ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Toxic effects from overdosage of atropine are not uncommon, especially in children. Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects. 0.5 mg Slight dryness of nose and mouth; bradycardia. mg Greater dryness of nose and mouth, with thirst; slowing then acceleration of heart; slight mydriasis. mg Very dry mouth; tachycardia with palpitation, mydriasis, slight blurring of near vision; flushed, dry skin. mg Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache, hot, dry skin; restlessness, with asthenia. 10 mg and over Above symptoms to extreme degree, plus ataxia, exctextent, disorientation, hallucinations, delirium, and coma. 65 mg May be fatal. scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual.In the treatment of atropine poisoning, respiratory assistance and symptomatic support are indicated.Pilocarpine is sometimes given but is of limited value.. Slight dryness of nose and mouth; bradycardia.. Greater dryness of nose and mouth, with thirst; slowing then acceleration of heart; slight mydriasis.. Very dry mouth; tachycardia with palpitation, mydriasis, slight blurring of near vision; flushed, dry skin.. Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache, hot, dry skin; restlessness, with asthenia.. Above symptoms to extreme degree, plus ataxia, exctextent, disorientation, hallucinations, delirium, and coma.. May be fatal.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Atropine has two actions. The most important therapeutic action is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. Atropine also has central-nervous system activity, which may be stimulating or depressing depending upon the dose.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Conditions in which inhibition of postganglionic cholinergic nerves are undesirable, such as glaucoma and tachycardia. Also contraindicated in asthma, because the parenteral dose which might relieve asthma would have an excessive drying effect upon mucous plugs in the bronchi. Prostatic hypertrophy, while not contraindication, requires special attention to signs of urinary retention.

DESCRIPTION SECTION.

DESCRIPTION. Atropine Sulfate Injection, USP is sterile, isotonic solution of Atropine Sulfate in Water for Injection q.s. Sodium Chloride added for isotonicity. pH adjusted with Sulfuric Acid. Preservative free.Atropine is white crystalline alkaloid which may be extracted from belladonna root and hyoscyamine or may be produced synthetically. It is used in the form of atropine sulfate because this compound has much greater solubility in water. The structural formula of Atropine is as follows:. d51a918e-figure-01.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The usual adult dose of atropine is 0.4 to 0.6 mg. Suggested doses for children are as follows: - 16 pounds 0.1 mg 17 24 pounds 0.15 mg 24 40 pounds 0.2 mg 40 65 pounds 0.3 mg 65 90 pounds 0.4 mg Over 90 pounds 0.4 to 0.6 mgAs indicated previously, however, these doses may be considerably exceeded in certain cases.Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Product No. Concentration Vial/Ampule Size NDC 0517-0805-25 0.4 mg/0.5 mL 0.5 mL Ampule packedin boxes of 25 NDC 0517-0101-25 1.0 mg/1 mL mL Ampule packedin boxes of 25 NDC 0517-0401-25 0.4 mg/1 mL mL Single Dose Vialpacked in boxes of 25 NDC 0517-1010-25 1.0 mg/1 mL mL Single Dose Vialpacked in boxes of 25Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) (See USP Controlled Room Temperature).AMERICANREGENT, INC.SHIRLEY, NY 11967IN1010Rev. 1/09.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.To relieve hypertonicity of the uterine muscle.To relax the spasm of biliary and uretered colic and bronchial spasm.To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.To control the crying and laughing episodes in patients with brain lesions.In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs.In the management of peptic ulcer.In anesthesia to control excessive salivation and bronchial secretions.To control rhinorrhea of acute rhinitis or hay fever.As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. Adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. If an atropine effect is not apparent within thirty minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements, and excessive sweating, salivation, and bronchial secretion), atropine sulfate, mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.. In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.. In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.. To relieve hypertonicity of the uterine muscle.. To relax the spasm of biliary and uretered colic and bronchial spasm.. To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.. To control the crying and laughing episodes in patients with brain lesions.. In cases of closed head injuries which cause acetylcholine to be released or to be present in cerebrospinal fluid which in turn causes abnormal EEG patterns, stupor and neurological signs.. In the management of peptic ulcer.. In anesthesia to control excessive salivation and bronchial secretions.. To control rhinorrhea of acute rhinitis or hay fever.. As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.. In poisoning by the organic phosphate cholinesterase inhibitors found in certain insecticides and by chemical warfare nerve gases, large doses of atropine relieve the muscarine-like symptoms and some of the central-nervous-system manifestations. Adults suspected of contact with organic phosphorus insecticides of the parathion type should be given atropine sulfate, 0.8 mg, intramuscularly. If an atropine effect is not apparent within thirty minutes or if definite symptoms of the poisoning occur (nausea, vomiting, diarrhea, pupillary constriction, pulmonary edema, fasciculations of eyelids and tongue, jerky ocular movements, and excessive sweating, salivation, and bronchial secretion), atropine sulfate, mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.

