Niflec Special Precautions

Careful Administration: Niflec should be administered with caution in the following patients: Patients with angina pectoris or patients with history of myocardial infarction. (As Niflec can cause chilliness in the body, chest pain may rarely occur.) Patients with impaired renal function. (Vomiting may rarely occur.)
Important Basic Precautions: Since Mallory-Weiss syndrome, intestinal perforation and ischaemic colitis may rarely occur, the following points should be kept in mind:
Since Mallory-Weiss syndrome can occur due to increased gastric internal pressure, vomiting and nausea, administration in a short period of time should be avoided (dosing should be given at a rate of 1 L/hr as a guide). Furthermore, careful administration is required since intestinal stricture or retention of Niflec or the intestinal contents may cause nausea or vomiting which can trigger the onset of the syndrome.
Careful administration is required since intestinal perforation and ischaemic colitis can be caused by the increased intestinal internal pressure, intestinal stricture or retention of intestinal contents eg, in case of constipation. Administration should be done after making sure that there was defecation on the previous day. Further, administration in a short period of time, which may give rise to increased intestinal internal pressure, should be avoided (dosing should be given at a rate of 1 L/hr as a guide). In addition, in the absence of defecation after dosing about 1 L, dosing should be resumed only in the absence of nausea, vomiting and abdominal pain. Close monitoring should be exercised until defecation is present. Particular caution should be exercised in patients having prior intestinal diverticulum, since it has been reported that intestinal perforation may be triggered by increased intestinal internal pressure in these patients.
When any other ingredient or flavor is added to the dissolved solution of Niflec, the osmotic pressure or concentration of electrolyte may change and inflammable gas may be produced due to enterobacterium; therefore, addition of such substances should be avoided.
In case patients are allowed to take Niflec at home, the following points should be kept in mind: Taking countermeasures may occasionally be difficult in case of adverse reactions. Patients should be advised to avoid taking the drug when there is nobody else nearby.
Particularly, patients should be guided to take the initial 2 or 3 glassfuls of Niflec slowly and to pay attention to any signs of anaphylactoid symptoms.
Patients should be advised of Niflec's adverse reactions eg, digestive symptoms (nausea, vomiting, abdominal pain, etc), shock, anaphylactoid symptoms, etc. When such symptoms appear, they should discontinue medication and consult their physician without delay. Moreover, similar symptoms may arise even after medication. When such symptoms arise, the patients should also consult their physician without delay.
Administration to Patients Receiving Insulin or Oral Hypoglycemic Agents: In patients whose blood glucose is being controlled by insulin or an oral hypoglycemic agent, administration of Niflec on the day preceding examination should be avoided. Patients should be given Niflec on the day of examination under close observation. Dosing of insulin or an oral hypoglycemic agent should be started after dietary intake on the day of examination (because dietary restriction may cause hypoglycemia).
Effect on the Absorption of Drugs: Caution should be exercised as to dosing time since intestinal lavage by Niflec may disturb the absorption of an orally administered drug. Moreover, in patients on any drug which can cause clinically serious problems once the drug's absorption is inhibited, administration should be exercised while closely monitoring the patient's condition in the hospital.
Use in pregnancy & lactation: Niflec should be administered to women who are or may be pregnant only when the benefit of the treatment in judged to outweigh its possible risks. Safety during pregnancy has not yet been established.
Use in children: Safety of Niflec in children has not been established. (Fewer previous uses.)
Use in the elderly: In general, physiological function in the elderly is decreasing; therefore, one should slow down the dosing velocity while closely observing elderly patients.