Details for: AA-LEVOCARB CR
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02272873 | AA-LEVOCARB CR | LEVODOPA; CARBIDOPA | 100 MG; 25 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02245211 | AA-LEVOCARB CR | LEVODOPA; CARBIDOPA | 200 MG; 50 MG | TABLET (EXTENDED-RELEASE) | 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
Your physician has prescribed AA-LEVOCARB CR to treat the symptoms of Parkinson’s disease. Parkinson’s disease is a chronic disorder characterized by slow and unsteady movement, muscular stiffness, and tremor. If untreated, Parkinson’s disease can cause difficulty in performing normal daily activities.
What it does
AA-LEVOCARB CR is a combination of levodopa, the metabolic precursor of dopamine, and carbidopa, an aromatic amino acid decarboxylase inhibitor, in a controlled-release tablet. It treats the symptoms of Parkinson’s disease.
AA-LEVOCARB CR tablets are formulated to slowly release the two active ingredients, levodopa and carbidopa.
It is believed that the symptoms of Parkinson’s disease are caused by a lack of dopamine, a naturally occurring chemical produced by certain brain cells. Dopamine has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced.
Levodopa acts to replenish dopamine in the brain, while carbidopa ensures that enough levodopa gets to the brain where it is needed. In many patients, this reduces the symptoms of Parkinson’s disease. The controlled release formula keeps the amount of levodopa in your body as even as possible
Levodopa acts to replenish dopamine in the brain, while carbidopa ensures that enough levodopa gets to the brain where it is needed. In many patients, this reduces the symptoms of Parkinson’s disease. The controlled release formula keeps the amount of levodopa in your body as even as possible
When it should not be used
Do not take AA-LEVOCARB CR if you:
- are allergic to any of its ingredients
- have any suspicious skin lesions (moles) which have not been examined by your doctor or if you have ever had skin cancer
- are being treated with certain MAO inhibitor drugs, such as for depression, within the last 2 weeks
- have narrow-angle glaucoma
- have untreated heart, liver, kidney, lung, blood or hormonal disease
- have been told that you should not take sympathomimetic drugs such as isoproterenol, amphetamines, epinephrine or cough and cold medications containing drugs related to epinephrine.
What the medicinal ingredient is
AA-LEVOCARB CR tablets contain the active ingredients carbidopa and levodopa.
What the non-medicinal ingredients are
AA-LEVOCARB CR contains the following non-medicinal ingredients: Hydroxypropyl Methylcellulose USP, Yellow Ferric Oxide NF (200 mg/50 mg tablets only), Red Ferric Oxide NF, Purified Water USP and Magnesium Stearate NF.
What dosage form it comes in
AA-LEVOCARB CR controlled-release tablets are available in 100 mg/25 mg (levodopa/carbidopa) and 200 mg/50 mg (levodopa/carbidopa) strengths.
Warnings and precautions
Serious Warnings and Precautions
Some people feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e. without feeling sleepy or drowsy) when taking AA- LEVOCARB CR. During treatment with AA- LEVOCARB CR take special care when you drive or operate a machine. If you experience excessive drowsiness or a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician
Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease.
It is not known if this problem is associated with Parkinson’s disease or the drugs used to treat Parkinson’s disease. Therefore, patients treated with AA-LEVOCARB CR should have periodic skin examinations.
Before taking AA-LEVOCARB CR tell your physician or pharmacist if you:
- have or have had any medical conditions including: allergies;depression or mental disturbances; lung, kidney, liver, heart or hormonal problems; skin cancer or suspicious skin lesions; ulcer in your gut (called “duodenal” or “peptic ulcer”); convulsions/seizures; or glaucoma
- have previously been treated with levodopa
- are pregnant or plan to become pregnant
- are breastfeeding or wish to breastfeed
- are going to have an operation that requires general anesthesia
- drive or operate machinery
Tell your doctor if you or your family member/caregiver notices you are developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others. These behaviors are called impulse control disorders. Your doctor may need to review your treatments. It is not recommended to use AA- LEVOCARB CR while you are pregnant or breast-feeding.
It is not known what effect AA-LEVOCARB CR may have on human pregnancy. Levodopa, one of the components of AA- LEVOCARB CR, is passed into human milk. If you are pregnant, may become pregnant or intend to breast-feed, tell your physician, who will help you weigh the benefits of the drug for you against possible risks to your baby.
As you improve on AA-LEVOCARB CR, you may increase your physical activity gradually and with caution related to any other medical conditions you may have. AA-LEVOCARB CR should not be given to children under 18 years of age.
Interactions with this medication
Although AA-LEVOCARB CR can generally be given with other medicines, there are exceptions.
Tell your physician about all medicines you are taking or plan to take, including those obtained without a prescription.
Tell your physician about all medicines you are taking or plan to take, including those obtained without a prescription.
