Indications
This preparation may be employed to advantage in the treatment of a wide range of gastrointestinal disorders, including such conditions as peptic ulcer, gastritis, hyperchlorhydria, functional diarrhea, irritable or spastic colon, pyloroduodenal irritability, pylorospasm, acute nonspecific gastroenteritis, biliary dyskinesia and chronic cholelithiasis, duodenitis, gastrointestinal spasm; it may also be used to treat genitourinary spasm. This preparation is particularly indicated where anxiety, tension, worry, or other emotional factors are thought to be wholly or partially responsible for the digestive dysfunction.
Pharmacology
Trifluoperazine inhibits dopamine D2 receptors in the brain. It has weak anticholinergic and sedative effects but strong extrapyramidal and antiemetic effects. It controls severely disturbed, agitated or violent behaviour but may also be used for nonpsychotic anxiety.
Dosage And Administration
Since both components of this preparation are inherently long-acting, a single tablet twice daily (every 12 hours) can provide continuous 24-hour control of symptoms of ulcer and other gastrointestinal disorders.
In addition to the convenience of twice-daily dosage, this tablet can provide significant therapeutic advantages: continuous reduction of gastric secretion; continuous inhibition of spasm and motility; continuous relief of anxiety and tension; continuous control of nausea and vomiting.
Interaction
Increased CNS depression with CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anaesthetics, or alcohol. Increased risk of side effects with drugs with antimuscarinic properties e.g. TCA, antiparkinsonian drugs. Antagonised effects of dopaminergic drugs such as levodopa. Increased risk of hypotension with antihypertensives, trazodone. Reverses antihypertensive effect of guanethidine. Increased risk of severe extrapyramidal side-effects or severe neurotoxicity with lithium. Possible decrease in absorption with antacids.
Contraindications
Because of the antiemetic action of the trifluoperazine component, this should not be used where nausea and vomiting are believed to be evidence of intestinal obstruction or brain tumor.
Side Effects
The usual anticholinergic side effects are dry mouth, blurred vision, urinary hesitancy and retention, and constipation–have been encountered with this tablet.
Pregnancy And Lactation
Use during pregnancy should be restricted to those cases where the potential benefit to the mother outweighs the potential risk to the fetus. Adequate human data on use during lactation and adequate animal reproduction studies are not available.
Precautions And Warnings
Use with caution in elderly patients, in patients with cardiac impairment, hyperthyroidism, or hiatal hernia associated with reflux esophagitis (anticholinergic drugs may aggravate this condition).
Therapeutic Class
Anticholinergics (antimuscarinics)/ Anti-spasmodics, Phenothiazine related drugs
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.