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PROPERTIES:
DISPERCAM is a nonsteroidal compound with marked antiinflammatory, antirheumatic, analgesic and antipyretic properties. Its active substance, piroxicam, strongly inhibits prostaglandin synthetase and also has an inhibitory effect on platelet aggregation. DISPERCAM is suitable for the treatment of inflammatory and degenerative rheumatic diseases, as well as for use in painful conditions due to inflammation of non-rheumatic origin, and in post-operative pain. It is structurally unrelated to other NSAIDs currently available. DISPERCAM has a long half-life and may be administered as a single daily dose. The antiinflammatory potential of DISPERCAM has been equated with that of indomethacin, and its analgesic activity has been shown to be greater than that of aspirin. The dispersible tablets have short disintegration times and are easily and quickly absorbed so that they give peak plasma levels in relatively shorter times than the conventional oral dosage forms.
INDICATIONS:
Inflammatory and degenerative forms of rheumatism (such as rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis and spondylarthritis), non-articular rheumatism, acute attacks of gout, painful post-operative and post-traumatic inflammation and swelling, painful inflammatory conditions in gynecology, headache and toothache especially prior to dental operations or workout to provide sustained analgesic effect after dental work owing to long duration of action.
DOSAGE AND ADMINISRATION:
Dispercam dispersible tablet is dropped in a quarter of a glass of water, wait for nearly 30 seconds, till complete dispersion, then stir and take orally. Dispercam ampoules are only given through deep intramuscular injection, preferably into the upper external quadrant of the gluteal muscle. Dispercam suppositories are inserted deeply in the rectum. The following dosages may be recommended:
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis: Initial treatment: One DISPERCAM 20-mg dispersible tablet, orally; or one DISPERCAM ampoule by intramuscular injection, or one DISPERCAM suppository rectally.
Maintenance treatment: One DISPERCAM 10mg or 20mg-tablet, or one DISPERCAM ampoule by intramuscular injection, or one DISPERCAM suppository rectally once daily.
Acute Gout: Therapy could be initiated with 30 up to 40 mg daily in single or divided doses for 4 to 6 days. DISPERCAM is not suitable for long term management of chronic gout.
Acute Musculoskeletal Disorders: Therapy may be initiated with 30 up to 40 mg daily in single or divided doses for the first 2 days, then maintained by 20 mg daily for 7 - 14 days. Long term administration of doses higher than 20mg is not recommended.
Postoperative and Post-traumatic Pain, or Dentistry: The recommended starting dose is a single 20 mg daily. In cases where a more rapid onset of action is desired, therapy could be initiated with 40 mg daily for the first 2 days given as a single or divided doses. For the remainder of the treatment period the dose should not exceed 20 mg daily.
Dysmenorrhea: Treatment should be initiated at the earliest onset of symptoms with a starting dose of 40 mg for 2 days and continuation with 20 mg dose.
Upper Respiratory Tract Inflammation, or Headache: Adult dose of 10mg up to 20mg daily orally.
Juvenile Rheumatoid Arthritis: Dose for children is based on the body weight as follows:

- 15-30 kg body weight: 5 mg.
- 31-45 kg body weight: 10 mg.
- 46-55 kg body weight: 15 mg.
PHARMACOKINETICS:
Absorption: After I.M., rectal or oral administration, Dispercam is rapidly and almost completely absorbed, with peak plasma concentrations occurring in 1-2 hours. The rate of absorption, but not the extent, is delayed by food, so that its bioavailability is unchanged.
Distribution: Piroxicam is highly (about 99%) plasma protein-bound. Its concentrations in synovial fluid are roughly 40% of plasma concentrations. Concentrations in breast milk are 1% of maternal plasma concentrations. It is unknown whether Piroxicam crosses the placenta.
Metabolism: About 50% of the drug is metabolized in the liver via hydroxylation and glucuronide conjugation to a hydroxy metabolite. The mean half-life is approximately 45 hours.
Excretion: Piroxicam undergoes enterohepatic circulation. Urinary excretion of piroxicam and its metabolites is twice that of fecal excretion.
CONTRAINDICATIONS:
Active or recurrent peptic ulcer.
Hypersensitivity to the active ingredient.
Patients in whom aspirin or other nonsteroidal antiinflammatory drugs induce the symptoms of asthma, rhinitis or urticaria.
The suppositories are contraindicated in patients with inflammatory lesions of rectum or anus.
PRECAUTIONS:

Monitor for GI ulceration or bleeding in patients who receive prolonged treatment, with special caution in tobacco smoking patients. Periodically monitor liver-function tests, especially serum transaminase levels. The drug should be discontinued if elevated liver-function tests persist or worsen, or if signs and symptoms of hepatic disease develop. Observe caution with patients with preexisting coagulopathy or hemophilia due to the effect of the drug on platelet function. Maintain therapy with the lowest effective dose.

