Voren | diclofenac sodium

Composition
Each Voren 25mg enteric coated tablet contains 25mg of diclofenac sodium. Each Voren 50mg enteric coated tablet contains 50mg of diclofenac sodium. Each Voren Microtech capsule 50mg contains 50mg of diclofenac sodium (as enteric coated pellets).
Mode of Action
Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Diclofenac inhibits prostaglandin synthesis by interfering with the action of prostaglandin synthetase. This inhibitory effect may partially explain its actions.
Pharmacokinetics
Absorption Diclofenac is 100% absorbed after oral administration. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available. Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of Distribution Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. Metabolism Five diclofenac metabolites have been identified in human plasma and urine. Excretion Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. The terminal half-life of unchanged diclofenac is approximately 2 hours. Special Populations Hepatic Insufficiency: Hepatic metabolism accounts for almost 100% of Voren elimination, so patients with hepatic disease may require reduced doses of Voren compared to patients with normal hepatic function. Renal Insufficiency: Diclofenac pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of diclofenac have been detected in studies of patients with renal impairment. In patients with renal impairment (inulin clearance 60-90, 30-60, and
Indications
Acute gout, pain and inflammation in rheumatic disease and in other musculoskeletal disorders, rheumatoid arthritis, osteroarthritis, periarthritis (especially frozen shoulder), low back pain, tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations, relief of pain in fractures, ankylosing spondylitis. It may be used in the control of pain and inflammation in orthopaedic, dental and other minor surgery.
Dosage & Administration
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The maximum daily dose of diclofenac sodium should not exceed 150 mg. Adults: One Voren tablet 50mg twice daily. Dose can be increased to one Voren tablet 50mg thrice daily in severe cases. One Voren Microtech capsule 50mg twice daily. Dose can be increased to one Voren capsule thrice daily in severe cases. Children: In children the dosage is 1 to 3 mg/kg daily in divided doses.
Side Effects
In patients taking Voren, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headache, increased bleeding time, pruritus, rashes and tinnitus. Additional adverse experiences reported occasionally include: Body as a Whole: fever, infection, sepsis. Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope. Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice. Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia. Metabolic and Nutritional: weight changes. Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo. Respiratory System: asthma, dyspnea. Skin and Appendages: alopecia, photosensitivity, increased sweating. Special Senses: blurred vision. Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure. Other adverse reactions, which occur rarely, are: Body as a Whole: anaphylactic reactions, appetite changes, death. Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis. Digestive System: colitis, eructation, liver failure, pancreatitis. Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia. Metabolic and Nutritional: hyperglycemia. Nervous System: convulsions, coma, hallucinations, meningitis. Respiratory System: respiratory depression, pneumonia. Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, urticaria. Special Senses: conjunctivitis, hearing impairment.
Drug Interactions
Aspirin: As with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects. Methotrexate: Caution should be used when NSAIDs are administered concomitantly with methotrexate. Methotrexate plasma levels may be increased and result in increased toxicity. Cyclosporine: Concomitant therapy with Voren may increase cyclosporine's nephrotoxicity. Caution should be used when Voren is administered with cyclosporine. ACE Inhibitors: Reports suggest that NSAIDs may diminish the anti-hypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. Furosemide: Voren can reduce the natriuretic effect of furosemide and thiazides in some patients. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy. Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Precautions
Diclofenac sodium should not be used concomitantly with diclofenac potassium since both exist in plasma as the same active organic ion. Patients on long-term diclofenac sodium treatment should have their hemopoietic system evaluated periodically. Periodic hematologic examinations (CBC and blood film examination) can detect anemias or blood dyscrasias secondary to possible gastrointestinal tract or bone marrow toxicity. There is a risk of hyperkalemia with NSAID treatment. Patients most at risk are: the elderly, those having conditions such as diabetes mellitus or renal failure, or those receiving concomitant therapy with B-adrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics. In humans there have been reports of acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome. In patients with prerenal conditions leading to reduction in renal blood flow or blood volume, renal prostaglandins have a supportive role in the maintenance of renal perfusion. Administration of NSAIDs may precipitate overt renal decompensation due to a dose-dependent reduction in prostaglandin formation. Patients at greatest risk are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly. Recovery to the pretreatment state usually follows discontinuation of NSAID therapy. During long-term therapy, kidney function should be monitored periodically. If abnormal liver function test results persist or worsen, or if systemic manifestations or clinical signs consistent with liver disease develop, discontinue diclofenac sodium treatment. Liver function should be monitored during long-term treatment with this drug. Caution is called for when using diclofenac sodium in patients with hepatic porphyria, since diclofenac sodium may trigger an attack. The anti-inflammatory, antipyretic, and analgesic effects of diclofenac sodium may mask the usual signs of infection. Blurred and/or diminished vision has been reported with the use of diclofenac sodium and with other NSAIDs. Ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without prior exposure to drug. Careful questioning for patient history of asthma, nasal polyps, urticaria, and hypotension associated with NSAIDs is important before starting therapy.
