Omeprazole for Injection 40mg (PRiLOSID) Technical Specification:

Product Name:Omeprazole for Injection
Brand Name:PRiLOSID
Strength:40mg
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: Omeprazole Injection is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux oesophagitis.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Omeprazole for Injection (40mg) (PRiLOSID)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Omeprazole for Injection (40mg)
    Composition:
    Each vial contains:
    Omeprazole Sodium BP
    Equivalent to Omeprazole………40mg
    Sterile Water for Injection BP…………10ml

THERAPEUTIC INDICATIONS:

Omeprazole Injection is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.

DIRECTION OF USE:

For IV use only after reconstitution.
Reconstitution: To Reconstitute, add 10mL of Sterile Water for Injection BP to make a solution containing 4mg/mL of Omeprazole(approximately).

The reconstituted solution should be used immediately after preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

It should not be allowed to freeze.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning: If any particle is visible after dissolving the contents do not use it & return for a replacement.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.

Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

When it comes to Omeprazole for Injection, Taj Pharma is your leading provider. We prioritize excellence in pharmaceuticals, offering healthcare professionals a dependable source for this vital medication. Our state-of-the-art facilities and rigorous quality control ensure that every Omeprazole dose meets the highest standards. We understand the critical role Omeprazole plays in patient care, and we are committed to delivering it with precision and integrity. At Taj Pharma, safety is paramount. Our Omeprazole for Injection undergoes meticulous testing and adheres to stringent safety protocols, allowing healthcare providers to administer it with confidence. We are dedicated to supporting your efforts in providing effective and reliable treatment options for your patients. Choose Taj Pharma for Omeprazole for Injection and experience the difference trusted by healthcare professionals worldwide. Elevate patient care with a partner you can rely on. Learn more about Taj Pharma’s commitment to quality and safety today.

What is Omeprazole for Injection and its Use?

Omeprazole for Injection is a medication used to treat various gastrointestinal conditions, primarily related to excessive stomach acid production. It is a formulation of omeprazole, which is a proton pump inhibitor (PPI). Here’s more information about Omeprazole for Injection and its uses:

What is Omeprazole for Injection?

Omeprazole for Injection contains the active ingredient omeprazole, which is a powerful acid-suppressing medication. Unlike oral forms of omeprazole (such as capsules or tablets), the injection form is used when rapid and reliable acid suppression is needed.

Uses of Omeprazole for Injection:

  • Gastroesophageal Reflux Disease (GERD): This condition is characterized by the backward flow of stomach acid into the esophagus, causing heartburn and irritation. Omeprazole for Injection can be used to manage severe cases of GERD.
  • Peptic Ulcers: It is used to treat both duodenal ulcers (located in the small intestine) and gastric ulcers (located in the stomach). Omeprazole helps heal and prevent the recurrence of ulcers, especially in cases associated with Helicobacter pylori infection.
  • Zollinger-Ellison Syndrome: This is a rare condition characterized by the overproduction of stomach acid. Omeprazole for Injection is used to control excessive acid secretion in such cases.
  • Stress Ulcer Prophylaxis: In hospital settings, Omeprazole for Injection may be used to prevent stress ulcers in critically ill patients who are at risk of developing gastric bleeding due to stress-induced hyperacidity.
  • Severe Esophagitis: It is also employed to manage severe esophagitis (inflammation of the esophagus) caused by stomach acid.
  • Administration:

Omeprazole for Injection is administered intravenously (IV) by healthcare professionals. This route of administration allows for rapid and precise delivery of the medication, making it suitable for patients who cannot take oral medications due to various reasons, including severe illness.

How does Omeprazole for Injection Work?

