MACROGOL 2014 DEFINITION Macrogol is the International Nonproprietary Name (INN) for polyethylene glycol. Macrogols have been used as laxatives, i.e. to treat constipation. They are also used as excipients in pharmaceutical products where lower molecular weight variants are used as solvents in oral liquids and soft capsules. Solid variants are used as ointment bases, tablet bindings, film coatings and lubricants. Popular types include: macrogol 3350 macrogol 4000 macrogol 6000 The number represents the average molecular weight of the polyethylene glycol. Combining different molecular weights provides some control over the consistency. Polyethylene glycol 1
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MACROGOL 2014
DEFINITION
Macrogol is the International Nonproprietary Name (INN) for polyethylene glycol.
Macrogols have been used as laxatives, i.e. to treat constipation.
They are also used as excipients in pharmaceutical products where lower molecular
weight variants are used as solvents in oral liquids and soft capsules. Solid variants
are used as ointment bases, tablet bindings, film coatings and lubricants.
Popular types include:
macrogol 3350
macrogol 4000
macrogol 6000
The number represents the average molecular weight of the polyethylene glycol.
Combining different molecular weights provides some control over the consistency.
Laxatives are a type of medicine that can help you empty your bowels if you are having trouble going to the toilet.
They are widely used to treat constipation and are available over the counter (without a prescription or 'OTC') from pharmacies and supermarkets.
Things to consider
Just because laxatives are available over the counter does not mean they are safe and suitable for everyone.
Laxatives are not usually recommended for children unless advised by a doctor and some types of laxatives may not be safe to use if you have a bowel condition such as Crohn’s disease or ulcerative colitis.
You should always read carefully the patient information leaflet that comes with medication to make sure it is safe for you to take.
Read more about the considerations regarding laxatives.
Types of laxatives
The four most widely used laxatives in England are:
osmotic laxatives which make your stools (‘poo’) softer by increasing the amount of water in your bowels
stimulant laxatives which speed up the movement of your bowel by stimulating the muscles that line your digestive tract
bulk-forming laxatives, also known as fibre supplements, work in the same way as dietary fibre; they increase the bulk of your stools by helping your stools retain fluid
stool softener laxatives add water to your stools to lubricate them, making them more slippery and easier to pass
Less commonly used types of laxatives include:
bowel cleansing solutions – these are often given to people who are going to have bowel surgery or a bowel examination to make sure that the bowel is empty and are not seen as a routine treatment for constipation
peripheral opioid-receptor antagonists– these are used to treat constipation in people who are terminally ill where the constipation is the result of taking powerful painkiller medications such as morphine
prucalopride – used to treat persistent constipation in women who have failed to respond to treatment (it is unclear whether prucalopride is safe or effective in men so its use in men is currently not recommended)
sachets of powder you mix with water and then drink
suppositories – a capsule you place inside your rectum (back passage) where it will dissolve
Ideally, laxatives should only be used for short periods of time as prolonged use can make your body dependent on them, so your bowel no longer functions normally without them.
Recommendations can vary depending on the type of laxative but generally it is recommended that you do not take laxatives for more than 5-7 days in a row. If symptoms persist after this time contact your GP for advice.
You should take a laxative with plenty of water as this can help prevent unpleasant side effects.
Side effects
Common side effects of laxatives include:
flatulence (breaking wind or ‘farting’)
bloating
abdominal pain
These side effects are usually mild and should pass once you stop taking the laxatives.
The long-term use of laxatives can cause more troublesome side effects such as:
dehydration
unbalanced levels of salts and minerals in your body
Alternatives
In many cases you can improve the symptoms of constipation without having to use laxatives through lifestyle changes, such as:
The appearance of MACROGOL products varies depending on the molecular weight. For example, MACROGOL 400 is a viscous liquid, while MACROGOL 1500 is a paste-like solid substance and MACROGOL 6000 is a waxy solid substance, the later is available in either flakes or powder. Each MACROGOL product is water-soluble, and has low toxicity.These features make MACROGOL ideal for use as a base material for ointments and suppositories, tablet coating agents, tablet binders, and other applications.
End Use Examples
Base Materials for Ointments
MACROGOL products are ideal as a base material for ointments (e.g. penicillin, Terramycin, streptomycin, and other antibiotics; antihistamine, benzocaine, and other narcotics; and for preservatives). These products can be used to adjust the concentration and viscosity of pharmaceuticals to be applied to the skin. These products make the pharmaceuticals easier to evenly apply, therefore allowing an accurate amount to persistently permeate into the affected area. These products also act to absorb body fluid oozing from the affected area.
