ox-AZ-e-pam

Therapeutic Classification: antianxiety agents, sedative/hypnotics

Pharmacologic Classification: benzodiazepines

• Anxiety.
• Symptomatic treatment of alcohol withdrawal.

• Depresses the CNS, probably by potentiating GABA, an inhibitory neurotransmitter.

• Decreased anxiety.
• Diminished symptoms of alcohol withdrawal.

Absorption: Well absorbed following oral administration. Absorption is slower than with other benzodiazepines.

Distribution: Widely distributed. Crosses the blood-brain barrier. May cross the placenta and enter breast milk.

Metabolism/Excretion: Metabolized by the liver to inactive compounds.

Protein Binding: 97%.

Half-life: 5–15 hr.

(sedation)

Contraindicated in:

• Hypersensitivity
• Cross-sensitivity with other benzodiazepines may exist
• Comatose patients or those with pre-existing CNS depression
• Uncontrolled severe pain
• Angle-closure glaucoma
• Some products contain tartrazine and should be avoided in patients with known intolerance.

Use Cautiously in:

• Hepatic impairment (may be preferred over some benzodiazepines due to short half-life)
• History of suicide attempt or substance use disorder
• Severe chronic obstructive pulmonary disease
• Myasthenia gravis
• OB: Use late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in neonates.
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <6 yr (safety and effectiveness not established)
• Geri: Appears on Beers list. ↑ risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults. If possible, avoid use in older adults.

CV: tachycardia.

Derm: rash.

EENT: blurred vision.

GI: constipation, diarrhea, drug-induced hepatitis, nausea, vomiting.

GU: urinary problems.

Hemat: leukopenia.

Neuro: dizziness, drowsiness, confusion, depression, hangover, headache, impaired memory, paradoxical excitation, slurred speech.

Resp: respiratory depression.

Misc: physical dependence, psychological dependence, tolerance.

Drug-Drug:

• Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, and other sedative/hypnotics (including other benzodiazepines).
• May ↓ the therapeutic effectiveness of levodopa.
• Hormonal contraceptives or phenytoin may ↓ effectiveness.
• Theophylline may ↓ sedative effects.

Drug-Natural Products:

• Concomitant use of kava-kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

• PO (Adults): Antianxiety agent: 10–30 mg 3–4 times daily. Sedative/hypnotic/management of alcohol withdrawal: 15–30 mg 3–4 times daily.
• PO (Geriatric Patients): 5 mg 1–2 times daily initially or 10 mg 3 times daily; may be ↑ as needed.

(Generic available)

• Capsules: 10 mg; 15 mg; 30 mg;
• Tablets: 10 mg; 15 mg; 30 mg;

• Assess patient for anxiety and orientation, mood and behavior.
• Assess level of sedation (ataxia, dizziness, slurred speech) periodically during therapy.
• Assess regularly for continued need for treatment.
• Prolonged high-dose therapy may lead to psychological or physical dependence. Restrict the amount of drug available to patient.
• Assess risk for addiction, abuse, or misuse prior to administration and periodically during therapy.
• Geri: Assess CNS effects and risk of falls. Institute falls prevention strategies.

• Monitor CBC and liver function tests periodically during prolonged therapy.
  • May cause decreased thyroidal uptake of ¹²³I and ¹³¹I.

• Medication should be tapered at the completion of therapy (taper by 0.5 mg every 3 days). Sudden cessation of medication may lead to withdrawal (insomnia, irritability, nervousness, tremors).
• PO: Administer with food if GI irritation becomes a problem.

