Chemically, trimethobenzamide HCl is N-[ p -[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride.
Capsules: Each 300-mg Tigan ® capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg. The capsule has an opaque purple cap marked “Tigan” and an opaque purple body marked “M079”.
Inactive Ingredients: D&C Red No. 28, FD&C Blue No.1, lactose, magnesium stearate, starch and titanium dioxide.
Suppositories (200 mg): Each suppository contains 200 mg trimethobenzamide hydrochloride and 2% benzocaine in a base compounded with polysorbate 80, white beeswax and propylene glycol monostearate.
Suppositories, Pediatric (100 mg): Each suppository contains 100 mg trimethobenzamide hydrochloride and 2% benzocaine in a base compounded with polysorbate 80, white beeswax and propylene glycol monostearate.
Ampuls: Each 2-mL ampul contains 200 mg trimethobenzamide hydrochloride compounded with 0.2% parabens (methyl and propyl) as preservatives, 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.
Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Published Studies Related to Tigan (Trimethobenzamide Rectal)
Randomized, placebo-controlled trial of trimethobenzamide to control nausea and
vomiting during initiation and continued treatment with subcutaneous apomorphine
may not be needed, although this has not been systematically studied... CONCLUSION: Our data suggest that trimethobenzamide helps reduce nausea/vomiting
A clinical trial of trimethobenzamide/diphenhydramine versus sumatriptan for acute migraines. [2006.06]
BACKGROUND: Although various classes of medication are used to treat acute migraine in the emergency department (ED), no treatment offers complete pain relief without side effects or recurrence of headache. Consequently, even though several antiemetic medications as well as SQ sumatriptan have demonstrated efficacy and tolerability for the ED treatment of migraine, there remains a need for more effective parenteral therapies. Open-label studies suggest that the combination of trimethobenzamide and diphenhydramine (TMB/DPH) may provide effective relief in a high proportion of migraineurs. OBJECTIVE: To test the hypothesis that ED patients with acute migraine, given intramuscular TMB/DPH, would have a larger reduction in their pain scores than patients given SQ sumatriptan... CONCLUSIONS: SQ sumatriptan is probably superior to TMB/DPH for treating the pain of acute migraine at 2 hours. However, TMB/DPH was well-tolerated, efficacious, and relieved pain comparably to sumatriptan at 24 hours. TMB/DPH might have a role in select populations in which sumatriptan is contraindicated or likely to be ineffective.
Clinical Trials Related to Tigan (Trimethobenzamide Rectal)
Safety/Efficacy of Tiganï¿½ to Control Nausea/Vomiting Experienced During Apokynï¿½ Initiation and Treatment [Recruiting]
The purposes of the study are to determine:
i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting
when initiating therapy with Apokyn® (apomorphine)
ii. To determine the optimal duration for continuation of Tigan® following initiation of
iii. To assess the safety of Tigan® in combination with Apokyn®
iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated
concomitantly with and without TiganÂ®
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) [Recruiting]
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects [Not yet recruiting]
This study will test the hypothesis that PF-06649751 with continuous co-administration of
trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of
PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose
projected to be under the current limits for drug concentration.
PET Scanning of Adults With Attention Deficit Hyperactivity Disorder (ADHD) [Recruiting]
This study will explore the brain in men with and without attention deficit hyperactivity
disorder (ADHD). It will use positron emission tomography (PET) and magnetic resonance
imaging (MRI) to study brain function and nerve cell communication involving phospholipids
(fatty molecules that make up the covering of nerve cell fibers in the brain and are
involved in communication between the cells). It will also look at how nerve cell
communication is related to blood flow. In particular, the study will explore communication
through the dopamine system, which is one of the main neurotransmitter systems in the brain
involved in ADHD.
Healthy men and men with ADHD between 18 and 55 years of age may be eligible for this study.
Participants undergo the following procedures:
" Medical history and psychiatric and medical evaluation, including blood and urine tests.
" MRI scan. This test uses a strong magnetic field and radio waves to obtain images of the
brain. The subject lies still on a table that slides into the scanner (a metal cylinder)
during the scanning.
" PET scanning. The subject lies on the scanner bed with his head held still using a special
facemask. A catheter (plastic tube or needle) is placed in an artery to collect blood
samples and in a vein to inject radioactive isotopes for measuring blood flow and
phospholipid metabolism. Scans are done after an injection of a saline solution and again
after injection of apomorphine, a medication that turns on dopamine receptors in the brain.
The injections are given under the skin of the abdomen, about one and a half hours apart....
Reports of Suspected Tigan (Trimethobenzamide Rectal) Side Effects
Drug Ineffective (3),
Breast Cancer (3),
Drug Hypersensitivity (3),
Disturbance in Attention (3),
Reading Disorder (2),
Suicidal Ideation (2),
Fatigue (2), more >>