Hydrocortisone Sodium Succinate Injection USP 100mg Technical Specification:

Product Name:Hydrocortisone Sodium Succinate Injection USP 100mg
Brand Name:HYDROTAJ
Strength:100mg, 200mg, 250mg, 500mg, 1000mg
Dosage Form:Dry Powder for Injection (Sterile) *Preservative Free
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.M or Slow 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:Steroids, Corticosteroids, Anti-inflammatory
Indication: This medication is used to treat various conditions such as severe allergies, certain cancers, eye diseases, and skin diseases.
Storage:Store in a cool, dry & dark place. Store below 25°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Hydrocortisone Sodium Succinate Injection USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydrocortisone Sodium Succinate Injection USP 100mg
    Each vial contains:
    Hydrocortisone Sodium Succinate U.S.P (Sterile)
    Eq. to Hydrocortisone…………………100 mg
    Dissolve the contents of vial in
    Sterile Water for Injections USP……5ml

THERAPEUTIC INDICATION:

This medication is used to treat various conditions such as arthritis, severe allergies, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases.

Hydrocortisone Sodium Succinate relieves inflammation in various part of the body. To treat or prevent allergic reaction. As treatment of certain kids of autoimmune disease, skin condition, asthma and other lung condition. As treatment for a variety of cancers, such as leukemia and multiple myeloma.

DIRECTION OF USE:

The Reconstituted with the 5ml/10ml of Water for Injection USP.

The constituted solution should be used immediately after preparation.

CAUTION & Warning:

CAUTION:  Do not use, if constituted solution contains Particles/suspended matter.

Administer/assist with patient provided emergency Injection. If not available use one locally approved steroid IM/IV.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning: To sold by the retail on the prescription of a registered medical practitioner only.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store in a cool, dry & dark place. Store below 25°C.

For administration and detailed direction for use, see the pack insert.

Dosage: As directed by Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a well-regarded pharmaceutical company known for its commitment to producing high-quality medications, including Hydrocortisone Sodium Succinate Injection. Their reputation is built on several key factors that make them a trusted choice in the pharmaceutical industry. First and foremost, Taj Pharmaceuticals boasts extensive expertise and experience in the field of pharmaceuticals. With a long history in the industry, they have garnered the trust of healthcare professionals and patients worldwide. This trust is further reinforced by their strict adherence to stringent quality control measures throughout the manufacturing process. Taj Pharmaceuticals operates state-of-the-art facilities that meet international quality standards, ensuring the safety and efficacy of their products. Reliability is another hallmark of Taj Pharmaceuticals. They maintain a robust supply chain, guaranteeing that medications like Hydrocortisone Sodium Succinate Injection are consistently available when needed, especially in emergency situations. Patient safety is of paramount importance to Taj Pharmaceuticals, and they take comprehensive precautions to prevent contamination, provide accurate dosages, and employ clear labeling and packaging to minimize the risk of medication errors.

Taj Pharmaceuticals’ reputation is underpinned by its strong endorsement from healthcare professionals, including doctors, nurses, and pharmacists, who trust and recommend their products. This trust is rooted in Taj Pharmaceuticals’ track record of delivering effective and reliable medications. Furthermore, Taj Pharmaceuticals diligently adheres to stringent regulatory standards and guidelines, ensuring that their medications consistently meet the highest quality and safety benchmarks. They invest in research and development to remain at the forefront of pharmaceutical innovation, constantly working to enhance existing medications and develop new solutions to address evolving healthcare needs. With a global presence, Taj Pharmaceuticals is well-equipped to supply medications to healthcare providers and patients worldwide. Their extensive distribution network guarantees accessibility to their products, enhancing their reach and impact. Taj Pharmaceuticals maintains a patient-centric approach, placing patients’ well-being at the heart of their operations. They aim to make healthcare more accessible and affordable, focusing on improving patients’ lives through their pharmaceutical offerings. In summary, Taj Pharmaceuticals is a reputable and trusted pharmaceutical company, known for its dedication to producing safe, effective, and reliable medications like Hydrocortisone Sodium Succinate Injection. Their commitment to quality, patient safety, and innovation has solidified their position as a preferred choice for healthcare professionals and patients alike.

