Overview
Ranitidine is a commonly used drug, classified as a histamine H2-receptor antagonist, and belongs to the same drug class as cimetidine and famotidine. This drug helps to prevent and treat gastric-acid associated conditions, including ulcers, because of its ability to decrease gastric acid secretion. Ranitidine is often referred to as Zantac, and is available in various forms, including tablet, injection, and effervescent tablet preparations. The prevalence of GERD is thought to be 10-20% in western countries. Ranitidine has proven to be an effective treatment for relieving uncomfortable symptoms of gastric acid associated conditions and is therefore widely used in GERD and other gastric-acid related conditions.
Indication
This drug is used alone or with concomitant antacids for the following conditions: short-term treatment of active duodenal ulcer, treating gastric acid hypersecretion due to Zollinger-Ellison syndrome, systemic mastocytosis, and other conditions that may pathologically raise gastric acid levels. It also used in the short term treatment of active benign gastric ulcers and maintenance therapy of gastric ulcers at a reduced dose. In addition to the above, ranitidine can be used for the treatment of GERD symptoms, treatment of erosive esophagitis (endoscopically diagnosed) and the maintenance of gastric or duodenal ulcer healing.
Associated Conditions
- Acid Aspiration Syndrome
- Ankylosing Spondylitis (AS)
- Duodenal Ulcer
- Erosive Esophagitis
- Gastric Ulcer
- Gastric hypersecretion
- Gastro-esophageal Reflux Disease (GERD)
- Healing
- Heartburn
- Osteoarthritis (OA)
- Peptic Ulcer Disease
- Rheumatoid Arthritis
- Stress Ulcers
- Zollinger-Ellison Syndrome
- Active Duodenal ulcer
- Benign gastric ulcer healing
- Benign gastric ulcers
- Duodenal ulcer healing
- Post-operative peptic ulcer
- Recurrent hemorrhage from bleeding ulcers
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/21 | Phase 1 | Completed | |||
2022/03/28 | Phase 2 | Not yet recruiting | Hellenic Society of Hematology | ||
2021/04/28 | Phase 2 | Completed | |||
2020/12/23 | Phase 1 | Active, not recruiting | City of Hope Medical Center | ||
2020/05/21 | Phase 1 | Completed | Food and Drug Administration (FDA) | ||
2020/03/04 | Phase 1 | Terminated | |||
2018/03/19 | Phase 1 | Terminated | |||
2017/12/11 | Phase 3 | Active, not recruiting | Genzyme, a Sanofi Company | ||
2017/05/09 | Phase 4 | Completed | |||
2017/05/04 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT Rx USA LLC | 16590-381 | ORAL | 300 mg in 1 1 | 10/3/2012 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-378 | ORAL | 150 mg in 1 1 | 1/15/2020 | |
| Bryant Ranch Prepack | 71335-1621 | ORAL | 300 mg in 1 1 | 12/7/2018 | |
| WOCKHARDT USA LLC | 64679-694 | ORAL | 15 mg in 1 mL | 1/19/2011 | |
| Northwind Pharmaceuticals, LLC | 51655-681 | ORAL | 150 mg in 1 1 | 11/10/2014 | |
| RxChange Co. | 33358-316 | ORAL | 150 mg in 1 1 | 11/25/2014 | |
| Contract Pharmacy Services-PA | 67046-648 | ORAL | 150 mg in 1 1 | 9/26/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-3162 | ORAL | 150 mg in 1 1 | 2/11/2021 | |
| Dr. Reddy's Laboratories Limited | 55111-130 | ORAL | 300 mg in 1 1 | 11/21/2018 | |
| Physicians Total Care, Inc. | 54868-5770 | ORAL | 150 mg in 1 mL | 5/24/2012 |
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 |
|---|---|---|---|---|---|
| ZYNOL-150 TABLET 150 mg | SIN10248P | TABLET, FILM COATED | 150 mg | 10/10/1998 | |
| HYZAN TABLET 150 mg | SIN10146P | TABLET, FILM COATED | 150 mg | 10/2/1998 | |
| GASTRIL INJECTION 50 mg/2 ml | SIN10081P | INJECTION | 50 mg/2 ml | 9/25/1998 | |
| APO-RANITIDINE TABLET 150 mg | SIN05429P | TABLET, FILM COATED | 150 mg | 2/18/1991 | |
| ACILOC 150 TABLET 150 mg | SIN11750P | TABLET, FILM COATED | 150 mg | 12/26/2001 | |
| ACILOC 300 TABLET 300 mg | SIN11751P | TABLET, FILM COATED | 300 mg | 12/26/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ranitidine Hydrochloride Chewable Tablets | 国药准字H20050183 | 化学药品 | 片剂 | 3/27/2020 | |
| Ranitidine Hydrochloride and Sodium Chloride Injection | 国药准字H20020275 | 化学药品 | 注射剂 | 9/29/2020 | |
| Ranitidine Hydrochloride and Sodium Chloride Injection | 国药准字H20067912 | 化学药品 | 注射剂 | 7/16/2022 | |
| Ranitidine Hydrochloride and Sodium Chloride Injection | 国药准字H20010334 | 化学药品 | 注射剂 | 7/16/2022 | |
| Ranitidine Hydrochloride and Sodium Chloride Injection | 国药准字H20030676 | 化学药品 | 注射剂 | 7/5/2021 | |
| Ranitidine Hydrochloride and Sodium Chloride Injection | 国药准字H20040231 | 化学药品 | 注射剂 | 9/20/2024 | |
| Ranitidine Hydrochloride Effervescent Granules | 国药准字H20030262 | 化学药品 | 颗粒剂 | 8/9/2024 | |
| Ranitidine Hydrochloride Effervescent Tablets | 国药准字H20040033 | 化学药品 | 泡腾片剂 | 6/12/2020 | |
| Ranitidine Hydrochloride Tablets | 国药准字H37023034 | 化学药品 | 片剂 | 3/31/2021 | |
| Ranitidine Hydrochloride Tablets | 国药准字H20045137 | 化学药品 | 片剂 | 5/19/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Help Us Improve
Your feedback helps us provide better drug information and insights.