PICO SALAX Product Information

Read all of this information carefully before you start using this medicine


PICO-SALAX®
(sodium picosulfate and magnesium oxide, and citric acid )

Purgative

Pharmacology:

The active components of Pico-Salax® are sodium picosulfate and magnesium citrate.

Picosulfate is a stimulant cathartic active locally in the colon.

Magnesium citrate (magnesium oxide and citric acid) acts as an osmotic laxative by retaining moisture in the colon. The action is of a powerful “washing out” effect combined with peristaltic stimulation to clear the bowel prior to radiography, colonoscopy or surgery. Full doses of the saline cathartic (e.g. 15 g of magnesium sulfate or its equivalent) produce a semi-fluid watery evacuation within 3-6 hours or less.

The product is not intended for routine use as a laxative.

Some absorption of the component ions of the saline cathartics does occur, and in certain instances they may produce systemic toxicity. This is especially true for magnesium salts, since 20% or more of the administered cation is absorbed. If renal function is normal, the absorbed magnesium is rapidly excreted. However, if a magnesium cation is given to an individual with impaired renal function, the accumulation of magnesium ion in the body fluids may be sufficient to cause magnesium intoxication.

In most instances, salts that gain access to the systemic circulation are rapidly excreted by the kidneys.

Indications and Administration:

Pico-Salax® is used for clearance of the bowel prior to x-ray examination, endoscopy or surgery.

Contraindications:

PICO-SALAX is contraindicated in:


  • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of this document.
  • Patients with congestive cardiac failure, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation.
  • Patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.
Warnings and Precautions:

General:

Care should also be taken in patients with renal impairment, heart disease or inflammatory bowel disease.

Use with caution in patients on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium (see Drug Interactions and Possible Adverse Reactions).

Pico-Salax® may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see Drug Interactions and Possible Adverse Reactions).

Patients should avoid taking oral iron preparations for a week before colonoscopy. Constipating drugs (i.e. cholinergics, opioids) should be suspended for a few days before the procedure, after consulting with your doctor.

An inadequate oral intake of water and electrolytes could create clinically significant, deficiencies, particularly in less fit patients. In this regard, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hyponatraemia.

The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.

Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during and after the use of PICO-SALAX. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PICO-SALAX, consider performing post-colonoscopy lab tests (electrolytes, creatinine and BUN) and treat accordingly. Approximately 20% of patients in clinical trials had orthostatic changes (changes in blood pressure and/or heart rate) on the day of colonoscopy; however these changes were not clinically relevant. In clinical trials orthostatic changes were documented out to seven days post colonoscopy [see Adverse Reactions].

Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias or seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with PICO-SALAX. In addition, use caution when prescribing PICO-SALAX for patients who have conditions or who are using medications that increase the risk for fluid and electrolyte disturbances or that may increase the risk of adverse events of seizure, arrhythmia, and renal impairment.

Seizures

There have been reports of generalized tonic-clonic seizures with the use of bowel preparation products in patients with no prior history of seizures. Seizures were associated with electrolyte abnormalities (e.g. hyponatremia, hypokalemia, hypocalcemia and hypomagnesemia) and low serum osmolality. Neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing PICO-SALAX for patients with a history of seizures and in patients at risk of seizure, such as patients taking medications that lower the seizure threshold (e.g. tricyclic antidepressants), patients withdraw from alcohol or benzodiazepines, patients with known or suspected hyponatremia. [see Adverse Reactions]

Use in Patients with Renal Impairment

As in other magnesium containing bowel preparations, use caution when prescribing PICO-SALAX for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at increased risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of PICO-SALAX. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine and BUN) in these patients. In patients with severely reduced renal function (creatinine clearance < 30 mL/min), accumulation of magnesium in plasma may occur.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PICO-SALAX for patients at increased risk of arrhythmias (e.g. patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy).

Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis

Osmotic laxatives may produce colonic mucosal aphthous ulceration and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with PICO-SALAX may increase this risk. The potential for mucosal ulceration should be considered when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease [see Adverse Reactions].

Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PICO-SALAX. Use with caution in patients with severe active ulcerative colitis.

Aspiration

Patients with an impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration of PICO-SALAX. Use with caution in these patients.


Not for Direct Ingestion

Each packet must be dissolved in 150 mL (5 oz) of cold water and administered at separate times according to the dosing regimen. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

Pregnancy and Lactation

Reproduction studies with sodium picosulfate performed in animals have revealed no evidence of a harmful action on the fetus. However, clinical experience of the use of PICO-SALAX® during pregnancy is limited and caution should be observed, particularly during the first trimester.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PICO-SALAX is administered to a nursing woman.

Geriatrics (≥ 65 years of age)

In controlled clinical trials of PICO-SALAX, 215 of 1201 (18%) patients were 65 years of age or older. The overall incidence of treatment-emergent adverse events was similar among patients ≥65 years of age (73%) and patients <65 years of age (71%).

Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

Use caution when prescribing PICO-SALAX for patients with conditions or who are using medications that increase the risk for fluid and electrolyte disturbances, or may increase the risk of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids, or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when PICO-SALAX is used in patients on non-steroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance. Consider additional patient evaluations as appropriate [see Adverse Reactions].

Potential for Altered Drug Absorption


Oral medication administered within one hour of the start of administration of PICO-SALAX solution may be flushed from the GI tract and the medication may not be absorbed.

