ALPRAZOLAM 1mg. Tablets.

$360.00$945.00

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SKU: ADD-25-1-2

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Description

FORMULATION:

Alprazolam USP 1mg.

 

BOXED WARNING

DOSAGE & INDICATIONS

Chronic obstructive pulmonary disease (COPD), coadministration with other CNS depressants, pulmonary disease, respiratory depression, sleep apnea

As with other benzodiazepines, alprazolam should be avoided in patients with pulmonary disease if possible. Additionally, avoid coadministration with other CNS depressants, especially opioids, unless no other alternatives are available as coadministration significantly increases the risk for respiratory depression, low  blood pressure, and death. Alprazolam should be avoided if possible in patients with respiratory depression severe chronic obstructive pulmonary disease (COPD), or sleep apnea because the drug can exacerbate ventilatory failure. In rare instances, death has occurred in patients with severe pulmonary disease shortly after the initiation of alprazolam.

DEA CLASS

Rx, schedule IV

DESCRIPTION

Oral benzodiazepine used for the management of anxiety including panic disorder; relatively shorter half-life and absence of active metabolites; potential for significant CYP3A4 interactions.

COMMON BRAND NAMES

Niravam, Xanax, Xanax XR

HOW SUPPLIED

Alprazolam Oral Sol: 1mg, 1mL
Alprazolam/Niravam Oral Tab Orally Dis: 0.25mg, 0.5mg, 1mg, 2mg
Alprazolam/Xanax Oral Tab: 0.25mg, 0.5mg, 1mg, 2mg
Alprazolam/Xanax XR Oral Tab ER: 0.5mg, 1mg, 2mg, 3mg

DOSAGE & INDICATIONS

For the treatment of transient symptoms of anxiety, anxiety associated with depression, or generalized anxiety disorder (GAD).
Oral dosage (immediate-release tablets, orally disintegrating tablets or oral solution)
Adults

Initially, 0.25 mg to 0.5 mg PO 3 times per day. Use the lower dose for debilitated adults initially. If clinically indicated, increase the dose as tolerated at intervals of 3 to 4 days, up to a maximum of 4 mg/day in divided doses. If discontinuation becomes necessary, the manufacturer suggests that the daily dose be decreased by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper.

Geriatric Adults

Initially, 0.25 mg PO 2 or 3 times daily. Lower initial doses may be appropriate in some patients. If indicated, the dose may be increased gradually as tolerated. The maximum adult dosage is 4 mg/day PO. The elderly may be more sensitive to the effects of benzodiazepines. If discontinuation becomes necessary, the manufacturer suggests that the daily dose be decreased by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 0.75 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.

Children† and Adolescents† 7 years and older

Definitive dosage not established. In a study of children 7 to 16 years old (n = 13), initial doses of 0.005 mg/kg/dose PO or 0.125 mg/dose PO were given 3 times per day for situational anxiety. Doses were increased in 0.125 mg to 0.25 mg increments. Max: 0.02 mg/kg/dose PO or 0.06 mg/kg/day PO. In another study of children with overanxious or avoidant disorder (n = 30), initial doses were 0.25 mg PO per day for children 40 kg or less and 0.5 mg PO per day for those more than 40 kg. Doses were titrated at 2-day intervals to a maximum of 0.04 mg/kg/day. Required doses ranged from 0.5 mg to 3.5 mg/day with a mean dose of 1.6 mg/day.

For the treatment of panic disorder with or without agoraphobia.
Oral dosage (immediate-release tablets, orally disintegrating tablets or oral solution)
Adults

Initially, 0.5 mg PO 3 times per day. In debilitated adults, a lower initial dose of 0.25 mg PO 2 or 3 times daily is recommended. The dose may be increased gradually as tolerated, by no more than 1 mg/day at intervals of 3 to 4 days. Many patients require more than 4 mg/day. It is advisable to slowly titrate to higher doses and divide the doses throughout the waking hours on a 3 to 4 times per day schedule. Periodically reassess for possible dose reduction. During clinical trials, the mean effective dosage was 5 to 6 mg/day, although doses up to 10 mg/day were required in some patients. If discontinuation becomes necessary, decrease the daily dose by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper.

