CARBIDEL Levodopa / Carbidopa 250mg / 25mg Tablet 1's
RXDRUG-DR-XY44640-1pc
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Features
Brand
CARBIDEL
Full Details
Dosage Strength
250 mg / 25 mg
Drug Ingredients
- Carbidopa
- Levodopa
Drug Packaging
Tablet 1's
Generic Name
Levodopa / Carbidopa
Dosage Form
Tablet
Registration Number
DR-XY44640
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism and symptomatic parkinsonism.
Dosage/Direction for Use
Parkinson's Disease: Initially start with Levodopa 100 mg carbidopa 25 mg given 3 time /day. Increase by 1 tablet/day every 1-2 days up to a max. of 8 tablets of any strength/day. If the patient has been taking Levodopa alone, the combination should be started after a gap of at least 8 hour after stopping Levodopa.
Initial Dose: Carbidopa 25 mg/levodopa 100 mg 3 times/day. Dosage adjustment: Alternate tablet strengths may be substituted according to individual carbidopa/levodopa requirements. Increase by 1 tablet every other day as necessary, except when using the carbidopa 25 mg/levodopa 250 mg tablets where increases should be made using ½-1 tablet every 1-2 days. Use of more than 1 dosage strength or dosing 4 times/day may be required (maximum 8 tablets of any strength/day or 200 mg of carbidopa and 2000 mg of levodopa).
Post Encephalitic Parkinsonism: Start with Levodopa 100 mg + carbidopa 25 mg given 3 times/day. Increase by 1 tablet/day every 1-2 days up to a max. of 8 tablets of any strength/day. If the patient has been taking Levodopa alone, the combination should be started after a gap of at least 8 hour after stopping Levodopa.
Initial Dose: Carbidopa 25 mg/levodopa 100 mg 3 times/day. Dosage adjustment: Alternate tablet strengths may be substituted according to individual carbidopa/levodopa requirements. Increase by 1 tablet every other day as necessary, except when using the carbidopa 25 mg/levodopa 250 mg tablets where increases should be made using ½-1 tablet every 1-2 days. Use of more than 1 dosage strength or dosing 4 times/day may be required (maximum 8 tablets of any strength/day or 200 mg of carbidopa and 2000 mg of levodopa).
Post Encephalitic Parkinsonism: Start with Levodopa 100 mg + carbidopa 25 mg given 3 times/day. Increase by 1 tablet/day every 1-2 days up to a max. of 8 tablets of any strength/day. If the patient has been taking Levodopa alone, the combination should be started after a gap of at least 8 hour after stopping Levodopa.
Administration
Should be taken on an empty stomach: May be taken w/ meals if GI discomfort occurs.
Contraindications
Hypersensitivity reactions. Patients with angle closure glaucoma; narrow-angle glaucoma. Should not be given to patients with or with a history of the disease or with skin disorders suggestive of it. History of melanoma or undiagnosed skin lesions. Use of MAO inhibitors within prior 14 days. However, drug may be administered concomitantly with the recommended dose of a MAO inhibitor with selectivity for MAO type B.
Special Precautions
CNS Effects: Certain adverse CNS effects (eg, dyskinesias) will occur at lower dosages and sooner during therapy with the sustained release form.
Levodopa: Caution in open-angle glaucoma, patients with cardiovascular disease, pulmonary disease, endocrine disorders, psychiatric disturbances, osteomalacia, hepatic or renal disease, or a history of peptic ulceration. Periodic evaluations of hepatic, psychiatric, hematological, renal and cardiovascular functions have been advised.
Concerns Related to Adverse Effects: Dyskinesias: May cause or exacerbate dyskinesias.
Orthostatic Hypotension:May cause orthostatic hypotension; Parkinson's disease patients appear to have an impaired capacity to respond to a postural challenge. Use with caution in patients at risk of hypotension (such as those receiving antihypertensive drugs) or where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or CV disease). Parkinson's patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk.
Somnolence: Patients have reported falling asleep while engaging in activities of daily living: this has been reported to occur without significant warning signs. Monitor for daytime somnolence or pre-existing sleep disorder; caution with concomitant sedating medication; discontinue if significant daytime sleepiness or episodes of falling asleep occur. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated.
