Carbidopa and Levodopa Extended-Release Tablets USP 25mg/250mg Taj Pharma

1. Name of the medicinal product

Carbidopa and Levodopa Extended-Release Tablets USP 10mg/100mg Taj Pharma
Carbidopa and Levodopa Extended-Release Tablets USP 25mg/100mg Taj Pharma
Carbidopa and Levodopa Extended-Release Tablets USP 25mg/250mg Taj Pharma
Carbidopa and Levodopa Extended-Release Tablets USP 50mg/200mg Taj Pharma

2. Qualitative and quantitative composition

a) Carbidopa and Levodopa Extended-Release Tablets USP 10mg/100mg Taj Pharma
Each uncoated tablets contains:
Carbidopa (Anhydrous) USP 10mg
Levodopa USP 100mg
Excipients: Q.S.

b) Carbidopa and Levodopa Extended-Release Tablets USP 25mg/100mg Taj Pharma
Each uncoated tablets contains:
Carbidopa (Anhydrous) USP 25mg
Levodopa USP 100mg
Excipients: Q.S.

c) Carbidopa and Levodopa Extended-Release Tablets USP 25mg/250mg Taj Pharma
Each uncoated tablets contains:
Carbidopa (Anhydrous) USP 25mg
Levodopa USP 250mg
Excipients: Q.S.

d) Carbidopa and Levodopa Extended-Release Tablets USP 50mg/200mg Taj Pharma
Each uncoated tablets contains:
Carbidopa (Anhydrous) USP 50mg
Levodopa USP 200mg
Excipients: Q.S.

For more excipients see section (6)

3. Pharmaceutical form

Uncoated Modified-release tablets.

4. Clinical particulars

• Therapeutic indications

Anti-Parkinson’s agent. Idiopathic Parkinson’s disease, in particular to reduce off-period in patients who previously have been treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations. The experience is limited with ‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ in patients who have not been treated with levodopa before.

• Posology and method of administration

‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ tablets contain a 1:4 ratio of carbidopa to levodopa (‘Carbidopa and Levodopa Taj Pharma ER’: carbidopa 50mg /levodopa 200mg, ‘Half Carbidopa and Levodopa Taj Pharma ER’ 25mg /100mg  per tablet). The daily dosage of ‘Carbidopa and Levodopa Taj Pharma ER’ must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of nausea or abnormal involuntary movements, including dyskinesias, chorea and dystonia.

Route of administration: oral

‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ may only be administered as whole tablets. So that the controlled release properties of the product can be maintained, tablets should not be chewed, crushed, or halved.

Standard Anti-Parkinson’s drugs, other than levodopa alone, may be continued while ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ are being administered, although their dosage may have to be adjusted. Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ can be given to patients receiving supplemental pyridoxine (vitamin B6).

Initial Dose

Patients currently treated with conventional levodopa/decarboxylase inhibitor combinations

Dosage with ‘Carbidopa and Levodopa Taj Pharma ER’ should be substituted initially at an amount that provides no more than approximately 10% more levodopa per day when higher dosages are given (more than 900mg  per day). The dosing interval between doses should be prolonged by 30 to 50% at intervals ranging from 4 to 12 hours. It is recommended to give the smaller dose, if divided doses are not equal, at the end of the day. The dose needs to be titrated further depending on clinical response, as indicated below under ‘Titration’. Dosages that provide up to 30% more levodopa per day may be necessary.

A guide for substitution of ‘Carbidopa and Levodopa Taj Pharma ER’ treatment for conventional levodopa/decarboxylase inhibitor combinations is shown in the table below:

Guideline for Conversion from ‘Levodopa And Carbidopa’ to ‘Carbidopa and Levodopa Taj Pharma ER’

‘Half Carbidopa and Levodopa Taj Pharma ER’ is available to facilitate titration when 100mg steps are required.

Patients currently treated with levodopa alone

Levodopa must be discontinued at least eight hours before therapy with ‘Carbidopa and Levodopa Taj Pharma ER’ is started. In patients with mild to moderate disease, the initial recommended dose is one tablet of ‘Carbidopa and Levodopa Taj Pharma ER’ twice daily.

Patients not receiving levodopa

In patients with mild to moderate disease, the initial recommended dose is one tablet of ‘Carbidopa and Levodopa Taj Pharma ER’ twice daily. Initial dosages should not exceed 600mg  per day of levodopa, nor be given at intervals of less than six hours.

Titration

Following initiation of therapy, doses and dosing intervals may be increased or decreased, depending upon therapeutic response. Most patients have been adequately treated with two to eight tablets per day of ‘Carbidopa and Levodopa Taj Pharma ER’ administered as divided doses at intervals ranging from four to twelve hours during the waking day. Higher doses (up to 12 tablets) and shorter intervals (less than four hours) have been used, but are not usually recommended.

