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| Dicloflam Pamphlet |
Dicloflam Tablets
Composition:
Each tablet contains:
Diclofenac potassium 25 mg or 50 mg
Pharmacodynamics:
Diclofenac potassium is a potent non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. Dictofenac inhibits cyclo-oxygenase actMty with a reduction in the tissue production of prostaglandins . Pharmacokinetics:
Diclofenac is rapidly and completely absorbed after oral adminisIraIon . )ts extensively rnetabollzed to a range of phenolic compounds which are excreted in the urine.
Indications:
Short term treatment in the following acute conditions:
Posttraumatic pain, initammation and swetling e.g . due to sprains.
Post-operative pain. inflammation and sweJng e.g . following dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology . e.g . primary dysmenorrhoea or adnexitis
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. pharyngotonsiltitis, otitis.
Side Effects:
Gastrointestinal Tract:
Abdominal pain or cramps . indigestion abdominal distension, diarrhoea , nausea , vomiting . dry mouth , constipation , flatulence . peptic ulcer with or without bleeding and/ or per- foration or bleeding without ulcer.
Occasional : Headache, dizziness. vertigo
Rare : Drowsiness
Isolated cases : Sensory disturbances . including paraesthesias, memory.disturbances. disorientation, insomnia. irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions , aseptic meningitis.
Special senses:
Isolated cases : Disturbances of vision (blurred vision, diplopia ) . impaired heanng , tinnitus, taste disturbances.
Skin:
Occasional : Skin rashes or skin eruptions .
Rare : Urticana
Isolated cases : Bullous eruptions . eczema, erythema multiform, Stevens - Johnson syndrome. LyeIf’s syndrome ( acute toxic epiderniotysis ) . erythroderma ( exfohalive dermatitis) , loss of hair, photosensitivity reactions purpura,including allergic purpura.
Kidney:
Rare : Oederna
Isolated cases: Acute renal failure, urinary abnormalities such as haematuria and proteinuria. interstitial nephntis , nephrotic syndrome, papillary necrosis.
Liver:
Occasional: Elevation of serum aminotranslerase values
Rare : Hepatitis with or without jaundice
Isolated cases: fulminant hepatitis
Blood:
Isolated cases: thrombocytooenia, leucopenia, haemolytic anaemia , apIastic anaemia, agranulocytosis
Hypersensitivity:
Rare : Hypersensi:ivity reactions such as asthma. systemic anaphylactic/anaphylactoid reactions including hypotension.
Isolated cases: vasculitis, pneumonhtis
Cardiovascular system:
Palpitation, flushing. tachycardia. myocardial infarction.
Others:
Hypoglycemia , weight loss
Contraindication:
Gastric or intestinal ulcer.
Known hypersensitivity to the active substance.
Like other non steroidal anti - inflammatory drugs ( NSAIDs ); Diclofenac is also contraindicaled in patients in whom attacks of asthma, urticaria, or acute rtiinitis are precipitated by acetyl saticyfic acid or other drugs with prostaglandin - synthetase inhibiting activity.
Warnings:
Gastrointestinal bleeding or ulceration perforation can occur at any Lime during treatment, with or without warning symptoms or a previous history.
They generally have more serious consequences In the elderly. In the rare cases where gastrointestinal bleeding or ulceration occur in patients receiving Dicloflam, the drug should be withdrawn . As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions can also occur in rare cases without earlier exposure to the drug Like olher NSAIDs Dicloflarn may mask the signs and symptoms of infection clue to its pharmacodynamic properties.
