Signature Care Clearlax

For the treatment of occasional constipation in adults and adolescents aged 17 years and older, the standard dose is 17 grams of powder once daily.

• Measurement: If using a multi-dose bottle, use the provided cap to measure the dose. Fill the cap to the indicated line (usually the top of the inner section) to reach the 17-gram mark.
• Duration: The medication should not be used for more than 7 consecutive days unless specifically directed by a physician. If constipation persists beyond a week, a medical evaluation is necessary to rule out more serious gastrointestinal pathology.

• Children 17 years and older: Follow the adult dosage of 17 grams once daily.
• Children under 17 years: Polyethylene Glycol 3350 is not FDA-approved for over-the-counter use in children under 17. However, it is very frequently prescribed 'off-label' by pediatricians for functional constipation.
• Pediatric Off-label Dosing: Typical pediatric doses range from 0.5 grams to 1.5 grams per kilogram of body weight per day, but this must be calculated and monitored by a pediatrician. Never give this medication to a child without professional medical guidance.

Renal Impairment

Because Polyethylene Glycol 3350 is minimally absorbed, no specific dosage adjustments are generally required for patients with mild to moderate renal impairment. However, patients with severe kidney disease should consult their doctor, as they may be more sensitive to the minor electrolyte shifts that can occur with laxative use.

Hepatic Impairment

There are no dosage adjustments required for patients with liver disease, as the drug is not metabolized by the liver and does not enter the portal circulation in significant amounts.

Elderly Patients

Elderly patients are at a higher risk for dehydration and electrolyte imbalances. While the standard 17-gram dose is generally used, healthcare providers may recommend more frequent monitoring or a lower starting frequency (e.g., every other day) for frail patients.

1. 1Preparation: Stir and dissolve the 17 grams of powder into 4 to 8 ounces (120 to 240 mL) of a beverage.
2. 2Beverage Choice: You may use water, juice, soda, coffee, or tea. The powder is unflavored and grit-free, so it should dissolve completely without changing the taste of the drink significantly.
3. 3Timing: It can be taken with or without food. Many patients find it most effective to take the dose in the morning, though the time of day is less important than consistency.
4. 4Storage: Store the powder at room temperature (68°F to 77°F). Keep the container tightly closed to protect it from moisture.

If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not double the dose to 'catch up,' as this increases the risk of diarrhea and abdominal cramping.

An overdose of Polyethylene Glycol 3350 is rarely life-threatening but can cause significant discomfort.

• Signs of Overdose: Severe diarrhea, intense abdominal bloating, vomiting, and signs of dehydration (extreme thirst, dark urine, dizziness).
• Emergency Measures: If an overdose occurs, stop taking the medication immediately and increase intake of clear fluids. If the patient is confused or cannot keep fluids down, seek emergency medical attention. Treatment usually involves supportive care to restore fluid and electrolyte balance.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance. If you have a sudden change in bowel habits that lasts over 2 weeks, consult a doctor before using this product.

Most patients tolerate Polyethylene Glycol 3350 well, but because it alters the fluid dynamics of the gut, some gastrointestinal symptoms are common. These usually resolve as the body adjusts to the medication or once the dose is discontinued.

• Abdominal Bloating and Gas (Flatulence): As the osmotic pressure draws water into the colon, you may feel a sense of fullness or 'puffiness' in the abdomen. This is often accompanied by increased gas production.
• Nausea: Some patients feel slight stomach upset shortly after drinking the solution, especially if it is consumed too quickly.
• Stomach Cramping: Mild, intermittent 'twinges' or cramping may occur as the colon begins to move the rehydrated stool.
• Increased Bowel Frequency: This is the intended effect, but it may initially feel like an urgency to use the bathroom.

• Diarrhea: If the dose is too high for your specific needs, the stool may become excessively watery. If this occurs, you should reduce the dose or stop use.
• Borborygmi: Loud rumbling or gurgling noises from the stomach or intestines as fluids and gas move through the GI tract.
• Dizziness: Usually secondary to mild fluid shifts, though rare if adequate hydration is maintained.

• Severe Allergic Reactions: While PEG is used in many products, some individuals may develop a hypersensitivity. Symptoms include hives, swelling of the face or tongue, and difficulty breathing.
• Electrolyte Imbalance: In rare cases, particularly with prolonged use, levels of sodium, potassium, or magnesium in the blood may become abnormal.
• Rectal Bleeding: This is usually not caused by the drug itself but may occur if the patient has hemorrhoids that are irritated by increased bowel movements.

