Patient Medication Information: uses, side effects, how to take - Ava-Risperidone (Avanstra, 1 mg)
ABOUT THIS MEDICATION
What the medication is used for:
AVA-RISPERIDONE (Risperidone Tartrate Oral Solution) belongs to a group of medicines called antipsychotic drugs.
Use in Schizophrenia
AVA-RISPERIDONE is used to treat the symptoms of schizophrenia and related psychotic disorders, which may include hallucinations (hearing or seeing things that are not there), delusions, unusual suspiciousness, emotional withdrawal. Patients suffering from schizophrenia may also feel depressed, anxious or tense.
Use in Inappropriate Behaviour Associated with Severe Dementia
AVA-RISPERIDONE may also be used for the short-term symptomatic management of behavioural disturbances such as verbal aggression (e.g., screaming, cursing) or physical aggression (e.g., kicking, hitting, biting, scratching, throwing things), as well as unusual suspiciousness and agitation in patients with severe dementia.
Use in Acute Mania Associated with Bipolar Disorder
AVA-RISPERIDONE may be used for the acute treatment of manic episodes associated with bipolar disorder. Signs and symptoms of bipolar mania include but are not limited to: feeling invincible or all powerful, inflated self-esteem, racing thoughts, easily lose your train of thought, overreaction to what you see or hear, misinterpretation of events, speeded-up activity, talking very quickly, talking too loudly, or talking more than usual, decreased need for sleep, and poor judgment.
The doctor has prescribed AVA-RISPERIDONE, also known as risperidone, to help relieve the symptoms that are bothering you / the patient you are caring for. Although AVA-RISPERIDONE cannot cure the illness, it can keep the symptoms under control and reduce the risk of relapse as you / the patient you are caring for continues treatment.
What it does:
Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how AVA-RISPERIDONE works is unknown. However it seems to readjust the balance of dopamine and serotonin.
When it should not be used:
Do not take / give AVA-RISPERIDONE if an allergic reaction to the medicine or any of the non-medicinal ingredients of the product has occurred.
Symptoms of an allergic reaction may include: itching, skin rash, swelling of the face, lips or tongue, shortness of breath. If you experience any of these symptoms / if these symptoms are experienced by the patient you are caring for, your doctor / the treating physician should be contacted immediately.
The safety and efficacy of risperidone in children under the age of 18 have not been established.
What the medicinal ingredient is:
risperidone
What the important nonmedicinal ingredients are:
AVA-RISPERIDONE Oral Solution: sorbitol, tartaric acid, benzoic acid, sodium hydroxide and purified water.
What dosage forms it comes in:
AVA-RISPERIDONE Oral Solution, 1 mg/mL risperidone.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Studies with various medicines of the group to which AVA-RISPERIDONE (Risperidone Tartrate Oral Solution) belongs, when used in elderly patients with dementia, have been associated with an increased rate of death. Some of these studies included treatment with risperidone.
BEFORE you use AVA-RISPERIDONE, talk to your doctor or pharmacist if you / the patient you are caring for:
- have/has a history of stroke, mini-strokes, high cholesterol or high blood pressure;
- have/has diabetes or a family history of diabetes;
- are/is pregnant or planning to become pregnant;
- are/is breast-feeding;
- have/has ever had blackouts or seizures;
- have/has a history of kidney or liver problems;
- have/has a history of problems with the heart and/or blood vessels;
- have/has Parkinson’s disease;
- are/is taking or planning to take any other medicines (prescription or over-the-counter medicines);
- drink/drinks alcoholic beverages or use/uses drugs;
- are/is prone to low blood pressure (hypotension);
- have/has or have had/has had breast cancer;
- have/has pituitary tumours;
- suffer/suffers from Alzheimer's Disease;
- suffer/suffers from Lewy body dementia;
- are/is dehydrated
- exercise/exercises strenuously.
Elderly Patients with Dementia
Studies in elderly patients with dementia have shown that risperidone taken by itself or with furosemide is associated with a higher rate of death (see Serious Warnings and Precautions Box).
Tell your doctor if you are taking furosemide. Furosemide is a drug which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by build-up of too much fluid.
In elderly patients with dementia, a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or instances of slurred speech have been seen. If any of these should occur, even for a short period of time, seek medical attention right away.
If you are taking blood pressure medication
Low blood pressure can result from using risperidone together with medications used to treat high blood pressure. If you need to use both AVA-RISPERIDONE and medications used to reduce blood pressure, consult your doctor.
If you may be pregnant
Shaking, muscle stiffness and difficulty in feeding, all of which are reversible, may occur in newborns, if a mother used risperidone in the last trimester of her pregnancy.
Other cautions
Very rarely, a state of confusion, reduced consciousness, high fever or stiff muscles might occur. If this should happen, contact a doctor right away and tell him or her that you are receiving AVA-RISPERIDONE.
During long-term treatment, AVA-RISPERIDONE might cause involuntary twitching in the face. Should this happen, consult your doctor.
