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Alprazolam is used to treat anxiety and panic disorders.
It is thought that alprazolam works by enhancing the activity of certain neurotransmitters in the brain. Many people who take Xanax recreationally, or without a prescription, describe the feeling as sedating or calming.
Alprazolam, sold under the brand name Xanax, among others, is a short-acting benzodiazepine.
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- XANAX is indicated for the management of anxiety disorders and the short-term relief of symptoms of anxiety in adults. XANAX is also indicated for the treatment of panic disorder in adults with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia). xanax pharmacy online
- XANAX is not intended for recreational use. There may be serious risks if XANAX is taken by someone for whom it is not prescribed.
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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation,
respiratory depression, coma, and death [see Warnings, Drug Interactions].
• Reserve concomitant prescribing of these drugs for use in patients for whom
alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation. Buy guns online
XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine
class of central nervous system-active compounds.
The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α]
The structural formula is represented to the right:
Alprazolam is a white crystalline powder, which is soluble in methanol or
ethanol but which has no appreciable solubility in water at physiological pH.
Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg
of alprazolam. Buy cough syrup online
XANAX Tablets, 2 mg, are multi-scored and may be divided as shown below:
Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium
stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains
FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.
CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding
at stereo specific receptors at several sites within the central nervous system. Their
exact mechanism of action is unknown. Clinically, all benzodiazepines cause a doserelated central nervous system depressant activity varying from mild impairment of task
performance to hypnosis. wockhardt Lean, promethazine with codeine
Following oral administration, alprazolam is readily absorbed. Peak concentrations in the
plasma occur in 1 to 2 hours following administration. Plasma levels are proportionate to
the dose given; over the dose range of 0.5 to 3.0 mg, peak levels of 8.0 to 37 ng/mL were
observed. Using a specific assay methodology, the mean plasma elimination half-life of
alprazolam has been found to be about 11.2 hours (range: 6.3-26.9 hours) in healthy adults.
In vitro, alprazolam is bound (80 percent) to human serum protein. Serum albumin
accounts for the majority of the binding.
Alprazolam is extensively metabolized in humans, primarily by cytochrome P450 3A4
(CYP3A4), to two major metabolites in the plasma: 4-hydroxyalprazolam and
α-hydroxyalprazolam. A benzophenone derived from alprazolam is also found in humans.
Their half-lives appear to be similar to that of alprazolam. The plasma concentrations of
4-hydroxyalprazolam and α-hydroxyalprazolam relative to unchanged alprazolam
concentration were always less than 4%. The reported relative potencies in benzodiazepine
receptor binding experiments and in animal models of induced seizure inhibition are 0.20
and 0.66, respectively, for 4-hydroxyalprazolam and α-hydroxyalprazolam. Such low
concentrations and the lesser potencies of 4-hydroxyalprazolam and α-hydroxyalprazolam
suggest that they are unlikely to contribute much to the pharmacological effects of
alprazolam. The benzophenone metabolite is essentially inactive.
Alprazolam and its metabolites are excreted primarily in the urine.
Changes in the absorption, distribution, metabolism and excretion of benzodiazepines
have been reported in a variety of disease states including alcoholism, impaired hepatic
function and impaired renal function. Changes have also been demonstrated in geriatric
patients. A mean half-life of alprazolam of 16.3 hours has been observed in healthy elderly
subjects (range: 9.0-26.9 hours, n=16) compared to 11.0 hours (range: 6.3-15.8 hours,
n=16) in healthy adult subjects. In patients with alcoholic liver disease the half-life of
alprazolam ranged between 5.8 and 65.3 hours (mean: 19.7 hours, n=17) as compared
to between 6.3 and 26.9 hours (mean=11.4 hours, n=17) in healthy subjects. In an
obese group of subjects the half-life of alprazolam ranged between 9.9 and 40.4 hours
(mean=21.8 hours, n=12) as compared to between 6.3 and 15.8 hours (mean=10.6 hours,
n=12) in healthy subjects.
Because of its similarity to other benzodiazepines, it is assumed that alprazolam
undergoes transplacental passage and that it is excreted in human milk.
Race — Maximal concentrations and half-life of alprazolam are approximately 15%
and 25% higher in Asians compared to Caucasians.
Pediatrics — The pharmacokinetics of alprazolam in pediatric patients have not
been studied. Buy white xanax bar online, yellow xanax for sale and order green xanax 2mg online
Gender — Gender has no effect on the pharmacokinetics of alprazolam.
Cigarette Smoking — Alprazolam concentrations may be reduced by up to 50% in
smokers compared to non-smokers.
Alprazolam is primarily eliminated by metabolism via cytochrome P450 3A (CYP3A). Most
of the interactions that have been documented with alprazolam are with drugs that inhibit
or induce CYP3A4. Buy wocklean purple syrup online
Compounds that are potent inhibitors of CYP3A would be expected to increase plasma
alprazolam concentrations. Drug products that have been studied in vivo, along with their
effect on increasing alprazolam AUC, are as follows: ketoconazole, 3.98 fold; itraconazole,
2.70 fold; nefazodone, 1.98 fold; fluvoxamine, 1.96 fold; and erythromycin, 1.61 fold (see
CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS–Drug Interactions).
