Duopa 4.63 mg/mL

Carbidopa and Levodopa · SUSPENSION · AbbVie Inc.

1 Recall on Record

Plain English

Duopa is a suspension containing carbidopa and levodopa at 4.63 mg/mL, taken enteral. Manufactured by AbbVie Inc..

Key Facts

Brand Name: Duopa
Generic Name: Carbidopa and Levodopa
NDC Code (Product): 0074-3012
Manufacturer: AbbVie Inc.
Strength: 4.63 mg/mL
Dosage Form: SUSPENSION
Route: ENTERAL
Marketing Status
Application #: NDA203952
Drug Class: Aromatic Amino Acid [EPC]
Marketing Start: 01/15/2015

Recall History

1 Recall on Record

Class II01/13/2017

AbbVie Inc.

Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fall1,664 reports

death975 reports

device issue903 reports

drug ineffective860 reports

device dislocation793 reports

parkinson^s disease775 reports

hallucination755 reports

dyskinesia738 reports

urinary tract infection583 reports

tremor577 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DUOPA ® is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. DUOPA is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The maximum recommended daily dose of DUOPA is 2000 mg of levodopa (i.e., one cassette per day) administered over 16 hours ( 2.2) Prior to initiating DUOPA, convert patients from all forms of levodopa to oral immediate-release carbidopa-levodopa tablets (1:4 ratio) ( 2.3 ) Titrate total daily dose based on clinical response for the patient ( 2.3 ) Administer DUOPA into the jejunum through a percutaneous endoscopic gastrostomy with jejunal tube (PEG-J) with the CADD®-Legacy 1400 portable infusion pump ( 2.4) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies including DUOPA, periodically during treatment, and as clinically indicated [see Warnings and Precautions ( 5.9 )] . If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with DUOPA while supplementing vitamin B6. 2. 2 DUOPA Daily Dose DUOPA is administered over a 16-hour infusion period. The daily dose is determined by individualized patient titration and composed of: A …

Contraindications

4 CONTRAINDICATIONS DUOPA is contraindicated in patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions ( 7.1 and 7.2 )] . DUOPA is contraindicated in patients taking nonselective monoamine oxidase (MAO) inhibitors ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Selective MAO-B inhibitors: May cause orthostatic hypotension ( 7.1 ) Antihypertensive drugs: May cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive drug may be needed ( 7.2 ) Dopamine D2 receptor antagonists, isoniazid, iron salts, and high-protein diet may reduce the effectiveness of DUOPA ( 7.3 , 7.4 , 7.5 ) 7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with DUOPA is contraindicated [see Contraindications ( 4 ) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating DUOPA. The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with DUOPA may be associated with orthostatic hypotension. Monitor patients who are taking these drugs. 7.2 Antihypertensive Drugs The concurrent use of DUOPA with antihypertensive medications can cause symptomatic postural hypotension. A dose reduction of the antihypertensive medication may be needed after starting or increasing the dose of DUOPA. 7.3 Dopamine D2 Receptor Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine) and isoniaz…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in labeling: Gastrointestinal and Gastrointestinal Procedure-Related Risks [see Warnings and Precautions ( 5.1 ) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.2 ) ] Orthostatic Hypotension [see Warnings and Precautions ( 5.3 ) ] Hallucinations/Psychosis/Confusion [see Warnings and Precautions ( 5.4 ) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions ( 5.5 ) ] Depression and Suicidality [see Warnings and Precautions ( 5.6 ) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.7 ) ] Dyskinesia [see Warnings and Precautions ( 5.8 ) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions ( 5.9 )] Neuropathy [see Warnings and Precautions ( 5.10 ) ] Cardiovascular Ischemic Events [see Warnings and Precautions ( 5.11 ) ] Laboratory Test Abnormalities [see Warnings and Precautions ( 5.12)] Glaucoma [see Warnings and Precautions ( 5.13 ) ] Most common adverse reactions for DUOPA (DUOPA incidence at least 7% greater than oral carbidopa-levodopa incidence) were: complication of device ins…

Frequently Asked Questions

What is Duopa used for?

Duopa contains Carbidopa and Levodopa. It is a suspension taken enteral. Consult your doctor for specific uses.

Is Duopa a controlled substance?

Duopa is not classified as a controlled substance by the DEA.

What is the generic name for Duopa?

The generic name for Duopa is Carbidopa and Levodopa. There are 12 other brand versions of Carbidopa and Levodopa.

What is the NDC code for Duopa 4.63 mg/mL?

The NDC (National Drug Code) for Duopa 4.63 mg/mL is 0074-3012, listed by AbbVie Inc..

Product NDC

0074-3012

Package NDC

0074-3012-07

Other Carbidopa Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)