Alprazolam ODT C-IV .5 mg/1
Alprazolam ODT C-IV · TABLET, ORALLY DISINTEGRATING · Direct_Rx
Alprazolam ODT C-IV is a prescription tablet, orally disintegrating containing alprazolam odt c-iv at .5 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Alprazolam ODT C-IV
- Generic Name
- Alprazolam ODT C-IV
- NDC Code (Product)
72189-637- Manufacturer
- Direct_Rx
- Strength
- .5 mg/1
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA078088
- Drug Class
- Benzodiazepine [EPC]; Benzodiazepines [CS]
- Marketing Start
- 08/22/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1.1 Generalized Anxiety Disorder Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials [see Clinical Studies (14.1)]. 1.2 Panic Disorder Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials [see Clinical Studies (14.2)]. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
Dosage & Administration
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. 2.1 Generalized Anxiety Disorder Initiate treatment with a dose of 0.25 mg to 0.5 mg three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. Use the lowest possible effective dose, and periodically reassess the need for continued treatment. The risk of dependence can increase with dose and duration of treatment. 2.2 Panic Disorder The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 mg to 10 mg daily were used. The mean dosage employed was approximatel…
Contraindications
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 [see Clinical Pharmacology (12.3), Warnings and Precautions (5.9), and Drug Interactions (7.4)].
Drug Interactions
7.1 Use with Other CNS Depressants 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 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. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. If alprazolam orally disintegrating tablets are coadministered with other psychotropic agents or anticonvulsant drugs, carefully consider the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines. The benzodiazepines, including alprazolam, produce additive CNS depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistaminics, alcohol and other drugs which themselves produce CNS depression. 7.2 Drugs Effecting Salivary Flow and Stomach pH Because alprazolam orally disintegrating tab…
Adverse Reactions
6.1 Clinical Trial Experience The most commonly reported (greater than or equal to 5% and ~ twice the rate of placebo) adverse reactions with alprazolam treatment are: sedation, impaired coordination, dysarthria, and increased libido. The data cited in the two tables below are estimates of adverse reactions occurring in patients who participated in clinical trials under the following conditions: relatively short duration (four weeks) placebo-controlled clinical studies with dosages up to 4 mg per 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 per day of alprazolam in patients with panic disorder, with or without agoraphobia. 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. Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and n…
Frequently Asked Questions
What is Alprazolam ODT C-IV used for?
Alprazolam ODT C-IV contains Alprazolam ODT C-IV. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.
Is Alprazolam ODT C-IV a controlled substance?
Yes, Alprazolam ODT C-IV is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Alprazolam ODT C-IV?
The generic name for Alprazolam ODT C-IV is Alprazolam ODT C-IV. There are no other listed brand versions of Alprazolam ODT C-IV.
What is the NDC code for Alprazolam ODT C-IV .5 mg/1?
The NDC (National Drug Code) for Alprazolam ODT C-IV .5 mg/1 is 72189-637, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)