What is Hydrocortisone Sodium Succinate Injection and its uses:

Hydrocortisone Sodium Succinate Injection is a medication that contains hydrocortisone, a corticosteroid hormone that is similar to the natural hormone produced by the adrenal glands. It is used for various medical conditions and situations where anti-inflammatory and immunosuppressive effects are required. Here are some of its primary uses:

  • Anti-Inflammatory: Hydrocortisone Sodium Succinate is often used to reduce inflammation in various medical conditions. It can be administered in cases of severe allergies, such as anaphylactic reactions, to alleviate inflammation and prevent or treat life-threatening symptoms.
  • Autoimmune Diseases: It is employed in the treatment of autoimmune diseases like rheumatoid arthritis, systemic lupus erythematosus (SLE), and inflammatory bowel disease (IBD). The medication helps suppress the overactive immune response responsible for these conditions.
  • Allergic Reactions: In severe allergic reactions, like those caused by insect stings, certain foods, or medications, Hydrocortisone Sodium Succinate can be administered intravenously to rapidly reduce allergic symptoms and prevent anaphylaxis.
  • Adrenal Insufficiency: It is used as hormone replacement therapy in individuals with adrenal insufficiency, a condition where the adrenal glands do not produce enough natural cortisol. This medication helps maintain essential bodily functions regulated by cortisol.
  • Asthma: In acute exacerbations of asthma, Hydrocortisone Sodium Succinate may be administered to reduce airway inflammation and improve breathing.
  • Shock: In cases of shock, such as septic shock or trauma-induced shock, this medication can help stabilize blood pressure and restore vascular tone by reducing inflammation and improving the body’s response to stress.
  • Organ Transplantation: Patients undergoing organ transplantation may receive Hydrocortisone Sodium Succinate as part of their immunosuppressive regimen to prevent rejection of the transplanted organ.
  • Inflammatory Skin Conditions: It may be used topically or through injections for various skin conditions with inflammation, such as severe eczema or psoriasis.
  • Other Conditions: The medication may also be considered in other conditions where its anti-inflammatory and immunosuppressive properties are beneficial, as determined by a healthcare provider.

It’s important to note that Hydrocortisone Sodium Succinate Injection should only be used under the guidance and supervision of a healthcare professional due to potential side effects and the need for careful dosing and monitoring. The appropriate dosage and duration of treatment will depend on the specific medical condition being treated and the patient’s individual health needs.

How do Hydrocortisone Sodium Succinate Injection work?

Hydrocortisone Sodium Succinate Injection works as a synthetic form of the natural hormone cortisol, which is produced by the adrenal glands. Cortisol is a glucocorticoid hormone that plays a crucial role in regulating various physiological processes in the body. When administered as an injection, Hydrocortisone Sodium Succinate has several mechanisms of action:

  • Anti-Inflammatory Effects: Cortisol and its synthetic form, hydrocortisone, have potent anti-inflammatory properties. They work by suppressing the body’s inflammatory response, which includes the release of inflammatory mediators like cytokines and prostaglandins. By inhibiting these inflammatory processes, hydrocortisone reduces swelling, redness, and pain associated with inflammation.
  • Immunosuppressive Effects: Hydrocortisone Sodium Succinate acts as an immunosuppressant, meaning it suppresses the activity of the immune system. This is particularly important in autoimmune diseases and conditions where the immune system mistakenly attacks the body’s own tissues. By dampening immune responses, hydrocortisone helps prevent the immune system from causing further damage.
  • Anti-Allergic Effects: In allergic reactions, the body’s immune system overreacts to allergens, triggering symptoms such as itching, swelling, and hives. Hydrocortisone can block the release of histamines and other allergy-related chemicals, reducing allergic symptoms.
  • Stress Response Regulation: Cortisol is a hormone released by the body during times of stress. It helps regulate the body’s response to stressors, including physical injury, infection, or surgery. Hydrocortisone can be administered in situations where the body’s natural cortisol production is insufficient to meet the demands of the stress response.
  • Anti-Shock Effects: In cases of shock, such as septic shock or trauma-induced shock, Hydrocortisone Sodium Succinate can help stabilize blood pressure and restore vascular tone. Shock often involves widespread inflammation and cardiovascular instability, and hydrocortisone can mitigate these effects.
  • Maintenance of Essential Functions: In individuals with adrenal insufficiency (inadequate cortisol production by the adrenal glands), hydrocortisone serves as hormone replacement therapy. It ensures that essential functions regulated by cortisol, such as metabolism, blood pressure, and immune response, are maintained.