CYP3A inducers would be expected to decrease alprazolam concentrations and this has
been observed in vivo. The oral clearance of alprazolam (given in a 0.8 mg single dose)
was increased from 0.90±0.21 mL/min/kg to 2.13±0.54 mL/min/kg and the elimination t1/2
was shortened (from 17.1±4.9 to 7.7 ±1.7 h) following administration of 300 mg/day
carbamazepine for 10 days (see PRECAUTIONS–Drug Interactions). However, the
carbamazepine dose used in this study was fairly low compared to the recommended
doses (1000-1200 mg/day); the effect at usual carbamazepine doses is unknown.
Interactions involving HIV protease inhibitors (eg, ritonavir) and alprazolam are complex
and time dependent. Short-term low doses of ritonavir (4 doses of 200 mg) reduced
alprazolam clearance to 41% of control values, prolonged its elimination half-life (mean
values, 30 versus 13 h) and enhanced clinical effects. However, upon extended exposure
to ritonavir (500 mg, twice daily), CYP3A induction offset this inhibition. Alprazolam
AUC and Cmax was reduced by 12% and 16%, respectively, in the presence of ritonavir
The ability of alprazolam to induce human hepatic enzyme systems has not yet been
determined. However, this is not a property of benzodiazepines in general. Further,
alprazolam did not affect the prothrombin or plasma warfarin levels in male volunteers
administered sodium warfarin orally.
XANAX Tablets were compared to placebo in double blind clinical studies (doses up to
4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive
symptomatology. XANAX was significantly better than placebo at each of the evaluation
periods of these 4-week studies as judged by the following psychometric instruments: Buy Juul pods online.
Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms,
Patient’s Global Impressions and Self-Rating Symptom Scale.
Support for the effectiveness of XANAX in the treatment of panic disorder came from
three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses
closely corresponding to DSM-III-R criteria for panic disorder.
The average dose of XANAX was 5-6 mg/day in two of the studies, and the doses of
XANAX were fixed at 2 and 6 mg/day in the third study. In all three studies, XANAX was
superior to placebo on a variable defined as “the number of patients with zero panic
attacks” (range, 37-83% met this criterion), as well as on a global improvement score. we also carry JUUL pods near me.
In two of the three studies, XANAX was superior to placebo on a variable defined as
“change from baseline on the number of panic attacks per week” (range, 3.3-5.2), and
also on a phobia rating scale. A subgroup of patients who were improved on XANAX
during short-term treatment in one of these trials was continued on an open basis up to
8 months, without apparent loss of benefit.
INDICATIONS AND USAGE
XANAX Tablets (alprazolam) are indicated for the management of anxiety disorder
(a condition corresponding most closely to the APA Diagnostic and Statistical Manual
[DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of
symptoms of anxiety. Anxiety or tension associated with the stress of everyday life
usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and
worry (apprehensive expectation) about two or more life circumstances, for a period
of 6 months or longer, during which the person has been bothered more days than not
by these concerns. At least 6 of the following 18 symptoms are often present in these
patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches,
or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of
breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold
clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other
abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump
in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle
response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble
falling or staying asleep; irritability). These symptoms must not be secondary to another
psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to XANAX.
XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded
closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a
discrete period of intense fear or discomfort in which four (or more) of the following
symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations,
pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4)
sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or
discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or
faint; (9) derealization (feelings of unreality) or depersonalization (being detached from
oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or
tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of XANAX by systematic clinical study are limited
to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder;
however, patients with panic disorder have been treated on an open basis for up to
8 months without apparent loss of benefit. The physician should periodically reassess
the usefulness of the drug for the individual patient.
XANAX Tablets are contraindicated in patients with known sensitivity to this drug or
XANAX is contraindicated with ketoconazole and itraconazole, since these medications
significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A)
(see WARNINGS and PRECAUTIONS–Drug Interactions).
Risks from Concomitant Use with Opioids
Concomitant use of benzodiazepines, including XANAX, and opioids may result in
profound sedation, respiratory depression, coma, and death. Because of these risks,
reserve concomitant prescribing of these drugs for use in patients for whom alternative
treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and
benzodiazepines increases the risk of drug-related mortality compared to use of opioids
alone. If a decision is made to prescribe XANAX concomitantly with opioids, prescribe the
lowest effective dosages and minimum durations of concomitant use, and follow patients
closely for signs and symptoms of respiratory depression and sedation. In patients
already receiving an opioid analgesic, prescribe a lower initial dose of XANAX than
indicated in the absence of an opioid and titrate based on clinical response. If an opioid is
initiated in a patient already taking XANAX, prescribe a lower initial dose of the opioid and
titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and
sedation when XANAX is used with opioids. Advise patients not to drive or operate heavy
machinery until the effects of concomitant use with the opioid have been determined
[see Drug Interactions].
Dependence and Withdrawal Reactions, Including Seizures
Certain adverse clinical events, some life-threatening, are a direct consequence of
physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the
most important is seizure (see DRUG ABUSE AND DEPENDENCE). Even after relatively
short-term use at the doses recommended for the treatment of transient anxiety
and anxiety disorder (ie, 0.75 to 4.0 mg per day), there is some risk of dependence.
