Oxazepam

Oxazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Anxiety associated with depression is also responsive to Oxazepam therapy.

This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients.

Alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy.

The effectiveness of Oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antihistamines such as diphenhydramine (Benadryl)
• digoxin (Lanoxin)
• levodopa (Larodopa, Sinemet)
• medication for depression, seizures, Parkinson's disease, pain, asthma, colds, or allergies
• muscle relaxants
• oral contraceptives
• phenytoin (Dilantin)
• probenecid (Benemid)
• rifampin (Rifadine)
• sedatives
• sleeping pills
• theophylline (Theo-Dur)
• tranquilizers

This is not a complete list of oxazepam drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of oxazepam, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

An increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested in several studies. Oxazepam, a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of starting therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physician about discontinuing the drug.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if oxazepam crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using oxazepam.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Effects appear to be mediated through the inhibitory neurotransmitter GABA; the site and mechanism of action within the CNS appear to involve a macromolecular complex (GABAA-receptor-chloride ionophore complex) that includes GABAA receptors, high-affinity benzodiazepine receptors, and chloride channels.

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 oxazepam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxazepam 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.

Pediatric

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.

Geriatric

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.

Interactions with 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 oxazepam, 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 oxazepam 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 oxazepam 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
• Amobarbital
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Dihydrocodeine
• Doxylamine
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Primidone
• Propofol
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Tramadol
• Zolpidem

Using oxazepam 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.

• St John's Wort
• Theophylline

Interactions with Food/Tobacco/Alcohol

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 oxazepam 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 oxazepam, 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 oxazepam. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Depression, or history of or
• Drug abuse or dependence, or history of or
• Hypotension (low blood pressure) or
• Lung or breathing problems 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about oxazepam, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about oxazepam. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using oxazepam.

Review Date: October 4, 2017

• Serax

• Benzodiazepine

Management of anxiety disorders, including anxiety associated with depression; management of ethanol withdrawal

Hypersensitivity to oxazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist)

10 mg orally, 3 times per day; if needed, increase cautiously to 15 mg orally, 3 or 4 times per day

Use: Management of anxiety, tension, irritability, and agitation in older patients

13 years and older:
10 to 15 mg orally, 3 or 4 times per day

Comments:
-The absolute dosage for patients 6 to 12 years is not established.

Use: Management of mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease:

15 to 30 mg orally, 3 or 4 times per day

Comments:
-The absolute dosage for patients 6 to 12 years is not established.

Use: Management of severe anxiety syndromes, agitation, or anxiety associated with depression

• May be used short-term (less than four months) to relieve symptoms of anxiety in anxiety-related disorders.
• May also be used short-term for the relief of symptoms related to alcohol withdrawal.
• May be used short-term for its calming effects to relieve tension, agitation, and irritability.
• Less sedating and shorter-acting than some other benzodiazepines.
• Oxazepam has fewer side effects compared with diazepam; however, its anti-seizure activity is not as strong.
• Generic oxazepam is available.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Mild drowsiness is common during the initial treatment with oxazepam; however, this is usually short-lasting, although a dosage reduction may be required. People should not drive, operate machinery, or perform tasks that require mental alertness if affected. Alcohol should be avoided because it can enhance these effects.
• Dizziness, headache, and vertigo are other common side effects.
• Oxazepam may rarely cause a drop in blood pressure, especially when going from a lying down or sitting position to standing. This may increase a person's risk of falls. This effect may be more likely to happen in elderly people.
• Other rare side effects include rashes, nausea, lack of energy, edema, slurred speech, tremor, hepatic and sexual dysfunction; and the dosage of oxazepam may need reducing. Blood counts and liver-function tests may be needed periodically.
• Withdrawal symptoms (tremor, abdominal and muscle cramps, vomiting, sweating, rarely seizures) may occur if oxazepam has been taken long-term or at higher-than-recommended dosages and is then stopped abruptly; discontinue slowly on a doctor's advice. Even after regular dosing, mild withdrawal symptoms (such as low mood, insomnia) may occur if oxazepam is discontinued abruptly.
• Oxazepam should not be used during pregnancy because it has been associated with an increased risk of birth defects. Oxazepam is incompatible with breastfeeding.
• Paradoxical reactions (the opposite of what is expected), such as over-excitation, anxiety, hallucinations, insomnia, and rage have been reported, mainly in people with other mental health concerns. Seek medical advice if these occur.
• May not be suitable for some people including those with glaucoma, respiratory disease, kidney or liver disease, or those with a history of substance abuse or addictive disorders.
• Oxazepam is addictive and can cause dependence. May not be suitable for people with a history of substance abuse or addictive disorders. Legitimate supplies of oxazepam should be kept out of sight of potential drug seekers.
• May interact with several other medicines, including other drugs that have sedation as a side effect. See prescribing information for a full list of interactions.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy. There are no adequate studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use should be avoided. AU TGA pregnancy category: C US FDA pregnancy category: Not Assigned Comments: -The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms. -Benzodiazepines may cause fetal harm when administered during pregnancy. -The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.