Overview
Hyoscyamine is a tropane alkaloid and the levo-isomer of atropine. It is commonly extracted from plants in the Solanaceae or nightshade family. Research into the action of hyoscyamine in published literature dates back to 1826. Hyoscyamine is used for a wide variety of treatments and therapeutics due to its antimuscarinic properties. Although hyoscyamine is marketed in the United States, it is not FDA approved.
Indication
As a drug that is not FDA approved, hyscyamine has no official indications. Intravenous hysocyamine has been used to reduce gastric motility, reduce pancreatic pain and secretions, to facilitate imaging of the gastrointestinal tract, treat anticholinesterase toxicity, treat certain cases of partial heart block, improve visualization of the kidneys, and for symptomatic relief of biliary and renal colic. Intravenous hyoscyamine is also used pre-operatively to reduce secretions of the mouth and respiratory tract to facilitate intubation. Oral hyoscyamine is used to treat functional intestinal disorders, for symptomatic relief of biliary and renal colic, and symptomatic relief of acute rhinitis.
Associated Conditions
- Biliary Colic
- Colic
- Cystitis
- Diverticulitis
- Heart Block
- Irritable Bowel Syndrome (IBS)
- Neurogenic Bladder
- Neurogenic Bowel Dysfunction
- Pancreatitis
- Parkinsonism
- Peptic Ulcer
- Poisoning caused by anticholinesterases
- Pylorospasm
- Renal Colic
- Spastic bladder
- Tracheo-bronchial secretion excess
- Acute Enterocolitis
- Acute Rhinitis
- Gastric secretions
- Mild Dysentery
- Pharyngeal secretions
- Salivary secretions
- Spastic colitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/11/23 | Phase 4 | Terminated | |||
2015/03/17 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rebel Distributors Corp | 21695-442 | ORAL | 0.125 mg in 1 1 | 1/11/2010 | |
| Bryant Ranch Prepack | 63629-1031 | ORAL | 0.125 mg in 1 1 | 10/1/2018 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0162 | ORAL | 0.1037 mg in 5 mL | 6/15/2018 | |
| Winder Laboratories, LLC | 75826-118 | ORAL | 0.1037 mg in 1 1 | 12/27/2019 | |
| Alvogen Inc. | 47781-012 | ORAL | 0.125 mg in 1 1 | 3/4/2022 | |
| H.J. Harkins Company, Inc. | 76519-1208 | SUBLINGUAL | 0.125 mg in 1 1 | 8/20/2018 | |
| Bryant Ranch Prepack | 72162-1939 | ORAL | 0.125 mg in 1 1 | 10/1/2018 | |
| Bryant Ranch Prepack | 63629-1028 | ORAL | 0.125 mg in 1 1 | 10/1/2018 | |
| Proficient Rx LP | 63187-058 | ORAL, SUBLINGUAL | 0.125 mg in 1 1 | 4/1/2020 | |
| ANI Pharmaceuticals, Inc. | 62559-423 | ORAL | 0.375 mg in 1 1 | 2/15/2024 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DONNATAB tablet blister pack | 60604 | Medicine | A | 7/8/1997 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AD HP | terra botanica products ltd. | 02233286 | Liquid - Oral | 30 C | 5/25/1998 |
| DIBAN CAP | wyeth-ayerst canada inc. | 02041626 | Capsule - Oral | 0.0519 MG | 2/18/1998 |
| LEVSIN DROPS 0.125MG/ML | schwarz pharma kremers urban company | 00553077 | Drops - Oral | 0.125 MG / ML | 12/31/1982 |
| DONNAGEL LIQ | ayerst laboratories | 01908006 | Liquid - Oral | 0.1037 MG / 30 ML | 12/31/1993 |
| DIBAN CAP | ayerst laboratories | 01909215 | Capsule - Oral | 0.0519 MG | 12/31/1992 |
| CALMITOL ITCHING RELIEF ONT | pfizer canada inc., consumer healthcare division | 01942565 | Ointment - Topical | .0001 % | 12/31/1964 |
| DONNATAL TAB | wyeth-ayerst canada inc. | 02042916 | Tablet - Oral | 0.1037 MG | 12/31/1994 |
| DONNATAL EXTENTABS SRT | wyeth-ayerst canada inc. | 02042908 | Tablet (Extended-Release) - Oral | 0.3111 MG / SRT | 12/31/1994 |
| DONNAGEL LIQ | wyeth-ayerst canada inc. | 02041774 | Liquid - Oral | 0.1037 MG / 30 ML | 12/31/1995 |
| DONNATAL ELIXIR | wyeth-ayerst canada inc. | 02042894 | Elixir - Oral | 0.1037 MG / 5 ML | 12/31/1994 |
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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