Prolopa Uses

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Prolopa indications

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Treatment of Parkinson's disease.

Prolopa dispersible is a formulation which is suitable for patients with dysphagia (difficulties in swallowing) or who require a formulation with a more rapid onset of action eg, patients suffering from early morning and afternoon akinesia, or who exhibit "delayed on" or "wearing off" phenomena.

Prolopa HBS is indicated for patients presenting with all types of fluctuations (eg, "peak-dose dyskinesia" and "end of dose deterioration" eg, nocturnal immobility).

Prolopa description

Prolopa is a combination of Levodopa (Prolopa) and the decarboxylase inhibitor besnerazide (as hydrochloride) in a ratio of 4:1 for the treatment of Parkinson's disease..

Prolopa 62.5 is Levodopa (Prolopa) 50 mg and Benserazide (Prolopa) 12.5 mg; 125 is Levodopa (Prolopa) 100 mg and Benserazide (Prolopa) 25 mg; 250 is Levodopa (Prolopa) 200 mg and besenrazide 50 mg.

Prolopa 250: Each capsule contains Levodopa (Prolopa) 200 mg and Benserazide (Prolopa) HCl 50 mg.

Prolopa HBS (Hydrodynamically Balanced System): Each capsule contains Levodopa (Prolopa) 100 mg and Benserazide (Prolopa) HCl 25 mg.

Prolopa dosage

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Standard

Dosage: Treatment with Prolopa should be introduced gradually, dosage should be assessed individually and titrated for optimal effect. The following dosage instructions should therefore be regarded as guidelines.

Initial Therapy: In the early stages of Parkinson's disease it is advisable to start treatment with 1 capsule of Prolopa '62.5' or half a tablet of Prolopa '125' 3-4 times daily. As soon as tolerability of the initial dosing schedule is confirmed, the dosage should be increased slowly in accordance with the patient's response.

An optimal effect is generally achieved with a daily dosage of Prolopa corresponding to Levodopa (Prolopa) 300-800 mg + Benserazide (Prolopa) 75-200 mg, to be divided into ≥3 doses. Between 4 and 6 weeks may be needed to achieve the optimal effect. If it proves necessary to further increase the daily dosage, this should be done on a monthly basis.

Maintenance Therapy: The average maintenance dosage is 1 capsule or tablet of Prolopa '125' 3-6 times daily. The number of individual doses (not <3) and their distribution throughout the day must be titrated for optimal effect. Prolopa HBS and Prolopa dispersible may substitute standard Prolopa to achieve an optimal effect.

Special Dosage Instructions: Dosage must be carefully titrated in all patients. Patients on other antiparkinsonian agents may receive Prolopa. However, as treatment with Prolopa proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or these drugs gradually withdrawn.

Prolopa dispersible tablets are particularly suitable for patients with dysphagia (difficulties in swallowing) or in situations where a more rapid onset of action is required eg, in patients suffering from early morning and afternoon akinesia or who exhibit "delayed on" or "wearing off" phenomena.

Patients who experience large fluctuations in the drug's effect in the course of the day (on-off phenomena) should receive smaller, more frequent single doses or be switched to Prolopa HBS.

The switch from standard Prolopa to Prolopa HBS is preferably made from 1 day to the next, beginning with the morning dose. The daily dose and dosing interval should initially be the same as with standard Prolopa.

After 2-3 days, the dosage should be gradually increased by about 50%. Patients should be informed that their condition may temporarily deteriorate.

Due to the pharmacokinetic properties of Prolopa HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Prolopa HBS together with standard Prolopa or Prolopa dispersible. This may prove especially useful for the 1st morning dose, which should preferably be higher than the subsequent daily doses. The individual titration for Prolopa HBS must be carried out slowly and carefully, allowing intervals of at least 2-3 days between dose changes.

In patients with nocturnal immobility, positive effects have been reported after gradually increasing the last evening dose to Prolopa HBS 250 mg on retiring.

Excessive responses to Prolopa HBS (dyskinesia) can be controlled by increasing the interval between doses rather than reducing the single doses.

Treatment with standard Prolopa or Prolopa dispersible should be resumed if the response to Prolopa HBS is inadequate.

Patients should be carefully observed for possible undesirable psychiatric symptoms.

Administration: When taking standard Prolopa capsules or Prolopa HBS, patients must always ensure to swallow the whole capsule without chewing it.

Standard Prolopa tablets are breakable to facilitate swallowing.

