Niflec

Niflec

Manufacturer:

Meiji
Full Prescribing Info
Contents
Macrogol 4000, sodium sulfate, sodium hydrogen carbonate, sodium chloride, potassium chloride.
Description
Each sachet contains Macrogol 4000 118 g, sodium sulfate 11.37 g, sodium hydrogen carbonate 3.37 g, sodium chloride 2.93 g, potassium chloride 1.485 g.
Action
When sufficient of PEG is taken, it leads to an increase in volume in the colon. This distends the colon and thereby stretch the receptors resulting in increased peristaltic movements. This produces voluminous liquid stool.
The sodium chloride, sodium sulfate, potassium chloride and sodium bicarbonate salts prevent both loss and net absorption or ions from the body.
Indications/Uses
Clean the remains in the intestinal tracts, as initial action prior to large intestine endoscopy and surgery.
Dosage/Direction for Use
Dilute 1 sachet of Niflec into 2 L water to make solution.
Normally for 1 time usage, an adult takes the solution of 4 L with drinking rate of about 1 L each hour. However, Niflec should be stopped if the excretion fluid is already clear. The dosage must not exceed 4 L.
Initial Action Prior to Large Intestine Endoscopy: Administered on the Day of Examination: Breakfast should not be taken on the same day (drinking is only allowed in order to add body fluid), administration commences 4 hrs prior to the scheduled examination.
Administered One Day Prior to the Day of Examination: Fasting should be done at the previous night (drinking is only allowed in order to add body fluid), administration commences 1 hr after dinner.
Initial Action Prior to Large Intestine Surgery: Fasting should commence after lunch on the day of surgery (drinking is only allowed in order to add body fluid), then administration of Niflec commences after about >3 hrs after lunch.
Contraindications
Patients with symptoms of digestive tract blockage (risks of tiny holes in the stomach and intestines). Tiny holes in the intestinal tract (risk of complications eg, peritonitis, etc). Symptoms of toxic colitis (appearance of tiny holes that causes peritonitis and intestinal tract bleeding).
Special Precautions
Niflec should be administered with caution to the following patients: Patients suffering from angina pectoris, myocardial infarction (with the administration of Niflec, the body temperature may decline, that sometimes resulted in chest pain). Patients with renal function disorder (sometimes it may induce nausea).
Basic Important Notes: Mallory Weis Syndrome: Sometimes it may result in Mallory Weis syndrome, tiny holes in the intestinal tract, followed by bleeding, large intestine inflammation, therefore, in administering Niflec, the following must be taken into notice:
Mallory Weis syndrome will appear due to the increasing pressure in the stomach or nausea, therefore avoid administering Niflec within a short period of time (administer Niflec about 1 L/hr).
The contraction in the intestinal tract or the detention of Niflec and the contents of intestines may cause nausea, that will result in such syndromes.
Tiny holes at the intestinal tract and bleeding of the large intestine inflammation are caused by the increasing pressure in the intestinal tract, thus at the time of contraction in the intestinal tract or the detention of remaining food in the intestinal tract, Niflec should be administered with caution.
Niflec is administered after bowel movement on the previous day prior to the administration of Niflec or prior to the administration of Niflec on the same day.
Avoid administering Niflec within a short period of time (administer Niflec about 1 L/hr).
If 1 L has been administered, but there is no bowel movement, first ensure that there is no nausea or abdominal pain before continued administration of Niflec, while monitoring bowel movements.
Caution should be taken in administering Niflec for patients with cavity in the intestinal tract, because development of tiny holes in the intestinal tract has been reported due to the increased pressure in the intestinal tract.
If other ingredients or aromatic materials are added into the solution of Niflec, this will change the osmotic pressure and electrolyte density and it will probably result in inflammable gas produced by bacteria in the intestine, thus such materials are prohibited.
Patients Applying Niflec at Home: The following should be taken notice:
In case of side effect, it will be difficult to handle, thus it is warned not to use Niflec while alone.
Drinking should be done slowly and it is warned to take notice of the initial syndromes of anaphylaxis.
Give detail of the side effects of using Niflec eg, syndromes of the digestive tract (nausea, abdominal pain and others), anaphylactic shock, and it should be warned that in case of any of the syndromes, stop using Niflec and seek medical assistance.
Administration of Niflec to Patient Who Uses Insulin or other Diabetes Drugs: For a patient who controls blood sugar by insulin or other diabetes drug, Niflec should be avoided prior to the day of examination.
