Dopair®

Prescribing Details



Description

Dopair ® is a combination of Levodopa and Carbidopa which is used for the treatment of Parkinson's disease and
syndrome. Current evidence indicates that symptoms of Parkinson's disease are related to depletion of dopamine in
the corpus striatum. Levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier and
presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby Levodopa relieves
symptoms of Parkinson's disease. Carbidopa allows patients treated for Parkinson's disease to use much lower
doses of Levodopa and increases the efficacy of 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. Carbidopa may also reduce nausea and vomiting and permit more rapid titration of Levodopa.


Uses

No Data


Indications

Dopair ® is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism and symptomatic
parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.


Dosage and administration

Route of administration: Dopair ® should be taken in oral route.


Initial dose
If Dopair ® 110 tablet is used, dosage may be initiated with one tablet 3 or 4 times a day. Titration upward may be
required in some patients to achieve optimum dosage of carbidopa (70-100 mg/day). The dosage may be increased
by one tablet every day or every other day until a total of eight tablets (two tablets q. i. d.) is reached.
For patients starting with Dopair ® 275 tablet, the initial dose is half tablet & taken 1-2 times a day. However, this
may not provide the optimal amount of carbidopa needed by many patients. If necessary, add half tablet every day
or every other day until optimal response is reached. The suggested starting dosage for most patients taking more
than 1500 mg of levodopa a day is one Dopair ® 275 tablet 3-4 times daily.
Levodopa must be discontinued at least 12 hours before starting Dopair ®. A daily dosage of Dopair ® should be
chosen that will provide approximately 25% of the previous levodopa dosage.


Maintenance dose
Therapy should be individualized and adjusted according to the desired therapeutic response. When more levodopa
is required, Dopair ® 275 tablet should be substituted at a dosage of one tablet 3-4 times a day. If necessary, the
dosage of Dopair ® 275 tablet may be increased by half to one tablet everyday or every other day to a maximum
eight tablets a day. Administration of total daily dosages of carbidopa greater than 200 mg is limited. Patient should
be monitored closely during dosage adjustment.


Use in pregnancy & lactation

Pregnancy: There are no adequate or well-controlled data on use of this combination in pregnant women. It can be
used during pregnancy only if therapeutic benefit outweighs the risk to mother and fetus.


Lactation: Levodopa has been detected in human milk. Caution should be exercised when administered to a
lactating mother.


Use in children and adolescent
Safety and effectiveness in pediatric patients have not been established. Use of this combination in patients below
the age of 18 is not recommended.


Geriatric use
No Data

Precautions

Warning and precaution
All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. It
should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma,
renal, hepatic or endocrine disease. Care should be exercised in administering the drug 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. Treatment with levodopa
and carbidopa combination may increase the possibility of upper gastrointestinal hemorrhage in patients with a
history of peptic ulcer. Patients should be advised not to drive and to avoid other potentially dangerous activities
that might result in harm as it can cause sleepiness, drowsiness and somnolence. Patient should be monitored for
any symptoms of hallucinations, psychotic or compulsive behaviour and skin manifestations (e.g., Melanoma).


Side effects

The most common side effects are nausea, choreiform dystonia & other involuntary movements. Other significant
reactions are convulsions, dementia & mental changes. The mental changes include paranoid ideation, psychotic
episodes & depression with or without suicidal tendencies


Contraindications

It is contraindicated in patients with history of known hypersensitivity to carbidopa and levodopa or any other
components of this product and in patients with narrow angle glaucoma.


Drug interactions

Drug interaction with medication: Concomitant use of levodopa and carbidopa with nonselective monoamine
oxidase (MAO) inhibitors are contraindicated as it can cause severe orthostatic hypotension. These inhibitors must
be discontinued at least two weeks prior to initiating therapy. Concomitant use with antihypertensive drugs can
cause symptomatic postural hypotension. Dosage adjustment of the antihypertensive drug may be required.
Concomitant use of dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and
isoniazid may reduce the therapeutic effects of levodopa. Dosage adjustments may be required. Concomitant use
with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine
stores is not recommended.


Drug interaction with food and others: Not applicable.


Overdose

In case of overdose, general supportive measures should be employed, along with immediate gastric lavage.
Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of
arrhythmias.


Preparation

No Data


Pharmaceutical precautions

No Data


Presentation

Composition
Dopair ® 110 Tablet: Each tablet contains Levodopa BP 100 mg and Carbidopa 10 mg as Carbidopa Monohydrate
USP.
Dopair ® 275 Tablet: Each tablet contains Levodopa BP 250 mg and Carbidopa 25 mg as Carbidopa Monohydrate
USP.


Package quantities

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.


Packing
Dopair ® 110 Tablet: Carton of 30 tablets in blister pack.
Dopair ® 275 Tablet: Carton of 30 tablets in blister pack.