Disease-Related Concerns: Cardiovascular Disease: Use with caution in patients with cardiovascular disease including a history of myocardial infarction and arrhythmias.
Endocrine Disease: Use with caution when interpreting plasma/ urine catecholamine levels: falsely-diagnosed pheochromocytoma has been rarely reported.
Glaucoma: Use with caution in patients with glaucoma; monitor IOP carefully in patients with wide-angle glaucoma.
Hepatic Impairment: Use with caution in patients with hepatic impairment.
Peptic Ulcer Disease: Use with caution in patients with peptic ulcer disease.
Psychotic Disorders: Use with extreme caution in patients with psychotic disorders; observe patients closely for development of depression with concomitant suicidal tendencies.
Renal Impairment: Use with caution in patients with renal impairment.
Respiratory Disease: Use with caution in patients with respiratory disease.
Use in Pregnancy and Lactation:Teratogenic effects were observed with levodopa and carbidopa in animal studies. There are case reports of levodopa crossing the placenta in humans. Excretion in breast milk is unknown. caution during breastfeeding.
Special Populations: Elderly: Use with caution in the elderly; may be sensitive to CNS effects of levodopa.
Safety and efficacy have not been established in children.
Other Warnings/Precautions: Dietary protein: Distribute dietary protein throughout the day to avoid fluctuations in levodopa absorption.
Discontinuation of Therapy: Dopaminergic agents have been associated with a syndrome resembling neuroleptic malignant syndrome on abrupt withdrawal or significant dosage reduction after long-term use.
Levodopa: Caution in open-angle glaucoma, patients with cardiovascular disease, pulmonary disease, endocrine disorders, psychiatric disturbances, osteomalacia, hepatic or renal disease, or a history of peptic ulceration. Periodic evaluations of hepatic, psychiatric, hematological, renal and cardiovascular functions have been advised.
Concerns Related to Adverse Effects: Dyskinesias: May cause or exacerbate dyskinesias.
Orthostatic Hypotension:May cause orthostatic hypotension; Parkinson's disease patients appear to have an impaired capacity to respond to a postural challenge. Use with caution in patients at risk of hypotension (such as those receiving antihypertensive drugs) or where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or CV disease). Parkinson's patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk.
Somnolence: Patients have reported falling asleep while engaging in activities of daily living: this has been reported to occur without significant warning signs. Monitor for daytime somnolence or pre-existing sleep disorder; caution with concomitant sedating medication; discontinue if significant daytime sleepiness or episodes of falling asleep occur. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated.
Disease-Related Concerns: Cardiovascular Disease: Use with caution in patients with cardiovascular disease including a history of myocardial infarction and arrhythmias.
Endocrine Disease: Use with caution when interpreting plasma/ urine catecholamine levels: falsely-diagnosed pheochromocytoma has been rarely reported.
Glaucoma: Use with caution in patients with glaucoma; monitor IOP carefully in patients with wide-angle glaucoma.
Hepatic Impairment: Use with caution in patients with hepatic impairment.
Peptic Ulcer Disease: Use with caution in patients with peptic ulcer disease.
Psychotic Disorders: Use with extreme caution in patients with psychotic disorders; observe patients closely for development of depression with concomitant suicidal tendencies.
Renal Impairment: Use with caution in patients with renal impairment.
Respiratory Disease: Use with caution in patients with respiratory disease.
Use in Pregnancy and Lactation:Teratogenic effects were observed with levodopa and carbidopa in animal studies. There are case reports of levodopa crossing the placenta in humans. Excretion in breast milk is unknown. caution during breastfeeding.
Special Populations: Elderly: Use with caution in the elderly; may be sensitive to CNS effects of levodopa.
Safety and efficacy have not been established in children.
Other Warnings/Precautions: Dietary protein: Distribute dietary protein throughout the day to avoid fluctuations in levodopa absorption.
Discontinuation of Therapy: Dopaminergic agents have been associated with a syndrome resembling neuroleptic malignant syndrome on abrupt withdrawal or significant dosage reduction after long-term use.