Prolopa dispersible tablets are to be dispersed in a quarter of a glass of water (approximately 25-50 mL). The tablets disintegrate completely, producing a milky-white dispersion within a few minutes. Because of rapid sedimentation, it is advisable to stir the dispersion before drinking. Prolopa dispersible tablets should be taken within ½ an hr of preparing the dispersion.

Prolopa should be taken 30 min before or 1 hr after meals where possible. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Prolopa with a small snack (eg, biscuits) or liquid or by increasing the dose slowly.

Prolopa interactions

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Pharmacokinetic Interactions: Co-administration of the anticholinergic drug trihexyphenidyl with standard Prolopa reduces the rate, but not the extent of Levodopa (Prolopa) absorption. Trihexyphenidyl given concomitantly with Prolopa HBS does not affect the pharmacokinetics of Levodopa (Prolopa).

Co-administration of antacids with Prolopa HBS reduces the extent of Levodopa (Prolopa) absorption by 32%.

Ferrous sulphate decreases the maximum plasma concentration and the AUC of Levodopa (Prolopa) by 30-50%. The pharmacokinetic changes observed during co-treatment with ferrous sulphate appear to be clinically significant in some but not all patients.

Metoclopramide increases the rate of Levodopa (Prolopa) absorption.

Domperidone may increase the bioavailability of Levodopa (Prolopa) by stimulation of gastric emptying.

Pharmacodynamic Interactions: Neuroleptics, opioids and antihypertensive medications containing reserpine inhibit the action of Prolopa.

If Prolopa is to be administered to patients receiving irreversible nonselective MAO inhibitors, an interval of at least 2 weeks should be allowed between cessation of the MAO inhibitor and the start of Prolopa therapy. Otherwise unwanted effects eg, hypertensive crises are likely to occur. Selective MAO-B inhibitors eg, selegiline and rasagiline and selective MAO-A inhibitors eg, moclobemide, can be prescribed to patients on Prolopa therapy; it is recommended to readjust the Levodopa (Prolopa) dose to the individual patient's needs, in terms of both efficacy and tolerability. Combination of MAO-A and MAO-B inhibitors is equivalent to nonselective MAO inhibition and hence this combination should not be given concomitantly with Prolopa.

Prolopa should not be administered concomitantly with sympathomimetics (agents eg, epinephrine, norepinephrine, isoproterenol or amphetamine which stimulate the sympathetic nervous system) as Levodopa (Prolopa) may potentiate their effects. Should concomitant administration prove necessary, close surveillance of the cardiovascular system is essential, and the dose of the sympathomimetic agents may need to be reduced.

Combination with other agents eg, anticholinergics, amantadine, selegiline,bromocriptine and dopamine agonists is permissible, though both the desired and the undesired effects of treatment may be intensified. It may be necessary to reduce the dosage of Prolopa or the other substance. When initiating an adjuvant treatment with a COMT inhibitor, a reduction of the dosage of Prolopa may be necessary. Anticholinergics should not be withdrawn abruptly when Prolopa therapy is instituted, as Levodopa (Prolopa) does not begin to take effect for some time.

Levodopa (Prolopa) may affect the results of laboratory tests for catecholamines, creatinine, uric acid and glucose.

Coombs' tests may give a false-positive result in patients taking Prolopa.

Concomitant administration of antipsychotics with dopamine-receptor blocking properties, particularly D2-receptor antagonists might antagonize the antiparkinsonian effects of Levodopa (Prolopa)-Benserazide (Prolopa). Levodopa (Prolopa) may reduce antipsychotic effects of these drugs. These drugs should be co-administration with caution.

A diminution of effect is observed when the drug is taken with a protein-rich meal.

General Anesthesia with Halothane: Prolopa should be discontinued 12-48 hrs before surgical intervention requiring general anesthesia with halothane as fluctuations in blood pressure and/or arrhythmias may occur.

For general anesthesia with other anesthetics see Precautions.

Prolopa side effects

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Post-Marketing: Blood and Lymphatic System Disorders: Hemolytic anemia, transient leukopenia and thrombocytopenia have been reported in rare cases. Therefore, as in any long-term Levodopa (Prolopa)-containing treatment, blood count and liver and kidney function should be monitored periodically.

Metabolic and Nutritional Disorders: Anorexia has been reported.

Psychiatric Disorders: Depression can be part of the clinical picture in patients with Parkinson's disease and may also occur in patients treated with Prolopa. Agitation, anxiety, insomnia, hallucinations, delusions and temporal disorientation may occur particularly in elderly patients and in patients with a history of such disorders.

