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Halflytely

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HalfLytely and Bisacodyl Tablets

HalfLytely and Bisacodyl Tablets

Halflytely Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

HalfLytely and Bisacodyl Tablets Bowel Prep Kit (sodium chloride-sodium bicarbonate and potassium chloride) is used to clean the bowel before colonoscopy or other intestinal procedure. It is a laxative that stimulates bowel movements. Common side effects include nausea, stomach fullness, cramping, or vomiting. These effects are usually temporary.

HalfLytely and Bisacodyl Tablets should be taken as directed by a physician. Take one 5 mg dose bisacodyl delayed-release tablet with water. Prepare the HalfLytely solution according to the instructions on the kit. Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes. Drink all of the solution. Before taking this medication, tell your doctor if you are also taking a diuretic (water pill), or heart or blood pressure medications. Other drugs may interact with HalfLytely and Bisacodyl. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, HalfLytely and Bisacodyl should be used only when prescribed. It is not known if this product passes into breast milk. Consult your doctor before breast-feeding.

Our HalfLytely and Bisacodyl Tablets Bowel Prep Kit (sodium chloride-sodium bicarbonate and potassium chloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Halflytely in Detail - Patient Information: Side Effects

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

Call your doctor if you have any of these serious side effects:

  • seizure (convulsions);
  • severe nausea, severe stomach pain or bloating;
  • coughing up blood or vomit that looks like coffee grounds;
  • rectal bleeding;
  • no bowel movement within 6 hours after use; or
  • gagging, choking, or vomiting.

Some of these side effects may be prevented by drinking the medication more slowly, or not using it for a short time. Follow your doctor's instructions.

Less serious side effects may include:

  • mild nausea or vomiting;
  • mild stomach cramps, or full feeling;
  • rectal pain or irritation;
  • passing gas; or
  • headache.

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.

Read the entire detailed patient monograph for Halflytely (Sodium Chloride-Sodium Bicarbonate and Potassium Chloride) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Halflytely FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

In a clinical study of HalfLytely and (5 mg vs. 10 mg) Bisacodyl Tablets Bowel Prep Kit overall discomfort, abdominal fullness, abdominal cramping, nausea, and vomiting, were the most common adverse reactions ( > 3%). The data in Table 1 reflects the 154 patients that received HalfLytely and 5 mg bisacodyl tablet vs. the 154 patients that received HalfLytely and 10 mg bisacodyl tablets. The HalfLytely and 5 mg Bisacodyl Tablet Bowel Prep Kit population was 29-87 years of age, 49% male, 51% female, 13% African American, 83% White, 5% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Table 1: Adverse Reactions Observed in at Least 3% of Randomized Patients

  HalfLytely and 5 mg Bisacodyl Tablet
Bowel Prep Kit (N=154)
HalfLytely and 10 mg Bisacodyl Tablets
Bowel Prep Kit (N=154)
Overall Discomfort 57% 66%
Abdominal fullness 40% 53%
Abdominal cramping 38% 46%
Nausea 34% 42%
Vomiting 10% 7%

 Postmarketing Experience

The following adverse reactions have been identified during post approval use of HalfLytely and Bisacodyl Tablet Bowel Prep Kit. 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.

Allergic Reactions

Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products.

Gastrointestinal

There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over 60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters of PEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patients who developed diarrhea, vomiting and dysnatremia [see WARNINGS AND PRECAUTIONS].

Ischemic colitis has been reported with use of HalfLytely and 20 mg and 10 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior to colonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl Tablet Bowel Prep Kit has not been established.

Neurologic

There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Halflytely (Sodium Chloride-Sodium Bicarbonate and Potassium Chloride) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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