Spontaneous reporting system data suggest that the risk of dependence and its severity
appear to be greater in patients treated with doses greater than 4 mg/day and for long
periods (more than 12 weeks). However, in a controlled postmarketing discontinuation
study of panic disorder patients, the duration of treatment (3 months compared to
6 months) had no effect on the ability of patients to taper to zero dose. In contrast,
patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering
to zero dose than those treated with less than 4 mg/day.
The importance of dose and the risks of XANAX as a treatment for panic disorder: Buy DMT online
Because the management of panic disorder often requires the use of average daily doses
of XANAX above 4 mg, the risk of dependence among panic disorder patients may be
higher than that among those treated for less severe anxiety. Experience in randomized
placebo-controlled discontinuation studies of patients with panic disorder showed a high
rate of rebound and withdrawal symptoms in patients treated with XANAX compared to
placebo-treated patients. order xanax 2mg online
Relapse or return of illness was defined as a return of symptoms characteristic of panic
disorder (primarily panic attacks) to levels approximately equal to those seen at baseline
before active treatment was initiated. Rebound refers to a return of symptoms of panic
disorder to a level substantially greater in frequency, or more severe in intensity than
seen at baseline. Withdrawal symptoms were identified as those which were generally
not characteristic of panic disorder and which occurred for the first time more frequently
during discontinuation than at baseline.
In a controlled clinical trial in which 63 patients were randomized to XANAX and
where withdrawal symptoms were specifically sought, the following were identified
as symptoms of withdrawal: heightened sensory perception, impaired concentration,
dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea,
blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and
insomnia, were frequently seen during discontinuation, but it could not be determined if
they were due to return of illness, rebound, or withdrawal.
In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue
medication was measured, 71%-93% of patients treated with XANAX tapered completely
off therapy compared to 89%-96% of placebo-treated patients. In a controlled
postmarketing discontinuation study of panic disorder patients, the duration of treatment
(3 months compared to 6 months) had no effect on the ability of patients to taper to
Seizures attributable to XANAX were seen after drug discontinuance or dose reduction in
8 of 1980 patients with panic disorder or in patients participating in clinical trials where
doses of XANAX greater than 4 mg/day for over 3 months were permitted. Five of these
cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses
of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship
to abrupt dose reduction or discontinuation. In one instance, seizure occurred after
discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every 3 days
from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in
both of these cases the patients had been receiving doses of 3 mg daily prior to seizure.
The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been
occasional voluntary reports of patients developing seizures while apparently tapering
gradually from XANAX. The risk of seizure seems to be greatest 24-72 hours after
discontinuation (see DOSAGE AND ADMINISTRATION for recommended tapering and
Status Epilepticus and its Treatment
The medical event voluntary reporting system shows that withdrawal seizures have been
reported in association with the discontinuation of XANAX. In most cases, only a single
seizure was reported; however, multiple seizures and status epilepticus were reported
Early morning anxiety and emergence of anxiety symptoms between doses of XANAX
have been reported in patients with panic disorder taking prescribed maintenance doses
of XANAX. These symptoms may reflect the development of tolerance or a time interval
between doses which is longer than the duration of clinical action of the administered
dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain
plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms
over the entire course of the interdosing interval. In these situations, it is recommended
that the same total daily dose be given divided as more frequent administrations (see
DOSAGE AND ADMINISTRATION).
Risk of Dose Reduction
Withdrawal reactions may occur when dosage reduction occurs for any reason. This
includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient
forgets, the patient is admitted to a hospital). Therefore, the dosage of XANAX should be
reduced or discontinued gradually (see DOSAGE AND ADMINISTRATION).
CNS Depression and Impaired Performance
Because of its CNS depressant effects, patients receiving XANAX should be cautioned
against engaging in hazardous occupations or activities requiring complete mental
alertness such as operating machinery or driving a motor vehicle. For the same reason,
patients should be cautioned about the simultaneous ingestion of alcohol and other CNS
depressant drugs during treatment with XANAX. Buy xanax 2mg online
Risk of Fetal Harm
Benzodiazepines can potentially cause fetal harm when administered to pregnant women.
If XANAX 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
of experience with other members of the benzodiazepine class, XANAX is assumed to
be capable of causing an increased risk of congenital abnormalities when administered
to a pregnant woman during the first trimester. Because use of these drugs is rarely a
matter of urgency, their use during the first trimester 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 advised that if they
become pregnant during therapy or intend to become pregnant they should communicate
with their physicians about the desirability of discontinuing the drug.
Alprazolam Interaction with Drugs that Inhibit Metabolism via Cytochrome P450 3A
The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome
P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect
on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients
receiving very potent inhibitors of CYP3A. With drugs inhibiting CYP3A to a lesser but
still significant degree, alprazolam should be used only with caution and consideration of
appropriate dosage reduction. For some drugs, an interaction with alprazolam has been
quantified with clinical data; for other drugs, interactions are predicted from in vitro data
and/or experience with similar drugs in the same pharmacologic class.
The following are examples of drugs known to inhibit the metabolism of alprazolam
and/or related benzodiazepines, presumably through inhibition of CYP3A.
