Mineral Oil

For the treatment of occasional constipation in adults and children 12 years of age and older:

• Oral Route: The standard dose is 15 mL to 45 mL (approximately 1 to 3 tablespoons) per day. This can be taken as a single daily dose or divided into smaller doses throughout the day.
• Rectal Route (Enema): A single 118 mL (4.5 fl oz) squeeze bottle is typically used as a one-time dose for acute relief of constipation or impaction.

Mineral Oil must be used with extreme caution in children due to the risk of aspiration.

• Children 6 to 11 years: The oral dose is 5 mL to 15 mL per day. Rectal enemas (59 mL) may be used if directed by a physician.
• Children under 6 years: Oral Mineral Oil is NOT recommended for children under the age of 6 unless specifically prescribed by a pediatrician. The risk of accidental inhalation into the lungs is significantly higher in this age group.

Renal Impairment

Because Mineral Oil is not absorbed and does not rely on renal clearance, dosage adjustments for patients with kidney disease are generally not required. However, these patients should be monitored for secondary electrolyte changes if they experience diarrhea.

Hepatic Impairment

No specific dosage adjustments are required for patients with liver disease, as the drug is not metabolized by the liver. However, caution is advised in patients with severe cirrhosis who may have impaired swallowing reflexes.

Elderly Patients

Geriatric patients are at a significantly higher risk for aspiration pneumonia. Healthcare providers often recommend avoiding oral Mineral Oil in patients who are frail, bedridden, or have difficulty swallowing. Rectal administration is often a safer alternative for this population.

To ensure safety and efficacy, follow these guidelines:

1. 1Timing: Do not take Mineral Oil within 2 hours of a meal or other medications, as it can interfere with the absorption of nutrients and drugs.
2. 2Positioning: Always take Mineral Oil while sitting or standing upright. NEVER take Mineral Oil while lying down or immediately before going to bed. Wait at least 30 to 60 minutes before lying down after a dose to prevent the oil from refluxing and entering the lungs.
3. 3Palatability: The oil can be mixed with cold fruit juice or water to make it easier to swallow, though it will not dissolve.
4. 4Storage: Store at room temperature (15°C to 30°C / 59°F to 86°F) in a tightly closed container, away from direct light.

If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose or if it is close to bedtime, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.

An acute overdose of Mineral Oil primarily results in gastrointestinal distress. Symptoms may include:

• Severe abdominal cramping
• Profuse diarrhea
• Nausea and vomiting
• Anal leakage (seepage of oil)

In the event of an overdose, contact a Poison Control Center or seek emergency medical care immediately. The primary concern with large ingestions is the risk of aspiration and subsequent lipid pneumonia.

> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or use this product for more than 7 consecutive days without medical guidance.

While Mineral Oil is generally well-tolerated when used correctly, the following common side effects may occur:

• Anal Seepage: Because the oil is not absorbed, it can leak from the rectum, potentially staining undergarments. This is often described as an oily orange or brown discharge.
• Perianal Irritation: The constant presence of oil around the anus can cause itching (pruritus ani) or mild skin irritation.
• Abdominal Cramping: Some patients may experience mild discomfort or a 'rumbling' sensation in the gut as the oil moves through the intestines.
• Nausea: The oily texture and 'mouthfeel' can cause transient nausea in some individuals.

• Diarrhea: Excessive dosing can lead to overly frequent or watery stools.
• Bloating: A feeling of fullness or gas may occur as the bowel contents shift.
• Decreased Appetite: Some patients report a temporary loss of appetite following oral administration.

• Lipid Pneumonia: This is the most serious rare side effect. It occurs when tiny droplets of oil are accidentally inhaled into the lungs. Because Mineral Oil inhibits the cough reflex and does not cause immediate irritation, patients may not realize they have aspirated until significant lung damage has occurred.
• Lipogranuloma: Small nodules formed by the accumulation of absorbed mineral oil in the lymph nodes or liver.

