Tanatril Special Precautions



Mitsubishi Tanabe Pharma


Full Prescribing Info
Special Precautions
Tanatril should be administered with care in the following patients: Patients with Renal Impairment: In patients with serious renal impairment whose creatinine clearance levels are <30 mL/min or serum creatinine levels are >3 mg/dL, Tanatril should be administered with care by decreasing the dose by half or prolonging the time interval between administrations. (Excessive hypotension or further decrease in renal function may occur due to decrease in urinary excretion rate.) (See Pharmacokinetics under Actions.)
Patients with Bilateral Renal Arterial Stenosis: Renal dysfunction may be exacerbated.
Patients with Cerebrovascular Disorders: Excessive hypotension may cause cerebral blood flow insufficiency which may worsen patient's condition.
Since the following patients may experience transient excessive hypotension after initiation of therapy with Tanatril, the administration should be initiated with a reduced dosage; the dosage may be gradually increased while closely observing the patient's condition: Patients with severe hypertension; patients who undergo hemodialysis; patients on diuretic therapy, especially those in whom diuretic therapy has been recently initiated; and patients on strict dietary salt restriction.
Administration is not recommended within 24 hrs prior to surgery.
Use only pursuant to prescription or directions of a physician.
Precautions Regarding Dispensing: Since Tanatril is dispensed in a press-through package (PTP), instruct the patient to remove the drug from the package prior to use. It has been reported that if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications eg, mediastinitis.
Other Precautions: It has been reported that the concomitant use of ACE inhibitors with insulin or hypoglycemic agents may easily cause hypoglycemia.
Effects on the Ability to Drive or Operate Machinery: Since dizziness or lightheadedness may occur due to its hypotensive effect, patients should be cautioned against engaging in potentially hazardous activities requiring alertness eg, driving a car, working at heights or operating machinery, etc.
Use in children: Safety of Tanatril in children has not been established (no clinical experience).
Use in the elderly: Therapy should be instituted with special care, starting at a reduced dosage (eg, 2.5 mg) with careful monitoring of the patient's conditions.
Tanatril is mainly excreted by the kidney. Since there is a possibility of persistent elevated blood concentrations in elderly patients who often have impaired renal function, adverse reactions are more likely to occur and the action of Tanatril may be enhanced.
An excessive reduction in blood pressure is undesirable in elderly patients. (Cerebral infarction, etc, may occur.)
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