Components:
Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 27.04.2022
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Inflammatory and degenerative forms of rheumatism: Rheumatoid arthritis; juvenile rheumatoid arthritis; ankylosing spondylitis; osteoarthrosis and spondylarthritis; painful syndromes of the vertebral column; non-articular rheumatism. Post-traumatic and postoperative pain, inflammation and swelling eg, following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology eg, primary dysmenorrhoea or adnexitis.
Voren Injection Tablet/Ampoule/Suppository: Acute attacks of gout.
Tablet/Suppository: As an adjuvant in severe painful inflammatory infections of the ear, nose or throat eg, pharyngotonsillitis and otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication.
Ampoule/Suppository: Severe migraine attacks.
Ampoule: IM Injection: Renal biliary colic. IV Infusion: Treatment and prevention of postoperative pain in a hospital setting.
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.
Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: Treatment with Voren Injection 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 Voren Injection only after careful consideration and only at doses ≤100 mg daily when initial treatment with Voren Injection continues with Voren Injection tablets or suppositories for >4 weeks.
IM: The dose is generally one 75 mg ampoule daily. In severe cases (eg, colic), the daily dose can exceptionally be increased to 2 injections of 75 mg, separated by an interval of a few hours (1 into each buttock). Alternatively, 75 mg can be combined with other pharmaceutical forms of Voren Injection (eg, tablets, suppositories) up to a total maximum daily dose of 150 mg.
Migraine Attacks: Clinical experience is limited to initial use of 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required. The total dose should not exceed 175 mg on the 1st day.
IV: Treatment of Moderate to Severe Post-Operative Pain: 75 mg should be infused continuously over a period of 30 min to 2 hrs. If necessary, treatment may be repeated after a few hours, but the dose should not exceed 150 mg within any period of 24 hrs.
Prevention of Post-Operative Pain: A loading dose of 25-50 mg should be infused after surgery over 15 min to 1 hr, followed by a continuous infusion of about 5 mg/hr up to a maximum daily dose of 150 mg.
Renal Impairment: Voren Injection is contraindicated in patients with renal failure.
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 Voren Injection to patients with mild to moderate renal impairment.
Hepatic Impairment: Voren Injection is contraindicated in patients with hepatic failure. 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 Voren Injection to patients with mild to moderate hepatic impairment.
Elderly: (≥65 years): No adjustment of the starting dose is required for elderly patients.
Administration: IM Injection: The following directions for IM injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.
The dose is administered by deep intragluteal injection into the upper outer quadrant.
IV Infusion: Voren Injection must not be given as an IV bolus injection.
Immediately before starting an IV infusion, Voren Injection must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate according to the instructions given in Cautions for Usage.
Hypersensitivity to diclofenac, sodium metabisulphite or any of the excipients of Voren Injection.
Active gastric or intestinal ulcer, bleeding or perforation; hepatic and renal failure.
Severe cardiac failure.
Like other NSAIDs, Voren Injection is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid (ASA) or other NSAIDs.
Use in pregnancy: There are insufficient data on the use of diclofenac in pregnant women. Do not use during the first 2 trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. As with other NSAIDs, use of diclofenac during the 3rd trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.
Use in lactation: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, diclofenac should not be administered during breastfeeding in order to avoid adverse effect in the infant.
The following interactions include those observed with Voren Injection and/or other pharmaceutical forms of diclofenac.
Observed Interactions to be Considered: Potent CYP2C9 Inhibitors: Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism.
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.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin 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.
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.
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.
Anticoagulants and Anti-platelet Agents: Caution is recommended since concomitant administration could increase the risk of bleeding. Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are isolated reports of an increased risk of haemorrhage in patients receiving diclofenac and anticoagulants concomitantly. Close monitoring of such patients is therefore recommended.
Selective Serotonin Reuptake Inhibitors (SSRIs): Concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding.
Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.
Methotrexate: Caution is recommended when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.
Frequency estimate: Frequent >10%, occasional >1-10%, rare >0.001-1%, isolated cases <0.001%.
Gastrointestinal Tract: Occasional: Epigastric pain, nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence and anorexia. Rare: Gastrointestinal bleeding, (haematemesis, melena, bloody diarrheas), gastric or intestinal ulcer with or without bleeding or perforation. Isolated Cases: Aphthous stomatitis, glossitis, oesophageal lesions, diaphragm-like intestinal strictures, lower gut disorders eg, nonspecific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis.
Central Nervous System: Occasional: Headache, dizziness, vertigo. Rare: Drowsiness. Isolated Cases: Sensory disturbances, including paraesthesiae, 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 hearing, tinnitus, taste disturbances.
Skin: Occasional: Rashes. Rare: Urticaria. Isolated Cases: Bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reaction, purpura, including allergic purpura.
Kidney: Rare: Oedema. Isolated Cases: Acute renal failure, urinary abnormalities eg, haematuria and proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
Liver: Occasional: Elevation of serum aminotransferase enzymes. Rare: Hepatitis with or without jaundice. Isolated Cases: Fulminant hepatitis.
Blood: Isolated Cases: Thrombocytopenia, leucopenia, haemolytic anaemia, aplastic anaemia, agranulocytosis.
Hypersensitivity: Rare: Hypersensitivity reactions eg, asthma, systemic anaphylactic/anaphylactoid reactions including hypotension. Isolated Cases: Vasculitis, pneumonitis.
Cardiovascular System: Isolated Cases: Palpitation, chest pain, hypertension, congestive heart failure.
Voren Injection: Suppository: Gastrointestinal Tract: Exacerbation of haemorrhoids.
Ampoules: Other Organ Systems: Occasional: IM injection site reactions eg, local pain and induration. Isolated Cases: Local abscesses and necrosis at the IM injection site.
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac sodium).
Voren Injection: One gastro-resistant tablet contains 50 mg of diclofenac sodium.
Voren Injection SR: One prolonged-release tablet contains 75 mg or 100 mg of diclofenac sodium.
Excipients/Inactive Ingredients: Tablet Core: Magnesium stearate; povidone and silica; colloidal anhydrous.
Tablet Coating: Hypromellose; iron oxide red (E172); macrogol 8000; talc and titanium dioxide (E171).
Voren Injection: Tablet Core: Cellulose microcrystalline; lactose monohydrate; maize starch and sodium starch glycolate (type A).
Tablet Coating: Iron oxide yellow (E172); macrogoglycerol hydroxystearate; methacrylic acid–ethyl acrylate copolymer; simeticone; alpha-octadecyl-omega-hydroxy polyglykolether and sorbic acid.
Voren Injection SR: Tablet Core: Cetyl alcohol and sucrose.
Tablet Coating: Polysorbate 80 and sucrose. Printing Ink: Carbon black, shellac, ammonium hydroxide and simethicone.
Pharmaceutical formulations may vary between countries.