ORPHENADRINE CITRATE injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9)

Pieejams no:

Actavis Pharma, Inc.

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculo-skeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man. Orphenadrine citrate is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction at the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Orphenadrine citrate is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Produktu pārskats:

Orphenadrine Citrate Injection USP, 30 mg/mL is available in 2 mL ampules in cartons of 10. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. DO NOT USE IF PRECIPITATE OCCURS. Literature revised: July 2016 Product No.: 1108-82 Mfd. by: Hikma Farmaceutica (Portugal) S.A. 2705-906 Terrugem SNT, Portugal Dist. by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

ORPHENADRINE CITRATE- ORPHENADRINE CITRATE INJECTION
ACTAVIS PHARMA, INC.
----------
ORPHENADRINE CITRATE INJECTION, USP
RX ONLY
DESCRIPTION
Orphenadrine Citrate Injection is a sterile aqueous solution of
orphenadrine citrate. It is intended for
intravenous or intramuscular administration.
Orphenadrine citrate is the citrate salt of orphenadrine and occurs as
a white, crystalline powder having
a bitter taste. It is practically odorless, sparingly soluble in water
and slightly soluble in alcohol. It has
the following structural formula:
N,N-Dimethyl-2-[(_o_-methyl-α-phenylbenzyl)oxy]ethylamine Citrate
(1:1).
Each mL contains: Orphenadrine Citrate 30 mg, Sodium Metabisulfite
0.91 mg, Sodium Chloride 2.9
mg, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric
Acid may have been used to
adjust pH.
CLINICAL PHARMACOLOGY
The mode of action has not been clearly identified but may be related
to analgesic properties.
Orphenadrine citrate possesses anticholinergic actions.
INDICATIONS AND USAGE
Orphenadrine citrate is indicated as an adjunct to rest, physical
therapy, and other measures for the relief
of discomfort associated with acute, painful musculo-skeletal
conditions. The mode of action of this
drug has not been clearly identified, but may be related to its
analgesic properties. Orphenadrine citrate
does not directly relax tense skeletal muscles in man.
CONTRAINDICATIONS
Orphenadrine citrate is contraindicated in patients with glaucoma,
pyloric or duodenal obstruction,
stenosing peptic ulcers, prostatic hypertrophy or obstruction at the
bladder neck, cardiospasm
(megaesophagus) and myasthenia gravis.
Orphenadrine citrate is contraindicated in patients who have
demonstrated a previous hypersensitivity to
the drug.
WARNINGS
Contains Sodium Metabisulfite, a sulfite that may cause allergic-type
reactions including anaphylactic
symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. The
overall prevalence of sulfite sensitivity in the general population is
unknown and p