Nulytely

Name: Nulytely

Warnings

Included as part of the PRECAUTIONS section.

Manufacturer

  • Braintree Laboratories, Inc.

  • Compumed Pharmaceuticals, Inc.

  • DispenseXpress, Inc.

Proper Use of polyethylene glycol 3350, sodium and potassium salts

This section provides information on the proper use of a number of products that contain polyethylene glycol 3350, sodium and potassium salts. It may not be specific to Nulytely. Please read with care.

Your doctor may have special instructions based on the schedule for your colonoscopy. If you have not received instructions, or if you do not understand them, check with your doctor in advance.

Take this medicine exactly as directed by your doctor. Otherwise, your test may not work correctly and may have to be repeated.

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

You must not eat any solid food for 2 hours before using this medicine. Once you drink your first dose of medicine, do not eat solid food until after your test.

You may drink water or clear liquids up until 2 hours before the test unless your doctor has different instructions. Do not drink red and purple liquids.

Do not take any oral medicines starting 1 hour before taking this medicine. Oral medicines may not be absorbed properly while you are cleaning out your colon. Talk to your doctor if you have any questions.

To use the medicine:

  • The powder must be mixed with water. Do not swallow the powder.
  • If you are using a flavor pack, add 1 pack to the bottle before adding water. Do not add any additional flavoring. Throw away extra flavor packs.
  • Add lukewarm water to the fill mark on the bottle.
  • Shake well until all of the powder is dissolved.
  • Keep the mixture in the refrigerator and use it within 48 hours.
  • Follow your doctor's orders about when to begin drinking the mixture.
  • Drink the mixture quickly instead of sipping it.
  • The medicine will start working about 1 hour after you drink the first glass. You will have diarrhea at first then very watery stools.
  • Keep drinking the mixture until your stools are clear and free of solids.
  • Throw away any unused mixture.
  • If you cannot swallow liquids, the mixture can be given through a tube inserted into your nose.

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 solution):
    • For cleansing of the colon:
      • Adults—240 milliliters (mL) (8 oz) every 10 minutes.
      • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 milliliters (mL) per kilogram (kg) every hour.
      • Children younger than 6 months of age—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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

After the powder is mixed with water, keep the mixture in the refrigerator. Use the liquid within 48 hours after adding water. Throw away any unused portion.

Precautions While Using Nulytely

It is important that your doctor check you closely for any unwanted effects caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Contact your doctor right away if you have a decrease in urine, dizziness, fainting, headaches, or vomiting. These could be symptoms of too much fluid loss (dehydration).

Tell your doctor right away if you have severe stomach bloating, distension, or pain after taking this medicine.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor right away.

Do not take additional stimulant laxatives (eg, bisacodyl) with this medicine. This includes prescription or nonprescription (over-the-counter [OTC]) medicines.

What do I need to tell my doctor BEFORE I take NuLYTELY?

  • If you have an allergy to polyethylene glycol or any other part of NuLYTELY (polyethylene glycol-electrolyte solution).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Bowel block, enlarged colon, hole in the GI (gastrointestinal) tract, or slow-moving GI (gastrointestinal) tract.
  • If you have electrolyte (like sodium, potassium, phosphate) problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take NuLYTELY with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out NuLYTELY?

  • Store powder at room temperature.
  • After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long this medicine may be used after mixing.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about NuLYTELY, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about NuLYTELY. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using NuLYTELY.

Review Date: October 4, 2017

Dosage Forms and Strengths

For oral solution: One 4 liter jug with powder for reconstitution with water.

Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Contraindications

NuLYTELY is contraindicated in the following conditions:

  • Gastrointestinal (GI) obstruction, ileus, or gastric retention
  • Bowel perforation
  • Toxic colitis or toxic megacolon
  • Known allergy or hypersensitivity to any component of NuLYTELY [see How Supplied/Storage and Handling (16)]

Adverse Reactions

The following adverse reactions have been identified during post-approval use of NuLYTELY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of NuLYTELY. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

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