TIGAN SUMMARY
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.
|
NEWS HIGHLIGHTS
Published Studies Related to Tigan (Trimethobenzamide Rectal)
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 Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment [Active, not recruiting]
The purposes of the study are to determine:
i. The rate of Apokyn®-related nausea and vomiting in subjects treated with oral Tigan®
compared to those treated with oral placebo (inactive substance).
ii. The need for continued use of Tigan® for control of nausea and vomiting with on-going
Apokyn® treatment for up to 12 weeks
iii. Possible side effects of Tigan® when used in combination with Apokyn® in subjects with
Parkinson's Disease
iv. If Tigan® slows or hastens the body's metabolism (clearance) of Apokyn®.
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....
|
