Prepopik ( Ingredients: Sodium picosulfate, magnesium oxide, and citric acid)

Prepopik is a combination of sodium picosulfate, magnesium oxide, and citric acid that is used for bowel cleansing before colonoscopy. Other bowel cleansing agents prior to colonoscopy include sodium, potassium, and magnesium sulfate (Suprep bowel preparation kit).

Prepopik (Sodium picosulfate, magnesium oxide, and citric acid) Uses:

Bowel cleansing:

  • Used for cleansing of the colon prior to a colonoscopy in adults and children ≥9 years of age.

Prepopik (Sodium picosulfate, magnesium oxide, and citric acid) Dose in Adults

Prepopik Dose in the treatment of Bowel cleansing: Oral:

Note:

  • Prior to administration correct fluid and electrolyte imbalances.

Clenpiq:

  • Split-dose regimen (preferred):

    • 160 mL (1 bottle) the evening before the colonoscopy (5 PM to 9 PM), followed by a second 160 mL dose ~5 hours before the colonoscopy.
  • Day-before regimen (alternative):

    • 160 mL (1 bottle) in the afternoon or early evening before the colonoscopy (4 PM to 6 PM), followed by a second 160 mL (1 bottle) dose 6 hours later (10 PM to 12 AM) the night before the colonoscopy.

Prepopik:

  • Split-dose regimen (preferred):

    • 150 mL (5 oz) the evening before the colonoscopy (5 PM to 9 PM), followed by a second 150 mL (5 oz) dose ~5 hours before the colonoscopy.
  • Day-before regimen (alternative):

    • 150 mL (5 oz) in the early evening before the colonoscopy (4 PM to 6 PM), followed by a second 150 mL (5 oz) dose 6 hours later (10 PM to 12 AM) the night before the colonoscopy.

Pico-Salax; Purg-Odan [Canadian products]:

  • Early colonoscopy (before 12 PM):

    • One sachet (mixed and dissolved in water) in the evening (5 PM) the day prior to the procedure, followed by a second dose of one sachet 5 hours later (10 PM) the night before the procedure.
  • Late colonoscopy (after 12 PM):

    • One sachet (mixed and dissolved in water) in the late evening (7 PM) the day prior to the procedure, followed by a second dose of one sachet in the morning (6 AM) on the day of the procedure.

Prepopik (Sodium picosulfate, magnesium oxide, and citric acid) Dose in Childrens

Prepopik Dose in the treatment of Bowel cleansing: Oral:

Prepopik:

  • Children ≥9 years of age and Adolescents:

    • Refer to adult dosing.

Pico-Salax; Purg-Odan [Canadian products]:

  • Children 1 to 5 years:

    • 1/4th of one sachet (mixed and dissolved in water) in the evening (6 PM) the day prior to the procedure, followed by a second dose of 1/4th of one sachet in the morning (8 AM) on the day of the procedure.
  • Children 6 to 12 years:

    • One-half of one sachet (mixed and dissolved in water) in the evening (6 PM) the day prior to the procedure, followed by a second dose of one-half of one sachet in the morning (8 AM) on the day of the procedure.

prepopik Pregnancy Risk Category: B

  • Animal reproduction studies with doses comparable to human doses did not show adverse events.

Prepopik use during breastfeeding:

  • For 8 days, lactating women (n=8) received sodium picosulfate 10, mg once daily as an oral solution.
  • The active metabolite, BPHM was detected in plasma, urine and breast milk, but not below the limit of detection (1 ng/mL). (Friedrich 2011, Friedrich 2011).
  • According to the manufacturer of the product, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks to infant exposure, the benefits to the infant and the benefits to the mother.
  • Refer to also the magnesium oxide individual monograph.

Prepopik Dose in Kidney Disease:

CrCl ≥30 mL/minute:

  • In the manufacturer's labeling, there are no dosage adjustments provided.

CrCl <30 mL/minute:

  • Use is contraindicated.