INTERACTIONS:

Concomitant administration of Piroxicam and Aspirin lowers plasma levels of Piroxicam and is not recommended.
Concomitant use of Piroxicam with Warfarin requires close monitoring of anticoagulant dosage as Piroxicam, like other NSAIDs, affects platelet function.
Concurrent use of Piroxicam with Digoxin, Methotrexate, or Cyclosporine may increase the toxicity of these drugs.
Concurrent use of Piroxicam with Lithium decreases the renal clearance of Lithium and therefore increases its plasma levels and may lead to lithium toxicity.
Concurrent use of Piroxicam with diuretics may inhibit the action of diuretics; use with potassium-sparing diuretics may increase serum potassium levels.

EFFECTS ON DIAGNOSTIC TESTS:

Piroxicam increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII.

OVERDOSE AND TREATMENT:

There is no special antidote. Supportive and symptomatic treatment may include induction of vomiting or gastric lavage. Treatment with activated charcoal may also be appropriate.

GERIATRIC USE:
Use with caution in elderly patients, as they may be more susceptible to adverse reactions. Reduce dosage to lowest level that controls symptoms.
BREAST - FEEDING:
Low levels of Piroxicam have been measured in human breast milk. Risk-to-benefit ratio must be considered.
PATIENT INFORMATION:

Avoid Aspirin and alcoholic beverages while taking medication.
If gastrointestinal upset occurs, take with food, milk or antacids. If GI symptoms persist, notify physician.
Piroxicam may cause drowsiness, dizziness or blurred vision. Observe caution while driving or performing tasks requiring alertness.
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Tell your doctor or pharmacist about all other medicines you are taking, caffeine or alcohol you are drinking regularly, or if you smoke.

HOW SUPPLIED:

DISPERCAM 10: Box of 20 Dispersible Tablets.
DISPERCAM 20: Box of 10 Dispersible Tablets.
DISPERCAM Ampoules: Box of Three 1-ml ampoules (20 mg per ml).
DISPERCAM Suppositories: Box of 5 suppositories.
DISPERCAM Topical Gel: Collapsible aluminium tubes, each contains 15 grams of 0.5% Piroxicam gel with a penetration enhancer.


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Copyright © 2002 Medical Union Pharmaceuticals
 
MUPEg.com > Products > Orthopedic > Dispercam > More Informtion

    About Us Careers HOME >>
 
Home > Products > Orthopedic > Dispercam > More Information
PROPERTIES:
DISPERCAM is a nonsteroidal compound with marked antiinflammatory, antirheumatic, analgesic and antipyretic properties. Its active substance, piroxicam, strongly inhibits prostaglandin synthetase and also has an inhibitory effect on platelet aggregation. DISPERCAM is suitable for the treatment of inflammatory and degenerative rheumatic diseases, as well as for use in painful conditions due to inflammation of non-rheumatic origin, and in post-operative pain. It is structurally unrelated to other NSAIDs currently available. DISPERCAM has a long half-life and may be administered as a single daily dose. The antiinflammatory potential of DISPERCAM has been equated with that of indomethacin, and its analgesic activity has been shown to be greater than that of aspirin. The dispersible tablets have short disintegration times and are easily and quickly absorbed so that they give peak plasma levels in relatively shorter times than the conventional oral dosage forms.
INDICATIONS:
Inflammatory and degenerative forms of rheumatism (such as rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis and spondylarthritis), non-articular rheumatism, acute attacks of gout, painful post-operative and post-traumatic inflammation and swelling, painful inflammatory conditions in gynecology, headache and toothache especially prior to dental operations or workout to provide sustained analgesic effect after dental work owing to long duration of action.
DOSAGE AND ADMINISRATION:
Dispercam dispersible tablet is dropped in a quarter of a glass of water, wait for nearly 30 seconds, till complete dispersion, then stir and take orally. Dispercam ampoules are only given through deep intramuscular injection, preferably into the upper external quadrant of the gluteal muscle. Dispercam suppositories are inserted deeply in the rectum. The following dosages may be recommended:
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis: Initial treatment: One DISPERCAM 20-mg dispersible tablet, orally; or one DISPERCAM ampoule by intramuscular injection, or one DISPERCAM suppository rectally.
Maintenance treatment: One DISPERCAM 10mg or 20mg-tablet, or one DISPERCAM ampoule by intramuscular injection, or one DISPERCAM suppository rectally once daily.
Acute Gout: Therapy could be initiated with 30 up to 40 mg daily in single or divided doses for 4 to 6 days. DISPERCAM is not suitable for long term management of chronic gout.
Acute Musculoskeletal Disorders: Therapy may be initiated with 30 up to 40 mg daily in single or divided doses for the first 2 days, then maintained by 20 mg daily for 7 - 14 days. Long term administration of doses higher than 20mg is not recommended.
Postoperative and Post-traumatic Pain, or Dentistry: The recommended starting dose is a single 20 mg daily. In cases where a more rapid onset of action is desired, therapy could be initiated with 40 mg daily for the first 2 days given as a single or divided doses. For the remainder of the treatment period the dose should not exceed 20 mg daily.
Dysmenorrhea: Treatment should be initiated at the earliest onset of symptoms with a starting dose of 40 mg for 2 days and continuation with 20 mg dose.
Upper Respiratory Tract Inflammation, or Headache: Adult dose of 10mg up to 20mg daily orally.
Juvenile Rheumatoid Arthritis: Dose for children is based on the body weight as follows:

- 15-30 kg body weight: 5 mg.
- 31-45 kg body weight: 10 mg.
- 46-55 kg body weight: 15 mg.
PHARMACOKINETICS:
Absorption: After I.M., rectal or oral administration, Dispercam is rapidly and almost completely absorbed, with peak plasma concentrations occurring in 1-2 hours. The rate of absorption, but not the extent, is delayed by food, so that its bioavailability is unchanged.
Distribution: Piroxicam is highly (about 99%) plasma protein-bound. Its concentrations in synovial fluid are roughly 40% of plasma concentrations. Concentrations in breast milk are 1% of maternal plasma concentrations. It is unknown whether Piroxicam crosses the placenta.
Metabolism: About 50% of the drug is metabolized in the liver via hydroxylation and glucuronide conjugation to a hydroxy metabolite. The mean half-life is approximately 45 hours.
Excretion: Piroxicam undergoes enterohepatic circulation. Urinary excretion of piroxicam and its metabolites is twice that of fecal excretion.
CONTRAINDICATIONS:
Active or recurrent peptic ulcer.
Hypersensitivity to the active ingredient.
Patients in whom aspirin or other nonsteroidal antiinflammatory drugs induce the symptoms of asthma, rhinitis or urticaria.
The suppositories are contraindicated in patients with inflammatory lesions of rectum or anus.
PRECAUTIONS:

Monitor for GI ulceration or bleeding in patients who receive prolonged treatment, with special caution in tobacco smoking patients. Periodically monitor liver-function tests, especially serum transaminase levels. The drug should be discontinued if elevated liver-function tests persist or worsen, or if signs and symptoms of hepatic disease develop. Observe caution with patients with preexisting coagulopathy or hemophilia due to the effect of the drug on platelet function. Maintain therapy with the lowest effective dose.

INTERACTIONS:

Concomitant administration of Piroxicam and Aspirin lowers plasma levels of Piroxicam and is not recommended.
Concomitant use of Piroxicam with Warfarin requires close monitoring of anticoagulant dosage as Piroxicam, like other NSAIDs, affects platelet function.
Concurrent use of Piroxicam with Digoxin, Methotrexate, or Cyclosporine may increase the toxicity of these drugs.
Concurrent use of Piroxicam with Lithium decreases the renal clearance of Lithium and therefore increases its plasma levels and may lead to lithium toxicity.
Concurrent use of Piroxicam with diuretics may inhibit the action of diuretics; use with potassium-sparing diuretics may increase serum potassium levels.

EFFECTS ON DIAGNOSTIC TESTS:

Piroxicam increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII.

OVERDOSE AND TREATMENT:

There is no special antidote. Supportive and symptomatic treatment may include induction of vomiting or gastric lavage. Treatment with activated charcoal may also be appropriate.

GERIATRIC USE:
Use with caution in elderly patients, as they may be more susceptible to adverse reactions. Reduce dosage to lowest level that controls symptoms.
BREAST - FEEDING:
Low levels of Piroxicam have been measured in human breast milk. Risk-to-benefit ratio must be considered.
PATIENT INFORMATION:

Avoid Aspirin and alcoholic beverages while taking medication.
If gastrointestinal upset occurs, take with food, milk or antacids. If GI symptoms persist, notify physician.
Piroxicam may cause drowsiness, dizziness or blurred vision. Observe caution while driving or performing tasks requiring alertness.
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
Tell your doctor or pharmacist about all other medicines you are taking, caffeine or alcohol you are drinking regularly, or if you smoke.

HOW SUPPLIED:

DISPERCAM 10: Box of 20 Dispersible Tablets.
DISPERCAM 20: Box of 10 Dispersible Tablets.
DISPERCAM Ampoules: Box of Three 1-ml ampoules (20 mg per ml).
DISPERCAM Suppositories: Box of 5 suppositories.
DISPERCAM Topical Gel: Collapsible aluminium tubes, each contains 15 grams of 0.5% Piroxicam gel with a penetration enhancer.


Site Map  |  Privacy Statement  |  Terms of Use
Copyright © 2002 Medical Union Pharmaceuticals