Potent CYP3A Inhibitors
Azole antifungal agents—Ketoconazole and itraconazole are potent CYP3A inhibitors
and have been shown in vivo to increase plasma alprazolam concentrations 3.98 fold
and 2.70 fold, respectively. The coadministration of alprazolam with these agents is not
recommended. Other azole-type antifungal agents should also be considered potent
CYP3A inhibitors and the coadministration of alprazolam with them is not recommended
(see CONTRAINDICATIONS). Buy marijuana online
Drugs demonstrated to be CYP3A inhibitors on the basis of clinical studies involving
alprazolam (caution and consideration of appropriate alprazolam dose reduction are
recommended during coadministration with the following drugs)
Nefazodone—Coadministration of nefazodone increased alprazolam concentration two-fold.
Fluvoxamine—Coadministration of fluvoxamine approximately doubled the maximum
plasma concentration of alprazolam, decreased clearance by 49%, increased half-life by
71%, and decreased measured psychomotor performance.
Cimetidine—Coadministration of cimetidine increased the maximum plasma concentration
of alprazolam by 86%, decreased clearance by 42%, and increased half-life by 16%.
HIV protease inhibitors – Interactions involving HIV protease inhibitors (eg, ritonavir) and
alprazolam are complex and time dependent. Low doses of ritonavir resulted in a large
impairment of alprazolam clearance, prolonged its elimination half-life and enhanced
clinical effects. However, upon extended exposure to ritonavir, CYP3A induction offset
this inhibition. This interaction will require a dose-adjustment or discontinuation of
Other drugs possibly affecting alprazolam metabolism
Other drugs possibly affecting alprazolam metabolism by inhibition of CYP3A are
discussed in the PRECAUTIONS section (see PRECAUTIONS–Drug Interactions).
As with other psychotropic medications, the usual precautions with respect to administration
of the drug and size of the prescription are indicated for severely depressed patients or
those in whom there is reason to expect concealed suicidal ideation or plans.
Panic disorder has been associated with primary and secondary major depressive
disorders and increased reports of suicide among untreated patients.
Episodes of hypomania and mania have been reported in association with the use of
XANAX in patients with depression.
Alprazolam has a weak uricosuric effect. Although other medications with weak
uricosuric effect have been reported to cause acute renal failure, there have been no
reported instances of acute renal failure attributable to therapy with XANAX.
Use in Patients with Concomitant Illness
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. (See DOSAGE AND ADMINISTRATION.) The usual precautions in
treating patients with impaired renal, hepatic or pulmonary function should be observed. Order percocet online
There have been rare reports of death in patients with severe pulmonary disease shortly
after the initiation of treatment with XANAX. A decreased systemic alprazolam elimination
rate (eg, increased plasma half-life) has been observed in both alcoholic liver disease
patients and obese patients receiving XANAX (see CLINICAL PHARMACOLOGY). Buy codeine online
Information for Patients
For all users of XANAX:
To assure safe and effective use of benzodiazepines, all patients prescribed XANAX
should be provided with the following guidance.
- Advise both patients and caregivers about the risks of potentially fatal respiratory
depression and sedation when XANAX is used with opioids and not to use such drugs
concomitantly unless supervised by a health care provider.
- Advise patients not to drive or operate heavy machinery until the effects of
concomitant use with the opioid have been determined [see Drug Interactions]. Buy Farmapram online
- Inform your physician about any alcohol consumption and medicine you are taking now,
including medication you may buy without a prescription. Alcohol should generally not
be used during treatment with benzodiazepines.
- Not recommended for use in pregnancy. Therefore, inform your physician if you are
pregnant, if you are planning to have a child, or if you become pregnant while you are
taking this medication.
- Inform your physician if you are nursing.
- Until you experience how this medication affects you, do not drive a car or operate
potentially dangerous machinery, etc.
- Do not increase the dose even if you think the medication “does not work
anymore” without consulting your physician. Benzodiazepines, even when used as
recommended, may produce emotional and/or physical dependence.
- Do not stop taking this medication abruptly or decrease the dose without consulting
your physician, since withdrawal symptoms can occur.
Additional advice for panic disorder patients:
The use of XANAX at doses greater than 4 mg/day, often necessary to treat panic
disorder, is accompanied by risks that you need to carefully consider. When used at
doses greater than 4 mg/day, which may or may not be required for your treatment,
XANAX has the potential to cause severe emotional and physical dependence in some
patients and these patients may find it exceedingly difficult to terminate treatment. In
two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue
medication was measured, 7 to 29% of patients treated with XANAX did not completely
taper off therapy. In a controlled postmarketing discontinuation study of panic disorder
patients, the patients treated with doses of XANAX greater than 4 mg/day had more
difficulty tapering to zero dose than patients treated with less than 4 mg/day. In all cases,
it is important that your physician help you discontinue this medication in a careful and
safe manner to avoid overly extended use of XANAX.
In addition, the extended use at doses greater than 4 mg/day appears to increase the
incidence and severity of withdrawal reactions when XANAX is discontinued. These are
generally minor but seizure can occur, especially if you reduce the dose too rapidly or
discontinue the medication abruptly. Seizure can be life-threatening.
