MoviPrep

Name: MoviPrep

MoviPrep Overview

MoviPrep is a brand name medication included in the following groups of medications: vitamin C products, plain, Organic acids, OTHER OPHTHALMOLOGICALS, Osmotically acting laxatives, Sodium, Electrolyte solutions, POTASSIUM, Salt solutions. For more information about MoviPrep see its generics Ascorbic Acid, Potassium Chloride, Sodium Chloride, Sodium Sulfate

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amantadine
  • Atropine
  • Belladonna
  • Belladonna Alkaloids
  • Benztropine
  • Biperiden
  • Clidinium
  • Darifenacin
  • Dicyclomine
  • Eplerenone
  • Fesoterodine
  • Glycopyrrolate
  • Hyoscyamine
  • Methscopolamine
  • Oxybutynin
  • Procyclidine
  • Scopolamine
  • Solifenacin
  • Tolterodine
  • Trihexyphenidyl
  • Trospium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alacepril
  • Amiloride
  • Amygdalin
  • Benazepril
  • Canrenoate
  • Captopril
  • Cilazapril
  • Deferoxamine
  • Delapril
  • Enalaprilat
  • Enalapril Maleate
  • Fosinopril
  • Imidapril
  • Indomethacin
  • Licorice
  • Lisinopril
  • Moexipril
  • Pentopril
  • Perindopril
  • Quinapril
  • Ramipril
  • Spirapril
  • Spironolactone
  • Temocapril
  • Trandolapril
  • Triamterene
  • Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Indinavir
  • Licorice

What is the most important information I should know about polyethylene glycol electrolyte solution?

Do not use this medication if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. Polyethylene glycol electrolyte solution can cause dangerous or life-threatening side effects in people with these conditions.

Polyethylene glycol electrolyte solution side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time. Call your doctor for instructions if you have:

  • gagging, choking, severe stomach pain or bloating;

  • no bowel movement within 2 hours after use;

  • nausea, vomiting, trouble drinking liquids, headache, little or no urinating; or

  • fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements.

Common side effects may include:

  • mild stomach cramps, gas, or bloating;

  • rectal pain or irritation;

  • hunger, thirst, mild nausea;

  • passing gas; or

  • dizziness, chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Proper Use of MoviPrep

Your doctor may have special instructions for you, depending on the schedule of your colonoscopy you are going to have. If you have not received such instructions, or if you do not understand them, check with your doctor in advance.

Take this medicine exactly as directed. Otherwise, the test you are going to have may not work and may have to be done again.

This medicine comes with a Medication Guide. You must read, understand, and follow these instructions carefully. Ask your doctor if you have any questions.

It is best if you do not eat any solid food before taking this medicine and until after your colonoscopy.

You may drink clear liquids (eg, water, clear fruit juices (without pulp), strained limeade or lemonade, coffee or tea, broth, soda, gelatin, popsicles) before, during, and up until 2 hours before the time of your colonoscopy. Do not drink anything colored red or purple. However, check first with your doctor.

You may have clear soup or plain yogurt for dinner on the evening that you start taking MoviPrep®. Dinner should be at least 1 hour before you take MoviPrep®.

To prepare the medicine:

  • The powder must be mixed with water before it is used. Add lukewarm water to the fill mark on the bottle. Do not add any other ingredients, such as flavoring, to the solution.
  • Shake well until all the ingredients are dissolved.
  • After you mix the solution, you must use it within 24 hours. You may refrigerate the solution before drinking.
  • You will need to drink 8 ounces (240 milliliters) of the mixed medicine about every 15 minutes until it is gone.
  • About 1 hour after you drink the first glass of liquid, you should have your first loose stool or mild diarrhea. This is how the medicine cleans out your bowels. You may have bloating or an upset stomach before the loose stools start.
  • If you cannot swallow the liquid, tell your doctor right away.

