Parcopa

Generic name: carbidopa/levodopa

What is Parcopa?

Parcopa is used to treat Parkinson’s disease.

It is used to treat signs like Parkinson’s disease caused by other health problems.

Parcopa may be given to you for other reasons. Talk to your doctor.

Description

Parcopa(carbidopa-levodopa orally disintegrating tablets) is a combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Parcopa is an orally administered formulation of carbidopa-levodopa which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.

Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (–)-L-α-hydrazino-α-methyl-ß-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4•H2O, and its structural formula is:

PARCOPA

Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23.

Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (–)-L-α-amino-ß-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:

Image from Drug Label Content

Mechanism of Action

Current evidence indicates that symptoms of Parkinson’s disease are related to depletion of dopamine in the corpus striatum. Administration of dopamine is ineffective in the treatment of Parkinson’s disease apparently because it does not cross the blood-brain barrier. However, levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson’s disease.

Before taking Parcopa, tell your doctor:

  • If you are allergic to Parcopa; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Glaucoma, a skin lump or growth, or a history of skin cancer.
  • If you are taking any of these drugs: Reserpine or tetrabenazine.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
  • If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Parcopa with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Parcopa?

  • Tell all of your health care providers that you take Parcopa. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Parcopa affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Parcopa.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
  • This medicine may “wear off” as the time for your next dose gets closer. Tell your doctor if this happens and it bothers you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • The chance of a type of skin cancer called melanoma may be raised in people with Parkinson’s disease. It is not known if Parcopa may also raise the chance. Have skin exams while you take Parcopa. Talk with your doctor.
  • Some products may cause a dark red, brown, or black color to appear in your saliva, urine, or sweat. This is not harmful but may discolor your clothes.
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after Parcopa was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take Parcopa. Call your doctor right away if this happens or you feel very sleepy.
  • Neuroleptic malignant syndrome (NMS) is a very bad and sometimes deadly health problem that has happened when Parcopa was stopped all of a sudden. NMS has also happened when the dose of Parcopa was lowered. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Parcopa best taken?

Use Parcopa as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Be sure your hands are dry before you touch Parcopa.
  • Take Parcopa out of the bottle right before you use it.
  • Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • If you take an iron product or a multivitamin that has iron, ask your doctor or pharmacist how to take it with Parcopa. Iron may lower how well your body is able to absorb Parcopa.
  • Diets high in protein, fat, or calories may lower how well your body absorbs Parcopa; tell your doctor if you have a diet like this or if you will be changing your diet. Talk with your doctor.
  • Do not stop taking Parcopa all of a sudden or lower your dose without talking to your doctor. Side effects may happen.
  • Keep taking Parcopa even when you are not having symptoms.
  • Keep a diary of your signs.
  • Keep taking Parcopa as you have been told by your doctor or other health care provider, even if you feel well.
  • Take Parcopa at the same time of day.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Parcopa that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
  • Change in the way you act.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling confused.
  • Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
  • A skin lump or growth.
  • Change in color or size of a mole.
  • Trouble controlling body movements that is new or worse.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Black, tarry, or bloody stools.
  • Stomach pain.
  • Chest pain or pressure.
  • Fast or abnormal heartbeat.
  • Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
  • Dark urine or yellow skin or eyes.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Shortness of breath.

What are some other side effects of Parcopa?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Bad dreams.
  • Constipation.
  • Dizziness.
  • Feeling sleepy.
  • Dry mouth.
  • Headache.
  • Trouble sleeping.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How supplied

PARCOPA®  (carbidopa-levodopa orally disintegrating tablets) 25/100 are yellow, round, flat-faced, mint-flavored, scored and engraved “25/100” on the unscored side and “SP” above and “342” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3342-01

Imprint 25/100 SP 342 - Parcopa 25 mg / 100 mg

 

 

PARCOPA®  (carbidopa-levodopa orally disintegrating tablets) 10/100 are blue, round, flat-faced, mint-flavored, scored and engraved “10/100” on the unscored side and “SP” above and “341” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3341-01

Imprint 10/100 SP 341 - Parcopa 10 mg / 100 mg

 

PARCOPA®  (carbidopa-levodopa orally disintegrating tablets) 25/250 are blue, round, flat-faced, mint-flavored, scored, and engraved “25/250” on the unscored side and “SP” above and “343” below the score on the other side. They are supplied as follows:

Bottles of 100NDC 0091-3343-01

Imprint 25/250 SP 343 - Parcopa 25 mg / 250 mg

 

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture and light.

Dispense in a tight, light-resistant container as defined in the USP/NF.

SRC: NLM .

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