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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. CARBIDOPA/LEVODOPA/ENTACAPONE - ORAL (KAR-bi-DOE-pa/LEE-vo-DOE-pa/en-TAK-a-pone) COMMON BRAND NAME(S): Stalevo
USES: This combination medication is used to treat symptoms of Parkinson's disease. Parkinson's disease is believed to be due to a lack of an important chemical (dopamine) in the brain. Levodopa is converted into dopamine in the brain, leading to the relief of Parkinson's disease symptoms. Both carbidopa and entacapone are given with levodopa to increase the amount of levodopa that is converted into dopamine.
HOW TO USE: Take this medication by mouth exactly as prescribed. Do not increase the dose or take more frequently without consulting your doctor. The manufacturer directs not to split the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split. Follow your doctor's directions on how to take this medication. It is best to avoid a high protein diet (decreases the amount of levodopa that your body takes in) during treatment, unless directed otherwise by your doctor. Consult your doctor or pharmacist for more details. The dosage is based on your medical condition, previous drug therapy, response to therapy, and side effects if they occur. Some patients may experience a "wearing-off" (worsening of symptoms) before the next dose is due. An "on-off" effect might also occur, in which sudden short periods of stiffness occur. If these effects occur, contact your doctor for possible dose adjustments that may help to lessen this effect. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. If symptoms worsen while using this medication, contact your doctor immediately.
SIDE EFFECTS: Diarrhea, nausea, vomiting, headache, dizziness, drowsiness, stomach upset, loss of appetite, dry mouth, or difficulty sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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. Tell your doctor immediately if any of these serious side effects occur: involuntary movements (especially twitching of the eyelid), fainting or falling, difficulty swallowing, stomach/abdominal pain, persistent diarrhea, vision changes (including blurred vision). Tell your doctor immediately if any of these unlikely but serious side effects occur: black/tarry stools, muscle pain, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide, compulsive behavior including urge to gamble), signs of infection (e.g., persistent sore throat). Seek immediate medical attention if any of these highly unlikely but very serious side effects occur: chest pain, high fever, severe muscle stiffness, fast heartbeat, fast breathing, increased sweating. This medication may cause the saliva, urine, or sweat to turn a dark color. This is harmless; however, it may discolor clothing. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma (wide-angle), breathing problems, heart disease (especially history of heart attack), kidney disease, ulcers, mental/mood disorders (e.g., depression, schizophrenia), blood disorders. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before you have surgery with a general anesthetic, including dental surgery, tell the doctor or dentist you are taking this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professional (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not stop or change the dosage of any medicine without checking with them first. This drug should not be used with the following medication because very serious interactions may occur: tetrabenazine. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Certain MAO inhibitors (rasagiline, selegiline) may be used cautiously with close monitoring by your doctor. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. If you are taking rasagiline or selegiline for Parkinson's disease, ask your doctor if you should continue taking it. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: medications to treat high blood pressure (hypertension), other drugs to treat Parkinson's disease (including other drugs that contain levodopa, carbidopa, or entacapone), iron vitamins, tricyclic antidepressants (e.g., amitriptyline), phenytoin, papaverine, isoproterenol, adrenaline (epinephrine), norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetharine, bitolterol, probenecid, cholestyramine, metoclopramide, selegiline, certain antibiotics (e.g., erythromycin, ampicillin, rifampin, chloramphenicol). Also, report use of any medicine that can make you drowsy, such as: sedatives, tranquilizers, anti-anxiety medicine, anti-seizure drugs, narcotic pain relievers (e.g., codeine), psychiatric medicines, certain drowsiness-causing antihistamines (e.g., diphenhydramine). This medication can cause false results with urine glucose testing in diabetics. Blood glucose testing should be performed instead. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness, irregular or fast heartbeat, increased blinking/eyelid spasms (blepharospasms).
NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function tests, eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59 to 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.
Prescription Return Policy
We are prevented by law from accepting returns for any prescription medication. If you need to dispose of any medication, please follow the steps below...
FDA Guidelines on Proper Methods of Disposing of Unused Medicine
For guidelines on proper methods of disposing of unused medicines, consult the following FDA link: www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm
As a general rule of thumb, do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so. For information on drugs that should be flushed visit the FDA’s website.
To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug take-back program is available in your community.
If a drug take-back or collection program is not available:
1. Take your prescription drugs out of their original containers.
2. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
3. Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
4. Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off.
5. Place the sealed container with the mixture, and the empty drug containers, in the trash.
Shipping Policy
Although we strive to fill your medication as quickly as possible, we are not an urgent facility. Please obtain a local fill of your medication if you have an emergency or urgent needs to ensure no disruption with your medical therapy.
All orders ship from Titusville, FL. We offer 100% FREE shipping on all orders. We ship orders Monday through Friday. We only ship to valid street addresses within the state of Florida. No Post Office boxes.
For all orders, you can expect the following shipping times: 1-2 business days.
Please note that prescription items cannot be shipped until a valid, verified prescription is on file. In addition to the shipping times stated above, please add up to 1-2 business days of processing time to all orders.