When doses of ‘Carbidopa and Levodopa Taj Pharma ER’ are given at intervals of less than four hours, or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day. In some patients the onset of effect of the first morning dose may be delayed for up to one hour compared with the response usually obtained from the first morning dose of ‘Levodopa And Carbidopa’.

An interval of at least three days between dosage adjustments is recommended.

Maintenance

Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ may be required.

Addition of other Anti-Parkinson’s medication

Anticholinergic agents, dopamine agonists and amantadine can be given with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’. Dosage adjustment of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ may be necessary when these agents are added to an existing treatment regimen for ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’.

Interruption of therapy

Patients should be observed carefully if abrupt reduction or discontinuation of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is required, especially if the patient is receiving ant USP sychotics (see 4.4 ‘Special warnings and precautions for use’).

Use in Children

Safety and effectiveness of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ in infants and children have not been established, and its use in patients below the age of 18 is not recommended.

• Contraindications

‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should not be given when administration of a sympathomimetic amine is contraindicated.

Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’. These inhibitors must be discontinued at least two weeks prior to initiating therapy with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’. ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g. selegiline hydrochloride) (See 4.5 ‘Interactions with other medicinal products and other forms of interaction’).

‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is contraindicated in patients with known hypersensitivity to any component of this medication, and in patients with narrow-angle glaucoma.

Because levodopa may activate a malignant melanoma, ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

Use in patients with severe psychoses.

• Special warnings and precautions for use

When patients are receiving levodopa monotherapy, levodopa must be discontinued at least eight hours before therapy with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is started (at least 12 hours if slow-release levodopa has been administered).

Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction.

‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ are not recommended for the treatment of drug-induced extrapyramidal reactions or for the treatment of Huntingdon’s chorea.

Based on the pharmacokinetic profile of ‘Carbidopa and Levodopa Taj Pharma ER’ the onset of effect in patients with early morning dyskinesias may be slower than with conventional ‘Levodopa And Carbidopa’. The incidence of dyskinesias is slightly higher during treatment with ‘Carbidopa and Levodopa Taj Pharma ER’ than with conventional ‘Levodopa And Carbidopa’ (16.5% vs 12.2%) in advanced patients with motor fluctuations.

‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or with a history of peptic ulcer disease or of convulsions.

Care should be exercised in administering ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ to patients with a history of recent myocardial infarction who have residual atrial, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration.

Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered.

As with levodopa, ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half CCarbidopa and Levodopa Taj Pharma ER’ may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone or levodopa/decarboxylase inhibitor combination should be observed carefully when ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa and use of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ may cause recurrence. Dosage reduction may be required. 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.

A symptom complex resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes, and increased serum creatine phosphokinase has been reported when ant USP arkinsonian agents were withdrawn abruptly. Therefore, patients should be observed carefully when the dosage of carbidopa-levodopa combinations is reduced abruptly or discontinued, especially if the patient is receiving ant USP sychotics.

Patients with chronic wide-angle glaucoma may be treated cautiously with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’, provided the intraocular pressure is well controlled and the patient monitored carefully for changes in intraocular pressure during therapy.

Periodic evaluations of hepatic, haematopoietic, cardiovascular and renal function are recommended during extended therapy.

If general anaesthesia is required, ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the usual dosage should be administered as soon as the patient is able to take oral medicine.

Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk of developing melanoma than the general population (approximately 2-6 fold higher). It is unclear whether the increased risk observed was due to Parkinson’s disease, or other factors such as drugs used to treat Parkinson’s disease. Therefore patients and providers are advised to monitor for melanomas on a regular basis when using ‘Carbidopa and Levodopa Taj Pharma ER’ for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Laboratory Tests

Abnormalities in various laboratory tests have occurred with carbidopa-levodopa preparations and may occur with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’. These include elevations of liver function tests such as alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, blood urea nitrogen, creatinine, uric acid and positive Coombs’ test.

Carbidopa-levodopa preparations 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 glycosuria.

Decreased haemoglobin and haematocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine have been reported with standard ‘Levodopa And Carbidopa’.

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/ levodopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).

Impulse control disorders

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa And Carbidopa. Review of treatment is recommended if such symptoms develop.

• Interaction with other medicinal products and other forms of interaction

Caution should be exercised when the following drugs are administered concomitantly with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’:

Antihypertensive agents

Symptomatic postural hypotension has occurred when levodopa/decarboxylase inhibitor combinations were added to the treatment of patients receiving some antihypertensive drugs. Therefore when therapy with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is started, dosage adjustment of the antihypertensive drug may be required.

Antidepressants

There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations. (For patients receiving monamine oxidase inhibitors, see 4.3 ‘Contraindications’).

Anticholinergics

Anticholinergics may affect the absorption and thus the patient’s response.

Iron

Studies demonstrate a decrease in the bioavailability of carbidopa and/or levodopa when it is ingested with ferrous sulphate or ferrous gluconate.

