Adcapone Tablets (Generic Entacapone Tablets)

Adcapone Tablets (Generic Entacapone Tablets)
© The Swiss Pharmacy

are used as an adjunct to Levodopa and Carbidopa
to treat end-of-dose “wearing-off” in patients with
Parkinson’s disease.
Entacapone tablets effectiveness has not been
systematically evaluated in patients with
Parkinson’s disease who do not experience end-of-
dose “wearing-off”.

Adcapone Tablets are manufactured
by Sun Pharmaceutical Industries
Limited, India in the strength of 200
mg.

Chemical Structure - Entacapone

The active ingredient contained in Adcapone
tablets is Entacapone.
Each Adcapone tablet contains 200 mg of
Entacapone.

Uses of Adcapone 200 mg tablets:
Adcapone Tablets (Generic Entacapone Tablets) is used with other
medications like Levodopa/Carbidopa to treat Parkinson's disease.
Entacapone belongs to a class of drugs known as COMT inhibitors. Many
people taking Levodopa for Parkinson's have problems with the effects of
the Levodopa wearing off between scheduled doses, causing symptoms to
return or worsen. Entacapone blocks a certain natural substance (COMT
enzyme) that breaks down the Levodopa in the body. This effect allows
the Levodopa to last longer in the system so that it doesn't wear off
before the next dose.

Recommended Adult Dosage
For most patients, the dose of
Adcapone Tablets (Generic Entacapone Tablets) is One 200 mg
tablet is taken with each Levodopa/Dopa Decarboxylase inhibitor
dose. The maximum recommended dose is 200 mg ten times
daily, i.e. 2,000 mg of Entacapone.
Entacapone enhances the effects of Levodopa. Hence, to reduce
Levodopa-related dopaminergic adverse reactions, e.g.
dyskinesias, nausea, vomiting and hallucinations, it is often
necessary to adjust Levodopa dosage within the first days to first
weeks after initiating Entacapone treatment.

Recommended Adult Dosage
The daily dose of Levodopa should be reduced by about 10
to 30% by extending the dosing intervals and/or by reducing
the amount of Levodopa per dose, according to the clinical
condition of the patient.

Contraindications
➔
Adcapone is contraindicated in patients with a known
hypersensitivity to Entacapone or any component of the tablet.
➔
Administration of Adcapone is contraindicated in patients with
Hepatic impairment.
➔
Patients with pheochromocytoma due to the increased risk of
hypertensive crisis.
➔
A previous history of neuroleptic malignant syndrome (NMS)
and/or non-traumatic rhabdomyolysis.

Contraindications
➔
Concomitant use of Entacapone and non-selective monoamine
oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine,
tranylcypromine) is contraindicated.
➔
Concomitant use of a selective MAO-A inhibitor plus a
selective MAO-B inhibitor and Entacapone.

Storage Instructions
Adcapone Tablets (Generic Entacapone 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
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant
syndrome (NMS) has been observed rarely in patients with Parkinson's
disease. Isolated cases of rhabdomyolysis have been reported with
Entacapone treatment.
Entacapone therapy should be administered with caution to patients with
ischaemic heart disease.
Because of its mechanism of action, Entacapone may interfere with the
metabolism of medicinal products containing a catechol group and
potentiate their action.
Entacapone is always given as an adjunct to Levodopa treatment. Hence,
the precautions valid for Levodopa treatment should also be taken into
account for Entacapone treatment.

Warnings
Entacapone may aggravate Levodopa-induced orthostatic hypotension.
Entacapone should be given cautiously to patients who are taking other
medicinal products which may cause orthostatic hypotension.
In clinical studies, adverse dopaminergic effects, e.g. dyskinesia, were
more common in patients who received Entacapone and dopamine
agonists (such as Bromocriptine), Selegiline or Amantadine compared to
those who received placebo with this combination. The doses of other
antiparkinsonian medications may need to be adjusted when Entacapone
treatment is initiated.
For patients experiencing diarrhoea, a follow-up of weight is
recommended in order to avoid potential excessive weight decrease.

Warnings
For patients who experience progressive anorexia, asthenia and
weight decrease within a relatively short period of time, a general
medical evaluation including liver function should be considered.
Patients should be regularly monitored for the development of impulse
control disorders. Patients and caregivers 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 such as Entacapone in association with Levodopa. Review
of treatment is recommended if such symptoms develop.

Warnings
Prolonged or persistent diarrhoea suspected to be related to Entacapone
may be a sign of colitis. In the event of prolonged or persistent diarrhoea,
Entacapone should be discontinued and appropriate medical therapy and
investigations considered.
Entapone tablets contain sucrose. Therefore, patients with rare
hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
Entacapone used in combination with Levodopa has been associated
with somnolence and episodes of sudden sleep onset in patients with
Parkinson's disease and caution should therefore be exercised when
driving or operating machines.