Omeprazole for Injection works by inhibiting the production of stomach acid through a mechanism that targets the proton pumps in the lining of the stomach. Here’s a detailed explanation of how Omeprazole for Injection works:

  • Proton Pump Inhibition: Omeprazole belongs to a class of medications known as proton pump inhibitors (PPIs). Proton pumps are specialized cells in the lining of the stomach that are responsible for producing stomach acid, which is essential for digestion.
  • Blocking Acid Production: When Omeprazole is administered intravenously (IV) through injection, it enters the bloodstream and is eventually transported to the gastric parietal cells, where the proton pumps are located.
  • Irreversible Inhibition: Omeprazole binds to the proton pumps, specifically to an enzyme called H+/K+ ATPase, which is responsible for pumping hydrogen ions (protons) into the stomach to produce hydrochloric acid. Omeprazole forms a covalent bond with this enzyme, leading to irreversible inhibition.
  • Reduced Acid Secretion: As a result of this irreversible inhibition, the proton pumps become less effective in pumping protons into the stomach. This leads to a significant reduction in the production of gastric acid.
  • Decreased Gastric Acidity: With the proton pumps inhibited, the stomach’s ability to secrete hydrochloric acid is greatly diminished. This reduction in gastric acidity has several important effects:
    It alleviates symptoms of conditions like gastroesophageal reflux disease (GERD) and peptic ulcers, as the reduced acid helps in healing and prevents further irritation of the esophagus and stomach lining.
    It decreases the risk of gastric ulcers and bleeding, particularly in individuals at risk due to conditions like Zollinger Ellison syndrome or stress induced hyperacidity.
    It can help manage conditions characterized by excess acid production, such as severe esophagitis and hyper-secretory disorders.
  • Promotion of Healing: By reducing stomach acid production, Omeprazole for Injection allows the damaged tissues in the esophagus, stomach, or duodenum to heal, providing relief from symptoms and preventing further complications.

Omeprazole for Injection works by irreversibly inhibiting the proton pumps responsible for stomach acid production. This leads to a significant reduction in gastric acidity, making it effective in treating conditions associated with excessive acid secretion, promoting the healing of ulcers, and alleviating symptoms of acid related disorders. The intravenous route of administration ensures rapid and precise delivery of the medication, making it suitable for patients who require immediate and reliable acid suppression. The use of Omeprazole for Injection should be determined by a healthcare provider based on the specific medical condition being treated.

Benefits and Side effects of Omeprazole for Injection?

Omeprazole for Injection is a medication used to treat various gastrointestinal conditions by reducing stomach acid production. Like any medication, it has both benefits and potential side effects. Here are the benefits and common side effects of Omeprazole for Injection:

Benefits:

  • Gastroesophageal Reflux Disease (GERD) Relief: Omeprazole for Injection is highly effective in providing relief from the symptoms of GERD, such as heartburn and regurgitation. It helps heal the esophagus when it has been damaged by stomach acid.
  • Peptic Ulcer Healing: It is used to promote the healing of both duodenal and gastric ulcers, reducing pain and discomfort. Omeprazole can also help prevent the recurrence of ulcers.
  • Prevention of Stress Ulcers: In hospital settings, Omeprazole for Injection may be used to prevent stress ulcers in critically ill patients who are at risk of developing gastric bleeding due to stress-induced hyperacidity.
  • Management of Zollinger-Ellison Syndrome: This rare condition involves excessive stomach acid production. Omeprazole effectively controls hyperacidity in individuals with this syndrome.
  • Reduced Risk of Gastric Bleeding: By lowering stomach acid production, Omeprazole for Injection reduces the risk of gastric ulcers and bleeding, especially in individuals at risk due to certain medical conditions or medications.

Common Side Effects:

  • Headache: Headaches are one of the more common side effects reported by individuals taking Omeprazole.
  • Nausea: Some people may experience mild nausea while using this medication, although this side effect is usually temporary.
  • Abdominal Pain: Abdominal discomfort or pain can occur in some individuals, typically as a mild and transient side effect.
  • Diarrhea: Diarrhea is another potential side effect, although it is generally not severe.
  • Increased Risk of Infections: Long-term use of PPIs like Omeprazole may be associated with a slightly increased risk of certain infections, particularly gastrointestinal infections.
  • Low Magnesium Levels: In rare cases, prolonged use of Omeprazole may lead to low magnesium levels, which can cause symptoms such as muscle spasms, irregular heartbeat, and weakness. Healthcare providers may monitor magnesium levels in patients on long-term therapy.
  • Potential Bone Health Concerns: Long-term and high-dose use of PPIs has raised some concerns about bone health, potentially increasing the risk of fractures, especially in older adults. This is more relevant to long-term use, and healthcare providers may consider alternatives or periodic reevaluation of the need for the medication.