Other drugs

Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of levodopa. 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 Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should be observed carefully for loss of therapeutic response.

Use of ‘Carbidopa and Levodopa Taj Pharma ER’ with dopamine-depleting agents (e.g., tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.

Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (See 4.3 ‘Contraindications’).

Since levodopa competes with certain amino acids, the absorption of levodopa may be impaired in some patients on a high protein diet.

The effect of simultaneous administration of antacids with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ on the bioavailability of levodopa has not been studied.

• Pregnancy and lactation

There are insufficient data to evaluate the possible harmfulness of this substance when used in human pregnancy (See 5.3 ‘Preclinical Safety Data’). It is not known whether carbidopa is excreted in human milk. In a study of one nursing mother with Parkinson’s disease, excretion of levodopa in breast milk was reported. ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should not be given during pregnancy and to nursing mothers.

• Effects on ability to drive and use machines

Individual responses to medication may vary. Certain side effects that have been reported with ‘Carbidopa and Levodopa Taj Pharma ER’ 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 other at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also section 4.4 ‘Special warnings and precautions for use’).

• Undesirable effects

In controlled clinical trials in patients with moderate to severe motor fluctuations ‘Carbidopa and Levodopa Taj Pharma ER’ did not produce side-effects which were unique to the modified-release formulation.

The side-effect reported most frequently was dyskinesia (a form of abnormal involuntary movements). A greater incidence of dyskinesias was seen with ‘Carbidopa and Levodopa Taj Pharma ER’ than with ‘Levodopa And Carbidopa’.

Other side-effects that also were reported frequently (above 2%) were: nausea, hallucinations, confusion, dizziness, chorea and dry mouth.

Side effects occurring less frequently (1-2%) were: dream abnormalities, dystonia, somnolence, insomnia, depression, asthenia, vomiting and anorexia.

Other side effects reported in clinical trials or in post-marketing experience include:

Body as a whole: chest pain, syncope.

Cardiovascular: palpitation, orthostatic effects including hypotensive episodes.

Gastro-intestinal: const USP ation, diarrhoea, dyspepsia, gastro-intestinal pain, dark saliva.

Hypersensitivity: angioedema, urticaria, pruritus.

Metabolic: weight loss.

Nervous System/Psychiatric: neuroleptic malignant syndrome (see 4.3 ‘Contraindications’), agitation, anxiety, decreased mental acuity, paraesthesia, disorientation, fatigue, headache, extrapyramidal and movement disorders, falling, gait abnormalities, muscle cramps, on-off phenomenon, increased libido, psychotic episodes including delusions and paranoid ideation. Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.

Respiratory: dyspnoea

Skin: flushing, alopecia, rash, dark sweat.

Special Senses: blurred vision.

Urogenital: dark urine.

Other side effects that have been reported with levodopa or levodopa/carbidopa combinations and may be potential side-effects with ‘Carbidopa and Levodopa Taj Pharma ER’ are listed below:

Cardiovascular: cardiac irregularities, hypertension, phlebitis.

Gastro-intestinal: bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, gastro-intestinal bleeding, flatulence, burning sensation of tongue, development of duodenal ulcer.

Haematologic: leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.

Nervous system/Psychiatric: ataxia, numbness, increased hand tremor, muscle twitching, blepharospasm, trismus, activation of latent Horner’s syndrome, euphoria, and dementia, depression with suicidal tendencies and Dopamine Dysregulation Syndrome.

DesERUSP tion of selected adverse reactions

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/ levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Carbidopa and Levodopa Taj Pharma ER(see section 4.4. ‘Special warnings and precautions for use’)

Skin: increased sweating.

Special senses: d USP lopia, dilated pupils, oculogyric crises.

Urogenital: urinary retention, urinary incontinence, priapism.

Miscellaneous: weight gain, oedema, weakness, faintness, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns, malignant melanoma (see 4.3 Contraindications), Henoch-Schonlein purpura.

Convulsions have occurred; however, a causal relationsh USP  with levodopa or levodopa/carbidopa combinations has not been established.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

• Overdose

Management of acute overdosage with ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ is basically the same as management of acute overdosage with levodopa; however, pyridoxine is not effective in reversing the actions of ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’.

Electrocardiographic monitoring should be instituted and the patient observed carefully for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as ‘Carbidopa and Levodopa Taj Pharma ER’ or ‘Half Carbidopa and Levodopa Taj Pharma ER’ should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known.

5. Pharmacological properties
   • Pharmacodynamic properties

‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ are a combination of carbidopa, an aromatic amino acid decarboxylase inhibitor, and levodopa, the metabolic precursor of dopamine, in a polymer-based controlled-release tablet formulation, for use in the treatment of Parkinson’s disease. ‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ are particularly useful to reduce ‘off’ time in patients treated previously with a conventional levodopa/decarboxylase inhibitor combination who have had dyskinesias and motor fluctuations.