Since medications of this type may interfere with the ability of the body to adjust to heat, it is best to avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking AVA-RISPERIDONE.
AVA-RISPERIDONE should be used with caution, and only after consultation with your doctor, if you have heart problems, particularly irregular heart rhythm, abnormalities in electrical activity of the heart, or if using medications that can change the heart's electrical activity.
Because some people experience drowsiness, you should not drive or operate machinery until you are reasonably certain that AVA-RISPERIDONE does not affect your ability to carry out these activities.
It is important for the doctor to have all the above information before prescribing treatment and dosage. This list should be carefully reviewed by you / the caregiver and discussed with the doctor.
INTERACTIONS WITH THIS MEDICATION
Inform all doctors, dentists and pharmacists who are treating you that you are taking AVA-RISPERIDONE (Risperidone Tartrate Oral Solution).
Inform them if you are taking or are planning on taking any other medicine. They will tell you which medicines you can take with AVA-RISPERIDONE.
AVA-RISPERIDONE can increase the effect of alcohol and drugs that reduce the ability to react (e.g., “tranquillizers”, narcotic painkillers, certain antihistamines, certain antidepressants). It is recommended that you DO NOT drink alcohol and only take drugs prescribed by your doctor.
Inform your doctor if you start or stop taking any of the following medications:
- Dopamine agonists, e.g. levodopa (antiparkinsonian agent), may decrease the effect of AVA-RISPERIDONE.
- Phenothiazines and some heart medications (e.g., medication for high blood pressure, antiarrhythmics, or β-blockers), as these may interact with AVA-RISPERIDONE to cause your blood pressure to drop too low.
- AVA-RISPERIDONE should be used with caution when taking medications that may change the electrical activity of the heart, such as but not restricted to: medicines for malaria, heart rhythm disorders, allergies, other antipsychotics, antidepressants, water tablets or other medicines affecting body salts (sodium, potassium, magnesium).
- Carbamazepine and topiramate (anticonvulsants), as these may change the effect of AVA-RISPERIDONE.
- PROZAC® (fluoxetine), PAXIL® (paroxetine) (anti-depressants) and CLOZARIL® (clozapine), as these may increase the level of AVA-RISPERIDONE in your blood.
- LASIX® (furosemide): Studies in elderly patients with dementia have shown that taking AVA-RISPERIDONE with furosemide, a drug, which is sometimes used to treat high blood pressure, some heart problems, or to treat swelling of parts of the body caused by build-up of too much fluid, is associated with an increased rate of death (see WARNINGS AND PRECAUTIONS).
AVA-RISPERIDONE Oral Solution is not compatible with cola or tea.
Bottle Cap Bottle Adapter
Plunger
Tip Cap PROPER USE OF THIS MEDICATION
Usual dose:
- It is very important that you take / give AVA-RISPERIDONE (Risperidone Tartrate Oral Solution) the way the doctor has prescribed it.
- The doctor has decided on the best dosage for you / the patient you are caring for based on individual needs. Dosage may be increased or decreased depending on the response.
You may take / give AVA-RISPERIDONE together with meals or between meals. Once a regular dose has been established, the total amount can be taken once a day, or divided into two intakes, one in the morning and one in the evening.
- Try to take / give AVA-RISPERIDONE at the same time each day.
- Before taking / giving AVA-RISPERIDONE Oral Solution, read the "Directions for Use of AVA-RISPERIDONE Oral Solution". Be sure to mix the exact dose of AVA-RISPERIDONE Oral Solution that the doctor has prescribed in 100 mL of one of the following beverages: water, coffee, orange juice or low-fat milk; DO NOT MIX it in cola or tea.
- It is important that you keep taking / giving AVA-RISPERIDONE even after your / the symptoms have improved or disappeared. Do not change or stop taking / giving AVA-RISPERIDONE without consulting the doctor.
DO NOT give AVA-RISPERIDONE to anyone else. The doctor has prescribed it for you / the patient you are caring for.
Directions for Use of AVA-RISPERIDONE Oral Solution
To open the bottle and use the syringe:
1
.
Push the plastic screw-cap on the bottle
down while turning it counter-clockwise.
Remove the unscrewed cap (see Figure 1).
Figure 1 2
.
Push the bottle adapter into the neck of the
bottle. Close the bottle tightly with the cap.
This will assure the proper seating of the
bottle adapter in the bottle (see Figure 2).
Figure 2 3
.
Remove the tip cap from the oral
dispensing-syringe. Before inserting the tip
of the syringe into the bottle adapter, push
the plunger completely down toward the tip
of the syringe (see Figure 3).
Figure 3
- 4.
Insert tip firmly into opening of the bottle
adapter. Turn the entire unit (bottle and
oral dispensing-syringe) upside down (see
Figure 4).
Figure 4 5. While holding the outer barrel of the
syringe and the bottle, pull the plunger out
slowly to the level (see markings on side)
that equals the dosage prescribed by your
physician (see Figure 5).