> Warning: Stop taking Polyethylene Glycol 3350 and call your doctor immediately if you experience any of these.

1. 1Severe or Persistent Diarrhea: This can lead to rapid dehydration and kidney strain. If you cannot stop the diarrhea by discontinuing the drug, medical intervention is required.
2. 2Severe Abdominal Pain: Sharp, localized, or worsening pain could indicate a bowel obstruction or perforation, which are contraindications for laxative use.
3. 3Signs of Dehydration: These include decreased urination, extreme thirst, dry mouth, lightheadedness, or fainting.
4. 4Blood in the Stool: Any bright red blood or black, tarry stools require an immediate medical evaluation to rule out internal bleeding.
5. 5Anaphylaxis: Signs of a severe allergic reaction, such as swelling of the throat, rapid heart rate, or a sudden drop in blood pressure.

Polyethylene Glycol 3350 is intended for short-term use (7 days). Using it longer than recommended can lead to:

• Laxative Dependency: Although PEG 3350 is not a stimulant, the body may become 'accustomed' to the osmotic assistance, making it difficult to have natural bowel movements without it.
• Chronic Electrolyte Depletion: Long-term use can slowly deplete the body of essential salts, which can affect heart and muscle function.
• Masking of Underlying Disease: Relying on laxatives can delay the diagnosis of serious conditions like colorectal cancer or inflammatory bowel disease (IBD).

No FDA black box warnings for Polyethylene Glycol 3350. It is generally considered one of the safest laxatives available when used according to the label instructions.

Report any unusual symptoms to your healthcare provider. If you experience persistent vomiting or a complete inability to pass gas or stool, seek medical help immediately.

Polyethylene Glycol 3350 is a safe and effective medication for most people, but it is not appropriate for everyone. The most critical safety rule is that it should never be used if you have a known or suspected bowel obstruction. Forcing bowel movements against a physical blockage can lead to serious complications, including intestinal perforation (a tear in the bowel wall).

No FDA black box warnings for Polyethylene Glycol 3350. Unlike some phosphate-based laxatives (which have warnings regarding acute phosphate nephropathy), PEG 3350 has a very high safety profile regarding kidney health in the general population.

• Allergic Reactions: Patients with a known allergy to polyethylene glycol should avoid this medication. PEG is also found in some injectable medications and processed foods; if you have had a reaction to those, consult an allergist before using PEG 3350.
• Kidney Disease: If you have a history of renal impairment, you must consult your doctor before use. While the drug isn't absorbed, the fluid shifts it causes can stress the kidneys or exacerbate existing electrolyte imbalances.
• Eating Disorders: There is a risk of misuse among individuals with eating disorders (such as bulimia or anorexia nervosa) who may use laxatives for weight control. This is dangerous and can lead to permanent damage to the digestive system and heart.
• Sudden Change in Bowel Habits: If you notice a sudden change in your bowel movements that lasts for more than two weeks, do not use a laxative. This could be a sign of a more serious condition that requires a diagnostic workup.

For short-term (7-day) use, no specific laboratory monitoring is required for healthy individuals. However, for those using it long-term under medical supervision, doctors may periodically check:

• Serum Electrolytes: To ensure sodium, potassium, and chloride levels remain within normal ranges.
• Renal Function: (BUN and Creatinine) to ensure the kidneys are handling fluid shifts appropriately.
• Clinical Assessment: Regular check-ups to ensure the constipation isn't a symptom of a new, underlying condition.

Polyethylene Glycol 3350 does not typically cause drowsiness or cognitive impairment. It is considered safe to drive or operate machinery while using this medication. However, if you experience dizziness due to dehydration, you should avoid these activities until you feel stable.

There is no direct chemical interaction between Polyethylene Glycol 3350 and alcohol. However, alcohol is a diuretic (it increases urine production), which can lead to dehydration. Since PEG 3350 also works by drawing water into the gut, combining the two can increase the risk of becoming dehydrated. It is best to limit alcohol intake while treating constipation.

When stopping Polyethylene Glycol 3350 after several days of use, no tapering is usually required. However, to prevent 'rebound' constipation, it is important to increase dietary fiber (fruits, vegetables, whole grains) and maintain high fluid intake as you stop the medication.

> Important: Discuss all your medical conditions with your healthcare provider before starting Polyethylene Glycol 3350. Be sure to mention if you have irritable bowel syndrome (IBS), ulcerative colitis, or Crohn's disease.

