seizures
  • Hypotension (low blood pressure)
  • Respiratory depression
  • Extrapyramidal symptoms (e.g., dystonia, akathisia, parkinsonism)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including maintaining airway, breathing, and circulation.

Drug Interactions

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Major Interactions

  • Phenothiazines (e.g., prochlorperazine, promethazine): Increased risk of extrapyramidal symptoms (EPS) and other CNS side effects.
  • Other CNS depressants (e.g., opioids, benzodiazepines, sedatives, hypnotics, general anesthetics): Additive CNS depression, including drowsiness and respiratory depression.
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Moderate Interactions

  • Alcohol: Additive CNS depression.
  • Anticholinergic drugs: May potentiate anticholinergic effects.

Monitoring

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Baseline Monitoring

Patient history (CNS disorders, liver/kidney function)

Rationale: To identify pre-existing conditions that may increase risk of adverse effects or require dose adjustment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Neurological status (drowsiness, dizziness, confusion)

Frequency: Periodically, especially during initial therapy or dose changes

Target: Absence of significant impairment

Action Threshold: Significant or worsening CNS depression; consider dose reduction or discontinuation.

Signs of extrapyramidal symptoms (EPS)

Frequency: Periodically

Target: Absence of EPS (e.g., dystonia, akathisia, parkinsonism)

Action Threshold: Development of EPS; discontinue drug and manage symptoms.

Skin reactions (rash, urticaria)

Frequency: Periodically

Target: Absence of allergic reactions

Action Threshold: Development of rash or other allergic symptoms; discontinue drug.

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Symptom Monitoring

  • Dizziness
  • Drowsiness
  • Headache
  • Diarrhea
  • Constipation
  • Muscle cramps
  • Blurred vision
  • Rash
  • Uncontrolled muscle movements (e.g., tremor, rigidity, restlessness)

Special Patient Groups

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Pregnancy

Category C. Trimethobenzamide 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

Trimethobenzamide is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Potential for adverse effects, including CNS depression and theoretical risk of Reye's syndrome (though less direct than in children).
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Pediatric Use

Contraindicated in neonates. Not recommended for use in children and adolescents, especially those with viral illnesses (e.g., chickenpox, flu-like symptoms), due to the potential association with Reye's syndrome and increased risk of CNS side effects (e.g., seizures, extrapyramidal symptoms).

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Geriatric Use

Elderly patients may be more susceptible to the CNS side effects (e.g., drowsiness, dizziness, confusion) and extrapyramidal symptoms. Use with caution and consider starting with lower doses.

Clinical Information

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Clinical Pearls

  • Trimethobenzamide is generally less effective for motion sickness compared to other antiemetics.
  • It is often used when other antiemetics are contraindicated or have failed, particularly for postoperative nausea and vomiting or nausea associated with gastroenteritis.
  • Patients should be advised to avoid activities requiring mental alertness until they know how the drug affects them.
  • The risk of Reye's syndrome in children is a significant concern, making its use in this population generally contraindicated.
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Alternative Therapies

  • Ondansetron (Zofran)
  • Promethazine (Phenergan)
  • Prochlorperazine (Compazine)
  • Metoclopramide (Reglan)
  • Dimenhydrinate (Dramamine)
  • Meclizine (Antivert)
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Cost & Coverage

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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.