Patients with Parkinson’s disease treated with preparations containing levodopa may develop motor fluctuations characterised by end-of-dose failure, peak dose dyskinesia, and akinesia. The advanced form of motor fluctuations (‘on-off’ phenomenon) is characterised by unpredictable swings from mobility to immobility. Although the causes of the motor fluctuations are not completely understood, it has been demonstrated that they can be attenuated by treatment regimens that produce steady plasma levels of levodopa.

Levodopa relieves the symptoms of Parkinson’s disease by being decarboxylated to dopamine in the brain. Carbidopa, which does not cross the blood-brain barrier, inhibits only the extracerebral decarboxylation of levodopa, making more levodopa available for transport to the brain and subsequent conversion to dopamine. This normally obviates the necessity for large doses of levodopa at frequent intervals. The lower dosage reduces or may help eliminate gastro-intestinal and cardiovascular side-effects, especially those which are attributed to dopamine being formed in extracerebral tissues.

‘Carbidopa and Levodopa Taj Pharma ER’ and ‘Half Carbidopa and Levodopa Taj Pharma ER’ are designed to release their active ingredients over a four-six hour period. With this formulation there is less variation in plasma levodopa levels and the peak plasma level is 60% lower than with conventional ‘Levodopa and Carbidopa’, as established in healthy volunteers.

In clinical trials, patients with motor fluctuations experienced reduced ‘off’-time with ‘Carbidopa and Levodopa Taj Pharma ER’ when compared with ‘Levodopa And Carbidopa’. The reduction of the ‘off’-time is rather small (about 10%) and the incidence of dyskinesias increases slightly after administration of ‘Carbidopa and Levodopa Taj Pharma ER’ compared to standard ‘Levodopa And Carbidopa’. Global ratings of improvement and activities of daily living in the ‘on’ and ‘off’ state, as assessed by both patient and physician, were better during therapy with ‘Carbidopa and Levodopa Taj Pharma ER’ than with ‘Levodopa And Carbidopa’. Patients considered ‘Carbidopa and Levodopa Taj Pharma ER’ to be more helpful for their clinical fluctuations, and preferred it over ‘Levodopa And Carbidopa’. In patients without motor fluctuations, ‘Carbidopa and Levodopa Taj Pharma ER’ under controlled conditions, provided the same therapeutic benefit with less frequent dosing than with ‘Levodopa And Carbidopa’. Generally, there was no further improvement of other symptoms of Parkinson’s disease.

• Pharmacokinetic properties

The pharmacokinetics of levodopa following administration of ‘Carbidopa and Levodopa Taj Pharma ER’ was studied in young and elderly healthy volunteers. The mean time to peak plasma levodopa level after ‘Carbidopa and Levodopa Taj Pharma ER’ was approximately two hours compared to 0.75 hours with ‘Levodopa And Carbidopa’. The mean peak plasma levodopa levels were 60% lower with ‘Carbidopa and Levodopa Taj Pharma ER’ than with ‘Levodopa And Carbidopa’. The in vivo absorption of levodopa following administration of ‘Carbidopa and Levodopa Taj Pharma ER’ was continuous for 4 to 6 hours. In these studies, as with patients, plasma levodopa concentrations fluctuated in a narrower range than with ‘Levodopa And Carbidopa’. Because the bioavailability of levodopa from ‘Carbidopa and Levodopa Taj Pharma ER’ relative to ‘Levodopa And Carbidopa’ is approximately 70%, the daily dosage of levodopa in the controlled release formulation will usually be higher than with conventional formulations. There was no evidence that ‘Carbidopa and Levodopa Taj Pharma ER’ released its ingredients in a rapid or uncontrolled fashion.

The pharmacokinetics of levodopa following administration of ‘Half Carbidopa and Levodopa Taj Pharma ER’ were studied in patients with Parkinson’s disease. Chronic three month, open-label, twice daily dosing with ‘Half Carbidopa and Levodopa Taj Pharma ER’ (range: 50mg  carbidopa, 200mg  levodopa up to 150mg  carbidopa, 600mg  levodopa per day) did not result in accumulation of plasma levodopa. The dose-adjusted bioavailability for one ‘Half Carbidopa and Levodopa Taj Pharma ER’ tablet was equivalent to that for one ‘Carbidopa and Levodopa Taj Pharma ER’ tablet. The mean peak concentration of levodopa following administration of one ‘Half Carbidopa and Levodopa Taj Pharma ER’ tablet was greater than 50% of that following one ‘Carbidopa and Levodopa Taj Pharma ER’ tablet. Mean time-to-peak plasma levels may be slightly less for ‘Half Carbidopa and Levodopa Taj Pharma ER’ than for ‘Carbidopa and Levodopa Taj Pharma ER’.

It is not known whether or not or to what extent the absorption is influenced by a protein rich diet. The bioavailability may be influenced by drugs which affect the gastro-intestinal propulsion.

