Drug: Atropine

ATROPINE SULFATE Injection, USP
0.1 mg/mI (Adult)
0.05 mg/mL (Pediatric)
ABBOJECT® Unit of Use Syringe 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, USP is chemically designated 1a H, 5a H-Tropan-3-a ol (±)-tropate(ester), sulfate (2:1) (salt) monohydrate, (C17H23NO3)2 • H2SO4 • H2O, colorless crystals or white crystalline powder very soluble in water. It has the following structural formula:

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Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur with chronic administration of therapeutic doses. Anhidrosis also may occur and produce heat intolerance or impair temperature regulation in persons living in a hot environment. Constipation and difficulty in micturition may occur in elderly patients. Occasional hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation. Adverse effects following single or repeated injections of atropine are most often the result of excessive dosage. These include palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to marked palpitation, restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. Read the Atropine (atropine) Side Effects Center for a complete guide to possible side effectsLearn More »

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Atropine Sulfate Injection, USP in Ansyr Syringe is intended fo rintravenous use, but may be administered subcutaneously or intramuscularly. Its use usually requires titration, using heart rate, PR interval, blook pressure and/or patient's symptoms as a guide for having reached an appropriate dose. Adults
Initial single doses in adults vary from around 0.5 mg to 1 mg (5 - 10 mL of the 0.1 mg/mL solution) for antisialagogue and other antivagal effects, to 2 to 3 mg (20 - 30 mL of the 0.1 mg/mL solution) as an antidote for organophosporous or muscarinic mushroom poisoning. When used as an antidote, the 2 to 3 mg dose should be repeated no less often that every 20 to 30 minutes until signs of poisoning are sufficiently lessened or signs of atropine poisoning (See ADVERSE REACTIONS and OVERDOSAGE) occur. When the recurrent use of atropine is essential in patients with coronary atery disease, the total dose should be restricted to 2 to 3 (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. For patients with bradyasystolic cardiac arrest, a 1 mg dose of atropine is administered inbravenously and is repeated every 3-5 minutes if asystole persists. Three milligrams (0.04 mg/kg) given I.V. is a fully vagolytic dose in most patients. The administration of less than 0.5 mg can produce a paradoxical bradycardia because of the central or peripheral parasympathomimatic effects of low dose in adults. Endotracheal administration of atropine can be used in patients without I.V. access. The recommended adult dose of atropine for endotracheal administration is 1 to 2 mg diluted to a total not to exceed 10 ml of sterile water or normal saline. Titration intervals of one or two hours are recommended tin circumstances that are not life-threatening. Pediatrics
Dosing information in pediatric populations ahs not been well studied. Usage history of initial dose has been in the range of 0.01to 0.03 mg/kg body weight. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

Source: http://www.rxlist.com

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Atropine Sulfate Injections, USP, is indicated when excessive (or sometime normal) muscarinic effects are judged to be life threatening or are producing symptoms sever enough to call of temporary, reversible muscarinic blockade. Examples, not an exhaustive list, of such possible uses are: 1. As an antisialogogue 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 tract 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 bradycardia 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

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Atropine generally is contraindicated in patients with glaucoma, pyloric stenosis or prostatic hypertrophy, except in doses ordinarily used for preanesthetic medication.Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In the event of toxic overdosage (See ADVERSE REACTIONS), a short acting barbiturate or diazepam may be given as needed to control marked excitement and convulsions. Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning. Central stimulants are not recommended. Physostigmine, given as an atropine antidote by slow intravenous injection of 1 to 4 mg (0.5 to 1.0 mg in children), rapidly abolishes delirium and coma caused by large doses of atropine. Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required. Artificial respiration with oxygen may be necessary. Ice bags and alcohol sponges help to reduce fever, especially in children. The fatal adult dose of atropine is not known; 200 mg doses have been used and doses as high as 1000 mg have been given. In children, 10 mg or less may be fatal. With a dose as low as 0.5 mg, undesirable minimal symptoms or responses of overdosage may occur. These increase in severity and extent with larger doses of the drug (excitement, hallucinations, delirium and coma with a dose of 10 mg or more).

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Atropine Sulfate Injection, USP is supplied in single-dose containers as follows: List No. Container Size Conc. Total Content (Atropine) 9629 Ansyr® Plastic Syringe 5mL 0.1 mg/mL (Adult) 0.5 mg 1630 Ansyr® Plastic Syringe 10mL 0.1 mg/mL (Adult) 1 mg 9630 Ansyr® Plastic Syringe 5mL 0.05 mg/mL (Pediatric) 0.25 mg
Store at controlled room temperature 15° to 30°C (59° to 86°F). Caution: Federal (USA) law prohibits dispensing without prescription. Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Do not administer unless solution is clear and seal is intact. Discard unused portion. Atropine Sulfate Injection, USP should be used with caution in all individuals over 40 years of age. Conventional systemic doses may precipitate acute glaucoma in susceptible patients, convert partial organic pyloric stenosis into complete obstruction, lead to complete urinary retention in patients with prostatic hypertrophy or cause inspissation of bronchial secretions and formation of dangerous viscid plugs in patients with chronic lung disease. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to evaluate the carcinogenic or mutagenic potential of atropine or its potential to adversely affect fertility. Pregnancy Category C. Animal reproduction studies have not been conducted with atropine. It also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. Atropine should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric populations have not been estabilished. Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease of other drug therapy.Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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