OVERDOSAGE SECTION.

OVERDOSAGE. If marked exctextent is present, short acting barbiturate, chloral hydrate of paraldehyde may be used for sedation. Large doses should be avoided if possible and must be carefully controlled so that they will not add to the depressive stages of atropine poisoning.Artificial respiration with oxygen is necessary when respiration is depressed.Depression may be controlled by use of caffeine, sodium benzoate or picrotoxin together with the inhalation of oxygen.As physiologic antidote, neostigmine methylsulfate may be given by intramuscular injection in doses of 500 mcg to mg and repeated every to hours.Remaining therapy is purely symptomatic. Icebags and alcohol sponges help to reduce fever, especially in children. Careful nursing is essential. The room should be darkened, because of the patients marked photophobia.. If marked exctextent is present, short acting barbiturate, chloral hydrate of paraldehyde may be used for sedation. Large doses should be avoided if possible and must be carefully controlled so that they will not add to the depressive stages of atropine poisoning.. Artificial respiration with oxygen is necessary when respiration is depressed.. Depression may be controlled by use of caffeine, sodium benzoate or picrotoxin together with the inhalation of oxygen.. As physiologic antidote, neostigmine methylsulfate may be given by intramuscular injection in doses of 500 mcg to mg and repeated every to hours.. Remaining therapy is purely symptomatic. Icebags and alcohol sponges help to reduce fever, especially in children. Careful nursing is essential. The room should be darkened, because of the patients marked photophobia.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. PRINCIPAL DISPLAY PANEL 1 mL CartonATROPINE SULFATEINJECTION, USP0.4 mg/mLNDC 0517-0401-2525 1 mL SINGLE DOSE VIALSFOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USEPRESERVATIVE FREERx OnlyEach mL contains: Atropine Sulfate 0.4 mg, Sodium Chloride mg, Water for Injection q.s. pH adjusted with Sulfuric Acid.WARNING: DISCARD UNUSED PORTION.Store at 20o-25oC (68o-77oF); excursions permitted to 15o-30oC (59o-86oF) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.AMERICAN REGENT, INC.SHIRLEY, NY 11967Rev. 11/05PRINCIPAL DISPLAY PANEL 1 mL CartonATROPINE SULFATEINJECTION, USP1 mg/mLNDC 0517-1010-2525 1 mL SINGLE DOSE VIALSFOR INTRAVENOUS, INTRAMUSCULAR OR SUBCUTANEOUS USEPRESERVATIVE FREERx OnlyEach mL contains: Atropine Sulfate mg, Sodium Chloride mg, Water for Injection q.s. pH adjusted with Sulfuric Acid.WARNING: DISCARD UNUSED PORTION. Store at 20o to 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.AMERICAN REGENT, INC.SHIRLEY, NY 11967Rev. 11/05. d51a918e-figure-02. d51a918e-figure-03.

SPL UNCLASSIFIED SECTION.

Rx Only(pH 3.0 6.5).

WARNINGS SECTION.

WARNINGS. This drug is effective in very low dosage and overdose may cause permanent damage or death, especially in children.