temazepam 30 mg/1
temazepam · CAPSULE · Bryant Ranch Prepack
temazepam is a capsule containing temazepam at 30 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- temazepam
- Generic Name
- temazepam
- NDC Code (Product)
72162-1825- Manufacturer
- Bryant Ranch Prepack
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA071457
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 04/21/1987
Recall History
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Failed Stability Specifications
Aidapak Services, LLC
Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, NDC 00904506260, Pedigree: AD28333_1, EXP: 5/8/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD49414_7, EXP: 5/17/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Dosage & Administration
DOSAGE AND ADMINISTRATION While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined. Discontinuation or Dosage Reduction of Temazepam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly ( see WARNINGS , Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE : Dependence ).
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam, 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 temazepam 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking temazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when temazepam is used …
Adverse Reactions
ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular – dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses – hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%). To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pha…
Frequently Asked Questions
What is temazepam used for?
temazepam contains temazepam. It is a capsule taken oral. Consult your doctor for specific uses.
Is temazepam a controlled substance?
Yes, temazepam is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for temazepam?
The generic name for temazepam is temazepam. There are 4 other brand versions of temazepam.
What is the NDC code for temazepam 30 mg/1?
The NDC (National Drug Code) for temazepam 30 mg/1 is 72162-1825, listed by Bryant Ranch Prepack.