Alprazolam - Extended Release (Alprazolam)

Trade Name : Alprazolam

Actavis Pharma, Inc.

TABLET, EXTENDED RELEASE

Strength 0.5 mg/1

ALPRAZOLAM Benzodiazepine [EPC],Benzodiazepines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alprazolam - Extended Release (Alprazolam) which is also known as Alprazolam and Manufactured by Actavis Pharma, Inc.. It is available in strength of 0.5 mg/1 per ml. Read more

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C-IV
40-9181
Revised u2013 May 2017
Rx Only

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death see .

Alprazolam extended-release tablets, USP 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-4--triazolo [4,3-u03b1] [1,4] benzodiazepine. The molecular formula is CHClN which corresponds to a molecular weight of 308.76.
The structural formula is represented below:
Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
Each alprazolam extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake.
Product meets USP Dissolution Test 2.

No data

Alprazolam extended-release tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia.
This claim is supported on the basis of two positive studies with alprazolam extended-release conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see ).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., 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.
The longer-term efficacy of alprazolam extended-release has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.

Alprazolam extended-release tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.
Alprazolam extended-release 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

The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with alprazolam extended-release tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.
Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.
Adverse Events Observed in Short-Term, Placebo-Controlled Trials of Alprazolam Extended-Release Tablets
Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials
Approximately 17% of the 531 patients who received alprazolam extended-release tablets in placebo-controlled clinical trials for panic disorder had at least one adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients. The most common events leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of the patients treated with alprazolam extended-release tablets at a rate at least twice that of placebo) are shown in the following table.
Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated with Alprazolam Extended-Release Tablets
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 alprazolam extended-release where the incidence in patients treated with alprazolam extended-release was greater than the incidence in placebo-treated patients. The most commonly observed adverse events in panic disorder patients treated with alprazolam extended-release (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).
Other Adverse Events Observed During the Premarketing Evaluation of Alprazolam Extended-Release Tablets
Following is a list of MedDRA terms that reflect treatment-emergent adverse events reported by 531 patients with panic disorder treated with alprazolam extended-release. 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 alprazolam extended-release, 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 1/l00 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients.
Cardiac Disorders: Frequentn- :n- Infrequent:
Ear and Labyrinth Disorders: n- Frequentn- :n- Infrequent
Eye Disorders:n- Frequent: n- Infrequent:
Gastrointestinal Disorders:n- Frequent: n- Infrequent
General Disorders and Administration Site Conditions:n- Frequentn- Infrequent:
Musculoskeletal and Connective Tissue Disorders:n- Frequent
Nervous System Disorders: n- Frequent: n- Infrequen
Psychiatric System Disorders:n- Frequentn- Infrequent:
Renal and Urinary Disorders:n- Frequentn- Infrequent
Respiratory, Thoracic, and Mediastinal Disorders: Frequentn- Infrequent:
Skin and Subcutaneous Tissue Disorders:n- Frequent: n- Infrequent:
Vascular Disordersn- Infrequent:
The categories of adverse events reported in the clinical development program for alprazolam tablets in the treatment of panic disorder differ somewhat from those reported for alprazolam extended-release tablets because the clinical trials with alprazolam tablets and alprazolam extended-release tablets used different standard medical nomenclature for reporting the adverse events. Nevertheless, the types of adverse events reported in the clinical trials with alprazolam tablets were generally the same as those reported in the clinical trials with alprazolam extended-release tablets.
Discontinuation-Emergent Adverse Events Occurring at an Incidence of 5% or More Among Patients Treated with Alprazolam Extended-Release Tablets.
The following table shows the incidence of discontinuation-emergent adverse events that occurred during short-term, placebo-controlled trials in 5% or more of patients treated with alprazolam extended-release where the incidence in patients treated with alprazolam extended-release 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 ).
To discontinue treatment in patients taking alprazolam extended-release tablets, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam extended-release tablets 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.
Various adverse drug reactions have been reported in association with the use of alprazolam 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 alprazolam tablets cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea (see ).
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA atu00a01-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Physical and Psychological Dependence
Withdrawal symptoms similar in character to those noted with sedative/hypnotics and alcohol have occurred following discontinuance of benzodiazepines, including alprazolam. 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 alprazolam 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 alprazolam at doses within the recommended range for the treatment of anxiety (e.g., 0.75 mg/day 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 ).
Patients, especially individuals with a history of seizures or epilepsy, should not be abruptly discontinued from any CNS depressant agent, including alprazolam. It is recommended that all patients on alprazolam who require a dosage reduction be gradually tapered under close supervision (see and ).
Psychological dependence is a risk with all benzodiazepines, including alprazolam. 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 alprazolam, especially those receiving higher doses for extended periods. Addiction-prone individuals should be under careful surveillance when receiving alprazolam. As with all anxiolytics, repeat prescriptions should be limited to those who are under medical supervision.
Alprazolam is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and alprazolam extended-release tablets have been assigned to Schedule IV.

Clinical Experience
Overdosage reports with alprazolam tablets are limited. 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 fatality.
Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage.
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 complete flumazenil package insert including and u00a0should be consulted prior to use.

Alprazolam extended-release tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.
The suggested total daily dose ranges between 3 mg/day to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.

Alprazolam extended-release tablets, USP are available as follows:
0.5 mg u2014 Each white to off white, round tablet imprinted with on one side and 83 on the other contains 0.5 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3083-06).
1 mg u2014 Each yellow, round tablet imprinted with on one side and 84 on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3084-06).
2 mg u2014 Each peach, round tablet imprinted with on one side and 87 on the other contains 2 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3087-06).
3 mg u2014 Each light green, round tablet imprinted with on one side and 86 on the other contains 3 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3086-06).
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP.
ANIMAL STUDIES
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.
Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USAn Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
40-9181
Revised u2013 May 2017

Alprazolam (al pra' zoe lam) Extended-Release Tablets, USPu00a0u00a0u00a0u00a0u00a0 C-IV
What is the most important information I should know about alprazolam extended-release tablets?
What are alprazolam extended-release tablets?
Do not take alprazolam extended-release tablets if:
Before you take alprazolam extended-release tablets, 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 extended-release tablets with certain other medicines can cause side effects or affect how well alprazolam extended-release tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
How should I take alprazolam extended-release tablets?
What should I avoid while taking alprazolam extended-release tablets?
What are the possible side effects of alprazolam extended-release tablets?
Alprazolam extended-release tablets may cause serious side effects, including:
The most common side effects of alprazolam extended-release tablets include:
These are not all the possible side effects of alprazolam extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store alprazolam extended-release tablets?
General information about the safe and effective use of alprazolam extended-release tablets.
What are the ingredients in alprazolam extended-release tablets?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
40-9181
Revised u2014 May 2017

NDC 0228--06
CIV
Alprazolam Extended-Release Tablets, USPu00a0u00a0u00a0
0.5 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Actavis
60 Tablets
Rx Only

NDC 0228--06
CIV
Alprazolam Extended-Release Tablets, USPu00a0u00a0u00a0
1 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Actavis
60 Tablets
Rx Only

NDC 0228--06
CIV
Alprazolam Extended-Release Tablets, USPu00a0u00a0u00a0
2 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Actavis
60 Tablets
Rx Only

NDC 0228--06
CIV
Alprazolam Extended-Release Tablets, USPu00a0u00a0u00a0
3 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Actavis
60 Tablets
Rx Only

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Alprazolam - Extended Release (Alprazolam)

Trade Name : Alprazolam

TABLET, EXTENDED RELEASE

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Alprazolam - Extended Release (Alprazolam)

Trade Name : Alprazolam

TABLET, EXTENDED RELEASE

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