Tetracycline and fluoroquinolone antibiotics, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PICO-SALAX to avoid chelation with magnesium.

Adverse Reactions:


Post-marketing Experience

The following spontaneous reports have been identified during use of formulations similar to PICO-SALAX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic reactions

Cases of hypersensitivity reactions including rash, urticaria and purpura have been reported.

Electrolyte abnormalities

There have been reports of hypokalemia, hyponatremia and hypermagnesemia with the use of PICO-SALAX for colon preparation prior to colonoscopy.

Gastrointestinal

Abdominal pain, diarrhea, fecal incontinence and proctalgia have been reported with the use of PICO-SALAX for colon preparation prior to colonoscopy. There have been isolated reports of reversible aphthoid ileal ulcers. Ischemic colitis has been reported with the use of PICO-SALAX for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of PICO-SALAX has not been established.

Neurologic

There have been reports of generalized tonic-clonic seizures associated with and without hyponatremia in epileptic patients.

Drug Interactions:

As a purgative, Pico-Salax® increases the gastrointestinal transit rate. The absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period (see Warnings and Precautions for Use).

The efficacy of Pico-Salax® is lowered by bulk-forming laxatives.

Dosage and Administration:

ADULTS:

PRE-DOSING INSTRUCTIONS:

If you have special dietary requirements, please discuss this with your doctor.

At least 3 days prior to your procedure:

  • Do not consume seeds or nuts due to digestive residue.
  • Do not consume any fresh fruits or raw vegetables (e.g. no salads) and no multigrain bread.
ADULT DOSING INSTRUCTIONS:

Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up- allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink. Following each sachet, drink 1.5 to 2 Litres of a variety of clear fluids over 4 hours. DO NOT DRINK JUST WATER ALONE. Drinking only water to replace the fluid losses may lead to electrolyte imbalance, particularly to hyponatremia and possibly seizures.

Recommended clear fluids include any fluid that you can see through that is not red or purple such as: sports drinks (e.g. Gatorade†), Pedialyte†, Gastrolyte†, Kool-Aid†, clear broth (chicken, vegetable or beef with no noodles, meat or vegetables), fruit juices (e.g. apple, white (not red) cranberry, white (not purple) grape, tea or coffee (black, sweetened to taste, no milk, cream or soy), clear sodas (e.g. ginger ale), plain Jell-O† (not red or purple), Popsicle† (not red or purple) and water. Diabetics can use a fibre free supplement/meal replacement.

One day before your procedure you should have clear fluids ONLY and no solid food. See list above.

Morning colonoscopy-before 12:00 pm (noon):

One day before your procedure: Take 1 sachet (first dose) at 5:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

One day before your procedure: Take 1 sachet (second dose) at 10:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

No fluid should be taken at least 2 hours prior to your procedure.

Afternoon colonoscopy - 12:00 pm (noon) or later:

One day before your procedure: Take 1 sachet (first dose) at 7:00 pm followed by 1.5 to 2 Litres of a variety of clear fluids.

On the same day as your procedure: Take 1 sachet (second dose) at 6:00 am, followed by 1.5 to 2 Litres of a variety of clear fluids.


No fluid should be taken at least 2 hours prior to your procedure.

PEDIATRIC DOSING INSTRUCTIONS:

Fill a mug with 150 ml (5 oz) of cold water. Empty contents of one sachet in the mug (rarely, mixture may heat up - allow to cool before drinking). Stir for 2-3 minutes until completely dissolved before you drink.

If possible, it is recommended that Pico-Salax should be given at least 5-6 hours before bedtime to avoid interference with sleep, therefore splitting the dose over two days is recommended for children as follows:

(1 to 6 years old):

One day before your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL, 8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM

On the same day as your procedure: Take ¼ of the prepared solution as per DOSING INSTRUCTIONS (second dose) at 8:00 am, followed by one cup of clear liquid (250 mL, 8 oz) every hour up to 2 hours prior to your child’s procedure.

(6-12 years old)

One day before your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (first dose) at 6:00 pm followed by one cup of clear liquid (250 mL, 8 oz) every hour while the child is awake. No solid food should be taken after 6:00 PM

On the same day as your procedure: Take ½ of the prepared solution as per DOSING INSTRUCTIONS (second dose) followed by one cup of clear liquid (250 mL, 8 oz) every hour up to 2 hours prior to your child’s procedure.

In order to replace fluid lost from the body, it is important to drink plenty of clear fluids throughout the treatment with PICO-SALAX® until bowel movements have ceased. In general, patients should drink about 250 mL of water or clear fluid and/or a balanced electrolyte solution (e.g.: Gastrolyte†, Pedialyte†) every hour while they feel the effects of PICO-SALAX®.

No fluid should be taken at least 2 hours prior to your procedure

OVERDOSE:

For management of suspected drug overdose, contact your regional poison control centre.

STORAGE AND STABILITY
Store between 15 - 25°C
Keep out of reach of children

How Supplied:

Each sachet contains: sodium picosulphate 10 mg, magnesium oxide 3.5 g, and citric acid 12 g.

Non-medicinal ingredients: natural orange(contains small amount of lactose) or natural cranberry flavour, potassium bicarbonate and saccharin sodium.

Each carton contains 1 or 2 sachets.

Full product monograph available upon request

Ferring Pharmaceuticals

Ferring Pharmaceuticals
Toronto, Ontario
M2J 5C1

Pico Salax Bowel Prep