> Warning: Stop taking Mineral Oil and call your doctor immediately if you experience any of these symptoms:

• Shortness of Breath or Wheezing: These may be early signs of lipid pneumonia or aspiration.
• Severe Abdominal Pain: Could indicate a bowel obstruction or more serious gastrointestinal issue.
• Rectal Bleeding: Any blood in the stool after using a laxative requires immediate medical evaluation.
• Persistent Diarrhea: Can lead to dehydration and electrolyte imbalances, characterized by extreme thirst, dark urine, or dizziness.
• Signs of Allergic Reaction: While extremely rare, symptoms include hives, swelling of the face or throat, and difficulty breathing.

Chronic use of Mineral Oil (longer than one week) can lead to significant health complications:

1. 1Hypovitaminosis: Mineral Oil dissolves fat-soluble vitamins (A, D, E, and K) and prevents their absorption from the gut. Prolonged use can lead to deficiencies, which may manifest as impaired vision (Vitamin A), weakened bones (Vitamin D), or bleeding disorders (Vitamin K).
2. 2Laxative Dependency: The bowel may become 'lazy' and lose its natural ability to move stool without the aid of lubricants.
3. 3Foreign Body Reaction: Chronic low-level absorption can lead to the formation of paraffinomas (oil-filled masses) in various organs.

There are currently no FDA black box warnings for Mineral Oil. However, the FDA requires strict labeling warnings regarding the risk of aspiration and the prohibition of use in children under 6, pregnant women, and the elderly without medical supervision.

Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.

Mineral Oil should only be used as a short-term solution for constipation. It is not a permanent fix for chronic bowel issues. Patients should be aware that the primary risk associated with this medication is not systemic toxicity, but rather mechanical complications such as aspiration and nutrient malabsorption.

No FDA black box warnings for Mineral Oil.

• Aspiration Risk: This is the most critical warning. Mineral Oil should never be given to patients who have difficulty swallowing, those who are bedridden, or those who have neurological conditions (like Parkinson's or stroke) that impair the gag reflex. Aspiration of mineral oil can cause irreversible lung scarring (fibrosis).
• Vitamin Malabsorption: Because Mineral Oil is a potent solvent for fat-soluble vitamins, it should never be taken with meals. Long-term use can lead to a deficiency in Vitamin K, which is essential for blood clotting.
• Docusate Interaction: Never use Mineral Oil in combination with stool softeners like docusate (Colace). Docusate acts as a detergent and can significantly increase the systemic absorption of mineral oil, leading to inflammation in the liver and lymph nodes.
• Abdominal Pain: Do not use any laxative if you have nausea, vomiting, or undiagnosed abdominal pain, as these could be signs of an appendicitis or bowel obstruction.

For short-term OTC use, regular lab monitoring is generally not required. However, for patients using it under medical supervision for longer periods, doctors may monitor:

• Vitamin Levels: Specifically Vitamins A, D, and K.
• Prothrombin Time (PT/INR): To ensure that Vitamin K depletion is not affecting blood clotting, especially in patients on anticoagulants.
• Electrolyte Panels: If the patient experiences chronic diarrhea.

Mineral Oil does not have any known psychoactive effects and does not cause drowsiness. It is generally safe to drive or operate machinery after taking this medication. However, the potential for sudden bowel urgency or anal leakage should be considered.

There is no direct chemical interaction between alcohol and Mineral Oil. However, alcohol can contribute to dehydration, which worsens constipation. It is recommended to limit alcohol intake while treating bowel irregularities.

Mineral Oil can be stopped abruptly without the physiological withdrawal symptoms seen with certain drugs. However, if you have been using it for an extended period, you may experience 'rebound constipation' as your bowel adjusts to the lack of lubrication. It is best to gradually increase dietary fiber and fluid intake while tapering off laxatives.

> Important: Discuss all your medical conditions, including any history of swallowing problems or lung disease, with your healthcare provider before starting Mineral Oil.

