Syndopa Tablets (Generic Carbidopa and Levodopa Tablets)

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

Syndopa Tablets (Generic Carbidopa and Levodopa Tablets) is
used in the treatment of Parkinson's disease, post-encephalitic
parkinsonism, and symptomatic parkinsonism (such as shakiness,
stiffness, difficulty moving) that may follow carbon monoxide
intoxication or manganese intoxication.
Parkinson's disease is thought to be caused by too little of a
naturally occurring substance (dopamine) in the brain. Levodopa
changes into dopamine in the brain, helping to control
movement. Carbidopa prevents the breakdown of levodopa in
the bloodstream so more levodopa can enter the brain.
Carbidopa can also reduce some of levodopa's side effects such
as nausea and vomiting.

Syndopa Tablets are manufactured by Sun
Pharmaceutical Industries Limited, India in the
strengths of 110mg , 125mg and 275mg.

Chemical Structure - - Levodopa

Chemical Structure - Carbidopa

The active ingredients contained in Syndopa tablets
are Levodopa and Carbidopa.
Each Syndopa tablet contains Levodopa 100mg &
Carbidopa 10mg or Levodopa 100mg & Carbidopa
25mg or Levodopa 250mg & Carbidopa 25mg

Uses of Syndopa 110mg , 125mg and 275mg Tablets:
Syndopa Tablets (Carbidopa and Levodopa combination) is used to treat
Parkinson's disease, sometimes called shaking palsy or paralysis agitans.
Parkinson's disease is a disorder of the central nervous system (brain and
spinal cord).
Levodopa and Carbidopa combination is also used to treat parkinsonism
caused by encephalitis, or parkinsonism caused by carbon monoxide or
manganese poisoning.
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.

Recommended Adult Dosage
For most patients, the starting dose of Syndopa tablets
(Generic Carbidopa and Levodopa Tablets) is one tablet of
Syndopa 25/100 three times a day.This dosage schedule
provided 75 mg of Carbidopa per day.
Dosage may be increased by one tablet every day or every
other day (given at intervals of 3 to 4 hours), as necessary, until
a dosage equivalent of eight tablets of Syndopa 25/100 a day
is reached.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9604_Syndopa-Tablets.html

Contraindications
➔
Syndopa 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 (Generic Levodopa and Carbidopa Tablets). These
inhibitors must be discontinued at least two weeks prior to initiating
therapy with Syndopa. 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 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.

Contraindications
➔
As with Levodopa, Syndopa should 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 tablets should not be used in patients
with suspicious, undiagnosed skin lesions or a history of
melanoma.

Storage Instructions
Syndopa Tablets (Generic Carbidopa and Levodopa
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.

Warnings
Patients receiving treatment with Syndopa tablets (Generic Carbidopa
and Levodopa 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, 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,
Levodopa must be discontinued for at least 12 hours or more before
Syndopa is started. Syndopa should be substituted at a dosage that will
provide approximately 20% of the previous Levodopa dosage.

Warnings
Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal
function are recommended during extended therapy with Syndopa (Generic
Levodopa and Carbidopa Tablets).
Patients who improve while on therapy with Syndopa 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 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 should be administered cautiously to patients with a history of peptic
ulcer disease due to the possibility of upper gastrointestinal hemorrhage.

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 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
tablets.

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.
If general anesthesia is required, therapy with Syndopa (Generic Levodopa
and Carbidopa Tablets) may be continued as long as the patient is permitted
to take fluids and medication by mouth. If 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.

Warnings
Patients 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.

Possible Side Effects
Most common Syndopa (Carbidopa and Levodopa Tablets)
side effects have included dyskinesias, such as choreiform,
dystonic, and other involuntary movements, and nausea.

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.

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.

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.

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.

Overdosage
Management of acute overdosage with Levodopa and Carbidopa
Tablets (Syndopa) 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 drugs as well as
Levodopa and Carbidopa tablets should be taken into consideration.

Syndopa Tablets During Pregnancy
Levodopa and Carbidopa Tablets (Syndopa 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.

Syndopa Tablets During Pregnancy
There are no adequate or well-controlled studies of Levodopa and
Carbidopa tablets (Syndopa) 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 in women of childbearing potential requires that
the anticipated benefits of the medicine be weighed against
possible hazards to mother and child.

Syndopa Tablets (Generic Carbidopa and Levodopa
Tablets) are manufactured by Sun Pharmaceutical
Industries Limited, India.

Syndopa Tablets (Generic Carbidopa and Levodopa Tablets)

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