Carbidopa and Levodopa Tablets USP 110

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10 mg + 100 mg

For the use of a Registered Medical Practitioner or a Hospital or a Institution only.

AN ANTI PARKINSONS

Parkinsons disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia

Management of tremor, dysphagia, sialorrhea, and postural instability associated with parkinsons disease and syndrome

DESCRIPTION:

CARBIDOPA AND LEVODOPA TABLETS are a combination of carbidopa and levodopa for the treatment of parkinson’s disease and syndrome. Carbidopa is a peripheral dopa-decarboxylase inhibitor with little or no pharmacological activity when given alone in usual doses. Levodopa a naturally occurring amino acid, is the immediate precursor of the neurotransmitter dopamine. Chemically, carbidopa is benzenepropanoic acid, α -hydrazino-3, 4-dihydroxy-α-methyl-, monohydrate, (s)-; (-)l-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. The molecular formula is C₁₀H₁₄N₂O₄ .H₂O and the molecular weight is 244.24. Chemically, levodopa is l-tyrosine, 3-hydroxy-. (-)-3-(3,4-dihydroxyphenyl)-l-alanine. The molecular formula is C9H11NO4 and molecular weight is 197.19.

STRUCTURAL FORMULA :
Its structural formula is :

DESCRIPTION OF TABLET:

CARBIDOPA AND LEVODOPA TABLETS 110 are white, to off white circular,flat,uncoated tablet with breakline on one side and other side is plain.

COMPOSITION :

CARBIDOPA AND LEVODOPA TABLETS 110

Each uncoated tablet contains :

Carbidopa (anhydrous) USP 10 mg

Levodopa USP 100 mg

Excipients q.s.

ACTIONS :

When levodopa is administered orally it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. For this reason, large doses of levodopa are required for adequate therapeutic effect, and these may often be accompanied by nausea and other adverse reactions, some of which are attributable to dopamine formed in extracerebral tissues. Since levodopa competes with certain amino acids for transport across the gut wall, the absorption of levodopa may be impaired in some patients on a high protein diet. Carbidopa inhibits decarboxylation of peripheral levodopa. It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.

The incidence of levodopa-induced nausea and vomiting is less with the combination product than with levodopa. In many patients, this reduction in nausea and vomiting will permit more rapid dosage titration. Since its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available for transport to the brain.

PHARMACOKINETICS :

Following oral dosing levodopa, in the absence of decarboxylase inhibitor, is rapidly but variably absorbed from the gastro-intestinal tract. It has a plasma half life of about 1 hour and is mainly converted by decarboxylation to dopamine, a proportion of which is converted to noradrenaline. Upto 30 % is converted to 3-O-methyldopa which has a half life of 9 to 22 hours. About 80 % of levodopa is excreted in the urine within 24 hours mainly as homovanillic acid and dihydroxyphenylactic acid. Less than 1 % is excreted unchanged. Once in the circulation it competes with other neutral amino acids for transport across the blood brain barrier. Once it has entered the striatal neurones it is decarboxylated to dopamine, stored and released from presynaptic neurones. Because levodopa is so rapidly decarboxylated in the gastro-intestinal tract and the liver, very little unchanged drug is available for transport into the brain. The peripheral decarboxylation reduces the therapeutic effectiveness of levodopa but is responsible for many of its side effects. For this reason levodopa is usually administered together with a peripheral decarboxylase inhibitor such as carbidopa, so that lower doses may be given to achieve the same therapeutic effect. Carbidopa in the absence of levodopa, is rapidly but incompletely absorbed from the gastrointestinal tract following oral dosing. Following an oral dose approximately 50 % is recorded in the urine, with about 3 % of this as unchanged drug. It does not cross the blood brain barrier but crosses the placenta and is excreted in breast milk. Turnover of the drug is rapid and virtually all unchanged drug appears in the urine within 7 hours. Carbidopa inhibits the peripheral decarboxylation of levodopa to dopamine but as it does not cross the blood brain barrier, effective brain levels of dopamine get produced with lower levels of levodopa therapy reducing the peripheral side effects, noticeably nausea and vomiting and cardiac arrhythmias.