Precautions:
Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders or a history suggestive of gastric or intestinal ulcer, patients with ulcerative colitis or Crohn’s disease , and in patients suffering from impaired hepatic function
As with other NSAIDs • values of one or more liver enzymes may icrease - During prolonged treatment with Dicloftam monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur ( e.g. eosinophilia. rash. etc.). Dicloflam should be discontinued. Hepatitis may occur without prodromal symptoms . Caution is caffed for when using Dicloflam in patients with hepatic porphyria; since Dicloflani may trigger an attack. Owing to the importance of prostaglandins in maintaining renal blood flow ; particular caution is called for in patients with impaired cardiac or renal function • the elderly patients being treated with diuretics, and patients with substantial extracellular volume depletion of any cause, e. g. before and after major surgery. Monitoring of renal function is recommended as a precautionary measure when using Dicloflam in such cases discontinuation of therapy is normally followed by a return to the pretreatment state. Treatment with Dicloflam in the aforementioned indications usually proves necessary only for a few days. But if contrary to the recommendations for its use • DicloHam Is administered over a more prolonged period; it is advisable - as with other NSAIDs- to perform blood counts, Like other NSAIDs, Dicloflam may temporarily inhibit platelet aggregation. Patients with haemostatic disorders should be carefully monitored. Caution is indicated in the elderly on basic medical grounds . In particular it is recommended that the lowest effective dosage should be used in trail elderly patients or those with a low body weight.
Pregnancy
During pregnancy Diclef lam should be enipioyed only for competeting reactions and only in the lowest effective doses. As in the case of other prostaglandin- synthetase inhbitors. This applies particularly to the last 3 months of pregnancy ( owing to the posibiiiLy of uterine inertia and I or premature closure of the dectus arteriosus)
Lactation:
Following oral doses of 50 mg administered every 8 hours, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be,expected.
Effects On The Ability To Drive And Use Machines:
Patients experiencing dizziness or other central nervous disturbances including visual disturbances should not drive or operate machinery.
Interactions with other drugs and other types of interactions:
(Including interactions observed with other dosage forms of Diclof lam and diclofanac sodium) Lithium, digoxin: Diclof lam may raise plasma concentrations of lithium or digoxin.
Diuretics: Like other NSAIDs; Dicfoflam may inhibit the activity of diuretics. Concomitant treatment with potassium sparing diuretics may be associated with increased serum potassium levels which should therefore be monitored.
NSAIDs: Concomitant administration of systemic NSA lDs may increase the frequency of side effects.
Anticoagulants: Although cnical investigations do not appear to indicate that Diclof lam affects the action of anticoagularits. there are isolated reports of an increaed risk of haernorrhage in patients receiving Dicloflarn and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Antidiabetics: Clinical studies have shown that Dicloflam can be given together with oral antidiabetic agents without influencing their clinical effect. However isolated cases have been reported of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of hypoglycaemic agents during treatment with Diclof lam. Methotrexate : Caution is called for ii NSAIDs are administered less than 24 hours before or alter treatment with Methotrexale since blood concentrations of Mothotrexate rise and the toxicity of this substance increases.
Cyclosporin : The effects of NSAIDs on renal postaglandins may increase the nephrotoxicity of Cyclosporin.
Quinolone : There have been isolated reports of convulsions whtch may have been due to concurrent use of Quinolone and NSAIDs.
Dosage:
Do not dispense or repeat without prescription.
The dosage of Diclottam should b individualized to the lowest effective dose to minimize adverse elfects
Osteoarlhritis: The recommended dosage is 100 150mg / day 50 mg b.i.d or t. Id.
Rheumatoid arthritis: The recomerided dosage is 100-200 mg/day 50mg t.i.d or q. i. d. Dosage above 225 mg/day is not recommended in patients with rheumatoid arthritis -
Ankylosing spondylitis: The recommended dosage is 100 to 125 mg/day. i. e 25 mg q. i. d with an extra 25 mg dose at bedtime if necessary.
Dosage above 125 mg/day have not been studied in patients with ankylosing spondylitis
Analgesia and primary dysmenorrhea:
The recommended starting dose of Diclof lam is 50 mg 1. i. d. With experience, physicians may find that in some patients an initial dose of 100 mg of Diclollam followed by 50mg doses will provide better relief after the first day, when lhe maximum recommended dose may be 200 mg. the total daily dose should generall not exceed 150 mg.
