Xerac BP 5 5% Gel

Side Effects:

Drowsiness, incoordination, headache, fatigue, change in sex drive, change in appetite, change in weight, difficulty urinating or stomach upset may occur the first few days as your body adjusts to the medication.

If any of these effects continue or become bothersome, inform your doctor.

Notify your doctor if you develop a rapid, pounding or irregular heartbeat, skin rash, changes in vision, slurred speech, confusion, depression or behavior changes while taking this medication.

This medication may cause drowsiness or dizziness.

Use caution operating machinery or engaging in activities requiring alertness.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use saliva substitute.

Precautions:

Tell your doctor of any over-the-counter or prescription medication you may take including any medication for seizures or depression, narcotic pain relievers, erythromycin-like antibiotics, cimetidine, sleeping pills, tranquilizers or azole antifungals.

This drug may cause an allergic reaction in patients with a history of sensitivity to the following: Benzodiazepines.

Use the Interactions Checker located on the main toolbar for additional interaction information for this drug.

Generic Name: Alprazolam

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Alprazolam 2 mg Tablet - Prescription

21434_xanax_lbl
http://www.fda.gov/cder/foi/label/2003/21434_xanax_lbl

Xanax, patients, doses, symptoms, treatment, drugs, discontinuation, alprazolam, administration, benzodiazepines, panic disorder, mg/day, tablets, dosage, metabolism.

XANAX XR Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.

The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76.

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 XR extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam.

The inactive ingredients are lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose.

In addition, the 1 mg and 3 mg tablets contains D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.

CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereospecific receptors at several sites within the central nervous system.

Their exact mechanism of action is unknown.

Clinically, all benzodiazepines cause a dose-related central nervous system depressant activity varying from mild impairment of task performance to hypnosis.

Following oral administration of XANAX (immediate-release) Tablets, alprazolam is readily absorbed.

Plasma levels are proportional 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.

The bioavailability and pharmacokinetics of alprazolam following administration of XANAX XR Tablets are similar to that for XANAX Tablets, with the exception of a slower rate of absorption.

The slower absorption rate results in a relatively constant concentration that is maintained between 5 and 11 hours after the dosing.

The pharmacokinetics of alprazolam and two of its major active metabolites (4-hydroxyalprazolam and -hydroxyalprazolam) are linear, and concentrations are proportional up to the recommended maximum daily dose of 10mg given once daily.

Multiple dose studies indicate that the metabolism and elimination of alprazolam are similar for the immediate-release and the extendedrelease products.

The extent of exposure (AUC) and elimination half-life (t1/2) were not affected by eating.

The mean plasma elimination half-life of alprazolam following administration of Xanax XR tablet ranges from 10.7-15.8 hours in healthy adults.

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.

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).

The oral clearance of alprazolam (given in a 0.8mg 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 comparing to the recommended doses (1000-1200mg/day); the effect at usual carbamazepine doses is unknown.

The efficacy of XANAX XR Tablets in the treatment of panic disorder was established in two 6-week, placebocontrolled studies of XANAX XR in patients with panic disorder.

In two 6-week, flexible-dose, placebo-controlled studies in patients meeting DSM-III criteria for panic disorder, patients were treated with XANAX XR in a dose range of 1 to 10 mg/day, on a once-a-day basis.

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.

Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam.

These include a spectrum of withdrawal symptoms; the most important is seizure (see DRUG ABUSE AND 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 who received XANAX Tablets, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose.

Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder who received XANAX Tablets showed a high rate of rebound and withdrawal symptoms compared to placebo treated patients.

third case involved multiple seizures after the patient completed treatment with XANAX XR 4 mg/day and missed taking the medication on the first day of taper.

Seizures have also been observed in association with dose reduction or discontinuation of XANAX Tablets, the immediate release form of alprazolam.

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 three 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 discontinuation schedule).

The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of XANAX Tablets.

In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well.

