Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains atropine sulfate, monohydrate 0.1 mg (adult strength) or 0.05 mg (pediatric strength), and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 4.2 (3.0 to 6.5). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate Injection is a parenteral anticholinergic agent and muscarinic antagonist.
Atropine Sulfate Injection, USP, is indicated when excessive (or sometimes normal) muscarinic effects are judged to be life threatening or are producing symptoms severe enough to call for temporary, reversible muscarinic blockade. Examples, not an exhaustive list, of such possible uses are: (1) as an antisialoagogue when reduction of secretions of the respiratory tract are thought to be needed; its routine use as a preanesthetic agent is discouraged, (2) to blunt the increased vagal tone (decreased pulse and blood pressure) produced by intra-abdominal traction or ocular muscle traction, its routine use to prevent such events is discouraged, (3) to temporarily increase heart rate or decrease AV-block until definitive intervention can take place, when bradycardias or AV-block are judged to be hemodynamically significant and thought to be due to excess vagal tone, (4) as an antidote for inadvertent overdose of cholinergic drugs or for cholinesterase poisoning such as from organophosphorus insecticides, (5) as an antidote for the “rapid” type of mushroom poisoning due to the presence of the alkaloid, muscarine, in certain species of fungus such as Amanita muscaria, and (6) to alleviate the muscarinic side effects of anticholinesterase drugs used for reversal of neuromuscular blockade.
Published Studies Related to Atropine
Intrathecal atropine to prevent postoperative nausea and vomiting after Cesarean section: a randomized, controlled trial. [2011.08]
BACKGROUND: Postoperative nausea and vomiting (PONV) is a common adverse effect of intrathecal morphine, especially after Cesarean section. This randomized controlled trial investigated the effects of intrathecal administration of a small-dose of atropine on postoperative nausea and vomiting after Cesarean section... CONCLUSION: Intrathecal atropine had a significant antiemetic effect, making it a useful adjunct for intrathecal opioid-related PONV.
Comparative study between atropine and hyoscine-N-butylbromide for reversal of detomidine induced bradycardia in horses. [2011.05]
REASONS FOR PERFORMING STUDY: Bradycardia may be implicated as a cause of cardiovascular instability during anaesthesia. HYPOTHESIS: Hyoscine would induce positive chronotropism of shorter duration than atropine, without adversely impairing intestinal motility in detomidine sedated horses... CONCLUSION: Hyoscine is a shorter acting positive chronotropic agent than atropine, but does not potentiate the impairment in intestinal motility induced by detomidine. Because of severe hypertension, routine use of anticholinergics combined with detomidine is not recommended. POTENTIAL RELEVANCE: Hyoscine may represent an alternative to atropine for treating bradycardia. (c) 2010 EVJ Ltd.
Addition of atropine to submaximal exercise stress testing in patients evaluated for suspected ischaemia with SPECT imaging: a randomized, placebo-controlled trial. [2011.02]
PURPOSE: To evaluate the effects of the addition of atropine to exercise testing in patients who failed to achieve their target heart rate (HR) during stress myocardial perfusion imaging with single-photon emission computed tomography (SPECT)... CONCLUSION: The addition of atropine at the end of exercise testing is more effective than placebo in raising HR to adequate levels, without additional risks of complications. The use of atropine in patients who initially failed to achieve their maximal predicted HR is associated with a higher probability of achieving a diagnostic myocardial perfusion study.
Pharmacokinetic analysis of pralidoxime after its intramuscular injection alone or in combination with atropine-avizafone in healthy volunteers. [2010.12]
BACKGROUND AND PURPOSE: Treatment of organophosphate poisoning with pralidoxime needs to be improved. Here we have studied the pharmacokinetics of pralidoxime after its intramuscular injection alone or in combination with avizafone and atropine using an auto-injector device... CONCLUSIONS AND IMPLICATIONS: The two approaches, non-compartmental and compartmental, showed that the administration of avizafone and atropine with pralidoxime results in a faster absorption into the general circulation and higher maximal concentrations, compared with the administration of pralidoxime alone.
A comparison of two different doses of rectal ketamine added to 0.5 mg x kg(-1) midazolam and 0.02 mg x kg(-1) atropine in infants and young children. [2010.09]
In some circumstances, a high degree of sedation that results in a child being unconscious at the time of parental separation is desirable.In cases where a high degree of sedation following premedication in infants and toddlers is desired, the addition of 8 mg x kg(-1) ketamine to 0.5 mg x kg(-1) midazolam and 0.02 mg x kg(-1) atropine administered rectally is more efficacious than 4 mg x kg(-1) ketamine.
Clinical Trials Related to Atropine
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old [Active, not recruiting]
The purpose of the study is:
- To compare the effectiveness and safety of weekend atropine augmented with a plano lens
for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100)
in children 3 to less than 7 years old.
- To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine
treatment with and without a plano lens.
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds [Active, not recruiting]
The purpose of this study is:
- To compare the effectiveness of weekend atropine plus near activities and daily patching
plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia
(20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
- To determine the maximum improvement in vision of the amblyopic eye with each
- To determine whether amblyopia is associated with structural abnormalities of optic
nerve fiber layer.
Trial Comparing Daily Atropine Versus Weekend Atropine [Completed]
The goals of this study are:
- To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of
atropine versus weekend-only use of atropine.
- To compare the proportion of patients achieving a complete treatment response (defined
as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a
reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy [Completed]
Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the
treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe
complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia
and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied
by clinical complications such as unconsciousness, respiratory arrest or seizure like
symptoms. Study purpose is to evaluate whether the use of i. v. Atropine before starting
ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized,
placebo controlled, double blinded study. Atropine or saline solution will be administered
intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A
6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal
possibly occurring dysrhythmias.
Adjunctive Atropine During Ketamine Sedation [Recruiting]
- Ketamine seems an obvious choice in the setting of an emergency department
- Ketamine leads to increased production of salivary and tracheal secretions
- Antisialagogues(atropine)therefore have been recommended as a routine adjunct
- We compare atropine with placebo as an adjunct to ketamine sedation in children
undergoing primary closure of lacerated wound
Reports of Suspected Atropine Side Effects
Blood Pressure Decreased (8),
Respiratory Depression (7),
Respiratory Arrest (7),
Acute Respiratory Distress Syndrome (5),
Acute Respiratory Failure (5),
Sinus Tachycardia (5),
Ventricular Arrhythmia (4), more >>