INDICATIONS :

CARBIDOPA AND LEVODOPA TABLETS is indicated for the treatment of Parkinson’s disease and syndrome. It is useful in relieving many of the symptoms of Parkinsonism, particularly rigidity and bradykinesia. CARBIDOPA AND LEVODOPA TABLETS frequently helpful in the management of tremor, dysphagia, sialorrhea, and postural instability associated with Parkinson’s disease and syndrome. When therapeutic response to levodopa alone is irregular, and signs and symptoms of Parkinson’s disease are not evenly controlled throughout the day, substitution of CARBIDOPA AND LEVODOPA TABLETS usually is effective in reducing fluctuations in response. By reducing certain adverse reactions produced by levodopa alone, CARBIDOPA AND LEVODOPA TABLETS permits more patients to obtain adequate relief of the symptoms of Parkinson’s disease. CARBIDOPA AND LEVODOPA TABLETS is also indicated for patients with Parkinsonism who are taking vitamin preparations that contain pyridoxine hydrochloride (Vitamin B6).

DOSAGE AND ADMINISTRATION:

Administration :
CARBIDOPA AND LEVODOPA TABLETS are for oral administration.

Dosage :
The optimum daily dosage of CARBIDOPA AND LEVODOPA TABLETS must be determined by careful titration in each patient. Carbidopa and levodopa tablets are available in a 1:4 ratio of carbidopa to levodopa (25 mg/100 mg) as well as a 1:10 ratio (25 mg/250 mg and 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

Usual Initial Dosage :
Dosage is best initiated with one CARBIDOPA AND LEVODOPA TABLET 25 mg/100 mg three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight carbidopa and levodopa tablets 25 mg/100 mg a day is reached. If CARBIDOPA AND LEVODOPA TABLETS, 10 mg/100 mg are used, dosage may be initiated with one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.

How to Transfer Patients From Levodopa :
Levodopa must be discontinued at least twelve hours before starting this combination product. A daily dosage of CARBIDOPA AND LEVODOPA TABLETS should be chosen that will provide approximately 25 % of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one carbidopa and levodopa tablet, 25 mg/100 mg three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one carbidopa and levodopa tablet, 25 mg/250 mg three or four times a day.

Maintenance :
Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one CARBIDOPA AND LEVODOPA TABLETS 25 mg/100 mg may be substituted for each CARBIDOPA AND LEVODOPA TABLETS 10 mg/100 mg. When more levodopa is required, each CARBIDOPA AND LEVODOPA TABLETS 25 mg/250 mg should be substituted for a CARBIDOPA AND LEVODOPA TABLETS 25 mg/100 mg or a CARBIDOPA AND LEVODOPA TABLETS 10 mg/100 mg. If necessary, the dosage of CARBIDOPA AND LEVODOPA TABLETS 25 mg/250 mg may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited. Because both therapeutic and adverse responses occur more rapidly with this combination product than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa and levodopa than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

Addition of Other Antiparkinsonian Medications :
Standard drugs for Parkinson’s disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa therapy is being administered, although dosage adjustments may be required.

Interruption of Therapy :
Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of CARBIDOPA AND LEVODOPA TABLETS. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa tablets is required, especially if the patient is receiving neuroleptics. If general anesthesia is required, carbidopa and levodopa therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

CONTRAINDICATIONS :
Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with CARBIDOPA AND LEVODOPA TABLETS. These inhibitors must be discontinued at least two weeks prior to initiating therapy with CARBIDOPA AND LEVODOPA TABLETS. CARBIDOPA AND LEVODOPA TABLETS may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g. selegiline HCl). CARBIDOPA AND LEVODOPA TABLETS is contraindicated in patients with known hypersensitivity to any component of this medication, and in patients with narrow angle glaucoma. Since levodopa may activate a malignant melanoma, CARBIDOPA AND LEVODOPA TABLETS should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

WARNINGS :
When this combination product is to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with this product is started. In order to reduce adverse reactions, it is necessary to individualize therapy.
The addition of carbidopa with levodopa in the form of the combination product reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa ; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Because carbidopa permits more levodopa to reach the brain and more dopamine to be formed, certain adverse CNS effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with the combination product than with levodopa alone.
Levodopa alone, as well as carbidopa and levodopa, is associated with dyskinesias. The occurrence of dyskinesias may require dosage reduction. As with levodopa, the combination product may cause mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Carbidopa and levodopa should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.