Early morning anxiety and emergence of anxiety symptoms between doses of XANAX Tablets have been reported in patients with panic disorder taking prescribed maintenance doses.

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.

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).

Because of its CNS depressant effects, patients receiving XANAX XR 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 XR.

Benzodiazepines can potentially cause fetal harm when administered to pregnant women.

If alprazolam 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.

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.

The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP3A.

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.

Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients.

1. Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription.

Proper discontinuation will help to decrease the possibility of withdrawal reactions that can range from mild reactions to severe reactions such as seizure.

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated with XANAX XR The prescriber should be aware that adverse event incidence cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials.

Similarly, the cited frequencies cannot be compared with event incidence obtained from other clinical investigations involving different treatments, uses, and investigators.

The cited values, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The following table shows the incidence of treatment-emergent adverse events that occurred during 6- to 8-week placebo-controlled trials in 1% or more of patients treated with XANAX XR where the incidence in patients treated with XANAX XR was greater than the incidence in placebo-treated patients.

The most commonly observed adverse events in panic disorder patients treated with XANAX XR (incidence of 5% or greater and at least twice the incidence in placebo patients) were: sedation; somnolence; memory impairment; dysarthria; coordination abnormal; ataxia; libido decreased (see table).

Following is a list of MedDRA terms that reflect treatment-emergent adverse events reported by 531 patients with panic disorder treated with XANAX XR.

All potentially important reported events are included except those already listed in the above table or elsewhere in labeling, those events for which a drug cause was remote, those event terms that were so general as to be uninformative, and those events that occurred at rates similar to background rates in the general population.

It is important to emphasize that, although the events reported occurred during treatment with XANAX XR, they were not necessarily caused by the drug.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on 1 or more occasions in at least l/l00 patients; infrequent adverse events are those occurring in less than l/100 patients but at least l/1000 patients; rare events are those occurring in fewer than l/1000 patients.

Cardiac disorders: Frequent: palpitation; Infrequent: sinus tachycardia Ear and Labyrinth disorders: Frequent: Vertigo; Infrequent: tinnitus, ear pain Eye disorders: Frequent: blurred vision; Infrequent: mydriasis, photophobia Gastrointestinal disorders: Frequent: diarrhea, vomiting, dyspepsia, abdominal pain; Infrequent: dysphagia, salivary hypersecretion General disorders and administration site conditions: Frequent: malaise, weakness, chest pains; Infrequent: fall, pyrexia, thirst, feeling hot and cold, edema, feeling jittery, sluggishness, asthenia, feeling drunk, chest tightness, increased energy, feeling of relaxation, hangover, loss of control of legs, rigors Musculoskeletal and connective tissue disorders: Frequent: back pain, muscle cramps, muscle twitching Nervous system disorders: Frequent: headache, dizziness, tremor; Infrequent: amnesia, clumsiness, syncope, hypotonia, seizures, depressed level of consciousness, sleep apnea syndrome, sleep talking, stupor Psychiatric system disorders: Frequent: irritability, insomnia, nervousness, derealization, libido increased, restlessness, agitation, depersonalization, nightmare; Infrequent: abnormal dreams, apathy, aggression, anger, bradyphrenia, euphoric mood, logorrhea, mood swings, dysphonia, hallucination, homicidal ideation, mania, hypomania, impulse control, psychomotor retardation, suicidal ideation Renal and urinary disorders: Frequent: difficulty in micturition; Infrequent: urinary frequency, urinary incontinence Respiratory, thoracic, and mediastinal disorders: Frequent: nasal congestion, hyperventilation; Infrequent: choking sensation, epistaxis, rhinorrhea Skin and subcutaneous tissue disorders: Frequent: sweating increased; Infrequent: clamminess, rash, urticaria Vascular disorders: Infrequent: hypotension The categories of adverse events reported in the clinical development program for XANAX Tablets in the treatment of panic disorder differ somewhat from those reported for XANAX XR Tablets because the clinical trials [...]