Offer to Counsel
If you have any questions regarding this prescription or any other medication, please feel free to contact us at info@atyourdoorpharmacy.com or during store counseling hours (Mon-Fri, 9am-6pm, Eastern) at (407) 476-1721.
Health Insurance Portability & Accountability Act
At Your Door is committed to protecting your privacy. As a healthcare provider, we know that your trust in us is of central importance. This policy discloses our information use and policies and procedures in detail. Please read it to learn more about the ways we protect the information we collect and to find out how you can limit the information about you that is shared. If At Your Door should change its information practices, we will provide you notice of any material changes.
Strict Security Measures
At Your Door takes the security of information very seriously and has established security standards and procedures to prevent unauthorized access to patient information. We maintain physical, electronic, and procedural safeguards to comply with federal standards to guard patient information.
The following are ways AtYourDoorPharmacy.com will use and disclosure your Personal Health Information (PHI). Every allowable use or disclosure may not be listed:
For Treatment AtYourDoorPharmacy.com will use and disclose PHI to coordinate and manage your healthcare in order to dispense your prescription medication.
For Payment AtYourDoorPharmacy.com will use and disclose PHI to receive payment for our services. We may disclose your PHI to other HIPAA covered entities or business associates who may need it for their processing of your healthcare payments.
For Healthcare Operations AtYourDoorPharmacy.com will use and disclose PHI for administrative purposes to evaluate and improve the quality of care we provide you.
We may also use or disclose PHI for the following purposes
Business associates AtYourDoorPharmacy.com may provide some services through contracts with HIPAA compliant business associates. The business associates must enter into a confidentiality agreement to protect your PHI from unauthorized use and disclosure.
Communication with individuals involved in your care If you do not object, AtYourDoorPharmacy.com may disclose PHI to a friend or family member who is involved in your care.
Parents or legal guardians If you are a minor, we may release your PHI to your parents or legal guardians when we are permitted or required to do so under federal and applicable state law.
Health related communications AtYourDoorPharmacy.com may contact you to provide refill reminders or other health-related services that may be of interest to you as permitted by law.
As required by law We may disclose PHI when required to do so by federal, state or local law.
Law enforcement We may disclose PHI for law enforcement purposes, in response to a subpoena or other legal process.
Public Health As required by law, we may disclose PHI about you to public health authorities to prevent or control a serious threat to the health and safety of another person. We may also disclose PHI for the purpose of reporting adverse events and product recalls
Health Oversight Activities We may disclose PHI to an oversight agency for activities authorized by law. These activities would include pharmacy investigations, audits, credentialing and inspections required for our licensure. These are governmental agencies who monitor the health care system who are subject to government regulation and civil right laws.
Judicial and administrative proceedings We may disclose your PHI in response to a subpoena, court or administrative order, or other lawful process, but only if efforts were made to notify you about the request or to obtain an order protecting the requested PHI as required by law.
Coroners, medical examiners, and funeral directors We may disclose PHI to a coroner or medical examiner. This may be necessary to identify a deceased person or determine the cause of death. We may also disclose PHI to funeral directors as necessary with applicable laws so they may carry out their duties.
Organ, eye and tissue donation We may disclose PHI, consistent with applicable law to organizations who engage in organ procurement or transplant to facilitate the donation.
Research Under certain circumstances, we may disclose PHI for research purposes. Before disclosing PHI we would either remove information that personally identifies you or obtain your written authorization.
Military and Veterans Under certain circumstances, we may disclose to military authorities PHI or armed forces personnel.
National Security We may disclose PHI to authorized federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
Correctional Institution We may disclose PHI of an inmate to the institution when necessary for your health or the health and safety of others.
Workers’ compensation We may disclose your PHI to comply with Workers’ Compensation Laws or other similar programs.
Individual Rights
In most cases, you have the right to look at or get a copy of health information about you that we use to make decisions about your care. You also have the right to receive a list of instances where we have disclosed health information about you for reasons other than treatment, payment, or related administrative purposes. If you believe that information in your record is incorrect or if important information is missing, you have the right to request that we correct or add the missing information. We will take precautions to prevent inappropriate or non-essential use or distribution of patient information when transmitted via the Internet and while the pharmacy possesses such information. You may request in writing that we not use or disclose your information for treatment payment and administrative purposes except when specifically authorized by you, when required by law, or in emergencies. We will consider your request but are not legally required to accept it.
Other Uses and Disclosures of your PHI
We are required by law to protect the privacy of your information, provide this notice of our information practices, and follow the information practices described in this notice. AtYourDoorPharmacy.com will request written authorization from you before using or disclosing your PHI for purposes not included in this document or as otherwise permitted or required by law. If you provide authorization and want to revoke this authorization at any time, or have any questions or complaints, this can be done in writing at any time by sending a written request to:
Atyourdoorpharmacy.com
Attn: Privacy Officer
100 E. Pine St.Suite 110
Orlando, FL
You may also call if you have any questions or complaints, please contact AtYourDoorPharmacy.com at (407) 476-1727
This revocation will not affect any use or disclosure of your PHI allowed by your authorization while it was in effect.