CATAFLAM Diclofenac Potassium 50mg Sugar-Coated Tablet 100's
RXDRUG-DR-XY29124
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Features
Brand
Cataflam
Full Details
Dosage Strength
50 mg
Drug Ingredients
- Diclofenac
Drug Packaging
Sugar Coated Tablet 100's
Generic Name
Diclofenac Potassium
Dosage Form
Sugar Coated Tablet
Registration Number
DR-XY29124
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Short-term treatment in the following acute conditions: Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
Post-operative pain, inflammation and swelling, e.g. following dental or orthopedic surgery.
Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis.
Migraine attacks.
Painful syndromes of the vertebral column.
Non-articular rheumatism.
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Post-operative pain, inflammation and swelling, e.g. following dental or orthopedic surgery.
Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis.
Migraine attacks.
Painful syndromes of the vertebral column.
Non-articular rheumatism.
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Dosage/Direction for Use
Dosage: As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see PRECAUTIONS).
General target population: adults: The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.
In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. An initial dose of 50 mg is usually sufficient. If necessary, an initial dose of 100 mg can be prescribed with a maximum of 200 mg/day reached over the course of several menstrual cycles. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 to 6 hours, not exceeding a total dose of 200 mg per day.
Special populations: Pediatric patients (below 18 years of age): Diclofenac Potassium (Cataflam) tablets are not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops or suppositories of diclofenac 12.5 mg and 25 mg could be used. For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient.
The maximum daily dose of 150 mg should not be exceeded. The total daily dose should generally be divided into 2 to 3 separate doses, as applicable.
The use of Diclofenac Potassium (Cataflam) (all forms) in migraine attacks has not been established in children and adolescents.
Geriatric patients (aged 65 years or above): No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight (see PRECAUTIONS).
Established cardiovascular disease or significant cardiovascular risk factors: Treatment with Diclofenac Potassium (Cataflam) is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease should be treated with Diclofenac Potassium (Cataflam) only after careful consideration and only at doses ≤100 mg daily if treated for more than 4 weeks (see PRECAUTIONS).
Renal impairment: Diclofenac Potassium (Cataflam) is contraindicated in patients with renal failure (GFR <15 mL/min/1.73m2) (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Diclofenac Potassium (Cataflam) to patients with renal impairment (see PRECAUTIONS).
Hepatic impairment: Diclofenac Potassium (Cataflam) is contraindicated in patients with hepatic failure (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Diclofenac Potassium (Cataflam) to patients with mild to moderate hepatic impairment (see PRECAUTIONS).
Method of administration: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
General target population: adults: The recommended initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 or 3 separate doses, as applicable.
In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. An initial dose of 50 mg is usually sufficient. If necessary, an initial dose of 100 mg can be prescribed with a maximum of 200 mg/day reached over the course of several menstrual cycles. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4 to 6 hours, not exceeding a total dose of 200 mg per day.
Special populations: Pediatric patients (below 18 years of age): Diclofenac Potassium (Cataflam) tablets are not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops or suppositories of diclofenac 12.5 mg and 25 mg could be used. For adolescents aged 14 years and over, a daily dose of 75 to 100 mg is usually sufficient.
The maximum daily dose of 150 mg should not be exceeded. The total daily dose should generally be divided into 2 to 3 separate doses, as applicable.
The use of Diclofenac Potassium (Cataflam) (all forms) in migraine attacks has not been established in children and adolescents.
Geriatric patients (aged 65 years or above): No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight (see PRECAUTIONS).
Established cardiovascular disease or significant cardiovascular risk factors: Treatment with Diclofenac Potassium (Cataflam) is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease should be treated with Diclofenac Potassium (Cataflam) only after careful consideration and only at doses ≤100 mg daily if treated for more than 4 weeks (see PRECAUTIONS).
Renal impairment: Diclofenac Potassium (Cataflam) is contraindicated in patients with renal failure (GFR <15 mL/min/1.73m2) (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Diclofenac Potassium (Cataflam) to patients with renal impairment (see PRECAUTIONS).
