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PLENVU is a brand name for Polyethylene Glycol 3350, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride and potassium chloride powder for oral solution) is indicated for cleansing of the colon in preparation for colonoscopy in adults. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Correct fluid and electrolyte abnormalities before treatment with PLENVU (see 7 WARNINGS AND PRECAUTIONS, General). • Two doses of PLENVU are required for a complete preparation for colonoscopy. 2 Recommended Dose and Dosage Adjustment).
2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment). • PLENVU must be reconstituted in water prior to ingestion. It may take 2 to 3 minutes for complete dissolution. 5 Drug-Food Interactions). 2 Recommended Dose and Dosage Adjustment, 7 WARNINGS AND PRECAUTIONS, General).
• Only clear liquids (no solid food) must be consumed from the start of PLENVU treatment until after the colonoscopy. • Patients must not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• Patients must not take other laxatives while taking PLENVU. 4 Drug-Drug Interactions). • Patients must ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy. 2 Recommended Dose and Dosage Adjustment A course of treatment consists of two separate non-identical 500 mL doses of PLENVU.
At least 500 mL of additional clear fluid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea, and/or coffee without milk must be taken with each dose.
There are two dosing regimen options for PLENVU:
Two-Day Split-Dosing Regimen and One- Day Morning Dosing Regimen. PLENVU® Product Monograph Page 6 of 40 Two-Day Split-Dosing Regimen Instruct adult patients to take the two separate doses in conjunction with clear liquids as follows: Dose 1 – In the evening before the colonoscopy, between approximately 4 pm and 8 pm: Drink the first dose of PLENVU over 30 minutes.
Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. Consume additional clear liquids during the evening. If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – The next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 (between approximately 4 am and 8 am): Drink the second dose of PLENVU over 30 minutes. Be sure to drink all of the solution.
). Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. Monitoring and Laboratory Tests In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia, and those at risk of electrolyte imbalance, the health professional should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate.
Any suspected dehydration should be corrected for before use of PLENVU. 4 Drug-Drug Interactions). Neurologic Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures.
, hyponatremia, hypokalemia, hypocalcaemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions).
These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of PLENVU, and consider performing pre- PLENVU® Product Monograph Page 14 of 40 dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients (see 7 WARNINGS AND PRECATIONS, Monitoring and Laboratory Tests).
1 Pregnant Women There are no available data with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. PLENVU should only be used during pregnancy if considered essential by the health professional.
Ingestion of large doses of ascorbic acid during pregnancy has resulted in scurvy in neonates. Animal reproduction studies have not been conducted with PLENVU (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
) ▪ ileus ▪ toxic megacolon which complicates severe inflammatory conditions of the intestinal tract including Crohn's disease and ulcerative colitis ▪ toxic colitis ▪ acute surgical abdominal conditions such as acute appendicitis and diverticulitis ▪ unconsciousness.
1 Dosing Considerations • Correct fluid and electrolyte abnormalities before treatment with PLENVU (see 7 WARNINGS AND PRECAUTIONS, General). • Two doses of PLENVU are required for a complete preparation for colonoscopy. 2 Recommended Dose and Dosage Adjustment).
2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment). • PLENVU must be reconstituted in water prior to ingestion. It may take 2 to 3 minutes for complete dissolution. 5 Drug-Food Interactions). 2 Recommended Dose and Dosage Adjustment, 7 WARNINGS AND PRECAUTIONS, General).
• Only clear liquids (no solid food) must be consumed from the start of PLENVU treatment until after the colonoscopy. • Patients must not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• Patients must not take other laxatives while taking PLENVU. 4 Drug-Drug Interactions). • Patients must ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy. 2 Recommended Dose and Dosage Adjustment A course of treatment consists of two separate non-identical 500 mL doses of PLENVU.
At least 500 mL of additional clear fluid, which may include water, clear soup, fruit juice without pulp, soft drinks, tea, and/or coffee without milk must be taken with each dose.
There are two dosing regimen options for PLENVU:
Two-Day Split-Dosing Regimen and One- Day Morning Dosing Regimen. PLENVU® Product Monograph Page 6 of 40 Two-Day Split-Dosing Regimen Instruct adult patients to take the two separate doses in conjunction with clear liquids as follows: Dose 1 – In the evening before the colonoscopy, between approximately 4 pm and 8 pm: Drink the first dose of PLENVU over 30 minutes.
PLENVU is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
) ▪ ileus ▪ toxic megacolon which complicates severe inflammatory conditions of the intestinal tract including Crohn's disease and ulcerative colitis ▪ toxic colitis ▪ acute surgical abdominal conditions such as acute appendicitis and diverticulitis ▪ unconsciousness.
