Carbidopa, Levodopa And Entacapone
Generic Name: carbidopa, levodopa and entacapone
Brand Names:
Carbidopa, Levodopa And Entacapone
11 DESCRIPTION Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3.
Overview
11 DESCRIPTION Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3.
Uses
1 INDICATIONS AND USAGE Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.
Dosage
2 DOSAGE AND ADMINISTRATION Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response. • The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient ( 2.1 ) • Individual tablets should not be split or fractionated.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling: • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1)] • Hypotension/Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.2)] • Dyskinesia [see Warnings and Precautions (5.3)] • Depression and suicidality [see Warnings and Precautions (5.4)] • Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.5)] • Impulse Control and/or Compulsive Behaviors [see Warnings and Precautions (5.6)] • Withdrawal-Emergent Hyperpyrexia and Confusion [ see Warnings and Precautions (5.7)] • Diarrhea and Colitis [see Warnings and Precautions (5.8)] • Rhabdomyolysis [see Warnings and Precautions (5.9...
Interactions
7 DRUG INTERACTIONS • Drugs metabolized by COMT: use with caution ( 5.11 , 7.2 ) • Anti-hypertensive agents: dose adjustment may be required ( 7.3 ) • Tricyclic antidepressants: risk of hypertension and dyskinesia reported during concomitant use with carbidopa/levodopa ( 7.4 ) • Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of carbidopa, levodopa and entacapone tablets ( 7.5 , 7.6 , 7.7 , 7.8 , 7.9 ) • Drugs that interfere with biliary excretion, glucuronidation and intestinal beta-glucuronidase: dose adjustment of carbidopa, levodopa and entacapone tablets may be required ( 7.10 ) • Drugs metabolized by CYP2C9 (e.g., coumadin): dose adjustment of carbidopa, levodopa and entacapone tablets may be required; monitor INR when initiating...
Warnings
5 WARNINGS AND PRECAUTIONS The following adverse reactions described in this section are related to at least one of the components of carbidopa, levodopa and entacapone tablets (i.e., levodopa, carbidopa, and/or entacapone) based upon the safety experience in clinical trials (especially pivotal trials) or in postmarketing reports. 4 CONTRAINDICATIONS Carbidopa, levodopa and entacapone tablets are contraindicated in patients: • Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets. • With narrow-angle glaucoma.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of carbidopa, levodopa and entacapone tablets in pregnant women. In animals, administration of carbidopa-levodopa or entacapone during pregnancy was associated with developmental toxicity, including increased incidences of fetal malformations (see Data) . The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Carbidopa, levodopa and entacapone tablets are supplied as film coated tablets for oral administration in the following six strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg film coated tablets containing 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP.
Frequently Asked Questions
What is Carbidopa, Levodopa And Entacapone used for?▼
1 INDICATIONS AND USAGE Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.
What are the side effects of Carbidopa, Levodopa And Entacapone?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling: • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1)] • Hypotension/Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.2)] • Dyskinesia [see Warnings and Precautions (5.3)] • Depression and suicidality [see Warnings and Precautions (5.4)] • Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.5)] • Impulse Control and/or Compulsive Behaviors [see Warnings and Precautions (5.6)] • Withdrawal-Emergent Hyperpyrexia and Confusion [ see Warnings and Precautions (5.7)] • Diarrhea and Colitis [see Warnings and Precautions (5.8)] • Rhabdomyolysis [see Warnings and Precautions (5.9...
Can I take Carbidopa, Levodopa And Entacapone during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of carbidopa, levodopa and entacapone tablets in pregnant women. In animals, administration of carbidopa-levodopa or entacapone during pregnancy was associated with developmental toxicity, including increased incidences of fetal malformations (see Data) . The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S.
What are the important warnings for Carbidopa, Levodopa And Entacapone?▼
5 WARNINGS AND PRECAUTIONS The following adverse reactions described in this section are related to at least one of the components of carbidopa, levodopa and entacapone tablets (i.e., levodopa, carbidopa, and/or entacapone) based upon the safety experience in clinical trials (especially pivotal trials) or in postmarketing reports. 4 CONTRAINDICATIONS Carbidopa, levodopa and entacapone tablets are contraindicated in patients: • Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets. • With narrow-angle glaucoma.
Related Medications
Wart Removerfor Common Plantar Warts
wart removerfor common plantar warts
Purpose Wart remover
Vitamin K
vitamin k
Manufactured by HOSPIRA. Dosage form: INJECTABLE. Route: INTRAVENOUS. Active ingredients: ASCORBIC ACID (200MG/5ML); BIOTIN (0.06MG/5ML); CYANOCOBALAMIN (0.005MG/5ML); DEXPANTHENOL (15MG/5ML); ERGOCALCIFEROL (0.005MG/5ML); FOLIC ACID (0.6MG/5ML); NIACINAMIDE (40MG/5ML); PYRIDOXINE HYDROCHLORIDE (6MG/5ML); RIBOFLAVIN 5'-PHOSPHATE SODIUM (3.6MG/5ML); THIAMINE HYDROCHLORIDE (6MG/5ML); VITAMIN A (1MG/5ML); VITAMIN E (10MG/5ML); VITAMIN K (0.15MG/5ML). Application: NDA021643.
Corn Removal Pads
corn removal pads
Purpose Corn and callus remover
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.