Rabeprazole Sodium for Injection BP 20mg Technical Specification:
Product Name: | Rabeprazole Sodium for Injection BP |
Brand Name: | RABITAJ |
Strength: | 20mg |
Dosage Form: | Lyophilized Dry Powder Injection (Sterile) *Preservative Free |
Packing: | 1 Vial + 1 Ampule + WFI Tray |
Route of Administration: | For I.V. use only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Proton-pump inhibitor |
Indication: | Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 year of age and older. |
Storage: | Store below 30°C. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Rabeprazole Sodium for Injection (20mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Rabeprazole Sodium for Injection (20mg)
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
THERAPEUTIC INDICATIONS:
Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which the backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 years of age and older.
DIRECTION OF USE:
For IV administration after reconstitution.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
Ampoules should not be given separately.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Why Taj Pharmaceuticals?
Meta Description: Taj Pharma is your premier destination for Rabeprazole Sodium for Injection BP. As a renowned pharmaceutical company, we prioritize your health and well-being above all else. Our dedication to quality assurance, rigorous testing, and adherence to international standards guarantees that you receive a product of the highest quality. With a proven track record of delivering safe and effective medications, Taj Pharma has earned the trust of healthcare professionals and patients worldwide. Our Rabeprazole Sodium for Injection BP is no exception, offering a reliable solution for gastrointestinal disorders. At Taj Pharma, we are committed to innovation and continuous improvement in pharmaceutical manufacturing. When you choose Taj Pharma, you choose a partner in your journey to better health. Experience the excellence of Rabeprazole Sodium for Injection BP with Taj Pharma – your trusted pharmaceutical provider.
What is Rabeprazole Sodium for Injection BP and its use?
Rabeprazole Sodium for Injection BP is a pharmaceutical product that contains the active ingredient Rabeprazole sodium, which is a proton pump inhibitor (PPI). It is commonly used to treat various gastrointestinal conditions and is administered via injection for rapid and effective relief.
Uses:
- Gastroesophageal Reflux Disease (GERD): Rabeprazole Sodium for Injection is often prescribed to manage GERD, a condition where stomach acid flows back into the esophagus, causing symptoms like heartburn, acid regurgitation, and chest discomfort. By inhibiting gastric acid production, Rabeprazole helps alleviate these symptoms and promotes healing of the esophageal lining.
- Peptic Ulcers: This medication is used to treat peptic ulcers, which can develop in the stomach or the first part of the small intestine (duodenum). Rabeprazole Sodium for Injection helps reduce stomach acid production, promoting ulcer healing and preventing their recurrence.
- Zollinger-Ellison Syndrome: In rare cases, it may be prescribed for individuals with Zollinger-Ellison syndrome, a condition characterized by excessive stomach acid production. Rabeprazole helps control acid levels in these cases.
- Prevention of Stress Ulcers: In hospital settings, Rabeprazole Sodium for Injection may be administered to critically ill patients to prevent stress ulcers, which can develop due to increased stress and decreased blood flow in the stomach lining during illness or injury.
How Does Rabeprazole Sodium for Injection BP Work?
Rabeprazole Sodium for Injection BP works by inhibiting the action of proton pumps in the stomach. Proton pumps are enzymes located in the lining of the stomach that play a crucial role in the production of gastric acid. Here’s how Rabeprazole Sodium works:
- Blocking Proton Pumps: Rabeprazole Sodium is a type of medication known as a proton pump inhibitor (PPI). It is in a class of drugs that specifically target the proton pumps in the stomach lining. When you receive the injection, the active ingredient Rabeprazole sodium enters the bloodstream and is distributed to the proton pumps in the stomach.
- Reducing Gastric Acid Production: Once inside the stomach lining, Rabeprazole Sodium binds to the proton pumps and inhibits their activity. This action significantly reduces the secretion of gastric acid into the stomach. Gastric acid is essential for digesting food but can lead to various gastrointestinal problems when produced excessively.
- Alleviating Gastrointestinal Symptoms: By decreasing gastric acid production, Rabeprazole Sodium helps alleviate symptoms associated with conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. These symptoms often include heartburn, acid regurgitation, chest pain, and stomach discomfort. Additionally, it promotes the healing of damaged esophageal or stomach lining caused by excessive acid exposure.
- Preventing Ulcer Formation: Rabeprazole Sodium also plays a role in preventing the formation of new ulcers and reducing the risk of ulcer recurrence. By lowering stomach acid levels, it creates an environment in which the damaged tissues can heal, and the ulcer can gradually improve.
- Long-lasting Effect: One of the advantages of Rabeprazole Sodium is its prolonged duration of action. It can provide relief from acid-related symptoms for an extended period, making it suitable for once-daily dosing in many cases.
