Oralax-C

White powder.
Each sachet (137.155 g) contains Polyethylene glycol (INN: Macrogol) 4000 118 g, Sodium chloride 2.930 g, Sodium bicarbonate 3.370 g, Potassium chloride 1.485 g, Anhydrous sodium sulfate 11.370 g.
Electrolytic concentration of the dissolved solution (dissolve one pack in water to make 2 L). (See Table 1.)

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Pharmacology: Pharmacodynamics: High molecular weight polyethylene glycol are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by oral route, they lead to an increase in volume of intestinal fluids. The volume of unabsorbed intestinal fluid accounts for laxative properties of solution. Polyethylene glycol is an osmotic agent that causes retention of water in the stool resulting in a softer stool and more frequent bowel movements.
Pharmacokinetics: Polyethylene glycols of high molecular weight are not significantly absorbed from gastrointestinal tract. The pharmacokinetic data confirm that polyethylene glycol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.

Elimination of the intestinal contents during pre-treatment for colonoscopy and large bowel operation.

Recommended Dose: Dissolve one pack of ORALAX-C in water to make about 2 L solution. Usually, orally administer 2 to 4 L of the dissolved solution at a rate of about 1 L/hour. However, discontinue dosing at the time excretion liquid becomes clear. Refrain from dosing more than 4 L.
Pre-treatment for colonoscopy: (1) In the case of administering on the day of examination: Refrain from having breakfast on the day (intake of water is only acceptable), and start dosing from about 4 hours ahead of the scheduled start time of examination.
(2) In the case of administering on the day before examination: Refrain from having any food after supper on the previous day (intake of water is only acceptable), and start dosing after the elapse of at least about 1 hour following the supper. However breakfast and lunch on the previous day must be those with smaller amount of residue and supper must be liquid food containing no solid matter.
Pre-treatment of large bowel operation: Fast after lunch on the day before operation (intake of water is only acceptable), and start dosing after the elapse of at least about 3 hours following lunch.
The elderly: In general, the biological function of the elderly has dropped, thus the administration of drug must be slowed down. Drug must be given under strict supervision.
Children: Safety in the administration of this drug is still uncertain.
Mode of Administration: Polyethylene glycol solutions are administered orally.

Overdose: Acute toxicity increases with decreasing molecular weight of polyethylene glycol. Solid forms of polyethylene glycol have a higher molecular weight (MW greater than 3000) and are not readily absorbed with oral ingestion, therefore these formulations rarely produce toxicity. Overdose could lead to diarrhea, excessive fluid loss by diarrhea or vomiting.
Treatment: There is no specific antidote. Treatment is symptomatic and supportive. Patients will generally recover with supportive care. Diarrhea which disappears when treatment is temporarily interrupted or the dosage is reduced. Excessive fluid loss by diarrhea or vomiting may require correction of electrolyte disturbances.

Hypersensitivity to any component, such as polyethylene glycol.
Gastrointestinal tract obstruction. (Intestinal perforation may occur.)
Intestinal perforation. (Peritonitis of other serious complications may occur.)
Toxic mega colon. (Peritonitis or intestinal bleeding may occur, following perforation triggered by the symptom.)

Should be used with caution in patients with impaired gag reflex, unconscious or semi-conscious patients, and those prone to regurgitation or aspiration; these patients should be observed during administration.
If severe discomfort or distention occurs while consuming polyethylene glycol solutions, administration of the drug should be slowed or temporarily discontinued until symptoms abate.
Patients with angina pectoris or patients with old myocardial infarction. (As product can give a chilliness in the body, chest pain may rarely occur.)
Patients with impaired renal. (Vomiting may rarely occur.)
Important Basic precautions: Since Mallory-Weiss syndrome, intestinal perforation and colitis ischaemic may nearly occur, the following points should be kept in mind: Since Mallory-Weiss syndrome can occur due to gastric internal pressure increased, vomiting, nausea, administration in a short period of time should be avoided (dosing should be given at a rate of 1 L/hour as a guide). Furthermore, since intestinal stricture or retention of product or the intestinal contents may cause nausea or vomiting. Thereby triggering the onset of the syndrome. Careful administration is required.
Since intestinal perforation and colitis ischaemic can be produced by the intestinal pressure increased, in case of intestinal stricture or retention of intestinal contests such as in case of constipation, careful administration is required. Administration should be given after making sure that was defecation on the previous day before administration of product on the day. Further, administration in a short period of time which may give rise to the intestinal pressure increased, should be avoided (dosing should be given at a rate of 1 L/hour as a guide). In addition, in case of absence of defecation after dosing about 1 L, dosing should be resumed upon identifying the absence of nausea, vomiting and abdominal pain, and close monitoring should be exercised until defecation is seen. Since it has been reported that in a patient having prior diverticulum intestinal, intestinal perforation was triggered by the intestinal internal pressure increased, particular caution should be exercised.
When any other ingredient or flavor is added to the dissolved solution of product, osmotic pressure or concentration of electrolyte may change or inflammable gas may be produced due to enterobacterium; therefore, addition, in a such substance should be avoided.
In the case of letting patients take the drug at home, the following points should be kept in mind: Since taking countermeasures may occasionally be difficult in case of adverse reaction, patients should be guided in a fashion to avoid taking the drug when there is nobody else nearby.
Particularly, patients should be guided to take the initial two or three glassfuls of product in a slow fashion and to pay attention to the signs of anaphylactoid symptoms.
Patient should be provided explanation of product adverse reaction such as digestive symptoms (nausea, vomiting, abdominal pain, etc.) shock, anaphylactoid symptoms and so on, and when such symptoms appear, they should discontinue medication and consult their physician without delay. Moreover, since similar symptoms may arise even after medication, when such symptoms appear, the patients should consult their physician without delay.
Administration to patients receiving insulin or an oral hypoglycemic agent: In the case of patients whose blood glucose is being controlled by insulin or an oral hypoglycemic agent, administration of product on the day preceding examination should be avoided. Patients should be given product 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 drugs: Since intestinal lavage by product may disturb the absorption of an orally administration drug, caution should be exercised as to dosing time. Moreover, in patients on any drug which can cause clinically serious problems once its absorption is inhibited, administration should be exercised while closely monitoring the patient's condition in the hospital.