• Preclinical safety data

The medicine has appeared harmful in animal trials (visceral and skeletal malformations in rabbits). For reproductive toxicity, see section 4.6 ‘Pregnancy and lactation’.

6. Pharmaceutical particulars
   • List of Excipients

Hydroxypropylcellulose, Magnesium Stearate, Poly (Vinyl Acetate-Crotonic Acid) Copolymer, Quinoline Yellow 10 Aluminium Lake (Carbidopa and Levodopa Taj Pharma ER only), Red Iron Oxide

• Incompatibilities

Not applicable

• Shelf life

36 months

• Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from light.

• Nature and contents of container

Amber glass bottles or HDPE bottles in packs of 100, 84, or 56 tablets. All aluminium blister pack of 60 tablets.

• Special precautions for disposal and other handling

Not applicable.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Carbidopa and Levodopa Extended-Release Tablets USP 25mg/250mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Carbidopa and Levodopa Taj Pharma ER is and what it is used for
2. What you need to know before you take Carbidopa and Levodopa Taj Pharma ER
3. How to take Carbidopa and Levodopa Taj Pharma ER
4. Possible side effects
5. How to store Carbidopa and Levodopa Taj Pharma ER
6. Contents of the pack and other information

1.What Carbidopa and Levodopa Taj Pharma ER is and what it is used for

Carbidopa and Levodopa Taj Pharma ER are used in the treatment of Parkinson’s disease. It reduces the “off” time (a sudden onset of muscle stiffness that can last for minutes or even hours) if you are being treated with levodopa alone, levodopa/decarboxylase inhibitor tablets with an immediate-release formulation (e.g. carbidopa) and if you suffer from sudden uncontrolled movements.

Carbidopa and Levodopa Taj Pharma ER belongs to a class of drugs used to treat Parkinson’s disease.

The symptoms of this disease are probably caused by a lack of dopamine, a substance that is normally produced by the brain. Dopamine plays a role in controlling muscle movement. A lack of it causes problems in muscle movement. Levodopa compensates for the lack of dopamine, whilst carbidopa ensures that enough levodopa reaches the brain.

2. What you need to know before you take Carbidopa and Levodopa Taj Pharma ER

Do not take Carbidopa and Levodopa Taj Pharma ER :

• if you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of

• Carbidopa and Levodopa Taj Pharma ER
• if you have increased eye ER essure (narrow-angle glaucoma)
• if you are suffering from severe heart failure
• if you have a serious heart rhythm disorder
• in the event of a sudden stroke
• if you are not allowed to use drugs that act on the central nervous system (sympathomimetic agents)
• if you are using non-selective monoamine oxidase inhibitors and selective, type-A MAO inhibitors (MAO inhibitors; drugs used in depression). You must stop taking these drugs for at least two weeks before starting treatment with Carbidopa and Levodopa Taj Pharma ER.
• Carbidopa and Levodopa Taj Pharma ER may be co-administered with the recommended dose of a MAO inhibitor which is selective for MAO type B (e.g. selegiline). Because levodopa may activate a malignant melanoma,
• Carbidopa and Levodopa Taj Pharma ER should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.
• Take special care with Carbidopa and Levodopa Taj Pharma ER
• If you are currently being, or have ever been, treated with levodopa on its own. You must wait for at least 12 hours before you can start taking Carbidopa and Levodopa Taj Pharma ER
• if you suffer from movement disorders such as facial muscle twitches, muscle rigidity and stiffness, difficulties in starting to move, trembling of the fingers or hands. It may be necessary to reduce the dose.
• if you have ever suffered from involuntary movements in the past
• if you have ever had a psychotic episode or suffered from psychosis. Psychosis is a severe mental illness whereby control over one’s own conduct and behaviour is impaired. Very rarely, there have been reports of patients who became depressed and who later developed suicidal tendencies. If you think that this also applies to you, you are advised to contact your doctor immediately.
• if you are constantly tired and/or prone to falling asleep without warning. You must not drive or operate machines; your doctor will adjust your dose if necessary, or stop your treatment altogether.
• if you have a severe cardiovascular condition
• if you have a severe lung disease or if you experience sudden attacks of breathlessness caused by muscular spasms and swelling of the mucous membrane inside the airways, often accompanied by coughing and the production of phlegm (bronchial asthma)
• if you have a kidney or liver disorder, or if you have problems with your endocrine system (glands that secrete hormones internally into the blood stream)
• if you have ever had stomach or intestinal ulcers, as there is a greater risk of stomach bleeding
• if you are vomiting blood
• if you have ever had seizures/ convulsions
• if you have recently had a heart attack and are still suffering from heart rhythm disorders
• if you have chronic glaucoma (increased eye pressure)
• if your levodopa/carbidopa dose is suddenly lowered or stopped, particularly if you are receiving drugs to treat psychosis; as this may trigger off a change in your mental condition; muscle rigidity and increased body temperature may occur
• if you have an hereditary disease characterised by sudden involuntary but coordinated movements (Huntington’s chorea). Use of Carbidopa and Levodopa Taj Pharma ER is not recommended.
• if you have ever had a malignant melanoma
• if you have a skin condition that has not yet been diagnosed by your doctor
• Carbidopa and Levodopa Taj Pharma ER could give rise to abnormalities in several laboratory tests. These include:
• liver function tests
• a false positive coombs test
• decreased haemoglobin and haemotocrit, elevated serum glucose and white blood cells, bacteria and blood in the urine
• When a test strip is used to determine ketonuria a false positive result for urinary ketone bodies can be shown. This reaction is not altered by boiling the urine sample.
• false negative results can also occur in the examination of glycosuria with the use of glucose oxidase methods
• the safety and efficacy of Carbidopa and Levodopa Taj Pharma ER in newly-born infants and children under the age of 18 has not been established; the use of Carbidopa and Levodopa Taj Pharma ER  in patients under the age of 18 is therefore not recommended
• pathologically driven gambling and obsessive increased sexual desire have been reported in patients treated for Parkinson’s disease with drugs belonging to the group of dopamine agonists, including Carbidopa and Levodopa Taj Pharma ER .