• Docusate (Sodium or Calcium): The combination of Mineral Oil and docusate is strictly contraindicated. Docusate is a surfactant that breaks down the surface tension of the oil, allowing it to be absorbed into the intestinal wall and systemic circulation. This can lead to lipid granulomas in the liver, spleen, and mesenteric lymph nodes.

• Warfarin (Coumadin): Mineral Oil can interfere with the absorption of Vitamin K. Since Warfarin works by inhibiting Vitamin K-dependent clotting factors, the use of Mineral Oil can potentially increase the blood-thinning effect of Warfarin, raising the risk of bleeding. Patients on anticoagulants should avoid Mineral Oil unless directed by a doctor.
• Oral Contraceptives: Some studies suggest that Mineral Oil may interfere with the absorption of estrogen-based birth control pills if taken at the same time. It is recommended to separate the administration of these drugs by at least 2 to 4 hours.
• Fat-Soluble Vitamins (A, D, E, K): Mineral Oil acts as a 'sink' for these vitamins, carrying them out of the body before they can be absorbed. Long-term concurrent use will lead to nutritional deficiencies.

• Digoxin: There is a theoretical risk that Mineral Oil could slightly decrease the absorption of digoxin, a medication used for heart failure. Monitoring of digoxin levels may be necessary if Mineral Oil is used frequently.
• Potassium-Sparing Diuretics: Chronic laxative use can lead to electrolyte shifts that may complicate the management of patients on diuretics like spironolactone.

• Meals: Mineral Oil should be taken on an empty stomach, ideally at least 2 hours after eating. Taking it with food significantly increases the risk that the oil will interfere with the absorption of essential fatty acids and fat-soluble nutrients from your meal.
• Dairy: While there is no direct interaction, some patients find that dairy products increase mucus production, which, when combined with mineral oil, can worsen gastrointestinal discomfort.

• St. John's Wort: No direct interaction, but general caution is advised as St. John's Wort affects many metabolic pathways.
• Omega-3 Fatty Acids (Fish Oil): Like other fats, the absorption of omega-3 supplements will be severely inhibited if taken with Mineral Oil.

• Stool Tests: Mineral Oil can interfere with certain stool tests, including those for parasites or fecal occult blood (Guaiac tests), by creating a physical film that obscures results.
• Vitamin Screening: May show falsely low levels of fat-soluble vitamins if the patient has been using Mineral Oil chronically.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to prevent dangerous interactions.

Mineral Oil must NEVER be used in the following circumstances:

1. 1Children Under 6 Years of Age: Due to the high risk of accidental aspiration and the potential for rapid dehydration.
2. 2Pregnancy: Mineral Oil can interfere with the mother's absorption of Vitamin K, which can lead to hypoprothrombinemia and hemorrhagic disease in the newborn. It may also stimulate uterine contractions.
3. 3Dysphagia (Difficulty Swallowing): Patients with impaired swallowing reflexes, such as those with stroke, Parkinson's disease, or esophageal strictures, are at an unacceptably high risk for lipid pneumonia.
4. 4Bedridden Patients: Those who cannot maintain an upright position for at least 30-60 minutes after dosing should not take oral Mineral Oil.
5. 5Bowel Obstruction: If a patient has a known or suspected blockage in the intestines, using a lubricant laxative can cause severe pressure buildup and potential perforation.

Conditions requiring careful risk-benefit analysis by a physician:

• Hiatal Hernia or GERD: Patients with severe acid reflux are at a higher risk of 'silent' aspiration of the oil during sleep.
• Chronic Constipation: Mineral Oil is not intended for chronic use. Underlying causes (such as colon cancer or metabolic disorders) must be ruled out first.
• Elderly/Frail Patients: Even without a diagnosed swallowing disorder, the physiological changes of aging increase the risk of aspiration.

There is no known cross-sensitivity between Mineral Oil and other classes of laxatives (like stimulants or osmotics). However, patients with a known hypersensitivity to petroleum-derived products should use Mineral Oil with caution, although true allergic reactions are extremely rare.

> Important: Your healthcare provider will evaluate your complete medical history before prescribing Mineral Oil to ensure it is the safest option for you.

