Patient Medication Information: uses, side effects, how to take - Clorazepate
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take CLORAZEPATE exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take CLORAZEPATE with:
Your doctor should:
Store CLORAZEPATE in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking CLORAZEPATE, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms. See Other warnings you should know about.
CLORAZEPATE with Opioids: Taking CLORAZEPATE with opioid medicines can cause:
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What is CLORAZEPATE used for?
- the short-term relief of severe anxiety and tension symptoms
- the management of alcohol withdrawal.
If you are 65 years or older, talk to your doctor before starting CLORAZEPATE. CLORAZEPATE may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
How does CLORAZEPATE work?
CLORAZEPATE belongs to the group of medicines called benzodiazepines. Benzodiazepines affect chemical activity in the brain to help with sleep and reduce anxiety and stress.
What are the ingredients in CLORAZEPATE?
Medicinal ingredients: Clorazepate dipotassium
Non-medicinal ingredients: capsule fill contains cornstarch, lactose monohydrate and stearic acid.
Capsule shell contains black iron oxide, D&C red #33 (7.5 mg capsule only), D&C yellow #10 (7.5 mg capsule only), gelatin, pharmaceutical ink and titanium dioxide.
CLORAZEPATE comes in the following dosage forms:
Capsule 3.75 mg, 7.5 mg and 15 mg
Do not use CLORAZEPATE if:
- you are allergic to clorazepate dipotassium or any other non-medicinal ingredients in this product.
- you have a long tern disease called myasthenia gravis. This causes weakness of muscles you use for movement.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLORAZEPATE. Talk about any health conditions or problems you may have, including if you:
- have or had depression, mood problems or suicidal thoughts or behaviour
- have a history of abnormal thinking and behaviour (psychotic reactions)
- have impaired kidney or liver function
- have abused drugs in the past or find it difficult to stop taking medicines
- have eye problems or blurred vision
are pregnant or planning to become pregnant
- are breastfeeding
- are elderly or weak, or have organic brain syndrome
- have lactose intolerance
have ever had a problem with:
- substance use, including prescribed or illegal drugs, or
- alcohol
- have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
Other warnings you should know about:
CLORAZEPATE may cause you to become drowsy or light-headed. Avoid driving, using heavy machinery or doing dangerous activities until you know how CLORAZEPATE affects you.
Do not drink alcohol or take drugs that make you sleepy while taking CLORAZEPATE without first talking to your healthcare professional.
Important:
- 1. Do not take more CLORAZEPATE than prescribed.
- 2. Do not take CLORAZEPATE when you drink alcohol.
- 3. Talk to your doctor about all your medicines, including over-the counter medicines and herbal products. You doctor will tell you if you can take CLORAZEPATE with your other medicine.
- 4. You and people close to you should watch unusual types of behavior when you are asleep. If you find out that you have done any such activities for which you have no memory, you should call your healthcare professional immediately.
Sleep-Related Behaviours:
Treatment with CLORAZEPATE can cause potentially dangerous sleeping-related behaviours such as getting out of bed while not fully awake and doing activities that you do not know you are doing. If this happens, you may not remember doing these activities when you wake up. This might happen when CLORAZEPATE is taken with alcohol or other drugs that can make you sleepy (e.g., medicines used to treat depression or anxiety). If you drink alcohol, do not take CLORAZEPATE. The activities you may do in these situations can put you and people around you in danger. This can include driving a car (“sleep-driving”), leaving the house, making and eating food, and talking on the phone.
Memory Problems:
In rare cases, CLORAZEPATE can cause a type of memory loss known as amnesia. This is shown by having difficulty remembering things that recently happened, usually several hours after taking the medication. If you are going to take CLORAZEPATE before sleeping, this is usually not a problem, but if you take CLORAZEPATE to help you sleep while travelling, such as during an airplane flight, you may wake up to memory lapse caused by the drug. This has been called “traveller's amnesia” and can be a problem. DO NOT TAKE CLORAZEPATE when a full night's sleep is not possible before you need to be active and functional (e.g., an overnight flight of less than 8 hours). Your body needs time to eliminate the medication.
Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop CLORAZEPATE.
Your risk of going through withdrawal is higher if you are taking CLORAZEPATE for a long time or at high doses. However, symptoms can still occur if you are taking CLORAZEPATE as directed for a short period of time or slowly reducing the dose.
The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).
Tell your doctor right away if you experience any symptoms of withdrawal after changing or stopping your treatment.
Severe symptoms of withdrawal include:
- feeling like you cannot move or respond (catatonia)
- severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
- feeling depressed
- feeling disconnected from reality (dissociation)
- seeing or hearing things that are not there (hallucinations)
- overactive behavior and thoughts (mania)
- believing in things that are not true (psychosis)
- convulsions (seizures), including some that do not stop
- thoughts or actions of suicide
For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).