Use In Pregnancy & Lactation
Teratogenic effects were observed with levodopa and carbidopa in animal studies. There are case reports of levodopa crossing the placenta in humans. Excretion in breast milk is unknown. caution during breastfeeding.
Adverse Reactions
Psychotic reactions are more likely in patients with postencephalitic parkinsonism or a history of mental disorders. Excessive daytime sleepiness and sudden onset of sleep have been reported very rarely.
Abnormal involuntary movements or dyskinesias are the most serious dose-limiting adverse effects of levodopa and are very common at the optimum dose required to control parkinsonism; their frequency Increases with duration of treatment. Involuntary movements of the face.
Cardiovascular: Orthostatic hypotension, arrhythmia, chest pain, hypertension. syncope, palpitation, phlebitis.
Central Nervous System: Dizziness, anxiety, confusion. nightmares, headache, hallucinations, on-off phenomenon, decreased mental acuity, memory impairment, disorientation, delusions, euphoria, agitation, somnolence. Insomnia, gait abnormalities, nervousness, ataxia, EPS, falling. psychosis. peripheral neuropathy. seizure (causal relationship not established).
Dermatologic: Rash, alopecia, malignant melanoma, hypersensitivity (angioedema, urticaria, pruritus. bullous lesions. Henoch-Schonlein purpura).
Endocrine & Metabolic: Increased libido.
Gastrointestinal: Anorexia, nausea, vomiting, constipation, GI bleeding, duodenal ulcer, diarrhea, dyspepsia, taste alterations, sialorrhea, heartburn.
Genitourinary: Discoloration of urine, urinary frequency.
Hematologic: Hemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia; decreased hemoglobin and hematocrit; abnormalities in AST and ALT, LDH, bilirubin, BUN, Coombs' test.
Neuromuscular & Skeletal: Choreiform and involuntary movements, paresthesia, bone pain, shoulder pain, muscle cramps, weakness.
Ocular: Blepharospasm, oculogyric crises (may be associated with acute dystonic reactions).
Renal: Difficult urination.
Respiratory: Dyspnea, cough Miscellaneous: Hiccups. discoloration of sweat, diaphoresis (increased).
Abnormal involuntary movements or dyskinesias are the most serious dose-limiting adverse effects of levodopa and are very common at the optimum dose required to control parkinsonism; their frequency Increases with duration of treatment. Involuntary movements of the face.
Cardiovascular: Orthostatic hypotension, arrhythmia, chest pain, hypertension. syncope, palpitation, phlebitis.
Central Nervous System: Dizziness, anxiety, confusion. nightmares, headache, hallucinations, on-off phenomenon, decreased mental acuity, memory impairment, disorientation, delusions, euphoria, agitation, somnolence. Insomnia, gait abnormalities, nervousness, ataxia, EPS, falling. psychosis. peripheral neuropathy. seizure (causal relationship not established).
Dermatologic: Rash, alopecia, malignant melanoma, hypersensitivity (angioedema, urticaria, pruritus. bullous lesions. Henoch-Schonlein purpura).
Endocrine & Metabolic: Increased libido.
Gastrointestinal: Anorexia, nausea, vomiting, constipation, GI bleeding, duodenal ulcer, diarrhea, dyspepsia, taste alterations, sialorrhea, heartburn.
Genitourinary: Discoloration of urine, urinary frequency.
Hematologic: Hemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia; decreased hemoglobin and hematocrit; abnormalities in AST and ALT, LDH, bilirubin, BUN, Coombs' test.
Neuromuscular & Skeletal: Choreiform and involuntary movements, paresthesia, bone pain, shoulder pain, muscle cramps, weakness.
Ocular: Blepharospasm, oculogyric crises (may be associated with acute dystonic reactions).
Renal: Difficult urination.
Respiratory: Dyspnea, cough Miscellaneous: Hiccups. discoloration of sweat, diaphoresis (increased).
Drug Interactions
Anticholinergics and Clonidine: may reduce the efficacy of levodopa. possibly due to reduced gastrointestinal absorption.
Antipsychotics and Benzodiazepines: may inhibit the antiparkinsonian effects of levodopa Via dopamine receptor blockade; use antipsychotics with low dopamine blockade such as clozapine. olanzapine, and quetiapine.
