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PRODUCT INFORMATION NAME OF THE MEDICINE Go Kit DESCRIPTION Go-Kit is a composite pack containing three yellow bisacodyl 5mg tablets and a 21.5g sachet of effervescent white crystalline powder composed of magnesium carbonate 7.5g and citric acid 14g, which together form magnesium citrate in solution. Bisacodyl is a white or almost white crystalline powder. It is practically insoluble in water and alkaline solutions. Soluble in acids, alcohol, acetone and other organic solvents. The chemical name is 4,4’-(2-pyridylmethylene)di (phenylacetate). It has a chemical formula of C22H19NO4, a MW of 361.4 and CAS No. 603-50-9. The structural formula is: Magnesium Citrate is a white crystalline powder. It has a chemical formula of C6H6MgO7 and a MW of 214.41. Magnesium Citrate is made in situ from: Magnesium Carbonate is a white powder practically insoluble in water. It dissolves in dilute acids with strong effervescence. Molecular formula is MgCO3 with an MW of 84.31 and CAS No. 546-93-0. Citric Acid Anhydrous is a white crystalline powder, colourless crystals or granules, very soluble in water and freely soluble in alcohol. It has a chemical formula of C6H8O7, a MW of 192.1 and CAS No. 77-92-9. PHARMACOLOGY Bisacodyl Bisacodyl is a stimulant laxative acting mainly in the large intestine. It acts locally in the gastrointestinal tract, stimulating the sensory nerve endings in the colonic mucosa to produce parasympathetic reflexes resulting in increased peristaltic contractions of the colon. Local axonic reflexes as well as segmental reflexes are initiated in the region of contact and contribute to the widespread peristaltic activity producing evacuation. For this reason bisacodyl may be used in patients with ganglionic blockage or spinal cord damage (e.g. paraplegia, poliomyelitis). Page 1 of 5 Magnesium Citrate Magnesium citrate is an osmotic laxative. It acts by increasing the intestinal osmotic pressure thereby promoting retention of fluid within the bowel. PHARMACOKINETICS Bisacodyl Following oral administration, bisacodyl is converted to the active desacetyl metabolite bis(p-hydroxyphenyl)pyridyl-2-methane by intestinal and bacterial enzymes. Absorption from the gastrointestinal tract is minimal with enteric coated tablets or suppositories. The small amount absorbed is excreted in the urine as the glucuronide. Bisacodyl is mainly excreted in the faeces. When taken on an empty stomach, bisacodyl tablets will have an effect within 6 to 8 hours. When taken with food the effect of the tablets is exhibited within 10 to 12 hours. Magnesium Citrate Magnesium citrate draws water from the tissues into the small intestine. This stimulates the normal forward movement of the intestines, peristalsis, resulting in bowel movement within 3 to 6 hours. INDICATIONS Go-Kit is indicated for bowel cleansing in conjunction with barium meal, barium enema, air contrast examination and intravenous pyelography (IVP) of the kidneys. CONTRAINDICATIONS Go-Kit should not be used by patients with an allergy to any of the ingredients, severe dehydration, acute abdominal conditions such as appendicitis, gastrointestinal obstruction, gastric retention, bowel perforation (frank or suspected), toxic megacolon, paralytic ileus, toxic colitis or whose body weight is less than 20kg. PRECAUTIONS Use with caution in patients with inflammatory bowel disease (IBD), marked bloody diarrhoea, impaired renal function, pre-existing electrolyte disturbances, congestive heart failure, diabetes, those with a stoma and the elderly. Go-Kit is likely to cause transient hypovolaemia, hence adequate fluid intake or replacement should be ensured (see Dosage and Administration). Patients with congestive heart failure should be monitored; as should patients using calcium channel blockers, diuretics or other medications that may affect electrolyte levels. Patients with kidney disease or impaired renal function should also be monitored, as should those with pre-existing electrolyte disturbances. Go-Kit may cause bloating, distension or abdominal pain. Page 2 of 5 Effects on Fertility No fertility studies have been conducted. Use in Pregnancy It is not known whether Go-Kit can cause foetal harm or affect reproductive capacity. Go-Kit should only be used if the benefits clearly outweigh the risks. Use in Lactation No studies with Go-Kit have been carried out on breast feeding mothers. Paediatric Use The safety and efficacy of Go-Kit in children has not been established. Use in the Elderly Caution should be exercised in the elderly as dehydration and electrolyte depletion may occur. Elderly patients must receive adequate fluids during administration. Carcinogenicity No carcinogenic studies with Go-Kit have