Subsyde-CR

Subsyde-CR

diclofenac

Manufacturer:

Raptakos Brett

Distributor:

Raptakos Brett
Full Prescribing Info
Contents
Diclofenac sodium.
Description
Each controlled release capsule contains: Diclofenac Sodium B.P. 100 mg.
Permitted colours used in capsule shell.
Action
Pharmacology: Diclofenac Sodium (Subsyde-CR) is a controlled-release formulation which employs the new Diffusion Rate Controlling Membrane (DRCM). Diclofenac Sodium (Subsyde-CR) is a multiple unit formulation containing many pellets. Each pellet is comprised of a core with alternative layers of drug and special dialyzing membrane, which controls the diffusion rate of the drug contents. After release of pellets into the stomach, entry of gastric fluid takes place via osmosis, starting from the fluid initial layer itself. This water dissolves Diclofenac until a saturated solution is formed internally. The drug then diffuses through the dialyzing membrane into the surrounding lumen for absorption into the blood stream. Dialyzing membrane ensures slow and steady release of the drug for absorption throughout its passage in the intestinal tract. This process continues layer by layer in a slow and steady manner ensuring that plasma Diclofenac concentrations are maintained for 24 hours after a single dose. When all the drug has been diffused out the pellets then it collapsed and are excreted out.
Properties/Effects: Diclofenac Sodium (Subsyde-CR) contains the sodium salts of diclofenac, a non-steroidal anti-inflammatory drug. In pharmacologic studies, diclofenac has shown anti-inflammatory, analgesic & antipyretic effects. Inhibition of prostaglandin biosynthesis which has been demonstrated in experiments are considered to be fundamental to the mechanism of action of diclofenac. Prostaglandins play a major role in the pathogenesis of inflammation, pain & fever. In rheumatic diseases, diclofenac produces marked relief from signs & symptoms such as pain at rest, pain on movement, morning stiffness & swelling of joints as well as by an improvement in function. Diclofenac Sodium (Subsyde-CR) is punctually suitable for patients requiring a daily dosage of 100 mg.
Pharmacokinetics: Absorption: Diclofenac in Subsyde-CR is completely absorbed from the gastrointestinal tract. After administration of 100 mg Diclofenac Sodium (Subsyde-CR), mean peak plasma concentrations of about 1.39 mcg/ml were reached at the mean of 4.83 hours. Pharmacokinetic behavior does not change after repeated administration of  drug. The area under plasma concentration curve (AUC) is 18.87 mcg/mL.
Distribution: More than 99 percent of Diclofenac is reversibly bound to human plasma-2 albumin. As with other NSAIDs, diclofenac diffuses into & out into synovial fluid. Diffusion into the joint occurs when plasma levels of diclofenac are higher than those of synovial fluid.
Metabolism & Excretion: Diclofenac is excreted through metabolism & subsequent urinary & biliary excretions of glucuronide & the sulphate conjugates of the metabolites. Approximately of the 65% of the dose is excreted in the urine & approximately 36% in the bile.
Indications/Uses
Inflammatory & degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, painful syndromes of vertebral column, non articular rheumatism, painful posttraumatic and post-operative inflammation & swelling e.g. following orthopedic or dental surgery, painful & inflammatory conditions in gynecology as an adjuvant in severe painful inflammatory infections of the ear, nose or throat e.g. otitis in accordance with general therapeutic principles, appropriate measures should be taken to treat underlying disease.
Dosage/Direction for Use
The dosage of Diclofenac sodium (Subsyde-CR) in adult is one capsule a day, preferably at around 6 PM-8 PM. Treatments should be started as soon as symptoms begin and continues for several days, depending on the symptomatology. Or as prescribed by the physician.
Overdosage
In case of acute over dosage, it is recommended that the stomach be emptied by vomiting or lavage. Force diuresis may theoretically be beneficial because the drug is excreted in the urine. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac.
Contraindications
Patients with peptic ulcer, patients with known hypersensitivity to the active substance & patients in which attacks of asthma, urticaria, or acute rhinitis have been precipitated by acetylsalicylic acid or other prostaglandin synthetase inhibitors.
Special Precautions
Accurate diagnosis and careful monitoring are essential in patients with gastrointestinal disorders, a history suggestive of peptic ulcer, ulcerative colitis or Crohn's disease and in patients with severely impaired hepatic function. Particular caution is called in patients with impaired cardiac or renal function as well as in elderly patients. As Diclofenac may increase the activity of one or more liver enzymes, hepatic function during prolonged treatment should be monitored.
Use in Children: Safety and effectiveness of diclofenac in children have not been established.
Use In Pregnancy & Lactation
Pregnancy: In 1st and 2nd trimesters, no controlled studies in pregnant women are available. Diclofenac (Subsyde-CR) should not be given during the 3rd trimester owing to the risk of premature closure of the ductus arterious and suppression of uterine contractility.
Lactation: As with other drugs that are excreted in milk, diclofenac is not recommended for use in nursing women.
Adverse Reactions
Gastrointestinal tract: Occasional epigastric pain, other gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence and anorexia.
Rare: Gastrointestinal bleeding, hematemesis, melena, peptic ulcer (with or without bleeding or perforation), bloody diarrhea, pancreatitis.
Central and peripheral nervous system: Occasional: Headache, dizziness, vertigo. Rare: Lethargy.
Skin: Occasional: Skin rash. Rare: Urticaria.
Kidneys: Isolated cases: Acute renal failure, hematuria, proteinuria, inter-nephritis.
Liver: Occasional: Elevated serum aminotransferase values (SGOT, SGPT). Rare: Hepatitis with or without jaundice.
Blood: Isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, hemolytic anemia, aplastic anemia.
Hypersensitivity reactions: Rare: Hypersensitivity reactions such as asthma, systemic anaphylactic/anaphylactoid reactions (including hypotension).
Other Organ System: Rare: edema.
Drug Interactions
Aspirin: Concomitant administration of Diclofenac & Aspirin is not recommended.
Anticoagulants: Caution should be exercised while administering anticoagulants with Diclofenac since interactions of anticoagulants have been seen with other NSAIDs. Digoxin, Methotrexate, Cyclosporine.
Lithium:
Patients who begin taking diclofenac or who increase their diclofenac dose while taking these drugs should be observed closely, particularly if renal functions are impaired. In case of digoxin, serum level should be maintained.
Oral Hypoglycemic: Isolated cases have been reported of hypoglycemic and hyperglycemic reactions necessitating an adjustment in the dosage of antidiabetic drugs treatment with diclofenac.
Diuretics: Concomitant treatment of diclofenac with potassium-sparing diuretics may raise serum potassium levels, which should therefore be monitored.
Storage
Store at a temperature not exceeding 30°C.
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
CR cap 100 mg x 100's.
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