Dextromethorphan: Toxic reactions have occurred with dextromethorphan.
Furazolidone: May increase the effect/toxicity of levodopa; hypertensive episodes have been reported; monitor.
Iron Salts: Binds levodopa and reduces its bioavailability; separate doses of iron and levodopa.
Linezolid is to be avoided due to MAO inhibition.
MAO Inhibitors: Concurrent use of levodopa with nonselective MAO inhibitors may result In hypertensive reactions via an increased storage and release of dopamine, norepinephrine, or both; use with carbidopa to minimize reactions if combination is necessary. otherwise avoid combination.
L-methionine may inhibit levodopa's antiparkinsonian effects; monitor for reduced effect.
Metoclopramide: May increase the absorption/effect of levodopa: hypertensive episodes have been reported. Levodopa antagonizes metoclopramide's effects on lower esophageal sphincter pressure. Avoid use of metoclopramide for reflux, monitor response to levodopa carefully used.
Methyldopa: May potentiate the effects of levodopa; levodopa may Increase the hypotensive response to methyldopa; monitor.
Papaverine: May decrease the efficacy of levodopa; includes other similar agents (ethaverine).
Penicillamine: May increase serum concentrations of levodopa; monitor for increased effect.
Phenytoin: May inhibit levodopa's antiparkinsonian effects: monitor for reduced effect.
Pyridoxine: May inhibit levodopa's antiparkinsonian effects; monitor for reduced effect (pyridoxine in doses >1025 mg for levodopa alone, higher doses >200 mg/day may be a problem for levodopa/carbidopa).
Spiramycin: May inhibit levodopa's antiparkinsonian effects: monitor for reduced effect.
Tacrine: May inhibit the effects of levodopa via enhanced cholinergic activity: monitor for reduced effect.
Tricyclic Antidepressants: May decrease the absorption (bioavailability) of levodopa; rare hypertensive episodes have also been attributed to this combination.
Avoid ethanol (due to CNS depression).
Avoid high protein diets and high intakes of vitamin B6; kava kava may decrease effects; pyridoxine in doses >1025 mg or higher doses >200 mg/day may decrease efficacy.
Antipsychotics and Benzodiazepines: may inhibit the antiparkinsonian effects of levodopa Via dopamine receptor blockade; use antipsychotics with low dopamine blockade such as clozapine. olanzapine, and quetiapine.
Dextromethorphan: Toxic reactions have occurred with dextromethorphan.
Furazolidone: May increase the effect/toxicity of levodopa; hypertensive episodes have been reported; monitor.
Iron Salts: Binds levodopa and reduces its bioavailability; separate doses of iron and levodopa.
Linezolid is to be avoided due to MAO inhibition.
MAO Inhibitors: Concurrent use of levodopa with nonselective MAO inhibitors may result In hypertensive reactions via an increased storage and release of dopamine, norepinephrine, or both; use with carbidopa to minimize reactions if combination is necessary. otherwise avoid combination.
L-methionine may inhibit levodopa's antiparkinsonian effects; monitor for reduced effect.
Metoclopramide: May increase the absorption/effect of levodopa: hypertensive episodes have been reported. Levodopa antagonizes metoclopramide's effects on lower esophageal sphincter pressure. Avoid use of metoclopramide for reflux, monitor response to levodopa carefully used.
Methyldopa: May potentiate the effects of levodopa; levodopa may Increase the hypotensive response to methyldopa; monitor.
Papaverine: May decrease the efficacy of levodopa; includes other similar agents (ethaverine).
Penicillamine: May increase serum concentrations of levodopa; monitor for increased effect.
Phenytoin: May inhibit levodopa's antiparkinsonian effects: monitor for reduced effect.
Pyridoxine: May inhibit levodopa's antiparkinsonian effects; monitor for reduced effect (pyridoxine in doses >1025 mg for levodopa alone, higher doses >200 mg/day may be a problem for levodopa/carbidopa).
Spiramycin: May inhibit levodopa's antiparkinsonian effects: monitor for reduced effect.
Tacrine: May inhibit the effects of levodopa via enhanced cholinergic activity: monitor for reduced effect.