You will need to consume 2 liters (about 64 ounces) of the oral solution and one additional liter (about 32 ounces) of clear liquid prior to the test. You may do one of the following ways:

  • Split-dose (2-day regimen) method: The night before the test, drink the first liter of oral solution over 1 hour and then drink 0.5 liters (about 16 ounces) of clear liquid. Then, on the morning of the test, drink the second liter of the oral solution over 1 hour and then drink another 0.5 liters of clear liquid at least 2 hours before the test.
  • Evening-only (1-day regimen) method: The night (around 6 pm) before the test, drink the first liter of the oral solution over 1 hour. After about 1.5 hours, drink the second liter of the oral solution over one hour. Drink an additional liter of clear liquid the night before the test.
  • Do not eat or drink anything 2 hours prior to your colonoscopy, unless your doctor provides you with different instructions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (powder for oral solution):
    • For cleansing the colon:
      • Adults—8 ounces (240 milliliters) every 15 minutes.
      • Children—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the carton containing the pouches of powder and the liquid for mixing with the powder at room temperature, away from heat, moisture, or light. Once the powder has been mixed with the liquid, refrigerate the mixed solution and use it within 24 hours.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Belly pain.
  • Swelling of belly.
  • Very upset stomach or throwing up.
  • Very bad headache.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Black, tarry, or bloody stools.
  • Bleeding from rectum or rectal pain.
  • This medicine may cause you to be dehydrated or have electrolyte problems. Rarely, this may be very bad or deadly. Tell your doctor right away if you get very dizzy, pass out, feel very tired or weak, or have a fast heartbeat, a heartbeat that does not feel normal, or seizures. Tell your doctor right away if you have headache, mood changes, confusion, muscle pain or weakness, more thirst, not hungry, dry mouth, dry eyes, very bad upset stomach or throwing up, if you are unable to pass urine, or if you have a change in the amount of urine produced.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Overdosage

There have been no reported cases of overdose with MoviPrep.  Purposeful or gross accidental ingestion of more than the recommended dose of MoviPrep might be expected to lead to severe electrolyte disturbances, including hyponatremia and/or hypokalemia, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. The patient who has taken an overdose should be monitored carefully, and treated symptomatically for complications.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential have not been performed with MoviPrep.  Studies to evaluate potential for impairment of fertility or mutagenic potential have not been performed with MoviPrep.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

• Advise patients who require a diet low in phenylalanine that MoviPrep contains aspartame – a maximum of 233 mg per treatment.  This sweetener, after hydrolysis in the body, provides 131 mg of phenylalanine to the patient. • Ask patients to inform you if they have trouble swallowing or are prone to regurgitation or aspiration. • Instruct patients that each pouch needs to be diluted in water before ingestion and that they need to drink additional clear liquid. Examples of clear liquids are:  • water • clear fruit juices without pulp including apple, white grape, or white cranberry • strained limeade or lemonade • coffee or tea (Do not use dairy or non-dairy creamer.) • clear broth • clear soda • gelatin (without added fruit or topping) • popsicles (without pieces of fruit or fruit pulp) • Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of MoviPrep. • Tell patients not to take other laxatives while they are taking MoviPrep. • Tell patients that MoviPrep produces a watery stool (diarrhea) which cleanses the colon before colonoscopy.  Advise patients receiving MoviPrep to adequately hydrate before, during, and after the use of MoviPrep. Patients may have clear soup and/or plain yogurt for dinner, finishing the evening meal at least one hour prior to the start of MoviPrep treatment.  No solid food should be taken from the start of MoviPrep treatment until after the colonoscopy. • Tell patients that the first bowel movement may occur approximately 1 hour after the start of MoviPrep administration. Abdominal bloating and distention may occur before the first bowel movement. If severe abdominal discomfort or distention occurs, stop drinking MoviPrep temporarily or drink each portion at longer intervals until these symptoms diminish.  If severe symptoms persist, notify your healthcare provider.