Frequently asked Questions about Omeprazole for Injection?

  1. What is Omeprazole for Injection used for?

Omeprazole for Injection is primarily used to reduce stomach acid production. It is commonly prescribed for conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, ZollingerEllison syndrome, and stress ulcer prophylaxis.

  1. How is Omeprazole for Injection administered?

Omeprazole for Injection is administered intravenously (IV) by a healthcare professional. This route of administration allows for rapid and precise delivery of the medication.

  1. Can I take Omeprazole for Injection at home?

Omeprazole for Injection is typically administered in a healthcare setting, such as a hospital or clinic, by trained medical personnel. It is not intended for selfadministration at home.

  1. How quickly does Omeprazole for Injection work to reduce stomach acid?

Omeprazole for Injection can provide rapid acid suppression, typically within hours of administration. It is often used when immediate relief or acid reduction is needed.

  1. Can I stop taking Omeprazole for Injection once my symptoms improve?

The duration of Omeprazole for Injection treatment should be determined by a healthcare provider. Stopping the medication abruptly may lead to the return of symptoms or the worsening of the underlying condition. Your healthcare provider will guide you on when and how to discontinue the medication safely.

  1. Are there any dietary restrictions while taking Omeprazole for Injection?

There are no specific dietary restrictions associated with Omeprazole for Injection. However, it’s generally recommended to avoid spicy, acidic, or fatty foods, as they can exacerbate symptoms in conditions like GERD.

  1. Can I drink alcohol while on Omeprazole for Injection?

Alcohol consumption is generally considered safe while taking Omeprazole for Injection. However, excessive alcohol intake can irritate the stomach lining and increase the risk of acidrelated symptoms.

  1. Are there any longterm side effects associated with Omeprazole for Injection?

Longterm and highdose use of proton pump inhibitors (PPIs) like Omeprazole has raised some concerns about potential side effects, including bone health issues and an increased risk of certain infections. Healthcare providers may periodically reassess the need for continued treatment.

  1. Is Omeprazole for Injection available over the counter (OTC)?

No, Omeprazole for Injection is not available over the counter. It is a prescription medication and should be administered under the guidance of a healthcare provider.

  1. Can Omeprazole for Injection interact with other medications?

Omeprazole can interact with certain medications, so it’s important to inform your healthcare provider about all the drugs you are taking to avoid potential interactions. Common interactions may occur with drugs like clopidogrel and certain antifungals.

As Omeprazole for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Omeprazole for Injection 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

Omeprazole for Injection 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 Omeprazole for Injection, 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:

A) Omeprazole for Injection (40mg) (PRiLOSID)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Omeprazole for Injection (40mg)
 Composition:
a) Each vial contains:
Omeprazole Sodium BP
Equivalent to Omeprazole………40mg
b) Sterile Water for Injection BP…………10ml


THERAPEUTIC INDICATIONS:

Omeprazole Injection is indicated primarily for the treatment of Zollinger-Ellison syndrome, and may also be used for the treatment of gastric ulcer, duodenal ulcer and reflux esophagitis.

DIRECTION OF USE:

For IV use only after reconstitution.
Reconstitution: To Reconstitute, add 10mL of Sterile Water for Injection BP to make a solution containing 4mg/mL of Omeprazole(approximately).
The reconstituted solution should be used immediately after preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
It should not be allowed to freeze.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: If any particle is visible after dissolving the contents do not use & return for replacement.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.