Mannitol 20% Inj, 500ml

Mannitol is an osmotic diuretic. It increases the osmotic pressure of the glomerular filtrate, which inhibits tubular reabsorption of water and electrolytes (sodium, chloride, potassium). This leads to increased urine output. When administered intravenously, mannitol increases the osmolality of the plasma, which draws water from tissues (e.g., brain, eye) into the intravascular space, thereby reducing intracranial pressure (ICP) and intraocular pressure (IOP).

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of acidosis (too much acid in the blood): confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, nausea and vomiting, excessive sleepiness, shortness of breath, or extreme fatigue or weakness.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure, or rapid heartbeat.
Confusion or feeling sluggish.
Blurred vision.
Swelling.
Fever or chills.
Muscle stiffness or pain.
Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Pain or irritation at the injection site.
Changes in skin color to black or purple.
Skin breakdown at the injection site.

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 experience any of the following side effects or any others that bother you or persist, contact your doctor:

Headache.
Runny nose.
Diarrhea, nausea, or vomiting.
Dizziness, fatigue, or weakness.
Excessive sweating.

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult 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 symptoms you experienced.
Certain health conditions, including:
+ Heart problems, such as heart failure (a weakened heart) or kidney problems.
+ Difficulty urinating.
+ Bleeding in the brain, fluid accumulation in the lungs, or dehydration (fluid loss).
If you are taking a diuretic (water pill).
If you are taking any medications that may increase the risk of kidney or nervous system problems. There are numerous drugs that can cause these issues, so consult your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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

Rarely, this drug can cause severe and potentially life-threatening allergic reactions. It is crucial to discuss this risk with your doctor.

To monitor your health, your doctor will likely recommend regular blood tests and other laboratory evaluations. This medication may interfere with certain lab tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.

In some cases, people taking this medication have experienced kidney problems, including kidney failure. These effects may be irreversible, even after stopping the medication. If you have concerns, consult your doctor.

This drug has also been associated with nervous system problems, which can be fatal in some instances.

If you are pregnant, planning to become pregnant, or breastfeeding, you must discuss the potential benefits and risks of this medication with your doctor to make an informed decision about your treatment.

• Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs, cyclosporine, amphotericin B): Increased risk of renal toxicity.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Additive diuretic effect, increased risk of electrolyte imbalance and dehydration.
• Digoxin: Increased risk of digoxin toxicity due to mannitol-induced hypokalemia.

• Oral anticoagulants: May increase risk of bleeding due to hemoconcentration.
• Lithium: Mannitol may increase lithium excretion, leading to decreased lithium levels.

• Signs of dehydration (dry mucous membranes, decreased skin turgor, thirst)
• Signs of fluid overload/pulmonary edema (dyspnea, crackles, peripheral edema, jugular venous distension)
• Signs of electrolyte imbalance (muscle weakness, cramps, arrhythmias, altered mental status)
• Headache, nausea, vomiting, dizziness
• Chills, fever, allergic reactions (rash, urticaria)
• Changes in neurological status (for ICP management)

Mannitol is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans.

It is not known whether mannitol is excreted in human milk. Caution should be exercised when mannitol is administered to a nursing mother. The decision to breastfeed during treatment should consider the potential for infant exposure, the benefits of breastfeeding, and the benefits of treatment to the mother.

Dosing is weight-based. Close monitoring of fluid and electrolyte balance, renal function, and serum osmolality is crucial due to higher susceptibility to fluid shifts and electrolyte imbalances in children. Use with caution in neonates and infants due to immature renal function.

Elderly patients may be more susceptible to adverse effects, particularly fluid and electrolyte imbalances, and acute kidney injury, due to age-related decline in renal function and comorbidities. Start with lower doses and monitor closely. Avoid in patients with severe heart failure or renal failure.

• Mannitol solutions may crystallize at low temperatures. If crystals are observed, warm the solution in a water bath (e.g., 60-80°C) with agitation until crystals dissolve, then cool to body temperature before administration. Do not administer if crystals persist.
• Always use an in-line filter (e.g., 5-micron filter) for mannitol infusions to prevent administration of any undissolved crystals.
• Monitor serum osmolality closely; target typically <320 mOsm/kg to prevent renal toxicity and rebound ICP.
• Ensure adequate hydration before administering mannitol, especially in patients with compromised renal function, to prevent acute kidney injury.
• Rapid administration or high doses can lead to transient hypervolemia, potentially exacerbating heart failure or pulmonary edema.
• Discontinue mannitol if progressive renal dysfunction, heart failure, or pulmonary congestion occurs.

• Hypertonic Saline (e.g., 3% NaCl, 7.5% NaCl): Used for reduction of ICP, often preferred over mannitol in hypotensive patients or those with renal impairment.
• Loop Diuretics (e.g., Furosemide): Can be used to reduce fluid overload and sometimes in conjunction with mannitol for ICP reduction, but primarily for diuresis.
• Barbiturate Coma (for refractory ICP): Induces cerebral vasoconstriction and reduces cerebral metabolic rate.
• Craniectomy (surgical intervention for ICP).

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.