Tranxene-SD (Oral)

Clorazepate is used to help with anxiety symptoms and to manage alcohol withdrawal. It is also used along with other medicines to treat partial seizures. Clorazepate is a benzodiazepine. Benzodiazepines are a type of medicine known as central nervous system (CNS) depressants, which means they slow down the nervous system.

You can only get this medicine with a prescription from your doctor.

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

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during late pregnancy may cause problems in your newborn baby (for example, sedation or withdrawal symptoms). Inform your doctor immediately if your baby experiences abnormal sleep patterns, diarrhea, feeding issues, 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 might be pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people, especially older adults, to feel drowsy, dizzy, lightheaded, clumsy, 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 enhance the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness or decrease alertness). Examples of CNS depressants include 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. Consult your medical doctor or dentist before taking any of these while using this medicine.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually decrease your dosage before stopping completely. This may help prevent worsening of your condition and reduce the risk of withdrawal symptoms, which can include 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 guidance.

If you or your child experience any unusual or strange thoughts and behaviors while taking this medicine, be sure to talk to 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: changes in consciousness, changes in speech patterns, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, excessive sleepiness or unusual drowsiness, shakiness and unsteady walking, slurred speech, difficulty speaking, trouble sleeping, unsteadiness, trembling, or other issues with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness, or feeling sluggish, unusual excitement, nervousness, restlessness, irritability, or an unusual feeling of weakness. Call your doctor immediately if you notice these symptoms.

Do not take other medicines unless they have been discussed 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 must weigh the risks of taking it against the benefits it may provide. Consider the following for this medicine:

Allergies

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

Pediatric

There have not been enough studies to understand how clorazepate affects children younger than 9 years old. Its safety and effectiveness in this age group have not been established.

Geriatric

Current studies have not shown any specific problems that would limit the use of clorazepate in elderly patients. However, older adults may be more likely to experience unwanted effects (such as severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and may have kidney, liver, or heart issues, which might require careful monitoring and possible dose adjustments for those taking clorazepate.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

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

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the 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 taking both may still be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain 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 can also lead to interactions. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Alcohol or drug abuse or dependence, or a history of it
• Depression, history of
• Lung or breathing problems (such as respiratory depression)
• Mental health issues, 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 because the body removes the medicine more slowly.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away if any of the following side effects happen:

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 right away if any of the following symptoms of overdose happen:

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 sluggish
• 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 the medicine. Also, your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.