Colistimethate Sodium and Ephedrine Hydrochloride

• Generic Name: colistimethate
• Dosage Forms: n.a.
• Other Brand Names: Coly Mycin M

Treatment of acute or chronic infections caused by certain susceptible gram-negative bacteria (e.g., Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa).

Used only when the causative agent is susceptible and other more effective and less toxic anti-infectives are contraindicated or ineffective.

May be useful alone or in conjunction with other anti-infectives for treatment of infections caused by multiple-drug resistant gram-negative bacteria, such as respiratory tract infections in cystic fibrosis patients caused by multiple-drug resistant Ps. aeruginosa.

Not indicated for infections caused by Proteus or Neisseria.

Administered by oral inhalation via nebulization in adult and pediatric cystic fibrosis patients for early treatment of Ps. aeruginosa respiratory tract infections and for suppressive therapy in those colonized with Ps. aeruginosa.

Safety and efficacy not established and the drug is not labeled by FDA for administration via nebulization. Adverse respiratory effects (e.g., bronchoconstriction) have occurred with this route and there has been at least one fatality in a patient who self-administered a nebulizer treatment using a premixed solution of the drug. (See Respiratory Effects under Cautions.)

• Generic Name: ephedrine
• Dosage Forms: n.a.
• Other Brand Names: Akovaz

Used parenterally for treatment of clinically important hypotension in the setting of anesthesia.

Increases systolic and mean arterial BP when administered as a direct IV (“bolus”) injection following development of hypotension in patients receiving neuraxial and/or general anesthesia. Such effects observed across a variety of surgical settings, including obstetric surgery in pregnant women undergoing cesarean delivery with neuraxial anesthesia.

Although ephedrine historically considered the vasopressor of choice in obstetric anesthesia, some evidence suggests that phenylephrine may provide more favorable fetal acid-base balance. Experts currently recommend either IV ephedrine or phenylephrine for treatment of hypotension during neuraxial anesthesia; however, consideration should be given to selection of phenylephrine in the absence of maternal bradycardia because of improved fetal acid-base status in uncomplicated pregnancies.

IM use of ephedrine also evaluated in this setting; however, results have been equivocal.

Bronchospasm

Used orally as a bronchodilator for symptomatic treatment of asthma.

Used in fixed-combination with guaifenesin as self-medication for the temporary relief of mild symptoms of intermittent asthma (e.g., wheezing, chest tightness, shortness of breath).

Use of an OTC bronchodilator may be appropriate in patients with mild symptoms of intermittent asthma; however, those with more severe asthma (i.e., persistent asthma) or worsening asthma (symptoms not relieved within 60 minutes or with maximum recommended dosages, increasing frequency of asthma attacks) should consult a clinician for other treatment options.

While oral ephedrine was once widely used in the treatment of asthma, the drug generally has been replaced by more selective and rapid-acting agents (e.g., inhaled β2-adrenergic agonists).

CNS Conditions

Has been used in the treatment of narcolepsy or depressive states; however, cardiovascular effects of the drug limit usefulness in these conditions.

Obesity

Previously used for self-medication in the management of obesity.

Dietary supplements containing ephedrine alkaloids are no longer commercially available in the US.

Nasal Congestion

Has been used as a nasal decongestant, but of doubtful value when used for this condition.

Myasthenia Gravis

Has been used in patients with myasthenia gravis; however, randomized controlled studies are needed to evaluate potential benefit.

Misuse and Abuse

Has been misused and abused by athletes, bodybuilders, weight lifters, and others, including high school- and college-aged individuals engaged in sports.

Dietary supplements containing ephedrine alkaloids are no longer commercially available in the US.

Ephedrine has been used in clandestine synthesis of methamphetamine and methcathinone. Federal restrictions to reduce the potential for misuse (diversion) and abuse of ephedrine include limiting the amount that can be purchased to 3.6 g per day or 9 g per month, requiring storage behind the counter or in a locked cabinet, requiring purchasers to provide approved photographic identification, and requiring retail distributors to maintain a written or electronic logbook of purchases for at least 2 years. Additional requirements have been enacted in some states; follow state requirements if such requirements are more stringent than federal restrictions.