Resectisol

Resectisol is part of the drug classes:

• Mucolytics

• Osmotically acting laxatives

• Other irrigating solutions

• Solutions producing osmotic diuresis

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Resectisol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• Very bad swelling.
• Fever or chills.
• Irritation or swelling where the shot was given.
• Pain where the shot was given.
• Skin breakdown where Resectisol is used.

Applies to mannitol: inhalation capsule

Along with its needed effects, mannitol (the active ingredient contained in Resectisol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking mannitol:

• Chest discomfort
• cough
• difficult or labored breathing
• dry heaves
• runny nose
• shortness of breath
• sore throat
• tightness in the chest
• troubled breathing
• vomiting
• wheezing

• Gagging

Some side effects of mannitol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache

• Dizziness
• nausea
• sore throat

Applies to mannitol: compounding powder, inhalation kit, intravenous solution, irrigation solution

Cardiovascular

Cardiovascular side effects have included hypotension and tachycardia. Venous thrombosis or phlebitis extending from the injection site and hypervolemia have occurred rarely and are generally associated with the solution or technique used in administration.[Ref]

Respiratory

Respiratory side effects have included pulmonary congestion and rhinitis. Respiratory side effects associated with mannitol (the active ingredient contained in Resectisol) inhalation have included cough, gagging, wheeze, and decreased forced expiratory volume.[Ref]

Metabolic

Metabolic side effects have included fluid and electrolyte imbalance, acidosis, and electrolyte loss.[Ref]

Nervous system

Nervous system side effects have included headache, convulsions, and dizziness.[Ref]

Hematologic

Hematologic side effects have included thrombophlebitis.[Ref]

Other

Eight cases of mannitol (the active ingredient contained in Resectisol) IV overdose in patients with preexisting renal failure were reviewed. Symptoms presented in the reviewed cases were CNS involvement out of proportion to uremia, severe hyponatremia, large osmolality gap, and fluid overload. Six patients were treated with hemodialysis, one patient with peritoneal dialysis, and one patient died before initiation of treatment. All patients received large doses over 1 to 3 days with a mean dose of 310 +/- 182.8 g. CNS involvement consisted of CNS depression, confusion, lethargy, stupor, and coma. Two patients recovered cerebral function and continued on lifetime dialysis, 3 patients recovered renal and cerebral function, and 1 patient recovered renal function but had severe cerebral dysfunction.[Ref]

Other side effects have included dryness of mouth, thirst, edema, arm pain, chills, dehydration, fever, mannitol intoxication, and angina-like pain.[Ref]

Renal

Renal side effects have included acute renal failure.[Ref]

Local

Local side effects have included extravasation. This effect is generally attributed to the solution or technique used in administration.[Ref]

Dermatologic

Dermatologic side effects have included urticaria and skin necrosis.[Ref]

Ocular

Ocular side effects have included blurred vision.[Ref]

Immunologic

Immunologic side effects have included infection at the injection site and febrile response. These effects are usually attributed to solution or technique used in administration.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Genitourinary

Genitourinary side effects have included marked diuresis and urinary retention.[Ref]

Psychiatric

Psychiatric side effects have rarely included mania (1 case report).[Ref]

A 75-year-old woman with severe major depression experienced a manic episode 30 minutes after initiation of a 20% mannitol intravenous infusion for the treatment of acute angle closure glaucoma. The patient had been started on nortriptyline 50 mg per day for the treatment of depression ten days earlier. She received oral acetazolamide, topical pilocarpine, topical timolol, and topical dexamethasone concomitantly for the treatment of glaucoma. The mania resolved within approximately 1 hour following discontinuation of the mannitol infusion, and the patient returned to a severe depressive state. An extensive lab evaluation, toxicology screening, and medical examination failed to show additional secondary causes for mania in this patient.[Ref]

Some side effects of Resectisol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.