Tricyclic Antidepressants: May decrease the absorption (bioavailability) of levodopa; rare hypertensive episodes have also been attributed to this combination.
Avoid ethanol (due to CNS depression).
Avoid high protein diets and high intakes of vitamin B6; kava kava may decrease effects; pyridoxine in doses >1025 mg or higher doses >200 mg/day may decrease efficacy.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Mechanism of Action: Levodopa circulates in the plasma where it crosses the blood-brain-barrier It is then converted by striatal enzymes to dopamine. Carbidopa works by inhibiting peripheral plasma breakdown of levodopa through inhibition of decarboxylation increasing available levodopa concentration.
Pharmacokinetics: Carbidopa undergoes rapid but incomplete absorption from the gastrointestinal tract. Both the unchanged and metabolite form of the compound is rapidly excreted in the urine. It does not cross the blood-brain barrier.
Levodopa is rapidly absorbed from the gastrointestinal tract by an active transport system. Most absorption takes place in the small intestine; absorption is very limited from the stomach, and since decarboxylation may take place in the stomach, delay in gastric emptying may reduce the amount of levodopa available for absorption. Peak plasma concentrations are achieved within 2 hours of oral doses. Levodopa is about 10 to 30% bound to plasma proteins.
Levodopa is rapidly decarboxylated by the enzyme aromatic L-amino acid decarboxylase, mostly in the gut, liver, and kidney, to dopamine, which is metabolized in turn, principally to dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA). Other routes of metabolism include o-methylation, transamination, and oxidation, producing a variety of minor metabolites including noradrenaline and 3-0-methyldopa; the latter may accumulate in the CNS due to its relatively long half-life. The elimination hall-life of levodopa itself is reported to be about 30 to 60 minutes.
Unlike dopamine, levodopa is actively transported across the blood-brain barrier, but because of the extent of peripheral decarboxylation very little is available to enter the CNS unless it is given with a peripheral dopa-decarboxylase inhibitor. In the presence of a peripheral dopa-decarboxylase inhibitor the major route of metabolism of levodopa becomes the formation of 3-0-methyldopa by the enzyme catechol-O-methyl-transferase.
About 80% of an oral dose of levodopa is excreted in the urine within 24 hours, mainly as dihydroxyphenyl acetic and homovanillic acids. Only small amounts of levodopa are excreted unchanged in the feces Levodopa crosses the placenta and is distributed into breast milk.
Pharmacokinetics: Carbidopa undergoes rapid but incomplete absorption from the gastrointestinal tract. Both the unchanged and metabolite form of the compound is rapidly excreted in the urine. It does not cross the blood-brain barrier.
Levodopa is rapidly absorbed from the gastrointestinal tract by an active transport system. Most absorption takes place in the small intestine; absorption is very limited from the stomach, and since decarboxylation may take place in the stomach, delay in gastric emptying may reduce the amount of levodopa available for absorption. Peak plasma concentrations are achieved within 2 hours of oral doses. Levodopa is about 10 to 30% bound to plasma proteins.
Levodopa is rapidly decarboxylated by the enzyme aromatic L-amino acid decarboxylase, mostly in the gut, liver, and kidney, to dopamine, which is metabolized in turn, principally to dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA). Other routes of metabolism include o-methylation, transamination, and oxidation, producing a variety of minor metabolites including noradrenaline and 3-0-methyldopa; the latter may accumulate in the CNS due to its relatively long half-life. The elimination hall-life of levodopa itself is reported to be about 30 to 60 minutes.
Unlike dopamine, levodopa is actively transported across the blood-brain barrier, but because of the extent of peripheral decarboxylation very little is available to enter the CNS unless it is given with a peripheral dopa-decarboxylase inhibitor. In the presence of a peripheral dopa-decarboxylase inhibitor the major route of metabolism of levodopa becomes the formation of 3-0-methyldopa by the enzyme catechol-O-methyl-transferase.
About 80% of an oral dose of levodopa is excreted in the urine within 24 hours, mainly as dihydroxyphenyl acetic and homovanillic acids. Only small amounts of levodopa are excreted unchanged in the feces Levodopa crosses the placenta and is distributed into breast milk.
MedsGo Class
Antiparkinsonian Drugs
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