Overdose of Dexketoprofeno Neredal in details
In case of accidental or excessive intake or administration, immediately institute symptomatic therapy according to the patient’s clinical condition. Dexketoprofeno Neredal trometamol may be removed by dialysis.
Tablet: Activated charcoal should be administered if >5 mg/kg has been ingested by an adult or a child within an hour.
Injection: The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.
Dexketoprofeno Neredal warnings
Pregnancy
Category C.
Lactation
Excreted in breast milk. Avoid breast-feeding.
Children
Children generally require higher doses to maintain trough tacrolimus levels similar to adults (oral and IV). Safety and efficacy not established in children younger than 2 yr of age (topical).
Renal Function
May require reduced doses; monitor closely.
Hepatic Function
Patients with hepatic disease may require reduced doses (Child-Pugh class 10 or higher).
Anaphylactic reactions
May occur with IV injection.
Diabetes mellitus
Insulin-dependent posttransplant diabetes mellitus has been reported.
Hyperglycemia
Frequently occurs with tacrolimus; may require treatment.
Hypertension
May occur. Antihypertensive therapy may be required.
Immunosuppression
Avoid use in immunocompromised patients (topical). Safety and efficacy not established.
Infections
Lymphoproliferative disorder related to Epstein-Barr virus infection and activation of latent viral infections (including BK virus associated neuropathy and JC virus associated PML) has been reported in patients on immunosuppressants.
Lymphadenopathy
Investigate the etiology of lymphadenopathy occurring in patients receiving the topical ointment.
Malignancies
Increased risk of developing malignancies, particularly of the skin, in patients treated with tacrolimus.
Myocardial hypertrophy
Has been reported; manifested by echocardiographically demonstrated concentric increases in left ventricular posterior wall and interventricular septum thickness.
Nephrotoxicity
May occur; particularly when used in high doses.
Netherton syndrome
Topical use is not recommended.
Neurotoxicity
Neurotoxicity (including headache and tremor) and other changes in motor function, mental status, and sensory function have been reported.
Topical infections
Resolve clinical infections at treatment sites before starting topical therapy.
Viral infections
The topical ointment may be associated with increased risk of varicella zoster virus infection (eg, chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.
Dexketoprofeno Neredal precautions
Caution in patients with a history of allergic conditions.
As with all NSAIDs, any history of esophagitis, gastritis and/or peptic ulcer must be sought in order to ensure their total cure before starting treatment with Dexketoprofeno Neredal trometamol. Patients with gastrointestinal symptoms or history of gastrointestinal disease should be monitored for digestive disturbances, especially gastrointestinal bleeding. In rare instances, where gastrointestinal bleeding or ulceration occurs in patients receiving Dexketoprofeno Neredal trometamol, treatment should be immediately discontinued.
All nonselective NSAIDs can inhibit platelet aggregation and prolong bleeding time via inhibition of prostaglandin synthesis. Therefore, the use of Dexketoprofeno Neredal trometamol in patients who are receiving other therapy that interferes with hemostasis eg, warfarin or other coumarins or heparins is not recommended.
As with all NSAIDs, it can increase plasma urea nitrogen and creatinine. As with other inhibitors of prostaglandin synthesis, it can be associated with adverse effects on the renal system which can lead to glomerular and interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
As with other NSAIDs, it can cause transient small increases in some liver parameters and also significant increases in SGOT and SGPT. In case of a relevant increase in such parameters, therapy must be discontinued.
Dexketoprofeno Neredal should be administered with caution to patients suffering from hematopoietic disorders, systemic lupus erythematosus (SLE) or mixed connective tissue disease. As other NSAIDs, Dexketoprofeno Neredal can mask the symptoms of infectious diseases.
Caution should be exercised in patients with impairment of hepatic, renal or cardiac function as well as in patients with other conditions predisposing to fluid retention. Special caution should be exercised in patients with a history of cardiac disease, in particular those with previous episodes of heart failure as there is an increased risk of triggering heart failure.
The use of Dexketoprofeno Neredal trometamol 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 Dexketoprofeno Neredal trometamol should be considered.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely in association with the use of NSAIDs. 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 1st month of treatment. Dexketoprofeno Neredal should be discontinued at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure (CHF) as fluid retention and edema have been reported in association with NSAIDs therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke). There are insufficient data to exclude such a risk for Dexketoprofeno Neredal trometamol.
Patients with uncontrolled hypertension, CHF, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with Dexketoprofeno Neredal trometamol after careful consideration. Similar consideration should be made before initiating longer-term treatment of the patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Hepatic Dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofeno Neredal should not be used in patients with severe hepatic dysfunction.
Renal Dysfunction: In these patients, the use of NSAIDs may result in deterioration of renal function and fluid retention. Caution is also required in patients receiving diuretic therapy or those who could develop hypovolemia as there is an increased risk of nephrotoxicity. The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function. Dexketoprofeno Neredal should not be used in patients with moderate to severe renal dysfunction.
Use in children & adolescents: Safety and efficacy has not been established.
Use in the
Elderly: Caution should be exercised in the treatment of elderly patients who are generally more prone to adverse reactions. The consequences eg, gastrointestinal bleeding and/or perforation are dose-dependent, often more serious and may occur without warning symptoms or previous history, at any time during treatment. Elderly patients are more likely to be suffering from impaired renal cardiovascular or hepatic function. In elderly patients, it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dosage may be increased to that recommended for the general population only after good general tolerance has been ascertained.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
