Serax (Oral)

Oxazepam is used to help with symptoms of anxiety, including anxiety that may come from depression, and also for symptoms of alcohol withdrawal. It can also be used to treat tension, agitation, and irritability in older patients. Oxazepam is a benzodiazepine. Benzodiazepines are part of a group of medicines called central nervous system (CNS) depressants, which slow down the nervous system.

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

It is very important that your doctor check your progress at regular visits to ensure 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 usually considered less than 4 months. If your condition does not improve or if it gets 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 prevent getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people, especially older individuals, to feel drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than usual. 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 increase the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, possibly causing drowsiness or making you less alert. Some examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, barbiturates or medicines 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 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 your condition from worsening 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 take 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the effects of oxazepam in children younger than 6 years. Safety and effectiveness have not been established for this age group.

Geriatric

Appropriate studies done so far have not shown specific problems in older adults that would limit the usefulness of oxazepam. However, older patients are more likely to experience side effects (such as severe drowsiness, dizziness, lightheadedness, fainting, unusual behavior) and age-related kidney or liver issues, which may require caution and a dose adjustment for those taking oxazepam.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together, in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe 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 needed in some cases. If both medicines are prescribed together, your doctor may change the dose or the frequency of use for one or both 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 increase the risk of certain side effects, but using both drugs may be necessary for your treatment. 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been chosen based on their potential significance and may not be all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or give you special instructions regarding food, alcohol, or tobacco use.

• Cabbage

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical problems, especially:

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

• Kidney disease or
• Liver disease—Use with caution. Effects may be stronger because the body removes the medicine more slowly.

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

Along with its needed effects, Serax (Oral) 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 Serax (Oral). 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.

In the U.S.

• Serax

Available Dosage Forms:

• Capsule

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

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.