Encarlev Tablet
Carbidopa + Entacapone + Levodopa
25 mg+200 mg +100 mg
Opsonin Pharma Limited
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 25.00 AED |
Available as:
Indications
Encarlev Tablet is used for:
Parkinson's disease, and 'end of dose' motor fluctuations
Adult Dose
Parkinson's disease
Adult: PO: Each tab contains levodopa and carbidopa in a ratio of 4:1 and entacapone 200 mg:
Initial: 1 tab/day. Titrate dose according to patient's response.
Recommended to take only 1 tab per dose administration.
Max: 8 tabs/day.
Child Dose
Safety & efficacy not established
Renal Dose
Administration
May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Fe salts (eg in multivit prep) may also reduce amount of levodopa available to the body. Swallow whole.
Contra Indications
Hypersensitivity. Narrow angle glaucoma. Should not be used in patients with suspicious, undiagnosed skin lesions or a history ot melanoma.
Precautions
May cause falling asleep during activities of daily living without apparent warning, and daytime drowsiness and somnolence
May cause syncope and hypotension/orthostatic hypotension
May cause or exacerbate dyskinesia
May cause depression and suicidality
May cause hallucinations and/or other psychotic-like behavior
May cause problems with impulse control and compulsive behaviors
Abrupt discontinuation may cause hyperpyrexia and confusion
May cause diarrhea and/or drug-induced colitis
May cause rhabdomyolysis
Pregnancy-Lactation
Pregnancy
There are no adequate data on developmental risk associated with use of drug in pregnant women
Animal data
In animals, administration of carbidopa-levodopa or entacapone during pregnancy was associated with developmental toxicity, including increased incidences of fetal malformations; estimated background risk of major birth defects and miscarriage in indicated population is unknown
Lactation
Levodopa has been detected in human milk after administration of carbidopa-levodopa; there are no data on presence of entacapone or carbidopa in human milk, effects of levodopa, carbidopa, or entacapone on breastfed infant, or on milk production; however, inhibition of lactation may occur because levodopa decreases secretion of prolactin; carbidopa and entacapone are excreted in rat milk; in lactating rat, oral administration of radiolabeled entacapone resulted in levels of entacapone and/or metabolites in milk up to 2 to 3 times that in plasma;
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed infant or from underlying maternal condition
Interactions
Drugs metabolized by COMT: use with caution
Severe orthostatic hypotension may result from concurrent usage with MAOIs.
Anti-hypertensive agents: Increased risk of postural hypotension when used concurrently with hypotensive drugs. Dose adjustment may be required
Tricyclic antidepressants: risk of hypertension and dyskinesia reported during concomitant use with carbidopa/levodopa
Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of Carbidopa + Entacapone + Levodopa
Drugs that interfere with biliary excretion, glucuronidation and intestinal beta-glucuronidase: dose adjustment of Stalevo may be required
Drugs metabolized by CYP2C9 (e.g., coumadin): dose adjustment of Stalevo may be required; monitor INR when initiating Carbidopa + Entacapone + Levodopa in patients on coumadin
Iron salts may reduce the bioavailability.
May depress prolactin secretion and increase growth hormone levels.
Contraindicated (8)
isocarboxazid
lonafarnib
phenelzine
phenelzine
procarbazine
selegiline
selegiline transdermal
tranylcypromine
Adverse Effects
Side effects of Carbidopa + Entacapone + Levodopa :
>10%
Entacapone
Dyskinesia (25%),Nausea (14%),Diarrhea (10%),Hyperkinesia (10%),Urine discoloration (10%)
1-10%
Entacapone
Hypokinesia (9%), dizziness (8%), Fatigue (6%), hallucinations (1-4%), anxiety (2%), somnolence (2%), asthenia (2%), agitation (1%),Increased sweating (2%),Purpura (2%),Abdominal pain (8%), constipation (6%), vomiting (4%), dry mouth (3%), dyspepsia (2%), flatulence (2%), taste perversion (1%), gastritis (1%),Back pain (4%),Dyspnea (3%),Bacterial infection (1%)
Frequency Not Defined
Levodopa/Carbodopa
Edema,Agitation, anxiety, ataxia, bruxism, confusion, daytime somnolence decreased attention span, dyskinesia, dystonia, euphoria, insomnia, fainting, fatigue, increased trembling of hands, insouciance, malaise, memory loss, nightmares, nervousness, restlessness, trismus, vivid dreams,Alopecia, hot flushes, increased &/or dark perspiration, skin eruptions,Abdominal pain & discomfort, burning feeling in tongue, constipation, diarrhea, dysgeusia, dry mouth, dysphagia, hiccups, meteorism, sialorrhea, nausea, weight loss,Muscular spasms, muscular cramp,Hematuria, dark urine, incontinence, priapism, urine retention,Blurred vision, diplopia, dilated pupil, oculogyric problems.
Entacapone
Postural hypotension,Insomnia,Confusion
Potentially Fatal: Rhabdomyolysis.
Mechanism of Action
Levodopa is the metabolic precurosor of dopamine, it crosses the blood-brain barrier and is converted to dopamine in the brain.
Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa.
Entacapone is a selective inhibitor of catechol-o-methyltransferase. Given concurrently, entacapone results in greater and more substained plasma levels of levodopa, leading to greater control of parkinsonism symptoms.
Note
Encarlev 25 mg+200 mg +100 mg Tablet manufactured by Opsonin Pharma Limited. Its generic name is Carbidopa + Entacapone + Levodopa. Encarlev is availble in Bangladesh.
Farmaco BD drug index information on Encarlev Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.