Sorbitol And Mannitol
FDA Drug Information • Also known as: Sorbitol-Mannitol
- Brand Names
- Sorbitol-Mannitol
- Drug Class
- Osmotic Diuretic [EPC]
- Route
- URETHRAL
- Dosage Form
- IRRIGANT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic, hypotonic, aqueous solution for urologic nonelectrolyte irrigation during transurethral surgical procedures. Each 100 mL contains sorbitol 2.70 g and mannitol 0.54 g in water for injection. The solution is nonelectrolytic and hypotonic (178 mOsmol/liter calc.); pH 5.2 (4.0 to 7.0). The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required the unused portion should be discarded. Sorbitol-Mannitol Irrigation is a nonelectrolyte urologic irrigant. Sorbitol, NF is chemically designated D-glucitol (C 6 H 14 O 6 ), white powder, granules or flakes very soluble in water. It has the following structural formula: Mannitol, USP is chemically designated D-mannitol (C 6 H 14 O 6 ), white crystalline powder or free-flowing granules, freely soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Sorbitol, NF structrual formula Mannitol,...
What Is Sorbitol And Mannitol Used For?
INDICATIONS AND USAGE Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
Dosage and Administration
DOSAGE AND ADMINISTRATION Sorbitol-Mannitol Irrigation should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable administration set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon. Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft) has been reported to increase intravascular absorption of the irrigating fluid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever container and solution permit. (See PRECAUTIONS .)
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Adverse reactions may result from intravascular absorption of sorbitol and mannitol. The literature reports occasional adverse reactions from intravenous sorbitol-mannitol infusions. Consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst and dehydration; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, diarrhea, rhinitis, chills, vertigo, backache and urticaria. Allergic reactions from sorbitol-mannitol have also been reported. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Warnings and Precautions
WARNINGS FOR UROLOGIC IRRIGATION ONLY. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes; thus, sorbitol-mannitol irrigant must be regarded as a systemic drug. Absorption of large amounts of fluids containing sorbitol-mannitol and the osmotic diuresis it produces may significantly alter cardiopulmonary and renal dynamics. Hyperglycemia from metabolism of sorbitol may occur in patients with diabetes mellitus. Hyperlactatemia from metabolism of sorbitol may potentially produce a significant lactic acidemia in metabolically compromised patients. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigation solution since it contains no preservatives. Do not heat over 66°C (150°F).
Contraindications
CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.
Overdosage
OVERDOSAGE In the event of dehydration, fluid or solute overload, discontinue the irrigation, evaluate the patient and institute corrective measures as indicated. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)
How Supplied
HOW SUPPLIED Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container (NDC No. 0409-7981-08 / 0990-7981-08). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 EN-4664 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.