Hepatic impairment: Diclofenac Potassium (Cataflam) is contraindicated in patients with hepatic failure (see CONTRAINDICATIONS).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Diclofenac Potassium (Cataflam) to patients with mild to moderate hepatic impairment (see PRECAUTIONS).
Method of administration: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
Overdosage
Symptoms: There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures: Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g., vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.
Therapeutic measures: Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g., vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.
Administration
Should be taken on an empty stomach: Preferably taken before meals. Swallow whole, do not chew/divide.
Contraindications
Known hypersensitivity to the active substance or any of the other excipients.
Active gastric or intestinal ulcer, bleeding or perforation (see PRECAUTIONS and also ADVERSE REACTIONS).
Last trimester of pregnancy (see USE IN PREGNANCY & LACTATION).
Hepatic failure.
Renal failure (GFR <15 mL/min/1.73m2).
Severe cardiac failure (see PRECAUTIONS).
Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria, or acute rhinitis (i.e. NSAID-induced cross reactivity reactions) (see PRECAUTIONS and also ADVERSE REACTIONS).
Active gastric or intestinal ulcer, bleeding or perforation (see PRECAUTIONS and also ADVERSE REACTIONS).
Last trimester of pregnancy (see USE IN PREGNANCY & LACTATION).
Hepatic failure.
Renal failure (GFR <15 mL/min/1.73m2).
Severe cardiac failure (see PRECAUTIONS).
Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom the use of acetylsalicylic acid or other NSAIDs can precipitate asthma, angioedema, urticaria, or acute rhinitis (i.e. NSAID-induced cross reactivity reactions) (see PRECAUTIONS and also ADVERSE REACTIONS).
Special Precautions
Discontinue at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Patients w/ symptoms indicative of GI disorders or w/ history suggestive of gastric or intestinal ulceration, bleeding or perforation; ulcerative colitis or Crohn's disease; asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie, nasal polyps), COPD or chronic infections of the resp tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke's edema or urticaria. Increased risk of GI anastomotic leak; close medical surveillance after GI surgery is recommended. Increased risk of serious CV thrombotic events (including MI & stroke). Not recommended in patients w/ established CV disease (CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN. Signs & symptoms of serious arteriothrombotic events (eg, chest pain, shortness of breath, weakness, slurring of speech). Hepatitis may occur w/o prodromal symptoms. May trigger an attack in patients w/ hepatic porphyria. Fluid retention & edema in patients w/ impaired cardiac or renal function, history of HTN, concomitant use w/ diuretics or medical products that can significantly impact renal function, & those w/ substantial extracellular vol depletion from any cause eg, before or after major surgery. May mask signs & symptoms of infection. Periodically re-evaluate the patient's need for symptomatic relief & response to therapy, especially when treatment continues for >4 wk. Monitoring of blood counts & hepatic function is recommended during prolonged treatment. Carefully monitor patients w/ defects of hemostasis. Consider combination therapy w/ protective agents (eg, PPI or misoprostol) in patients w/ history of ulcer & those requiring low dose ASA. Concomitant use w/ systemic corticosteroids, anticoagulants, anti-platelet agents or SSRIs. Avoid use w/ other systemic NSAIDs including COX-2 inhibitors. May impair female fertility in women attempting to conceive. Pregnancy (1st & 2nd trimester). Not to be administered during lactation. Not recommended in childn & adolescents <14 yr. Elderly (especially frail or w/ low body wt).
Use In Pregnancy & Lactation
Women of child-bearing potential: There are no data to suggest any recommendations for women of child-bearing potential.
Pregnancy: There are insufficient data on the use of diclofenac in pregnant women. Some epidemiological studies suggest an increased risk of miscarriage after use of a prostaglandin synthesis inhibitor (such as NSAIDs) in early pregnancy. Diclofenac Potassium (Cataflam) should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. Risk of fetal renal impairment with subsequent oligohydramnios has been observed when NSAIDs (including diclofenac) were used from the 20th week of pregnancy onwards.
