Rytary

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa and levodopa. Talk with your doctor or nutrition counselor about the best foods to eat while you are taking this medicine.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when medication is taken during pregnancy.

Rytary falls into category C. In animal stidues, pregnancy animals were given this medication and had some babies born with problems. No well-controlled studies have bene done in humans. Therefore, this medication may be used if the potential benefits to the mother outweight the potential risks to the unborn child.

• Store Rytary at room temperature.
• Keep this and all medications out of the reach of children.

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.

In the U.S.

• Parcopa
• Rytary
• Sinemet 10-100
• Sinemet 25-100
• Sinemet 25-250
• Sinemet CR

In Canada

• Sinemet 100/10
• Sinemet 100/25
• Sinemet 250/25
• Sinemet CR 100/25
• Sinemet CR 200/50

Available Dosage Forms:

• Tablet, Extended Release
• Capsule, Extended Release
• Tablet
• Tablet, Disintegrating

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Decarboxylase Inhibitor

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.
• Hard stools (constipation).
• Dizziness.
• Feeling sleepy.
• Dry mouth.
• Headache.
• Not able to sleep.
• 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Rytary, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rytary. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Rytary.

Review Date: October 4, 2017

. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

In rats, oral administration of carbidopa-levodopa for two years resulted in no evidence of carcinogenicity.

Mutagenesis

Carbidopa was mutagenic in the in vitro Ames test and in the in vitro mouse lymphoma tk assay but was negative in the in vivo mouse micronucleus assay.

Impairment of Fertility

In reproduction studies, no effects on fertility were observed in rats receiving carbidopa-levodopa.

. How Supplied

Rytary (carbidopa and levodopa) extended-release capsules are available in the following strengths:

• 23.75 mg carbidopa and 95 mg of levodopa: blue and white capsule imprinted with IPX066 on the capsule cap and 95 on the capsule body in bottles of 100 (NDC#64896-661-01) and 240 (NDC#64896-661-43)
• 36.25 mg carbidopa and 145 mg levodopa: blue and light blue capsule imprinted with IPX066 on the capsule cap and 145 on the capsule body in bottles of 100 (NDC#64896-662-01) and 240 (NDC#64896-662-43)
• 48.75 mg carbidopa and 195 mg levodopa: blue and yellow capsule imprinted with IPX066 on the capsule cap and 195 on the capsule body in bottles of 100 (NDC#64896-663-01) and 240 (NDC#64896-663-43)
• 61.25 mg carbidopa and 245 mg levodopa: blue capsule imprinted with IPX066 on the capsule cap and 245 on the capsule body in bottles 100 (NDC#64896-664-01) and 240 (NDC#64896-664-43)

Storage and Handling

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container.

Dosing Instructions

• Advise patients to not take other carbidopa-levodopa preparations with Rytary without consulting their healthcare provider [see Dosage and Administration (2.2)].
• Advise patients to call their healthcare provider before stopping Rytary. Discontinue Rytary slowly. Tell patients to call their healthcare provider if they develop withdrawal symptoms such as fever, confusion or severe muscle stiffness [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].
• Advise patients to swallow Rytary capsules whole, without chewing, dividing, or crushing [see Dosage and Administration (2.4)].
• For patients with difficulty swallowing, the entire contents of the Rytary capsule may be sprinkled on 1 to 2 tablespoons of applesauce and should be taken immediately [see Dosage and Administration (2.4)].
• Inform patients that a high fat, high calorie meal may delay the absorption of levodopa and the onset of action by 2 to 3 hours. For this reason, consideration should be given to taking the first dose of the day about 1 to 2 hours before eating [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

Falling Asleep

Advise patients that certain side effects such as sleepiness and dizziness that have been reported with Rytary may affect some patients' ability to drive and operate machinery safely [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Hallucinations and Psychosis

Inform patients that hallucinations can occur with levodopa products [see Warnings and Precautions (5.4)].

Impulse Control Disorder

Inform patients of the potential for experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson's disease [see Warnings and Precautions (5.5)].

Dyskinesia

Instruct patients to notify their healthcare provider if abnormal involuntary movements appear or get worse during treatment with Rytary [see Warnings and Precautions (5.6 )].

Hypotension and Syncope

Advise patients that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sweating [see Adverse Reactions (6.1)]. Advise patients to rise slowly after sitting or lying down, especially if they have been doing so for a prolonged period.

Advise patients of the possible additive sedative effects when taking other CNS depressants in combination with Rytary.

Pregnancy and Breast-feeding

Instruct patients to notify their physicians if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].

Instruct patients to notify their physicians if they intend to breast-feed or are breast-feeding an infant [see Use in Specific Populations (8.3)].

Manufactured for:
Impax Pharmaceuticals, a division of Impax Laboratories, Inc.
Hayward, CA, USA 94544

By Impax Laboratories (Taiwan), Inc.
Jhunan, Taiwan

Printed in USA
Copyright 2015 Impax Laboratories, Inc.
All rights reserved

1566-01
Iss. 01/2015