Date of approval.
Date of revision.
Polyethylene glycol 4000 dispersion instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Polyethylene glycol 4000 dispersion
Trade name: Chang Song
English name: Macrogol 4000 Powder
Chinese Pinyin: Juyi’ erchun 4000 San
Ingredients
The main ingredient of this product is polyethylene glycol 4000, which is a mixture of ethylene oxide and water condensation, and the excipients are sodium saccharin and fruit flavor.
Properties
This product is white powder with citrus fragrance.
Indications
Adults and children over 8 years old (including 8 years old) for the treatment of constipation symptoms. Children should be short-term treatment, the longest course of treatment should not exceed three months.
Specification
10g
Dosage and Administration
Adults and children over 8 years old (including 8 years old) 1 sachet each time, 1 to 2 times a day; or 2 sachets per day, one time in a single dose. The contents of each sachet should be dissolved in a glass of water (at least 50ml) and then taken. The daily dose should be adjusted according to the clinical outcome of the patient after taking it, ranging from 1 sachet every other day (especially in children) to 2 sachets per day.
The effect is apparent 24-48 hours after taking Chang Song 10g.
[Adverse Reactions].
Adverse drug reactions are listed according to the event rate classification.
Very common (³1/10); common (³1/100,<1/10); uncommon (³1/1000,<1/100), rare (³1/10,000,<1/1000); very rare (<1/10,000); unknown (cannot be estimated from the available data).
Adults.
The adverse reactions listed in the table below are from clinical trials (600 adults) and post-marketing use. Overall, the majority of adverse reactions were mild and transient, primarily in the digestive system.
Systemic Organ Classification Adverse Reactions Digestive System Symptoms Common
Abdominal pain
abdominal distention
Diarrhea
nausea uncommon vomiting
Acute diarrhea
Fecal incontinenceMetabolic and nutritional disordersUnknown electrolyte disturbances (hyponatremia, hypokalemia) and/or dehydration, especially in the elderlyImmune system symptomsVery rareAllergic reactions (erythema, pruritus, rash, urticaria, angioedema, anaphylaxis)Children.
The adverse reactions listed in the table below are from clinical trials and post-marketing use in 147 children (age 6 months to 15 years). Similar to adults, adverse reactions were mostly mild and transient, mainly in the digestive system.
Systemic Organ Classification Adverse Reactions Digestive system symptoms common
Abdominal pain
Diarrhea* uncommon Vomiting
Abdominal distention
Nausea Immune system symptoms unknown Allergic reactions (pruritus, rash, urticaria, angioedema, anaphylaxis) *Diarrhea can cause pain around the anus.
[Contraindications] This product is contraindicated in the following conditions.
1. severe inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or toxic megacolon.
2. Gastrointestinal perforation or risk of GI perforation.
3. intestinal obstruction or suspected intestinal obstruction, or symptomatic stricture
4. Symptoms of unexplained abdominal pain.
5. Known hypersensitivity to one of the components of polyethylene glycol or excipients.
[Caution].
Special warnings.
Pharmacologic treatment of constipation needs to be supplemented with lifestyle and dietary modifications to.
-Increase water intake and intake of plant fiber-rich foods
-Physical exercise and restoration of the bowel reflex are recommended.
Prior to the start of treatment, organic diseases should be excluded.
This product contains polyethylene glycol. Allergic reactions (erythema, pruritus, rash, urticaria, angioedema, anaphylaxis) to drugs containing polyethylene glycol have been reported and are described under “Adverse reactions”.
In case of diarrhea, caution should be exercised in patients with water-electrolyte disturbances (e.g. elderly, patients with hepatic or renal insufficiency or patients taking diuretics) and electrolyte monitoring is recommended.
Tracheal aspiration has been reported when large amounts of polyethylene glycol and electrolytes are given via nasogastric tube. In particular, children with neurological impairment who have oral motor dysfunction are at particular risk of tracheal aspiration.
Precautions.
1. This product does not contain significant amounts of sugar or polyols and may be used in patients with diabetes or those requiring a lactose-free diet.
2. For long-term use, consult your physician.
For Pregnant and Lactating Women
Pregnant women: Animal studies have not demonstrated direct or indirect reproductive toxic effects. Clinical data on the use of this product in pregnant women are limited (less than 300 studies in pregnant women).
No effects during pregnancy are expected due to negligible systemic exposure. This product may be used during pregnancy.
Lactating Women: There are no data to suggest that this product passes into breast milk. Because systemic exposure to this product is negligible in nursing women, no effects can be expected in newborns or infants who are breastfed. This product can be used during lactation.
Fertility: No fertility studies have been conducted with this product and no effect on fertility can be expected since polyethylene glycol 4000 is not absorbed.
[Pediatric Use].
Overseas, there are published evidence-based medical reports on the efficacy and safety of this product in children under 8 years of age. Due to the lack of clinical data on the use in children for more than 3 months, the treatment period for children should not exceed 3 months. Recovery of treatment-induced bowel motility can be maintained by lifestyle and dietary measures.
[Geriatric Use].
There is no experience with the large-scale use of polyethylene glycol 4000 in elderly patients.
[Drug Interactions].
In a study of possible drug interactions in rats, this product did not affect the gastrointestinal absorption of some NSAIDs, anticoagulants, gastric secretion inhibitors, and hypoglycemic agents. In general, it is best to take it at longer intervals (at least 2 hours) with other drugs.
To avoid interactions between several drugs, please carefully inform your doctor or pharmacist of any concurrent treatment.
Drug overdose]
Diarrhea, abdominal pain and vomiting have been reported. Diarrhea due to overdose may disappear after temporary discontinuation or dose reduction.
In case of excessive water loss due to diarrhea or vomiting, electrolyte disorders may need to be corrected.
Pharmacology and Toxicology
Pharmacological effects.
Macromolecular polyethylene glycol (4000) is a linear long-chain polymer that retains water in the colon by fixing water molecules through hydrogen bonding, increasing stool water content and softening stool, restoring stool volume and weight to normal, and promoting the final completion of bowel movement, thus improving constipation symptoms.
Toxicological studies.
Toxicity studies on polyethylene glycol (4000) conducted on different species of animals did not show significant systemic or GI toxicity, and no teratogenic or mutagenic effects were observed. No carcinogenicity studies were conducted.
Pharmacokinetics]
Pharmacokinetic data confirm that polyethylene glycol 4000 is neither absorbed nor biotransformed by the digestive tract after oral administration.
Storage】Seal and store in dry place.
Package】6 bags per box, 10 bags per box, 13 bags per box, 15 bags per box, 20 bags per box.
Expiration date】12 months.
Execution Standard
Approval Number】State Drug Administration H20050809
【Manufacturing enterprise
Enterprise name: Chongqing Huasen Pharmaceutical Co.
Production Address: Chongqing Rongchang District Industrial Park
Postal Code: 402460
Telephone number: 023-67622999, 46785738
Fax number: 023-67506555, 46761105
Web address: www.pharscin.com