Example formula for base materials ofwater-soluble ointment
Materials (wt %)
MACROGOL 4000 20
Stearyl alcohol 37
Glycerin 30
Purified water 12
Sodium lauryl sulfate 1
Total 100
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Base Materials for Suppositories
We offer a wide range of MACROGOL products, from MACROGOL 400 that has a freezing point of approximately 6ºC, to MACROGOL 20000 which has a freezing point of approximately 60ºC. It is possible to mix two or more MACROGOL products to produce a base material that has an ideal melting point and an ideal dissolving rate for suppositories.In general, thermal stability (storage stability) is improved at ambient temperature by the use of MACROGOL products with a high average molecular weight.
Binders for Tablets
MACROGOL products can also be used as a tablet surface smoother, coating agent, or binder.MACROGOL 6000 (powder) has a shorter tablet coating time than the common sugar coating agent. With this product, you can obtain a tablet that looks good appearance and has a hard surface.This product can also be used in tablets for diabetics.
Properties
Hygroscopic Properties
MACROGOL products are hygroscopic, and their hygroscopic properties decrease in accordance with the increase in their molecular weight. For example, MACROGOL 200 has a high hygroscopic property similar to that of a propylene glycol, whereas MACROGOL 4000 and MACROGOL 20000 have very low hygroscopic properties. The following figure shows the equilibrium moisture regain of MACROGOL.
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Safety
MACROGOL products have low toxicity according to the following LD50 values for rats.
Product NameLD50
g/kg (oral, rat)
MACROGOL 200 28
MACROGOL 400 30.2
MACROGOL 1500 44.2
MACROGOL 4000 50
MACROGOL 6000(powder) 50
MACROGOL 6000(flake) 50
Registry of Toxic Effects of Chemical Substances, Feb. 2003 (NIOSH)(CD-ROM).
Other properties
MACROGOL is readily esterified and etherified, because it has primary hydroxyl groups at both ends of its molecule.
MACROGOL's water solubility is not affected by the presence of an electrolyte. It is solubule in hard water and aqueous salt solution, as well as in acids and alkalis (except for extremely concentrated acids or alkalis).
MACROGOL and its aqueous solutions show excellent lubricity. It decomposes at high temperatures, but no residue remains.
MACROGOL's temperature-kinematic viscosity curve and its aqueous solutions' temperature-kinematic viscosity curves are shown below.
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MACROGOL Lineup
The table below shows the MACROGOL products
Product NameAppearance(20±5℃)
Viscositymm2/s(21°F*1)
MolecularWeight
FreezingPoint℃
Flash*2
Point°C
pH*3
MACROGOL 200 Colorless liquid 4 200 <-35 196 5.5
MACROGOL 400 Colorless liquid 7 400 6 230 5.5
MACROGOL 1500 White paste 16 *4 40 240 5.5
MACROGOL 4000 White flake 80 3,200 55 270 7.0
MACROGOL 6000(powder)
White powder 800 8,300 59 256 7.0
MACROGOL 6000(flake)
White flake 800 8,300 59 256 7.0
MACROGOL 20000 White flake 14,000 20,000 60 296 7.0
*1 Measured at 98.9°C (210°F).*2 Measured according to the COC method.*3 Measured as a 5 wt % aqueous solution.*4 A mixture of equal amount of HOCH2(CH2OCH2)nCH2OH in which n is both 5 to 6 and 28 to 36
For Safe Material Handling
For further information, Safety Data Sheets (SDS) are available from Sanyo Chemical.
Compound Macrogol Oral Powder is a laxative used to treat chronic constipation and the build-up of hard faeces in your bowel. It works by softening your faeces, making it easier to pass.
Product Discription
Compound Macrogol Oral Powder has electrolytes that help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation and it works by softening your faeces, making it easier to pass. In general this drug is used for the treatment of constipation, especially if you have been constipated for a long time. It is also used to treat the build-up of hard faeces in your bowel, which can occur if you have been constipated for a long time.
Benefits of being on this drug can include relief from constipation
Listed below are the typical uses of macrogol
Chronic constipation
Build-up of hard faeces in the bowel (faecal impaction)
Usage / Instruction
How to take Compond Macrogol:
Please take Compond Macrogol as prescribed by your doctor or medical professional.
Direction details will be available on your medication container
Warning
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Caution before taking Compound Macrogol Oral Powder:
The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.
Mild adverse drug reactions are possible such as allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, erythema, urticaria, and pruritus; metabolism and nutrition disorders; electrolyte disturbances, particularly hyperkalaemia and hypokalaemia; nervous system disorders; headache; gastrointestinal disorders; abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort; general disorders and administration site conditions & peripheral oedema.
