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Apo-alpraz
0.25 mg and 0.5 mg aiprazolam

Anxiolytic-Sedative

Pharmacology
APO-ALPRAZ (alprazolam) is a benzodiazepine with anxiolytic properties. Orally administered alprazolam is readily absorbed in man with peak plasma concentrations occurring 1 to 2 hours following administration. The half-life range of alprazolam is 6 to 20 hours following single dose administration. With multiple doses, given 3 times daily, steady state is reached within 7 days. Alprazolam and its metabolites are excreted primarily in the urine. Degradation of alprazolam occurs mainly by oxidation yielding the primary metabolites a-hydroxy-alprazolam and a benzophenone derivative. The a-hydroxy-metabolite is further transformed to demethylalprazolam. The a-hydroxy-alprazolam and demethylalprazolam are active and appear to have half-lives similar to alprazolam but are present at only low levels in the plasma. Alprazolam is 80% protein-bound.

In sleep laboratory studies in man, alprazolam decreased sleep latency, increased duration of sleep and decreased the number of nocturnal awakenings. Alprazolam produced small decreases in both stage 3 and 4 and REM sleep. Alprazolam increased REM latency in a dose-related manner.

Alprazolam 0.5mg, administered 3 times a day for 14 days, did not affect prothrombin times or plasma warfarin levels in male volunteers administered sodium warfarin orally.

Indications

APO-ALPRAZ (alprazolam) is indicated for the short-term symptomatic relief of excessive anxiety in patients with anxiety neurosis.

Adverse Effects

The most frequently reported adverse reactions with APO-ALPRAZ (alprazolam) were drowsiness, coordination difficulties and dizziness. Release of hostility and other paradoxical effects such as irritability, excitability and hallucinations are known to occur with the use of benzodiazepines.


Other side effects less frequently reported, listed by body systems, include the following :
Neurologic : Blurred vision, headache, seizures, slurred speech, difficulty in depth perception.
Psychiatric : Agitation, mental confusion, depression, irritability, nervousness, sleep disturbances, euphoria, lethargy, stupor. Gastrointestinal : Dry mouth, nausea, non-specific gastrointestinal disturbances, vomiting.
Musculoskeletal : Muscle spasm, muscle weakness.

Cardiovascular : Hypotension, palpitations, tachycardia.

Dermatologic : Pruritus, rash.
Genitourinary : Incontinence, change in libido.
Hematologic : Decreased hemoglobin and hematocrit increased and decreased WBC.
Hepatic : Elevations of alkaline phosphatase, bilirubin, SGOT, SGPT.
Miscellaneous : Increased and decreased blood sugar levels.

Precautions /Warnings
Use in the Elderly : Elderly and debilitated patients, or those with organic brain syndrome, have been found to be prone to the CNS depressant activity of benzodiazepines even after low doses. Manifestations of this CNS depressant activity include ataxia, over-sedation and hypotension. Therefore, medication should be administered with caution to these patients, particularly if a drop in blood pressure might lead to cardiac complications. Initial doses should be low and increments should be made gradually, depending on the response of the patient, in order to avoid oversedation, neurological impairment and other possible adverse reactions.


Dependence Liability : Alprazolam should not be administered to individuals prone to drug abuse. Caution should be observed in all patients who are considered to have potential for psychological dependence. Withdrawal symptoms have been observed after abrupt discontinuation of benzodiazepines. These include irritability, nervousness, insomnia, agitation, tremors, convulsions, diarrhea, abdominal cramps, vomiting and mental impairment. Since these symptoms may be similar to those for which the patient is being treated, it may appear that he has suffered a relapse upon discontinuation. It is suggested that alprazolam should be withdrawn gradually if the individual is suspected of having become dependent, or the drug perhaps has been used in prolonged high doses.

 

Use in Mental and Emotional Disorders : It should be recognized that suicidal tendencies may be present in patients with emotional disorders, particularly when depressed and that protective measures and appropriate treatment may be necessary and should be instituted without delay.

 

Since excitement and other paradoxical reactions can result from the use of anxiolytic-sedatives in psychotic patients, alprazolam should not be used in patients suspected of having psychotic tendencies. As with other benzodiazepines, alprazolam should not be used in individuals with physiological anxiety or normal stress of daily living but only in the presence of disabling manifestations of an appropriate pathological anxiety disorder. The drugs are not effective in patients with characterological and personality disorders or those with obsessive-compulsive disorders. Alprazolam is not recommended for the management of depressive or psychotic disorders.

 

Use in Patients with Impaired Renal or Hepatic Function : If treatment is necessary in patients with impaired hepatic or renal function, therapy should be initiated at a very low dose and the dosage increased only to the extent that it is compatible with the degree of residual function of these organs. Such patients should be followed closely and have periodic laboratory assessments.

 

Laboratory Tests : If alprazolam is administered for repeated cycles of therapy, periodic blood counts and liver function tests are advisable.


Epileptic Patients : Since benzodiazepines may occasionally exacerbate grand mal seizures, caution is required when alprazolam is used in epileptic patients and an adjustment may be necessary in their anticonvulsive medication. Abrupt withdrawal of alprazolam should be avoided.

 

APO-ALPRAZ (alprazolam) is not recommended for use in patients whose primary diagnosis is psychosis or depression.

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken.


Complex sleep-related behaviors which may include sleep driving, making phone calls, preparing and eating food (while asleep).


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