| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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Indications
Rheumatoid arthritis; Osteoarthrosis; Low back pain; Migraine attacks; Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures; Ankylosing spondylitis; Acute gout; Control of pain and inflammation in orthopaedic, dental and other minor surgery; Pyrophosphate arthropathy and associated disorders.
Dosage and Administration
Usage: Oral
The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100 mg daily in two or three divided doses is usually sufficient.
Precautions & Warning:
1. General: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
2. Gastrointestinal effects: Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
3. Hepatic effects: Close medical surveillance is required when prescribing Voltarol to patients with impairment of hepatic function as their condition may be exacerbated.
4. Particular caution is called for in patients with impaired cardiac or renal function
5. Skin effects:Serious skin reactions, some of them fatal, including exfoliative dermatitis
6. SLE and mixed connective tissue disease:In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
7. Cardiovascular and cerebrovascular effects: Patients with congestive heart failure (NYHA-I) or patients with significant risk factors for cardiovascular events should only be treated with diclofenac after careful consideration.
Contraindications:
• Hypersensitivity to the active substance or any of the excipients.
• Active, gastric or intestinal ulcer, bleeding or perforation.
• History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Last trimester of pregnancy; Hepatic failure; Renal failure
• Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
• Contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
Adverse Reactions:
1. Immune system disorders: Hypersensitivity, anaphylactic and anaphylactoid reactions.
2. Nervous system disorders: Headache, dizziness, Somnolence, tiredness.
3. Ear and labyrinth disorders: Vertigo.
4. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
5. Hepatobiliary disorders: Transaminases increased.
6. Skin and subcutaneous tissue disorders: Rash.
Storage instructions:
Do not store above 30° C. Store in the original package in order to protect from moisture.
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