Effects On Ability To Drive And Use Machines
Entacapone in association with Levodopa may have major influence on the
ability to drive and use machines.
Patients being treated with Entacapone in association with Levodopa and
presenting with somnolence and/or sudden sleep onset episodes must
be instructed to refrain from driving or engaging in activities where
impaired alertness may put themselves or others at risk of serious injury or
death (e.g. operating machines) until such recurrent episodes have
resolved .
Entacapone may, together with Levodopa, cause dizziness and
symptomatic orthostatism.
Therefore, caution should be exercised when driving or using machines.

Possible Side Effects
Very common Entacapone (Adcapone Tablets) side effects found
in double-blind placebo controlled phase III studies are
dyskinesia, nausea, and abnormal urine.
Common side effects found in double-blind placebo controlled
phase III studies are diarrhoea, Parkinsonism aggravated,
dizziness, abdominal pain, insomnia, dry mouth, fatigue,
hallucinations, constipation, dystonia, increased sweating,
hyperkinesia, headache, leg cramps, confusion, paranoia, fall,
postural hypotension, vertigo and tremor.

The following side effects, listed below, have been accumulated both from clinical
studies with Entacapone and since the introduction of Entacapone into the market.
Psychiatric disorders
Common Insomnia, hallucinations, confusion, nightmares
Very rare Agitation
Nervous system disorders
Very common Dyskinesia
Common Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
Cardiac disorders
Common Ischaemic heart disease events other than myocardial
Infarction (e.g. angina pectoris)
Uncommon Myocardial infarction
Gastrointestinal disorders
Very common Nausea

The following side effects, listed below, have been accumulated both from
clinical studies with Entacapone and since the introduction of Entacapone into
the market.
Gastrointestinal disorders
Common Diarrhoea, abdominal pain, dry mouth, constipation, vomiting
Very rare Anorexia, colitis
Hepato-biliary disorders
Rare Hepatic function tests abnormal
Not known Hepatitis with mainly cholestatic features
Skin and subcutaneous tissue disorders
Rare Erythematous or maculopapular rash
Very rare Urticaria
Not known Skin, hair, beard and nail discolourations

The following side effects, listed below, have been accumulated both
from clinical studies with Entacapone and since the introduction of
Entacapone into the market.
Renal and urinary disorders
Very common Urine discolouration
General disorders and administration site conditions
Common Fatigue, sweating increased, fall
Very rare Weight decrease

Adcapone Tablets Overdosage
The post-marketing data includes isolated cases of Entacapone (Adcapone
Tablets) overdose in which the reported highest daily dose of
Entacapone has been 16,000 mg.
The acute symptoms and signs in these cases of overdose included
agitation, dsyskinesia, confusional state, coma, bradycardia, ventricular
tachycardia, Cheyne-Stokes respiration, mydriasis, decreased activity,
somnolence, hypotonia,
discolouration of the skin, tongue and conjunctiva, chromaturia, mild renal
failure, neuroleptic malignanat syndrome and urticaria.

Treatment of Adcapone Tablets Overdosage
Management of acute overdosing is symptomatic. Hospitalization is advised and
general supportive care is indicated. There is no known antidote to entacapone.
The drug is rapidly absorbed and eliminated with a short mean residence time.
There is no experience with dialysis or hemoperfusion, and these procedures are
unlikely to be of benefit, because Entacapone is highly bound to plasma proteins.
An immediate gastric lavage and repeated doses of charcoal over time may hasten
the elimination of entacapone by decreasing the absorption/reabsorption of
entacapone from GI tract. The adequacy of the respiratory and circulatory
systems should be carefully observed and appropriate supportive measures
employed.
In managing overdosage, the possibility of interaction among drugs, especially
catechol-structured drugs, should be borne in mind.

Adcapone Tablets During Pregnancy
Entacapone (Adcapone Tablets) has been classified by the US FDA as
Pregnancy Category C.
In embryofetal development studies, Entacapone was administered to
pregnant animals throughout organogenesis at doses of up to 1,000
mg/kg/day in rats and 300 mg/kg/day in rabbits. Increased
incidences of fetal variations were evident in litters from rats treated
with the highest dose, in the absence of overt signs of maternal
toxicity.
There is no experience from clinical studies regarding the use of
Entacapone in pregnant women.
Therefore, Adcapone tablets should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.

Adcapone Tablets are manufactured by Sun
Pharmaceutical Industries Limited, India.
For More details Click Here

Adcapone Tablets (Generic Entacapone Tablets)

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