Tigan Injection (Trimethobenzamide Hydrochloride Injectable)
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Tigan Injection (Trimethobenzamide Hydrochloride Injectable)

Tigan®
(trimethobenzamide hydrochloride) Injectable

For Intramuscular Use Only

Not for Use in Pediatric Patients

DRUG DESCRIPTION

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Tigan® (trimethobenzamide hydrochloride)  Structural Formula Illustration

Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

What are the possible side effects of trimethobenzamide (Tigan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • jaundice (yellowing of the skin or eyes);
  • seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • tremor (uncontrolled shaking); or
  • muscle cramps, severe muscle spasms.

Continue using trimethobenzamide and talk with your doctor if you have any of...

Read All Potential Side Effects and See Pictures of Tigan Injection »

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Tigan® (trimethobenzamide hydrochloride injectable) is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

DOSAGE AND ADMINISTRATION

(See WARNINGS and PRECAUTIONS.)

Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.

Geriatric Patients

Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients with Renal Impairment

In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

INJECTABLE, 100 mg/mL (Not for use in pediatric patients)

Usual Adult Dosage

2 mL (200 mg) t.i.d. or q.i.d. intramuscularly.

NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use.

Intramuscular administration may cause pain, stinging, burning, redness and swelling at the site of injection. Such effects may be minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.

Storage

Store at 25°C (77°F).

Excursions permitted to 15-30°C (59-86°F).

[See USP Controlled Room Temperature]

HOW SUPPLIED

Single-Dose Vials, 2 mL, trays of 25

NDC 42023-119-25 100 mg/mL in 2 mL Single-Dose Vials

Multi-Dose Vials, 20 mL

NDC 42023-118-01 100 mg/mL in 20 mL Multi-Dose Vials

Prescribing Information as of January 2008. Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307. FDA Rev date: 04/18/08

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

There have been reports of hypersensitivity reactions and Parkinson-like symptoms. There have been instances of hypotension reported following parenteral administration to surgical patients. There have been reports of blood dyscrasias, blurring of vision, coma, convulsions, depression of mood, diarrhea, disorientation, dizziness, drowsiness, headache, jaundice, muscle cramps and opisthotonos. If these occur, the administration of the drug should be discontinued. Allergic-type skin reactions have been observed; therefore, the drug should be discontinued at the first sign of sensitization. While these symptoms will usually disappear spontaneously, symptomatic treatment may be indicated in some cases.

Read the Tigan Injection (trimethobenzamide hydrochloride injectable) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Tigan® (trimethobenzamide hydrochloride injectable) may produce drowsiness. Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined.

Usage in Pregnancy: Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.

Usage with Alcohol: Concomitant use of alcohol with Tigan® (trimethobenzamide hydrochloride injectable) may result in an adverse drug interaction.

PRECAUTIONS

During the course of acute febrile illness, encephalitides, gastroenteritis, dehydration and electrolyte imbalance, especially in children and the elderly or debilitated, CNS reactions such as opisthotonos, convulsions, coma and extrapyramidal symptoms have been reported with and without use of Tigan® (trimethobenzamide hydrochloride injectable) (trimethobenzamide hydrochloride) or other antiemetic agents. In such disorders caution should be exercised in administering Tigan® (trimethobenzamide hydrochloride injectable) , particularly to patients who have recently received other CNS-acting agents (phenothiazines, barbiturates, belladonna derivatives). Primary emphasis should be directed toward the restoration of body fluids and electrolyte balance, the relief of fever and relief of the causative disease process. Overhydration should be avoided since it may result in cerebral edema.

The antiemetic effects of Tigan® (trimethobenzamide hydrochloride injectable) may render diagnosis more difficult in such conditions as appendicitis and obscure signs of toxicity due to overdosage of other drugs.

General

Adjustment of Dose in Renal Failure

A substantial route of elimination of unchanged trimethobenzamide is via the kidney. Dosage adjustment should be considered in patients with reduced renal function including some elderly patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of trimethobenzamide hydrochloride did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Although there are studies reported in the literature that included elderly patients > 65 years old with younger patients, it is not known if there are differences in efficacy or safety parameters for elderly and non-elderly patients treated with trimethobenzamide. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

The injectable form of Tigan® (trimethobenzamide hydrochloride injectable) is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of Tigan® (trimethobenzamide hydrochloride injectable) as determined in animals is obscure, but may involve the chemoreceptor trigger zone (CTZ), an area in the medulla oblongata through which emetic impulses are conveyed to the vomiting center; direct impulses to the vomiting center apparently are not similarly inhibited. In dogs pretreated with trimethobenzamide HCl, the emetic response to apomorphine is inhibited, while little or no protection is afforded against emesis induced by intragastric copper sulfate.

Pharmacokinetics

The pharmacokinetics of trimethobenzamide have been studied in healthy adult subjects. Following administration of 200 mg (100 mg/mL) Tigan I.M. injection, the time to reach maximum plasma concentration (Tmax) was about half an hour, about 15 minutes longer for Tigan 300 mg oral capsule than an I.M. injection. A single dose of Tigan 300 mg oral capsule provided a plasma concentration profile of trimethobenzamide similar to Tigan 200 mg I.M. The relative bioavailability of the capsule formulation compared to the solution is 100%. The mean elimination half-life of trimethobenzamide is 7 to 9 hours. Between 30 - 50% of a single dose in humans is excreted unchanged in the urine within 48 - 72 hours. The metabolic disposition of trimethobenzamide in humans is not known. Specifically, it is not known if active metabolites are generated in humans.

