Sorbitol-mannitol
Sorbitol And Mannitol
Icu Medical Inc.
Human Prescription Drug
NDC 0990-7981Sorbitol-mannitol also known as Sorbitol And Mannitol is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Sorbitol-mannitol is 0990-7981. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Sorbitol-mannitol drug includes Mannitol - .54 g/100mL Sorbitol - 2.7 g/100mL . The currest status of Sorbitol-mannitol drug is Active.
Drug Information:
| Drug NDC: | 0990-7981 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sorbitol-mannitol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sorbitol And Mannitol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Icu Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | MANNITOL - .54 g/100mL
SORBITOL - 2.7 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | URETHRAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA018316 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | ICU Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311446
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175359
N0000010288
N0000175810
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 3OWL53L36A
506T60A25R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Osmotic Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Osmotic Diuretic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Diuresis [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Increased Diuresis [PE]
Osmotic Activity [MoA]
Osmotic Diuretic [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0990-7981-08 | 4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG | 01 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sorbitol-mannitol sorbitol and mannitol sorbitol sorbitol mannitol mannitol water
Indications and Usage:
Indications and usage sorbitol-mannitol irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
Warnings:
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
Read more...°c (150°f).
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 .)
Contraindications:
Contraindications not for injection by usual parenteral routes. do not use in patients with anuria.
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.
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 .)
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, usp structural formula
Clinical Pharmacology:
Clinical pharmacology sorbitol and mannitol are hexitols and are nonelectrolytes. a solution of these constituents in water is therefore nonconductive and suitable for urologic irrigation during electrosurgical procedures. a 3% (approx.) total concentration of sorbitol-mannitol contains sufficient solute to minimize the risk of intravascular hemolysis which can occur from absorption of plain water through open prostatic veins during transurethral resection (tur). any solution that is absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount depending primarily on the extent of surgery, will be excreted by the kidney. when absorbed intravascularly, sorbitol and mannitol act as osmotic diuretics. intravascular absorption of sorbitol has been shown to produce elevations of serum lactate after tur above preoperative values owing to sorbitol's favored metabolism to lactate from pyruvate. increased lactate levels were not sufficient to produce ev
Read more...idence of metabolic acidosis. mannitol is only slightly metabolized and rapidly excreted by the kidney.
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
Package Label Principal Display Panel:
Principal display panel - 3000 ml bag label 3000 ml ndc 0990-7981-08 sorbitol- mannitol irrigation each 100 ml contains sorbitol 2.70 g; mannitol 0.54 g. ph 5.2 (4.0 to 7.0) 178 mosmol/liter (calc.) sterile, nonpyrogenic. indications: for urologic irrigation. contraindications: not for injection. use only if solution is clear and container is undamaged. warnings: do not heat over 66°c (150°f) or store above 40°c (104°f). single-dose container. contains no bacteriostat. discard unused portion. use aseptic technique. usual dosage: see insert. rx only im-4383 3 v contains dehp icu medical, inc., lake forest, illinois, 60045, usa icumedical principal display panel - 3000 ml bag label
Principal display panel - overwrap label 2 hdpe to open tear at notch do not remove from overwrap until ready for use. after removing the overwrap, check for minute leaks by squeezing container firmly. if leaks are found, discard solution as sterility may be impaired. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see insert. 98-4321-r14-3/98 principal display panel - overwrap label