Gastro-Resistant Diclofenac Tablets Bp 100 Mg Tablet

Gastro-Resistant Diclofenac Tablets Bp 100 Mg Tablet

Product Name :

Salbutamol Tablets Bp 2 Mg Tablet

Available Strength :

Salbutamol 2 mg

Packing :

10x10 Alu-Pvc Blister / As per your requirement

Pack Insert/ Leaflet :

Available upon request

Therapeutical Use :

Bronchodilator therapy

Production Capacity :

10 Million Tablets/Month

Description:

What is Gastro-Resistant Diclofenac Tablets Bp 100 Mg Tablet?

Gastro-Resistant Diclofenac Tablets BP 100 Mg contain diclofenac, a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation. The gastro-resistant formulation is designed to resist dissolution in the stomach and release the active ingredient further along the gastrointestinal tract, according to the approved product specification.

Uses / Indications

Gastro-Resistant Diclofenac Tablets may be indicated for the short-term or appropriate management of pain and inflammation associated with conditions such as:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Musculoskeletal pain
  • Acute inflammatory conditions
  • Other painful inflammatory disorders where diclofenac is clinically appropriate

The indication, treatment duration, and suitability depend on the patient’s clinical condition and professional assessment.

Benefits

  • Helps relieve pain associated with inflammatory conditions.
  • Provides anti-inflammatory activity through inhibition of prostaglandin synthesis.
  • The gastro-resistant formulation is designed to delay release of diclofenac until after passage through the stomach.
  • Available as a 100 mg oral dosage form for appropriate clinical use.
  • May be incorporated into a pain and inflammation management plan when prescribed appropriately.

Side Effects

Common Side Effects

Possible side effects may include:

  • Indigestion
  • Nausea
  • Abdominal pain or discomfort
  • Diarrhea
  • Headache
  • Dizziness
  • Skin rash

Less Common or Serious Side Effects

NSAIDs including diclofenac can cause serious gastrointestinal, cardiovascular, renal, hepatic, or hypersensitivity reactions.

Serious effects may include:

  • Gastrointestinal ulceration or bleeding
  • Severe allergic reactions
  • Liver injury
  • Kidney impairment
  • Fluid retention or worsening hypertension
  • Cardiovascular events such as heart attack or stroke

Seek immediate medical attention for black or bloody stools, vomiting blood, severe abdominal pain, chest pain, difficulty breathing, facial or throat swelling, severe skin reactions, or yellowing of the skin or eyes.

How Does It Work?

Diclofenac is an NSAID that inhibits cyclooxygenase (COX) enzymes involved in the production of prostaglandins.

Reduced prostaglandin synthesis decreases mediators associated with pain, inflammation, and swelling. The gastro-resistant coating is designed to protect the tablet from immediate dissolution in the stomach and allow release further along the gastrointestinal tract.

Dosage Guidelines

The appropriate dose depends on the indication, severity of symptoms, age, kidney and liver function, cardiovascular and gastrointestinal risk factors, and other medicines being used.

The 100 mg gastro-resistant tablet should be swallowed whole with water. It should not be crushed, chewed, or broken, as doing so may interfere with the gastro-resistant properties of the dosage form.

Diclofenac should be used at the lowest effective dose for the shortest appropriate duration.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

When Not to Use

Diclofenac should not be used in individuals with:

  • Known hypersensitivity to diclofenac, aspirin, or other NSAIDs.
  • Previous NSAID-associated asthma, urticaria, or allergic-type reactions.
  • Active gastrointestinal ulceration or bleeding.
  • A history of recurrent gastrointestinal ulceration or bleeding where contraindicated.
  • Severe kidney or liver impairment where use is contraindicated.
  • Severe heart failure or certain established cardiovascular conditions where NSAID treatment is inappropriate.
  • The perioperative setting for coronary artery bypass graft surgery.

Diclofenac should also be avoided during the later stages of pregnancy unless specifically directed by a qualified healthcare professional.

Drug / Product Interactions

Relevant interaction considerations include:

  • Other NSAIDs or aspirin: May increase the risk of gastrointestinal and other adverse effects.
  • Anticoagulants and antiplatelet medicines: May increase the risk of bleeding.
  • Corticosteroids: May increase gastrointestinal ulceration or bleeding risk.
  • ACE inhibitors, angiotensin receptor blockers, and diuretics: May affect kidney function and blood-pressure control.
  • Lithium: Diclofenac may increase lithium concentrations.
  • Methotrexate: Diclofenac may increase methotrexate exposure and toxicity risk.
  • Cyclosporine or tacrolimus: May increase the risk of kidney-related adverse effects.
  • Certain antidepressants such as SSRIs: May increase gastrointestinal bleeding risk.
  • Digoxin: Diclofenac may increase digoxin exposure in some circumstances.

The complete medication list should be reviewed by a healthcare professional before treatment.

