Alprazolam (Alprazolam)

Trade Name : Alprazolam

Actavis Pharma, Inc.

TABLET, ORALLY DISINTEGRATING

Strength 0.25 mg/1

ALPRAZOLAM Benzodiazepine [EPC],Benzodiazepines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alprazolam (Alprazolam) which is also known as Alprazolam and Manufactured by Actavis Pharma, Inc.. It is available in strength of 0.25 mg/1 per ml. Read more

Alprazolam (Alprazolam) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death see .
  • WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
  • See full prescribing information for complete boxed warning
  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death see .
  • 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.
  • Alprazolam orally disintegrating tabletsu00a0are a benzodiazepine indicated for:
  • The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials ().
  • The treatment of generalized anxiety disorder (). The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials. ().
  • The treatment of panic disorder, with or without agoraphobia ().u00a0
  • 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 per day. In such cases, the dosage should be increased cautiously to avoid adverse reactions. In general, benzodiazepines should be prescribed for short periods. Reevaluate the need for continued therapy before extending the treatment period.
  • With dry hands, place the tablet on top of the tongue where it will disintegrate and be swallowed with saliva ().
  • Depending on response, the dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days (, ).
  • Use the lowest possible effective dose.
  • Periodically reassess the need for continued treatment ().
  • In general, benzodiazepines should be prescribed for short periods ().u00a0Discontinuation of treatment or dose reduction should be gradual and under close physician supervision. Decrease the dosage by no more thanu00a00.5 mg per day every 3 days. Some patients may require an even slower dosage reduction (, ).
  • Dosing in elderly: the starting dose is 0.25 mg, given two or three times daily ().u00a0
  • Severe hepatic impairment: the starting dose is 0.25 mg, given two or three times daily ().u00a0
  • 0.25 mg, 0.5 mg, 1 mg, and 2 mg scored orally disintegrating tablets.
  • 0.25 mg, 0.5 mg, 1 mg, or 2 mg scored orally disintegrating tablets ().
  • Alprazolam orally disintegrating tablets are contraindicated in patients with acute narrow angle glaucoma. Alprazolam orally disintegrating tablets can exacerbate narrow angle closure. Alprazolam orally disintegrating tablets may be used in patients with open angle glaucoma who are receiving appropriate therapy.
  • Alprazolam orally disintegrating tablets are contraindicated in patients treated with potent CYP3A4 inhibitors (e.g., ketoconazole and itraconazole), because these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) and can increase alprazolam exposures n n n n n .
  • Acute narrow angle glaucoma. Alprazolamu00a0can exacerbate narrow angle closure ().
  • Concomitant Use with potent CYP3A inhibitors (e.g., ketoconazole and itraconazole).u00a0Can increase the serum concentration of alprazolam ().
  • No data
  • Suicide:
  • Status Epilepticus and Seizure:
  • Physical dependence
  • Withdrawal reactions
  • Fetal Harm:
  • CNS Depression and Impaired Cognitive and Motor Performance:
  • Interdose anxiety symptoms:
  • Patients with Concomitant Illnessn- :
  • No data
  • Anxiety Disorder
  • Panic Disorder
  • No data
  • Alprazolam produces additive CNS depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistaminics, alcohol and other drugs that produce CNS depression ().n
  • The formulation requires an acidic environment to dissolve; therefore, drugs or diseases that cause dry mouth or raise stomach pH may slow disintegration or dissolution, resulting in decreased absorption ().n
  • Drugs which inhibit the hydroxylation catalyzed by cytochrome P450 3A (CYP3A) metabolic pathway can decrease the clearance of alprazolam and increase the serum concentration ().
  • No data
  • Teratogenic Effects:
  • Nonteratogenic Effects:
  • Nursing n- Mn- others:
  • Geriatric n- Un- se:
  • Pediatric n- Un- se:
  • No data
  • No data
  • Alprazolam orally disintegrating tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds.
  • Alprazolam orally disintegrating tablets, USP are an orally administered formulation of alprazolam which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.
  • The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H--triazolo [4,3-u03b1] [1,4] benzodiazepine. The molecular formula is CHCIN and the molecular weight is 308.76.
  • The structural formula is:
  • Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
  • No data
  • No data
  • No data
  • Alprazolam orally disintegrating tablets, USP are supplied as follows:
  • 0.25 mg - Each white to off-white, round tablet imprinted with on one side and 019 and bisect on the other side contains 0.25 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-4019-11).
  • 0.5 mg - Each white to off-white, round tablet imprinted with on one side and 022 and bisect on the other side contains 0.5 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-4022-11).
  • 1 mg - Each yellow, round tablet imprinted with on one side and 024 and bisect on the other side contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-4024-11).
  • 2 mg - Each yellow, round tablet imprinted with on one side and 025 and bisect on the other side contains 2 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-4025-11).
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00baF) [See USP Controlled Room Temperature]. Protect from moisture.
  • Dispense in tight, light-resistant containers as defined in the USP.
  • Keep container tightly closed.
  • See FDA-approved patient labeling (Medication Guide).n
  • Counseling Information n- for n- All Users of n- Alprazolam Orally Disintegrating Tablets
  • Inform patients and caregivers that potentially fatal additive effects may occur if alprazolam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider n
  • To assure safe and effective use of benzodiazepines, all patients prescribed alprazolam orally disintegrating tabletsu00a0should be provided with the following guidance.
  • Additional Counseling Information for Panic Disorder Patients
  • The use of alprazolam orally disintegrating tabletsu00a0at doses greater than 4 mg per 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 per day, which may or may not be required for your treatment, alprazolam orally disintegrating tabletsu00a0have the potential to cause severe psychological 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 alprazolam orally disintegrating tabletsu00a0did not completely taper off therapy. In a controlled postmarketing discontinuation study of panic disorder patients, the patients treated with doses of alprazolam orally disintegrating tabletsu00a0greater than 4 mg per day had more difficulty tapering to zero dose than patients treated with less than 4 mg per 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 alprazolam orally disintegrating tablets.
  • In addition, the extended use at doses greater than 4 mg per day appears to increase the incidence and severity of withdrawal reactions when alprazolam orally disintegrating tabletsu00a0are 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.
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Rev. A 11/2019
  • Alprazolam (al-PRAE-zoe-lam) Orally Disintegrating Tablet (ODT), u00a0C-IV
  • u00a0n- Rx Only
  • What is the most important information I should know about alprazolam ODT?
  • What is alprazolam ODT?
  • Do not take alprazolam ODT if you:
  • u00a0
  • Before you take alprazolam ODT, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take
  • Taking alprazolam ODT with certain other medicines can cause side effects or affect how well alprazolam ODT or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
  • How should I take alprazolam ODT?
  • u00a0n- What should I avoid while taking alprazolam ODT?
  • What are the possible side effects of alprazolam ODT?
  • Alprazolam ODT may cause serious side effects, including:
  • u00a0
  • The most common side effects of alprazolam ODT include:
  • These are not all the possible side effects of alprazolam ODT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • u00a0
  • How should I store alprazolam ODT?
  • General information about the safe and effective use of alprazolam ODT.n
  • What are the ingredients in alprazolam ODT?n n- Active ingredient: n- Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Rev. A 11/2019
  • NDC 0228--11n n 100 Tabletsn n n n n
  • NDC 0228--11n n 100 Tabletsn n n n
  • u00a0
  • NDC 0228--11n n 100 Tabletsn n n n
  • u00a0
  • Arrayn- Array
  • NDC 0228--11n n 100 Tabletsn n n n
  • u00a0
  • u00a0
  • Arrayn- Array

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