Prepopik Dose in Liver disease:

  • In the manufacturer's labeling, there are no dosage adjustments provided.

Common Side Effects of prepopik (Sodium picosulfate, magnesium oxide, and citric acid):

  • Cardiovascular:

    • Altered blood pressure
    • change in pulse
  • Endocrine & metabolic:

    • Hypermagnesemia
  • Genitourinary:

    • Decreased estimated GFR

Less Common Side Effects of prepopik (Sodium picosulfate, magnesium oxide, and citric acid):

  • Central nervous system:

    • Headache
  • Endocrine & metabolic:

    • Decreased serum potassium
    • Decreased serum glucose
    • Decreased serum sodium
    • Hypochloremia
  • Gastrointestinal:

    • Nausea
    • Vomiting
    • Abdominal pain
  • Renal:

    • Increased serum creatinine

Contraindication to prepopik (Sodium picosulfate, magnesium oxide, and citric acid):

  • Hypersensitivity to magnesium oxide, sodium picosulfate and anhydrous citric acids or any other component of the formulation
  • Ileus or GI obstruction
  • Bowel perforation.
  • Gastric retention
  • Toxic colitis
  • Toxic megacolon.
  • Severe renal impairment (CrCl >30 mL/minute).

Canadian labeling: Additional contraindications not listed in the US labeling:

  • Congestive heart failure.
  • GI ulceration.
  • Nausea.
  • Vomiting.
  • Acute abdominal surgical conditions (eg acute appendicitis).

Warnings and precautions

  • Arrhythmias:

    • Rarely have serious arrhythmias been caused by the use of ionic-osmotic laxatives.
    • Patients at higher risk of arrhythmias (eg unstable angina, recent MI, unstable cardiomyopathy, history QT, HF, uncontrolled arrhythmias) should be used with caution
    • Patients at higher risk of arrhythmia should be evaluated by a physician.
  • Atypical electrolyte and fluid conditions:

    • Fluid and electrolyte disturbances may occur, especially in patients at higher risk (eg, kidney impairment, concomitant medication that alters electrolyte balance).
    • Any electrolyte abnormalities that may have existed prior to the use of this product should be rectified. Patients should also be properly hydrated before, throughout, and after each use.
    • Patients who experience significant vomiting, dehydration or orthostatic hypotension should be evaluated and treated for electrolyte abnormalities after colonoscopy.
  • GI effects

    • Osmotic laxatives can cause colonic mucosal and aphthous ulcerations. This includes cases of ischemic or colitis.
    • When interpreting the colonoscopy results of patients suffering from inflammatory bowel disease, be cautious.
  • Seizures:

    • There have been seizures associated with electrolyte abnormalities, such as hyponatremia and hypocalcemia.
    • Patients with electrolyte disorders or patients at high risk of seizures should be cautious.
  • Gagging reflex in the impaired

    • Watch out for semiconscious patients who have impaired gag reflex, or are prone to regurgitation during administration.
  • Renal impairment

    • Patients with kidney impairment or those taking medication that can adversely affect their renal function (eg, diuretics and NSAIDs), should be cautious.
    • These patients need to be hydrated properly.
    • Patients with impaired renal function should be closely monitored for severe vomiting, including electrolyte measurement.
    • In severe renal impairment (CrCl 30mL/minute), use is not recommended.
  • Ulcerative colitis

    • Patients with severe active ulcerative colitis should be cautious.
    • To rule out obstruction or perforation, it is important to perform diagnostic tests before initiating therapy.

Sodium picosulfate, magnesium oxide, and citric acid: Drug Interaction

Risk Factor C (Monitor therapy)

Alfacalcidol

May increase the serum concentration of Magnesium Salts.

Aluminum Hydroxide

Citric Acid Derivatives may increase the absorption of Aluminum Hydroxide.

Calcium Channel Blockers

May enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers.

Neuromuscular-Blocking Agents

Magnesium Salts may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents.