Laboratory tests are not ordinarily required in otherwise healthy patients. However, when
treatment is protracted, periodic blood counts, urinalysis, and blood chemistry analyses
are advisable in keeping with good medical practice.
Use with Opioids
The concomitant use of benzodiazepines and opioids increases the risk of respiratory
depression because of actions at different receptor sites in the CNS that control
respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily
at mu receptors. When benzodiazepines and opioids are combined, the potential for
benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Limit dosage and duration of concomitant use of benzodiazepines and opioids, and
monitor patients closely for respiratory depression and sedation.
Use with Other CNS Depressants
If XANAX Tablets are to be combined with other psychotropic agents or anticonvulsant
drugs, careful consideration should be given to the pharmacology of the agents
to be employed, particularly with compounds which might potentiate the action of
benzodiazepines. 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
Use with Digoxin
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.
Use with Imipramine and Desipramine
The steady state plasma concentrations of imipramine and desipramine have been
reported to be increased an average of 31% and 20%, respectively, by the concomitant
administration of XANAX Tablets in doses up to 4 mg/day. The clinical significance of
these changes is unknown.
Drugs that inhibit alprazolam metabolism via cytochrome P450 3A
The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome
P450 3A (CYP3A). Drugs which inhibit this metabolic pathway may have a profound
effect on the clearance of alprazolam (see CONTRAINDICATIONS and WARNINGS for
additional drugs of this type).
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis
of clinical studies involving alprazolam (caution is recommended during coadministration
Fluoxetine—Coadministration of fluoxetine with alprazolam increased the maximum
plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased
half-life by 17%, and decreased measured psychomotor performance.
Propoxyphene—Coadministration of propoxyphene decreased the maximum plasma
concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life
Oral Contraceptives—Coadministration of oral contraceptives increased the maximum
plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased
half-life by 29%.
Drugs and other substances demonstrated to be CYP3A inhibitors on the basis of clinical
studies involving benzodiazepines metabolized similarly to alprazolam or on the basis
of in vitro studies with alprazolam or other benzodiazepines (caution is recommended
during coadministration with alprazolam)
Available data from clinical studies of benzodiazepines other than alprazolam suggest a
possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide
antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from
in vitro studies of alprazolam suggest a possible drug interaction with alprazolam for the
following: sertraline and paroxetine. However, data from an in vivo drug interaction study
involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to
150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of
alprazolam. Data from in vitro studies of benzodiazepines other than alprazolam suggest
a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone,
nicardipine, and nifedipine. Caution is recommended during the coadministration of any
of these with alprazolam (see WARNINGS).
Drugs demonstrated to be inducers of CYP3A
Carbamazepine can increase alprazolam metabolism and therefore can decrease plasma
levels of alprazolam.
Drug/Laboratory Test Interactions
Although interactions between benzodiazepines and commonly employed clinical
laboratory tests have occasionally been reported, there is no consistent pattern for a
specific drug or specific test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenic potential was observed during 2-year bioassay studies of
alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended
daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the
maximum recommended daily human dose).
Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg,
which is 500 times the maximum recommended daily human dose of 10 mg/day.
Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or
the Ames Assay.
Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which
is 25 times the maximum recommended daily human dose of 10 mg/day.
Teratogenic Effects: See WARNINGS section.
Nonteratogenic Effects: It should be considered that the child born of a mother who is
receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug
during the postnatal period. Also, neonatal flaccidity and respiratory problems have been
reported in children born of mothers who have been receiving benzodiazepines.
Labor and Delivery
XANAX has no established use in labor or delivery.
Benzodiazepines are known to be excreted in human milk. It should be assumed that
alprazolam is as well. Chronic administration of diazepam to nursing mothers has been
reported to cause their infants to become lethargic and to lose weight. As a general rule,
nursing should not be undertaken by mothers who must use XANAX.
Safety and effectiveness of XANAX in individuals below 18 years of age have not been
The elderly may be more sensitive to the effects of benzodiazepines. They exhibit
higher plasma alprazolam concentrations due to reduced clearance of the drug as
compared with a younger population receiving the same doses. The smallest effective
dose of XANAX should be used in the elderly to preclude the development of ataxia and
oversedation (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Side effects to XANAX Tablets, if they occur, are generally observed at the beginning
of therapy and usually disappear upon continued medication. In the usual patient, the
most frequent side effects are likely to be an extension of the pharmacological activity of
alprazolam, eg, drowsiness or light-headedness.
The data cited in the two tables below are estimates of untoward clinical event incidence
among patients who participated under the following clinical conditions: relatively short
duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day
of XANAX (for the management of anxiety disorders or for the short-term relief of the
symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical
studies with dosages up to 10 mg/day of XANAX in patients with panic disorder, with or
These data cannot be used to predict precisely the incidence of untoward events in the
course of usual medical practice where patient characteristics, and other factors often
differ from those in clinical trials. These figures cannot be compared with those obtained
from other clinical studies involving related drug products and placebo as each group of
drug trials are conducted under a different set of conditions.
Comparison of the cited figures, however, can provide the prescriber with some basis
for estimating the relative contributions of drug and non-drug factors to the untoward
event incidence in the population studied. Even this use must be approached cautiously,
as a drug may relieve a symptom in one patient but induce it in others. (For example,
an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but
induce it [an untoward event] in others.)