Please tell your doctor if any one of the above-mentioned warnings applies to you, or has ever applied to you in the past.

Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.

Taking Carbidopa and Levodopa Taj Pharma ER with other medicines

Carbidopa and Levodopa Taj Pharma ER may interfere with the effects/side effects of other drugs, and vice versa. This is particularly true in the case of:

• drugs used to treat high blood ER essure; your doctor will need to adjust the dosage
• drugs used to treat depression (see also section “Do not take Levodopa/Carbidopa”)
• drugs that act on the central nervous system (anticholinergics; bronchodilators used in asthma), such as ipratropium and tiotropium. The effect of levodopa may be reduced; your doctor will adjust the dosage if necessary
• drugs used to treat psychosis
• isoniazid (a drug used to treat tuberculosis)
• benzodiazepines (certain sleeping pills and tranquilisers), such as diazepam, oxazepam and lormetazepam; the effect of Carbidopa and Levodopa Taj Pharma ER may be reduced
• Phenytoin (a drug used in epilepsy); the effect of Carbidopa and Levodopa Taj Pharma ER may be reduced
• Papaverine (a drug used to treat spasms in the gastrointestinal tract); the effect of Carbidopa and Levodopa Taj Pharma ER may be reduced
• selegiline (a drug used in Parkinson’s disease); when used at the same time as Carbidopa and Levodopa Taj Pharma ER , severe low blood pressure may occur
• COMT inhibitors (used in Parkinson’s disease); when used at the same time as Carbidopa and Levodopa Taj Pharma ER , the levels of levodopa reaching the brain may increase. The Levodopa/Carbidopa dose may need to be adjusted.
• amantadine (used in Parkinson’s disease). The side effects of levodopa may increase. The Levodopa/Carbidopa dose may need to be adjusted.
• metoclopramide (a gastrointestinal drug)
• drugs that act on the central nervous system (sympathomimetics; bronchodilators used in asthma), such as apraclonidine, dipivefrin and brimonidine. Cardiovascular-related side effects may increase.
• ferrous sulphate. Levodopa absorption may decrease.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a ER escription.

Taking Carbidopa and Levodopa Taj Pharma ER with food and drink

The effect of levodopa can sometimes be impaired in patients on a high-protein diet.

ER egnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

• Any woman of childbearing potential who is receiving Carbidopa and Levodopa Taj Pharma ER 10mg/100mg, 25mg/100mg, 25mg/250mg and 50/200mg must ER actise effective contraception.
• Not enough is known about the use of Carbidopa and Levodopa Taj Pharma ER during human ER egnancies. It was shown to be harmful in animal experiments. It is not known whether carbidopa is excreted in human milk. Do not take Carbidopa and Levodopa Taj Pharma ER if you are ER egnant, or trying to conceive.
• Levodopa is excreted into breast milk.

You must therefore not breastfeed during treatment with Carbidopa and Levodopa Taj Pharma ER.

Driving and using machines

Carbidopa and Levodopa Taj Pharma ER cause side effects such as

• dizziness,
• drowsiness,
• double vision, which may affect your ability to react.

You should bear this in mind if you intend driving or using machines. Patients who are known to be prone to drowsiness and falling asleep without warning may not drive or use machines.

Carbidopa and Levodopa Taj Pharma ER contains lactose monohydrate

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Carbidopa and Levodopa Taj Pharma ER

Dosage

Adults and the elderly

Your doctor has prescribed how much Carbidopa and Levodopa Taj Pharma ER you should take.