Polyethylene Glycol-Electrolyte Solution

Sodium Picosulfate may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution.

Risk Factor D (Consider therapy modification)

Alpha-Lipoic Acid

Magnesium Salts may decrease the absorption of Alpha-Lipoic Acid. AlphaLipoic Acid may decrease the absorption of Magnesium Salts.

Antibiotics

May diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Exceptions: Acetic Acid (Otic); Acetic Acid (Topical); Aluminum Acetate; Azithromycin (Ophthalmic); Aztreonam (Oral Inhalation); Bacitracin (Ophthalmic); Bacitracin (Topical); Chlortetracycline; Ciprofloxacin (Ophthalmic); Clindamycin (Topical); Dapsone (Topical); Dibrompropamidine (Ophthalmic); Dibrompropamidine (Topical); Erythromycin (Ophthalmic); Erythromycin (Topical); Framycetin; Fusidic Acid (Ophthalmic); Fusidic Acid (Topical); Gatifloxacin; Gentamicin (Ophthalmic); Gentamicin (Topical); MetroNIDAZOLE (Topical); Mupirocin; Nitrofurazone; Ozenoxacin; Sulfacetamide (Ophthalmic); Tobramycin (Ophthalmic).

Bictegravir

Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended.

Bisphosphonate Derivatives

Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid.

Calcitriol (Systemic)

May increase the serum concentration of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving calcitriol. If magnesium-containing products must be used with calcitriol, serum magnesium concentrations should be monitored closely.

Deferiprone

Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours.

Dolutegravir

Magnesium Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral magnesium salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral magnesium salts.

Doxercalciferol

May enhance the hypermagnesemic effect of Magnesium Salts. Management: Consider using a non-magnesium-containing antacid or phosphate-binding product in patients also receiving doxercalciferol. If magnesium-containing products must be used with doxercalciferol, serum magnesium concentrations should be monitored closely.

Eltrombopag

Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product.

Gabapentin

Magnesium Salts may enhance the CNS depressant effect of Gabapentin. Specifically, high dose intravenous/epidural magnesium sulfate may enhance the CNS depressant effects of gabapentin. Magnesium Salts may decrease the serum concentration of Gabapentin. Management: Administer gabapentin at least 2 hours after use of a magnesiumcontaining antacid. Monitor patients closely for evidence of reduced response to gabapentin therapy. Monitor for CNS depression if high dose IV/epidural magnesium sulfate is used.

Levothyroxine

Magnesium Salts may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and oral magnesium salts by at least 4 hours.

Multivitamins/Fluoride (with ADE)

Magnesium Salts may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, magnesium salts may decrease fluoride absorption. Management: To avoid this potential interaction separate the administration of magnesium salts from administration of a fluoride-containing product by at least 1 hour.

Mycophenolate

Magnesium Salts may decrease the serum concentration of Mycophenolate. Management: Separate doses of mycophenolate and oral magnesium salts. Monitor for reduced effects of mycophenolate if taken concomitant with oral magnesium salts.

PenicillAMINE

Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour.

Phosphate Supplements

Magnesium Salts may decrease the serum concentration of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral magnesium salt as possible to minimize the significance of this interaction. Exceptions: Sodium Glycerophosphate Pentahydrate.

Trientine

Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour.

Risk Factor X (Avoid combination)

Baloxavir Marboxil

Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil.

Calcium Polystyrene Sulfonate

Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. More specifically, concomitant use of calcium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of calcium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives.

Raltegravir

Magnesium Salts may decrease the serum concentration of Raltegravir. Management: Avoid the use of oral / enteral magnesium salts with raltegravir. No dose separation schedule has been established that adequately reduces the magnitude of interaction.

Sodium Polystyrene Sulfonate

Laxatives (Magnesium Containing) may enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of sodium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of sodium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives.