Niflec should be given on the day of examination under strict supervision. Insulin or other diabetes drugs should be administered after meal on the day of examination (because during the period of food control, it is worried that low blood sugar condition may arise).
Effect on Absorption of Other Drugs: Administration of Niflec may probably cause the impediment in absorbing other drugs.
Niflec may also cause problems for patient who takes clinical test, this drugs must be administered in hospital under strict supervision.
Use in pregnancy & lactation: Niflec is only administered to pregnant women or those with pregnancy probability, when it is determined that the advantages in treatment exceed the potential risk. Safety in the administration of Niflec to pregnant women is still uncertain.
Use in children: Safety in the administration of Niflec is still uncertain.
Use in the elderly: In general, the biological function of the elderly has dropped, thus the administration of Niflec must be slowed down. It must be given under strict supervision.
Use In Pregnancy & Lactation
Niflec is only administered to pregnant women or those with pregnancy probability, when it is determined that the advantages in treatment exceed the potential risk. Safety in the administration of Niflec to pregnant women is still uncertain.
Side Effects
Shock and Anaphylaxis: Niflec must be under strict supervision due to the probability of shock and anaphylaxis. It must be stopped and appropriate action should be taken in case of symptoms eg, paleness, declining blood pressure, vomiting, continued nausea, anxiety, dizziness, cold feeling, rash, respiratory problems, swelling on the face. Tiny Holes in the Intestinal Tract: Niflec must be administered under strict supervision because tiny holes may develop in the intestinal tract. It must be stopped and appropriate actions must be taken when abnormal symptom is detected.
Heavy Vomiting: Heavy vomiting which results in low sodium vomiting may cause consciousness problem and others. In case of such syndrome, appropriate actions must be given eg, compensation of fluid electrolyte and others.
Other Side Effects: Above 5% or Unclear Percentage: Central and Peripheral Nervous System: Unsteadiness, cold feeling.
Digestive System: Abdominal swelling, nausea, abdominal pain, vomiting.
Others: Fatigue.
0.1% to <5%: Psychotropic Nervous System: Insomnia.
Digestive System: Noise in the stomach.
Internal Secretory System: Positive ketone body.
Liver: Increased SGOT, SGPT, LDH, bilirubin and alkali postage. Increase or decrease of protein.
Kidney: Protein in urine being positive.
Blood: Leukopenia.
Others: Headache, dry mouth, frequent bowel movements, heat in chest.
Below 0.1%: Hypersensitivity: Measles, rash.
Digestive System: Anus pain.
Respiratory System: Chest pain.
Internal Secretory System: Syndromes of low blood sugar, high blood pressure, increase in uric acid.
Blood: Sharp increase of leukocytes, increase or decrease of sodium in blood serum.
Others: Fever, shivering, feeling of heavy head.
Drug Interactions
Administration of Niflec to Patients who Uses Insulin or Other Drugs: Niflec should not be administered prior to the day of examination. It should be given on the day of examination under strict supervision. Insulin or other diabetes drugs should be administered after meal on the day of examination.
Administration of Niflec may probably cause the impediment in absorbing other drugs.
Caution For Usage
Method of Preparation: Dissolve 1 sachet of Niflec in water about 2 L, then patient should take it orally.
During Preparation: The solution of Niflec must not be added with other composition or aromatic substances.
During Storage: After being dissolved, better to use it directly. If kept in the refrigerator, it must be used within 48 hrs.
Length of Time in Administering Drug: Move the solution (about 180 mL) into the glass. Within 1 hr, drink about 6 glasses (about 1 L).
During Administration of Niflec: In many cases, bowel movement usually commences after administration of about 1 L solution.
Administration of Niflec is continued until the excretion fluid becomes clear.
Maximum dosage is 4 L.
After administration of Niflec is completed, the patient will still have a few bowel movements.
If there is still no bowel movement after administration of 2 L solution, Niflec must be stopped and may only be re-administered after there is no nausea, vomiting, abdominal pain and after bowel movement.
Purpose of Usage: Niflec is not suitable for initial actions prior to intestine x-ray inspection with barium injection.
Storage
Store at room temperature (15°-30°C).
ATC Classification
A06AD65 - macrogol, combinations ; Belongs to the class of osmotically acting laxatives.
Presentation/Packing
Powd 137.155 g x 1's.
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