Alprazolam C-iv
Generic Name: alprazolam c-iv
Brand Names:
Alprazolam C-iv
Alprazolam 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-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is: [Chemical Structure] Alprazolam USP 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.
Overview
Alprazolam 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-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is: [Chemical Structure] Alprazolam USP 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.
Uses
Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults.
Dosage
2.1 Dosage in Generalized Anxiety Disorder The recommended starting oral dosage of alprazolam tablets for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses). Use the lowest possible effective dose and frequently assess the need for continued treatment [see WARNINGS AND PRECAUTIONS (5.2)]. 2.2 Dosage in Panic Disorder The recommended starting oral dosage of alprazolam tablets for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.
Side Effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS (5.1)] Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS (5.2)] Dependence and Withdrawal Reactions [see WARNINGS AND PRECAUTIONS (5.3)] Effects on Driving and Operating Machinery [see WARNINGS AND PRECAUTIONS (5.4)] Patients with Depression [see WARNINGS AND PRECAUTIONS (5.6)] Neonatal Sedation and Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS (5.8)] Risks in Patients with Impaired Respiratory Function [see WARNINGS AND PRECAUTIONS (5.9)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be...
Interactions
7.1 Drugs Having Clinically Important Interactions with Alprazolam Table 4 includes clinically significant drug interactions with alprazolam [see CLINICAL PHARMACOLOGY (12.3)]. Table 4: Clinically Significant Drug Interactions with Alprazolam Opioids Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at gamma-aminobutyric acid(GABAA) sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Warnings
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. 5.1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including alprazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Alprazolam tablets are contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see ADVERSE REACTIONS (6.2)]. taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see DOSAGE AND ADMINISTRATION (2.6), WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7.1)]
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Alprazolam C-iv used for?▼
Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults.
What are the side effects of Alprazolam C-iv?▼
The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS (5.1)] Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS (5.2)] Dependence and Withdrawal Reactions [see WARNINGS AND PRECAUTIONS (5.3)] Effects on Driving and Operating Machinery [see WARNINGS AND PRECAUTIONS (5.4)] Patients with Depression [see WARNINGS AND PRECAUTIONS (5.6)] Neonatal Sedation and Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS (5.8)] Risks in Patients with Impaired Respiratory Function [see WARNINGS AND PRECAUTIONS (5.9)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be...
What are the important warnings for Alprazolam C-iv?▼
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. 5.1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including alprazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Alprazolam tablets are contraindicated in patients: with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see ADVERSE REACTIONS (6.2)]. taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see DOSAGE AND ADMINISTRATION (2.6), WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7.1)]
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.