Carbidopa; Levodopa Biphasic-Release Capsules

What is this medication?

CARBIDOPA; LEVODOPA (kar bi DOE pa; lee voe DOE pa) treats the symptoms of Parkinson disease. It works by increasing the amount of dopamine in your brain, a substance which helps manage body movements and coordination. This reduces the symptoms of Parkinson, such as body stiffness and tremors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CREXONT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression or other mental health conditions
• Feel very sleepy during the day, fall asleep suddenly during the day
• Glaucoma
• Have had a heart attack
• Heart disease
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to levodopa, carbidopa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

If you can, take the first dose of the day 1 to 2 hours before eating. Avoid eating a large meal high in fat close to the time you take this medication.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs, such as Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Alcohol
• Benzodiazepines, such as alprazolam, diazepam, lorazepam
• Certain antihistamines
• Certain medications for mental health conditions, such as amitriptyline, haloperidol, risperidone, trazodone
• Droperidol
• Iron supplements or multivitamins with iron
• Isoniazid
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that help you fall asleep
• Medications that relax muscles
• Metoclopramide
• Opioids for pain or cough
• Papaverine
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
• Phenytoin
• Rasagiline
• Selegiline
• Tetrabenazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not drink alcohol while taking this medication. Drinking alcohol may alter the effects of your medication. Serious side effects may occur.

A severe reaction similar to neuroleptic malignant syndrome (NMS) may occur if you reduce the dose of or stop taking this medication too quickly. Symptoms of NMS include high fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion. Contact your care team right away if you think you have NMS.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

When taking this medication, you may fall asleep without notice. You may be doing activities, such as driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your care team right away if this happens to you.

There have been reports of increased sexual urges or other strong urges, such as gambling while taking this medication. If you experience any of these while taking this medication, you should report this to your care team as soon as possible.

You may experience a 'wearing off' effect before it is time to take your next dose of this medication. You may also experience an 'on-off' effect where the medication seems to stop working for minutes to hours, then suddenly starts working again. Tell your care team if this happens to you. Your dose may need to be adjusted.

Eating high protein foods may affect how this medication works. Tell your care team if you change your diet.

This medication can make your saliva, sweat, or urine look dark red or black. This is normal but may stain clothing or fabrics.

This medication may cause low levels of vitamin B6 in your body. Make sure that you get enough vitamin B6 while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Falling asleep during daily activities
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• New or worsening uncontrolled and repetitive movements of the face, mouth, or upper body
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Urges to engage in impulsive behaviors such as gambling, binge eating, sexual activity, or shopping in ways that are unusual for you

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dark red or black saliva, sweat, or urine
• Dizziness
• Drowsiness
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.