Diclofenac Sodium Suppositories 100mg Technical Specification:

Product Name:Diclofenac Sodium Suppositories 100mg
Brand Name:Diclotaj
Strength:Pediatric: 12.5mg, 25mg
Adult: 50mg, 75mg, 100mg
Pharmaceuticals Form:Suppositories, External preparation
Route of Administration:FOR RECTAL ADMINISTRATION ONLY
Packing:10s (2 Strips X 5 Suppositories)
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Inflammatory (nonsteroidal NSAID), Analgesic, Anti- pyretic
Indication: Diclofenac Sodium is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities.
Storage:Store below 25°C. Protect from light. Keep in a cool dry place.
Improper storage may be deteriorated the product

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Diclofenac Sodium Suppositories 100mg (Diclotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Diclofenac Sodium Suppositories 100mg (Diclotaj)
    Each suppository contains:
    Diclofenac sodium BP…………..100mg
    Suppository base………………….qs

THERAPEUTIC INDICATION:

Diclofenac suppositories are used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis.

DIRECTION OF USE:

For rectal administration only.
Unwarp the suppository and insert rectally while lying down on your side.
Suppository should be moistened with water before inserting.

CAUTION & SCHEDULE:

Caution: Not to be taken by mouth.
Not for veterinary use.
Keep out of reach of children

WARNING: For external use only.

STORAGE AND DOSAGE:

STORAGE: Do not store above 25℃.
Protect from light.
Keep in a cool dry place.
Improper storage may be deteriorated the product.

DOSAGE: As directed by the Physician.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals stands as a reputable pharmaceutical company known for its unwavering commitment to providing high-quality healthcare solutions. Here, we delve into the compelling reasons why you should consider us for Diclofenac Sodium:

  • Quality Assurance and Safety: At Taj Pharmaceuticals, stringent quality control standards are our cornerstone. We take patient safety seriously, ensuring that every medication, including Diclofenac Sodium, is produced in strict accordance with industry best practices. Our dedication to safety ensures the delivery of safe and effective medications.
  • Proven Efficacy: Diclofenac Sodium are meticulously designed for therapeutic effectiveness. Our robust research and development efforts guarantee that our medications, including this one, effectively address specific medical needs, offering patients the best possible treatment outcomes.
  • Affordability and Accessibility: We recognize the significance of accessible healthcare. Taj Pharmaceuticals strives to make healthcare affordable by offering cost-effective solutions. This commitment ensures that Diclofenac Sodium are accessible to patients without compromising quality, making essential treatments more affordable for all.
  • Global Reach and Distribution: With a global presence, Taj Pharmaceuticals ensures that Diclofenac Sodium are available to patients worldwide. Our extensive distribution network is designed to reach patients wherever they reside, facilitating global healthcare access.
  • Customer-Centric Approach: Taj Pharmaceuticals places customer satisfaction at the forefront of its mission. We are dedicated to providing exceptional service and support, ensuring a positive healthcare experience for both healthcare professionals and patients alike.
  • Environmental Responsibility: Sustainability matters to us. Taj Pharmaceuticals is committed to environmentally responsible manufacturing practices, aiming to minimize our ecological footprint. We prioritize sustainability to contribute positively to the environment.

By choosing Taj Pharmaceuticals for Diclofenac Sodium, you are choosing a reliable and patient-focused healthcare partner. Our commitment to quality, safety, affordability, and customer satisfaction underscores our dedication to meeting your healthcare needs with trust and reliability. Your health and well-being are central to our mission.

What is Diclofenac Sodium and its uses:

Diclofenac Sodium is a combination medication that contains two active ingredients: diclofenac sodium and misoprostol. Each of these ingredients serves a distinct purpose in addressing specific medical conditions.

  • Diclofenac Sodium: Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing inflammation and pain in the body. Diclofenac sodium is commonly used to relieve pain, inflammation, and swelling caused by various conditions, including arthritis, musculoskeletal injuries, and certain types of acute and chronic pain.
  • Misoprostol: Misoprostol is a medication known as a prostaglandin analog. It is often used to protect the stomach lining from damage caused by NSAIDs like diclofenac sodium. NSAIDs can sometimes irritate the stomach and increase the risk of gastrointestinal ulcers or bleeding. Misoprostol helps reduce these risks by promoting the production of protective mucus in the stomach and reducing acid secretion.

Uses of Diclofenac Sodium:

Diclofenac Sodium are primarily prescribed for the following medical conditions:

  • Osteoarthritis: This medication is often used to manage the pain, stiffness, and inflammation associated with osteoarthritis, a degenerative joint disease that affects the cartilage in the joints.
  • Rheumatoid Arthritis: Diclofenac Sodium may be prescribed to alleviate the symptoms of rheumatoid arthritis, an autoimmune disorder that causes joint pain, swelling, and damage.
  • Ankylosing Spondylitis: Ankylosing spondylitis is a type of arthritis that primarily affects the spine and sacroiliac joints. Diclofenac Sodium can help reduce pain and inflammation in individuals with this condition.
  • Pain Management: These tablets are used for pain management in various situations, including musculoskeletal injuries, postoperative pain, and other types of acute or chronic pain.
  • Gastrointestinal Protection: Misoprostol in combination helps protect the stomach lining in individuals taking diclofenac sodium or other NSAIDs to reduce the risk of stomach ulcers or bleeding.