Safety Advice

  • Use the lowest effective dose for the shortest appropriate duration.
  • Inform the healthcare professional about any history of stomach ulcer, gastrointestinal bleeding, heart disease, high blood pressure, kidney disease, or liver disease.
  • Avoid combining diclofenac with other NSAIDs unless specifically prescribed.
  • Monitor for signs of gastrointestinal bleeding.
  • Long-term treatment may require monitoring of kidney and liver function and blood pressure.
  • Diclofenac may increase cardiovascular risk, particularly with higher doses or prolonged use.
  • Avoid use in the later stages of pregnancy unless specifically directed by a healthcare professional.
  • Discuss breastfeeding with a qualified healthcare professional before use.
  • Older adults may have increased susceptibility to gastrointestinal, kidney, and cardiovascular adverse effects.
  • Children should receive diclofenac only when specifically indicated and according to an appropriate age- and weight-based regimen.
  • If dizziness or visual disturbance occurs, use caution when driving or operating machinery.
  • If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

General Instructions

  • Take the tablet exactly as prescribed.
  • Swallow the gastro-resistant tablet whole with water.
  • Do not crush, chew, or break the tablet.
  • Follow the prescribed dosing schedule.
  • Do not take a double dose to compensate for a missed dose.
  • Do not combine with other NSAIDs unless instructed by a healthcare professional.
  • Use for the shortest duration appropriate for the clinical indication.
  • Seek medical attention if pain persists or symptoms worsen despite treatment.

Special Dietary / Lifestyle Tips

  • Take the medicine with appropriate consideration of food and gastrointestinal tolerance according to the approved product information.
  • Avoid excessive alcohol consumption, particularly because it may increase gastrointestinal risks associated with NSAIDs.
  • Maintain adequate hydration unless fluid restriction has been advised.
  • Follow a balanced diet and appropriate physical activity plan for the underlying condition.
  • Patients with hypertension, heart disease, kidney disease, or gastrointestinal disorders should follow individualized dietary and lifestyle guidance.

Comparison with Other Treatments

Diclofenac is an NSAID that provides both analgesic and anti-inflammatory effects. Other NSAIDs and non-NSAID pain medicines may differ in their mechanism, gastrointestinal effects, cardiovascular considerations, dosing, and suitability for individual patients.

The choice of treatment depends on the cause and severity of pain, inflammatory status, gastrointestinal and cardiovascular risk, kidney and liver function, and concurrent medicines. A qualified healthcare professional should determine the appropriate treatment option.

Precautions & Warnings

  • Gastro-resistant coating does not eliminate the risk of gastrointestinal ulceration or bleeding associated with diclofenac.
  • Use caution in patients with previous gastrointestinal disorders.
  • Monitor blood pressure in patients receiving treatment where clinically appropriate.
  • Long-term treatment may require assessment of kidney and liver function.
  • Avoid unnecessary concurrent use of other NSAIDs.
  • Diclofenac can increase cardiovascular risk, particularly with prolonged use or higher doses.
  • Discontinue and seek medical attention if serious allergic or skin reactions occur.
  • Do not exceed the prescribed dose.
  • Product details should be confirmed against the approved product specification.

Can I Use It With Other Medicines?

Diclofenac can interact with several commonly used medicines. A healthcare professional should review the complete medication profile before treatment.

Generally Compatible With

Diclofenac may be prescribed alongside selected medicines when clinically appropriate and monitored. Compatibility depends on the indication, dose, treatment duration, and individual risk factors.

Use With Caution / Avoid

Particular caution is required with anticoagulants, antiplatelet medicines, corticosteroids, other NSAIDs, lithium, methotrexate, certain blood-pressure medicines, diuretics, cyclosporine, tacrolimus, and some antidepressants.

Do not start another painkiller or anti-inflammatory medicine without checking whether it contains an NSAID.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

  • Keep the tablets in their original packaging until use.
  • Protect the product from unsuitable environmental conditions as specified on the approved label.
  • Keep out of reach of children.
  • Do not use the product after the expiry date stated on the packaging.

Frequently Asked Questions

1. What is Gastro-Resistant Diclofenac Tablets BP 100 Mg used for?

Diclofenac 100 mg gastro-resistant tablets are used for the management of pain and inflammation associated with selected musculoskeletal and inflammatory conditions.

2. What does gastro-resistant mean?

A gastro-resistant tablet is designed to resist dissolution in the stomach and release its active ingredient further along the gastrointestinal tract.

3. Can Gastro-Resistant Diclofenac 100 mg tablets be crushed or chewed?

No. Gastro-resistant tablets should generally be swallowed whole with water because crushing or chewing can interfere with the protective formulation.

4. Can diclofenac be taken with other painkillers?

Diclofenac should not be combined with other NSAIDs unless specifically advised by a healthcare professional because this may increase the risk of adverse effects, particularly gastrointestinal complications.

5. What are the common side effects of diclofenac?

Common side effects may include indigestion, nausea, abdominal discomfort, diarrhea, headache, dizziness, and skin rash.

6. Can diclofenac cause stomach bleeding?

Yes. Diclofenac and other NSAIDs can cause gastrointestinal ulceration or bleeding. The risk may be higher with prolonged use, higher doses, older age, or certain interacting medicines.

7. Can Diclofenac 100 mg be used during pregnancy?

Diclofenac use during pregnancy requires medical assessment. NSAIDs are generally avoided during the later stages of pregnancy unless specifically directed by a qualified healthcare professional.

8. How should Gastro-Resistant Diclofenac Tablets BP 100 Mg be stored?

Store the tablets according to the conditions stated on the approved product label and package insert, keeping them in their original packaging and out of reach of children.

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