Diazepam 5mg Tablets

• Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for patients for whom alternative treatment options are inadequate.
• Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics): Additive CNS depressant effects, leading to increased sedation, respiratory depression, and psychomotor impairment.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May significantly increase diazepam plasma concentrations, leading to increased and prolonged sedative effects.
• Strong CYP2C19 inhibitors (e.g., fluoxetine, fluvoxamine, omeprazole): May significantly increase diazepam plasma concentrations.

• Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, grapefruit juice): May increase diazepam levels.
• Moderate CYP2C19 inhibitors (e.g., cimetidine, esomeprazole): May increase diazepam levels.
• Phenytoin: Diazepam may alter phenytoin levels (increase or decrease); monitor phenytoin levels.
• Digoxin: Diazepam may increase digoxin levels.

• Antacids: May delay the rate of diazepam absorption but not the extent.

• Excessive sedation
• Dizziness
• Confusion
• Ataxia (impaired coordination)
• Slurred speech
• Respiratory depression (slow, shallow breathing)
• Paradoxical reactions (e.g., excitement, aggression, hallucinations)
• Signs of withdrawal upon discontinuation (e.g., rebound anxiety, insomnia, tremors, seizures, muscle cramps, vomiting, sweating)

Category D. Diazepam can cause fetal harm when administered to a pregnant woman. There is evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g., in life-threatening situations or for a serious disease for which safer drugs cannot be used or are ineffective).

Diazepam and its active metabolites are excreted into breast milk. Due to the long half-life of diazepam and its active metabolites, accumulation can occur in the infant, leading to sedation, poor feeding, and weight loss. Use is generally not recommended during breastfeeding.

Not recommended for use in infants younger than 6 months due to potential for prolonged sedation and respiratory depression. Use with caution in older children; start with the lowest effective dose and titrate slowly. Children may be more sensitive to the CNS depressant effects.

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased sedation, dizziness, ataxia, and falls. Reduced hepatic metabolism and renal clearance can lead to prolonged half-life and accumulation. Lower initial doses (e.g., 2-2.5 mg 1-2 times daily) are recommended, and titration should be done slowly with close monitoring.

• Diazepam has a very long half-life and active metabolites, leading to prolonged effects and potential for accumulation, especially with repeated dosing or in patients with impaired liver function.
• Due to its rapid onset of action, diazepam is often preferred for acute anxiety, acute alcohol withdrawal, or acute muscle spasms.
• Tolerance and physical dependence can develop with chronic use. Tapering is crucial to avoid withdrawal symptoms.
• Paradoxical reactions (e.g., excitement, aggression, hallucinations) can occur, particularly in pediatric, geriatric, or psychiatric patients.
• The 5mg tablet is a common starting dose for many indications, but individual patient response and tolerability should guide titration.
• Educate patients thoroughly about the risks of concomitant opioid use and the importance of not abruptly discontinuing the medication.

• Other benzodiazepines (e.g., lorazepam, alprazolam, clonazepam) for anxiety or seizures.
• Buspirone for generalized anxiety disorder (non-benzodiazepine).
• SSRIs (e.g., escitalopram, sertraline) or SNRIs (e.g., venlafaxine, duloxetine) for long-term management of anxiety disorders.
• Anticonvulsants (e.g., levetiracetam, valproic acid) for seizure disorders.
• Muscle relaxants (e.g., cyclobenzaprine, tizanidine) for muscle spasms.
• Beta-blockers (e.g., propranolol) for situational anxiety (e.g., performance anxiety).
• Non-pharmacological therapies such as cognitive behavioral therapy (CBT), psychotherapy, and lifestyle modifications.