Alprazolam (trade name Xanax) is a potent short-acting drug of the benzodiazepine class. It is primarily used to treat moderate to severe anxiety disorders (e.g., social anxiety disorder) and panic attacks, and is used as an adjudicative treatment for anxiety associated with moderate depression. Alprazolam possesses anxiolytic, sedative, hypnotic, anti-convulsant, and muscle relaxant properties.
(Alprazolam tablets, U.S.P.)
Each Pinix 0.25 mg tablets contains:
Alprazoiam U.S.P-……0,25 mg
Each Pinix O.S mg tablets contains;
Atprazoiam U.S.P………0.5 mg
Each Pinix 1 mg tablets contains:
Alprazoiam U.S.P..-…….1 mg
Alprazotaff’ is chemically 8-chioro-1-melhyi-6″phynyl-4H-s-iriazoto [4,3-o’3[1,4l benzodiazapine.
PINiX Tablets contain a tri-azoio-benzodiazepine.
The benzodiazepiries have qualitatively similar properties: anxiousness, hypnotherapist, myo-relaxation, y,anttconvulsion. There are however, quantitative differences in their pharmacol dynamic properties that have led to varying patterns of therapeutic application. Currently, there ‘.s s general agreement that the action of benzodiazepines is a result of the potentiate of the neural inhibition that is mediated by gamiTiaaiT’iinoautyr.c acid(GABA). –
Following oral administration, peak concentrations in plasma occur in one to two hours following administration. The mean half-life of Alprazolam is 12-15 hours. Alprazolam. is mainly oxidized. The predominant metabolites are alpha-hydroxy-alprazotarn and a – benzophenone derived from Alprazolam. Plasma levels of these metabolite extremely low. The biological activity of alpha-hydroxy-alprazotarn is approximately one- half that of aiprazoiam. Their half-lives appear to be of the same order of- magnitude as that 01 aiprazoiam. The bonzophenone metabolite is essentially inactive. Alprazolam and its metabolites are excreted primarily in the urine. In vitro, Alprazolam is bound (80%) to human serum protein.
PINIX Tablets (Alprazolam) are indicated for the treatment of: • .
–Anxiety States (Anxiety Neuroses)
Symptoms which occur in such patients include anxiety, tension, agitation, insomnia, apprehension, irritability and/or autonomic hyperactivity resulting in a variety of somatic.compiaints.
Symptoms of both anxiety and depression occur simultaneously in such patients.
-Naurotre or reactive depression. Such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure.
Symptoms of anxiety, psycho-motor agitation and insomnia are usually present.
Other characteristics include appetite disturbances, changes in weight, somatic complaint, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, or thoughts of death or suicide.
–Anxiety States, Mixed Anxiety-Depression, or Neurotic Depression associated with some other diseases such as the chronic phase of alcohol withdrawal and flinctiGna! organic disease First ‘cuiariy certain ‘ Qastrsilntestinai.cardiovascular.ordermatotogicatc disorders.
-Panic reflate Disorders
Pinix indicated in the treatment of panic disorder with or without some phobic avoidance- PINIX as is also indicated for the blocking-or attenuation of panic attacks arid phobia in patients who have agoraphobia with panic attacks.
The effectiveness of PINIX in the treatment of anxiety, anxiety associated with depression and neurotic
(reactive) depression tor long-term use exceeding six months has not been established by systematic
clinical trials; however, patients with panic-related disorders have been effectively treated for up to eight
months. – ‘*•
The physician should periodically reassess the usefulness of the drug for the individual patient.
Dosage and Administration
The optimum dosage of PINIX (Alprazofam) 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 which require lower doses than those previously treated with minor tranqoitizers antidepressants, or hypnotics or those with a history of chronic alcoholism. It is recommended, that the general principle of using the lowest effective dosage be followed in eider!/ or debilitated patients to preclude the development of over-sedation or ataxia. Patients should be periodically re-assessed and dosage adjustments made, as appropriate.
Usual starting dosage Usual dosage range
Anxiety 0.25 to 0.5 mg given 0.5 to 4.0 mg daily, given
three times daily.. in divided doses-Depression 0.5 mg; given three . 1.5 to 4:5 mg daily, given
times daily. in divided doses.
Geriatric patients 0.25 mg, given two to 0.5 to 0.75 mg daily, or in the presence ‘ three times daily, given in divided doses; to . of debilitating • – be gradually increased if disease needed and tolerated. Panic-related 0.5 to 1 .O mg. The dose should be adjusted disorders given at bedtime. – to patient response. Dosage
adjustments should be in increments no greater than 1 mg every 3 to 4 days.Additional doses can be added any time or old schedule is achieved. The mean dose in a large multi clinic study was 5.7 f 2.3 mg/day with rare patients requiring a maximum of 10 mg daily. If side effects occur, the dose should be lowered.
The dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of PINIX be decreased by no more then 0.5 mg every three days. Some patients may require an even slower dosage reduction.
PINIX is contraindicated in patients with known sensitivity to the benzodiazepines.
Side effects, if they occur,.are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage, In patients treated for anxiety, anxiety associated with depression, and neurotic (reactive) depression, the most common adverse reactions to PINIX were ‘ drowsiness and iignt-headedness / dizziness. Less common adverse reactions were blurred vision, headache, depression, insomnia, nervousness/anxiety, tremor, change in weight, memory impairment/ amnesia, coordination disorders, various gastro-intestinal symptoms, and autonomic manifestations.
In addition, the following adverse events have been reported in association with the use of anxious benzodiazepines including Alprazolam: dystonia, irritability, anorexia, fatigue, slurred speech, jaundice, musculus skeletal weakness, changes in libido, menstrual irregularities, incontinence, urinary retention and abnormal liver function.
Increased intra-muscular pressure has been rarely reported. The most common adverse reactions in patients with panic-related disorders were sedation\drowsiness,” fatigue.ataxia/impaired -coordination, and sfurred speech. Less common adverse reactions were altered mood, gastro-intestinal symptoms, dermatitis, memory problems, sexual dysfunction,
Isolated published reports involving small numbers of patients have suggested that 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.
Usage has not been established in depression with psychiatric features, in bipolar disorders or in
1 “endogenous” depression (i.e. Severely depressed in-patients). Habituation and emotional/physical
dependence may occur with bsnzodiazepines, 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. Withdrawal symptoms
.have occurred following rapid decrease or abrupt discontinuance of benzodiazepines including
Alprazolam. These can range from mild dysphoria and insomnia to. a major syndrome which may
include abdominal and muscle cramps, vomiting, sweating, tremor and convulsions. The signs and
symptoms, especially the more serious ones, ere 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 discontinuations should be avoided and a gradual tapering in dosage followed
. (see DOSAGE AND ADMINISTRATION- Discontinuation therapy). 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 b& done with appropriate precaution
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 higlier doses of PINIX 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 idealization or plans.
The usual precaution for treating patients with impaired renal or hepatic function should be, observed.
The safety and efficacy of PINIX in children less than 18 years of age has not been established. •
Pregnancy and Lactation:
Because of experience with other members of the benzodiazepine class, PINIX is assumed to be
capable of causing an increased risk of congenital abnormalities when administered to a pregnant
women during the first trimester.
If PINIX is used during pregnancy; or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus, Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided.
Benzodiazepines are known to be excreted in human milk. As a general rule, nursing should not be undertaken by mothers who must use PIN IX.
Benzodiazepines, including Alprazolam, produce additive central nervous system (CNS) depressant
effects when co-administered with other psychotropic medications, anticonvulsarits antihistamines,
alcohol and other drugs which themselves produce CNS depression- Tri steady state plasma
concentration of imipramine and desipramine have been reported to be increased an average of 31 %
and 20% respectively, by the concomitant-administration of PINIX Tablets ‘n doses up to Arrcy lay. The clinical significance of these changes is unknown.
Pharmacol kinetic interactions of benzodiazepines with other drugs have been reported. For example, the clearance of Alprazolam and certain other benzodiazepines can be delayed by the co-administration of cimetidine or macroiide antibiotics. The clinical significance of this is unclear.
Ability to Drive and To Operate Machinery:
As with other CNS active drugs, patients receiving PINIX 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 PINIX.
Manifestations of Alprazolam over dosage include somnolence, confusion, impaired coordination. diminished reflexes and coma. Over dosage reports with PINIX Tablets are limited. As in all cases of drug over dosage, respiration, pulse rate, and blood pressure should be monitored. General supportive measures should be employed, along with immediate gastric lavage.
Intravenous fluids should be administered and an adequate airway maintained. If hypo-tension occurs, it may be combated’by the use of vasopressors. Dialysis is of limited value. As with, the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested.
Store in a dry place below 30°C. Protect from light.
Keep out of the reach of children.
On medical prescription only. . ” ,
Pinix 0.25 mg tabtets: Pack of 3×10’s
Pinix 0.5 mg tablets: Pack of 3×10’s
Pinix 1 mg tablets: Pack of 3×10’s