Geriatric Adults

Initially, 0.25 mg PO 2 or 3 times daily. Lower initial doses may be appropriate in some patients. The dose may be increased gradually as tolerated, at intervals of 3 to 4 days. During clinical trials in younger adults, the mean effective dosage was 5 to 6 mg/day. The geriatric patient is more sensitive to the effects of benzodiazepines; use lowest effective dose. If discontinuation becomes necessary, decrease the daily dose by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 0.75 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.

Oral dosage (extended-release tablets, Xanax XR)
Adults

Initially, 0.5 mg to 1 mg PO once a day, preferably in the morning. Use the lower initial dose in debilitated adult patients. Increase by no more than 1 mg/day, at intervals of every 3 to 4 days, as needed and tolerated. 3 to 6 mg PO once daily was the effective dose in most patients during clinical trials. Up to 10 mg/day has been required in occasional patients. To switch from immediate-release alprazolam, calculate the total daily dose and administer once daily using the XR formulation. If discontinuation becomes necessary, decrease the daily dose by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper.

Geriatric Adults

Initially, 0.5 mg PO once daily, preferably in the morning. Gradually increase as needed and tolerated. In younger patients, doses were increased in increments of 1 mg/day or less, at intervals of every 3 to 4 days. Doses as high as 10 mg/day have been used in adults. However, the elderly are more sensitive to the effects of benzodiazepines; use the lowest effective dose. To switch from immediate-release alprazolam, calculate the total daily dose and administer once daily using the XR formulation. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 0.75 mg/day PO in residents meeting criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.

For the treatment of anxiety and mood-symptoms associated with premenstrual syndrome (PMS)† or premenstrual dysphoric disorder (PMDD)† that are unresponsive to non-pharmacologic therapy.
Oral dosage (immediate-release tablets or oral solution)
Adult females

0.25 mg PO three times daily administered during the luteal phase through the second day of menses has been studied and was found to be superior to placebo in treating the emotional symptoms associated with PMS. A maximum dose up to 4 mg/day is recommended. Dose should be tapered by 25% per day through menses. In a placebo-controlled, comparative study with oral progesterone of 138 subjects, after 3 months, alprazolam was superior to progesterone or placebo overall but progesterone was better than alprazolam for physical symptoms while alprazolam was better than progesterone for controlling mood and mental function. Alprazolam was initially dosed at 0.25 mg PO four times per day administered from day 18 of the menstrual cycle to the first day of menses with a taper on the first 2 menstrual days, however, dosing was flexible; patients could receive up to twelve 0.25 mg capsules/day if necessary. The actual alprazolam dose taken during the third treatment cycle was 1.5 mg/day PO.

†Indicates off-label use

MAXIMUM DOSAGE

Adults

10 mg/day PO.

Geriatric

10 mg/day PO.

Adolescents

Safety and efficacy have not been established; 0.06 mg/kg/day PO (immediate-release tablets or oral solution) has been suggested for the treatment of anxiety.

Children

7 years and older: Safety and efficacy have not been established; 0.06 mg/kg/day PO (immediate-release tablets or oral solution) has been suggested for the treatment of anxiety.
Less than 7 years: Safety and efficacy have not been established.

DOSING CONSIDERATIONS

Hepatic Impairment

Quantitative guidelines are not available for the immediate-release product; consider initial dose reduction in those with hepatic impairment. A lower initial adult dose of extended-release alprazolam (e.g., 0.5 mg PO once daily) is suggested. Titrate as needed and tolerated to attain clinical goals.

Renal Impairment

Guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

ADMINISTRATION

Oral Administration
Oral Solid Formulations

Immediate-release tablets
May be administered without regard to meals.

Orally disintegrating tablets (ODT)
Do not remove ODT from the package until just prior to administration.
With dry hands, place the tablet on top of the tongue where it will disintegrate and be swallowed with saliva.
Administration with liquid is not necessary.

Extended-release tablets
Do not chew, break or crush. Patient should swallow whole with a drink of water.
Extended-release tablets should be taken preferably in the morning.

Oral Liquid Formulations

Oral solution
May be administered without regard to meals.
Measure with a calibrated oral liquid medicine measuring device to give an accurate dose.

STORAGE

Generic:
– Discard opened bottle after 90 days
– Protect from light
– Store at room temperature (between 59 to 86 degrees F)
Niravam:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Xanax:
– Store at controlled room temperature (between 68 and 77 degrees F)
Xanax XR:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

Additional information

months

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Tablets

90 tablets, 180 tablets, 270 tablets

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