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Dicyclomine

Generic Name
Dicyclomine
Brand Names
Bentyl
Drug Type
Small Molecule
Chemical Formula
C19H35NO2
CAS Number
77-19-0
Unique Ingredient Identifier
4KV4X8IF6V

Overview

Dicyclomine is a muscarinic M1, M3, and M2 receptor antagonist as well as a non-competitive inhibitor of histamine and bradykinin used to treat spasms of the intestines seen in functional bowel disorder and irritable bowel syndrome. Though it is commonly prescribed, its recommendation may have been based on a small amount of evidence and so its prescription is becoming less favourable. Dicyclomine was granted FDA approval on 11 May 1950.

Indication

Dicyclomine is indicated for the treatment of functional bowel disorder and irritable bowel syndrome.

Associated Conditions

  • Bowel; Functional Syndrome
  • Irritable Bowel Syndrome (IBS)
  • Gastrointestinal cramps caused by Gas

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

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
MECLOSIL TABLET
SIN10845P
TABLET
2.5 mg
3/25/1999
RELESTAL PEDIATRIC SYRUP 10 mg/5 ml
SIN12259P
SYRUP
10 mg/5 ml
4/25/2003
COLIMIX SYRUP
SIN03333P
SYRUP
5 mg/5 ml
6/16/1989
VERAGEL-DMS TABLET
SIN02547P
TABLET
2.5 mg
4/19/1989
ACOLIC SYRUP
SIN10344P
SYRUP
5 mg/5 ml
11/4/1998

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
VANTYL INJ 'PANBIOTIC' 10MG/ML
N/A
N/A
N/A
2/8/2010
WEICHI TAB
N/A
N/A
N/A
5/3/1995

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

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

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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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