• Instruct patient to take oxazepam exactly as directed. Missed doses should be taken within 1 hr; if remembered later, omit and return to regular dosing schedule. Do not double or increase doses. If dose is less effective after a few wk, notify health care professional.
• Inform patient that oxazepam is usually prescribed for short-term use; do not take more than prescribed or for a longer period than prescribed.
• Advise patient that oxazepam is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• Teach other methods to decrease anxiety, such as increased exercise, support group, relaxation techniques.
• May cause drowsiness or dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to avoid the use of alcohol, other CNS depressants, including opioids, and to consult health care professional prior to the use of OTC preparations that contain antihistamines or alcohol. May cause overdose.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Rep: May cause fetal harm. Advise females of reproductive potential to use a nonhormonal method of contraception during use. Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. Monitor infants exposed to oxazepam during 2nd and 3rd trimester or immediately prior to or during childbirth for decreased fetal movement and/or fetal heart rate variability, "floppy infant syndrome," dependence, and symptoms of withdrawal (hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, vomiting); may occur shortly after delivery up to 3 wk after birth. Monitor breast-fed infants for sedation and poor sucking. Encourage pregnant patients to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334; information is available at .
• Emphasize the importance of follow-up exams to monitor effectiveness of medication.
• Geri: Instruct patient and family how to reduce falls risk at home.

• Decreased sense of anxiety.
  • Increased ability to cope.
• Prevention or relief of acute agitation, tremor, and hallucinations during alcohol withdrawal.

Serax

Schedule IV (C-IV)

NDC Code^*

• 0228- Actavis Pharma, Inc.
  • 0228-2067- Oxazepam
    • 0228-2067-10- 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0228-2067-10)

• 0228- Actavis Pharma, Inc.
  • 0228-2069- Oxazepam
    • 0228-2069-10- 100 CAPSULE, GELATIN COATED in 1 BLISTER PACK (0228-2069-10)

• 0228- Actavis Pharma, Inc.
  • 0228-2073- Oxazepam
    • 0228-2073-10- 100 CAPSULE, GELATIN COATED in 1 BOTTLE (0228-2073-10)

• 43353- Aphena Pharma Solutions - Tennessee, Inc.
  • 43353-074- Oxazepam
    • 43353-074-30- 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-074-30)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-965- Oxazepam
    • 43353-965-30- 30 CAPSULE in 1 BOTTLE (43353-965-30)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-965- Oxazepam
    • 43353-965-53- 60 CAPSULE in 1 BOTTLE (43353-965-53)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-965- Oxazepam
    • 43353-965-60- 90 CAPSULE in 1 BOTTLE (43353-965-60)

• 43353- Aphena Pharma Solutions - Tennessee, LLC
  • 43353-980- Oxazepam
    • 43353-980-30- 30 CAPSULE in 1 BOTTLE (43353-980-30)

• 52817- TruPharma, LLC
  • 52817-290- Oxazepam
    • 52817-290-10- 100 CAPSULE in 1 BOTTLE (52817-290-10)

• 52817- TruPharma, LLC
  • 52817-291- Oxazepam
    • 52817-291-10- 100 TABLET in 1 BOTTLE (52817-291-10)

• 62584- American Health Packaging
  • 62584-812- Oxazepam
    • 62584-812-01- 100 BLISTER PACK in 1 CARTON (62584-812-01) > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-812-11)

• 62584- American Health Packaging
  • 62584-813- Oxazepam
    • 62584-813-01- 100 BLISTER PACK in 1 CARTON (62584-813-01) > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-813-11)

• 62584- American Health Packaging
  • 62584-814- Oxazepam
    • 62584-814-01- 100 BLISTER PACK in 1 CARTON (62584-814-01) > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-814-11)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-117- Oxazepam
    • 67544-117-30- 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-30)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-117- Oxazepam
    • 67544-117-53- 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-53)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-117- Oxazepam
    • 67544-117-60- 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-60)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-117- Oxazepam
    • 67544-117-70- 120 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-70)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-268- Oxazepam
    • 67544-268-30- 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-268-30)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-268- Oxazepam
    • 67544-268-53- 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-268-53)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-268- Oxazepam
    • 67544-268-60- 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-268-60)

• 67544- Aphena Pharma Solutions - Tennessee, LLC
  • 67544-268- Oxazepam
    • 67544-268-70- 120 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-268-70)