CARBIDOPA AND LEVODOPA tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH), LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J)

Dostupné s:

Alembic Pharmaceuticals Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Carbidopa and levodopa extended-release tablets, USP are indicated  in  the  treatment  of  Parkinson’s  disease,  post-encephalitic  parkinsonism,  and  symptomatic  parkinsonism  that  may  follow  carbon  monoxide  intoxication  or  manganese  intoxication. Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa extended-release tablets. These  inhibitors  must  be  discontinued  at  least  two  weeks  prior  to  initiating  therapy  with  carbidopa and levodopa extended-release tablets. Carbidopa and levodopa extended-release tablets may  be  administered  concomitantly  with  the  manufacturer’s  recommended  dose  of  an  MAO  inhibitor  with  selectivity  for  MAO   type  B  (e.g.,  selegiline  HCl)  (see  PRECAUTIONS,  Drug  Interactions ). Carbidopa and levodopa extended-release tablets are contraindicated in patients with known hypersensitivity to any component of this  drug, and  in  patients  with  narrow-angle  glaucoma.

Přehled produktů:

Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg containing 25  mg of  carbidopa  and  100  mg  of  levodopa,  are  dappled-purple  in  color,  oval shaped mottled tablets  debossed with “L519”  on  one  side  and  plain  on  other side.  They  are  supplied  as  follows: NDC 62332-332-30                Bottle of 30 tablets NDC 62332-332-31                Bottle of 100 tablets NDC 62332-332-91                Bottle of  1000 tablets Carbidopa and levodopa extended-release tablets USP, 50 mg/200 mg containing 50  mg of  carbidopa  and  200  mg  of  levodopa,  are  dappled-purple  in  color,  oval shaped mottled tablets debossed with “L520”  on  one  side  and  plain  on  other side.  They  are  supplied  as  follows: NDC 62332-333-30                Bottle of 30 tablets NDC 62332-333-31                Bottle of 100 tablets NDC 62332-333-91                Bottle of  1000 tablets   Storage and  Handling   Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled  Room  Temperature].  Store  in  a  tightly  closed  container,  protected  from  light  and  moisture. Dispense  in  a  tightly  closed,  light-resistant  container. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India  Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA  Revised:  01/2018

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CARBIDOPA AND LEVODOPA - CARBIDOPA AND LEVODOPA TABLET, EXTENDED
RELEASE
ALEMBIC PHARMACEUTICALS INC.
----------
CARBIDOPA AND LEVODOPA EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Carbidopa and levodopa extended-release tablets, USP are an
extended-release combination of
carbidopa and levodopa for the treatment of Parkinson’s disease and
syndrome.
Carbidopa, USP , an inhibitor of aromatic amino acid decarboxylation,
is a white to creamy white,
odorless or practically odorless powder, freely soluble in 3N
hydrochloric acid, slightly soluble in
water and in methanol, practically insoluble in alcohol, in acetone,
in chloroform and in ether, with a
molecular weight of 244.24. It is designated chemically as
(-)-L-αhydrazino-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
226.24.
Levodopa, USP, an aromatic amino acid, is a white to off-white,
odorless , crystalline powder,
slightly soluble in water, freely soluble in 3N hydrochloric acid and
insoluble in alcohol with
a molecular weight of 197.19. 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:
Carbidopa and levodopa extended-release tablets, USP are supplied as
extended-release tablets
containing either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg
of carbidopa and 200 mg of
levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium
stearate, and hypromellose.
Carbidopa and levodopa extended-release tablets USP, 25 mg/100 mg and
carbidopa and levodopa
extended-release tablets USP, 50 mg/200 mg also contain FD&C Blue #2
Aluminium Lake and FD&C
Red #40 Aluminium Lake.
The 25 mg/100 mg tablet is supplied as an oval shaped mottled tablet
that is dappled-purple in
color and is debossed with “L519” on one side and plain on the
other. The 50 mg/200 mg tablet
10
14