Zolysan

Each caplet contains: Alprazolam 0.5 mg or 1 mg.

Pharmacology: Alprazolam is an effective anxiolytic, antidepressant, and antipanic agent. Because of its similarity to other Benzodiazepines, it is assumed that Alprazolam undergoes transplacental passage, and that it is excreted in human milk. Alprazolam and its metabolites are excreted primarily in the urine. The predominant metabolites are alpha-hydroxy-alprazolam, 4-hydroxy Alprazolam, and a Benzophenone derived from Alprazolam. The biological activity of alpha-hydroxy-alprazolam is approximately one-half that of Alprazolam. The Benzophenone metabolite is essentially inactive.

ZOLYSAN 0.5 or 1 Caplet are indicated for the treatment of: Anxiety: Including anxiety neurosis, anxiety disorders, symptoms of anxiety, etc.
Mixed Anxiety: Depression, including anxiety associated with depression.
Panic Disorders: Including panic disorder with or without agoraphobia. The essential feature of panic disorder is the unexpected panic attack, a sudden onset of intense apprehension, fear, or terror.

The optimum dosage of ZOLYSAN 0.5 or 1 Caplet should be individualized based upon the severity of the symptoms and individual patient response. The daily dosage (see table) will meet the needs of most patients. In the few patients who require higher doses, dosage should be increased cautiously to avoid adverse effects. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those previously treated with minor tranquilizers, antidepressants, or hypnotics or those with a history of chronic alcoholism. Patients should be periodically reassessed and dosage adjustments made, as appropriate. (See table.)


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Discontinuation Therapy: The dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of ZOLYSAN 0.5 or 1 Caplet be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.

Manifestation of Alprazolam overdosage include somnolence, confusion, impaired coordination, slurred speech, respiratory depression, diminished reflexes, and coma. Death has been reported in association with overdoses of Alprazolam by itself, as it has with other Benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single Benzodiazepine, including Alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.
Treatment of overdosage is primarily supportive of respiratory and cardiovascular function. The value of dialysis has not been determined. Flumazenil may be used as an adjunct to the management of respiratory and cardiovascular function associated with overdose.

ZOLYSAN 0.5 or 1 Caplet are contraindicated in patients with known sensitivity to Benzodiazepines, Alprazolam, or to any component of these product's formulation.
ZOLYSAN 0.5 or 1 Caplet may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.

Usage has not been established in depression with psychosis features, in bipolar disorders or in "endogenous" depression (i.e., severely depressed in-patients).
Habituation and emotional/physical dependence may occur with Benzodiazepines, including Alprazolam.
Caution should be particularly used when prescribing Benzodiazepines to patients who are prone to abuse drugs (e.g., alcoholics and drug addicts) because of their predisposition to habituation and dependence.
ZOLYSAN 0.5 or 1 Caplet are not recommended for use inpatients whose primary diagnosis is schizophrenia.
Episodes of hypomania and mania have been reported in association with the use of Alprazolam in patients with depression.

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.

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.
Nursing Mothers: As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.

Side effects, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage.
Very common: Depression, sedation, somnolence, ataxia, memory impairment, dysarthria, dizziness, headache, constipation, dry mouth, fatigue, and irritability. The most common adverse reactions in patients with panic-related disorders were drowsiness, and slurred speech.
Common: Decreased appetite, confusional state, disorientation, libido decreased, anxiety, insomnia, nervousness, libido increased, balance disorder, coordination abnormal, disturbance in attention, hypersomnia, lethargy, tremor, vision blurred, nausea, dermatitis, sexual dysfunction, weight decreased, and weight increased.
Uncommon: Mania, hallucination, anger, agitation, amnesia, muscular weakness, incontinence, and menstruation irregular.
Frequency not known: Hyperprolactinaemia, hypomania, aggression, hostility, thinking abnormal, psychomotor hyperactivity, autonomic nervous system imbalance, dystonia, gastrointestinal disorder, hepatitis, hepatic function abnormal, jaundice, angioedema, photosensitivity reaction, urinary retention, oedema peripheral, and intraocular pressure increased. Less common adverse reactions were altered mood and intellectual impairment confusion.
In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuance of Alprazolam in patients with post-traumatic stress disorder.
In addition, the following adverse events have been reported in association with the use of anxiolytic Benzodiazepines including Alprazolam, anorexia, fatigue, and slurred speech.

The Benzodiazepines, including Alprazolam, produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol, and other drugs which themselves produce CNS depression.
The co-administration of Alprazolam with Ketoconazole, Itraconazole, or other azole type antifungals is not recommended.
Caution and consideration of dose reduction is recommended when alprazolam is co-administered with Nefazodone, Fluvoxamine, and Cimetidine.
Caution is recommended when Alprazolam is coadministered with Fluoxetine, Propoxyphene, oral contraceptives, Diltiazem, or macrolide antibiotics such as Erythromycin and Troleandomycin.
Interactions involving HIV protease inhibitors (e.g., Ritonavir) and Alprazolam are complex and time dependent.
Increased Digoxin concentrations have been reported when Alprazolam was given, especially in elderly (> 65 years of age). Patients who receive Alprazolam and Digoxin should therefore be monitored for signs and symptoms related to Digoxin toxicity.

Store below 30°C.

Anxiolytics

N05BA12 - alprazolam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.

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