Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum

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Replacement for other antiepileptic drugs when current therapy provides insufficient seizure control (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). Contraindications : Known hypersensitivity to oxcarbazepine or to any of the excipients. Hypersensitivity: Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, int j pediatr otorhinolaryngol and reports of anaphylaxis have been received in the post-marketing period.

Cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of oxcarbazepine (Trileptal). If a patient develops these reactions after treatment, the drug should be discontinued and an alternative treatment started. Hypersensitivity reactions, Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum multi-organ hypersensitivity reactions, may also occur in patients without history of hypersensitivity to carbamazepine.

Such reactions can affect the skin, liver, blood and lymphatic system or other organs, either individually or together in the context of a systemic reaction (see Adverse Reactions). In general, if signs and symptoms suggestive Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum hypersensitivity reactions occur, treatment should be withdrawn immediately. Patients with serious dermatological reactions may require hospitalization, as these conditions may be life-threatening and very rarely be fatal.

Associated cases occurred in both children and adults. The median time to onset was 19 days. Several isolated cases of recurrence of the Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum skin reaction when re-challenged with oxcarbazepine were reported.

Should a patient develop a skin reaction, consideration should be given to discontinuing Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum and prescribing another anti-epileptic drug. Pharmacogenomics: There is growing evidence that different Human Leukocyte Antigen (HLA) alleles play a role in association with adverse cutaneous reactions in predisposed patients.

Therefore, the percentage of patients who may be at risk is nearly twice the allele frequency. The allele frequencies listed here represent the percentage of chromosomes in the specified population that carry the allele of interest, meaning that the percentage of patients who carry a copy of the allele on at least one of their two chromosomes (i.

Limitation of genetic screening: Genetic screening results must never substitute for appropriate clinical vigilance and patient management. The role of other possible factors in the development of, and morbidity from, these severe cutaneous adverse reactions, such as AED dose, compliance, concomitant medications, co-morbidities, and the level of dermatologic monitoring have not been studied.

Risk of seizure aggravation: Risk of seizure aggravation has been reported with oxcarbazepine (Trileptal). The risk of seizure aggravation is seen especially in children but may also occur in adults.

In case of seizure aggravation, treatment should be discontinued. Experience from clinical trials shows that serum chem med chem lett levels returned towards normal when the dosage was reduced, discontinued or the patient was treated conservatively (e. In patients with pre-existing renal conditions associated with low sodium (e.

Thereafter, serum sodium levels should be measured after approximately two weeks and then at monthly intervals for the first three months during therapy, or according to clinical need. These risk factors may apply especially to elderly patients. For patients on oxcarbazepine (Trileptal) therapy when starting on sodium-lowering drugs, the same approach for sodium checks should be followed.

In general, if clinical symptoms suggestive of hyponatraemia occur on therapy (see Adverse Reactions), serum sodium measurement may be considered. Other patients may have serum sodium assessed as part of their routine laboratory studies. All patients with cardiac insufficiency and secondary heart failure should have regular weight measurements to determine occurrence of fluid retention.

In case of fluid retention or worsening of the cardiac condition, serum sodium should be checked. If hyponatraemia is observed, water restriction is an important counter-measure. As oxcarbazepine may, very rarely, lead to impairment of cardiac conduction, patients with pre-existing conduction disturbances (e.

AV-block, arrhythmia) should be monitored carefully. Hypothyroidism: Hypothyroidism is a very rare adverse drug reaction of oxcarbazepine. In case of suspected hepatitis, discontinuation of oxcarbazepine (Trileptal) should be considered.

Hematological effects: Very rare reports of agranulocytosis, aplastic anemia and pancytopenia have been seen in patients treated with oxcarbazepine (Trileptal) during post-marketing experience (see Adverse Reactions). However, due to the very low incidence of these conditions and confounding factors (e. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Suicidal ideation and behavior: Suicidal ideation and behavior have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs has shown a small increased risk of suicidal ideation and behavior. The mechanism of this risk is not known. Therefore patients should be monitored for signs of suicidal ideation and behavior and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Additional, non-hormonal forms of Amlodipine Besylate and Benazepril Hydrochloride Capsules (Amlobenz)- Multum are therefore recommended.

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