Special Populations

Age

The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in elderly patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney and that elderly patients may have various degrees of renal impairment. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION).

Gender

Systemic exposure to trimethobenzamide was similar between men (N=40) and women (N=28).

Race

Pharmacokinetics appeared to be similar for Caucasians (N=53) and African Americans (N=12).

Renal Impairment

The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

Tigan®
(trimethobenzamide hydrochloride) Injectable

For Intramuscular Use Only

Not for Use in Pediatric Patients

DRUG DESCRIPTION

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Tigan® (trimethobenzamide hydrochloride)  Structural Formula Illustration

Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

Tigan®
(trimethobenzamide hydrochloride) Injectable

For Intramuscular Use Only

Not for Use in Pediatric Patients

DRUG DESCRIPTION

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Tigan® (trimethobenzamide hydrochloride)  Structural Formula Illustration

Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

Tigan®
(trimethobenzamide hydrochloride) Injectable

For Intramuscular Use Only

Not for Use in Pediatric Patients

DRUG DESCRIPTION

Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula:

Tigan® (trimethobenzamide hydrochloride)  Structural Formula Illustration

Single-Dose Vials: Each 2-mL single-dose vial contains 200 mg trimethobenzamide hydrochloride compounded with 1 mg sodium citrate and 0.4 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Multi-Dose Vials: Each mL contains 100 mg trimethobenzamide hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to approximately 5.0 with sodium hydroxide.

Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.

Tigan Injection Patient Information Including Side Effects

Brand Names: Tigan

Generic Name: trimethobenzamide (Pronunciation: trye METH oh BENZ a mide)

What is trimethobenzamide (Tigan Injection)?

Trimethobenzamide affects the areas of the brain that stimulate nausea and vomiting.

Trimethobenzamide is used to treat nausea and vomiting.

Trimethobenzamide may also be used for purposes other than those listed in this medication guide.

Tigan 250 mg

blue, imprinted with TIGAN, ROBERTS 187

What are the possible side effects of trimethobenzamide (Tigan Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • jaundice (yellowing of the skin or eyes);
  • seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • tremor (uncontrolled shaking); or
  • muscle cramps, severe muscle spasms.

Continue using trimethobenzamide and talk with your doctor if you have any of these less serious side effects:

  • drowsiness or dizziness;
  • headache;
  • feeling depressed or disoriented; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tigan Injection (trimethobenzamide hydrochloride injectable) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about trimethobenzamide (Tigan Injection)?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a trimethobenzamide overdose may include drowsiness, uncontrollable movements, muscle spasms, blurred vision, seizures or convulsions, difficulty breathing, and death.

Trimethobenzamide may increase the side effects of other drugs that make you sleepy (such as alcohol, cold medicine, pain medication, muscle relaxants, and medicine for seizures, depression or anxiety). Before using trimethobenzamide, tell your doctor if you are using any of these medicines.

Trimethobenzamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while you are using trimethobenzamide. Alcohol may increase drowsiness and dizziness.

Side Effects Centers

Tigan Injection Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking trimethobenzamide (Tigan Injection)?

Before taking this medication, tell your doctor if you have:

  • kidney or liver disease;
  • an enlarged prostate;
  • difficulty urinating or other bladder problems;
  • glaucoma;
  • asthma; or
  • heart disease or a heart rhythm disorder.

If you have any of these conditions, you may not be able to use trimethobenzamide, or you may need a dosage adjustment or special tests during treatment.

It is not known whether trimethobenzamide will be harmful to an unborn baby. Do not take trimethobenzamide without telling your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether trimethobenzamide passes into breast milk. Do not take trimethobenzamide without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child, especially if the child has a fever or has recently had chicken pox.

How should I take trimethobenzamide (Tigan Injection)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

Take this medication with a full glass of water.

Trimethobenzamide is normally used three or four times a day. You may also be using the medicine only as needed. Follow your doctor's instructions.

Store trimethobenzamide at room temperature away from moisture and heat.

Side Effects Centers

Tigan Injection Patient Information including If I Miss a Dose

What happens if I miss a dose (Tigan Injection)?

This medicine is often used only when needed to control nausea or vomiting, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Tigan Injection)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a trimethobenzamide overdose may include drowsiness, uncontrollable movements, muscle spasms, blurred vision, seizures or convulsions, difficulty breathing, and death.

What should I avoid while taking trimethobenzamide (Tigan Injection)?

Trimethobenzamide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while you are using trimethobenzamide. Alcohol may increase drowsiness and dizziness.

What other drugs will affect trimethobenzamide (Tigan Injection)?

Trimethobenzamide may increase the side effects of other drugs that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for seizures, depression or anxiety). Before using trimethobenzamide, tell your doctor if you are using any of these medicines.

There may be other drugs that can affect trimethobenzamide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about trimethobenzamide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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