Triazolam .125 mg/1
Triazolam · TABLET · Zydus Lifesciences Limited
Triazolam is a tablet containing triazolam at .125 mg/1, taken oral. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Triazolam
- Generic Name
- Triazolam
- NDC Code (Product)
70771-1576- Manufacturer
- Zydus Lifesciences Limited
- Strength
- .125 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA213003
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 12/30/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam tablets are a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults: Recommended dosage is 0.25 mg once daily before bedtime. Maximum recommended dosage is 0.5 mg once daily ( 2.1 ) Geriatric patients: Reduce starting dosage to 0.125 mg once daily. May increase to 0.25 mg if no response. Geriatric patients should not exceed 0.25 mg once daily ( 2.2 , 8.5 ) Triazolam should not be prescribed in quantities exceeding a 1-month supply ( 2.1 ) 2.1 Dosing Information The recommended dosage is 0.25 mg once daily before bedtime. A dosage of 0.125 mg once daily may be sufficient for some patients (e.g., patients with low body weight). A dosage of 0.5 mg should be used only for patients who do not respond adequately to a trial of a lower dose. The maximum recommended dosage is 0.5 mg once daily. Use the lowest effective dose for the patient as there are significant dose related adverse reactions. Use of triazolam for more than 3 weeks requires evaluation of the patient for a primary psychiatric or medical condition [see Warnings and Precautions ( 5.4 , 5.6 )] . Prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. 2.2 Use in …
Contraindications
4 CONTRAINDICATIONS Triazolam is contraindicated in: Patients with known hypersensitivity to triazolam, any of component of triazolam, or other benzodiazepines. Reactions consistent with angioedema (involving the tongue, glottis, or larynx), dyspnea, and throat closing have been reported and may be fatal. Concomitant administration of strong cytochrome P450 (CYP 3A) enzyme inhibitors (e.g., ketoconazole, itraconazole, nefazodone, lopinavir, ritonavir) [see Warnings and Precautions ( 5.8 ), Drug Interactions ( 7.1 )]. Known hypersensitivity to triazolam or other benzodiazepines ( 4 ) Concomitant use with medications that significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) including ketoconazole, itraconazole, nefazodone, and several human immunodeficiency virus (HIV) protease inhibitors ( 4 , 5.8 , 17 )
Drug Interactions
7 DRUG INTERACTIONS Use with Opioids: Increase the risk of respiratory depression ( 7.1 ) Use with Other CNS Depressants: Produces additive CNS depressant effects ( 7.1 ) Use with CYP 3A4 Inhibitors: Increased risk of adverse reactions ( 4 , 5.8 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions With Triazolam Table 2 includes clinically significant drug interactions with triazolam [see Clinical Pharmacology ( 12.3 )] . Table 2 Clinically Important Drug Interactions with Triazolam 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 GABA A 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 triazolam and opioids, and monitor patients closely for respiratory depression and sedation [see Warnings and Precautions ( 5.1 )] . CNS Depressants Clinical implication Triazolam prod…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: 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 )] Persistent or Worsening Insomnia [see Warnings and Precautions ( 5.4 )] "Sleep-driving" and Other Complex Behaviors [see Warnings and Precautions ( 5.5 )] Central Nervous System Manifestations [see Warnings and Precautions ( 5.6 )] Effects on Driving and Operating Heavy Machinery [see Warnings and Precautions ( 5.7 )] Patients with Depression [see Warnings and Precautions ( 5.9 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.10 )] Compromised Respiratory Function [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence ≥4% and twice placebo) are drowsiness, dizziness, light-headedness, and coordination disorder/ataxia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experienc…
Frequently Asked Questions
What is Triazolam used for?
Triazolam contains Triazolam. It is a tablet taken oral. Consult your doctor for specific uses.
Is Triazolam a controlled substance?
Yes, Triazolam is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Triazolam?
The generic name for Triazolam is Triazolam. There are 1 other brand versions of Triazolam.
What is the NDC code for Triazolam .125 mg/1?
The NDC (National Drug Code) for Triazolam .125 mg/1 is 70771-1576, listed by Zydus Lifesciences Limited.