Voltaren Ampoules

/ Masrouji Co.

As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration.
General target population: Voltaren solution for injection should not be given for more than 2 days; if necessary, treatment can be continued with Voltaren tablets or suppositories.
Special populations
Pediatrics: Because of their dosage strength, the ampoules of Voltaren solution for injection are not suitable for children and adolescents.
Geriatrics (Patients aged 65 or above): No adjustment of the starting dose is required for elderly patients.
Renal impairment: No adjustment of the starting dose is required for renally impaired patients.
Hepatic impairment: No adjustment of the starting dose is required for hepatically impaired patients.
For full details see prescribing information.

Intramuscular injection Treatment of:
– Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, non-articular rheumatism.
– Treatment of painful conditions due to inflammation of non rheumatic origin.
– Renal colic and biliary colic.
– Post-traumatic and post-operative pain, inflammation and swelling.

– Known hypersensitivity to the active substance, sodium metabisulphite or any of the other excipients.
– Active gastric or intestinal ulcer, bleeding or perforation.
– Last trimester of pregnancy.
– Severe hepatic, renal and cardiac failure.
– The treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
– Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
For full details see prescribing information.

Gastrointestinal effects: Gastrointestinal bleeding ulceration or perforation, which can be fatal, have been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving Voltaren, the medicinal product should be withdrawn. As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing Voltaren in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation. The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation and in the elderly.
Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include smoking and the use of alcohol. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose. Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (ASA)/aspirin, or other medicinal products likely to increase gastrointestinal risk. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors. Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may by exacerbated.
Pre-existing asthma: In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), Quincke’s edema or urticaria are more frequent than in other patients. Therefore special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria. Special caution is recommended when Voltaren is used parenterally in patients with bronchial asthma because symptoms may be exacerbated.
Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Voltaren. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltaren should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with diclofenac without earlier exposure to the drug.
Hepatic effects: Close medical surveillance is required when prescribing Voltaren to patients with impaired hepatic function, as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Voltaren (e.g. in the form of tablets or suppositories), regular 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), Voltaren should be discontinued. Hepatitis may occur with use of diclofenac without prodromal symptoms. Caution is called for when using Voltaren in patients with hepatic porphyria, since it may trigger an attack.
Renal effects: As fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion of any cause, e.g. before or after major surgery. Monitoring of renal function is recommended as a precautionary measure when using Voltaren in such cases. Discontinuation of therapy is normally followed by recovery to the pre-treatment state.
Cardiovascular effects: Treatment with NSAIDs including diclofenac, particularly at high dose and in long term, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). To minimize the potential risk of an adverse cardiovascular event in patients taking a NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration. Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
Haematological effects: During prolonged treatment with Voltaren, as with other NSAIDs, monitoring of the blood count is recommended. Like other NSAIDs, Voltaren may temporarily inhibit platelet aggregation. Patients with defects of hemostasis, should be carefully monitored.
Geriatrics: Caution is indicated in the elderly on basic medical grounds. In particular it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.
Interactions with NSAIDs: The concomitant use of Voltaren with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided.
Special excipients: The sodium metabisulphite in the solution for injection can lead to isolated severe hypersensitivity reactions and bronchospasm.
Masking signs of infections: Like other NSAIDs, Voltaren may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Effects on ability to drive: and use machines Patients experiencing visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disturbances while taking Voltaren should refrain from driving or using machines.
For full details see prescribing information.

Nervous system disorders  Common: Headache, dizziness.
Ear and labyrinth disorders:  Common: Vertigo.
Gastrointestinal disorders: Common: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite. Hepatobiliary disorders: Common:  Transaminases increased.
Skin and subcutaneous tissue disorders: Common: Rash.
General disorders and administration site conditions: Common: Injection site reaction, injection site pain, injection site induration.
For full details see prescribing information.

The following interactions include those observed with Voltaren solution for 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 hemorrhage 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 hypoglycemic and hyperglycemic 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.
For full details see prescribing information.

Women of child-bearing potential: There are no data to suggest any recommendations for women of child-bearing potential.
Pregnancy: There are insufficient data on the use of diclofenac in pregnant women. Therefore, Voltaren should not be used during the first two trimesters of pregnancy unless the expected benefit to the mother outweighs the risk to the fetus. As with other NSAIDs, use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.
Breast-feeding: Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltaren should not be administered during breast-feeding in order to avoid undesirable effect in the infant.
Fertility: As with other NSAIDs, the use of Voltaren may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Voltaren should be considered.

Symptoms: There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures: Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to the high protein binding and extensive metabolism.