CARBIDOPA, LEVODOPA AND ENTACAPONE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA - UNII:MNX7R8C5VO), ENTACAPONE (UNII: 4975G9NM6T) (LEVODOPA - UNII:46627O600J), LEVODOPA (UNII: 46627O600J) (ENTACAPONE - UNII:4975G9NM6T)

제공처:

Wockhardt Limited

INN (국제 이름):

CARBIDOPA

구성:

CARBIDOPA 12.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

- To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products. - 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, see DOSAGE AND ADMINISTRATION). Carbidopa, levodopa 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 catech

제품 요약:

Carbidopa, levodopa and entacapone are supplied as film-coated tablets for oral administration in the following six strengths: Carbidopa, levodopa and entacapone film-coated tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. The round, bi-convex shaped tablets are brownish- or grayish- red, unscored, and embossed "W782" on one side.            HDPE bottle of 100 tablets     NDC 64679-782-02            HDPE bottle of 500 tablets    NDC 64679-782-03 Carbidopa, levodopa and entacapone film-coated tablets containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are light brownish red, unscored and embossed with code "W783" on one side.             HDPE bottle of 100 tablets     NDC 64679-783-02            HDPE bottle of 500 tablets     NDC 64679-783-03 Carbidopa, levodopa and entacapone film-coated tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are brownish- or grayish-red, unscored, and embossed "W784" on one side.            HDPE bottle of 100 tablets     NDC 64679-784-02            HDPE bottle of 500 tablets     NDC 64679-784-03 Carbidopa, levodopa and entacapone film-coated tablets containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. The oval-shaped tablets are light brownish red, unscored and embossed with code "W785" on one side.            HDPE bottle of 100 tablets     NDC 64679-785-02            HDPE bottle of 500 tablets     NDC 64679-785-03 Carbidopa, levodopa and entacapone film-coated tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone The elongated-ellipse shaped tablets are brownish- or grayish-red, unscored, and embossed "W786" on one side.             HDPE bottle of 100 tablets     NDC 64679-786-02            HDPE bottle of 500 tablets     NDC 64679-786-03 Carbidopa, levodopa and entacapone film-coated tablets containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone The oval shaped tablets are dark brownish red, unscored, and embossed "W787" on one side.             HDPE bottle of 100 tablets     NDC 64679-787-02            HDPE bottle of 500 tablets     NDC 64679-787-03 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in tight container (USP).

승인 상태:

New Drug Application Authorized Generic

제품 특성 요약

CARBIDOPA, LEVODOPA AND ENTACAPONE- CARBIDOPA, LEVODOPA AND ENTACAPONE
TABLET,
FILM COATED
WOCKHARDT LIMITED
----------
CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Carbidopa, levodopa and entacapone tablet 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-(α-
hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid
monohydrate. Its empirical formula is
C
H N O ●H O, and its structural formula is
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-α-amino-β-(3,4-dihydroxybenzene)
propanoic acid. Its empirical formula is C H NO , and its structural
formula is
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 C
H N O and its
structural formula is
10
14
2
4
2
9
11
4
14
15
3
5
Carbidopa, levodopa and entacapone is supplied as tablets in six
strengths:
Carbidopa, levodopa and entacapone tablet, containing 12.5 mg of
carbidopa, 50 mg of levodopa and
200 mg of entacapone;
Carbidopa, levodopa and entacapone tablet, containing 18.75 mg of
carbidopa, 75 mg of levodopa and
200 mg of entacapone;
Carbidopa, levodopa and entacapone tablet, containing 25 mg of
carbidopa, 100 mg of levodopa and 200
mg of entacapone;
Carbidopa, levodopa and entacapone tablet, containing 31.25 mg of
carbidopa, 125 mg of levodopa and
200 mg of entacapone;
Carbidopa, levodopa and entacapone tablet, containing 37.5 mg of
carbidopa,