Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (20mg/5ml) Technical Specification:

Product Name:Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (20mg/5ml)
Brand Name:Dexataj
Strength:4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml), 10mg/ml (100mg/10ml)
Dosage Form:Liquid Injection (Ampoule/Vial)
Packing:1 mL, 5 mL, 10 mL, 30 mL
Route of Administration:For Intravenous/Intramuscular 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:Corticosteroids
Indication: Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing’s syndrome).
Storage:Store at 20° to 25°C. Protected from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
    Each ml contains:
    Dexamethasone Sodium Phosphate USP
    Equivalent to Dexamethasone phosphate…………4mg
    Water for Injection USP…………………………………. q.s.

THERAPEUTIC INDICATION:

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing’s syndrome).

The use of Dexamethasone Sodium Phosphate Injection USP in active tuberculosis should be restricted to those cases of fulminating or disseminated.

Dexamethasone Injection is used to treat severe allergic reactions.

PACKING:

  • 4mg/ml
  1. 8mg/2ml
  2. 20mg/5ml
  3. 120mg/30ml
  • 10mg/ml
  1. 100mg/10ml

DIRECTION OF USE:

For Intravenous/Intramuscular use only.

See insert for detailed dosage, directions for use and precautions.

CAUTION & WARNING:

CAUTION: The injection should be discarded if any visible particle appears.

Discard any unused product immediately after use.

WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

Discard Unused portion.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C. Protected from light.

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a renowned pharmaceutical company known for its commitment to producing high-quality medications that contribute to the well-being of patients. Their Dexamethasone Sodium Phosphate Injection stands as a testament to their dedication to quality and innovation. Taj Pharmaceuticals ensures the highest standards of quality through rigorous testing and adherence to international benchmarks, guaranteeing that patients receive safe and effective medications. With a focus on expertise and innovation, Taj Pharmaceuticals continuously seeks to improve their formulations, offering the latest and most effective treatment options. This commitment extends to providing reliable and consistent supplies of medications, ensuring that healthcare providers and patients have access to Dexamethasone Sodium Phosphate Injection when needed for critical medical conditions. Taj Pharmaceuticals’ Dexamethasone Sodium Phosphate Injection finds utility in various medical specialties, underscoring its versatility and broad application. Importantly, Taj Pharmaceuticals maintains a commitment to affordability, ensuring cost-effective solutions for patients who rely on this medication for conditions like inflammation, allergies, and autoimmune disorders. The trust placed in Taj Pharmaceuticals by healthcare professionals and patients alike is a testament to their unwavering dedication to producing safe and effective medications that alleviate a range of medical conditions. In summary, Taj Pharmaceuticals is a trusted and reliable choice for Dexamethasone Sodium Phosphate Injection, offering quality, innovation, affordability, and patient-centered solutions. Consulting a healthcare professional is essential for personalized guidance on the appropriate use of this medication.

What is Dexamethasone Sodium Phosphate Injection and its uses:

Dexamethasone Sodium Phosphate Injection is a medication that contains dexamethasone, a potent synthetic corticosteroid. It is administered as an injectable solution and serves various therapeutic purposes in the field of medicine. Here are its primary uses:

  • Anti-Inflammatory: Dexamethasone Sodium Phosphate Injection is widely used as an anti-inflammatory medication. It helps reduce inflammation in various conditions, such as allergic reactions, skin disorders, and inflammatory joint diseases like rheumatoid arthritis. By suppressing the immune response and inflammatory processes, it alleviates symptoms like swelling, redness, and pain.
  • Immunosuppression: Dexamethasone is employed to suppress the immune system’s activity. This property is valuable in preventing and treating rejection in organ transplant recipients, as it helps reduce the body’s immune response against the transplanted organ.
  • Allergic Reactions: It is used to manage severe allergic reactions, including anaphylaxis, by swiftly controlling the immune system’s response to allergens.
  • Respiratory Conditions: Dexamethasone Sodium Phosphate Injection may be prescribed for respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) to reduce airway inflammation and improve breathing.
  • 5. Cerebral Edema: In cases of cerebral edema (swelling of the brain), often associated with brain tumors or head injuries, dexamethasone can help reduce swelling and alleviate symptoms.
  • Autoimmune Disorders: Dexamethasone is used in autoimmune disorders like systemic lupus erythematosus (SLE) and multiple sclerosis (MS) to suppress immune-mediated inflammation and disease flares.
  • Cancer Treatment: In some cases, dexamethasone is part of chemotherapy regimens to manage chemotherapy-related side effects like nausea, vomiting, and allergic reactions.
  • Adrenal Insufficiency: It can be used as replacement therapy in individuals with adrenal insufficiency, a condition where the adrenal glands do not produce sufficient hormones.
  • Shock: Dexamethasone may be utilized in the management of certain types of shock to stabilize blood pressure and reduce inflammation.