There are no medications that are strictly 'contraindicated' in a way that causes a toxic chemical reaction with Polyethylene Glycol 3350. However, it should not be used simultaneously with other osmotic or stimulant laxatives unless directed by a doctor, as this significantly increases the risk of severe dehydration and electrolyte collapse.

• Oral Medications with Narrow Therapeutic Indices: Because PEG 3350 increases the speed at which contents move through the intestines (decreased transit time), it may reduce the absorption of other oral medications. This is particularly concerning for drugs where a precise blood level is required, such as:
• Digoxin (for heart failure)
• Antiepileptics (for seizures, like phenytoin or carbamazepine)
• Warfarin (a blood thinner)
• Immunosuppressants (like cyclosporine)
• Strategy: Take other oral medications at least 2 hours before or 2 hours after taking your Polyethylene Glycol 3350 dose.

• Diuretics (Water Pills): Medications like furosemide or hydrochlorothiazide already lower the body's fluid and salt levels. Combining them with a laxative increases the risk of dehydration and low potassium (hypokalemia).
• Licorice Root: Large amounts of natural licorice can lower potassium levels, which may be worsened by the use of PEG 3350.

• Starch-Based Thickeners: A specific and important interaction exists with starch-based food thickeners (often used for patients with swallowing difficulties or dysphagia). Polyethylene Glycol 3350 can counteract the thickening effect of starch, making the liquid thin and increasing the risk of choking or aspiration. If you use thickeners, consult a speech-language pathologist or doctor before using PEG 3350.
• General Diet: There are no restrictions on grapefruit, dairy, or high-fat meals. In fact, a high-fiber diet is encouraged to assist the medication's effect.

• Psyllium and Fiber Supplements: While often taken together, taking large amounts of fiber and PEG 3350 simultaneously without enough water can actually worsen constipation or cause a 'plug' in the intestines. Always drink at least 8 ounces of water with any fiber supplement.
• Herbal Laxatives: Avoid using senna, cascara, or buckthorn while using PEG 3350 unless instructed, as this can lead to excessive bowel stimulation.

Polyethylene Glycol 3350 does not typically interfere with common blood or urine laboratory tests. However, if used as part of a high-dose bowel prep, it may temporarily affect tests for:

• Fecal Occult Blood: Some formulations may interfere with certain types of stool tests.
• Electrolyte Panels: Results may be skewed if the patient is currently experiencing diarrhea from the medication.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Even 'natural' products can change how your body responds to laxatives.

Polyethylene Glycol 3350 must NEVER be used in the following circumstances:

1. 1Known or Suspected Gastrointestinal Obstruction: If there is a physical blockage in the intestines (due to a tumor, stricture, or twisting), using an osmotic laxative will build up pressure behind the blockage. This can lead to a surgical emergency known as a bowel perforation.
2. 2Bowel Perforation: If there is already a hole in the intestinal wall, PEG 3350 can leak into the abdominal cavity, causing life-threatening peritonitis (infection of the abdominal lining).
3. 3Toxic Megacolon: This is a severe complication of inflammatory bowel disease where the colon becomes massively dilated. Laxatives can cause the colon to rupture in this state.
4. 4Severe Inflammatory Bowel Disease (IBD) Flares: During acute, severe episodes of ulcerative colitis or Crohn's disease, the bowel wall is extremely fragile.
5. 5Hypersensitivity: A known allergy to Polyethylene Glycol 3350 or any component of the formulation.

These conditions require a careful risk-benefit analysis by a healthcare provider:

• Kidney Disease: Due to the risk of fluid shifts and potential (though minor) electrolyte changes.
• Eating Disorders: High risk for laxative abuse and metabolic disturbances.
• Undiagnosed Abdominal Pain: If the cause of the pain is unknown, a laxative could worsen an underlying condition like appendicitis.
• Nausea and Vomiting: These symptoms may indicate an obstruction or other serious issue that should be diagnosed before using a laxative.

There is potential cross-sensitivity with other polyethylene glycol-containing products. PEG is a common 'excipient' (inactive ingredient) in many tablets, topical creams, and even some COVID-19 mRNA vaccines. If you have had an anaphylactic reaction to any of these, you must be evaluated by an allergist before using PEG 3350 powder.

> Important: Your healthcare provider will evaluate your complete medical history before prescribing Polyethylene Glycol 3350. Do not assume that because it is OTC, it is safe for everyone.

Polyethylene Glycol 3350 is generally considered the preferred laxative for use during pregnancy.

