Alprazolam C-IV 1 mg/1
Alprazolam C-IV · TABLET · Direct_Rx
Alprazolam C-IV is a tablet containing alprazolam c-iv at 1 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Alprazolam C-IV
- Generic Name
- Alprazolam C-IV
- NDC Code (Product)
72189-443- Manufacturer
- Direct_Rx
- Strength
- 1 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA203346
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 03/14/2023
Recall History
Direct Rx
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Direct Rx
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Direct Rx
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Direct Rx
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Direct Rx
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Full Prescribing Information
Indications & Usage
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 & Administration
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. Controlled trials of alprazolam tablets in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day. For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with…
Contraindications
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)]
Drug 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. Prevention or management Limit dosage and duration of concomitant use of alprazolam and opioids, and monitor patients closely for respiratory depression and sedation [see WARNINGS AND PRECAUTIONS (5.1)]. Examples Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorpenol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. CNS Depressants Clinical implication The benzodiazepines, includ…
Adverse Reactions
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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in: 4-week placebo-controlled clinical studies with alprazolam dosages up to 4 mg per day for the acute treatment of generalized anxiety disorder (Table 1) Short-term …
Frequently Asked Questions
What is Alprazolam C-IV used for?
Alprazolam C-IV contains Alprazolam C-IV. It is a tablet taken oral. Consult your doctor for specific uses.
Is Alprazolam C-IV a controlled substance?
Yes, Alprazolam C-IV is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Alprazolam C-IV?
The generic name for Alprazolam C-IV is Alprazolam C-IV. There are no other listed brand versions of Alprazolam C-IV.
What is the NDC code for Alprazolam C-IV 1 mg/1?
The NDC (National Drug Code) for Alprazolam C-IV 1 mg/1 is 72189-443, listed by Direct_Rx.
Other Alprazolam C-IV Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)