Generally speaking, the following doses apply:

If you have never been treated with levodopa:

Starting dose

1 Carbidopa and Levodopa Taj Pharma ER 10mg/100mg, 25mg/100mg, 25mg/250mg and 50/200mg twice daily.

Maximum starting dose 3 tablets of 1 Carbidopa and Levodopa Taj Pharma ER 10mg/100mg, 25mg/100mg, 25mg/250mg and 50/200mg daily (600mg of levodopa per day).

Doses should be taken at intervals of at least 6 hours.
If you are switching from normal Levodopa/Carbidopa tablets to Extended-Release tablets:

Such a switch should take place gradually and under the supervision of a doctor.

If you are currently being treated with levodopa alone (i.e. on its own):
Treatment with levodopa should be stopped for at least 12 hours before using Carbidopa and Levodopa Taj Pharma ER .

Starting dose in patients with a mild-to-moderate form of Parkinson’s disease:

1 Carbidopa and Levodopa Taj Pharma ER  10mg/100mg, 25mg/100mg, 25mg/250mg and 50/200mg twice daily

Maintenance dose:

Your doctor will monitor you on a regular basis and adjust your dosage if necessary.
An interval of at least three days should be allowed between each dose adjustment.
Swallow the tablet whole with a glass of water irrespective of meals, do not break or chew the tablet.

If you have the impression that the effect of Carbidopa and Levodopa Taj Pharma ER is too strong or too weak, talk to your doctor or pharmacist.

Children and adolescents (under 18 years of age)

The use of Carbidopa and Levodopa Taj Pharma ER in patients under the age of 18 is not recommended (see section “Take special care with Carbidopa and Levodopa Taj Pharma ER”)

Length of treatment

Your doctor will tell you how long you must keep using Carbidopa and Levodopa Taj Pharma ER. Do not stop treatment before you should; otherwise, your symptoms may return.

If you take more Carbidopa and Levodopa Taj Pharma ER than you should

If you have taken too much Carbidopa and Levodopa Taj Pharma ER contact your doctor or pharmacist immediately.

Overdose symptoms may include: spasms of the orbicularis oculi muscle surrounding the eye (see also section 4. “Possible side effects”).

If you forget to take Carbidopa and Levodopa Taj Pharma ER

Do not take a double dose of Carbidopa and Levodopa Taj Pharma ER to make up for a forgotten dose. If you have forgotten a dose, you can still take it unless it is almost time for your next dose. If this occurs, continue on your normal dosage schedule.

If you stop taking Carbidopa and Levodopa Taj Pharma ER

Your doctor will monitor you regularly if your dosage is suddenly lowered or if your treatment is stopped. Please read the section: “Take special care with Carbidopa and Levodopa Taj Pharma ER”, particularly if you are using drugs in the treatment of psychosis (antipsychotic agents).

If you have any further questions on the use of this ER oduct, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carbidopa and Levodopa Taj Pharma ER can cause side effects, although not everybody gets them.

Side effects that may occur are:

• very common in more than one in 10 patients
• common in more than one in 100 patients, but less than one in 10 patients
• uncommon in more than one in 1,000 patients, but less than one in 100 patients
• rare in more than one in 10,000 patients, but less than one in 1,000 patients
• very rare in less than one in 10,000 patients

Blood and lymphatic system disorders

Rare:

– a blood disorder (lack of white blood cells) accompanied by an increased susceptibility to infections (leukopenia)

– anaemia (haemolytic and non-haemolytic)

– a blood disorder (lack of blood platelets) accompanied by bruising and a tendency to bleed (thrombocytopenia)

Very rare:

• a very serious blood disorder (lack of white blood cells) accompanied by sudden high fever, severe sore throat and mouth ulcers (agranulocytosis).

Metabolism and nutrition disorders

Common:

• loss of appetite (anorexia)

Uncommon:

• weight loss
• weight gain.

Psychiatric disorders

Common:

• seeing things that are not there (hallucinations)
• confusion
• dizziness
• nightmares
• drowsiness
• tiredness
• sleeplessness
• depression with (very rarely) suicidal tendencies
• feeling of well-being (euphoria)
• dementia
• episodes of serious mental illness, during which control over one’s own conduct and behaviour is impaired (psychosic episodes including delusions and paranoid ideation)
• feeling of stimulation
• dream abnormalities

Rare:

• excitement (agitation)
• anxiety
• impaired ability to think
• disorientation
• headache
• increased sexual desire
• numbness
• fits/ seizures.

Not known:

– It was reported that patients treated for Parkinson’s disease with drugs belonging to the group of dopamine agonists, including Carbidopa and Levodopa Taj Pharma ER, have shown signs of pathologically driven gambling and obsessive increased sexual desire, especially at high doses. These side effects generally disappeared upon reduction of the dose or treatment discontinuation.

