Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
Salix Pharmaceuticals, Inc
PRESCRIPTION DRUG
PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults. PLENVU is contraindicated in the following conditions: Risk Summary There are no available data with PLENVU in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with PLENVU. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data available to assess the presence of PLENVU in human milk, the effects on the breastfed 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
PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride: NDC 65649-400-01. Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride: NDC 65649-400-01. Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid: NDC 65649-400-01. PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 65649-400-01. PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 65649-400-01. Storage Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.
New Drug Application
SODIUM ASCORBATE Salix Pharmaceuticals, Inc ---------- MEDICATION GUIDE MEDICATION GUIDE PLENVU® (plen-vu) (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) Read this Medication Guide and Instructions for Use before your colonoscopy and again before you start taking PLENVU. What is the most important information I should know about PLENVU? PLENVU and other bowel preparations can cause serious side effects, including: • Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: o abnormal heartbeats that can cause death. o seizures. This can happen even if you have never had a seizure. o kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU is higher if you: • have heart problems. • have kidney problems. • take water pills (diuretics), high blood pressure medicine or non-steroidal anti-inflammatory drugs (NSAIDs). Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking PLENVU: • vomiting • dizziness • urinating less often than normal • headache See “What are the possible side effects of PLENVU?” for more information about side effects. What is PLENVU? PLENVU is a prescription medicine used by adults to clean the colon before a colonoscopy. PLENVU cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if PLENVU is safe and effective in children. Do not take PLENVU if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction). • an opening in the wall of your stomach or intestine (bowel perforation). • problems with food and fluid emptying from your stomach (gastric retention). • a problem with food moving too slowly through your intestines (ileus) Прочитайте повний документ
PLENVU- POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE SALIX PHARMACEUTICALS, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PLENVU SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PLENVU. PLENVU (POLYETHYLENE GLYCOL 3350, SODIUM ASCORBATE, SODIUM SULFATE, ASCORBIC ACID, SODIUM CHLORIDE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION) INITIAL U.S. APPROVAL: 2006 RECENT MAJOR CHANGES Dosage and Administration (2.1) 9/2023 INDICATIONS AND USAGE PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. (1) DOSAGE AND ADMINISTRATION Preparation and Administration: • • • • Recommended Dosage Regimens: • • • DOSAGE FORMS AND STRENGTHS For Oral Solution: First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B. • • • CONTRAINDICATIONS • • • • • • WARNINGS AND PRECAUTIONS • • • ® Two doses of PLENVU are required for a complete preparation for colonoscopy, using a “Two-Day” or “One-Day” dosage regimen. (2.1) Reconstitute PLENVU in water prior to ingestion. (2.1) Consume additional clear liquids after each dose of PLENVU in both dosing regimens. (2.1, 5.1) Administer oral medications at least 1 hour before starting each dose of PLENVU. (2.1, 7.2) _Two-Day Split Dosage_: Dose 1 the evening before the colonoscopy (approximately 4 pm to 8 pm) and Dose 2 the next morning (approximately12 hours after the start of Dose 1). (2.1, 2.2) _One-Day Morning Dosage_: Dose 1 the morning of the colonoscopy (approximately 3 am to 7 am) and Dose 2 a minimum of 2 hours after the start of Dose 1. (2.1, 2.3) For complete information on dosing, preparation and administration, see full prescribing information. (2.1, 2.2, 2.3) Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium Прочитайте повний документ