Dexpanthenol

Overview

Dexpanthenol is an alcohol derivative of pantothenic acid, a component of the B complex vitamins and an essential component of a normally functioning epithelium. Dexpanthenol is enzymatically cleaved to form pantothenic acid, which is an essential component of Coenzyme A, which acts as a cofactor in many enzymatic reactions that are important for protein metabolism in the epithelium. Due to its good penetration and high local concentrations, dexpanthanol is used in many topical products, such as ointments and lotions for treatment of dermatological conditions to relieve itching or promote healing. Dermatological effects of the topical use of dexpanthenol include increased fibroblast proliferation and accelerated re-epithelialization in wound healing. Furthermore, it acts as a topical protectant, moisturizer, and has demonstrated anti-inflammatory properties . Dexpanthenol is also available as a racemic mixture containing both the dextrorotatory form (dexpanthenol) and the levorotatory form (levopanthenol) as Panthenol. While pantothenic acid is optically active, only the dextrorotatory form (dexpanthenol) is biologically active.

Indication

Injection: 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. Topical: This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy).

Associated Conditions

Allergic Rhinitis (AR)
Bursitis
Canker Sore
Contusions
Dermabrasion
Diaper Rash
Dry Skin
Edema
Hoarseness
Inflammation
Inflammation of Mouth
Insect Bites
Lateral Epicondylitis
Lesions of the Mucous Membranes
Nasal Congestion
Pharyngeal inflammation
Pruritus
Respiratory Tract Infections (RTI)
Seasonal Allergic Rhinitis
Sinusitis
Skin Roughness
Sore Throat
Sunburn
Tendinitis
Tooth Extraction Site Healing
Traumatic Injuries caused by Dental Prosthesis
Urticaria
Vitamin Deficiency
Wounds caused by Surgery, Oral of the Tonsils
Dry, cracked skin
Dryness of the nose
Superficial Conjunctival injuries
Superficial Corneal injuries
Superficial Traumatic Injuries of the Nasal Mucosa
Superficial Wounds

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis	2020/01/07	NCT04219358	Phase 1	Terminated	Hospital de Clinicas de Porto Alegre
Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.	2018/05/09	NCT03520348	Phase 1	Completed	Laboratorios Sophia S.A de C.V.
Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Laser Therapy	2017/03/30	NCT03095872	Phase 3	Completed	RWTH Aachen University
Pilot Study to Assess Number of Patients for Main Trial	2016/04/12	NCT02734628	Phase 4	Completed	Bayer
Dexpanthenol Mouthwash to Treat Oral Mucositis	2011/03/21	NCT01318889	Phase 2	UNKNOWN	Shahid Beheshti University of Medical Sciences
Comparative Safety Study of New Sinecort Formulation Versus Positive Control	2009/04/22	NCT00885937	Phase 1	Completed	Bayer
Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries	2009/03/10	NCT00859196	Phase 4	Completed	Bayer
Efficacy of Dexpanthenol in Thermic Erythema	2009/02/09	NCT00839462	Phase 2	Completed	Bayer
Moisturizing Effect of Two Dexpanthenol Formulations	2009/02/09	NCT00839280	Phase 2	Completed	Bayer
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).	2008/04/18	NCT00661102	Phase 3	Completed	Hoffmann-La Roche