been performed. Genotoxicity No genotoxic studies with Go-Kit have been performed. INTERACTIONS WITH OTHER MEDICINES Oral medication taken within one hour of the commencement of the administration of Go-Kit may be flushed from the gastrointestinal tract and not absorbed. ADVERSE EFFECTS Bisacodyl may cause abdominal discomfort such as colic or cramps. Prolonged use can result in diarrhoea with excessive loss of water and electrolytes. Hypersensitivity reactions including angioedema and anaphylactoid reactions have been reported rarely. Other adverse effects from Go-Kit include nausea, vomiting and anal soreness. These adverse effects are usually transient and subside rapidly. DOSAGE AND ADMINISTRATION Information for Patients Go-Kit produces watery stools or bowel motions within 2 to 3 hours after the first administration. This action cleanses the bowel before the procedure. Patients should be warned that Go-Kit will cause frequent loose bowel motions and there may also be a number of bowel actions during the night. Patients should ensure bathroom facilities are within easy access. Go-Kit should be prepared and taken according to the directions on the box, the Consumer Medicine Information leaflet found in the box or in the following Dosage and Administration section. Page 3 of 5 The tablets should be taken whole and not crushed or chewed. It is important the patient follows the recommended dosing schedule and ensures an adequate intake of fluids. Unless Otherwise Directed by Your Doctor Usual Dosage (Adult) Preparation for the procedure begins at noon on the day before the procedure commencing with a low residue meal. Directions Preparation of the Magnesium Citrate Solution Prepare the solution by dissolving the contents of the sachet in one large glassful of hot water (approximately 250mL) - the powder will effervesce. Refrigerate prior to use. Recommended Clear Fluids Recommended clear fluids which may be consumed whilst taking Go-Kit include water, strained fruit juice without the pulp (apple, white grape, pineapple, pear), clear broth, tea or coffee without milk or cream, clear sugar-free cordials such as lemon or lime (no red or purple colourings), plain sugar-free jelly and clear ice blocks. Do not drink carbonated beverages. Do not drink alcoholic beverages. 1. Starting at 12 noon, eat only the following low residue meal: One (1) cup of clear soup (e.g. chicken or beef broth) with dry crackers; One (1) white bread chicken or yeast extract spread (e.g. Marmite/Vegemite®) sandwich with no butter, lettuce or additions; Half a glass of clear fluids; One (1) serving of plain jelly (no cream or other additives). 2. At approximately 1pm drink one full glass or more of water (approx. 250mL) with or without clear cordial. 3. At approximately 3pm drink one full glass or more of water (approx. 250mL) with or without clear cordial. 4. At approximately 5pm, eat only the following low residue meal: One (1) cup of clear soup; One (1) glass of clear apple or grape juice and One (1) serving of plain jelly with no cream or other additives. 5. At approximately 6pm drink the cold solution of Magnesium Citrate which was previously prepared. 6. At approximately 8pm take the three (3) Bisacodyl tablets with one full glass or more of water (approx. 250mL). Continue to drink clear fluids throughout the evening. Page 4 of 5 7. At approximately 10pm drink one full glass or more of water (approx. 250mL) with or without clear cordial. 8. On the day of the procedure NO FOOD or DRINK to be taken unless directed by your doctor. OVERDOSAGE Overdose is unlikely as the carton contains only enough medication for one treatment. However in the event of overdosage, dehydration may occur. Calcium, potassium, chloride and sodium levels should be carefully monitored and immediate corrective action should be taken to restore electrolyte balance with appropriate fluid replacements. Contact the Poisons Information Centre for further information. Australia: 13 11 26 New Zealand: 0800 764 766 PRESENTATION AND STORAGE CONDITIONS A carton containing a blister pack of three yellow bisacodyl 5mg tablets, a sachet containing 21.5g of a dry white effervescent crystalline powder labelled Magnesium Citrate and a Consumer Medicine Information leaflet. The Australian registration number is AUST R 200381. Store below 25°C in a dry place. NAME AND ADDRESS OF THE SPONSOR Fresenius Kabi Australia Pty Limited 964 Pacific Highway NSW 2073 Australia Telephone: (61-2) 9391 5555 Fresenius Kabi New Zealand Limited c/o Fresenius Medical Care Australia Pty Ltd 60 Pavilion Drive Airport Oaks Auckland New Zealand POISON SCHEDULE OF THE MEDICINE Unscheduled DATE OF FIRST INCLUSION THERAPEUTIC GOODS IN THE 27 August 2012 Page 5 of 5 AUSTRALIAN REGISTER OF