As with levodopa, care should be exercised in administering the combination product to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care. As with levodopa, treatment with the combination product may increase the possibility of upper gastrointestinal haemorrhage in patients with a history of peptic ulcer.

Neuroleptic Malignant Syndrome (NMS)
Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of therapy with carbidopa and levodopa. Therefore, patients should be observed carefully when the dosage of carbidopa and levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes ; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin have been reported.

The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

The management of NMS should include : 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS, however, their effectiveness has not been demonstrated in controlled studies.

PRECAUTIONS :
General :
As with levodopa, periodic evaluations of hepatic, haematopoietic, cardiovascular, and renal function are recommended during extended therapy. Patients with chronic wide-angle glaucoma may be treated cautiously with carbidopa and levodopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.Dopaminergic agents, including levodopa, may be associated with somnolence and very rarely episodes of sudden onset of sleep. In some cases, these episodes may occur without awareness or warning during daily activities. Patients must be informed of this and advised to exercise caution while driving or operating machines while being treated with dopaminergic agents, including levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.

Melanoma :
Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2 to approximately 6 fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using carbidopa and levodopa for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Laboratory Tests :
Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, and bilirubin. Abnormalities in blood urea nitrogen and positive Coombs test have also been reported. Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of this combination product than with levodopa. Carbidopa and levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria. This reaction will not be altered by boiling the urine specimen. False-negative tests may result with the use of glucose-oxidase methods of testing for glucosuria. Cases of falsely diagnosed pheochromocytoma in patients on carbidopa-levodopa therapy have been reported very rarely. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or carbidopa-levodopa therapy.

Drug Interactions :
Caution should be exercised when the following drugs are administered concomitantly with carbidopa and levodopa. Symptomatic postural hypotension has occurred when carbidopa and levodopa was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa is started, dosage adjustment of the antihypertensive drug may be required. For patients receiving MAO inhibitors (Type A or B),. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone. There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa and levodopa.

Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with carbidopa and levodopa should be carefully observed for loss of therapeutic response. Iron salts may reduce the bioavailability of levodopa and carbidopa. The clinical relevance is unclear. Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone. Since levodopa competes with certain amino acids, the absorption of CARBIDOPA AND LEVODOPA TABLETS may be impaired in some patients on a high protein diet.
The effect of simultaneous administration of antacids with CARBIDOPA AND LEVODOPA TABLETS on the bioavailability of levodopa has not been studied. CARBIDOPA AND LEVODOPA TABLETS may be given to patients with Parkinson’s disease and syndrome who are taking vitamin preparations that contain pyridoxine hydrochloride (Vitamin B 6)

Carcinogenesis, Mutagenesis, Impairment of Fertility :
In a two-year bioassay of carbidopa and levodopa, no evidence of carcinogenicity was found in rats receiving doses of approximately two times the maximum daily human dose of carbidopa and four times the maximum daily human dose of levodopa.

PREGNANCY AND LACTATION:

Pregnancy : Pregnancy Category C.

No teratogenic effects were observed in a study in mice receiving up to 20 times the maximum recommended human dose of carbidopa and levodopa. There was a decrease in the number of live pups delivered by rats receiving approximately two times the maximum recommended human dose of carbidopa and approximately five times the maximum recommended human dose of levodopa during organogenesis. Carbidopa and levodopa caused both visceral and skeletal malformations in rabbits at all doses and ratios of carbidopa/levodopa tested, which ranged from 10 times/5 times the maximum recommended human dose of carbidopa/levodopa to 20 times/10 times the maximum recommended human dose of carbidopa/levodopa. There are no adequate or well-controlled studies in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the foetus, and is metabolized. Carbidopa concentrations in foetal tissue appeared to be minimal. Use of CARBIDOPA AND LEVODOPA TABLETS in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to mother and child.

Nursing mothers :

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CARBIDOPA AND LEVODOPA TABLETS is administered to a nursing woman.

Paediatric Use :

Safety and effectiveness in paediatrics patients have not been established. Use of the drug in patients below the age of 18 is not recommended.

Effects on ability to drive and use machines :

Individual responses to medication may vary and certain side effects that have been reported with CARBIDOPA AND LEVODOPA TABLETS may affect some patients’ ability to drive or operate machinery. Patients treated with levodopa and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines), until such recurrent episodes and somnolence have resolved.

