splendid Dexpanthenol Dosage Form: injection, solution Overview Side Effects Professional Reviews Q & A More Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Dexpanthenol INJECTION Rx Only Dexpanthenol Description Dexpanthenol is a derivative of pantothenic acid, a B complex vitamin. Dexpanthenol Injection is a sterile, nonpyrogenic, aqueous solution indicated for use as a gastrointestinal stimulant. The chemical name is D-(+)-2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethybutylamide. The structural formula is: Each mL contains Dexpanthenol 250 mg in Water for Injection q.s. pH (range 4 - 7) may be adjusted with Sodium Citrate and/or Citric Acid. Slideshow Shingles: Settling The Score Dexpanthenol - Clinical Pharmacology Pantothenic acid is a precursor of coenzyme A, which serves as a cofactor for a variety of enzyme-catalyzed reactions involving transfer of acetyl groups. The final step in the synthesis of acetylcholine consists of the choline acetylase transfer of acetyl group from acetylcoenzyme A to choline. Acetylcholine is the neurohumoral transmitter in the parasympathetic system and as such maintains the normal functions of the intestine. Decrease in acetylcholine content would result in decreased peristalsis and in extreme cases adynamic ileus. The pharmacological mode of action of the drug is unknown. Pharmacokinetics data in humans is unavailable. Indications and Usage for Dexpanthenol Prophylactic use immediately after major abdominal surgery to minimize the possibility of paralytic ileus. Intestinal atony causing abdominal distention; postoperative or postpartum retention of flatus, or postoperative delay in resumption of intestinal motility; paralytic ileus. Contraindications There are no known contraindications to the use of Dexpanthenol Injection. Warnings There have been rare instances of allergic reactions of unknown cause during the concomitant use of Dexpanthenol Injection with drugs such as antibiotics, narcotics and barbiturates. Administration of Dexpanthenol Injection directly into the vein is not advised (See Dosage and Administration ). Dexpanthenol Injection should not be administered within one hour of succinylcholine. Precautions General If any signs of a hypersensitivity reaction appear, Dexpanthenol Injection should be discontinued. If ileus is a secondary consequence of mechanical obstruction, primary attention should be directed to the obstruction. The management of adynamic ileus includes the correction of any fluid and electrolyte imbalance (especially hypokalemia), anemia and hypoproteinemia, treatment of infection, avoidance where possible of drugs which are known to decrease gastrointestinal motility and decompression of the gastrointestinal tract when considerably distended by nasogastric suction or use of a long intestinal tube. Drug Interactions The effects of succinylcholine appeared to have been prolonged in a woman administered Dexpanthenol. Carcinogenicity, Mutagenicity, and Impairment of Fertility - There have been no studies in animals to evaluate the carcinogenic, mutagenic, or impairment of fertility potential of Dexpanthenol. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with Dexpanthenol Injection. It is also not known whether Dexpanthenol Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dexpanthenol Injection should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dexpanthenol Injection is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established. Adverse Reactions There have been a few reports of allergic reactions and single reports of several other adverse events in association with the administration of Dexpanthenol. A causal relationship is uncertain. One patient experienced itching, tingling, difficulty in breathing. Another patient had red patches of skin. Two patients had generalized dermatitis and one patient urticaria. One patient experienced temporary respiratory difficulty following administration of Dexpanthenol injection 5 minutes after succinylcholine was discontinued. One patient experienced a noticeable but slight drop in blood pressure after administration of Dexpanthenol while in the recovery room. One patient experienced intestinal colic one-half hour after the drug was administered. Two patients vomited following administration and two patients had diarrhea 10 days post-surgery and after Dexpanthenol Injection. One elderly patient became agitated after administration of the drug. Dexpanthenol Dosage and Administration Prevention of post-operative adynamic ileus: 250 mg (1 mL) or 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours until all danger of adynamic ileus has passed. Treatment of adynamic ileus: 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours as needed. Intravenous administration: Dexpanthenol Injection 2 mL (500 mg) may be mixed with bulk I.V. solutions such as glucose or Lactated Ringer s and slowly infused intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. How is Dexpanthenol Supplied Dexpanthenol Injection 250 mg/mL NDC 0517-0131-25 2 mL Single Dose Vial Packed in boxes of 25 Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN0131 Rev. 1/09 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL 2 mL Carton Dexpanthenol INJECTION 250 mg/mL NDC 0517-0131-25 25 X 2 mL SINGLE DOSE VIALS FOR INTRAMUSCULAR USE. FOR INTRAVENOUS USE AFTER DILUTION. Rx Only Each mL contains: Dexpanthenol 250 mg in Water for Injection q.s. pH may be adjusted with Sodium Citrate and/or Citric Acid. Sterile, nonpyrogenic. WARNING: DISCARD UNUSED PORTION. Store at 20 -25 C (68 -77 F); excursions permitted to 15 -30 C (59 -86 F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. AMERICAN REGENT, INC. SHIRLEY, NY 11967 Rev. 7/06 Dexpanthenol Dexpanthenol injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-0131 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexpanthenol (Dexpanthenol) Dexpanthenol 250 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE CITRIC ACID MONOHYDRATE WATER Packaging # Item Code Package Description 1 NDC:0517-0131-25 25 VIAL, SINGLE-DOSE (VIAL) in 1 TRAY 1 2 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/20/1993 Labeler - American Regent, Inc. (622781813) Revised: 10/2011 American Regent, Inc. Next User Reviews Print this page Add to My Med List More about dexpanthenol Side Effects Support Group 0 Reviews Add your own review/rating Drug class: GI stimulants Consumer resources Dexpanthenol FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class GI stimulants Related Drugs GI stimulants metoclopramide , Reglan , cisapride , Propulsid Dexpanthenol Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! which looking back
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