Pregnancy: Safety in the administration of this drug to pregnant women is still uncertain. This drug is only administered to pregnant women or those with pregnancy probability, when it is determined that the advantages in treatment exceed the potential risk.

Results obtained up to the time of completion of post-marketing surveillance for reexamination: Out of a total of 11,866 patients, 298 patients (2.51%) presented adverse reactions. The primary reactions were 100 cases of vomiting (0.84%), 55 cases of abdomen enlarged feeling (0.46%), 54 cases of retching (0.46%), 40 cases of feeling cold (0.34%), 37 cases of nausea (0.31%), etc. Anomaly of laboratory findings was seen in 157 patients (0.31%) or 224 cases. The primary ones were 28 cases of ketone bodies urine positive (0.24%), 22 cases of GOT increased (0.19%) and 16 cases of LDH increased (0.13%).
Results of a controlled study dedicated to the addition of the previous day dosing method: Out of a total 147 dosed patients, 130 patients (88.4%) (including anomaly of laboratory findings) presented adverse reactions. The primary ones were 92 cases of abdomen enlarged feeling (62.6%), 52 cases of nausea (35.4%), 34 cases of abdominal pain (23.1%), 40 cases of feeling cold (27.2%), 20 cases of malaise (13.6%), 15 cases of dizzy feeling (10.2%), 9 cases of vomiting (6.1%), 7 cases of headache (4.8%), 6 cases of sleep loss (appeared only in the previous day dosing method) (4.1%). 6 cases of bilirubin value increased (4.1%), 4 cases of GOT increased (2.7%), 2 cases of GPT increased (1.4%), etc. It should be noted that in this paragraph, all subjective and symptoms with which causal relationship of product cannot be denied were included in the category of adverse reactions.
Clinically significant adverse reactions: Shock, anaphylactoid symptoms: Since shock and anaphylactoid symptoms may occur, close monitoring should be carried out and when pallor facial, blood pressure decreased, vomiting, continuous nausea, feeling bed, vertigo, feeling cold, urticaria, dyspnea, face oedema and so forth arise, administration should be discontinued and adequate treatment should be given. In the case of letting patients take product at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Intestinal perforation: Since intestinal perforation may occur, close monitoring should be carried out and when anomaly is observed, administration should be discontinued and adequate treatment should be given. In the case of letting patients take product at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Hyponatremia: Since vomiting may cause hyponatremia which can lead to the consciousness disturbed, convulsion and so on, when such symptoms arise, adequate treatment should be given such as correction of electrolytes. In the case of letting patients take drug at home, it is necessary to offer them guidance by referring to Important Basic precautions under Precautions.
Other adverse reactions: See Table 2.

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Oral medication should not be taken within one hour of administration of polyethylene glycol solutions as it may be flushed from the gastrointestinal tract and not absorbed. Administration of polyethylene glycol solutions may probably cause the impediment in absorbing other drugs. The therapeutic effect of drugs with narrow therapeutic index or short half-life may be particularly affected.

Method of preparation: Dissolve one full bag of product in water to make about 2 L, and then administer it to subjects (since the individual ingredients in the bag are not being mixed homogeneously, be sure to dissolve one full bag at a time).
Preparation: No additional ingredients or flavoring should be added to product solution (refer to Important Basic precautions under Precautions).
Storage: Use product immediately after dissolution. When unused, keep product solution refrigerated and use it within 48 hours of dissolution.
Dosing velocity: Transfer the dissolved solution (about 180 mL) to glasses to get six glassfuls of it (about 1 L/hour) as a guide.
Administration: If more case of defecation starts more or less from the time about 1 L of the product is administered, and defecation occurs several times thereafter; however, administration should be continued until the rectal effluent turns clear with a maximum of 4 L. Defecation may be produced several times even after the subjects are given 2 L, administration should be discontinued, and be resumed upon identifying the absence of nausea, vomiting and abdominal pain as well as the presence of defecation.
Intended purpose: It should be noted that product is not suited for the pre-treat for barium enema x-ray colonography.

Store below 30°C.

Laxatives, Purgatives

A06AX - Other drugs for constipation ; Used in the treatment of constipation.

NDD