Package: Pack contains 1 strip Xl 0 tablets -
- ALEXANDRIA Co. FOR PHARMACEUTICALS
ALEXANDRIA- EGYPT
Composition:
Each tablet contains:
Diclofenac potassium 25 mg or 50 mg
Pharmacodynamics:
Diclofenac potassium is a potent non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. Dictofenac inhibits cyclo-oxygenase actMty with a reduction in the tissue production of prostaglandins . Pharmacokinetics:
Diclofenac is rapidly and completely absorbed after oral adminisIraIon . )ts extensively rnetabollzed to a range of phenolic compounds which are excreted in the urine.
Indications:
Short term treatment in the following acute conditions:
Posttraumatic pain, initammation and swetling e.g . due to sprains.
Post-operative pain. inflammation and sweJng e.g . following dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology . e.g . primary dysmenorrhoea or adnexitis
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. pharyngotonsiltitis, otitis.
Side Effects:
Gastrointestinal Tract:
Abdominal pain or cramps . indigestion abdominal distension, diarrhoea , nausea , vomiting . dry mouth , constipation , flatulence . peptic ulcer with or without bleeding and/ or per- foration or bleeding without ulcer.
Occasional : Headache, dizziness. vertigo
Rare : Drowsiness
Isolated cases : Sensory disturbances . including paraesthesias, memory.disturbances. disorientation, insomnia. irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions , aseptic meningitis.
Special senses:
Isolated cases : Disturbances of vision (blurred vision, diplopia ) . impaired heanng , tinnitus, taste disturbances.
Skin:
Occasional : Skin rashes or skin eruptions .
Rare : Urticana
Isolated cases : Bullous eruptions . eczema, erythema multiform, Stevens - Johnson syndrome. LyeIf’s syndrome ( acute toxic epiderniotysis ) . erythroderma ( exfohalive dermatitis) , loss of hair, photosensitivity reactions purpura,including allergic purpura.
Kidney:
Rare : Oederna
Isolated cases: Acute renal failure, urinary abnormalities such as haematuria and proteinuria. interstitial nephntis , nephrotic syndrome, papillary necrosis.
Liver:
Occasional: Elevation of serum aminotranslerase values
Rare : Hepatitis with or without jaundice
Isolated cases: fulminant hepatitis
Blood:
Isolated cases: thrombocytooenia, leucopenia, haemolytic anaemia , apIastic anaemia, agranulocytosis
Hypersensitivity:
Rare : Hypersensi:ivity reactions such as asthma. systemic anaphylactic/anaphylactoid reactions including hypotension.
Isolated cases: vasculitis, pneumonhtis
Cardiovascular system:
Palpitation, flushing. tachycardia. myocardial infarction.
Others:
Hypoglycemia , weight loss
Contraindication:
Gastric or intestinal ulcer.
Known hypersensitivity to the active substance.
Like other non steroidal anti - inflammatory drugs ( NSAIDs ); Diclofenac is also contraindicaled in patients in whom attacks of asthma, urticaria, or acute rtiinitis are precipitated by acetyl saticyfic acid or other drugs with prostaglandin - synthetase inhibiting activity.
Warnings:
Gastrointestinal bleeding or ulceration perforation can occur at any Lime during treatment, with or without warning symptoms or a previous history.
They generally have more serious consequences In the elderly. In the rare cases where gastrointestinal bleeding or ulceration occur in patients receiving Dicloflam, the drug should be withdrawn . As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions can also occur in rare cases without earlier exposure to the drug Like olher NSAIDs Dicloflarn may mask the signs and symptoms of infection clue to its pharmacodynamic properties.
