Patient Medication Information: uses, side effects, how to take - Diazepam
What the medication is used for:
- DIAZEPAM is used for the short-term relief of severe anxiety.
- DIAZEPAM is used to reduce muscle spasms caused by medical conditions such as local trauma or by disorders such as cerebral palsy, paraplegia and “stiff man syndrome”.
- DIAZEPAM can also be used to treat trembling, confusional states or anxiety associated with alcohol withdrawal
If you are 65 years or older, talk to your doctor before starting DIAZEPAM. DIAZEPAM may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
What it does:
DIAZEPAM contains the active ingredient diazepam, which belongs to a group of medicines known as benzodiazepines. DIAZEPAM has sedative properties which help in the treatment of anxiety.
When it should not be used:
- If you are allergic to the group of medicines known as benzodiazepines (examples: clonazepam, chlordiazepoxide, bromazepam, or flurazepam).
If you are allergic to the medicinal ingredient (diazepam).
- If you are allergic to any of the other ingredients it contains (see ‘What the non-medicinal ingredients are’).
- If you suffer from lung disease or have sleep apnea.
- If you have a liver condition.
- If you have glaucoma.
- If you have myasthenia gravis.
In children under 6 months.
What the medicinal ingredient is:
Diazepam
What the non-medicinal ingredients are:
The non-medicinal ingredients in DIAZEPAM are: D&C yellow #10 (5 mg only), FD&C blue #1 (10 mg only), FD&C blue #2 (10 mg only), FD&C yellow #6 (5 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch.
What dosage forms it comes in:
DIAZEPAM is available as:
2 mg, 5 mg & 10 mg tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take DIAZEPAM 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 DIAZEPAM with:
Your healthcare professional should:
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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 DIAZEPAM.
- Your risk of going through withdrawal is higher if you are taking DIAZEPAM for a long time or at high doses. However, symptoms can still occur if you are taking DIAZEPAM 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 behaviour 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 DIAZEPAM 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
DIAZEPAM with Opioids: Taking DIAZEPAM 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 DIAZEPAM
DIAZEPAM may affect your ability to be alert. Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and DIAZEPAM affects you. This effect of DIAZEPAM may be made worse if you take alcoholic drinks. If your doctor has increased your dose or if you have changed the timings of when you take your medication this may also modify your reactions
Falls and Fractures: Benzodiazepines like DIAZEPAM can cause you to feel sleepy, dizzy and affect your balance. This increases your risk 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
Store DIAZEPAM in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking DIAZEPAM, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms. (See the Withdrawal section below)
DIAZEPAM with Opioids: Taking DIAZEPAM with opioid medicines can cause:
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Serious Drug Interactions
Taking DIAZEPAM and opioids may cause:
- severe drowsiness
- trouble breathing
- coma
- death
- Memory loss may occur when DIAZEPAM is used at therapeutic doses.
- If you develop any unusual or disturbing thoughts or behaviour while using DIAZEPAM, discuss the matter immediately with your doctor.
Do not take this medicine if you are pregnant, or might become pregnant, unless advised by your doctor. Contact your doctor if you think you may be pregnant, or are intending to become pregnant.
- Diazepam passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.
BEFORE you use DIAZEPAM talk to your doctor or pharmacist if you:
- Have a lung, liver or kidney condition.
- Have glaucoma.
- Are taking or plan on taking ANY other drugs (including herbal preparations, drugs you purchase without prescriptions, and those not prescribed by your doctor).
- Regularly drink alcohol or use recreational drugs or have a history of dependence /addiction to alcohol or drugs.
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)
- Have a history of depression and/or suicide attempts.
- Have the rare hereditary problems of galactose intolerance.
- Are pregnant or plan on becoming pregnant
INTERACTIONS WITH THIS MEDICATION
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food store without a prescription.
Some medicines may interact with DIAZEPAM. These medicines include:
- medicines to control seizures (flumazenil, carbamazepine, phenytoin)
- narcotics and narcotic pain relievers (opioids) (see Serious Warnings and Precautions box)
- muscle relaxants
- sleeping medication or hypnotics (ketamine)
- antihistamines or allergy medications.
