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Mannitol

    Brands

    DEA Class; Rx

    Common Brand Names; Osmitrol

    • Diuretics, Osmotic Agents

    mannitol inhalation (Rx)

    Brand and Other Names:Aridol, Bronchitol
    • Classes: Pulmonary, Other
    Parenteral osmotic diuretic; also uses as an orally inhaled bronchoconstrictor
    Used parenterally to reduce intracranial pressure, cerebral edema, and intraocular pressure; can promote diuresis in acute renal failure; enhances renal elimination of some drugs
    Mannitol inhalation testing kit aides in diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma; another inhalation product is used as add-on chronic therapy to improve pulmonary function in adults with cystic fibrosis who have passed a BRONCHITOL Tolerance Test (BTT)

    Indicated for reduction of intracranial pressure associated with cerebral edema and/or brain mass

    Indicated for the assessment of bronchial hyperresponsiveness in patients who do not have clinically apparent asthma

    Indicated as add-on maintenance therapy to improve pulmonary function in adults aged 18 years and older with cystic fibrosis

    Hypersensitivity

    Anuria

    Severe hypovolemia

    Pre-existing severe pulmonary vascular congestion or pulmonary edema

    Active intracranial bleeding, except during craniotomy

    Hypersensitivity reactions: Cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticarial/rash, pruritus, generalized pain, discomfort, nausea, vomiting, and headache

    Renal failure: acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria

    CNS toxicity: Headache, coma, seizures, confusion, lethargy; rebound increase in intracranial pressure; dizziness

    Fluid and electrolyte imbalances: Hypovolemia, hypervolemia, peripheral edema, dehydration, hyponatremia, hypernatremia, hyperkalemia, hypokalemia; metabolic acidosis

    Infusion site reactions: Infection, venous thrombosis or phlebitis, inflammation, pain, rash, erythema, pruritus, compartment syndrome and swelling associated with extravasation

    Cardiac and respiratory disorders: Rhinitis, congestive cardiac failure, pulmonary edema, palpitations, hypotension, hypertension, tachycardia, and angina-like chest pains

    Gastrointestinal disorders: Thirst, dry mouth, nausea, vomiting

    Other: Asthenia, malaise, fever, chills, urticaria

    Infusion of hypertonic solutions through a peripheral vein, at a concentration of 10% w/v or greater, may result in peripheral venous irritation, including phlebitis; other severe infusion site reactions, such as compartment syndrome and swelling associated with extravasation, can occur; administer, preferably, into a large central vein

    Do not mix with blood

    Serious hypersensitivity reactions, including anaphylaxis, hypotension and dyspnea resulting in cardiac arrest and death reported; stop infusion immediately if signs or symptoms of suspected hypersensitivity reaction develop

    Available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus

    Mannitol is present in amniotic fluid when administered to pregnant women during the third trimester of pregnancy

    There are no data on presence of mannitol in either human or animal milk, effects on breastfed infant, or on milk production

    When administering intravenous (IV) mannitol, the total dosage, concentration, and rate of administration should be governed by the nature and severity of the condition being treated, fluid requirement, and urinary output. While the usual adult dosage ranges from 20 to 100 grams IV in a 24-hour period, there is no absolute maximum dosage; however doses in excess of 200 grams/day IV or 400 grams/48 hours IV have been associated with acute renal failure. In patients with increased intracranial pressure or cerebral edema, the plasma osmolality should not exceed 320 mOsm/kg.

    Adults

    Aridol test kit for bronchial challenge: 635 mg (19 capsules)/day via oral inhalation; BRONCHITOL for cystic fibrosis: 800 mg (20 capsules)/day via oral inhalation.

    Geriatric

    Aridol test kit for bronchial challenge: 635 mg (19 capsules)/day via oral inhalation; BRONCHITOL for cystic fibrosis: 800 mg (20 capsules)/day via oral inhalation.

    Adolescents

    Aridol test kit for bronchial challenge: 635 mg (19 capsules)/day via oral inhalation.

    Children

    6 to 12 years: Aridol test kit for bronchial challenge: 635 mg (19 capsules)/day via oral inhalation.
    Less than 6 years: Safety and efficacy of inhaled mannitol have not been established.

    Infants

    Safety and efficacy of inhaled mannitol have not been established.

    Mannitol

    injectable solution

    • 5%
    • 10%
    • 15%
    • 20%
    • 25%

    capsule, powder for oral inhalati

    • 40mg (Bronchitol)

    dry powder capsules for inhalation

    • 0mg, 5mg, 10mg, 20mg, and 40mg per kit (Aridol)
    • Each kit contains one, single patient use, dry powder inhaler device and 3 consecutively numbered foil blister packs containing 19 capsules of graduated doses of mannitol for oral inhalation