Warnings
Caution is required if administrated to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients. NSAIDs should only be given with care to patients with a history of gastrointestinal disease. Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration. Side effects are generally more serious in the elderly and if serious, diclofenac sodium should be withdrawn. Patients on long term treatment should be monitored and patients with severe hepatic, cardiac or renal insufficiency should be kept under close surveillance as the use of NSAIDs may result in deterioration of renal function. Patients with impaired cardiac or renal function or recovering from major surgery or being treated with diuretics should be considered because of the importance of prostaglandins in maintaining blood flow. The dose should be kept as low as possible and renal function should be monitored in these patients. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with NSAIDs administration. If there is persistency in abnormal liver function tests or there are symptoms consistent with liver disease or if there are other manifestations such as rash or eosinophilia, diclofenac sodium treatment should be discontinued. Attacks of hepatic porphyria may be triggered in susceptible patients. Diclofenac sodium in common with other non-steroidal anti-inflammatory drugs can reversibly inhibit platelet aggregation.
Pregnancy
Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Use of prostaglandin synthetase inhibitors may result in premature closure of the foetal ductus arteriosus or uterine inertia and therefore are not recommended during the last trimester of pregnancy.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Voren, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Geriatric Use
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
Overdose
Symptoms Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Treatment Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Contraindications
Voren is contraindicated in patients with known hypersensitivity to diclofenac. Voren should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Voren is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Presentation
VOREN tablet 25mg: 10 x 10's / pack. VOREN tablet 50mg: 10 x 10's / pack. VOREN Microtech capsule 50mg: 10 x 10's / pack.
Issued: 05-04-2009
Composition
Each 3ml Voren® ampoule contains 75mg of diclofenac sodium.
Mode of Action
1. Voren® is a nonsteroidal anti-inflammatory agent that possesses analgesic and antipyretic activities. Its mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known; however, its therapeutic action is not due to pituitary adrenal stimulation, but may be from the inhibitory action in the synthesis of prostaglandin. 2. Voren® exhibits very marked antirheumatic, anti-inflammatory, analgesic, and antipyretic properties and is thus suitable for use in inflammatory and degenerative rheumatic disease, as well as for the treatment of post-traumatic inflammation and swelling. 3. In patients treated with Voren® for rheumatoid arthritis and osteoarthritis, the anti-inflammatory action of Voren® has been shown by reduction in joint swelling, reduction in pain, also reduction on duration of morning stiffness.
Indications
Inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis. Painful syndromes of the vertebral column. Non-Articular rheumatism. Acute attack of gout. Painful post-traumatic and post-operative inflammation and swelling of orthopedic surgery. Painful and inflammatory condition in gynaeocology, e.g. primary dysmenorrhea & adnexitis. As an adjuvent therapy in severe painful inflammatory infection of ear, nose and throat. Painful post-operative, inflammatory condition of dental surgery.
Dosage & Administration
By intramuscular injection: 75mg, once daily (twice daily in severe cases). Intramuscular injection should be given deeply into the gluteal muscle to ensure intramuscular delivery. Use alternate sites for subsequent injections. By intravenous infusion (in hospital setting): 75mg over 30~120 minutes repeated if necessary after 4~6 hours for maximal 2 days. Prevention of postoperative pain, initially after surgery 25~50mg over 15~60 minutes then 5mg/hour for maximal 2 days. To be used by a physician.
Side Effects
At the start of treatment, patients may complain of epigastric pain, eructation, nausea and diarrhoea, headache, or dizziness. These side effects, however, are usually of a mild nature and generally disappear after a few days despite continuation of the medication. Skin rashes may also occur very occasionally.
