Zolterol SR Special Precautions

Patients are advised as a precautionary measure to monitor their renal function, hepatic function, blood counts and signs of hypersensitivity reactions during prolonged treatment with diclofenac.
In patients with kidney, liver or cardiac impairment and coagulation defects, diclofenac has to be used cautiously and doses kept as low as possible. Renal functions of these patients should be monitored.
In rare cases, diclofenac has been associated with serious liver injury.
Like other NSAIDs, diclofenac may trigger allergic reactions including anaphylactic reactions even if the patient is receiving the medication for the first time.
Patients should inform physician immediately if symptoms such as chills, fever or muscle aches and pains occur shortly before or together with a skin rash as these symptoms may indicate a serious reaction to the medication.
Patients experiencing central nervous effects such as dizziness or blurred vision should not drive or operate machinery.
Cardiovascular and Cerebrovascular Risk: Treatment with diclofenac is not recommended in patients with pre-existing cardiovascular disease or cerebrovascular disease, or presenting risk factors for cardiovascular disease. For these patients, treatment options other than NSAIDs, particularly COX-2 inhibitors and diclofenac, should be considered first.
Diclofenac, particularly at higher doses (150 mg per day), is associated with an increased risk of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events which can be fatal) that is comparable to COX-2 inhibitors. Evidence suggests that the risk may increase with the dose and duration of use.
There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
Hypertension: NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired antihypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure could be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.
Heart Failure: Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with the history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately.
Doctors should warn patient about signs and symptoms of serious gastrointestinal toxicity.
The concurrent use of aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of diclofenac in patients with advanced renal disease. Therefore, treatment with diclofenac is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Severe Skin Reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported with diclofenac sodium. Patients treated with diclofenac sodium should be closely monitored for signs of hypersensitivity reactions. Discontinue diclofenac sodium immediately if rash occurs.
Use in Pregnancy & Lactation: Diclofenac should not be given during pregnancy because of possible risks such as the premature closure of the ductus arteriosus leading to persistent pulmonary hypertension in the newborn and suppression of uterine contractility.
The amount of diclofenac that passes into the breast milk is in such small quantity that no unwanted effects on the infant are likely to occur.
Use in Children: Due to the high active substance content, Zolterol SR tablet is not recommended for children.
Use in the Elderly: Should be used with caution in geriatrics, as they are susceptible to side effects of diclofenac especially gastrointestinal bleeding and ulceration/perforation. In cases where gastrointestinal ulceration and bleeding occurs during treatment, Zolterol SR tablet should be discontinued with advice from physician.