Additionally, for anxiety disorders the cited figures can provide the prescriber with
an indication as to the frequency with which physician intervention (eg, increased
surveillance, decreased dosage or discontinuation of drug therapy) may be necessary
because of the untoward clinical event.
Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of
Treatment-Emergent Incidence of Intervention
Because of Symptom
Number of Patients XANAX PLACEBO XANAX
% of Patients 565 505 565
Central Nervous System
Drowsiness 41.0 21.6 15.1
Light-headedness 20.8 19.3 1.2
Depression 13.9 18.1 2.4
Headache 12.9 19.6 1.1
Confusion 9.9 10.0 0.9
Insomnia 8.9 18.4 1.3
Nervousness 4.1 10.3 1.1
Syncope 3.1 4.0 *
Dizziness 1.8 0.8 2.5
Akathisia 1.6 1.2 *
Tiredness/Sleepiness * * 1.8
Dry Mouth 14.7 13.3 0.7
Constipation 10.4 11.4 0.9
Diarrhea 10.1 10.3 1.2
Nausea/Vomiting 9.6 12.8 1.7
Increased Salivation 4.2 2.4 *
Tachycardia/Palpitations 7.7 15.6 0.4
Hypotension 4.7 2.2 *
Blurred Vision 6.2 6.2 0.4
Rigidity 4.2 5.3 *
Tremor 4.0 8.8 0.4
Dermatitis/Allergy 3.8 3.1 0.6
Nasal Congestion 7.3 9.3 *
Weight Gain 2.7 2.7 *
Weight Loss 2.3 3.0 *
None reported † Events reported by 1% or more of XANAX patients are included. In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention. Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder PANIC DISORDER Treatment-Emergent Symptom Incidence
Number of Patients 1388 1231
% of Patients Reporting:
Central Nervous System
Drowsiness 76.8 42.7
Fatigue and Tiredness 48.6 42.3
Impaired Coordination 40.1 17.9
Irritability 33.1 30.1
Memory Impairment 33.1 22.1
Light-headedness/Dizziness 29.8 36.9
Insomnia 29.4 41.8
Headache 29.2 35.6
Cognitive Disorder 28.8 20.5
Dysarthria 23.3 6.3
Anxiety 16.6 24.9
Abnormal Involuntary Movement 14.8 21.0
Decreased Libido 14.4 8.0
Depression 13.8 14.0
Confusional State 10.4 8.2
Muscular Twitching 7.9 11.8
Increased Libido 7.7 4.1
Change in Libido (Not Specified) 7.1 5.6
Weakness 7.1 8.4
Muscle Tone Disorders 6.3 7.5
Syncope 3.8 4.8
Akathisia 3.0 4.3
Agitation 2.9 2.6
Disinhibition 2.7 1.5
Paresthesia 2.4 3.2
Talkativeness 2.2 1.0
Vasomotor Disturbances 2.0 2.6
Derealization 1.9 1.2
Dream Abnormalities 1.8 1.5
Fear 1.4 1.0
Feeling Warm 1.3 0.5
Decreased Salivation 32.8 34.2
Constipation 26.2 15.4
Nausea/Vomiting 22.0 31.8
Diarrhea 20.6 22.8
Abdominal Distress 18.3 21.5
Increased Salivation 5.6 4.4
Nasal Congestion 17.4 16.5
Tachycardia 15.4 26.8
Chest Pain 10.6 18.1
Hyperventilation 9.7 14.5
Upper Respiratory Infection 4.3 3.7
Blurred Vision 21.0 21.4
Tinnitus 6.6 10.4
Muscular Cramps 2.4 2.4
Muscle Stiffness 2.2 3.3
Sweating 15.1 23.5
Rash 10.8 8.1
Increased Appetite 32.7 22.8
Decreased Appetite 27.8 24.1
Weight Gain 27.2 17.9
Weight Loss 22.6 16.5
Micturition Difficulties 12.2 8.6
Menstrual Disorders 10.4 8.7
Sexual Dysfunction 7.4 3.7
Edema 4.9 5.6
Incontinence 1.5 0.6
Infection 1.3 1.7
*Events reported by 1% or more of XANAX patients are included.
In addition to the relatively common (ie, greater than 1%) untoward events enumerated
in the table above, the following adverse events have been reported in association with
the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia,
elevated bilirubin, elevated hepatic enzymes, and jaundice.
Panic disorder has been associated with primary and secondary major depressive disorders
and increased reports of suicide among untreated patients (see PRECAUTIONS, General).
Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic
Disorder in Placebo-Controlled Trials
In a larger database comprised of both controlled and uncontrolled studies in which
641 patients received XANAX, discontinuation-emergent symptoms which occurred at
a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo
treated group were as follows:
DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE
Percentage of 641 XANAX-Treated Panic Disorder
Patients Reporting Events
Light-headedness 19.3 Diarrhea 13.6
Abnormal involuntary movement 17.3 Decreased salivation 10.6
Headache 17.0 Metabolic-Nutritional
Muscular twitching 6.9 Weight loss 13.3
Impaired coordination 6.6 Decreased appetite 12.8
Muscle tone disorders 5.9
Weakness 5.8 Dermatological
Psychiatric Sweating 14.4
Fatigue and Tiredness 18.4 Cardiovascular
Irritability 10.5 Tachycardia 12.2
Cognitive disorder 10.3
Memory impairment 5.5 Special Senses
Depression 5.1 Blurred vision 10.0
Confusional state 5.0
From the studies cited, it has not been determined whether these symptoms are clearly
related to the dose and duration of therapy with XANAX in patients with panic disorder.
