CLONIDINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CLONIDINE HYDROCHLORIDE

Composition:

CLONIDINE HYDROCHLORIDE 100 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonidine Hydrochloride Injection, USP 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 der

Product summary:

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, 8, 8A e 8B – Fervença 2705 – 906 Terrugem SNT PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: May 2022 PIN265-WES/2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLONIDINE HYDROCHLORIDE- CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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CLONIDINE HYDROCHLORIDE INJECTION, USP
Rx Only
The 500 mcg/mL strength product should be diluted prior to use in an
appropriate
solution.
NOTE: Clonidine hydrochloride injection (epidural clonidine) is not
recommended for
obstetrical, postpartum, 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
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:
Clonidine Hydrochloride Injection, USP 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 1 mg (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 an