Tonizep FDT

Tonizep FDT Special Precautions



T. O. Chemicals


T. O. Chemicals
Full Prescribing Info
Special Precautions
Treatment should be initiated by a physician experienced in the treatment of dementia.
Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil hydrochloride should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil hydrochloride should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present. Individual response to donepezil hydrochloride cannot be predicted. The use of donepezil hydrochloride in patients with other types of dementia or other types of memory impairment (e.g. amnestic mild cognitive impairment), is under investigation.
Anaesthesia: Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia.
Cardiovascular conditions: Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on heart rate (e.g. bradycardia). The potential for this action may be particularly important to patients with "sick sinus syndrome" or other supraventricular cardiac conduction conditions, such as sinoatrial or atrioventricular block.
There have been reports of syncope and seizures. In investigating such patients the possibility of heart block or long sinusal pauses should be considered.
Gastrointestinal conditions: Peptic ulcer/ GI bleeding: Patients at increased risk for developing ulcer or GI bleeding, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), should be monitored for symptoms. However, the clinical studies with donepezil hydrochloride 5 to 10 mg/day showed no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
Nausea/Vomiting: Donepezil hydrochloride, as a predictable consequence of its pharmacological properties, produced diarrhea, nausea, and vomiting. Although in most case, these effects were mild and transient, sometimes lasting 1 to 3 weeks, and resolved during continued use of donepezil hydrochloride, closely observe patients at the initiation of treatment and after dose increases.
Genitourinary: Although not observed in clinical trials of donepezil hydrochloride, cholinomimetics may cause bladder outflow obstruction.
Neurological conditions: Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity may also be a manifestation of Alzheimer's disease. Cholinomimetics may have the potential to exacerbate or induce extrapyramidal symptoms.
Pulmonary conditions: Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
The administration of donepezil hydrochloride concomitantly with other inhibitors of acetylcholinesterase, agonists or antagonists of the cholinergic system should be avoided.
Severe hepatic impairment: There are no data for patients with severe hepatic impairment.
Effects on the Ability to Drive and Use Machines: Donepezil hydrochloride has minor to moderate influence in the ability to drive and use machines.
Dementia may cause impairment of driving performance or compromise the ability to use machinery. Furthermore, donepezil hydrochloride can induce fatigue, dizziness and muscle cramps, mainly when initiating or increasing the dose. The treating physician should routinely evaluate the ability of patients on donepezil hydrochloride to continue driving or operating complex machines.
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