PEG 3350-Kcl-nacl Solution(2pouch)

Polyethylene Glycol (PEG) is an osmotic agent that causes water to be retained in the colon, resulting in a watery stool. The electrolyte components (potassium chloride, sodium chloride, sodium sulfate, sodium ascorbate, ascorbic acid) are included to prevent significant shifts in fluid and electrolytes across the intestinal wall, thereby minimizing the risk of dehydration and electrolyte imbalance during the rapid bowel evacuation.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
+ Swelling of the abdomen
Severe headache
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
Rectal bleeding or pain

This medication may also cause dehydration or electrolyte imbalances, which can be severe or life-threatening. If you experience any of the following symptoms, contact your doctor immediately:

Dizziness or fainting
Fatigue or weakness
Inability to pass urine
Fast or abnormal heartbeat
Seizures
Headache
Mood changes
Confusion
Muscle pain or weakness
Increased thirst
Decreased appetite
Dry mouth or eyes
Severe nausea or vomiting
Changes in urine output

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Stomach pain
Anal irritation
Bloating
Feeling full
Nausea or vomiting
Stomach cramps
Sleep disturbances
Increased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel problems, such as a bowel block or hole in the bowel
+ Electrolyte imbalances (e.g., low sodium, potassium, or phosphate levels)
+ Dehydration (fluid loss)
+ Previous stomach or bowel surgery

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To avoid potential interactions, do not use other laxatives or stool softeners unless your doctor has instructed you to do so.

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.

Adults over 60 years old should exercise caution when using this drug, as they may be more susceptible to side effects.

Individuals with low levels of the enzyme glucose-6-phosphate dehydrogenase (G6PD) should be aware that they may be at a higher risk of developing anemia. This enzyme deficiency is more common in people of African, South Asian, Middle Eastern, and Mediterranean descent.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Oral medications taken within 1 hour of starting the bowel preparation: May be flushed from the GI tract and not absorbed. Consider delaying or rescheduling oral medications.
• Diuretics: Increased risk of dehydration and electrolyte imbalance (especially hypokalemia).

• ACE inhibitors/ARBs: Increased risk of electrolyte abnormalities (e.g., hyperkalemia if combined with other potassium-sparing agents) and renal impairment.
• NSAIDs: Increased risk of renal impairment, especially in dehydrated patients.
• Laxatives (other): Concomitant use may increase risk of severe abdominal cramping or dehydration.
• Drugs that prolong QT interval: Risk of arrhythmias due to potential electrolyte disturbances (e.g., hypokalemia, hypomagnesemia).

• Signs of dehydration (excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness)
• Symptoms of electrolyte imbalance (muscle cramps, weakness, irregular heartbeat, confusion, seizures)
• Severe abdominal pain, bloating, or distension
• Nausea or vomiting that prevents completion of the preparation
• Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Use with caution. While systemic absorption is minimal, there are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not shown fetal harm. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Considered low risk. PEG 3350 is minimally absorbed and not expected to be excreted in breast milk. Electrolytes are naturally occurring. Caution is advised, but generally considered compatible with breastfeeding due to minimal systemic exposure to the infant.

This specific formulation (MoviPrep, Plenvu) is generally not approved for pediatric use. Other PEG-electrolyte solutions (e.g., GoLYTELY) have specific pediatric dosing and are used for bowel preparation in children. Use in children should be under strict medical supervision due to increased risk of fluid and electrolyte imbalances.

Use with caution. Elderly patients may be at increased risk for fluid and electrolyte disturbances, dehydration, and renal impairment. Monitor closely for signs of dehydration and electrolyte imbalance. Consider lower volumes or alternative preparations if significant comorbidities exist.

• Ensure patients understand the importance of completing the entire preparation for an effective colonoscopy.
• Emphasize the need for adequate clear liquid intake beyond the prescribed solution to prevent dehydration.
• Advise patients to chill the solution and use a straw to make it more palatable.
• Instruct patients to apply a barrier cream (e.g., petroleum jelly, zinc oxide) to the perianal area to prevent skin irritation from frequent bowel movements.
• Review all concomitant medications, especially those affecting electrolytes (diuretics, ACE inhibitors, ARBs) or those that may be poorly absorbed (oral contraceptives, antiepileptics) during the prep.
• For patients with a history of seizures, renal impairment, or cardiac issues, close monitoring of electrolytes is crucial.

• Oral Sodium Phosphate products (e.g., OsmoPrep, Visicol - less commonly used due to renal risk)
• Magnesium Citrate (less effective for full colon cleansing)
• Bisacodyl tablets/suppositories (often used as an adjunct)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.