Details for: XANAX
Company: UPJOHN CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00548359 | XANAX | ALPRAZOLAM | 0.25 MG | TABLET | ORAL |
| 00548367 | XANAX | ALPRAZOLAM | 0.5 MG | TABLET | ORAL |
| 00723770 | XANAX | ALPRAZOLAM | 1 MG | TABLET | ORAL |
| 00813958 | XANAX TS | ALPRAZOLAM | 2 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
XANAX has been prescribed to you by your doctor to relieve your symptoms of the following conditions:
- Generalized anxiety disorder (excessive anxiety or worry)
- Panic disorder (repeated, unexpected panic attacks of extreme fear and worry about these attacks)
If you are 65 years or older, talk to your doctor before starting XANAX or XANAX TS. XANAX or XANAX TS may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
What it does
XANAX contains the active ingredient alprazolam, which belongs to a group of medicines known as benzodiazepines. XANAX has sedative properties which help in the treatment of anxiety and panic.
When it should not be used
Do not take XANAX if you:
- are allergic to the group of medicines known as benzodiazepines (examples: clonazepam, chlordiazepoxide, diazepam, or flurazepam).
- are allergic to XANAX or any of the ingredients listed in the section “What the nonmedicinal ingredients are”.
- have acute narrow angle glaucoma, a condition associated with increased pressure in the eye that may cause loss of sight.
- have myasthenia gravis, a chronic disease characterized by weakness of the skeletal muscles.
- have a liver condition.
- have lung disease or breathing problems.
- have a sleep disorder that causes pauses in breathing or shallow breathing while sleeping (sleep apnea).
- are taking ketoconazole (e.g., Nizoral) or itraconazole (e.g., Sporanox), medicines used to treat fungal infections.
XANAX should not be used in patients under 18 years of age.
What the medicinal ingredient is
alprazolam
What the non-medicinal ingredients are
All tablets contain lactose monohydrate, docusate sodium-sodium benzoate, colloidal silicon dioxide, corn starch, magnesium stearate.
The 0.5 mg tablet also contains yellow aluminum lake.
The 1 mg tablet also contains blue aluminum lake and erythrosine aluminum lake.
What dosage form it comes in
XANAX 0.25 mg tablet: white in color, single s cored on one side and engraved with “Upjohn 29” on the other.
XANAX 0.5 mg tablet: light orange in color, single scored on one side and engraved with “Upjohn 55” on the other.
XANAX 1 mg tablet: lavender in color, single scored on one side and engraved with “Upjohn 90” on the other.
XANAX TS 2 mg tablet: white in color, capsule shaped, triscored on one side and engraved with “U94” on the other. This can be broken into 4 individual 0.5 mg tablets.
Warnings and precautions
Withdrawal
Always contact your doctor before stopping or reducing your dosage of XANAX. 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 XANAX and XANAX TS.
Your risk of going through withdrawal is higher if you are taking XANAX and XANAX TS for a long time or at high doses. However, symptoms can still occur if you are taking XANAX and XANAX TS 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
Therefore, always follow the treatment as prescribed by your doctor.
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 XANAX and XANAX TS 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
Dependence
Benzodiazepines such as XANAX have caused dependence (addiction) and withdrawal symptoms can occur when treatment is stopped suddenly. The risk of dependence (addiction) increases with higher doses and longer duration of treatment, or after suddenly stopping treatment.
BEFORE you use XANAX talk to your doctor or pharmacist if you:
- 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 lung, liver or kidney condition.
- have a history of alcohol or drug abuse.
- have a history of depression and/or suicide attempts.
- are pregnant, think you may be pregnant, or are planning to become pregnant.
- are breast feeding.
- regularly drink alcohol.
- have lactose intolerance.
Mental alertness
XANAX can cause drowsiness and affect your ability to be alert. You should not perform activities that require mental alertness such as driving or operating machinery until you know how this drug will affect you. This effect of XANAX 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 change how the drug affects you.
Risk of memory loss
Memory loss has been reported. This has occurred in people taking the usual doses.
Falls and Fractures:Benzodiazepines like XANAX and XANAX TS can cause you to feel sleepy, dizzy and affect your balance.This increases the 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
Worsening of side effects with alcohol and other drugs
XANAX may have more pronounced sedative effects when taken with alcohol or other drugs that can make you sleep, such as: narcotic pain relievers, sleeping pills, antihistamines, medications to control seizures, antidepressants or antipsychotics. Do not take XANAX if you drink alcohol. Do not use XANAX with these other medications without first discussing with your doctor.
XANAX and XANAX TS with Opioids: Taking XANAX and XANAX TS 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 XANAX and XANAX TS
Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and XANAX and XANAX TS affects you.
Pregnancy
Some benzodiazepines have been linked to birth defects when taken during the early months of pregnancy. Babies born to mothers who have taken benzodiazepines during the last weeks of pregnancy or during labour have been known to have overly relaxed muscles and breathing problems, and may also have withdrawal symptoms after birth.