PLENVU® Product Monograph Page 5 of 40
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Polyethylene Glycol 3350 in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy.
Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort, or distention occurs, until these symptoms resolve. One-Day Morning Dosing Regimen Instruct adult patients to take the two separate doses in conjunction with clear liquids as follows: Dose 1 – On the day of the colonoscopy, between approximately 3 am and 7 am: Drink the first dose of PLENVU over 30 minutes.
Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – On the day of the colonoscopy, a minimum of 2 hours after the start of Dose 1: Drink the second dose of PLENVU over 30 minutes. Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes.
Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy. Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.
Patients should be reminded of the importance of hydration while taking these products and to seek medical attention if they experience any signs of severe dehydration, such as excessive thirst, dizziness, confusion and decreased urine output or dark coloured urine.
1. Pediatrics).
Geriatrics (≥ 65 years of age):
No dose adjustment is required in patients 65 years of age and older. 4 Geriatrics).
Patients with Renal Impairment:
PLENVU has been studied in patients with mild and a limited number of patients with moderate renal impairment. No dose adjustment is considered necessary in these populations. However, caution should be used with the administration of PLENVU to patients with renal impairment as these […]
2 Breast-feeding It is unknown if PLENVU is excreted in human milk. Precaution should be exercised because many drugs are excreted in human milk. There are no data available to assess the presence of PLENVU in human milk, the effects on the breast-fed child or the effects on milk production.
The lack of clinical data during lactation precludes a clear determination of the risk of PLENVU to a child during lactation; therefore, the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for PLENVU and any potential adverse effects on the breast-fed child from PLENVU or from the underlying maternal condition.
1 Pediatrics). 4 Geriatrics Of the approximately one thousand patients in clinical trials receiving PLENVU, 222 (21%) patients were over 65 years of age. No overall differences in safety were observed between geriatric patients and younger patients.
2 Geriatrics). Potentially serious complications may arise if abnormal fluid intake or losses occur simultaneously in this sub-population. Suboptimal oral intake of water and electrolytes could create clinically significant deficiencies in less fit patients, in particular elderly, debilitated and patients at risk of hypokalemia.
Published literature contains reports of serious adverse events following the administration of PEG-based products in patients over 60 years of age. 1 Adverse Reaction Overview). Caution should be used with the administration of PLENVU to frail or debilitated patients.
1 Adverse Reaction Overview The safety of PLENVU as a Two-Day Split-Dosing and One-Day Morning Dosing Regimen was evaluated in a multicenter randomized, parallel group, investigator-blinded clinical trial (MORA) in 805 adult patients undergoing colonoscopy.
The mean age of the study population was 55 years (range 18 to 84 years), 98% of patients were Caucasian and 54% were female. In the MORA trial, 67% had mild renal impairment and 5% had moderate renal impairment. 1 Clinical Trials by Indication).
The most common adverse reactions (> 2%) in the PLENVU treatment groups were vomiting, nausea, dehydration and abdominal pain/discomfort. Published literature contains reports of serious adverse events following the administration of macrogol (PEG)-based products in […]
Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. Consume additional clear liquids during the evening. If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – The next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 (between approximately 4 am and 8 am): Drink the second dose of PLENVU over 30 minutes. Be sure to drink all of the solution.
Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy.
Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort, or distention occurs, until these symptoms resolve. One-Day Morning Dosing Regimen Instruct adult patients to take the two separate doses in conjunction with clear liquids as follows: Dose 1 – On the day of the colonoscopy, between approximately 3 am and 7 am: Drink the first dose of PLENVU over 30 minutes.
Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes. If severe bloating, abdominal distention, or abdominal pain occurs following the first dose, delay the second dose until the symptoms resolve.
Dose 2 – On the day of the colonoscopy, a minimum of 2 hours after the start of Dose 1: Drink the second dose of PLENVU over 30 minutes. Be sure to drink all of the solution. Refill the container (at least 500 mL) with clear liquids and drink over the next 30 minutes.
Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your doctor. Then stop drinking liquids until after the colonoscopy. Stop drinking PLENVU temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.
Patients should be reminded of the importance of hydration while taking these products and to seek medical attention if they experience any signs of severe dehydration, such as excessive thirst, dizziness, confusion and decreased urine output or dark coloured urine.
1. Pediatrics).
Geriatrics (≥ 65 years of age):
No dose adjustment is required in patients 65 years of age and older. However, caution should be used with the administration of PLENVU to geriatric patients as these patients are more likely to have […]