The effectiveness of Hydrocortisone Sodium Succinate Injection in treating specific conditions depends on the underlying cause and the body’s response to the medication. It is important to use this medication under the guidance of a healthcare professional, as improper use or abrupt discontinuation can lead to side effects and complications. The dosage and duration of treatment are determined by the healthcare provider based on the patient’s medical condition and individual needs.

Benefits of Hydrocortisone Sodium Succinate Injection:

  • Anti-Inflammatory Action: One of the primary benefits of Hydrocortisone Sodium Succinate Injection is its potent anti-inflammatory effect. It can rapidly reduce inflammation and alleviate symptoms associated with inflammatory conditions such as arthritis, asthma, and skin disorders.
  • Immunosuppression: This medication can suppress an overactive immune system, making it beneficial in autoimmune diseases like lupus and rheumatoid arthritis, where the immune system attacks the body’s own tissues.
  • Allergy Relief: Hydrocortisone can effectively manage allergic reactions by reducing itching, swelling, and redness associated with allergies, insect bites, or contact dermatitis.
  • Shock Treatment: In emergency situations like septic shock or severe trauma, Hydrocortisone Sodium Succinate Injection can help stabilize blood pressure and prevent further deterioration.
  • Stress Response Support: It is used in critical care settings to support the body’s stress response during surgery or severe illness.
  • Adrenal Insufficiency Management: For individuals with adrenal insufficiency, hydrocortisone serves as hormone replacement therapy to maintain essential functions regulated by cortisol.

Side Effects of Hydrocortisone Sodium Succinate Injection:

  • Immunosuppression: While the immunosuppressive effect can be beneficial in some cases, it can also increase the risk of infections as the body’s ability to fight off pathogens is compromised.
  • Increased Blood Sugar: Hydrocortisone can elevate blood sugar levels, which may be problematic for individuals with diabetes or prediabetes.
  • Gastrointestinal Issues: Common side effects include stomach upset, indigestion, and ulcers when used long-term or in high doses.
  • Fluid Retention: It can lead to fluid retention, causing swelling and edema, particularly in the legs and ankles.
  • Weight Gain: Prolonged use may result in weight gain due to increased appetite and fat redistribution.
  • Mood Changes: Some individuals may experience mood swings, anxiety, or even depression.
  • Bone Health: Long-term use can weaken bones, increasing the risk of fractures and osteoporosis.
  • Skin Issues: Skin problems like thinning, bruising, and delayed wound healing can occur with prolonged use.
  • Eye Issues: Cataracts and increased intraocular pressure may develop with long-term use.
  • Adrenal Suppression: Prolonged use may suppress the body’s natural cortisol production, which can make it difficult to discontinue the medication safely.

It’s important to note that the benefits of Hydrocortisone Sodium Succinate Injection often outweigh the risks in specific medical situations, especially when used under the guidance of a healthcare professional. The dosage, duration of treatment, and potential side effects should be carefully considered by a healthcare provider based on the individual’s condition and needs. Patients should be monitored regularly during treatment to manage side effects and adjust treatment as necessary.

Frequently Asked Questions About Hydrocortisone Sodium Succinate Injection:

  1. What is Hydrocortisone Sodium Succinate Injection used for?

Hydrocortisone Sodium Succinate Injection is used to treat a variety of medical conditions, including inflammation, allergic reactions, autoimmune diseases, adrenal insufficiency, and as part of critical care in emergency situations.

  1. How is Hydrocortisone Sodium Succinate Injection administered?

It is typically administered as an intravenous (IV) injection or as an intramuscular (IM) injection. The specific dosage and administration method will depend on the patient’s condition and the healthcare provider’s recommendation.

  1. What is the recommended dosage of Hydrocortisone Sodium Succinate Injection?

Dosage varies widely depending on the condition being treated, the patient’s age, weight, and overall health. It is essential to follow the prescribed dosage and administration instructions provided by a healthcare professional.