It’s important to use Diclofenac Sodium strictly as prescribed by a healthcare provider. These tablets are typically taken orally, with or without food, as directed. The dosage and duration of treatment will depend on the specific medical condition being treated and the individual’s response to the medication.

How Do Diclofenac Sodium work?

Diclofenac Sodium work through the combination of two active ingredients, diclofenac sodium and misoprostol, to provide both pain relief and gastrointestinal protection.

  • Diclofenac Sodium (NSAID Nonsteroidal Anti-inflammatory Drug): Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID). Its primary mode of action is to reduce inflammation, relieve pain, and lower fever by inhibiting the activity of enzymes known as cyclooxygenases (COX). These enzymes play a crucial role in the production of prostaglandins, which are substances that contribute to inflammation, pain, and fever.
    Here’s how diclofenac sodium works:
    Inhibition of COX: Diclofenac sodium inhibits the action of COX enzymes, specifically COX1 and COX2. COX1 is involved in maintaining normal bodily functions, including protecting the stomach lining. COX2 is induced during inflammation.
    Reduction of Prostaglandins: By inhibiting COX enzymes, diclofenac sodium reduces the production of prostaglandins. This results in a decrease in inflammation, pain, and fever.
    Diclofenac sodium is particularly effective in managing pain and inflammation associated with conditions like osteoarthritis, rheumatoid arthritis, and musculoskeletal injuries.
  • Misoprostol (Prostaglandin Analogue): Misoprostol is a prostaglandin analog that has a different mechanism of action. It is added to Diclofenac Sodium to protect the stomach lining from potential damage caused by NSAIDs like diclofenac sodium.
    Here’s how misoprostol works:
    Gastrointestinal Protection: NSAIDs, including diclofenac sodium, can sometimes irritate the stomach lining and increase the risk of gastrointestinal ulcers or bleeding. Misoprostol helps mitigate this risk by promoting the production of protective mucus in the stomach and reducing the secretion of stomach acid.
    Stomach Lining Defense: Misoprostol supports the stomach lining’s natural defense mechanisms, making it less susceptible to the harmful effects of NSAIDs.

By combining diclofenac sodium with misoprostol in a single tablet, Diclofenac Sodium provide effective pain relief and inflammation reduction while simultaneously protecting the stomach lining. This combination is often prescribed when individuals require pain management with NSAIDs but are at a higher risk of developing stomach ulcers or bleeding due to the use of these medications. It’s important to use Diclofenac Sodium strictly as prescribed by a healthcare provider and to follow their guidance regarding dosing, duration of treatment, and any potential side effects or contraindications.

Benefits of Diclofenac Sodium:

  • Pain Relief: These tablets are effective in relieving pain associated with various conditions, including osteoarthritis, rheumatoid arthritis, musculoskeletal injuries, and postoperative pain. By reducing pain, they can enhance an individual’s quality of life and ability to perform daily activities.
  • Inflammation Reduction: Diclofenac sodium, an NSAID in the combination, is known for its anti-inflammatory properties. It helps reduce inflammation in conditions where inflammation is a significant contributor to pain and discomfort.
  • Fever Reduction: In addition to pain and inflammation relief, these tablets can also lower fever, making them suitable for managing fever associated with various illnesses.
  • Gastrointestinal Protection: Misoprostol, the other component of the combination, provides protection to the stomach lining. It reduces the risk of gastrointestinal ulcers and bleeding, which can be potential side effects of NSAIDs like diclofenac sodium.
  • Improved Quality of Life: For individuals with chronic conditions like arthritis, Diclofenac Sodium can significantly improve their quality of life by reducing pain and inflammation, allowing for better mobility and function.

Common Side Effects of Diclofenac Sodium:

  • Gastrointestinal Discomfort: While misoprostol helps protect the stomach, some individuals may still experience gastrointestinal side effects such as nausea, vomiting, diarrhea, or abdominal pain. These side effects are typically mild and transient.
  • Headache: Headaches can occur as a side effect of these tablets.
  • Dizziness: Some people may experience dizziness when taking this medication.
  • Indigestion: Indigestion or heartburn is a possible side effect.
  • Skin Reactions: Skin rashes or itching can occur in rare cases.
  • Fluid Retention: Fluid retention, leading to swelling of the ankles or legs, can be a side effect, although it is less common.
  • High Blood Pressure: In some individuals, especially those with pre-existing hypertension, diclofenac sodium can increase blood pressure. Regular monitoring is essential for those at risk.
  • Rare but Serious Side Effects: While uncommon, there are more severe side effects associated with NSAIDs, including diclofenac sodium, such as stomach ulcers, bleeding, liver problems, and hypersensitivity reactions. It’s crucial to seek immediate medical attention if any severe side effects occur.