As with other NSAIDs, use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus (see CONTRAINDICATIONS and PHARMACOLOGY: TOXICOLOGY: NON-CLINICAL SAFETY DATA under ACTIONS).
Breast-feeding: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, it should not be administered during breast-feeding in order to avoid undesirable effects in the infant.
Fertility: As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Diclofenac potassium (Cataflam) should be considered.
Pregnancy: There are insufficient data on the use of diclofenac in pregnant women. Some epidemiological studies suggest an increased risk of miscarriage after use of a prostaglandin synthesis inhibitor (such as NSAIDs) in early pregnancy. Diclofenac Potassium (Cataflam) should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. Risk of fetal renal impairment with subsequent oligohydramnios has been observed when NSAIDs (including diclofenac) were used from the 20th week of pregnancy onwards.
As with other NSAIDs, use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus (see CONTRAINDICATIONS and PHARMACOLOGY: TOXICOLOGY: NON-CLINICAL SAFETY DATA under ACTIONS).
Breast-feeding: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, it should not be administered during breast-feeding in order to avoid undesirable effects in the infant.
Fertility: As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Diclofenac potassium (Cataflam) should be considered.
Adverse Reactions
abulated summary of adverse drug reactions: Adverse drug reactions from clinical trials and/or spontaneous or literature reports (table) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Description of selected adverse drug reactions: Arteriothrombotic events: Meta-analysis and pharmacoepidemiological data point towards a small increased risk of arteriothrombotic events (for example myocardial infarction) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment (see PRECAUTIONS).
Visual effects: Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.
Visual effects: Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.
Drug Interactions
The following interactions include those observed with diclofenac (Cataflam) sugar-coated tablets and/or other pharmaceutical forms of diclofenac.
Observed interactions to be considered: CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with CYP2C9 inhibitors (such as voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac.
Lithium: If used concomitantly, diclofenac may raise plasma concentrations of lithium. Monitoring of the serum lithium level is recommended.
Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin. Monitoring of the serum digoxin level is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g., beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity (see PRECAUTIONS).
Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin and tacrolimus due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.
Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently (see PRECAUTIONS).
Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
Anticipated interactions to be considered: Other NSAIDs and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects (see PRECAUTIONS).
Observed interactions to be considered: CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with CYP2C9 inhibitors (such as voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac.
Lithium: If used concomitantly, diclofenac may raise plasma concentrations of lithium. Monitoring of the serum lithium level is recommended.
Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin. Monitoring of the serum digoxin level is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g., beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity (see PRECAUTIONS).
Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin and tacrolimus due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.
Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently (see PRECAUTIONS).
Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.
Anticipated interactions to be considered: Other NSAIDs and corticosteroids: Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects (see PRECAUTIONS).
Caution For Usage
Incompatibilities: Not applicable.
Instructions for Use and Handling: No special requirements.
Instructions for Use and Handling: No special requirements.
Storage
Store at temperatures not exceeding 30°C.
Store in the original package in order to protect from light. Protect from moisture.
Store in the original package in order to protect from light. Protect from moisture.
Action
Pharmacology: Mechanism of action (MOA): Cataflam contains potassium salt of diclofenac, a non-steroidal compound with pronounced antirheumatic, analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated in experiments, is considered fundamental to its mechanism of action. Prostaglandins play an important role in causing inflammation, pain and fever.
Diclofenac potassium (Cataflam) tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.
Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in humans.
Pharmacodynamics: Diclofenac has been found to exert a pronounced analgesic effect in moderate and severe pain. In the presence of inflammation, e.g., due to trauma or following surgical interventions, it rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and wound edema.
Diclofenac potassium (Cataflam) tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.
Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in humans.
Pharmacodynamics: Diclofenac has been found to exert a pronounced analgesic effect in moderate and severe pain. In the presence of inflammation, e.g., due to trauma or following surgical interventions, it rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and wound edema.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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