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STALEVO (LEVODOPA WITH CARBIDOPA AND ENTACAPONE) TABLETS: PRESCRIBING INFORMATION
Stalevo (Carbidopa, Levodopa and Entacapone) is a combination of carbidopa, levodopa and entacapone for the treatment of Parkinson's disease.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(alpha-hydrazino-(alpha-methyl-beta-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4xH2O.
Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-alpha-amino-beta(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4.
Entacapone, an inhibitor of catechol-O-methyltransferase (COMT), is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5.
Stalevo (Levodopa/Carbidopa/Entacapone) is supplied as tablets in six strengths: Stalevo 50, containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; Stalevo 75, containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; Stalevo 100, containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; Stalevo 125, containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; Stalevo 150, containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; Stalevo 200, containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone.
The inactive ingredients of the Stalevo tablet are croscarmellose sodium, corn starch, glycerol 85%, magnesium stearate, hypromellose, mannitol, povidone, polysorbate 80, sucrose, red iron oxide, and titanium dioxide.
Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.
Stalevo clinical pharmacology
PHARMACOKINETICS IN SPECIAL POPULATIONS
Stalevo pharmacokinetics in special populations
Stalevo clinical studies
Stalevo (Levodopa with Carbidopa and Entacapone) is indicated to treat patients with idiopathic Parkinson's disease:
1. To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.
2. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias.
Stalevo (Levodopa with Carbidopa and Entacapone) tablets are contraindicated in patients who have demonstrated hypersensitivity to any component (carbidopa, levodopa, or entacapone) of the drug or its excipients.
Monoamine oxidase (MAO) and COMT are the two major enzyme systems involved in the metabolism of catecholamines. It is theoretically possible, therefore, that the combination of entacapone and a non-selective MAO inhibitor (e.g., phenelzine and tranylcypromine) would result in inhibition of the majority of the pathways responsible for normal catecholamine metabolism. As with carbidopa-levodopa, nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Stalevo. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Stalevo. Stalevo may be administered concomitantly with the manufacturer's recommended dose of MAO inhibitors with selectivity for MAO type B (e.g., selegiline HCl).
Stalevo is contraindicated in patients with narrow-angle glaucoma.
Because levodopa may activate malignant melanoma, Stalevo should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
Stalevo special precautions
Stalevo laboratory tests
Stalevo drug interactions
Stalevo nonclinical toxicology
USE IN SPECIAL POPULATIONS
Stalevo use in special populations
Stalevo adverse reactions
DRUG ABUSE AND DEPENDENCE
Controlled substance class
Stalevo (Levodopa/Carbidopa/Entacapone) is not a controlled substance in the USA.
Physical and psychological dependence
Stalevo has not been systematically studied, in animal or humans, for its potential for abuse, tolerance or physical dependence. In premarketing clinical experience, carbidopa-levodopa did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. However, there are rare postmarketing reports of abuse and dependence of medications containing levodopa. In general, these reports consist of patients taking increasing doses of medication in order to achieve a euphoric state.
DOSAGE AND ADMINISTRATION
Stalevo dosage and administration
Stalevo how supplied
Manufactured and distributed by Novartis, Orion Corporation pharmaceutical companies and their divisions.
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