Manufactured for:

Salix Pharmaceuticals, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Product protected by U.S. Patent Nos. 7,169,381 and 7,658,914.

MoviPrep is a trademark of Velinor AG used under license.

©Valeant Pharmaceuticals North America LLC

Please see www.salix.com for patent information.

PI2017503107

9522400

Rev.05/2016

 Medication Guide

 

MoviPrep®

(moo-vee-prěp)

 (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution)

Read this Medication Guide before you start taking MoviPrep.  This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about MoviPrep?

MoviPrep 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:

• abnormal heartbeats that can cause death • seizures. This can happen even if you have never had a seizure. • kidney problems

Your risk of having fluid loss and changes in body salts with MoviPrep is higher if you:

• have heart problems • have kidney problems • take water pills (diuretics), high blood pressure medication, or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking MoviPrep:

• vomiting • dizziness • urinating less often than normal • headache

See “What are the possible side effects of MoviPrep?” for more information about side effects.

What is MoviPrep?

MoviPrep is a prescription medicine used by adults 18 years of age and older to clean the colon before a colonoscopy. MoviPrep cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if MoviPrep is safe and effective in children.

Who should not take MoviPrep?

Do not take MoviPrep 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 very dilated intestine (toxic megacolon) • an allergy to any of the ingredients in MoviPrep. See the end of this leaflet for a complete list of ingredients in MoviPrep.

What should I tell my healthcare provider before taking MoviPrep?

Before you take MoviPrep, tell your healthcare provider if you:

• have heart problems • have a history of seizures • have kidney problems • have stomach or bowel problems, including ulcerative colitis • have problems with swallowing or gastric reflux • have a condition that destroys red blood cells called Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency • are withdrawing from drinking alcohol • have a low blood salt (sodium) level • are on a diet low in phenylalanine • have any other medical conditions • are pregnant or plan to become pregnant. It is not known if MoviPrep will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if MoviPrep passes into your breast milk. You and your healthcare provider should decide if you will take MoviPrep while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

MoviPrep may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of MoviPrep.

Especially tell your healthcare provider if you take:

• medicines for blood pressure or heart problems • medicines for kidney problems • medicines for seizures • water pills (diuretics) • non-steroidal anti-inflammatory (NSAID) pain medicines • laxatives • medicines for depression or mental health problems

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take MoviPrep?

See the Instructions for Use on the outer MoviPrep carton for dosing instructions. You must read, understand, and follow these instructions to take MoviPrep the right way.

• Take MoviPrep exactly as your healthcare provider tells you to take it.  Your healthcare provider will prescribe the Split-dose (2-Day) option or the Evening only (1-Day) dosing option, depending on the scheduling of your colonoscopy. • Do not take MoviPrep that has not been mixed with water. • Drink clear liquids before, during, and after you take MoviPrep to help prevent fluid loss (dehydration).  It is important for you to drink the additional prescribed amount of clear liquids listed in the Instructions for Use.

Examples of clear liquids are:

• water • clear fruit juices without pulp including apple, white grape, or white cranberry • strained limeade or lemonade • coffee or tea (Do not use any dairy or non-dairy creamer). • clear broth • clear soda • gelatin (without added fruit or topping) • popsicles (without pieces of fruit or fruit pulp) • Do not eat or drink anything colored red or purple. • Do not take other laxatives while taking MoviPrep. • You may eat clear broth and plain yogurt for dinner on the evening that you start taking MoviPrep. Finish eating this meal at least 1 hour before you start taking MoviPrep. • Do not eat solid foods while taking MoviPrep and until after your colonoscopy. • Drink only clear liquids: • while taking MoviPrep • after taking MoviPrep and until 2 hours before your colonoscopy

Do not eat or drink anything 2 hours before your colonoscopy.