It’s essential to use Diclofenac Sodium strictly as prescribed by a healthcare provider and to follow their guidance regarding dosing, duration of treatment, and any potential side effects or contraindications. Individuals with a history of stomach ulcers, bleeding disorders, or certain medical conditions should discuss the risks and benefits of these tablets with their healthcare provider before starting treatment.

Frequently Asked Questions About Diclofenac Sodium:

Certainly, here are some frequently asked questions (FAQs) about Diclofenac Sodium:

  • What are Diclofenac Sodium?

Diclofenac Sodium is a combination medication containing diclofenac sodium, an anti-inflammatory and pain-relieving drug, and misoprostol, a medication that helps protect the stomach lining from potential damage caused by NSAIDs like diclofenac sodium.

  • What conditions are Diclofenac Sodium used to treat?

These tablets are commonly prescribed to manage pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, musculoskeletal injuries, and postoperative pain.

  • How do Diclofenac Sodium work?

Diclofenac sodium reduces inflammation and pain by inhibiting enzymes called cyclooxygenases (COX) that are involved in prostaglandin production. Misoprostol protects the stomach lining by promoting the production of protective mucus and reducing stomach acid secretion.

  • What are the benefits of taking Diclofenac Sodium?

The benefits include pain relief, reduction of inflammation, fever reduction, improved quality of life for individuals with chronic pain conditions, and gastrointestinal protection against potential NSAID-related stomach ulcers and bleeding.

  • What are the common side effects of Diclofenac Sodium?

Common side effects may include gastrointestinal discomfort (nausea, vomiting, diarrhea, abdominal pain), headache, dizziness, indigestion, skin rashes, fluid retention, and high blood pressure. Some individuals may also experience more severe side effects, such as stomach ulcers or hypersensitivity reactions.

  • How should I take Diclofenac Sodium?

These tablets are typically taken orally with or without food, as prescribed by your healthcare provider. Follow the recommended dosing schedule and do not exceed the prescribed dosage.

  • Can I drink alcohol while taking Diclofenac Sodium?

It is generally recommended to avoid excessive alcohol consumption while taking these tablets, as alcohol can increase the risk of gastrointestinal side effects.

  • What precautions should I take when using these tablets?

Inform your healthcare provider about your medical history, including any history of stomach ulcers, bleeding disorders, or other medical conditions. Follow your provider’s guidance and report any severe side effects promptly.

  • Are there any drug interactions I should be aware of?

Yes, Diclofenac Sodium can interact with other medications. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.

  • Can these tablets be used during pregnancy or while breastfeeding?

These tablets are not typically recommended during pregnancy, especially in the third trimester, and should be used with caution while breastfeeding. Consult with your healthcare provider for guidance if you are pregnant or nursing. Always consult with your healthcare provider or pharmacist for personalized information and guidance regarding Diclofenac Sodium and their use in your specific medical situation.

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

Diclofenac Sodium 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 Diclofenac Sodium, 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:

• Diclofenac Sodium Suppositories 25mg (Diclotaj)
• Diclofenac Sodium Suppositories 50mg (Diclotaj)
• Diclofenac Sodium Suppositories 75mg (Diclotaj)
Diclofenac Sodium Suppositories 100mg (Diclotaj)
• Diclofenac Sodium Suppositories 12.5mg (Diclotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Diclofenac Sodium Suppositories 12.5mg (Diclotaj)
Each suppository contains:
Diclofenac sodium BP…………..12.5mg
Suppository base………………….qs

• Diclofenac Sodium Suppositories 25mg (Diclotaj)
Each suppository contains:
Diclofenac sodium BP…………..25mg
Suppository base………………….q.s

• Diclofenac Sodium Suppositories 50mg (Diclotaj)
Each suppository contains:
Diclofenac sodium BP…………..50mg
Suppository base………………….qs

• Diclofenac Sodium Suppositories 75mg (Diclotaj)
Each suppository contains:
Diclofenac sodium BP…………..75mg
Suppository base………………….qs

Diclofenac Sodium Suppositories 100mg (Diclotaj)
Each suppository contains:
Diclofenac sodium BP…………..100mg
Suppository base………………….qs


THERAPEUTIC INDICATIONS:

Diclofenac suppositories are used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis.

DIRECTION OF USE:

For rectal administration only.
Unwarp the suppository and insert rectally while lying down on your side.
Suppository should be moistened with water before inserting.

CAUTION & WARNING:

Caution: Not to be taken by mouth.
Not for veterinary use.
Keep out of reach of children.
WARNING: For external use only.

STORAGE AND DOSAGE:

STORAGE: Do not store above 25℃.
Protect from light
Keep in a cool dry place.
Improper storage may be deteriorated the product.
DOSAGE: As directed by the Physician.