Mannitol 25% Inj, 50ml

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, calcium, magnesium, bicarbonate). This leads to increased excretion of water and electrolytes. Additionally, mannitol increases plasma osmolality, drawing water from tissues (e.g., brain, eye) into the interstitial fluid and plasma, thereby reducing intracranial pressure (ICP) and intraocular pressure (IOP).

Serious 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Signs of fluid and electrolyte imbalance, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or fast heart rate
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Rapid breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of high or low blood pressure, such as:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Chest pain or pressure
Fast heartbeat
Feeling confused
Feeling sluggish
Blurred vision
Swelling
Fever or chills
Muscle stiffness
Muscle 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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

Headache
Runny nose
Diarrhea
Stomach upset or vomiting
Dizziness
Fatigue
* Excessive sweating

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Heart problems, such as heart failure (a weak heart)
+ Kidney problems
+ Difficulty passing urine
Other health issues, including:
+ Bleeding in the brain
+ Fluid accumulation in the lungs
+ Dehydration (fluid loss)
If you are currently 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 interact with this medication, so it is crucial to ask your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is vital 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 consulting your doctor first.

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. Discuss any concerns with your doctor.

Regular blood tests and other laboratory assessments are crucial while taking this medication, as directed by your doctor. Additionally, be aware that this drug may interfere with certain lab tests. Therefore, it is vital to notify all healthcare providers and laboratory personnel that you are taking this medication.

There is a risk of kidney problems, including kidney failure, associated with this drug. In some cases, these effects may be permanent, even after stopping the medication. If you have any questions or concerns, consult your doctor.

This medication has also been linked to nervous system problems, which can be fatal in some instances.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your treatment and the well-being of your baby.

• Nephrotoxic drugs (e.g., aminoglycosides, cyclosporine, NSAIDs): Increased risk of renal toxicity when co-administered with mannitol, especially in patients with pre-existing renal impairment.
• Lithium: Mannitol can increase renal excretion of lithium, potentially leading to decreased lithium levels and therapeutic effect.

• Diuretics (e.g., loop diuretics, thiazide diuretics): Concurrent use may enhance diuretic effect and increase risk of electrolyte imbalances (e.g., hypokalemia, hyponatremia).
• Corticosteroids: Increased risk of hypokalemia when co-administered with mannitol due to enhanced potassium excretion.
• Neuromuscular blockers: Mannitol may enhance the effect of depolarizing and non-depolarizing neuromuscular blockers due to electrolyte changes.

• Headache (can indicate rebound ICP)
• Nausea and vomiting
• Dizziness
• Chills/fever
• Chest pain or tightness
• Shortness of breath or difficulty breathing (signs of pulmonary edema)
• Peripheral edema
• Signs of dehydration (dry mouth, thirst, decreased skin turgor)
• Confusion or altered mental status
• Muscle weakness or cramps (electrolyte imbalance)
• Urinary retention or decreased urine output

Category C. Mannitol 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 and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

L3 (Moderately safe). It is not known whether mannitol is excreted in human milk. Caution should be exercised when mannitol is administered to a nursing mother. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for mannitol and any potential adverse effects on the breastfed infant from mannitol or from the underlying maternal condition.

Dosing is weight-based. Use with caution in neonates and infants due to immature renal function and increased susceptibility to fluid and electrolyte imbalances. Close monitoring of fluid status, electrolytes, and renal function is crucial.

Elderly patients may be more susceptible to fluid and electrolyte imbalances, acute renal failure, and cardiovascular complications (e.g., congestive heart failure, pulmonary edema) due to age-related decreases in renal function and pre-existing cardiovascular disease. Start with lower doses and monitor closely for adverse effects.

• Mannitol solutions may crystallize at low temperatures. If crystals are observed, warm the bottle in a water bath (e.g., 60°C) with agitation until crystals dissolve. Cool to body temperature before administration.
• Always use an in-line filter for mannitol infusions to prevent administration of any undissolved crystals.
• Rapid administration of mannitol can lead to transient increases in cerebral blood volume and ICP, especially in patients with disrupted blood-brain barrier. Administer slowly over 30-60 minutes.
• Monitor serum osmolality closely; maintaining it below 310-320 mOsm/kg is often recommended to prevent rebound ICP and minimize renal toxicity.
• Contraindicated in severe dehydration, active intracranial bleeding (unless during craniotomy), severe pulmonary congestion or frank pulmonary edema, and anuria unresponsive to a test dose.
• Monitor for signs of rebound ICP (e.g., worsening headache, neurological deterioration) after the osmotic effect wears off.
• Ensure adequate hydration before administering mannitol, especially in patients at risk for dehydration, to prevent exacerbation of renal dysfunction.

• Hypertonic saline (e.g., 3% NaCl, 7.5% NaCl) for reduction of intracranial pressure.
• Loop diuretics (e.g., Furosemide) for diuresis and fluid overload (though mechanism differs and not typically used for ICP reduction as primary agent).
• Glycerol (oral osmotic agent, less commonly used for acute ICP).

If your symptoms or health problems do not improve or worsen over time, it is essential to consult your doctor for further evaluation and guidance.

To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed for someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Properly dispose of unused or expired medications. Unless instructed otherwise by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.

Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.