Tigan 100mg/ml Inj, 2ml

Manufacturer PAR Active Ingredient Trimethobenzamide Injection Solution(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
Anticholinergic-like agent; Chemoreceptor Trigger Zone (CTZ) Inhibitor
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Pregnancy Category
Category C
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FDA Approved
Jul 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 affecting a specific area in your brain that controls vomiting.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via intramuscular injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other sedating medications while taking trimethobenzamide, as this can increase drowsiness.
  • Stay hydrated, especially if experiencing vomiting.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg (2 mL) intramuscularly (IM) 3 or 4 times daily
Dose Range: 200 - 800 mg

Condition-Specific Dosing:

postoperative_nausea_vomiting: 200 mg IM prior to or during surgery, or 200 mg IM postoperatively, repeated as needed every 3-4 hours.
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Pediatric Dosing

Neonatal: Not recommended (contraindicated in premature infants and neonates)
Infant: Not recommended
Child: Not recommended for injection (oral capsules for children > 30 lbs, but injection is generally contraindicated/not recommended for pediatric use due to risk of adverse effects)
Adolescent: Not recommended for injection (adult dosing may be considered for older adolescents, but caution advised)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment provided; use with caution.
Moderate: No specific adjustment provided; use with caution.
Severe: No specific adjustment provided; use with caution, as a portion is renally excreted.
Dialysis: Considerations: Not well-studied; monitor for increased adverse effects.

Hepatic Impairment:

Mild: No specific adjustment provided; use with caution.
Moderate: No specific adjustment provided; use with caution.
Severe: No specific adjustment provided; use with caution.

Pharmacology

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Mechanism of Action

Trimethobenzamide is an antiemetic agent thought to act on the chemoreceptor trigger zone (CTZ) in the medulla oblongata. Its exact mechanism is not fully understood, but it is believed to block emetic impulses from reaching the vomiting center.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for IM, but rapidly absorbed.
Tmax: Approximately 15-30 minutes (IM)
FoodEffect: Not applicable for injection.

Distribution:

Vd: Not well-established.
ProteinBinding: Not well-established.
CnssPenetration: Limited, but sufficient to act on CTZ.

Elimination:

HalfLife: Approximately 4-5 hours
Clearance: Not precisely quantified.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 30-50% within 24 hours.
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Pharmacodynamics

OnsetOfAction: 15-30 minutes (IM)
PeakEffect: Not precisely quantified, generally within 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. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Diarrhea
Dizziness or drowsiness
Headache
* Burning, stinging, or redness at the injection site

Reporting Side Effects

These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact 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 stiffness (e.g., tremors, difficulty moving, restlessness)
  • Blurred vision or eye pain
  • Difficulty urinating
  • Severe headache
  • Rash or itching
  • Signs of an allergic reaction (e.g., swelling of face/throat, severe rash, 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 drugs that can cause this side effect, so it is crucial to consult with 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 medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Disclose any health problems you have, as these may affect the medication's safety and efficacy.
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 with 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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Additionally, refrain from consuming alcohol while using this medication.

Prior to using marijuana, other forms of cannabis, or taking prescription or over-the-counter (OTC) drugs that may cause drowsiness, consult with your doctor. This medication is not intended for children, so discuss its use with your doctor if you have any questions.

If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to 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.
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Overdose Information

Overdose Symptoms:

  • Profound drowsiness
  • Dizziness
  • Disorientation
  • Hypotension
  • Extrapyramidal symptoms (e.g., dystonia, akathisia, parkinsonism)
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining airway, breathing, and circulation, and managing symptoms.

Drug Interactions

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Major Interactions

  • Phenothiazines (e.g., prochlorperazine, promethazine): Increased risk of extrapyramidal symptoms (EPS) and other CNS effects.
  • Other drugs with anticholinergic properties (e.g., tricyclic antidepressants, antihistamines): Increased risk of anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention).
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Moderate Interactions

  • CNS depressants (e.g., opioids, benzodiazepines, alcohol, sedatives, hypnotics): Additive CNS depression, increased sedation and drowsiness.
  • Antihistamines (sedating): Additive CNS depression and anticholinergic effects.

Monitoring

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Baseline Monitoring

Patient history (allergies, concurrent medications, underlying conditions)

Rationale: To identify contraindications, potential drug interactions, and risk factors for adverse effects.

Timing: Prior to administration

Physical examination (neurological status, vital signs)

Rationale: To establish baseline and identify pre-existing neurological conditions or instability.

Timing: Prior to administration

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Routine Monitoring

Efficacy (reduction in nausea/vomiting)

Frequency: As needed, after each dose

Target: Subjective improvement

Action Threshold: Lack of efficacy may require alternative antiemetic or investigation of underlying cause.

Adverse effects (drowsiness, dizziness, headache, blurred vision, extrapyramidal symptoms)

Frequency: Regularly during therapy, especially after initial doses

Target: Absence or mild, tolerable effects

Action Threshold: Severe or persistent adverse effects may require dose reduction or discontinuation.

Injection site reaction

Frequency: After IM administration

Target: Absence of pain, redness, swelling

Action Threshold: Significant reaction may require alternative administration site or drug.

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Headache
  • Blurred vision
  • Muscle spasms
  • Tremors
  • Restlessness (akathisia)
  • Difficulty speaking or swallowing (dysphonia, dysphagia)
  • Hypotension
  • Rash

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects at high doses, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies suggest potential risk at high doses.
Second Trimester: Limited human data.
Third Trimester: Limited human data.
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Lactation

Use with caution. It is not known if trimethobenzamide is excreted in human milk. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant.

Infant Risk: Unknown; potential for drowsiness or other CNS effects in the infant.
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Pediatric Use

Contraindicated in premature infants and neonates. Not recommended for use in pediatric patients for injection due to potential for extrapyramidal symptoms and other adverse effects. Oral capsules are indicated for children > 30 lbs.

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Geriatric Use

Use with caution in elderly patients due to increased susceptibility to adverse effects, particularly CNS effects (drowsiness, dizziness) and anticholinergic effects. Start with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Trimethobenzamide is often considered a weaker antiemetic compared to dopamine receptor antagonists (e.g., ondansetron, metoclopramide) but may be useful for mild to moderate nausea or as an adjunct.
  • IM administration should be deep into the upper outer quadrant of the gluteus maximus to minimize local irritation.
  • Avoid use in patients with known hypersensitivity to trimethobenzamide or benzocaine (due to structural similarity).
  • Monitor for extrapyramidal symptoms, especially in children and elderly, although rare with trimethobenzamide alone.
  • Not effective for motion sickness.
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Alternative Therapies

  • Ondansetron (5-HT3 receptor antagonist)
  • Granisetron (5-HT3 receptor antagonist)
  • Prochlorperazine (Dopamine D2 receptor antagonist)
  • Promethazine (H1 receptor antagonist, D2 receptor antagonist)
  • Metoclopramide (Dopamine D2 receptor antagonist, prokinetic)
  • Dimenhydrinate (Antihistamine)
  • Meclizine (Antihistamine)
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Cost & Coverage

Average Cost: Variable, typically $50-$150 per 2ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand) for most commercial and government plans.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.