Parcopa

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Other drugs may interact with carbidopa 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.

This section provides information on the proper use of a number of products that contain carbidopa and levodopa. It may not be specific to Parcopa. Please read with care.

Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

Since protein may interfere with the body's response to carbidopa and levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

Sinemet® tablet or Parcopa® disintegrating tablet begins to release its ingredients 30 minutes after you take it.

Swallow the extended-release capsule or sustained release tablet whole. Do not crush, break, or chew it.

If you have trouble swallowing the extended-release capsules: The capsules can be opened and the contents can be sprinkled on 1 to 2 tablespoons of applesauce. This mixture must be swallowed immediately without chewing.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not remove the tablet from the bottle until you are ready to take it. Place the tablet on the top of your tongue, where it will melt quickly.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Parkinson's disease:
  • For oral dosage form (extended-release capsules):
    • Adults—
      • For patients starting on carbidopa and levodopa treatment: At first, one capsule three times a day for the first 3 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 capsules per day.
      • For patients taking carbidopa and levodopa already: At first, 3 or 4 capsules three times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 capsules per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (disintegrating tablets):
    • Adults—
      • For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
      • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Parcopa®. The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (sustained release tablets):
    • Adults—
      • For patients switching from Sinemet® to Sinemet® CR: The starting dose is based on the amount of Sinemet® you are currently taking per day. Your doctor may adjust your dose as needed.
      • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Sinemet® CR. The starting dose is one tablet two times a day. Your doctor may adjust your dose as needed.
      • For patients not taking levodopa: At first, one tablet two times a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—
      • For patients starting on carbidopa and levodopa treatment: At first, one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
      • For patients taking levodopa already: Levodopa should be discontinued at least 12 hours before starting Lodosyn® plus levodopa or Sinemet®. The starting dose is one tablet three or four times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
      • For patients taking carbidopa and levodopa already: 25 milligrams (mg) of Lodosyn® per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine, Nardil®, Parnate®) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, drowsy, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• It is used to treat Parkinson's disease.
• It is used to treat signs like Parkinson's disease caused by other health problems.
• It may be given to you for other reasons. Talk with the doctor.

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, 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.
• Belly pain.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Fever or chills.
• Sore throat.
• Any unexplained bruising or bleeding.
• Very bad dizziness or passing out.
• Very bad headache.
• Dark urine or yellow skin or eyes.
• Change in eyesight, eye pain, or very bad eye irritation.
• Shortness of breath.
• Feeling very tired or weak.

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Parcopa®. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Parcopa®. Parcopa®  may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (See PRECAUTIONS, Drug Interactions).

Parcopa®  is contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

Because levodopa may activate a malignant melanoma, Parcopa®  should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

The most common adverse reactions reported with carbidopa and levodopa therapy have included dyskinesias, such as choreiform, dystonic, and other involuntary movements and nausea.

The following other adverse reactions have been reported with carbidopa and levodopa:

Body as a Whole: chest pain, asthenia.

Cardiovascular: cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.

Gastrointestinal: dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.

Hematologic: agranulocytosis, hemolytic and nonhemolytic anemia, thrombocytopenia, leukopenia.

Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions).

Musculoskeletal: back pain, shoulder pain, muscle cramps.

Nervous System/Psychiatric: psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome (see WARNINGS), bradykinetic episodes (“on-off” phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with carbidopa and levodopa has not been established.

Respiratory: dyspnea, upper respiratory infection.

Skin: rash, increased sweating, alopecia, dark sweat.

Urogenital: urinary tract infection, urinary frequency, dark urine.

Laboratory Tests: decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.

Other adverse reactions that have been reported with levodopa alone and with various carbidopa and levodopa formulations, and may occur with Parcopa®  are:

Body as a Whole: abdominal pain and distress, fatigue.

Cardiovascular: myocardial infarction.

Gastrointestinal: gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups.

Metabolic: edema, weight gain, weight loss.

Musculoskeletal: leg pain.

Nervous System/Psychiatric: ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner’s syndrome, peripheral neuropathy.

Respiratory: pharyngeal pain, cough.

Skin: malignant melanoma (see also CONTRAINDICATIONS), flushing.

Special Senses: oculogyric crises, diplopia, blurred vision, dilated pupils.

Urogenital: urinary retention, urinary incontinence, priapism.

Miscellaneous: bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.

Laboratory Tests: decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.

Management of acute overdosage with Parcopa®  is the same as management of acute overdosage with levodopa. Pyridoxine is not effective in reversing the actions of Parcopa®.

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 anti-arrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Parcopa®  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 carbidopa were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1500-2000 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 carbidopa. The addition of carbidopa 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.

Applies to carbidopa / levodopa: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release

Other dosage forms:

• route not applicable suspension

Along with its needed effects, carbidopa / levodopa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carbidopa / levodopa:

• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

• Bladder pain
• bloody or cloudy urine
• chest pain
• confusion
• difficult, burning, or painful urination
• discouragement
• feeling sad or empty
• frequent urge to urinate
• inability to move the eyes
• increased blinking or spasms of the eyelid
• irritability
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• seeing, hearing, or feeling things that are not there
• sticking out of tongue
• tiredness
• trouble concentrating
• trouble in breathing, speaking, or swallowing
• trouble sleeping
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions

• Anxiety
• black, tarry stools
• bluish color
• blurred vision
• changes in skin color
• chest discomfort
• chills
• convulsions
• cough or hoarseness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• false beliefs that cannot be changed by facts
• fast, irregular, pounding, or racing heartbeat or pulse
• feelings about hurting oneself or others
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• hyperventilation
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased sweating
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• lower back or side pain
• nausea
• pain
• pain or discomfort in the arms, jaw, back, or neck
• restlessness
• seeing, hearing, or feeling things that are not there
• severe muscle stiffness
• shaking
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the foot or leg
• swollen glands
• tenderness
• tiredness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusually pale skin
• vomiting

Some side effects of carbidopa / levodopa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• back or shoulder pain
• belching
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• difficulty having a bowel movement (stool)
• ear congestion
• headache
• heartburn
• indigestion
• loss of voice
• muscle cramps
• nasal congestion
• runny nose
• sneezing
• stomach discomfort, upset, or pain
• unusual dreams
• weight loss

• Abdominal or stomach distress
• bad, unusual, or unpleasant (after) taste
• belching
• change in taste
• dark sweat
• double vision
• enlarged pupils
• feeling of warmth
• hair loss or thinning of the hair
• lack or loss of strength
• redness of the face, neck, arms, and occasionally, upper chest
• seeing double
• skin rash, hives or welts, itching