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Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials.
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Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety of MoviPrep as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy. Hypersensitivity Reactions īecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.Risks in Patients with Phenylketonuria.Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency.Patients with Significant Gastrointestinal Disease.Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis.Serious Fluid and Electrolyte Abnormalities.The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Read the entire detailed patient monograph for MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Ascorbic Acid ) vomiting, stomach pain, indigestion, bloating.fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements.nausea, vomiting, headache, trouble drinking liquids, little or no urinating or.gagging, choking, severe stomach pain or bloating.Call your doctor for instructions if you have: You may need to drink the liquid more slowly, or stop using it for a short time if you have certain side effects. signs of an electrolyte imbalance-increased thirst or urination, dry mouth, confusion, constipation, muscle pain or weakness, leg cramps, irregular heartbeats, tingly feeling.dizziness, feeling like you might pass out.no bowel movement within 2 hours after use.Get emergency medical help if you have signs of an allergic reaction: hives difficult breathing swelling of your face, lips, tongue, or throat.
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You may report side effects to FDA at 1-80. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. Our MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Consult your doctor before breastfeeding. It is unknown if MoviPrep could affect a fetus. Tell your doctor if you are pregnant before using MoviPrep. MoviPrep During Pregnancy and Breastfeeding Tell your doctor all medications and supplements you use. MoviPrep may interact with oral medication administered within 1 hour of the start of administration of MoviPrep, as the medication may be flushed from the gastrointestinal tract and may not be absorbed. What Drugs, Substances, or Supplements Interact with MoviPrep? The MoviPrep dose for colon cleansing for adult patients is 2 liters (approximately 64 ounces) of MoviPrep solution (with 1 additional liter of clear fluids) taken orally prior to the colonoscopy, as directed. general feeling of being unwell ( malaise),.MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution) is a bowel cleanser indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.