Dexpanthenol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
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Overview
Dexpanthenol is a gastrointestinal stimulant that is FDA approved for the prophylaxis of major abdominal surgery to minimize the possibility of paralytic ileus. Common adverse reactions include allergic reactions, Hypotension.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- 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.
Dosage
- 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dexpanthenol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexpanthenol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Dexpanthenol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dexpanthenol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexpanthenol in pediatric patients.
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.
- 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.
Adverse Reactions
Clinical Trials Experience
- 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.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Dexpanthenol in the drug label.
Drug Interactions
- The effects of succinylcholine appeared to have been prolonged in a woman administered dexpanthenol.
Use in Specific Populations
Pregnancy
- 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.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dexpanthenol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dexpanthenol during labor and delivery.
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.
Geriatic Use
There is no FDA guidance on the use of Dexpanthenol with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Dexpanthenol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dexpanthenol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dexpanthenol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dexpanthenol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dexpanthenol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dexpanthenol in patients who are immunocompromised.
Administration and Monitoring
Administration
Monitoring
There is limited information regarding Monitoring of Dexpanthenol in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Dexpanthenol in the drug label.
Overdosage
There is limited information regarding Overdose of Dexpanthenol in the drug label.
Pharmacology
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Mechanism of Action
- 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.
Structure
- 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:
This image is provided by the National Library of Medicine.
- 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.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dexpanthenol in the drug label.
Pharmacokinetics
- Pharmacokinetics data in humans is unavailable.
Nonclinical Toxicology
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.
Clinical Studies
There is limited information regarding Clinical Studies of Dexpanthenol in the drug label.
How Supplied
- Dexpanthenol Injection 250 mg/mL
- NDC 0517-0131-25 2 mL Single Dose Vial Packed in boxes of 25
Storage
- Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)
Images
Drug Images
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Package and Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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Ingredients and Appearance
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Dexpanthenol in the drug label.
Precautions with Alcohol
- Alcohol-Dexpanthenol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- DEXPANTHENOL®[1]
Look-Alike Drug Names
There is limited information regarding Dexpanthenol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.