Alprazolam (Alprazolam)

Trade Name : Alprazolam

Aidarex Pharmaceuticals LLC

TABLET

Strength 0.5 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 Aidarex Pharmaceuticals LLC. It is available in strength of 0.5 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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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.

Read more
  • No data
  • Alprazolam 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 [4,3-1] [1,4] benzodiazepine.
  • The structural formula is represented to the right:
  • Alprazolam is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
  • Each ALPRAZOLAM Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.
  • Inactive ingredients: crospovidone, docusate sodium, lactose, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium benzoate and starch 1500. In addition, the 0.5 mg tablet contains D&C Yellow No. 10 and the 1 mg and 2 mg tablet contains Green Lake Blend.
  • No data
  • No data
  • No data
  • ALPRAZOLAM Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. ALPRAZOLAM may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.
  • ALPRAZOLAM is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see and ).
  • No data
  • No data
  • Side effects to ALPRAZOLAM 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 ALPRAZOLAM (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 ALPRAZOLAM in patients with panic disorder, with or without agoraphobia.
  • 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.
  • 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.
  • 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 ALPRAZOLAM: 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 ).
  • u00a0In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received ALPRAZOLAM, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with ALPRAZOLAM and at a greater rate than the placebo treated group were as follows:
  • From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with ALPRAZOLAM in patients with panic disorder.
  • There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of ALPRAZOLAM Tablets (see ).
  • To discontinue treatment in patients taking ALPRAZOLAM, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of ALPRAZOLAM be decreased by no more than 0.5 mg every three days (see ). 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:
  • No data
  • No data
  • 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.
  • ALPRAZOLAM Tablets are available as follows:
  • 0.25 mg
  • Bottles of 10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-10
  • Bottles ofu00a015u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-15
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0594-30
  • Bottles ofu00a042u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0594-42
  • Bottles ofu00a045u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-45
  • Bottles ofu00a060u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-60
  • Bottles ofu00a090u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-90
  • Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-100
  • Bottles of 120u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0594-120
  • 0.5 mg
  • Bottles of 10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-10
  • Bottles ofu00a015u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-15
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0004-30
  • Bottles ofu00a042u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0004-42
  • Bottles ofu00a045u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-45
  • Bottles ofu00a060u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-60
  • Bottles ofu00a090u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-90
  • Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-100
  • Bottles of 120u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0004-120
  • 1 mg
  • Bottles of 10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-10
  • Bottles ofu00a015u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-15
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0005-30
  • Bottles ofu00a042u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0005-42
  • Bottles ofu00a045u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-45
  • Bottles ofu00a060u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-60
  • Bottles ofu00a090u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-90
  • Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-100
  • Bottles of 120u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0005-120
  • 2 mg
  • Bottles of 10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-10
  • Bottles ofu00a015u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-15
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0500-30
  • Bottles ofu00a042u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 33261-0500-42
  • Bottles ofu00a045u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-45
  • Bottles ofu00a060u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-60
  • Bottles ofu00a090u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-90
  • Bottles of 100u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-100
  • Bottles of 120u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 33261-0500-120
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. n n
  • Rx only
  • 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.n n
  • Manufactured for:
  • DAVA Pharmaceuticals, Inc.
  • Fort Lee, NJ 07024, USAn n
  • By:
  • ULTRAtab Laboratories, Inc.
  • Highland, NY 12528, USAn n
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Rev. 09/10
  • Arrayn- Array
  • NDC 33261-0594-60
  • ALPRAZOLAM TABLETS, USPn- C-IV
  • 0.25 mg
  • 60 tablets
  • Rx only
  • Each tablet contains:
  • Alprazolam, USP 0.25 mg
  • Usual Dosage:
  • See attached product literature. This is a bulk
  • package, not intended for household use.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See
  • USP Controlled Room Temperature]. Keep container tightly closed.
  • Dispense in a tight, light-resistant
  • container with a child-resistant n- closure.
  • Manufactured for:
  • DAVA Pharmaceuticals, Inc.
  • Fort Lee, NJ 07024, USA
  • By:
  • ULTRAtab Laboratories, Inc.
  • Highland, NY 12528, USA
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Rev. 09/10
  • Arrayn- Array
  • NDC 33261-0004-30
  • ALPRAZOLAM TABLETS, USPn- C-IV
  • 0.5 mg
  • 30 tablets
  • Rx only
  • Each tablet contains:
  • Alprazolam, USP 0.5 mg
  • Usual Dosage:
  • See attached product literature. This is a bulk
  • package, not intended for household use.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See
  • USP Controlled Room n- Temperature]. Keep container tightly closed.
  • Dispense in a tight, light-resistant
  • container with a child-resistant n- closure.
  • Manufactured for:
  • DAVA Pharmaceuticals, Inc.
  • Fort Lee, NJ 07024, USA
  • By:
  • ULTRAtab Laboratories, Inc.
  • Highland, NY 12528, USA
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Rev. 2/11
  • Arrayn- Array
  • NDC 33261-0005-60
  • ALPRAZOLAM TABLETS, USPn- C-IV
  • 1 mg
  • 60 tablets
  • Rx only
  • Each tablet contains:
  • Alprazolam, USP 1 mg
  • Usual Dosage:
  • See attached product literature. This is a bulk
  • package, not intended for household use.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See
  • USP Controlled Room Temperature]. Keep container tightly closed.
  • Dispense n- in a tight, light-resistant container with
  • a child-resistant closure.
  • Manufactured for:
  • DAVA Pharmaceuticals, Inc.
  • Fort Lee, NJ 07024, USA
  • By:
  • ULTRAtab Laboratories, Inc.
  • Highland, NY 12528, USA
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Rev. 9/10
  • Arrayn- Array
  • NDC 33261-0500-60
  • ALPRAZOLAM TABLETS, USPn- C-IV
  • 2 mg
  • 60 tablets
  • Rx only
  • Each tablet contains:
  • Alprazolam, USP 2 mg
  • Usual Dosage:
  • See attached product literature. This is a bulk
  • package, not intended for household use.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See
  • USP Controlled Room
  • Temperature]. Keep container tightly closed.
  • Dispense in a tight, light-resistant
  • container with a child-resistant n- closure.
  • Manufactured for:
  • DAVA Pharmaceuticals, Inc.
  • Fort Lee, NJ 07024, USA
  • By:
  • ULTRAtab Laboratories, Inc.
  • Highland, NY 12528, USA
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • Rev. 9/10

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