Figure 5 6. Turn the entire unit right side up and
remove the syringe slowly from the bottle,
being careful not to depress the plunger
prematurely (see Figure 6).
Figure 6 7. Empty the entire contents of the syringe into 3-4 ounces
(100 mL) of a beverage by pushing the plunger down inside the syringe barrel. Stir the mixture thoroughly before consuming. AVA-RISPERIDONE is compatible with water, coffee, orange juice, or low-fat milk: IT IS NOT COMPATIBLE with cola or tea.
- 8. Replace the cap on the bottle by screwing it clockwise. 9. Rinse the empty syringe with water and cover its tip with the tip cap.
Overdose:
In overdose, one or more of the following signs may occur in an overdose: reduced consciousness, drowsiness, sleepiness, rapid heartbeat, excessive trembling or excessive muscle stiffness, dizziness or lightheadedness when standing up.
If you take / give too much AVA-RISPERIDONE, immediately contact the doctor, regional poison control centre or go / take the patient to the nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. Make sure to bring this medication bottle with you.
Missed Dose:
If you miss a dose, try not to miss any more. DO NOT TAKE / GIVE TWO DOSES AT ONCE.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like other medications, AVA-RISPERIDONE (Risperi-done Tartrate Oral Solution) can cause some side effects. Some side effects are minor and temporary; however, some may be serious and need medical attention. Many of the side effects are dose related, so it is important not to exceed your prescribed dose. Should you experience these symptoms, please consult your doctor.
In patients with schizophrenia, the most common side effects of AVA-RISPERIDONE include the following:
- sleeplessness / sleepiness
- anxiety
- trembling, decreased motor function or activity such as slight muscle stiffness
- a feeling of restlessness (akathisia)
- dizziness
- headache
- runny nose
- constipation
- weight gain
- increased heart rate
In severely demented patients, the most common side effects of AVA-RISPERIDONE include the following:
- sleepiness
- trembling, decreased motor function or activity such as slight muscle stiffness
- a feeling of restlessness (akathisia)
- swelling of the ankles
- runny nose
- dizziness, lightheadedness
- difficulty breathing
- increased heart rate
In patients with bipolar disorder, the most common side effects of AVA-RISPERIDONE were:
- sleeplessness / sleepiness
- trembling, decreased motor function or activity such as slight muscle stiffness
- dizziness
- headache
- constipation
- anxiety
- weight gain
- nausea
- heartburn
- increased salivation
AVA-RISPERIDONE may cause sudden dizziness or lightheadedness (symptoms of postural hypotension). You/ the patient you are caring for should not rise rapidly after having been sitting or lying for prolonged periods, especially when you start taking AVA-RISPERIDONE.
In addition, the following undesired effects may occur in some cases: agitation, headache, dizziness.
In women, medicines of this type may cause changes in the regularity of their monthly periods or leakage of milk from the breast even if they are not pregnant. In some men, after prolonged treatment, there may be some diminished sexual function and breast enlargement may be experienced.
In rare cases, the following may happen: tiredness, concentration difficulties, blurred vision, indigestion, nausea, vomiting, abdominal pain, some loss of urine.
In very rare cases, high blood sugar has been reported. See your doctor if you experience symptoms such as excessive thirst or urination.
Do not be alarmed by this list of possible side effects. You may not experience any of them. If any of these side effects are experienced, they are usually mild and temporary. However, do not hesitate to report any undesired side effects to your doctor.
If you have taken AVA-RISPERIDONE in the last three months of your pregnancy and you notice that your newborn baby develops shaking, muscle stiffness and difficulty in feeding. These symptoms can be reversible. Contact your doctor immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Call your doctor right away | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Rare | |||
| Symptoms of allergic reaction, such as itching, skin rash, swelling of the face, lips, or tongue, or shortness of breath. | √ | ||
| Very Rare | |||
| A state of confusion, reduced consciousness, high fever, or pronounced muscle stiffness. | √ | ||
| Marked changes in body temperature (generally as a result of several factors together including extreme heat or cold). | √ | ||
| Continuous erection of the penis | √ | ||
| Muscle twitching or abnormal movements of the face or tongue | √ | ||
| Sudden change in mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, slurred speech or vision problems, even for a short period of time. | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking AVA-RISPERIDONE, contact your doctor or pharmacist.
HOW TO STORE IT
Store AVA-RISPERIDONE (Risperidone Tartrate Oral Solution) in its original package.
Store at room temperature between 15-30°C (59-86°F). Protect from light and freezing.
Keep AVA-RISPERIDONE out of the reach of children.
The expiry date for AVA-RISPERIDONE is printed on the package. Do not use the medicine in the package after this date.
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 www.healthcanada.gc.ca/medeffect
- Call 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 0701D 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.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Avanstra Inc. at:
1-855-708-3678 or medinfo@avanstra.com
Last revised: February 21, 2011
PROZAC® is a registered trademark of Eli Lilly and Company. PAXIL® is a registered trademark of GlaxoSmithKline Inc. LASIX® is a registered trademark of Sanofi Aventis.