Monitoring parameters (prepopik):

  • Serum electrolytes & renal function tests (baseline & post-colonoscopy) in patients with or at risk for renal impairment or seizure, & in patients who have a history of electrolyte abnormality.
  • Consider ECG (baseline and post-colonoscopy) in patients at risk for prolonged QT or arrhythmias.

How to administer Sodium picosulfate, magnesium oxide, and citric acid?

Clenpiq

  • It is ready-to-drink and does not require diluting.
  • Clear liquids are best avoided the day before and for up to 2 hours after the procedure.
  • Stop drinking any fluids at least two hours before the procedure.
  • While taking Clenpiq, do not eat solid foods or dairy, red or purple liquids, drink alcohol or use any other laxatives.
  • Within one hour of starting the cleansing, do not take any oral medication.
  • After the first dose, take five 8-ounce clear liquids within 5 hours before going to bed (split dose regimen) or the next dose (day prior).
  • After the second dose, drink three 8-ounce clear liquids at least two hours before the colonoscopy (split dosage regimen) or five hours before bed (day before regimen).
  • If severe abdominal pain, distention, or bloating occurs after the first dose, either regimen may delay the second dose.

Prepopik

  • Clear liquids are best avoided the day before and for at least 2 hours after the procedure.
  • Within 5 hours of the first dose, you should drink at least five 8-ounce clear liquid beverages (eg. water, clear broth white cranberry juice white grape juice ginger ale, plain gelatin [not red or purple], frozen juice bars [not red or purple]).
  • After the second dose, drink at least three 8-ounce clear liquids at least 2 hours prior to the colonoscopy (split dosage regimen) or within 5 hour (day-before regime).
  • If severe abdominal pain, distention, or bloating occurs after the first dose, either regimen may delay the second dose.

Pico-Salax and Purg-Odan [Canadian Products]:

  • Minimum 3 days before the procedure:
    • Avoid eating nuts, seeds, fruits, vegetables, and multigrain bread.
  • Day before the procedure:
    • Clear liquids are only to be consumed (eg water, clear power drinks and white [not red] Cranberry juice, white [not violet] grape juice, ginger ale, broth, and tea [without milk cream, soy, or soy]) without solid food. A fiber-free supplement may be recommended for diabetic patients.
  • After each dose:
    • Drink 1.5-2 L of a variety clear fluids (including a balanced Electrolyte Solution) for at least 4 hours before the procedure.
    • Children should have one 8-ounce glass of water every hour they are awake, and two hours before the procedure.

Mechanism of action of prepopik (Sodium picosulfate, magnesium oxide, and citric acid):

  • Prodrug sodium picosulfate is hydrolyzed to an active metabolite by colonic bacteria. This stimulates colonic peristalsis.
  • Magnesium citrate is formed when magnesium oxide and citric acid react. This induces catharsis through the osmotic effects the unabsorbed ions within the GI tract.

Absorption:

  • Magnesium cation: ≥20%

Metabolism: Sodium picosulfate:

  • Hydrolyzed by colonic bacteria to the active compound bis-(phydroxy-phenyl)-pyridyl-2-methane (BHPM)

Half-life elimination:

  • Sodium picosulfate: ~7.5 hours.

Time to peak:

  • Sodium picosulfate: ~7 hours;
  • Magnesium: 10 hours

Excretion:

  • Urine

International Brands of Sodium picosulfate, magnesium oxide, and citric acid:

  • Clenpiq
  • Prepopik
  • Oral Purgative
  • Pico-Salax
  • Picodan
  • Picoflo
  • Purg-Odan
  • CitraFleet
  • Dramrin
  • Pico-Salax
  • Picolax
  • Picolight Powder
  • Picoprep
  • Picoprep Powder
  • Picoprep Powder for Oral Solution
  • PicoPrep Powder for Solution
  • Picosalax
  • Picosalax Powder for Oral Administration
  • Pikoprep
  • Tsytraflit

Sodium picosulfate, magnesium oxide, and citric acid Brand Names in Pakistan:

  • No Brands Available in Pakistan.

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