- antihypertensive drugs (used to treat elevated blood pressure)
- some medications used to treat psychiatric conditions or mental depression (including phenothiazines, butyrophenones, risperidone, selegiline, tricyclic antidepressants and monoamine oxidase inhibitors)
- tetrabenazine (medications used to treat conditions related to involuntary movements such as Huntingtons Disease
- phenytoin (anti-epileptic medication) papaverine (medication for intestinal spasms)
- isoniazid (medication to treat tuberculosis)
- metoclopramide (for nausea and vomiting)
- iron salts (such as multivitamins) which may reduce the amount of carbidopa and/or levodopa available to the body
A change in diet to foods that are high in protein (such as meat, fish, dairy products, seeds and nuts) may delay the absorption of levodopa and AA-LEVOCARB CR may not work as well as it should.
Proper use of this medication
Usual Dose
The dosage of AA-LEVOCARB CR is variable and your physician will adjust it according to the severity of your disease and your response to treatment.
AA-LEVOCARB CR is a sustained-release formulation of levodopa/carbidopa, which releases these ingredients over a 4- to 6- hour period.
The effect of the first morning dose of AA-LEVOCARB CR may be delayed for up to 1 hour compared with the response usually obtained from the first morning dose of levodopa/carbidopa immediate-release tablets. Consult your physician if such delayed responses pose a problem in treatment.
AA-LEVOCARB CR should only be administered as whole tablets. In order to maintain the slow-release properties of AA-LEVOCARB CR, do not chew or crush the tablets.
For best results take AA-LEVOCARB CR every day. It is important to carefully follow your physician’s advice on how much AA-LEVOCARB CR to take and how often to take it. Promptly inform your physician of any change in your condition such as nausea or abnormal movements, as this may require an adjustment in your prescription.
Do not change the dose regimen prescribed by your physician and do not add any additional antiparkinson medications, including other levodopa/carbidopa preparations, without first consulting your physician.
Do not stop taking this medicine abruptly or lower the dosage without checking with your physician. If you suddenly stop or reduce your dosage you may experience the following symptoms: stiff muscles, high temperature (fever) and mental changes.
Overdose
In case of an overdose, contact your physician immediately so that medical attention may be given promptly.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
If you think you have taken too much AA-LEVOCARB CR, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
Try to take AA-LEVOCARB CR as prescribed. However, if you have missed a dose, take it as soon as you remember. If it is almost time to take your next tablet, do not take the missed tablet, but resume your normal schedule.
Side effects and what to do about them
AA-LEVOCARB CR is generally well tolerated. Like any other medicine, however, AA-LEVOCARB CR may have unintended or undesirable effects, so called side-effects.
Very rare but serious side effects that have been reported include sudden sleep onset episodes (see WARNINGS AND PRECAUTIONS).
Certain side effects that have been reported with AA- LEVOCARB CR may affect some patients’ ability to drive or operate machinery.
AA-LEVOCARB CR can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. Therefore you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see WARNINGS AND PRECAUTIONS).
The most frequent side effects are: abnormal movements (which may or may not resemble your Parkinson’s symptoms), nausea, hallucinations, confusion, dizziness, dry mouth.
Other possible side effects include: abnormal dreams or difficulty sleeping, mental changes, depression, weakness, vomiting, loss of appetite, flushing, and hair loss (see WARNINGS AND PRECAUTIONS)
Occasionally, dark color (red, brown or black) may appear in your saliva, urine or sweat after you take AA-LEVOCARB CR.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Most Common | |||
| Abnormal Involuntary movements, such as spasms or twitching | ✔ | ||
| Common | |||
| Hallucinations (seeing or hearing things that are not there) | ✔ | ||
| Feeling of lightheadedness when standing quickly; fainting | ✔ | ||
| Rare | |||
| Allergic reactions [red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing or swallowing] | ✔ | ||
| Falling asleep without warning | ✔ | ||
| Impulse control symptoms (inability to resist the impulse to perform an action that could be harmful) such as compulsive gambling, increased sexual urges and/or behaviours, uncontrollable excessive shopping or spending, binge/ compulsive eating, and/or other urges. | ✔ | ||
| Changed patches of pigmented skin, including irritated or irregular moles, or moles in which you have noticed changes (melanoma) | ✔ | ||
| Uneven (irregular) heart beat or palpitations | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AA-LEVOCARB CR, contact your doctor or pharmacist.
How to store
Store your tablets in a tightly closed container at room temperature (15°C to 30°C). Protect from light and moisture.
Do not use outdated medicine.
Keep all medicines out of the reach of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
- Calling toll-free at 1-866-234-2345.
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
If you want more information about AA-LEVOCARB CR:
- 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. Find the Consumer Information on the manufacturer’s website, or by callcfqgC
This leaflet was prepared by AA Pharma Inc.
Last revised: March 24, 2020