Zolysan Special Precautions

As with other CNS active drugs, patients receiving ZOLYSAN 0.5 or 1 Caplet should be advised not to operate motor vehicles or dangerous machinery until it is established that they do not become drowsy or dizzy while receiving medication.
Withdrawal symptoms have occurred following rapid decrease or abrupt discontinuance of Benzodiazepines including Alprazolam. Therefore, dosage must be gradually tapered to preclude sequelae of rapid withdrawal. These can range from mild dysphoria and insomnia to a major syndrome which may include abdominal and muscle cramps, vomiting, sweating, tremor, and convulsions. These signs and symptoms, especially the more serious ones, are generally more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of Benzodiazepines taken at therapeutic levels. Consequently, abrupt discontinuation should be avoided and a gradual tapering in dosage followed (see Dosage & Administration). When therapy is discontinued in patients with panic-related disorders, the symptoms associated with recurrence of panic attacks often mimic those of withdrawal.
Administration to severely depressed or suicidal patients should be done with appropriate precautions and appropriate size of prescription. Panic-related disorders have been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Therefore, the same precaution must be exercised when using the higher doses of ZOLYSAN 0.5 or 1 Caplet in treating patients with panic-related disorders as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans.
It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients. The usual precautions for treating patients with impaired renal or hepatic function should be observed.
The safety and efficacy of ZOLYSAN 0.5 or 1 Caplet in children less than 18 years of age has not been established.
Use in Pregnancy: An increased risk congenital malformations associated with minor tranquilizers (Chlordiazepoxide, Diazepam, and Meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because the use of these drug is rarely a matter of urgency, the use of ZOLYSAN 0.5 or 1 Caplet during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be considered. Patients should be advised that if they become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
Use in Lactation: As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.