sodium picosulfate/magnesium oxide/anhydrous citric acid

General

Pronunciation:
soe-dee-um pi-koe-sul-fate/mag-nee-zhum ox-side/an-hye-druss sit-ric as-id

Trade Name(s)

• Clenpiq
• Pico-Salax 
• Prepopik
• Purg-Odan 

Ther. Class.

laxatives

Pharm. Class.

osmotic laxatives

stimulant laxatives

Indications

Cleansing of the colon in preparation for colonoscopy.

Action

Sodium picosulfate: converted by colonic bacteria to BHPM, which directly stimulates colonic peristalsis.  Magnesium oxide and anhydrous citric acid: combine to form magnesium citrate, an osmotic laxative that causes water retention within the GI tract.

Therapeutic Effect(s):

With concurrent fluid ingestion produces watery diarrhea and colonic purging in preparation for colonoscopy.

Pharmacokinetics

Absorption: Minimal systemic absorption.

Distribution: Action is primarily local.

Metabolism and Excretion: Action is primarily local.

Half-life: Sodium picosulfate: 7.4 hr.

TIME/ACTION PROFILE (onset of watery diarrhea)

Contraindication/Precautions

Contraindicated in:

• Severe renal impairment (CCr <30 mL/min);
• GI obstruction/ileus/bowel perforation/toxic colitis or megacolon/gastric retention.

Use Cautiously in:

• Renal impairment/concurrent medications affecting renal function (↑ risk of renal impairment);
• Known risk factors for arrhythmias including prolonged QT interval, recent MI, unstable angina pectoris, HF, or cardiomyopathy;
• Known/suspected inflammatory bowel disease (may cause mucosal ulcerations);
• Electrolyte abnormalities (correct prior to administration);
• History of seizures or concurrent use of medications that ↓ seizure threshold (may ↑ risk of seizures);
• At risk for aspiration;
• OB:  Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
• Pedi:   Children <9 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

CV: ARRHYTHMIAS, orthostatic hypotension, syncope

F and E: dehydration, fluid/electrolyte abnormalities

GI: abdominal distention, abdominal pain, nausea, vomiting

GU: RENAL IMPAIRMENT

Neuro: headache, SEIZURES

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

• Concurrent use of drugs affecting fluid and electrolyte status/renal function including  ACE inhibitors,  angiotensin receptor blockers,  corticosteroids,  NSAIDs,  diuretics, and other  laxatives  may ↑ risk of dehydration, renal impairment, seizures, hypotension, and fluid/electrolyte abnormalities.
• Concurrent use of medications that ↓ seizure threshold, including  tricyclic antidepressants  or concurrent  alcohol / benzodiazepine  withdrawal (may ↑ risk of seizures).
• Absorption of  oral medications  taken within 1 hr of start may be altered.
• Prior/concurrent  anti-infectives  may ↓ efficacy.
• Concurrent use of other  laxatives  (may ↑ risk of mucosal ulcerations).
• Concurrent of use of  digoxin  (electrolyte abnormalities may ↑ risk of toxicity).
• Concurrent use of drugs that may induce the syndrome if inappropriate secretion of antidiuretic hormone (SIADH) including  antipsychotics,  carbamazepine,  tricyclic antidepressants, and  SSRIs  may ↑ risk of water retention and electrolyte abnormalities.
• Magnesium in preparation chelates and prevents the absorption of  chlorpromazine,  digoxin,  fluoroquinolones,  penicillamine, and  tetracycline ; these should be given at least 2 hr before or 6 hr after.

Route/Dosage

PO (Adults and Children ≥9 yr): One bottle during evening before colonoscopy; repeat during the morning 5 hr prior to the colonoscopy.

Availability (generic available)

Oral solution (cranberry flavor): 10 mg sodium picosulfate/3.5 g magnesium oxide/12 g anhydrous citric acid per bottle (160 mL)

Assessment

• Assess patient for abdominal distention, presence of bowel sounds, and usual pattern of bowel function.
• Assess color, consistency, and amount of stool produced. Watery diarrhea to clear liquid should be defecated at the completion.
• Monitor for significant vomiting or signs of dehydration (orthostatic hypotension) following medication. Consider postcolonoscopy lab tests (electrolytes, serum creatinine, BUN) and treat accordingly. May occur up to 7 days after colonoscopy.
• Assess for seizures, especially in patients with a seizure disorder or patients taking medications that lower seizure threshold, withdrawing from alcohol or benzodiazepines, or with hyponatremia.
• Monitor ECG predose and postcolonoscopy in patients with increased risk of arrhythmias (history of prolonged QT interval, uncontrolled arrhythmias, recent MI, unstable angina, HF, cardiomyopathy).

Lab Test Considerations:

May cause ↓ serum potassium, sodium, chloride, calcium, and eGFR and ↑ serum magnesium and creatinine.

Implementation

• Correct fluid and electrolyte abnormalities prior to therapy.
• Assess for difficulty swallowing or history of regurgitation or aspiration prior to administering.
• PO Clenpiq  is ready to drink and dose not need to be diluted. Solution is clear with possible presence of visible particles. One bottle of  Clenpiq  is equal to one dose. Take bottle the night before colonoscopy followed by five 8-oz drinks (upper line of dosing cup) of clear liquid within 5 hr and before bed. On day of colonoscopy, second bottle followed by at least four 8-oz drinks of clear liquid before colonoscopy. Drinking clear liquids may continue until 2 hr of colonoscopy.

Patient/Family Teaching

• Instruct patient to consume only clear liquids (no solid food or milk) on the day before colonoscopy and up to 2 hr before time of the colonoscopy. Reconstitute powder as directed and follow dosing regimen.
• Caution patient to hydrate adequately with clear liquids before, during, and after use. Clear liquids include water, clear broth, apple juice, white cranberry juice, white grape juice, ginger ale, plain jello (not red or purple), and frozen juice bars (not purple or red). Do not eat solid foods or drink milk or alcohol during therapy.
• Advise patient to notify health care professional if severe bloating, distention, or abdominal pain occurs following first bottle. Delay administration of second bottle administration until symptoms resolve.
• Advise patient not to take any other laxatives during therapy.
• Instruct patient to notify health care professional promptly if hives, rash, vomiting that prevents them from keeping down the additional prescribed amounts of clear liquids needed after taking medication, dizziness, urinating less than normal, or headache occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Clean colon prior to colonoscopy.