• FDA/TGA Category: Formerly Category C.
• Risk Summary: Because systemic absorption is less than 0.2%, the drug does not reach the fetus in any significant amount. Clinical guidelines from the American College of Obstetricians and Gynecologists (ACOG) often suggest osmotic laxatives like PEG 3350 as a first-line pharmacological option if lifestyle changes (fiber and fluid) are insufficient.
• Trimester Risks: There is no evidence of increased teratogenicity (birth defects) in any trimester.

Polyethylene Glycol 3350 is considered compatible with breastfeeding. Due to the extremely low maternal absorption, it is not expected to be excreted into breast milk in any detectable quantity. There have been no reported adverse effects on nursing infants whose mothers were taking PEG 3350. It is considered a 'Lactation Category L1' (Safest).

• Approved Use: Only for those 17 years and older in the OTC setting.
• Off-label Use: Widely used in pediatrics for 'functional constipation.'
• Safety Note: In 2014, the FDA investigated reports of neuropsychiatric events (such as tremors, tics, or anxiety) in children taking PEG 3350. However, subsequent reviews and studies have not established a definitive causal link. Parents should always use the lowest effective dose for the shortest duration and only under a pediatrician's supervision.

Patients over the age of 65 are at a higher risk for constipation but also at a higher risk for the side effects of laxatives.

• Dehydration: Seniors often have a diminished 'thirst mechanism' and may not drink enough water to compensate for the osmotic effect of the drug.
• Polypharmacy: Seniors are more likely to be on medications (like blood pressure pills) that interact with the fluid-moving effects of PEG 3350.
• Renal Clearance: While the drug isn't absorbed, the minor fraction that is may stay in the system longer if kidney function is declined.

In patients with a GFR (Glomerular Filtration Rate) below 30 mL/min, Polyethylene Glycol 3350 should be used with caution. While it does not cause kidney damage, the shift of fluids into the bowel can lead to 'pre-renal' strain if the patient is not carefully hydrated. Dialysis patients should only use this medication under the strict guidance of their nephrologist.

No dosage adjustments are required for patients with liver cirrhosis or hepatic failure. The drug's action is localized to the gut lumen and does not rely on hepatic metabolism for activation or clearance.

> Important: Special populations require individualized medical assessment. Always consult with a specialist if you are pregnant, nursing, or managing chronic kidney disease.

Polyethylene Glycol 3350 is a long-chain, linear polymer of ethylene oxide. Its molecular formula is H(OCH2CH2)nOH, where 'n' represents the average number of oxyethylene groups. The '3350' refers to its average molecular weight.

Its pharmacology is entirely based on osmotic pressure. In the colon, the PEG 3350 molecules form hydrogen bonds with water molecules. This 'traps' the water in the stool. Because the osmotic pressure in the intestinal lumen becomes higher than in the surrounding plasma, water is not reabsorbed. The resulting increase in fecal water content softens the stool and increases its volume. This volume expansion stretches the colonic walls, stimulating the mechanoreceptors that trigger the defecation reflex. It does not affect the absorption of nutrients or electrolytes in the small intestine.

• Onset of Action: 24 to 72 hours. This delay is because the medication must travel through the entire length of the GI tract to reach the accumulated stool in the colon.
• Duration of Effect: The effect lasts as long as the drug is present in the colon. Once the PEG 3350 is excreted, the osmotic effect ceases.
• Tolerance: Unlike stimulant laxatives (like bisacodyl), there is no evidence that the body develops a 'tolerance' to the osmotic mechanism of PEG 3350, meaning the dose does not usually need to be increased over time to achieve the same effect.

| Parameter | Value |

|---|---|

| Bioavailability | < 0.2% |

| Protein Binding | 0% |

| Half-life (absorbed fraction) | 4–6 hours |

| Tmax (time to peak effect) | 24–72 hours (clinical effect) |

| Metabolism | None |

| Excretion | Fecal (>99%), Renal (<1%) |

• Molecular Formula: C2nH4n+2On+1
• Molecular Weight: Approximately 3350 Daltons
• Solubility: Highly soluble in water; also soluble in many organic solvents.
• Structure: A polyether compound consisting of repeating ethylene glycol units. It is non-toxic, non-immunogenic, and chemically inert under physiological conditions.

Polyethylene Glycol 3350 is classified as an Osmotic Laxative. Related medications in this class include Lactulose, Sorbitol, and Magnesium Hydroxide (Milk of Magnesia). Among these, PEG 3350 is often preferred because it is not fermented by colonic bacteria, which generally results in less gas and bloating compared to lactulose or sorbitol.