Drug Interactions
Aspirin: As with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects. Methotrexate: Caution should be used when NSAIDs are administered concomitantly with methotrexate. Methotrexate plasma levels may be increased and result in increased toxicity. Cyclosporine: Concomitant therapy with Voren® may increase cyclosporine’s nephro-toxicity. Caution should be used when Voren® is administered with cyclosporine. ACE Inhibitors: Reports suggest that NSAIDs may diminish the anti-hypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. Furosemide: Voren® can reduce the natriuretic effect of furosemide and thiazides in some patients. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy. Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Precautions
In accordance with currently accepted views on the employment of drugs during pregnancy, Voren® should not be prescribed in the first three months of pregnancy unless its use is strictly indicated. Diclofenac sodium should not be used concomitantly with diclofenac potassium since both exist in plasma as the same active organic ion. Patients on long-term diclofenac sodium treatment should have their hemopoietic system evaluated periodically. Administration of NSAIDS may precipitate overt renal decompensation due to a dose-dependent reduction in prostaglandin formation. Patients at greatest risk are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly. During long-term therapy, kidney function should be monitored periodically. Liver function should be monitored during long-term treatment with this drug. Caution is called for when using diclofenac sodium in patients with hepatic porphyria, since diclofenac sodium may trigger an attack. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur without prior exposure to drug.
Warnings
Caution is required if administrated to patients suffering from, or with a previous history of bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients. NSAIDs should only be given with care to patients with a history of gastrointestinal disease. Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with NSAID administration.
Contraindications
Patients with known hypersensitivity to diclofenac, or other non-steroidal anti-inflammatory medicines. Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid, or other medicines with prostaglandin synthetase inhibiting activity. Diclofenac sodium is contra-indicated in patients with a history of active gastro-intestinal bleeding or peptic ulceration, or severe hepatic or renal impairment. Patients with porphyria. Last trimester of pregnancy. Severe hepatic, renal and cardiac failure.
Presentation
Voren Injection 100mg in 3 ml
What is Voren?
Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body. Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis. Diclofenac powder is used to treat a migraine headache attack. Diclofenac may also be used for other purposes not listed in this medication guide.
What are the possible side effects of Voren?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking diclofenac and seek medical attention or call your doctor at once if you have any of these serious side effects: chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance; black, bloody, or tarry stools; coughing up blood or vomit that looks like coffee grounds; swelling or rapid weight gain, urinating less than usual or not at all; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; bruising, severe tingling, numbness, pain, muscle weakness; or neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions). Less serious side effects may include: upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas; dizziness, headache, nervousness; skin itching or rash; blurred vision; or ringing in your ears. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
What is the most important information I should know about Voren?
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use diclofenac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG). Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking diclofenac. Older adults may have an even greater risk of these serious gastrointestinal side effects. Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac.
What should I discuss with my healthcare provider before taking Voren?
Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG). NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects. Do not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs. If you have any of these other conditions, you may need a dose adjustment or special tests to safely take diclofenac: a history of heart attack, stroke, or blood clot; heart disease, congestive heart failure, high blood pressure; a history of stomach ulcers or bleeding; liver or kidney disease, asthma; polyps in your nose; a bleeding or blood clotting disorder; or if you smoke. FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not take diclofenac during pregnancy unless your doctor has told you to. Diclofenac can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.
How should I take Voren?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. If you switch brands of diclofenac, your dose needs may change. Follow your doctor’s instructions about how much medicine to take. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Dissolve the diclofenac powder (Cambia) with 1 to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Diclofenac powder works best if you take it on an empty stomach. Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of diclofenac powder without your doctor’s advice. Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. If you take diclofenac for a long period of time, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled visits to your doctor. Store diclofenac at room temperature away from moisture and heat.
What happens if I miss a dose of Voren?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose on Voren?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, and fainting.
What should I avoid while taking diclofenac Voren?
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking diclofenac. Alcohol can increase the risk of stomach bleeding caused by diclofenac. Avoid prolonged exposure to sunlight. Diclofenac may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
What other drugs will affect Voren?
Tell your doctor if you are taking an antidepressant such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine. Taking any of these drugs with diclofenac may cause you to bruise or bleed easily. Tell your doctor about all other medications you use, especially: a blood thinner such as warfarin; cyclosporine; lithium; methotrexate; diuretics (water pills) such as furosemide. steroids; aspirin or other NSAIDs such as ibuprofen, diclofenac, etodolac, indomethacin, meloxicam, nabumetone, naproxen, piroxicam, and others; or an ACE inhibitor such as benazepril, enalapril, fosinopril, lisinopril, quinapril, ramipril, and others. This list is not complete and there may be other drugs that can interact with diclofenac. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
Your doctor or pharmacist can provide more information about diclofenac.
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