AA-LEVOCARB CR 200 MG — DIN 02245211

What is AA-LEVOCARB CR?

AA-LEVOCARB CR 200 MG contains LEVODOPA : 200 MG CARBIDOPA : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02245211, held by AA PHARMA INC, supplied as TABLET (EXTENDED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 12-Jun-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is AA-LEVOCARB CR used for?

AA-LEVOCARB CR (levodopa and carbidopa controlled-release tablets) is indicated for the treatment of Parkinson's disease. AA-LEVOCARB CR is not recommended for the treatment of drug-induced extrapyramidal reactions.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The daily dosage of AA-LEVOCARB CR must be determined by careful titration. Patients should be monitored closely during the dose adjustment period for nausea or abnormal involuntary movements. Standard antiparkinson drugs, other than levodopa alone, may be continued with AA-LEVOCARB CR, but dosage may need adjustment. If patients are receiving levodopa monotherapy or levodopa/carbidopa immediate-release tablets, this medication must be discontinued at least 8 hours before starting AA-LEVOCARB CR. AA-LEVOCARB CR tablets contain a 4:1 ratio of levodopa to carbidopa. AA-LEVOCARB CR 200 mg/50 mg contains levodopa 200 mg/carbidopa 50 mg per tablet. AA-LEVOCARB CR 100 mg/25 mg contains levodopa 100 mg/carbidopa 25 mg per tablet. Initial Dosage and Titration for Patients Currently Treated with Conventional Levodopa/Carbidopa Combinations: Dosage with AA-LEVOCARB CR 200 mg/50 mg should be substituted at an amount that eventually provides approximately 10 to 30 percent more levodopa per day. The interval between doses should be prolonged by 30 to 50 percent. Initially, patients should receive AA-LEVOCARB CR 200 mg/50 mg at a dosage that provides the same amount of levodopa, but with a longer dosing interval. Initial Dosage for Patients Currently Treated with Levodopa Alone: Levodopa must be discontinued at least eight hours before therapy with AA-LEVOCARB CR 200 mg/50 mg. AA-LEVOCARB CR should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of AA-LEVOCARB CR 200 mg/50 mg two times daily. Initial Dosage for Patients Without Prior Levodopa Therapy: AA-LEVOCARB CR 100 mg/25 mg tablets may be used in early-stage patients or to facilitate titration. The initial recommended dose is 1 tablet of AA-LEVOCARB CR 100 mg/25 mg twice daily. For patients requiring more levodopa, a daily dose of 1 to 4 tablets of AA-LEVOCARB CR 100 mg/25 mg twice a day is generally well-tolerated. Initial dosages should not exceed 600 mg per day of levodopa or be given at intervals of less than 6 hours. Titration: Doses and dosing intervals must be adjusted on an individual basis, depending upon therapeutic response. An interval of at least 3 days between dosage adjustments is recommended. Most patients have been adequately treated with 2 to 8 levodopa/carbidopa controlled-release tablets 200 mg/50 mg per day, administered as divided doses at intervals ranging from 4 to 12 hours during the waking day. If the divided doses of AA-LEVOCARB CR 200 mg/50 mg are not equal, it is recommended that the smaller doses be given at the end of the day. Maintenance: Periodic clinical evaluations and adjustment of the dosage regimen may be required. Discontinuation: Patients should be observed carefully if abrupt reduction or discontinuation is required, especially if the patient is receiving neuroleptics. If general anesthesia is required, AA-LEVOCARB CR may be continued as long as the patient is permitted to take oral medication. Administration: AA-LEVOCARB CR 200 mg/50 mg may be administered as a whole or as half tablets. AA-LEVOCARB CR 100 mg/25 mg should only be administered as whole tablets. Tablets should not be chewed or crushed. Missed Dose: If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken, and the normal schedule resumed.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

AA-LEVOCARB CR are contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • taking non-selective monoamine oxidase inhibitors (MAOIs). These inhibitors must be discontinued at least two weeks prior to initiating therapy with AA-LEVOCARB CR. • with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease. • with narrow angle glaucoma. • for whom administration of a sympathomimetic amine is contraindicated (e.g., epinephrine, norepinephrine, amphetamines or isoproterenol). • with suspicious, undiagnosed skin lesions or a history of melanoma; because levodopa may activate a malignant melanoma.

Warnings and precautions

Sudden Onset of Sleep: Patients receiving treatment with levodopa and carbidopa and other dopaminergic agents have reported suddenly falling asleep while engaged in activities of daily living, including driving, which has sometimes resulted in accidents. Patients should be alerted to this risk, which is not limited to initiation of therapy and can occur without warning signs. Physicians should caution patients about operating hazardous machinery, including driving, while taking AA-LEVOCARB CR. If drowsiness or sudden onset of sleep occurs, patients should refrain from driving or operating machines and contact their physician immediately. Dose reduction may reduce somnolence but may not eliminate episodes of falling asleep. Episodes of falling asleep have also been reported with other dopaminergic agents. The precise cause is unknown, but Parkinson's disease patients often experience altered sleep architecture and dopaminergic agents can induce sleepiness. Neuroleptic Malignant Syndrome: A symptom complex resembling neuroleptic malignant syndrome (muscular rigidity, elevated body temperature, altered consciousness, mental changes, autonomic instability, increased serum creatine phosphokinase) has been reported with rapid dose reduction, withdrawal, or changes in antiparkinsonian therapy. Patients should be observed carefully when AA-LEVOCARB CR dosage is reduced abruptly or discontinued, especially if receiving neuroleptics.