- medications to control fungus infections (ketoconazole, itraconazole, fluconazole and voriconazole)
- medications to control viral infections (ritonavir)
- birth control medications
- medications to help digestion, prevent heartburn (such as antacids omeprazole or esomeprazole) or treat ulcers (cimetidine)
- medications to treat cancer of the blood (idelalisib)
- medications to treat addiction to drugs (methadone, buprenorphine) or alcohol (disulfiram)
- antibiotic medications to treat bacterial infections, including tuberculosis (clarithromycin, erythromycin, isoniazid, rifampicin)
- medications used to treat high blood pressure (diltiazem, verapamil)
- medications used to treat narcolepsy and shift work disorder (modafinil, sodium oxybate)
- medicines to treat your anxiety or mood, such as monoamine oxidase inhibitors, tricyclic antidepressants, serotonin specific reuptake inhibitors (fluvoxamine, fluoxetine)
- medications to treat psychosis (methotrimeprazine, clozapine, olanzapine)
- medications to treat Parkinson’s disease (levodopa)
- medications to help you stay awake (theophylline and caffeine)
These medicines may be affected by DIAZEPAM or may affect how well DIAZEPAM works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
You must not consume alcohol while taking DIAZEPAM as its effects may worsen side effects that some patients experience with DIAZEPAM.
Do not drink grapefruit juice during the time that you are taking DIAZEPAM.
If you have not told your doctor about any of the above, tell him/her before you start taking DIAZEPAM.
PROPER USE OF THIS MEDICATION
Usual dose:
Always take the tablets exactly as your doctor tells you to. Your doctor will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and body weight. The table below shows the different doses that your doctor may prescribe according to your age. Your doctor will start you on an initial low dose and gradually increase it until the desired effect is achieved.
| Usual Daily Dose | |
Adults Relief of Severe anxiety and tension | Depending upon severity of symptoms – 2 mg to 10 mg, two to four times daily. |
| Relief of Acute Alcohol Withdrawal | 10 mg, three or four times during the first 24 hours, reducing to 5 mg, three or four times daily as needed. |
| Relief of severe muscle spasm | 2 mg to 10 mg, three to four times daily. |
| Elderly | 2 mg, one or two times daily initially, increase gradually as needed and tolerated |
| Children (7 months and older) | 1 mg to 2.5 mg, three or four times daily initially; increase gradually as needed and tolerated. |
The total daily dose should be taken as advised by your doctor.
Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.
Your doctor will advise you when to stop taking the medicine. 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:
| If you think you, or a person you are caring for, have taken too much DIAZEPAM, contact a healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications DIAZEPAM can cause some side effects. For most patients these side effects are likely to be minor and temporary as your body adjusts to the medicine. However, some may be serious. Consult your doctor or pharmacist as soon as you can if you do not feel well while taking DIAZEPAM.
The most common side effects are:
- Feeling drowsy or tired, especially at the start of treatment.
- Some muscle weakness and dizziness.
Less common possible side effects are:
- Changes in your skin colour, nausea, headache, blurred vision, tremors, hypotension (low blood pressure), urinary incontinence, and constipation.
- Memory loss may occur in some patients using DIAZEPAM.
- In rare cases changes in your blood and liver may occur and your doctor will monitor for these.
- Falls and fractures.
Withdrawal-related side effects:
- With long-term DIAZEPAM treatment development of physical and psychological dependence may occur. If treatment is stopped suddenly symptoms of withdrawal may occur, including: headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases of withdrawal, symptoms may include numbness and tingling of the extremities, hallucinations, increased sensitivity to light, noise and physical contact, and epileptic seizures.
| SERIOUS SIDE EFFEC TS 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 | ||||
| Rare | Unusual behavioural problems (aggression, rage, sudden anxiety or excitation; restlessness, agitation, irritability; hallucinations (see or hear things that are not there) | ✓ | |||
or delusions; severe sleep disturbances, nightmares, inappropriate behaviour | ||||
Allergic reactions (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) | ✓ | |||
Depression. Symptoms may include: difficulty sleeping, changes in weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced libido (sex drive), and thoughts of death or suicide. | ✓ | |||
| Unkn -own | 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. | ✓ | |||
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. |
This is not a complete list of side-effects. If you are concerned about these or any other unwanted side-effects, talk to your doctor or pharmacist.
HOW TO STORE IT
- Keep DIAZEPAM in tight, light resistant containers. Store at room temperature (15°C to 30°C).
- Keep this medicine out of the reach and sight of children.
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. |
MORE INFORMATION
Reminder: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.
If you want more information about DIAZEPAM:
Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.aapharma.ca/en/, or by calling 1-877-998-9097.