Nervous System Disorder: Isolated cases of ageusia or dysgeusia have been reported. At later stages of the treatment, dyskinesia (eg, choreiform or athetotic) may occur. These can usually be eliminated or be made tolerable by a reduction of dosage. With prolonged treatment, fluctuations in therapeutic response may also be encountered.

They include freezing episodes, end-of-dose deterioration and the "on-off" effect. These can usually be eliminated or made tolerable by adjusting the dosage and by giving smaller single doses more frequently. An attempt at increasing the dosage again can subsequently be made in order to intensify the therapeutic effect. Prolopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.

Cardiac Disorders: Cardiac arrhythmias may occur occasionally.

Vascular Disorders: Orthostatic hypotension may occur occasionally. Orthostatic disorders commonly improve following reduction of the Prolopa dosage.

Gastrointestinal Disorders: Nausea, vomiting and diarrhea have been reported with Prolopa. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Prolopa with some food or liquid or by increasing the dose slowly.

Skin and Subcutaneous Tissue Disorders: Allergic skin reactions eg, pruritus and rash may occur in rare cases.

Investigations: Transient elevation of liver transaminase and alkaline phosphatase may occur. Increase of γ-glutamyltransferase has been reported.

Rises in blood urea nitrogen have been noted with Prolopa.

Urine may be altered in color, usually acquiring a red tinge which turns dark on standing. Other body fluids or tissues may also be discoloured or stained including saliva, the tongue, teeth or oral mucosa.

Laboratory Abnoramlities: See Post-Marketing as previously mentioned.

Prolopa contraindications

Hypersensitivity to Levodopa (Prolopa) or Benserazide (Prolopa).

In conjunction with nonselective monoamine oxidase (MAO) inhibitors. However, selective MAO-B inhibitors eg, selegiline and rasagiline or selective MAO-A inhibitors eg, moclobemide are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to nonselective MAO inhibition and hence, this combination should not be given concomitantly with Prolopa.

Patients with decompensated endocrine, renal (except patients on dialysis) or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma.

Pregnant women or to women of childbearing potential in the absence of adequate contraception. If pregnancy occurs in a woman taking Prolopa, the drug must be discontinued (as advised by the prescribing physician).

Patients <25 years (skeletal development must be complete).

Use in pregnancy: Prolopa is contraindicated during pregnancy and in women of childbearing potential in the absence of adequate contraception.



Active ingredient matches for Prolopa:

Benserazide/Levodopa in Belgium, Brazil, Canada, Chile, Luxembourg, Uruguay.

Benserazide Hcl/Levodopa

Benserazide hydrochloride/Levodopa in Canada, Belgium, Brazil, Chile.


Unit description / dosage (Manufacturer)Price, USD
Capsule; Oral; Benserazide Hydrochloride 12.5 mg; Levodopa 50 mg
Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg
Capsule; Oral; Benserazide Hydrochloride 50 mg; Levodopa 200 mg

List of Prolopa substitutes (brand and generic names):

Tablet; Oral; Levodopa 100 mg; Benserazide Hydrochloride 25 mg
Tablet; Oral; Levodopa 200 mg; Benserazide Hydrochloride 50 mg
Madopar 125 cap 100's (Roche)
Madopar Dispersible / dispersible tab 100's (Roche)
Madopar HBS SR cap 100's (Roche)
Madopar 250 tab 100's (Roche)
Tablet; Oral; Benserazide 50 mg; Levodopa 200 mg (Tecnofarma)
Capsule; Oral; Benserazide Hydrochloride 12.5 mg; Levodopa 50 mg (Eureco)
Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Eureco)
Capsule; Oral; Benserazide Hydrochloride 50 mg; Levodopa 200 mg (Eureco)
Capsule, Prolonged Release; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Eureco)
Capsule, Prolonged Release; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg
Pardoz 5 x 10's (Kalbe)$ 18.60
Tablet; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg (Merz)
Capsule; Oral; Benserazide Hydrochloride 25 mg; Levodopa 100 mg
Capsule, Retard; Oral; Benserazide Hydrochloride; Levodopa (Roche)
Tablet; Oral; Benserazide Hydrochloride; Levodopa (Roche)
Vopar 100's (Unison)
Vopar 10 x 10's (Unison)
Vopar 250 mg tab 10 x 10's (Unison)

References

  1. DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "levodopa". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "benserazide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Prolopa are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Prolopa. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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2 consumers reported age

Users%
> 601
50.0%
16-291
50.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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