Nevertheless, the types of adverse events reported in the clinical trials with XANAX Tablets were generally the same as those reported in the clinical trials with XANAX XR Tablets.

Discontinuation-Emergent Adverse Events Occurring at an Incidence of 5% or More Among Patients Treated with XANAX XR The following table shows the incidence of discontinuation-emergent adverse events that occurred during shortterm, placebo-controlled trials in 5% or more of patients treated with XANAX XR where the incidence in patients treated with XANAX XR was two times greater than the incidence in placebo-treated patients.

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of alprazolam (see WARNINGS).

To discontinue treatment in patients taking XANAX XR Tablets, the dosage should be reduced slowly in keeping with good medical practice.

It is suggested that the daily dosage of XANAX XR Tablets 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.

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.

Various adverse drug reactions have been reported in association with the use of XANAX Tablets 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 Tablets cannot be readily determined.

When necessary, immediate management of withdrawal symptoms requires re-institution of treatment at doses of alprazolam sufficient to suppress 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.

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.

Alprazolam is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and XANAX XR Tablets have been assigned to Schedule IV. OVERDOSAGE

be some patients who require doses greater than 6 mg/day.

In such cases, dosage should be increased cautiously to avoid adverse effects.

In elderly patients, in patients with advanced liver disease, or in patients with debilitating disease, the usual starting dose of XANAX XR is 0.5 mg once daily.

This may be gradually increased if needed and tolerated (see Dose Titration).

The elderly may be especially sensitive to the effects of benzodiazepines.

Treatment with XANAX XR may be initiated with a dose of 0.5 mg to 1 mg once 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/day.

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 attained.

In controlled trials conducted to establish the efficacy of XANAX XR Tablets in panic disorder, doses in the range of 1 to 10 mg/day were used.

Most patients showed efficacy in the dose range of 3 to 6 mg/day.

Occasional patients required as much as 10 mg/day to achieve a successful response The necessary duration of treatment for panic disorder patients responding to XANAX XR 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 phenomena.

Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided.

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 three days, with the understanding that some patients may benefit from an even more gradual discontinuation.

Some patients may prove resistant to all discontinuation regimens.

Switch from XANAX (immediate-release) Tablets to XANAX XR (extended-release) Tablets Patients who are currently being treated with divided doses of XANAX (immediate release) Tablets, for example 3 to 4 times a day, may be switched to XANAX XR Tablets at the same total daily dose taken once daily.

If the therapeutic response after switching is inadequate, the dosage may be titrated as outlined above.

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 corneal vascularization was observed in males.

These lesions did not appear until after 11 months of treatment.

Xanax, health, benzodiazepines, alcohol, drug, dangers, risk, students, sedation, medication, prescription, abuse, life threatening, tolerance, Panic Disorder.

The large majority of students don't use Xanex and fewer still mix with alcohol for recreational purposes.

However, some students do place themselves at serious risk, the following article discusses Xanex and the associated dangers.

Xanax is the trade name for the generic medication alprazolam.

It is a type of sedative medication in the class of benzodiazepines.

The Drug Enforcement Agency (DEA) considers it a schedule IV drug as defined in the Controlled Substances Act.

Either way, one should be monitored by a health professional to avoid potentials health risks.

As sedation escalates, one becomes confused, blacks out, falls into a coma, and eventually stops breathing if too much is taken.

pain, dose, patient, opioids, oxycodone, analgesics, Wisconsin Cancer Pain, morphine, hydromorphone, home health, tablets.

On assessment, this patient reports knee pain of 7 out of 10.

A trial of opioids left her unacceptably sedated with no pain relief.

If the patient is taking the full amount of medication prescribed, contact the physician to discuss an appropriate dose increase.

Since the current med is also oxycodone, take the 24 hour dose (60mg) and divide by the number of doses per day (2), which yields 30mg Oxycontin q12h.

3. To decide on a reasonable dose increase of the opioid, consider the following: For mild (1-4/10) to moderate (5-6/10) pain, increase the dose by 25-50% of the current dose.

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