AHFS Class:

24:24 Central alpha-Agonists

Generic Name

• CloNIDine Hydrochloride

Clonidine hydrochloride is available as a 0.1-mg/mL (100-mcg/mL) injection solution and a 0.5-mg/mL (500-mcg/mL) concentrate for injection in 10-mL single-dose, preservative-free vials.³⁷⁷¹; ³⁷⁷² Each mL of the injection solution or concentrate for injection also contains sodium chloride 9 mg in water for injection.³⁷⁷¹; ³⁷⁷² Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.³⁷⁷¹; ³⁷⁷²

pH

From 5 to 7.³⁷⁷¹; ³⁷⁷²

Trade Name(s)

Duraclon

Clonidine hydrochloride injection is administered by continuous epidural infusion using an appropriate epidural infusion device.³⁷⁷¹; ³⁷⁷² The 0.5-mg/mL concentrate for injection must be diluted with sodium chloride 0.9% to 0.1 mg/mL for use.³⁷⁷² Clonidine hydrochloride injection must not be used with a preservative.³⁷⁷¹; ³⁷⁷²

Clonidine hydrochloride injection and the concentrate for injection are clear, colorless solutions.³⁷⁷¹; ³⁷⁷² Intact vials should be stored at controlled room temperature.³⁷⁷¹; ³⁷⁷² One manufacturer reported the drug to be stable for 6 months stored at an elevated temperature of 40°C, remaining clear and colorless with no loss of clonidine hydrochloride.²⁰⁶⁹

Clonidine hydrochloride (Roxane) 100 mcg/mL was filled into plastic syringes (Becton Dickinson), pump reservoirs (Bard), and glass vials and stored at 22 to 27°C for 7 days. The solution was also filled into administration set tubing (Kendall McGaw) and stored under the same conditions. In all cases, the solution remained clear and colorless and no loss of potency was found.²⁰⁶⁹

Clonidine hydrochloride 100 mcg/mL was delivered at a rate of 0.1 mL/hr for 7 days through 2 epidural catheter sets, Epi-Cath (Abbott) and Port-A-Cath (Pharmacia Deltec). The temperature was maintained at 37°C to simulate internal use of the set. The delivered solution remained clear and colorless throughout the study. Furthermore, the solution delivered through the Epi-Cath resulted in little or no loss. With the Port-A-Cath, a concentrating effect due to a loss of water was countered by a small clonidine hydrochloride loss of drug (about 5%). The net effect was delivery of about 95% of the clonidine hydrochloride dose.²⁰⁶⁹

Syringes

Clonidine hydrochloride (Boehringer Ingelheim) 9 mcg/mL in sodium chloride 0.9% was packaged in 2 types of polypropylene syringes. The Omnifix (B. Braun) syringes had polyisoprene piston tips while the Terumo syringes had no natural or synthetic rubber in the product. Stored at 4, 21, and 35°C for 30 days, the test solutions in Terumo syringes exhibited no visual changes or changes in measured pH. Stored at 4, 21, and 35°C for 30 days, the test solutions in Omnifix syringes exhibited no visual changes but substantial changes in measured pH occurred in some samples. An acceptable pH was maintained for 30 days at 4°C, 5 days at 21°C, and less than 1 day at 35°C. Although the pH remained within the stability range for the drug in most of the samples, this does not definitively demonstrate stability.²³⁸⁷

Clonidine hydrochloride (Medicianz) 0.5 and 5 mcg/mL in dextrose 5%, dextrose 10%, and sodium chloride 0.9% was packaged in 20-mL plastic syringes (MicroAnalytix).³⁵⁰⁶ Solutions were physically stable with little to no loss of drug in 24 hours at 35°C.³⁵⁰⁶

Implantable Pumps

An admixture of bupivacaine hydrochloride 25 mg/mL, clonidine hydrochloride 2 mg/mL, and morphine sulfate 50 mg/mL in sterile water for injection was reported to be physically and chemically stable for 90 days at 37°C in SynchroMed implantable pumps. Little or no loss of any drug occurred.²⁵⁸⁵

Clonidine hydrochloride and morphine sulfate powders were dissolved in ziconotide acetate (Elan) injection to yield concentrations of 2 and 35 mg/mL and 25 mcg/mL, respectively. Stored at 37°C, 11% ziconotide loss in 7 days, 4% clonidine loss in 20 days, and no morphine loss in 28 days occurred.²⁷⁵²

Morphine sulfate (Infumorph) 20 mg/mL with clonidine hydrochloride (Boehringer Ingelheim) 50 mcg/mL and morphine sulfate 2 mg/mL with clonidine hydrochloride 1.84 mg/mL were evaluated in SynchroMed EL (Medtronic) implantable pumps with silicone elastomer intrathecal catheters at 37°C for 3 months. No visible incompatibilities were observed, and delivered concentrations of both drugs were in the range of 94 to 99.6% of the theoretical concentrations throughout the study. Furthermore, no impairment of mechanical performance of the pump or any of its components was found.²⁴⁷⁷

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1: Standardize 4 Safety Epidural Standard Concentrations for Clonidine as a Single Drug³⁹⁹⁰

Table 2: Standardize 4 Safety ADULT Epidural Combination Drug Standard Concentrations for Clonidine³⁹⁹⁰

Table 3: Standardize 4 Safety PEDIATRIC (50 kg) Epidural Combination Drug Standard Concentrations for Clonidine³⁹⁹⁰

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions September 12, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.