Precautions:
Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders or a history suggestive of gastric or intestinal ulcer, patients with ulcerative colitis or Crohn’s disease , and in patients suffering from impaired hepatic function
As with other NSAIDs • values of one or more liver enzymes may icrease - During prolonged treatment with Dicloftam monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur ( e.g. eosinophilia. rash. etc.). Dicloflam should be discontinued. Hepatitis may occur without prodromal symptoms . Caution is caffed for when using Dicloflam in patients with hepatic porphyria; since Dicloflani may trigger an attack. Owing to the importance of prostaglandins in maintaining renal blood flow ; particular caution is called for in patients with impaired cardiac or renal function • the elderly patients being treated with diuretics, and patients with substantial extracellular volume depletion of any cause, e. g. before and after major surgery. Monitoring of renal function is recommended as a precautionary measure when using Dicloflam in such cases discontinuation of therapy is normally followed by a return to the pretreatment state. Treatment with Dicloflam in the aforementioned indications usually proves necessary only for a few days. But if contrary to the recommendations for its use • DicloHam Is administered over a more prolonged period; it is advisable - as with other NSAIDs- to perform blood counts, Like other NSAIDs, Dicloflam may temporarily inhibit platelet aggregation. Patients with haemostatic disorders should be carefully monitored. Caution is indicated in the elderly on basic medical grounds . In particular it is recommended that the lowest effective dosage should be used in trail elderly patients or those with a low body weight.
Pregnancy
During pregnancy Diclef lam should be enipioyed only for competeting reactions and only in the lowest effective doses. As in the case of other prostaglandin- synthetase inhbitors. This applies particularly to the last 3 months of pregnancy ( owing to the posibiiiLy of uterine inertia and I or premature closure of the dectus arteriosus)
Lactation:
Following oral doses of 50 mg administered every 8 hours, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be,expected.
Effects On The Ability To Drive And Use Machines:
Patients experiencing dizziness or other central nervous disturbances including visual disturbances should not drive or operate machinery.
Interactions with other drugs and other types of interactions:
(Including interactions observed with other dosage forms of Diclof lam and diclofanac sodium) Lithium, digoxin: Diclof lam may raise plasma concentrations of lithium or digoxin.
Diuretics: Like other NSAIDs; Dicfoflam may inhibit the activity of diuretics. Concomitant treatment with potassium sparing diuretics may be associated with increased serum potassium levels which should therefore be monitored.
NSAIDs: Concomitant administration of systemic NSA lDs may increase the frequency of side effects.
Anticoagulants: Although cnical investigations do not appear to indicate that Diclof lam affects the action of anticoagularits. there are isolated reports of an increaed risk of haernorrhage in patients receiving Dicloflarn and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Antidiabetics: Clinical studies have shown that Dicloflam can be given together with oral antidiabetic agents without influencing their clinical effect. However isolated cases have been reported of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of hypoglycaemic agents during treatment with Diclof lam. Methotrexate : Caution is called for ii NSAIDs are administered less than 24 hours before or alter treatment with Methotrexale since blood concentrations of Mothotrexate rise and the toxicity of this substance increases.
Cyclosporin : The effects of NSAIDs on renal postaglandins may increase the nephrotoxicity of Cyclosporin.
Quinolone : There have been isolated reports of convulsions whtch may have been due to concurrent use of Quinolone and NSAIDs.
Dosage:
Do not dispense or repeat without prescription.
The dosage of Diclottam should b individualized to the lowest effective dose to minimize adverse elfects
Osteoarlhritis: The recommended dosage is 100 150mg / day 50 mg b.i.d or t. Id.
Rheumatoid arthritis: The recomerided dosage is 100-200 mg/day 50mg t.i.d or q. i. d. Dosage above 225 mg/day is not recommended in patients with rheumatoid arthritis -
Ankylosing spondylitis: The recommended dosage is 100 to 125 mg/day. i. e 25 mg q. i. d with an extra 25 mg dose at bedtime if necessary.
Dosage above 125 mg/day have not been studied in patients with ankylosing spondylitis
Analgesia and primary dysmenorrhea:
The recommended starting dose of Diclof lam is 50 mg 1. i. d. With experience, physicians may find that in some patients an initial dose of 100 mg of Diclollam followed by 50mg doses will provide better relief after the first day, when lhe maximum recommended dose may be 200 mg. the total daily dose should generall not exceed 150 mg.
Package: Pack contains 1 strip Xl 0 tablets -
- ALEXANDRIA Co. FOR PHARMACEUTICALS
ALEXANDRIA- EGYPT
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