To reduce your chances of going through withdrawal:
- always contact your doctor before stopping or reducing your dose of CLORAZEPATE or changing medications
- always follow your doctor’s instructions on how to reduce your dose carefully and safely
- tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment
CLORAZEPATE with Opioids: Taking CLORAZEPATE with opioid medicines can cause severe drowsiness and breathing problems.
Tell your doctor if you:
- are taking opioid medicines
- are prescribed an opioid medicine after you start taking CLORAZEPATE
Do NOT drive or operate heavy machinery or do tasks that require special attention if you are taking an opioid medicine and CLORAZEPATE.
Driving and using machines: CLORAZEPATE may affect your ability to be alert. This may be worse if you drink alcohol or take other sedatives. Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how CLORAZEPATE affects you. Avoid driving or using machinery if taking CLORAZEPATE with other sedative.
Falls and Fractures: Benzodiazepines like CLORAZEPATE can cause you to feel sleepy, dizzy and affect your balance. This increases your risks of falling, which can cause fractures or other fall related-injuries, especially if you:
- take other sedatives
- consume alcohol
- are elderly or
- have a condition that causes weakness or frailty
Blood Tests: Monitoring and Tests:
Your healthcare professional may want to do blood tests if you are on certain medication to follow your progress. It is important that you do have your blood tested.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with CLORAZEPATE:
- drugs to help you to sleep
- drugs to treat sleeplessness, convulsions or fits and headache (such as hexobarbital)
- drugs used to treat pain
- drugs used to treat mental and emotional disorders (such as chlorpromazine)
- Monoamine oxidase inhibitors, and other antidepressants used to treat depression
- Alcohol
Serious Drug Interactions Taking CLORAZEPATE and opioids may cause:
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How to take CLORAZEPATE:
Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Take CLORAZEPATE capsules by mouth.
Usual dose:
CLORAZEPATE is not for use in children under 18 years of age.
For the management of anxiety:
Adults: The usual dose is 30 mg per day in divided doses. Your doctor may adjust the dose within the range of 15 to 60 mg depending on your condition.
Elderly and/or Debilitated Patients: Should start with 3.75 mg just before bedtime. Your doctor will adjust the dose carefully and gradually depending on your condition.
For the management of acute alcoholic withdrawal:
Your doctor will decide which dose you should take. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Your doctor will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Overdose:
CLORAZEPATE overdosage include:
- drowsiness,
- confusion,
- difficulty with balance and walking, speaking and swallowing (ataxia),
- coma,
- Hyporeflexia (muscles are less responsive to stimuli) may occur.
| If you think you, or a person you are caring for, have taken too much CLORAZEPATE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take CLORAZEPATE, do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.
What are possible side effects from using CLORAZEPATE?
These are not all the possible side effects you may have when taking CLORAZEPATE. If you experience any side effects not listed here, tell your healthcare professional.
Other side effects may include:
- trouble sleeping,
- skin rashes,
- feeling tired,
- impaired coordination,
- irritability,
- double vision,
- slurred speech,
- Falls and fractures
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| drowsiness | |||
| LESS COMMON | |||
| dizziness, various gastrointestinal problems, nervousness, blurred vision, dry mouth, headache, confusion | |||
| RARE | |||
| Amnesia (a type of memory loss): difficulty recalling events that recently happened | |||
| Mental and behavioral changes: Unexpected reactions such as agitation, anxiety, hyperactivity, excitement, hallucination, impaired concentration or memory, worsened insomnia, feeling nervous, irritable, increased muscle spasticity, aggressiveness, irritability, rages, psychoses and violent behavior | |||
Severe allergic reaction: (swelling of the tongue or throat, trouble breathing, nausea and vomiting) | |||
| Depression: Depressed mood; thoughts of death or suicide | |||
| VERY RARE | |||
| Somnambulism: (sleepwalking) – getting out of bed while not fully awake and do activities you do not remember the day after | |||
| UNKNOWN FREQUENCY | |||
| Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure. | ✓ | ||
| Respiratory Depression: slow, shallow or weak breathing. | ✓ | ||
| Urinary problems | ✓ | ||
Serious side effects and what to do about them
| Symptoms / effects | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
| Only if severe | In all cases | |
Withdrawal: Severe symptoms include: Catatonia: feeling like you cannot move or respond Delirium Tremens: severe confusion, shivering, irregular heartrate and excessive sweating Feeling depressed Dissociation: feeling disconnected from reality Hallucinations: seeing or hearing things that are not there Mania: overactive behaviour and thoughts Psychosis: believing in things that are not true Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking Thoughts or actions of suicide Other symptoms include: Stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety or panic-attacks; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; sweating. | ||
| ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15-25°C) in a tightly closed container.
Keep out of reach and sight of children.
If you want more information about CLORAZEPATE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp; the manufacturer’s website https://www.aapharma.ca/en/, or by calling 1-877-998-9097.