Benefits of Rabeprazole Sodium for Injection BP:
- Effective Acid Suppression: Rabeprazole Sodium for Injection BP is highly effective at reducing gastric acid production, providing rapid relief from symptoms associated with conditions like GERD, peptic ulcers, and Zollinger-Ellison syndrome.
- Ulcer Healing: It promotes the healing of ulcers in the stomach or duodenum and helps prevent their recurrence.
- Symptom Relief: Patients often experience relief from symptoms such as heartburn, acid regurgitation, chest pain, and stomach discomfort.
- Prevention of Stress Ulcers: In a hospital setting, it is used to prevent stress ulcers in critically ill patients.
- Long-lasting Action: Rabeprazole Sodium has a prolonged duration of action, allowing for once-daily dosing in many cases.
Common Side Effects of Rabeprazole Sodium for Injection BP:
- Headache: Mild to moderate headaches are a common side effect.
- Nausea: Some individuals may experience nausea, which is usually temporary and mild.
- Diarrhea: Diarrhea can occur in some cases, but it’s generally mild and resolves on its own.
- Abdominal Pain: Mild abdominal discomfort or pain may occur in some individuals.
- Flatulence: Increased gas production and flatulence can occasionally occur.
- Infection Risk: Reducing stomach acid may slightly increase the risk of gastrointestinal infections, but this risk is generally low.
- Rare Side Effects: In rare cases, more severe side effects like allergic reactions, liver problems, or low magnesium levels may occur. It’s essential to seek medical attention if you experience any unusual or severe symptoms.
Frequently Asked Questions about Rabeprazole Sodium for Injection BP:
Certainly, here are some frequently asked questions (FAQs) about Rabeprazole Sodium for Injection BP:
- What is Rabeprazole Sodium for Injection BP used for?
Rabeprazole Sodium for Injection BP is primarily used to treat conditions associated with excessive stomach acid production, including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.
- How does Rabeprazole Sodium for Injection BP work?
It works by inhibiting the action of proton pumps in the stomach lining, reducing the production of gastric acid and alleviating symptoms related to acid reflux and ulcers.
- How is Rabeprazole Sodium for Injection BP administered?
This medication is typically administered via intravenous (IV) injection by a healthcare professional in a hospital or clinical setting. It is not meant for self-administration.
- What are the common side effects of Rabeprazole Sodium for Injection BP?
Common side effects may include headaches, nausea, diarrhea, abdominal discomfort, and flatulence. Most side effects are mild and temporary.
- Is Rabeprazole Sodium for Injection BP safe during pregnancy and breastfeeding?
It’s essential to consult with a healthcare provider before using this medication during pregnancy or breastfeeding, as the potential benefits and risks need to be evaluated on an individual basis.
- Can I drink alcohol while taking Rabeprazole Sodium for Injection BP?
Alcohol consumption should be minimized while taking this medication, as alcohol can exacerbate gastrointestinal symptoms and interact with its effectiveness.
- Are there any drug interactions with Rabeprazole Sodium for Injection BP?
Yes, Rabeprazole Sodium may interact with certain medications. It’s crucial to inform your healthcare provider of all the medications you are taking to prevent potential interactions.
- How long does it take for Rabeprazole Sodium for Injection BP to work?
Relief from symptoms like heartburn and acid reflux can occur within hours after administration, but the duration of treatment varies depending on the underlying condition.
- Can I abruptly stop taking Rabeprazole Sodium for Injection BP?
It’s important not to stop this medication suddenly without consulting your healthcare provider, as it may lead to a rebound effect with increased acid production. The dosage should be gradually tapered if discontinuation is necessary.
- Is Rabeprazole Sodium for Injection BP available over the counter (OTC)?
No, Rabeprazole Sodium for Injection BP is not available as an OTC medication. It is typically prescribed by a healthcare professional.
As Rabeprazole Sodium for Injection BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Rabeprazole Sodium for Injection BP product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Rabeprazole Sodium for Injection BP Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Rabeprazole Sodium for Injection BP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF MEDICINAL PRODUCT:
Rabeprazole Sodium for Injection BP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Rabeprazole Sodium for Injection BP 20mg
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
Composition:
a) Each vial contains:
Rabeprazole Sodium BP………20mg
Excipients…………………………q.s.
b) Sterile Water for Injection BP…………10ml
No preservative added.
THERAPEUTIC INDICATIONS:
Rabeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which the backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube that connects the throat and stomach) in adults and children 12 years of age and older.
DIRECTION OF USE:
For IV administration after reconstitution.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
To be reconstituted with Sterile Water for Injection BP (10ml) provided with the pack. For reconstitution, refer to the package insert.
The reconstituted injection is to be used:
Within 4 hours: If stored at room temperature.
Within 24 hours: If stored in the refrigerator.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
Ampoules should not be given separately.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Ampoules should not be given separately.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.