If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Compound Macrogol Oral Powder Sugar Free should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.
The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by Compound Macrogol Oral Powder Sugar Free.
Ingredients
Each Compond Macrogol sachet contains the following quantitative composition of active ingredients:
Macrogol compound is a laxative used to treat chronic constipation and the build up of hard faeces in your bowel. It works by softening your faeces, making it easier to pass. The electrolytes help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation.
In general this drug is used for the treatment of constipation, especially if you have
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been constipated for a long time. It is also used to treat the build up of hard faeces in your bowel, which can occur if you have been constipated for a long time.
Benefits of being on this drug can include relief from constipation.
Listed below are the typical uses of macrogol.
Chronic constipation Build up of hard faeces in the bowel (faecal impaction). Colonic clearance before examination or surgery requiring a clean colon.
HOW TO USE/TAKE
How often do I take it?
Dissolve the contents of a package in a glass of water (125ml) to take this medication. For constipation, one sachet should be used one to three times a day, for faecal impaction eight sachets should be taken within a six hour time frame (all eight sachets may be dissolved in one litre of water. Use this medication for the duration of prescription, and as instructed by your doctor or pharmacist in order to get the most benefit from it. Remember to use it at the same time each day - unless specifically told otherwise by your doctor. Certain medical conditions may require different dosage instructions as directed by your doctor.
What dose?
Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
Macrogol compound has no influence on the ability to drive or use machines.
When can I stop?
Always complete the full course as prescribed by your doctor.
Details
MACROGOL COMPOUND NPF INTERACTIONS
Your doctor or pharmacist may already be aware of any possible drug interactions
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and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
Other medicines should not be taken orally for one hour before and for one hour after taking macrogol compound.
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use.
This information does not contain all possible interactions. Therefore, before using macrogol compound, tell your doctor or pharmacist of all the products you use.
MACROGOL COMPOUND NPF SIDE EFFECTS
Allergic reaction (rash, itching, shortness of breath) Changes in your body's fluid or electrolyte levels (swollen ankles, other swelling, fatigue, dehydration, increased thirst with headache) Abdominal pain Mild diarrhoea Nausea Vomiting Swollen abdomen Stomach rumbling
If any of these persist or you consider them severe then inform your doctor or pharmacist.
Tell your doctor immediately if you develop any of the following symptoms:
signs of an allergic reaction; signs of a change in your body's fluid or electrolyte levels.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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In the UK you may report side-effects to the MHRA
MACROGOL COMPOUND NPF OVERDOSE
If you take more macrogol compound than you should, you may experience severe pains and swelling in your abdomen, or vomiting or diarrhoea. If this happens, contact your doctor or pharmacist.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of Macrogol compound or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on 0845 4647.
MISSED DOSE
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
MACROGOL COMPOUND NPF PRECAUTIONS
Before taking macrogol compound, tell your doctor or pharmacist if you are allergic to it; or to other laxatives; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blockage of the intestine, perforation in the intestine, paralysis of the intestine, ulcerative colitis, Crohn's disease, toxic megacolon, patients with allergies to any of the ingredients.
Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: intestinal obstruction or perforation, severe inflammatory conditions of the intestinal tract, allergies to macrogol compound or any of the other ingredients.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Alcohol intake does not appear to affect this drug.
The elderly: macrogol compound can be used in the elderly.
Pregnancy and breastfeeding - please ensure you read the detailed information
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below
PREGNANCY
Pregnancy
Macrogol compound is not safe to take if you are, or are planning to become, pregnant.
Ask your doctor or pharmacist if you have any doubts or questions about this.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
BREAST FEEDING
breastfeeding
Macrogol compound is not safe to take if you are breastfeeding.
Ask your doctor or pharmacist if you have any doubts or questions about this.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
MACROGOL COMPOUND NPF WARNINGS
Macrogol compound should not be used for faecal impact unless the diagnosis has been confirmed by your doctor.
It should not be used in:
blockage of the intestine, perforation in the intestine, paralysis of the intestine, ulcerative colitis, Crohn's disease, toxic megacolon, patients with allergies to any of
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the ingredients, other medicines should not be taken within an hour either before or after taking macrogol compound.
Also see list of precautions and interactions
STORAGE
You should store unopened sachets below 25ºC.Reconstituted Compound Macrogol Oral Powder solution can be covered and stored in the refrigerator (2°C to 8°C), and should be used within six hours. After six hours, any unused solution should be discarded.