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pediatric Infuvite Multiple Vitamins	Sandoz Inc	54643-9023	INTRAVENOUS	5 mg in 5 mL	10/28/2016
Adult Infuvite Multiple Vitamins	Sandoz Inc	54643-9015	INTRAVENOUS	15 mg in 10 mL	10/28/2016
Emotional Eating	Dr. Donna Restivo DC	62185-0059	ORAL	6 [hp_X] in 1 mL	5/23/2025
RENO CAPS	Carilion Materials Management	68151-1928	ORAL	5 mg in 1 1	11/11/2013
Vitamin B Complex	Raw Materials International Overseas LLC	69877-026	INTRAMUSCULAR, INTRAVENOUS	2 mg in 1 mL	12/31/2015
B-PLEX 100	Merit Pharmaceutical	30727-300	INTRAMUSCULAR, INTRAVENOUS	2 mg in 1 mL	12/4/2020
Adult Infuvite Multiple Vitamins	Sandoz Inc	54643-7874	INTRAVENOUS	15 mg in 10 mL	10/28/2016
Infuvite Adult Multiple Vitamins	Sandoz Inc	54643-5650	INTRAVENOUS	15 mg in 10 mL	3/17/2016
Zintrexyl-C	PureTek Corporation	59088-180	ORAL	15 mg in 1 1	1/11/2023
VITAMIN B COMPLEX	FLON LABORATORIES LLC	71414-225	INTRAVENOUS, INTRAMUSCULAR	2 mg in 1 mL	9/29/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TAMIPOOL FOR INJECTION	CELLTRION PHARM, INC.	SIN11849P	INJECTION, POWDER, FOR SOLUTION	15 mg/vial	3/15/2002
CERNEVIT FOR INJECTION	FAREVA PAU 1 (Sub-contractor), Baxter S.A.	SIN11975P	INJECTION, POWDER, FOR SOLUTION	17.25 mg/vial	6/5/2002
ENZYPLEX TABLET	PT MEDIFARMA LABORATORIES INC	SIN06211P	ENTERIC COATED TABLET	5 mg	5/3/1991
IBERET-FOLIC-500 TABLET	PT Abbott Indonesia	SIN05447P	TABLET, FILM COATED	10 mg	2/19/1991
SOLUVIT N FOR INFUSION	Fresenius Kabi SSPC	SIN05209P	INJECTION, POWDER, FOR SOLUTION	16.5mg /vial	11/14/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
CERNEVIT FOR INJ	N/A	Baxter Healthcare Ltd	N/A	N/A	4/18/2008
CORNEREGEL EYE GEL 50MG/G	N/A	Bausch & Lomb Incorporated	N/A	N/A	7/23/2007

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BIOLOGICAL THERAPIES B-DOSE PLUS 10ml injection vial	47755	Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies	Medicine	A	1/31/1994
BIOLOGICAL THERAPIES B-DOSE AE 2mL injection vial	22269	Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies	Medicine	A	10/8/1991
BIOLOGICAL THERAPIES B-DOSE FORTE 2.5mL injection vial	22408	Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies	Medicine	A	10/8/1991
EverMax Dyneaway	422951	Evermax Nutriceutical Pty Ltd ATF Evermax Nutriceutical Trust	Medicine	A	9/28/2023
DyneAway	465034	Evermax Nutriceutical Pty Ltd	Medicine	A	10/21/2024
BIOLOGICAL THERAPIES B-DOSE AE 10mL injection vial	47753	Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies	Medicine	A	1/31/1994
BIOLOGICAL THERAPIES B DOSE FORTE 10mL injection vial	47762	Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies	Medicine	A	1/31/1994
Refresh Spritz	426715	Sinaclear IP Pty Ltd	Medicine	A	10/24/2023
AllClear	140382	BlueSkyGreenEarth Herbs Pty Ltd	Medicine	A	6/13/2007
HIVITA HAPPY ENERGY LIQUID MULTIVITAMIN FOR KIDS	401154	Hivita Happy Energy Pty Ltd	Medicine	A	12/15/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MYCELIZED CHILDRENS MULTI-VITAMIN LIQ	METAGENICS, INC.	00653829	Drops - Oral	1 MG / 1 ML	12/31/1985
B VITAMIN COMPOUND WITH B12 THUNAS	thuna herbal remedies ltd.	00190357	Liquid - Oral	.5 MG / ML	5/31/1984
B COMPLEX W C AND B12 INJ	e l stickley and co ltd.	00549762	Liquid - Intravenous , Intramuscular	60 MG / 10 ML	12/31/1963
TINI-CAL AMPOULES	pharmetics (2011) inc	00479128	Liquid - Oral	5 MG / AMP	12/31/1966
THOMAS FORMULA NO 67	thomas hair and scalp specialists	00289337	Liquid - Topical	1.03 %	12/31/1974
MVC 9 PLUS 3 INJ	lyphomed, division of fujisawa canada inc.	01945637	Liquid - Intravenous	15 MG / 5 ML	12/31/1984
MVC 9+4 INJ	lyphomed canada inc.	00871990	Liquid - Intravenous	5 MG / 10 ML	12/31/1990
THOMAS FORMULA NO 27	thomas hair and scalp specialists	00289345	Liquid - Topical	0.98 %	12/31/1974
BEMINAL W C FORTIS INJ	ayerst laboratories	00053937	Powder For Solution - Intravenous , Intramuscular	10 MG / VIAL	12/31/1951
NEO-BEX INJECTABLE	brostel inc.	00147680	Solution - Intramuscular , Intravenous	10 MG / ML	12/31/1951

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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