• You may have stomach-area (abdomen) bloating before you have your first bowel movement. • Stop drinking MoviPrep for a short time or wait a longer time between each dose of MoviPrep if you have severe stomach-area (abdomen) discomfort or bloating until your symptoms improve. If symptoms continue, tell your healthcare provider. • Your first bowel movement may happen about 1 hour after you start taking MoviPrep. • If you take too much MoviPrep, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of MoviPrep?

MoviPrep can cause serious side effects, including:

• See Section “What is the most important information I should know about MoviPrep?” • changes in certain blood tests. Your healthcare provider may do blood tests after you take MoviPrep to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: • vomiting • nausea • bloating • dizziness • stomach-area (abdomen) cramping • headache • urinate less than usual • trouble drinking clear liquid • ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

The most common side effects of MoviPrep for split dosing include:

• discomfort • nausea • stomach-area (abdomen) pain • vomiting • indigestion

The most common side effects of MoviPrep for the Evening only (1-Day) dosing option include:

• stomach-area (abdominal) bloating • anal discomfort • thirst • nausea • stomach-area (abdomen) pain • sleep problems • chills • hunger • discomfort • vomiting • dizziness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of MoviPrep. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store MoviPrep?

• Store MoviPrep that has not been mixed with water at room temperature, between 20° to 25°C (68° to 77°F). • Store MoviPrep that has been mixed with water in an upright position in the refrigerator. • MoviPrep should be taken within 24 hours after it has been mixed with water.

Keep MoviPrep and all medicines out of the reach of children.

General information about the safe and effective use of MoviPrep.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MoviPrep for a condition for which it was not prescribed. Do not give MoviPrep to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about MoviPrep. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, call 1-800-321-4576 or go to www.MoviPrep.com.

What are the ingredients in MoviPrep?

Active ingredients:

Pouch A: polyethylene glycol (PEG) 3350, sodium sulfate, sodium chloride, potassium chloride.

Pouch B: ascorbic acid and sodium ascorbate.

Inactive ingredients: 

Pouch A: aspartame, acesulfame potassium, and lemon flavoring.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Salix Pharmaceuticals, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

Product protected by U.S. Patent Nos.

7,169,381 and 7,658,914.

Please see www.salix.com for patent information.

PI2017503107

9522400

Rev.  05/2016

What should I avoid while taking MoviPrep?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking MoviPrep. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using MoviPrep unless your doctor has told you to.

For Healthcare Professionals

Applies to polyethylene glycol 3350 with electrolytes: oral kit, oral powder for reconstitution

General

The most common adverse events were abdominal distension, anal discomfort, thirst, nausea, and abdominal pain. Since diarrhea is considered part of the efficacy of this product, it was not defined as an adverse reaction.[Ref]

Gastrointestinal

Very common (10% or more): Abdominal distension (59.8%), anal discomfort (52%), nausea (47.3%), abdominal pain (39.1%), vomiting (12.8%)
Common (1% to 10%): Upper abdominal pain, dyspepsia
Frequency not reported: Upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation, borborygmi, flatulence[Ref]

Metabolic

Very common (10% or more): Hunger (70.8%)
Common (1% to 10%): Hypokalemia, hyperphosphatemia
Frequency not reported: Electrolyte disturbances, hyperkalemia[Ref]

Other

Very common (10% or more): Rigors (33.7%), malaise (26.6%)
Frequency not reported: Peripheral edema[Ref]

Nervous system

Very common (10% or more): Dizziness (18.1%)
Common (1% to 10%): Headache[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (34.9%)[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction
Postmarketing reports: Hypersensitivity reactions (including anaphylaxis, rash, angioedema, urticaria, lip and facial swelling, dyspnea, chest tightness, throat tightness)[Ref]

Cardiovascular

Frequency not reported: Asystole[Ref]

Dermatologic

Frequency not reported: Urticaria, dermatitis[Ref]

Respiratory

Frequency not reported: Rhinorrhea, acute pulmonary edema, acute pulmonary edema after aspirating the PEG-based preparation[Ref]

Some side effects of MoviPrep may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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