There have also been reports of withdrawal seizures upon rapid decrease or abrupt
discontinuation of XANAX Tablets (see WARNINGS).
To discontinue treatment in patients taking XANAX, the dosage should be reduced
slowly in keeping with good medical practice. It is suggested that the daily dosage of
XANAX be decreased by no more than 0.5 mg every three days (see DOSAGE AND
ADMINISTRATION). Some patients may benefit from an even slower dosage reduction.
In a controlled postmarketing discontinuation study of panic disorder patients which
compared this recommended taper schedule with a slower taper schedule, no difference
was observed between the groups in the proportion of patients who tapered to zero dose;
however, the slower schedule was associated with a reduction in symptoms associated
with a withdrawal syndrome.
As with all benzodiazepines, paradoxical reactions such as stimulation, increased
muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral
effects such as agitation, rage, irritability, and aggressive or hostile behavior have been
reported rarely. 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. Should any of the above events occur, alprazolam
should be discontinued. 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
discontinuation of alprazolam in patients with posttraumatic stress disorder.
Post Introduction Reports: Various adverse drug reactions have been reported in
association with the use of XANAX since market introduction. The majority of these
reactions were reported through the medical event voluntary reporting system. Because
of the spontaneous nature of the reporting of medical events and the lack of controls,
a causal relationship to the use of XANAX cannot be readily determined. Reported
events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations,
hepatitis, hepatic failure, Stevens- Johnson syndrome, photosensitivity reaction,
angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea
DRUG ABUSE AND DEPENDENCE
Physical and Psychological Dependence
Withdrawal symptoms similar in character to those noted with sedative/hypnotics and
alcohol have occurred following discontinuance of benzodiazepines, including XANAX.
The symptoms can range from mild dysphoria and insomnia to a major syndrome
that may include abdominal and muscle cramps, vomiting, sweating, tremors and
convulsions. Distinguishing between withdrawal emergent signs and symptoms and
the recurrence of illness is often difficult in patients undergoing dose reduction. The
long term strategy for treatment of these phenomena will vary with their cause and the
therapeutic goal. When necessary, immediate management of withdrawal symptoms
requires re-institution of treatment at doses of XANAX sufficient to suppress symptoms.
There have been reports of failure of other benzodiazepines to fully suppress these
withdrawal symptoms. These failures have been attributed to incomplete cross-tolerance
but may also reflect the use of an inadequate dosing regimen of the substituted
benzodiazepine or the effects of concomitant medications.
While it is difficult to distinguish withdrawal and recurrence for certain patients, the time
course and the nature of the symptoms may be helpful. A withdrawal syndrome typically
includes the occurrence of new symptoms, tends to appear toward the end of taper or
shortly after discontinuation, and will decrease with time. In recurring panic disorder,
symptoms similar to those observed before treatment may recur either early or late, and
they will persist.
While the severity and incidence of withdrawal phenomena appear to be related to dose
and duration of treatment, withdrawal symptoms, including seizures, have been reported
after only brief therapy with XANAX at doses within the recommended range for the
treatment of anxiety (eg, 0.75 to 4 mg/day). Signs and symptoms of withdrawal are often
more prominent after rapid decrease of dosage or abrupt discontinuance. The risk of
withdrawal seizures may be increased at doses above 4 mg/day (see WARNINGS).
Patients, especially individuals with a history of seizures or epilepsy, should not
be abruptly discontinued from any CNS depressant agent, including XANAX. It is
recommended that all patients on XANAX who require a dosage reduction be gradually
tapered under close supervision (see WARNINGS and DOSAGE AND ADMINISTRATION).
Psychological dependence is a risk with all benzodiazepines, including XANAX. The risk
of psychological dependence may also be increased at doses greater than 4 mg/day
and with longer term use, and this risk is further increased in patients with a history of
alcohol or drug abuse. Some patients have experienced considerable difficulty in tapering
and discontinuing from XANAX, especially those receiving higher doses for extended
periods. Addiction-prone individuals should be under careful surveillance when receiving
XANAX. As with all anxiolytics, repeat prescriptions should be limited to those who are
under medical supervision.
Controlled Substance Class
Alprazolam is a controlled substance under the Controlled Substance Act by the Drug
Enforcement Administration and XANAX Tablets have been assigned to Schedule IV.
Manifestations of alprazolam overdosage include somnolence, confusion, impaired
coordination, 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
The acute oral LD50 in rats is 331-2171 mg/kg. Other experiments in animals have
indicated that cardiopulmonary collapse can occur following massive intravenous doses
of alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human
dose of 10 mg/day). Animals could be resuscitated with positive mechanical ventilation
and the intravenous infusion of norepinephrine bitartrate.
Animal experiments have suggested that forced diuresis or hemodialysis are probably of
little value in treating overdosage.