It’s important to note that Dexamethasone Sodium Phosphate Injection is a potent medication with potential side effects. Its use should be carefully supervised by a healthcare professional, and the dosage and duration of treatment should be determined based on the specific medical condition and individual patient needs. Patients should be aware of possible side effects and follow their healthcare provider’s guidance closely.

How does Dexamethasone Sodium Phosphate Injection work?

Dexamethasone Sodium Phosphate Injection works as a potent synthetic corticosteroid medication with anti-inflammatory and immunosuppressive properties. Its mechanism of action involves several key processes:

  • Anti-inflammatory Effect: Dexamethasone primarily exerts its therapeutic effects by suppressing inflammation. Inflammation is a complex biological response involving the activation of immune cells and the release of inflammatory substances. Dexamethasone interferes with this process in multiple ways:
    Inhibition of Inflammatory Mediators: Dexamethasone reduces the production and release of various inflammatory mediators, including cytokines, chemokines, and prostaglandins. These molecules play key roles in initiating and amplifying the inflammatory response.
    Immune Cell Function: Dexamethasone inhibits the activation and function of immune cells, particularly white blood cells like lymphocytes and macrophages. This dampens the immune system’s response to harmful stimuli, such as allergens or foreign invaders like bacteria and viruses.
    Vascular Permeability: Dexamethasone reduces vascular permeability, which helps prevent fluid and immune cells from leaking into tissues. This action contributes to the reduction of swelling, redness, and pain associated with inflammation.
  • Immunosuppressive Effect: Dexamethasone has potent immunosuppressive properties, meaning it suppresses the immune system’s activity. This is beneficial in various clinical situations, such as organ transplantation and autoimmune disorders, where an overactive immune response can lead to tissue damage and disease.
    Anti-Allergic Action: Dexamethasone helps control severe allergic reactions by blocking the immune response triggered by allergens, thus preventing or mitigating allergic symptoms.
  • Anti-Shock Properties: In cases of certain types of shock, such as septic shock or adrenal crisis, dexamethasone may be used to stabilize blood pressure and improve the body’s response to stress.

Dexamethasone Sodium Phosphate Injection is typically administered intravenously or intramuscularly to achieve rapid systemic effects. The dosage and duration of treatment are determined by healthcare professionals based on the specific medical condition being treated. It’s essential to follow medical guidance closely when using dexamethasone, as its potent effects can have significant implications for a patient’s health and wellbeing.

Benefits of Dexamethasone Sodium Phosphate Injection:

  • Anti-Inflammatory Effect: Dexamethasone is highly effective in reducing inflammation, making it a valuable medication for conditions characterized by excessive inflammation, such as arthritis, asthma, and skin disorders.
  • Immunosuppression: Dexamethasone’s immunosuppressive properties are beneficial in preventing the rejection of transplanted organs and managing autoimmune diseases where the immune system attacks healthy tissues.
  • Allergic Reaction Control: Dexamethasone can swiftly control severe allergic reactions, including anaphylaxis, by suppressing the immune response to allergens, reducing symptoms like swelling and respiratory distress.
  • Cerebral Edema Management: In cases of cerebral edema, such as those associated with brain tumors or head injuries, dexamethasone helps reduce brain swelling and alleviate related symptoms.
  • Respiratory Conditions: Dexamethasone is used to manage respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD), improving breathing and reducing airway inflammation.
  • Nausea and Vomiting Control: In cancer treatment, dexamethasone is often prescribed alongside chemotherapy to manage treatment-related nausea and vomiting.

Side Effects of Dexamethasone Sodium Phosphate Injection:

While dexamethasone offers many benefits, it can also have side effects, especially when used at high doses or for prolonged periods. Common side effects may include:

  • Increased Appetite: Dexamethasone can lead to increased appetite and weight gain.
  • Mood Changes: Some individuals may experience mood swings, anxiety, or even mood disorders.
  • Insomnia: Difficulty falling asleep or staying asleep is a potential side effect.
  • Gastrointestinal Issues: Dexamethasone can cause gastrointestinal problems such as indigestion, stomach ulcers, and increased stomach acid production.
  • Fluid Retention: Fluid retention and swelling (edema) in the extremities can occur.
  • Elevated Blood Sugar: Dexamethasone can raise blood sugar levels, which is a concern for individuals with diabetes.
  • High Blood Pressure: Long-term use may lead to increased blood pressure.
  • Weakening of Bones: Prolonged use can result in bone thinning (osteoporosis) and an increased risk of fractures.
  • Cataracts and Glaucoma: Eye problems, including cataracts and glaucoma, are potential side effects.
  • Immune Suppression: While beneficial in certain situations, immunosuppression can increase susceptibility to infections.
  • Adrenal Suppression: Long-term use can suppress the body’s natural production of cortisol, requiring careful management and tapering of the medication.
  • Skin Issues: Skin problems like thinning, easy bruising, and increased susceptibility to skin infections may occur.

