Sodium Dihydrogen Phosphate + Disodium Hydrogen Phosphate

This is an stable clear, colorless, buffered, ginger-lemon flavored, aqueous oral solution, that is used to treat relief of occasional constipation, bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for X-Ray or endoscopic examination.

Sodium phosphate can be used in the management of hypophosphataemia. It also acts as a mild osmotic laxative when given orally as dilute solutions or by the rectal route. Phosphate enemas or concentrated oral solutions are used for bowel cleansing before surgery or endoscopy procedures.

Dose for bowel preparation-

Adults and children 5 years of age & over: The recommended dosage for adults and children 5 years of age & over is 45 ml and repeated 10 to 12 hours later. The intake of clear liquids is an essential part of this regimen. On the day before the procedure, the patient should only take clear liquids for breakfast, lunch and dinner and between doses. No solid food, milk or milk products should be taken on the day before the procedure. The patient should not drink anything colored red or purple. Medical procedure is intended to be performed at early morning, mid-morning or later, by two alternative dosage regimens.

Early morning procedure: The first dose is taken at 7 a.m. on the morning before the procedure. The second dose is taken at 7 p.m. on the evening before the procedure.

Mid-morning (or later) procedure: The first dose is taken at 7 p.m. on the evening before the procedure. The second dose is taken at 7 a.m. (or at least 3 hours before leaving for the appointment) on the morning before the procedure.

• First dose: Mix 15 ml (one third of the bottle) of This into a full glass (approximately 250 ml) of clear liquids and drink. Repeat two more times within the next 20 minutes.
• Between Doses: Between the first and second doses, the patient should drink at least three more glasses (approximately 250 ml each) of clear liquids or more if desired to prevent dehydration and to ensure that their bowel remains easily examinable for the procedure.
• Second Dose: Mix 15 ml of This into a full glass of clear liquid and drink. Repeat two more times within the next 20 minutes. Please refer to clear liquids list below. Beverages, water, tea or coffee (no milk or non dairy creamer), sweeteners are acceptable, carbonated or non carbonated soft drinks (not colored red or purple) fruit flavored cordials (not colored red or purple) and strained fruit juices without pulp. Do not drink any alcoholic beverage.

Dose for occasional constipation-

Adult/child over:

• 12 years old: 20-45 ml
• 10-11 years old child: 10-20 ml
• 5-9 years old child: 5-10 ml

Use with caution in patients taking calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors (ACE-Is), angiotensin receptor blockers (ARBs), non-steroidal anti-inflammatory drugs (NSAIDs), and lithium preparations or other medication that might affect electrolyte levels, as hyperphosphataemia, hypocalcaemia, hypernatraemic dehydration and acidosis may occur. Concurrent administration of polyethylene glycol bowel cleansing preparations and this solution may be dangerous and is not recommended.

CHF, renal failure or clinically significant impaired renal function, congenital or acquired megacolon, bowel/GI obstructions, ascites, perforation of ileus, active inflammatory bowel disease.

Gastrointestinal side effects of sodium biphosphate and sodium phosphate have included bloating (31% to 41%), nausea (26% to 30%), abdominal pain (23% to 25%), and vomiting (4% to 9%). Nervous system side effects have included dizziness, headache, and seizures. Renal side effects have included renal impairment, increased blood urea nitrogen (BUN), increased creatinine, acute renal failure, acute phosphate nephropathy, nephrocalcinosis, and renal tubular necrosis. Hypersensitivity reactions reported have included anaphylaxis, rash, pruritus, urticaria, throat tightness, bronchospasm, dyspnea .

Use in pregnancy: Because of potential harm to the fetus from phosphate absorbed across the placenta, the use of this product is not recommended in pregnant women unless the probable clinical benefit outweighs the possible risk.

Use in lactation: Because of potential harm to the infant from phosphate excreted in breast milk, the use of this product is not recommended in nursing mothers unless the probable clinical benefit outweighs the possible risk.

This solution should be used with extreme caution, in the elderly, the frail or debilitated, patients with colostomy and this solution patients on a low salt diet, as they are particularly at risk. These patients should receive additional fluids by mouth, both prior to, and after administration of this solution, to ensure that dehydration does not occur. Patients undergoing major bowel procedures, who are on nil by mouth for significant periods of time, should have their electrolytes monitored and receive intravenous fluids containing potassium and calcium, prior to surgery. Use with caution in patients taking diuretics and in patients using medicines known to prolong the QT interval. Concurrent administration of polyethylene glycol bowel cleansing preparations and this solution may be dangerous and is not recommended. Patients should be advised not to use this solution when nausea, vomiting or abdominal pain are present, unless directed by a physician.

Enema & bowel cleansing solution.

Use in children: This is not to be taken by children under 5 years of age.

Use in diabetics:As the liquid diet during the period of administration and prior to bowel surgery, X-Ray of the colon or colonoscopy may affect the diabetic patients’ glucose blood levels, adjustment of their insulin or oral anti-diabetic medication may be necessary.

Store in a cool and dry place, procted from light. Keep out of children’s reach.