Do not take this medicine if you are pregnant (or think you may be pregnant), unless advised by your doctor. Consult with your doctor before taking XANAX if you are planning to become pregnant
Breast feeding
XANAX may pass into breast milk. Therefore, if you are breast feeding, this medicine should be avoided.
Interactions with this medication
| Serious Drug Interactions |
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.
XANAX may have more pronounced side effects when taken with alcohol or other drugs that affect the central nervous system. Do not drink alcohol while taking XANAX. Do not use XANAX with the following other medicines without first discussing with your doctor:
- narcotic pain relievers (opioids, e.g., morphine, codeine)(see Serious Warnings and Precautions box)
- sleeping pills
- antihistamines (medicines used for relief of allergy symptoms)
- anticonvulsants (medications used to control seizures)
- antidepressants (medicines used to treat anxiety or depression)
- antipsychotics (medicines used to treat mental illnesses such as schizophrenia)
XANAX should not be taken with ketoconazole or itraconazole (medicines used to treat fungal infections) because these medicines can cause an increase in the amount of XANAXin your blood and can enhance side effects.
Other medicines that can affect the amount of XANAXin your blood include cimetidine, fluvoxamine, carbamazepine, HIV protease inhibitors, and birth control pills.
Talk to your doctor if you are using XANAX with digoxin, as XANAX may affect the amount of digoxin in your blood.
Always tell your doctor about any other medicines you are taking or plan to take.
Proper use of this medication
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 your illness and how you respond to the medicine. The table below showsthe different doses that your doctor may prescribe according to your illness.
| Usual Daily Dose | |
| Anxiety disorders | 0.25 mg, two to three times per day. Maximum 3 mg/day. |
| Panic disorders | 0.5 mg, three times per day. Maximum 10 mg/day. |
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 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.
Because elderly patients can be more sensitive to the effects of alprazolam, lower doses may be prescribed.
Because elderly patients can be more sensitive to the effects of XANAX, lower doses may be prescribed.
Usual Dose:
Overdose:
| Contact your doctor, regional Poison Control Centre or pharmacist immediately if you suspect you have taken an overdose or someone else accidentally takes your XANAX. If you are unable to contact them, go to a hospital emergency department for medical help, even though you may not feel sick. Show the doctor your bottle of tablets. |
Missed Dose
Side effects and what to do about them
Like all medications XANAX 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 XANAX.
The most common side effects are:
- Feeling drowsy or tired, especially at the start of treatment.
- Dizziness
- Loss of some balance and coordination
- Falls and fractures
- Memory problems
- Constipation
- Slurred speech
Less common possible side effects are:
- Agitation
- Changes in sex drive (increased or decreased)
- Changes in weight (gain or loss)
- Increased appetite
- Difficulty urinating
- Bladder control problems
In rare cases, XANAX can affect liver function, and disorders such as hepatitis or liver failure may occur. Your doctor will monitor your blood for effects of XANAX on your liver.
Elderly patients may be especially susceptible to side effects. Excessive drowsiness or loss of balance may increase the risk of falls and fractures in elderly patients.
All patients should be cautious about performing hazardous activities that require complete mental alertness, such as operating machinery or driving a car.
Withdrawal-related side effects:
If treatment is stopped suddenly or there is a large decrease in dose, symptoms of withdrawal may occur, including: restlessness and trouble sleeping. In severe cases of withdrawal, symptoms may include: irritability, nervousness, trouble sleeping, diarrhea, stomach pains, vomiting, sweating, tremors, numbness and tingling of the extremities, hallucinations (seeing or hearing things that are not there), being unusually sensitive to light, noise and physical contact and seizures.
| Symptom / effect | Talk to your doctor or pharmacist Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and seek immediate emergency help |
|---|---|---|---|
| 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, skin rashes, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath) | ✔ | ||
| 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 | ✔ | ||
| Hepatitis, liver failure (yellow skin and eyes, nausea, vomiting, pain in upper right abdomen, loss of appetite, dark-colored urine) | ✔ | ||
| Serious skin reactions (rash that may be severe, red skin, blistering of the lips, eyes or mouth, peeling skin) | ✔ | ||
| Increased pressure in the eyes (change in side vision, sudden severe pain in the eye, decreased or cloudy vision, seeing rainbowlike halos around lights, eyes feeling swollen) | ✔ | ||
| Unknown | |||
| 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 of side effects. For any unexpected effects while taking XANAX, contact your doctor or pharmacist.
How to store
XANAX should be stored at controlled room temperature (15 - 30ºC).
Keep out of the reach of children.
Reporting side effects
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program Health Canada Postal Locator 1908C Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
- www.canada.ca/en/health-canada/services/drugs-healthproducts/medeffect-canada/adverse-reaction-reporting.html
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
This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.Pfizer.ca or by contacting UpjohnCanada ULC Medical Information at 1-800-463-6001
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.gsk.ca/, or by calling 1-800-387-7374.