As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function are recommended during extended therapy.
Patients with chronic wide-angle glaucoma may be treated cautiously with Apo-Levocarb and Levodopa extended-release tablets provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Levodopa alone, as well as Apo-Levocarb and Levodopa extended-release tablets, is associated with dyskinesias. The occurrence of dyskinesias may require dosage reduction.
Hallucinations / Psychotic-Like Behavior
Hallucinations and psychotic-like behavior have been reported with dopaminergic medications. In general, hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion and to a lesser extent sleep disorder (insomnia) and excessive dreaming.
Apo-Levocarb and Levodopa extended-release tablets may have similar effects on thinking and behavior. This abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
Ordinarily, patients with a major psychotic disorder should not be treated with Apo-Levocarb and Levodopa extended-release tablets, because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson’s disease and may decrease the effectiveness of Apo-Levocarb and Levodopa extended-release tablets.
Impulse Control / Compulsive Behaviors
Reports of patients taking dopaminergic medications (medications that increase central dopaminergic tone), suggest that patients may experience an intense urge to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or the caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with Apo-Levocarb and Levodopa extended-release tablets. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Apo-Levocarb and Levodopa extended-release tablets .
Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using Apo-Levocarb and Levodopa extended-release tablets for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).
Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of Apo-Levocarb per day should be provided. When a greater proportion of Apo-Levocarb is required, one tablet of SINEMET 25-100 may be substituted for each tablet of SINEMET 10-100. When more levodopa is required, SINEMET 25-250 should be substituted for SINEMET 25-100 or SINEMET 10-100. If necessary, the dosage of Apo-Levocarb levodopa 25-250 may be increased by onehalf or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of Apo-Levocarb greater than 200 mg is limited.
Because both therapeutic and adverse responses occur more rapidly with SINEMET than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with SINEMET than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.
What other drugs will affect Sinemet?
Other drugs may interact with Apo-Levocarb and levodopa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg/100 mg
NDC 62332-332-30 Apo-Levocarb and Levodopa Extended-Release Tablets, USP 25 mg /100 mg Rx only 30 Tablets Alembic
Management of acute overdosage with Apo-Levocarb and Levodopa extended-release tablet is the same as with levodopa. Pyridoxine is not effective in reversing the actions of Apo-Levocarb and Levodopa extended-release tablets.
General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Apo-Levocarb and Levodopa extended-release tablets should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known.
Based on studies in which high doses of levodopa and/or Apo-Levocarb were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1500 to 2000 mg/kg are expected to die. A significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg. A significant proportion of rats are expected to die after treatment with similar doses of Apo-Levocarb. The addition of Apo-Levocarb in a 1:10 ratio with levodopa increases the dose at which a significant proportion of mice are expected to die to 3360 mg/kg.
This medication contains Apo-Levocarb. Do not take Lodosyn if you are allergic to Apo-Levocarb or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
TERMS AND CONDITIONS
AbbVie Inc. is providing this service to help patients find a doctor in their area who has prescribed Duopa.
No fees have been received by or paid to doctors for inclusion in this specialist locator directory. Inclusion of a physician in this directory does not represent an endorsement by or a recommendation from AbbVie Inc., nor does it imply that the doctor on the list will determine that Duopa is right for you.
You are ultimately responsible for the selection of a physician and it is an important decision that you should consider carefully. This tool is just one source of information available to you.
AbbVie Inc. is the maker and marketer ofDUOPA® (Apo-Levocarb and levodopa) enteral suspension.
Hyperpyrexia and Confusion
Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, Apo-Levocarb-levodopa, or Apo-Levocarb-levodopa extended-release. Therefore, patients should be observed carefully when the dosage of levodopa or Apo-Levocarb-levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
Neuroleptic malignant syndrome (NMS) is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper-or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin, have been reported.
The early diagnosis of this condition is important for the appropriate management of these patients. Considering neuroleptic malignant syndrome (NMS) as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.
The management of neuroleptic malignant syndrome (NMS) should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of neuroleptic malignant syndrome (NMS); however, their effectiveness has not been demonstrated in controlled studies.
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase (LDH), and bilirubin. Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported. Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of Apo-Levocarb levodopa preparations than with levodopa.
Apo-Levocarb and levodopa preparations, such as Apo-Levocarb and Levodopa tablets and Apo-Levocarb and Levodopa extended-release tablets, may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria. This reaction will not be altered by boiling the urine specimen. False-negative tests may result with the use of glucose oxidase methods of testing for glucosuria.
Cases of falsely diagnosed pheochromocytoma in patients on Apo-Levocarb levodopa therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or Apo-Levocarb levodopa therapy.