FDA Pregnancy Category: Not Formally Assigned (Generally Avoided).

Mineral Oil is generally not recommended during pregnancy. The primary concern is the inhibition of Vitamin K absorption. Vitamin K is essential for the synthesis of clotting factors. If the mother becomes deficient, the fetus may be born with a dangerous tendency to bleed (hemorrhagic disease of the newborn). Additionally, chronic use of laxatives can lead to electrolyte imbalances that are harmful during pregnancy. Always consult an obstetrician before using any laxative.

Mineral Oil is not absorbed systemically in significant amounts and is therefore unlikely to be excreted into breast milk. However, because it can interfere with the mother's nutritional status (specifically fat-soluble vitamins), it should be used only sparingly and under medical advice. There are no known direct effects on the nursing infant, but maternal health is paramount for quality milk production.

• Ages 6-12: Can be used under adult supervision for short periods.
• Under Age 6: Contraindicated for oral use. Pediatricians may occasionally recommend a mineral oil enema for severe impaction, but this must be done under strict medical guidance.
• Growth Effects: Long-term use in children can lead to malnutrition and failure to thrive due to the malabsorption of essential vitamins A, D, E, and K.

In the elderly, the risks of Mineral Oil often outweigh the benefits. The risk of aspiration pneumonia is significantly elevated due to age-related changes in swallowing and the increased likelihood of being in a recumbent (lying down) position. Furthermore, elderly patients are more likely to be taking multiple medications (polypharmacy), such as Warfarin or Digoxin, which interact with Mineral Oil. Safer alternatives like polyethylene glycol (Miralax) are usually preferred.

Mineral Oil is safe for patients with renal impairment as it does not enter the bloodstream or require kidney filtration. However, these patients must be careful to maintain hydration, as any laxative-induced diarrhea can cause rapid shifts in fluid balance that the kidneys may struggle to manage.

Patients with liver disease (cirrhosis or hepatitis) can use Mineral Oil, but they should be monitored for Vitamin K deficiency. Since the liver produces clotting factors using Vitamin K, any reduction in vitamin absorption can exacerbate existing coagulopathy (bleeding problems) associated with liver failure.

> Important: Special populations require individualized medical assessment to avoid complications.

Mineral Oil is a pharmacologically inert substance. Its primary mechanism is mechanical lubrication. By coating the intestinal mucosa and the fecal mass with a hydrophobic film, it prevents the colonic reabsorption of water. This keeps the stool hydrated and soft. Unlike stimulant laxatives (e.g., senna), it does not stimulate the myenteric plexus or increase intestinal secretions. It simply makes the existing stool 'slippery' enough to pass with minimal effort.

• Onset of Action: 6 to 8 hours (Oral); 2 to 15 minutes (Rectal).
• Duration of Effect: The effect lasts as long as the oil remains in the colon, typically being cleared within one or two bowel movements.
• Tolerance: While physical 'tolerance' in the cellular sense does not occur, the bowel can become dependent on the lubricant to move stool if used chronically.

| Parameter | Value |

|---|---|

| Bioavailability | <5% (Minimal) |

| Protein Binding | N/A (Not systemically active) |

| Half-life | N/A (Physical transit time 6-12 hours) |

| Tmax | N/A (Local action) |

| Metabolism | None |

| Excretion | Fecal (>95% unchanged) |

• Molecular Formula: A complex mixture of $C_{15}$ to $C_{40}$ hydrocarbons.
• Molecular Weight: Variable (approx. 250-450 g/mol).
• Solubility: Insoluble in water and alcohol; soluble in benzene, chloroform, and ether.
• Description: A colorless, transparent, oily liquid that is free from fluorescence in daylight.

Mineral Oil is classified as a Lubricant Laxative. It is distinct from Bulk-forming laxatives (fiber), Osmotic laxatives (magnesium citrate), and Stimulant laxatives (bisacodyl). In some regulatory contexts, it is also listed as an emollient or a pharmaceutical solvent.