Vexdopa

Vexdopa

carbidopa + levodopa

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Levodopa 250 mg, carbidopa monohydrate 25 mg
Indications/Uses
Idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, & symptomatic parkinsonism w/c may follow injury to the nervous system by carbon monoxide &/or Mn intoxication.
Dosage/Direction for Use
1 tab (100 mg/25 mg) tid-qid. May be increased by 1/2 or 1 tab daily or every other day. Max: 8 tab. Maintenance: Individualized dosage. At least 70-100 mg carbidopa/day. When more carbidopa is required, 100 mg/25 mg should be substituted for each tab of 100 mg/10 mg. When more levodopa is required, 100 mg/25 mg should be substituted for 100 mg/25 mg or 100 mg levodopa. If necessary, 100 mg/25 mg may be increased by half or 1 tab every day or every other day to a max of 8 tab/day. Patient receiving levodopa Discontinue levodopa at least 12 hr before therapy. Daily dose should be approx 25% of the previous levodopa dose. Levodopa requirement >1,500 mg/day: 1 tab (100 mg/25 mg) tid-qid. Levodopa requirement <1,500 mg/day: 1 tab (100 mg/25 mg) tid-qid.
Contraindications
Hypersensitivity. Narrow-angle glaucoma; suspicious, undiagnosed skin lesions or a history of melanoma. MAOIs.
Special Precautions
Dyskinesia. Observe patients carefully for the development of depression w/ concomitant suicidal tendencies. Past or current psychoses; severe CV or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.  History of MI who have residual atrial, nodal or ventricular arrhythmias. Increased possibility of upper GI hemorrhage in patients w/ a history of peptic ulcer. Neuroleptic malignant syndrome (NMS) or NMS-like symptom; avoid abrupt w/drawal or reduction.  Require periodic evaluation of hepatic, hematopoietic, CV & renal function; skin exam. Long-term use. Chronic wide-angle glaucoma. Monitor for melanomas frequently & on a regular basis during treatment. Dark color (red, brown/black) may appear in saliva, urine or sweat or may discolor garments. Change in diet to foods high in protein may delay absorption; excessive acidity; Fe salts (eg, multivit tab). Consider dose reduction or stopping the medication if patient develops new or increased gambling, sexual or other intense urges. Elevated LFT, abnormal BUN & +ve Coombs' test. False +ve result for ketonuria determination in urine & false -ve result w/ glucose-oxidase test for glucosuria. May experience somnolence &/or sudden sleep onset; caution while driving or operating machinery. Pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Dyskinesias eg, choreiform, dystonic, & other involuntary movements & nausea. Chest pain, asthenia; cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, HTN, syncope, phlebitis, palpitation; dark saliva, GI bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations; agranulocytosis, hemolytic & non-hemolytic anemia, thrombocytopenia, leukopenia; angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions); back & shoulder pain, muscle cramps; psychotic episodes including delusions, hallucinations, & paranoid ideation, neuroleptic malignant syndrome, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression w/ or w/o development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms; convulsions; dyspnea, upper resp infection; rash, increased sweating, alopecia, dark sweat; UTI, urinary frequency, dark urine; abdominal pain & distress, fatigue, MI, GI pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups. Metabolic: Edema, wt gain, wt loss. Musculoskeletal: Leg pain. 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 Homer's syndrome, peripheral neuropathy. Pharyngeal pain, cough. Malignant melanoma, flushing. Oculogyric crises, diplopia, blurred vision, dilated pupils. Decreased Hb & hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, BUN, Coombs test; elevated serum glucose; WBC, bacteria, & blood in the urine.
Drug Interactions
Symptomatic postural hypotension w/ antihypertensives. Severe orthostatic hypotension w/ selegiline. Rarely, HTN & dyskinesia w/ TCAs. Reduced bioavailability w/ Fe salts. Levodopa: Reduced therapeutic effects w/ dopamine D2 receptor antagonists (eg, phenothiazines, butyrophenones, risperidone) & INH. Reversed beneficial effects w/ phenytoin & papaverine. May increase bioavailability & may also affect disease control by its dopamine receptor antagonistic properties w/ metoclopramide.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BA02 - levodopa and decarboxylase inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Vexdopa tab
Packing/Price
100's
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