  1. Are there any potential side effects of Hydrocortisone Sodium Succinate Injection?

Yes, there are potential side effects, including immunosuppression, increased blood sugar levels, gastrointestinal issues, fluid retention, weight gain, mood changes, skin problems, and more. It’s crucial for patients to be aware of these potential side effects and report any concerning symptoms to their healthcare provider.

  1. Can Hydrocortisone Sodium Succinate Injection be used during pregnancy or while breastfeeding?

The use of this medication during pregnancy or breastfeeding should be discussed with a healthcare provider. In some cases, the benefits may outweigh the risks, but the decision should be made carefully with medical guidance.

  1. Can I abruptly stop taking Hydrocortisone Sodium Succinate Injection?

No, abrupt discontinuation of this medication, especially if used long-term, can lead to adrenal insufficiency. It should be tapered off gradually under the supervision of a healthcare provider.

  1. Are there any drug interactions with Hydrocortisone Sodium Succinate Injection?

Yes, it can interact with other medications, so it’s important to inform your healthcare provider about all the medications, supplements, and herbal products you are taking. They can help manage potential interactions.

  1. How should Hydrocortisone Sodium Succinate Injection be stored?

It should be stored at room temperature, away from light and moisture. Follow the storage instructions provided with the medication.

  1. Can I drink alcohol while taking Hydrocortisone Sodium Succinate Injection?

It’s advisable to limit or avoid alcohol consumption while taking this medication, as it may increase the risk of certain side effects and interact with the drug.

  1. What should I do if I miss a dose of Hydrocortisone Sodium Succinate Injection?

If you miss a dose, contact your healthcare provider immediately for instructions. Do not double up on doses to make up for a missed one.

Remember that these FAQs provide general information and should not replace advice from a healthcare professional. Always consult your healthcare provider for personalized guidance on the use of Hydrocortisone Sodium Succinate Injection.

As Hydrocortisone Sodium Succinate Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Hydrocortisone Sodium Succinate 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

Hydrocortisone Sodium Succinate 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 Hydrocortisone Sodium Succinate 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 THE MEDICINAL PRODUCT:

(A) Hydrocortisone Sodium Succinate Injection USP 100mg
(B) Hydrocortisone Sodium Succinate Injection USP 200mg
(C) Hydrocortisone Sodium Succinate Injection USP 250mg
(D) Hydrocortisone Sodium Succinate Injection USP 500mg
(E) Hydrocortisone Sodium Succinate Injection USP 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Hydrocortisone Sodium Succinate Injection USP 100mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone…………………100 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP……5ml


B) Hydrocortisone Sodium Succinate Injection USP 200mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone…………………200 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP……5ml

C) Hydrocortisone Sodium Succinate Injection USP 250mg
c) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone…………………250 mg
d) Dissolve the contents of vial in
Sterile Water for Injections USP……5ml

D) Hydrocortisone Sodium Succinate Injection USP 500mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone…………………500 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP…………10ml

E) Hydrocortisone Sodium Succinate Injection USP 1000mg
a) Each vial contains:
Hydrocortisone Sodium Succinate U.S.P (Sterile)
Eq. to Hydrocortisone…………………1000 mg
b) Dissolve the contents of vial in
Sterile Water for Injections USP………10ml

THERAPEUTIC INDICATIONS:

This medication is used to treat various conditions such as arthritis, severe allergies, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases.
Hydrocortisone Sodium Succinate relieves inflammation in various part of the body. To treat or prevent allergic reaction. As treatment of certain kids of autoimmune disease, skin condition, asthma and other lung condition. As treatment for a variety of cancers, such as leukemia and multiple myeloma.

DIRECTION OF USE:

The Reconstituted with the 5ml/10ml of Water for Injection USP.
The constituted solution should be used immediately after preparation.

CAUTION & WARNING:

CAUTION: Do not use, if constituted solution contains Particles/suspended matter.
Administer/assist with patient provided emergency Injection. If not available use one locally approved steroid IM/IV.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Warning: To sold by the retail on the prescription of a registered medical practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store in a cool, dry & dark place.
Store below 25°C.
For administration and detailed direction for use, see the pack insert.
Dosage: As directed by Physician.