DURACLON- clonidine hydrochloride injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02)

Boleh didapati daripada:

Mylan Institutional LLC

INN (Nama Antarabangsa):

CLONIDINE HYDROCHLORIDE

Komposisi:

CLONIDINE HYDROCHLORIDE 0.1 mg in 1 mL

Laluan pentadbiran:

EPIDURAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ). Duraclon is contraindicated in patients with a history of sensitization or allergic reactions to clonidine. Epidural administration is contraindicated in the presence of an injection site infection, in patients on anticoagulant therapy, and in those with a bleeding diathesis. Administration of Duraclon above the C4 dermatome is contraindicated since there are no adequate safety data to support such use (see WARNINGS )

Ringkasan produk:

NDC 67457-218-10, 100 mcg/mL solution in 10 mL vials, packaged individually. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free. Discard unused portion. Duraclon® is a registered trademark of Astellas US LLC, licensed to the Viatris Companies. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0919L103 Revised: 3/2021 MI:DURAIJ:R6 To request medical information or to report suspected adverse reactions, contact Drug Safety at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Status kebenaran:

New Drug Application

Ciri produk

DURACLON- CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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NOTE: DURACLON (EPIDURAL CLONIDINE) IS NOT RECOMMENDED FOR
OBSTETRICAL, POST-PARTUM, OR PERI-OPERATIVE PAIN MANAGEMENT. THE RISK
OF
HEMODYNAMIC INSTABILITY, ESPECIALLY HYPOTENSION AND BRADYCARDIA, FROM
EPIDURAL CLONIDINE MAY BE UNACCEPTABLE IN THESE PATIENTS. HOWEVER, IN
A
RARE OBSTETRICAL, POST-PARTUM OR PERI-OPERATIVE PATIENT, POTENTIAL
BENEFITS MAY OUTWEIGH THE POSSIBLE RISKS.
DESCRIPTION
Duraclon (clonidine hydrochloride injection, USP) is a
centrally-acting analgesic solution
for use in continuous epidural infusion devices.
Clonidine Hydrochloride, USP, is an imidazoline derivative and exists
as a mesomeric
compound. The chemical names are
Benzenamine,2,6-dichloro-N-2-imidazolidinylidene-
,monohydrochloride and 2-[(2,6-dichlorophenyl)imino]imidazolidine
monohydrochloride.
The following is the structural formula:
Duraclon (clonidine hydrochloride injection, USP) is supplied as a
clear, colorless,
preservative-free, pyrogen-free, aqueous sterile solution (pH 5 to 7)
in single-dose, 10
mL vials.
Each mL of the 100 mcg/mL (0.1 mg/mL) concentration contains 100 mcg
of Clonidine
Hydrochloride, USP and 9 mg Sodium Chloride, USP in Water for
Injection, USP.
Hydrochloric Acid and/or Sodium Hydroxide may have been added for pH
adjustment.
Each 10 mL vial contains 1 mg (1000 mcg) of clonidine hydrochloride.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
®
Epidurally administered clonidine produces dose-dependent analgesia
not antagonized
by opiate antagonists. The analgesia is limited to the body regions
innervated by the
spinal segments where analgesic concentrations of clonidine are
present. Clonidine is
thought to produce analgesia at presynaptic and postjunctional
alpha-2-adrenoceptors
in the spinal cord by preventing pain signal transmission to the
brain.
PHARMACOKINETICS
Following a 10 minute intravenous infusion of 300 mcg clonidine HCl to
five male
volunteers, plasma clonidine levels showed an initial rapid
distribution phase (