CLONIDINE HCI injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine hydrochloride 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 PHARMACOLOGY: 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). Clonidine hydrochloride injection 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 clonidine hydrochloride injection above the C4 dermatome is

Product summary:

CLONIDINE HCI INJECTION is supplied in the following dosage forms. NDC 51662-1346-1 CLONIDINE HCI INJECTION 1000mcg/10mL (100mcg/mL) 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms NDC 0143-9724-01, 100 mcg/mL solution in 10 mL vials, packaged individually. NDC 0143-9723-01, 500 mcg/mL solution in 10 mL vials, packaged individually. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Preservative Free. Discard unused portion. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B – Fervença 2705 – 906 Terrugem SNT PORTUGAL Distributed by: WEST-WARD PHARMACEUTICAL Corp. 465 Industrial Way West Eatontown, NJ 07724 USA Revised: March 2011

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HCI- CLONIDINE HCI INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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CLONIDINE HCI INJECTION 1000MCG/10ML (100MCG/ML) 10ML VIAL
SPL UNCLASSIFIED
Rx Only
DESCRIPTION
Clonidine hydrochloride injection is a centrally-acting 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:
Clonidine hydrochloride injection is supplied as a clear, colorless,
preservative-free,
pyrogen-free, aqueous sterile solution (pH 5 to 7) in 10 mL
single-dose vials.
Each mL of the 1000 mcg/10 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 1mg (1000 mcg) of clonidine
hydrochloride.
Each mL of the 5000 mcg/10 mL (0.5 mg/mL) concentration contains 500
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 5 mg (5000 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 (mean ± SD
t1/2=