General Treatment of Overdose
Overdosage reports with XANAX Tablets are limited. As in all cases of drug overdosage,
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 hypotension 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.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or
partial reversal of the sedative effects of benzodiazepines and may be used in situations
when an overdose with a benzodiazepine is known or suspected. Prior to the administration
of flumazenil, necessary measures should be instituted to secure airway, ventilation
and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for,
proper management of benzodiazepine overdose. Patients treated with flumazenil should
be monitored for re-sedation, respiratory depression, and other residual benzodiazepine
effects for an appropriate period after treatment. The prescriber should be aware of
a risk of seizure in association with flumazenil treatment, particularly in long-term
benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil
package insert including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be
consulted prior to use. Order percocet online
DOSAGE AND ADMINISTRATION
Dosage should be individualized for maximum beneficial effect. While the usual daily
dosages given below will meet the needs of most patients, there will be some who
require doses greater than 4 mg/day. In such cases, dosage should be increased
cautiously to avoid adverse effects. Buy Farmapram online
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given
three times daily. The dose may be increased to achieve a maximum therapeutic effect,
at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The
lowest possible effective dose should be employed and the need for continued treatment
reassessed frequently. The risk of dependence may increase with dose and duration of
treatment. BUY oxycodone 30mg online
In all patients, dosage should be reduced gradually when discontinuing therapy or
when decreasing the daily dosage. Although there are no systematically collected data
to support a specific discontinuation schedule, it is suggested that the daily dosage be
decreased by no more than 0.5 mg every 3 days. Some patients may require an even
slower dosage reduction.
The successful treatment of many panic disorder patients has required the use of
XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish
the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were
used. The mean dosage employed was approximately 5 to 6 mg daily. Among the
approximately 1700 patients participating in the panic disorder development program,
about 300 received XANAX in dosages of greater than 7 mg/day, including approximately
100 patients who received maximum dosages of greater than 9 mg/day. Occasional
patients required as much as 10 mg a day to achieve a successful response.
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the
response, the dose may be increased at intervals of 3 to 4 days in increments of no more
than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be
advisable to allow full expression of the pharmacodynamic effect of XANAX. To lessen the
possibility of interdose symptoms, the times of administration should be distributed as
evenly as possible throughout the waking hours, that is, on a three or four times per
Generally, therapy should be initiated at a low dose to minimize the risk of adverse
responses in patients especially sensitive to the drug. Dose should be advanced until
an acceptable therapeutic response (ie, a substantial reduction in or total elimination of
panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration
of dosage reduction is advised. In a controlled postmarketing dose-response study, patients
treated with doses of XANAX greater than 4 mg/day for 3 months were able to taper to
50% of their total maintenance dose without apparent loss of clinical benefit. Because of
the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See
WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to XANAX is
unknown. After a period of extended freedom from attacks, a carefully supervised tapered
discontinuation may be attempted, but there is evidence that this may often be difficult
to accomplish without recurrence of symptoms and/or the manifestation of withdrawal
Because of the danger of withdrawal, abrupt discontinuation of treatment should be
avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or
when decreasing the daily dosage. Although there are no systematically collected data
to support a specific discontinuation schedule, it is suggested that the daily dosage be
decreased by no more than 0.5 mg every three days. Some patients may require an even
slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must
be gradual. If significant withdrawal symptoms develop, the previous dosing schedule
should be reinstituted and, only after stabilization, should a less rapid schedule of
discontinuation be attempted. In a controlled postmarketing discontinuation study of
panic disorder patients which compared this recommended taper schedule with a slower
taper schedule, no difference was observed between the groups in the proportion of
patients who tapered to zero dose; however, the slower schedule was associated with a
reduction in symptoms associated with a withdrawal syndrome. It is suggested that the
dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some
patients may benefit from an even more gradual discontinuation. Some patients may
prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating
disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be
gradually increased if needed and tolerated. The elderly may be especially sensitive to the
effects of benzodiazepines. If side effects occur at the recommended starting dose, the
dose may be lowered.
XANAX Tablets are available as follows:
0.25 mg (white, oval, scored, imprinted “XANAX 0.25”)
Bottles of 100 NDC 0009-0029-01
Unit Dose (100) NDC 0009-0029-46
Bottles of 500 NDC 0009-0029-02
Bottles of 1000 NDC 0009-0029-14
0.5 mg (peach, oval, scored, imprinted “XANAX 0.5”)
Bottles of 100 NDC 0009-0055-01
Unit Dose (100) NDC 0009-0055-46
Bottles of 500 NDC 0009-0055-03
Bottles of 1000 NDC 0009-0055-15
1 mg (blue, oval, scored, imprinted “XANAX 1.0”)
Bottles of 100 NDC 0009-0090-01
Bottles of 500 NDC 0009-0090-04
Bottles of 1000 NDC 0009-0090-13
2 mg (white, oblong, multi-scored, imprinted “XANAX ” on one side and “2” on the
Bottles of 100 NDC 0009-0094-01
Bottles of 500 NDC 0009-0094-03
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the
maximum recommended human dose) orally for 2 years, a tendency for a dose related
increase in the number of cataracts was observed in females and a tendency for a dose
related increase in