It’s important to note that the severity and likelihood of side effects depend on factors such as the dose, duration of treatment, and individual sensitivity. Healthcare providers carefully weigh the benefits and risks of dexamethasone when prescribing it and monitor patients closely to minimize side effects. The medication should never be abruptly discontinued without medical guidance to prevent adrenal insufficiency. Patients should discuss any concerns or side effects with their healthcare provider.

Frequently Asked Question About Dexamethasone Sodium Phosphate Injection:

Certainly, here are some frequently asked questions (FAQs) about Dexamethasone Sodium Phosphate Injection:

  1. What is Dexamethasone Sodium Phosphate Injection used for?

Dexamethasone Sodium Phosphate Injection is used to treat a variety of conditions, including inflammation, allergic reactions, autoimmune disorders, organ transplant rejection prevention, and certain types of shock.

  1. How is Dexamethasone Sodium Phosphate Injection administered?

It is typically administered as an intravenous (IV) or intramuscular (IM) injection by a healthcare professional. The specific dosage and administration route depend on the medical condition being treated.

  1. Is Dexamethasone Sodium Phosphate Injection safe during pregnancy?

The use of dexamethasone during pregnancy should be carefully considered, and the potential benefits should outweigh the risks. It is essential to consult with a healthcare provider to assess the risks and benefits on a case-by-case basis.

  1. Can I take Dexamethasone Sodium Phosphate Injection with other medications?

Dexamethasone may interact with other medications, so it’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you are taking. They can assess potential interactions and adjust your treatment accordingly.

  1. Are there any dietary restrictions while taking Dexamethasone Sodium Phosphate Injection?

It’s advisable to follow a balanced diet while on dexamethasone. Limiting sodium intake is often recommended to reduce the risk of fluid retention and high blood pressure associated with this medication.

  1. Can I consume alcohol while using Dexamethasone Sodium Phosphate Injection?

Alcohol consumption should be limited while taking dexamethasone, as it can increase the risk of gastrointestinal issues and may interact with the medication. Consult your healthcare provider for personalized guidance.

  1. Can I abruptly stop taking Dexamethasone Sodium Phosphate Injection?

Abruptly discontinuing dexamethasone can lead to adrenal insufficiency, a condition where the body’s natural cortisol production is suppressed. It’s crucial to follow your healthcare provider’s instructions for tapering the medication when discontinuing it.

  1. What are the common side effects of Dexamethasone Sodium Phosphate Injection?

Common side effects may include increased appetite, mood changes, insomnia, gastrointestinal discomfort, fluid retention, elevated blood sugar, and increased susceptibility to infections. It’s essential to report any side effects to your healthcare provider.

  1. How long can I take Dexamethasone Sodium Phosphate Injection?

The duration of treatment with dexamethasone varies depending on the medical condition. It may be a short-term course to address acute inflammation or a more extended course for chronic conditions. The duration should be determined by your healthcare provider.

  1. Can Dexamethasone Sodium Phosphate Injection be used in children?

Dexamethasone can be prescribed for children in certain medical situations, but the dosage and duration should be carefully monitored and determined by a pediatrician.

Always consult with your healthcare provider for personalized guidance and answers to specific questions about Dexamethasone Sodium Phosphate Injection, as its use should be tailored to individual medical needs and conditions.

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

Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate 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. Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
B. Dexamethasone Sodium Phosphate Injection USP 10mg/ml (100mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Dexamethasone Sodium Phosphate Injection USP 4 mg/ml (8mg/2ml, 20mg/5ml, 120mg/30ml)
Each ml contains:
Dexamethasone Sodium Phosphate USP
Equivalent to Dexamethasone phosphate…………4mg
Water for Injection USP…………………………………. q.s.


A. Dexamethasone Sodium Phosphate Injection USP 10mg/ml (100mg/10ml)
Each ml contains:
Dexamethasone Sodium Phosphate USP
Equivalent to Dexamethasone phosphate…………10mg
Water for Injection USP…………………………………. q.s.

THERAPEUTIC INDICATIONS:

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing's syndrome).
The use of Dexamethasone Sodium Phosphate Injection USP in active tuberculosis should be restricted to those cases of fulminating or disseminated.
Dexamethasone Injection is used to treat severe allergic reactions.

PACKING:

1) 4mg/ml
a. 8mg/2ml
b. 20mg/5ml
c. 120mg/30ml
2) 10mg/ml
a. 100mg/10ml

DIRECTION OF USE:

For Intravenous/Intramuscular use only.
See insert for detailed dosage, directions for use and precautions.

CAUTION AND WARNING:

CAUTION: The injection should be discarded if any visible particle appears.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE AND DOSAGE:

Storage: Store at 20° to 25°C.
Protected from light.
Dosage: As directed by the Physician.