SIDE EFFECTS :

The most common adverse effect reported with carbidopa and levodopa have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.

The following other adverse effects have been reported with carbidopa and levodopa :

Body as a Whole : Chest pain, asthenia.

Cardiovascular : Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.

Gastrointestinal : Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhoea, constipation, dyspepsia, dry mouth, taste alterations.

Haematologic : Agranulocytosis, haemolytic and non-haemolytic anaemia, thrombocytopenia, leucopoenia.

Hypersensitivity : Angioedema, urticaria, pruritus, Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions).

Musculoskeletal : Back pain, shoulder pain, muscle cramps.

Nervous System/Psychiatric : Psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome bradykinetic episodes (“on-off” phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with carbidopa and levodopa has not been established.

Respiratory : Dyspnoea, upper respiratory infection.

Skin : Rash, increased sweating, alopecia, dark sweat.

Urogenital : Urinary tract infection, urinary frequency, dark urine.

Laboratory Tests : Decreased haemoglobin and haematocrit ; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen (BUN), Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine. Other adverse effects that have been reported with levodopa alone and with various carbidopa-levodopa formulations, and may occur with CARBIDOPA AND LEVODOPA TABLETS are :

Body as a Whole : Abdominal pain and distress, fatigue.

Cardiovascular : Myocardial infarction.

Gastrointestinal : Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups.

Metabolic : Oedema, weight gain, weight loss.

Musculoskeletal : Leg pain.

Nervous System/Psychiatric : 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 Horner’s syndrome, peripheral neuropathy.

Respiratory : Pharyngeal pain, cough.

Skin : Malignant melanoma flushing.

Special Senses : Oculogyric crises, diplopia, blurred vision, dilated pupils.

Urogenital : Urinary retention, urinary incontinence, pianism.

Miscellaneous :

Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.

Laboratory Tests :

Decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.

INFORMATION FOR PATIENTS :

The patient should be informed that carbidopa and levodopa tablets are immediate-release formulations of carbidopa-levodopa that are designed to begin release of ingredients within 30 minutes. It is important that this product be taken at regular intervals according

to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinson medications, including other carbidopa-levodopa preparations, without first consulting the physician.

Patients should be advised that sometimes a ‘wearing-off’ effect may occur at the end of the dosing interval. The physician should be notified if such response poses a problem to lifestyle. Patients should be advised that occasionally, dark colour (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of carbidopa and levodopa. Although the colour appears to be clinically insignificant, garments may become discoloured.

The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multivitamin tablets) may also reduce the amount of levodopa available to the body. The above factors may reduce the clinical effectiveness of the levodopa or carbidopa-levodopa therapy. Patients should be alerted to the possibility of sudden onset of sleep during daily activities, in some cases without awareness or warning signs, when they are taking dopaminergic agents, including levodopa. Patients should be advised to exercise caution while driving or operating machinery and that if they have experienced somnolence and/or sudden sleep onset, they must refrain from these activities There have been reports of patients 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 and that are generally used for the treatment of Parkinson’s disease, including carbidopa and levodopa. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with carbidopa and levodopa. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking carbidopa and levodopa. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking carbidopa and levodopa.

NOTE : The suggested advice to patients being treated with carbidopa and levodopa is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

OVERDOSAGE :
Treatment :

Management of acute overdosage with CARBIDOPA AND LEVODOPA TABLETS is basically the same as management of acute overdosage with levodopa; however pyridoxine is not effective in reversing the actions of CARBIDOPA AND LEVODOPA TABLETS.

ECG monitoring should be instituted, and the patient carefully observed for the possible development of arrhythmias; if required, appropriate anti-arrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as CARBIDOPA AND LEVODOPA TABLETS should be taken into consideration. To date, no experience has been reported with dialysis, and hence its value in the treatment of overdosage is not known.

STORAGE :

Store below 30°C, protected from moisture and light.

Do not refrigerate.

SHELF LIFE :

24 months from the date of manufacture.

PRESENTATION :

CARBIDOPA AND LEVODOPA TABLETS 110 tablets contains Carbidopa (anhydrous) USP 10 mg and Levodopa USP 100 mg.

3 Strips of 10 Tablets per Box.

Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.