Nervous system disorders

Common:

• movement disorders (dyskinesia)
• a disorder characterised by sudden involuntary movements (chorea)
• muscle tone disorder (dystonia)
• movement disorders caused from outside the nervous system (extrapyramidal)
• sudden changes in Parkinson’s symptoms (“on-off” symptoms)
• slowdown in movements during “on-off” periods (bradykinesia)

Uncommon:

• ataxia
• increase in hand tremors

Rare:

• a serious condition as a result of using neuroleptics, which may manifest as muscle stiffness, a severe inability to sit still, high fever, sweating, increased salivation and impaired consciousness (neuroleptic malignant syndrome)
• feelings of ER ickling, tingling and itchiness without any apparent cause (paraesthesia)
• fits
• gait disorders
• increased libido

Not known:

• Drowsiness and (very rarely) constant daytime fatigue/ sudden attacks of sleep.
• muscle twitching

Eyes disorders

Rare:

• blurred vision
• spasm of the orbicularis oculi muscle surrounding the eye (this may be a sign of overdosage)
• activation of a pre-existing Horner’s syndrome (an eye disorder)
• double vision
• dilated pupils
• a deterioration in eye movements.

Cardiac (heart) disorders

Common:

• palpitations
• irregular heartbeat.

Vascular disorders

Common:

• a drop in blood pressure caused e.g. by getting up too quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)
• tendency to faint
• sudden loss of consciousness

Uncommon:

• increase in blood pressure

Rare:

• inflammation of the veins (phlebitis).

Respiratory, thoracic (chest) and mediastinal disorders (i.e. the area between the lungs)

Uncommon:

• hoarseness
• chest pain

Rare:

• breathlessness
• abnormal breathing patterns.
• Gastrointestinal disorders

Common:

• nausea
• vomiting
• dry mouth
• bitter taste

Uncommon:

• constipation
• diarrhoea
• increased salivation
• difficulties in swallowing (dysphagia)
• wind

Rare:

• impaired digestion with symptoms such as feelings of fullness in the upper abdomen, upper abdominal pain, belching, nausea, vomiting and heartburn (dyspepsia)
• stomach and intestinal pain
• dark saliva
• bruxism (grinding of teeth)
• hiccups
• stomach and intestinal bleeding burning tongue
• duodenal ulcers.

Skin and subcutaneous tissue disorders:

Uncommon:

• fluid accumulation (oedema)

Rare:

• sudden build-up of fluid in the skin and mucous membranes (e.g. throat and tongue), breathing difficulties and/or itching and skin rash, often appearing as an allergic reaction (angioedema)
• skin rash with severe itching and the formation of wheals (urticaria)
• itching
• facial redness
• hair loss
• skin rash
• increased sweating
• dark sweat
• in children, allergy-related bleeding in the skin and gastrointestinal tract wall (SchönleinHenoch purpura).

Musculoskeletal and connective tissue disorders

Uncommon:

• muscle spasms.

Renal and urinary disorders:

Uncommon:

• dark urine

Rare:

• urine retention
• involuntary passing of urine
• persistent erection (priapism).

General disorders and administration site conditions

Uncommon:

• weakness
• feeling of being unwell (malaise)
• hot flushes
• asthenia

You may experience the following side effects:

 inability to resist the impulse to perform an action that could be harmful, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences.
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
• uncontrollable excessive shopping or spending
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carbidopa and Levodopa Taj Pharma ER

• Children: Keep out of the reach and sight of children.
• Use by Date: Do not take Carbidopa and Levodopa Taj Pharma ER 10mg/100mg, 25mg/100mg, 25mg/250mg and 50/200mg after the expiry date which is stated on the blister, HDPE label and carton after ‘EXP.’ The expiry date refers to the last day of that month.

HDPE bottle pack should be used within 2 months after first opening.

• Storage conditions:

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Carbidopa and Levodopa Taj Pharma ER contains

Carbidopa and Levodopa Taj Pharma ER contains two active substances i.e.

Each Extended-Release tablet contains 10mg Carbidopa and 100mg of Levodopa.
Each Extended-Release tablet contains 25mg Carbidopa and 100mg of Levodopa.
Each Extended-Release tablet contains 25mg Carbidopa and 250mg of Levodopa.
Each Extended-Release tablet contains 50mg Carbidopa and 200mg of Levodopa.

The other ingredients are:

Cellulose microcrystalline, Lactose monohydrate, Ferric oxide red, Ferric oxide yellow, Hypromellose K4M, Hypromellose E5, Silica, colloidal anhydrous, Magnesium stearate.

What Carbidopa and Levodopa Taj Pharma ER and contents of the pack

Carbidopa and Levodopa Taj Pharma ER  are available in the following pack sizes:

Blister(s) in outer carton: Alu/Alu blister of 10, 20, 30, 49, 50, 56, 60, 84, 98, 100, 196, 200 and/or 300 Tablets.

HDPE bottle inserted with cotton and desiccant, fitted with PPCRC closure. Each bottle contains 14, 15, 28, 30, 56, 60, 84, 100 and 500 tablets.

Not all pack sizes may be marketed.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com