Side effects of Apo-Levocarb/levodopa therapy
Some of the most common side effects of Apo-Levocarb/levodopa therapy include nausea, vomiting, orthostatic hypotension (falling blood pressure that occurs upon standing), worsening of glaucoma, dyskinesia, hallucination, psychosis, low blood pressure, confusion, dry mouth, and dizziness. 1
It is important to talk with your healthcare provider before starting or stopping any new treatments, including over-the-counter medications and alternative treatments.
Apo-Levocarb dosing information
Usual Adult Dose for Parkinsonian Tremor:
Patients on Apo-Levocarb-levodopa therapy requiring additional Apo-Levocarb:Initial dose: 25 mg orally with the first dose of Apo-Levocarb-levodopa each dayMaintenance dose: Additional doses of 12.5 mg or 25 mg may be given with each dose of Apo-Levocarb-levodopaMaximum dose: 200 mg orally per day
Patients requiring individual titration of Apo-Levocarb and levodopa:Initial dose: 25 mg orally three to four times a day, given at the same time as levodopaMaximum dose: 200 mg orally per day
Comments:-In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with Apo-Levocarb and levodopa.
Uses: With Apo-Levocarb-levodopa or with levodopa in the treatment of symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism
In people whose symptoms of PD are not controlled adequately by Apo-Levocarb/levodopa therapy, additional treatments may be added, or the person may be switched to other medications. Some additional treatments for PD include dopamine agonists, monoamine oxidase-B (MAO-B) inhibitors, and surgery for deep brain stimulation. 6
- Parkinson’s Disease Foundation. Accessed online on 1/11/17 at http://www.pdf.org/
- Gazewood JD, Richards DR, Clebak K. Parkinson disease: an update. Am Fam Physician. 2013 Feb 15;87(4):267-73.
- U.S. Food and Drug Administration. Accessed online on 1/18/16 at http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf
- Parkinson’s Disease. NIH Publication No. 15-139. Dec 2014. National Institute of Neurological Disorders and Stroke, National Institutes of Health.
- Stefani A, Pierantozzi M, Koch G, Galati S, Stanzione P. Therapy for dyskinesias in Parkinson’s disease patients. Future Neurology. 2010;5(2):277-299. Accessed online at http://www.medscape.com/viewarticle/718544
- Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83.
- Michael J. Fox Foundation for Parkinson’s Research. Accessed online on 3/9/17 at https://www.michaeljfox.org/understanding-parkinsons/living-with-pd/topic.php?dyskinesia
Before taking this medicine
You should not use Sinemet if you are allergic to it, or if you have:
Do not use Sinemet if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure Sinemet is safe for you, tell your doctor if you have:
liver or kidney disease;
an endocrine (hormonal) disorder;
a stomach or intestinal ulcer;
open-angle glaucoma; or
a history of depression, mental illness, or psychosis.
People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.
It is not known whether Sinemet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Apo-Levocarb and levodopa can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
The Sinemet disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of Apo-Levocarb and levodopa if you have phenylketonuria (PKU).
Dizziness, lightheadedness, nausea, vomiting, loss of appetite, trouble sleeping, unusual dreams, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause saliva, urine, or sweat to turn a dark color. This effect is harmless, but your clothes may be stained.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people taking this medication have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with Apo-Levocarb/levodopa even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or do other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Tell your doctor right away if you have any serious side effects, including: new/worsening movements you can't control/spasms, greatly increased eye blinking/twitching, fainting, vision changes (such as blurred vision, double vision), eye pain, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, mental/mood changes (such as agitation, hallucinations, depression, thoughts of suicide), signs of infection (such as sore throat that doesn't go away), easy bleeding/bruising, unusual tiredness, tingling of the hands/feet, unusual strong urges (such as increased gambling, increased sexual urges).
Get medical help right away if you have any very serious side effects, including: chest pain.
Abruptly stopping or reducing the dose of this medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, unusual muscle stiffness, severe confusion, sweating, fast/irregular heartbeat, rapid breathing.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
What is carb >
Apo-Levocarb is used with another medicine called levodopa to treat the symptoms of Parkinson's disease (stiffness, tremors, spasms, poor muscle control). Symptoms of Parkinson's disease may be caused by low levels of a chemical called dopamine (DOE pa meen) in the brain.
Levodopa is converted to dopamine in the brain. Apo-Levocarb helps prevent the breakdown of levodopa before it can reach the brain and take effect.
Apo-Levocarb is only used in combination with levodopa. Apo-Levocarb has no effect when used alone.
Apo-Levocarb is also used with levodopa to treat muscle symptoms similar to Parkinson's disease that are caused by certain drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.
Apo-Levocarb may also be used for purposes not listed in this medication guide.