Remitch Special Precautions

Careful administration (Caution should be exercised when administering REMITCH to the following patients): Elderly patients.
Patients with hepatic dysfunction: No clinical studies have been conducted in patients with severe hepatic dysfunction (Child-Pugh grade C); Blood concentration may increase for patients with moderate hepatic dysfunction (Child-Pugh grade B).
Patients with renal impairment: Blood concentration may increase.
Important precautions: For the use of this product in patients with severe hepatic dysfunction (Child-Pugh grade C), risk/benefit should be considered, and the patient's condition should be carefully monitored during the treatment period.
If no efficacy is observed after using this product, be careful not to aimlessly prescribe it to patients over a long period of time.
Endocrine dysfunction, such as an elevation of the prolactin level, may appear when receiving this product. Therefore, it is desirable to examine the patient as needed.
Precautions concerning use: Precautions regarding dispensing: If the product comes in a press-through package (PTP), instruct the patients to remove the product from the PTP sheet before use. It has been reported that, if the PTP sheet is swallowed, its sharp corners may penetrate the esophageal mucosa, leading to perforation and severe complications such as mediastinitis.
Precautions related to storage: Store unopened packages as aluminum pillow packages (with oxygen absorbers). If the packages are open, store this product away from moisture and take it as soon as possible.
Precautions related to administration: This product can be swallowed with saliva after placing it on the tongue, wetting it, mashing it slightly with the tongue, and then letting it disintegrate. This product can also be taken by swallowing with a drink of water.
Other precautions: An animal study in dogs has shown that intravenous administration of this product at 0.1 μg/kg or more decreased blood pressure under general anesthesia.
An animal study in rats has shown that intramuscular administration of this product at 40 μg/kg/day or more has shown a decrease in the conception rate.
Effects on ability to drive and use machine: Since this product may induce sleepiness, dizziness, etc., patients should be cautioned against engaging in potentially hazardous activities requiring alertness, such as operating machinery or driving a car.
Use in the Elderly: In general, elderly patients often have reduced physiological functions. Thus, this product should be administered with care to elderly patients while monitoring the patients' conditions.
Use in Children: The safety of this product in premature, neonates, nursing infants, infants and children has not been established (no clinical studies have been conducted in pediatric patients).