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.
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 […]