Pronunciation:

ox-AZ-e-pam

Brand Names:

• Serax

Dosage Forms:

• Capsule

Warnings:

Warning: Risks from Concomitant use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal ReactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimum required.Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including oxazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing oxazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including oxazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of oxazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage .

Classifications:

Therapeutic—

Antianxiety

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

Oxazepam is used to relieve symptoms of anxiety, including anxiety caused by depression, and the symptoms of alcohol withdrawal. This medicine may also be used to treat tension, agitation, and irritability in older patients. Oxazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of oxazepam in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, lightheadedness, fainting, unusual behavior) and age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving oxazepam.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clobazam
• Clonazepam
• Codeine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Doxylamine
• Esketamine
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Ivacaftor
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rifapentine
• St John's Wort
• Theophylline

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, or history of or
• Depression, or history of or
• Hypotension (low blood pressure) or
• Lung or breathing problems (eg, respiratory depression) or
• Mental health problems, or history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Mental illness (eg, bipolar disorder, schizophrenia)—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For anxiety:
    • Adults—10 to 30 milligrams (mg) 3 or 4 times a day.
    • Older adults—At first, 10 mg 3 times a day. Your doctor may increase your dose if needed.
    • Children 6 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 6 years of age—Use is not recommended.
  • For alcohol withdrawal:
    • Adults—15 to 30 milligrams (mg) 3 or 4 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine is for short-term use only, which is generally considered less than 4 months. If your condition does not improve or if it becomes worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including hallucinations, nausea or vomiting, seizures, stomach or muscle cramps, tremors, sweating, or unusual behavior.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Symptoms of an overdose include: blurred vision, change in consciousness, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, loss of consciousness, loss of strength or energy, confusion, muscle pain or weakness, shakiness and unsteady walk, sleepiness or unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, sweating, or unsteadiness, trembling, or other problems with muscle control or coordination. Call your doctor right away if you notice these symptoms.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Black, tarry stools

chest pain

chills

clay-colored stools

cough

dark urine

dizziness

fainting

fever with or without chills

headache

itching or rash

light-colored stools

loss of appetite

nausea and vomiting

painful or difficult urination

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

slurred speech

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

swelling

swollen glands

trouble breathing

unpleasant breath odor

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Incidence not known

Being forgetful

confusion about identity, place, and time

cough or hoarseness

decreased awareness or responsiveness

false or unusual sense of well-being

general feeling of tiredness or weakness

hallucinations

loss of bladder control

loss of memory

lower back or side pain

nightmares

pale skin

problems with memory

severe sleepiness

trouble sleeping

unusual excitement, nervousness, restlessness, or irritability

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

change in consciousness

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

loss of consciousness

loss of strength or energy

muscle pain or weakness

shakiness and unsteady walk

sweating

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Decreased interest in sexual intercourse

feeling of constant movement of self or surroundings

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

loss in sexual ability, desire, drive, or performance

rash with flat lesions or small raised lesions on the skin

sensation of spinning

Incidence not known

Double vision

menstrual changes

seeing double

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.