Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)

Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

1. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy

2. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR (Generic Levodopa and Carbidopa CR Tablets)
is used in the treatment of the symptoms of idiopathic
Parkinson’s disease (paralysis agitans), postencephalitic
parkinsonism, and symptomatic parkinsonism which may
follow injury to the nervous system by carbon monoxide
intoxication and/or manganese intoxication.
Parkinson's disease is a disorder of the central nervous
system (brain and spinal cord).

3. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR Tablets are manufactured by Sun Pharmaceutical
Industries Limited, India in the strengths of Levodopa 100mg and
Carbidopa 25mg as well as Levodopa 200mg and Carbidopa 50mg.

4. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Chemical Structure - Levodopa

5. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Chemical Structure - Carbidopa

6. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
The active ingredients contained in Syndopa CR tablets are
Levodopa and Carbidopa. Each uncoated prolonged release
Syndopa CR tablet contains Levodopa 100mg & Carbidopa 25mg
or Levodopa 200mg & Carbidopa 50mg.

7. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Uses of Syndopa CR 125 mg and 250 mg tablets:
Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used for
the treatment of Parkinson's disease (sometimes called shaking palsy or
paralysis agitans) and syndrome. Parkinson's disease is a disorder of the
central nervous system (brain and spinal cord).
It is useful in relieving many of the symptoms of Parkinsonism,
particularly rigidity and bradykinesia. Syndopa frequently is helpful
in the management of tremor, dysphagia, sialorrhoea, and postural
instability associated with Parkinson's disease and syndrome.
Syndopa CR (Generic Levodopa and Carbidopa CR Tablets) is used to
treat Idiopathic Parkinson's disease, Postencephalitic Parkinsonism,
Symptomatic Parkinsonism (carbon monoxide or manganese
intoxication) and patients with Parkinson's disease or Parkinsonism
who are taking vitamin preparations that contain Pyridoxine.

8. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Uses of Syndopa CR 125 mg and 250 mg tablets:
This medicine is also used to reduce "off" time in patients previously
treated with Levodopa/Decarboxylase inhibitor preparations, or with
Levodopa alone, who have had motor fluctuations characterised by
end-of-dose deterioration ("wearing-off" phenomenon), peak dose
dyskinesias, akinesia, or similar evidence of short-duration motor
disturbances.
Carbidopa allows patients treated for Parkinson's disease to use much
lower doses of Levodopa. Some patients who responded poorly to
Levodopa have improved on Carbidopa and Levodopa. This is most
likely due to decreased peripheral decarboxylation of Levodopa caused
by administration of Carbidopa rather than by a primary effect of
Carbidopa on the nervous system.
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9. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Uses of Syndopa CR 125 mg and 250 mg tablets:
Dopamine is a naturally occurring substance in the brain that helps
provide control of movement and activities such as walking and
talking. In patients with Parkinson's disease, there is not enough
dopamine in some parts of the brain.
Levodopa enters the brain and helps replace the missing dopamine,
which allows people to function better.
By increasing the amount of Dopamine in the brain, Levodopa helps
control symptoms and helps you to perform daily activities such as
dressing, walking, and handling utensils.
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10. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Recommended Adult Dosage
The dose of Syndopa CR Tablets (Generic Levodopa and
Carbidopa CR Tablets) is given below:
Patients Who Have Not Received Prior Levodopa Therapy:
In early stage patients who have not had prior Levodopa
therapy, the initial recommended dose is one tablet of Syndopa
CR 50/200 once daily. When appropriate, the dosage may be
increased to 1 tablet of Syndopa CR 50/200 two or three times
daily.
Initial dosages should not exceed 600 mg per day of Levodopa
or be given at intervals of less than 6 hours.
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11. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Recommended Adult Dosage
Patients Currently Treated With Conventional
Levodopa/ Decarboxylase Inhibitor Combinations:
For such patients the dosage with Syndopa CR 50/200
should be substituted at an amount that provides
approximately 10% more Levodopa per day, although this
may need to be increased to a dosage that provides up to
30% more Levodopa per day depending on the clinical
response.
The interval between doses of Syndopa CR 50/200 should
be 4 to 8 hours during the waking day.
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12. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Contraindications
➔Syndopa CR tablets are contraindicated in patients with a known
hypersensitivity to Levodopa, Carbidopa or any component of the tablet.
➔Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for
use with Syndopa CR (Generic Levodopa and Carbidopa CR Tablets). These
inhibitors must be discontinued at least two weeks prior to initiating therapy
with Syndopa CR. Carbidopa and Levodopa may be administered
concomitantly with the manufacturer's recommended dose of an MAO
inhibitor with selectivity for MAO type B (e.g., selegiline HCl).
➔Syndopa CR should not be administered to patients with clinical or
laboratory evidence of uncompensated cardiovascular, endocrine,
hematologic, hepatic, pulmonary (including bronchial asthma), or renal
disease; or to patients with narrow angle glaucoma.
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13. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Contraindications
➔
As with Levodopa, Syndopa CR must not be given when
administration of a sympathomimetic amine is contraindicated
(e.g., Epinephrine, Norepinephrine or Isoproterenol).
➔Because Levodopa may activate a malignant melanoma,
Levodopa and Carbidopa CR tablets should not be used in
patients with suspicious, undiagnosed skin lesions or a history of
melanoma.
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14. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Storage Instructions
Syndopa CR Tablets (Generic Levodopa and Carbidopa CR
Tablets) have to be stored at controlled room temperature i.e.
from 20°C to 25°C (68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from children and
pets.
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15. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Warnings
Patients undergoing therapy with Syndopa CR (Generic Levodopa and
Carbidopa CR Tablets) and other dopaminergic agents have reported
suddenly falling asleep while engaged in activities of daily living, including
the driving of a car, which has sometimes resulted in accidents. Although
some of the patients reported somnolence while on Syndopa CR, others
perceived that they had no warning signs, such as excessive drowsiness,
and believed that they were alert immediately prior to the event.
When patients already receiving Levodopa are switched to Syndopa CR,
Levodopa must be discontinued for at least 12 hours or more before
Syndopa CR is started. Syndopa CR should be substituted at a dosage that
will provide approximately 20% of the previous Levodopa dosage.
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16. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Warnings
Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal
function are recommended during extended therapy with Syndopa CR (Generic
Levodopa and Carbidopa CR Tablets).
Patients who improve while on therapy with Syndopa CR should increase
physical activities gradually, with caution, consistent with other medical
considerations such as the presence of osteoporosis or phlebothrombosis.
Care should be exercised in administering Syndopa CR to patients with a
history of myocardial infarction or who have 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.
Syndopa CR should be administered cautiously to patients with a history of
peptic ulcer disease due to the possibility of upper gastrointestinal
hemorrhage.

17. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Warnings
The Levodopa induced involuntary movements and ‘on and off’
phenomenon may appear earlier with combination therapy.
A symptom complex resembling the neuroleptic malignant syndrome
including muscular rigidity, elevated body temperature, altered
consciousness, mental changes, autonomic instability and increased serum
creatine phosphokinase has been reported in association with rapid dose
reduction, withdrawal of, or changes in antiparkinsonian therapy.
Certain side effects that have been reported with Syndopa CR may affect
some patients’ ability to drive or operate machinery. Given the reported
cases of somnolence and sudden onset of sleep (not necessarily preceded
by somnolence), physicians should caution patients about the risk of
operating hazardous machinery, including driving motor vehicles, while
taking Syndopa CR tablets.
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18. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Warnings
Pupillary dilatation and activation of latent Horner’s syndrome have been
reported during Levodopa treatment. Patients with chronic wide angle
glaucoma should therefore be treated cautiously with Syndopa CR .
If general anesthesia is required, therapy with Syndopa CR (Generic
Levodopa and Carbidopa CR Tablets) may be continued as long as the
patient is permitted to take fluids and medication by mouth. If Syndopa CR
therapy is interrupted temporarily, the usual daily dosage may be
administered as soon as the patient is able to take oral medication.
Patients should be monitored carefully for the development of depression
with suicidal tendencies. Patients with past or current psychoses should be
treated with caution.
Patients and caregivers should be advised to adhere to dosage instructions
given by the physician.
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19. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Warnings
Patients undergoing treatment with this medicine should be regularly
monitored for the development of impulse control disorders. Patients
and caregivers should be made aware that behavioral symptoms of
impulse control disorders.
Hallucinations and confusion are known side effects of treatment with
dopaminergic agents, including Levodopa. Patients should be aware of
the fact that hallucinations (mostly visual) can occur.
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.
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20. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Possible Side Effects
Most common Syndopa CR (Generic Levodopa and Carbidopa
CR Tablets) side effects have included dyskinesias, such as
choreiform, dystonic, and other involuntary movements, and
nausea.
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21. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Possible Side Effects
The following other side effects have been reported with Levodopa and Carbidopa:
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, diarrhea, constipation, dyspepsia, dry mouth, taste
alterations.
Hematologic: agranulocytosis, hemolytic and non-hemolytic anemia,
thrombocytopenia, leukopenia.
Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schönlein purpura,
bullous lesions (including pemphigus-like reactions).
Musculoskeletal: back pain, shoulder pain, muscle cramps.
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22. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Possible Side Effects
The following other side effects have been reported with Levodopa and Carbidopa
tablets:
Nervous System/Psychiatric: psychotic episodes including delusions, hallucinations, and
paranoid ideation, 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: dyspnea, upper respiratory infection.
Skin: rash, increased sweating, alopecia, dark sweat.
Urogenital: urinary tract infection, urinary frequency, dark urine.
Laboratory Tests: decreased hemoglobin and hematocrit; abnormalities in alkaline
phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum
glucose; white blood cells, bacteria, and blood in the urine.
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23. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Possible Side Effects
Other side effects that have been reported with Levodopa alone and with various
Carbidopa Levodopa formulations, and may occur with this combination product 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: edema, 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.
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24. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Possible Side Effects
Other side effects that have been reported with Levodopa alone and with various
Carbidopa Levodopa formulations, and may occur with this combination product
are:
Respiratory: pharyngeal pain, cough.
Skin: malignant melanoma, flushing.
Special Senses: oculogyric crises, diplopia, blurred vision, dilated pupils.
Urogenital: urinary retention, urinary incontinence, priapism.
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.
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25. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR Tablets Overdosage
Management of acute overdosage with Levodopa and Carbidopa CR
Tablets (Syndopa CR) is the same as management of acute overdosage
with Levodopa. Pyridoxine is not effective in reversing the actions of this
product.
General supportive measures should be employed, along with immediate
gastric lavage. Intravenous fluids should be administered judiciously and
an adequate airway maintained.
Electrocardiographic monitoring should be instituted and the patient
carefully observed for the development of arrhythmias; if required,
appropriate antiarrhythmic therapy should be given.
The possibility that the patient may have taken other medicines as well as
Levodopa and Carbidopa tablets should be taken into consideration.
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26. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR Tablets During Pregnancy
Levodopa and Carbidopa CR Tablets (Syndopa CR Tablets) has been
classified by the US FDA as Pregnancy Category C.
No teratogenic effects were observed in a study in mice receiving
up to 20 times the maximum recommended human dose of
Levodopa and Carbidopa Tablets.
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.
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27. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR Tablets During Pregnancy
There are no adequate or well-controlled studies of Levodopa and
Carbidopa CR tablets (Syndopa CR) in pregnant women.
It has been reported from individual cases that Levodopa crosses
the human placental barrier, enters the fetus, and is metabolized.
Carbidopa concentrations in fetal tissue appeared to be minimal.
Use of Syndopa CR in women of childbearing potential requires
that the anticipated benefits of the medicine be weighed against
possible hazards to mother and child.
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28. Syndopa CR Tablets (Generic Levodopa and Carbidopa CR Tablets)
© The Swiss Pharmacy
Syndopa CR Tablets (Generic Levodopa and Carbidopa
CR Tablets) are manufactured by Sun Pharmaceutical
Industries Limited, India.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9873_Syndopa-CR-Tablets.html