Gen-Xene (Oral)

Clorazepate is used to help reduce symptoms of anxiety and alcohol withdrawal. It is also used with other medicines to treat partial seizures. Clorazepate is a benzodiazepine. Benzodiazepines are part of a 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.

It is very important for your doctor to check the progress of you or your child during regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during later pregnancy may cause problems in your newborn baby (for example, sedation or withdrawal symptoms). Tell your doctor right away if your baby has any of the following: abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause some people, especially older individuals, to feel drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than usual. It may also cause double vision or other vision problems. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are not alert or able to think or see clearly.

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

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping 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, 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.

If you or your child develop any unusual or strange thoughts and behaviors while taking this medicine, be sure to discuss it with your doctor. Clorazepate may cause confusion, worsening depression, hallucinations (seeing, hearing, or feeling things that are not there), thoughts of self-harm, and unusual excitement, nervousness, or irritability.

Symptoms of an overdose include: change in consciousness, changes in speech patterns and rhythms, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, sleepiness or unusual drowsiness, shakiness and unsteady walking, slurred speech, trouble speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling sluggish, unusual excitement, nervousness, restlessness, irritability, or feeling unusually weak. Call your doctor right away if you notice these symptoms.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how clorazepate affects children younger than 9 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Studies have not found any specific problems in older adults that would limit the use of clorazepate. However, older patients may be more likely to experience side effects (such as severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and may have kidney, liver, or heart issues that could need caution and a dose adjustment for those taking clorazepate.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In such cases, your doctor may need to change the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been selected for their potential significance but are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change some of the other medicines you are taking.

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• 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
• Omeprazole
• Orlistat
• 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 might be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amprenavir
• Ginkgo
• Rifapentine
• St John's Wort
• Theophylline

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Alcohol or drug abuse or dependence, or a history of
• Depression, history of or
• Lung or breathing problems (such as respiratory depression) or
• Mental health problems, history of—Use with caution. May worsen these conditions.

• Glaucoma, narrow angle—Should not be used in patients with this condition.

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

Along with its needed effects, Gen-Xene (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

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

Less common

• Bladder pain
• Bloody or cloudy urine
• Difficult, burning, or painful urination
• Frequent urge to urinate
• Lower back or side pain
• Shakiness and unsteady walk
• Slurred speech
• Trembling or shaking of the hands or feet
• Unsteadiness, trembling, or other problems with muscle control or coordination

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

Symptoms of overdose

• Agitation
• Change in consciousness
• Changes in patterns and rhythms of speech
• Drowsiness
• Loss of consciousness
• Loss of strength or energy
• Mood or mental changes
• Nightmares
• Shakiness and unsteady walk
• Sleepiness
• Slurred speech
• Talkativeness
• Trouble speaking
• Unsteadiness, trembling, or other problems with muscle control or coordination
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• Unusual excitement, nervousness, restlessness, or irritability

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 Gen-Xene (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:

Less common

• Blurred vision
• Diarrhea
• Discouragement
• Dizziness
• Double vision
• Dry mouth
• Feeling sad or empty
• Headache
• Indigestion
• Irritability
• Loss of appetite
• Loss of interest or pleasure
• Mental confusion
• Nausea or vomiting
• Nervousness
• Passing of gas
• Seeing double
• Skin rash
• Stomach pain, fullness, or discomfort
• Trouble with concentrating
• Trouble with sleeping
• Unusual tiredness or weakness

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.

• Gen-Xene
• Tranxene
• Tranxene-SD
• Tranxene T-Tab

Available Dosage Forms:

• Tablet

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Long 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 these instructions carefully. Ask your doctor if you have any questions.

This medicine may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

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 (tablets): For anxiety: Adults—30 milligrams (mg) per day, taken in divided doses. Your doctor may adjust your dose if needed. Older adults—At first, 7.5 to 15 mg per day, taken at bedtime or in divided doses. Your doctor may increase your dose if needed. Children—Use and dose must be determined by your doctor. For symptoms of alcohol withdrawal: Adults—At first, 30 milligrams (mg), followed by 30 to 60 mg in divided doses. Your doctor will set up a schedule that will gradually adjust your dose until your symptoms improve. The dose is usually not more than 90 mg per day. Children—Use and dose must be determined by your doctor. For partial seizures: Adults and children 13 years of age and older—At first, 7.5 milligrams (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mg per day. Children 9 to 12 years of age—The starting dose is up to 7.5 mg 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day. Children up to 9 years of age—Use is not recommended.

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.