Atropine Sulfate 1 mg/mL Injection, USP 1 mL Single Dose Ampule | Atropine Sulfate

05:31 EST 27th November 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Atropine Sulfate Injection, USP is a 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 a 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:

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.

1. In the treatment of parkinsonism. Rigidity and tremor relieved by the apparently selective depressant action.

2. In the gastrointestinal tract to relieve pylorospasm, hypertonicity of the small intestine and the hypermotility of the colon.

3. To relieve hypertonicity of the uterine muscle.

4. To relax the spasm of biliary and uretered colic and bronchial spasm.

5. To diminish the tone of the detrusor muscle of the urinary bladder in the treatment of urinary tract disorders.

6. To control the crying and laughing episodes in patients with brain lesions.

7. 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.

8. In the management of peptic ulcer.

9. In anesthesia to control excessive salivation and bronchial secretions.

10. To control rhinorrhea of acute rhinitis or hay fever.

11. As an antidote for pilocarpine, physostigmine, isoflurophate, choline esters, certain species of Aminata and in cases of anticholinesterase insecticide poisoning.

12. 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, 2 mg, should be given intramuscularly at hourly intervals until signs of atropinization are observed. Up to two or three times this dose (4 to 6 mg) may be required in severe cases. Removing contaminated clothing, washing the skin, and commencing artificial respiration and supportive therapy are also indicated.

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 a contraindication, requires special attention to signs of urinary retention.

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

Doses of 0.5 to 1 mg of atropine are mildly stimulating to the central nervous system. Larger doses may produce mental disturbances; still larger doses are depressing. Death from atropine poisoning, though rare, is usually due to paralysis of the medullary centers.

Pregnancy: Teratogenic effects: Pregnancy Category B. Reproduction studies have been performed in mice in doses of 50 mg/kg of body weight and have revealed no evidence of impairedfertility or harm to the fetus due to Atropine Sulfate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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.

A 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 alarmingcondition, 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.

0.5 mg
Slight dryness of nose and mouth; bradycardia.
1 mg
Greater dryness of nose and mouth, with thirst; slowing then acceleration of heart; slight mydriasis.
2 mg
Very dry mouth; tachycardia with palpitation, mydriasis, slight blurring of near vision; flushed, dry skin.
5 mg
Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache, hot, dry skin; restlessness, with asthenia.
10 mg
Above symptoms to extreme degree, plus ataxia, excitement, disorientation, hallucinations, delirium, and coma.
65 mg
May be fatal.

1. If marked excitement is present, a 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.

2. Artificial respiration with oxygen is necessary when respiration is depressed.

3. Depression may be controlled by use of caffeine, sodium benzoate or picrotoxin together with the inhalation of oxygen.

4. As a physiologic antidote, neostigmine methylsulfate may be given by intramuscular injection in doses of 500 mcg to 1 mg and repeated every 2 to 9 hours.

5. 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 patient’s marked photophobia.

The usual adult dose of atropine is 0.4 to 0.6 mg. Suggested doses for children are as follows:

7 - 16 pounds - 0.1 mg17 - 24 pounds - 0.15 mg24 - 40 pounds - 0.2 mg40 - 65 pounds - 0.3 mg65 - 90 pounds - 0.4 mgOver 90 pounds - 0.4 to 0.6 mg

As 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.

Product No. Concentration Vial/Ampule Size
NDC 0517-0805-25
0.4 mg/0.5 mL
0.5 mL Ampule packed in boxes of 25
NDC 0517-0101-25
1.0 mg/1 mL
1 mL Ampule packed in boxes of 25
NDC 0517-0401-25
0.4 mg/1 mL
1 mL Single Dose vial packed in boxes of 25
NDC 0517-1010-25
1.0 mg/1 mL
1 mL Single Dose vial packed in boxes of 25

Manufacturer

General Injectables & Vaccines, Inc

Active Ingredients

Source

Drugs and Medications [557 Associated Drugs and Medications listed on BioPortfolio]

Atropine sulfate [American Regent, Inc.]

ATROPINE SULFATE INJECTION, USP

Atropine sulfate [General Injectables & Vaccines, Inc]

Atropine Sulfate 0.4 mg/mL Injection, USP Vial

Atropine care [Akorn, Inc.]

ATROPINE CARE™(Atropine Sulfate Ophthalmic Solution, 1%)

Dicyclomine [Med Health Pharma, LLC]

Dicyclomine [Rebel Distributors Corp.]

Dicyclomine Hydrochloride

Clinical Trials [575 Associated Clinical Trials listed on BioPortfolio]

Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression...

Trial Comparing Daily Atropine Versus Weekend Atropine

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. - T...

Remifentanil and Atropine for Intubation in Neonates

The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine...

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Ch...

Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section. ...

PubMed Articles [726 Associated PubMed Articles listed on BioPortfolio]

Determination of atropine sulfate using a novel sensitive DNA-biosensor based on its interaction on a modified pencil graphite electrode.

A novel, selective, rapid and simple electrochemical method is developed for the determination of atropine sulfate. UV-Vis and differential pulse voltammetry are used to study the interaction of atrop...

Keratan sulfate: biosynthesis, structures, and biological functions.

Keratan sulfate is a glycosaminoglycan that has been investigated in the cornea and skeletal tissues for decades. Endoglycosidases and monoclonal antibodies specific for keratan sulfate have been deve...

Heritability and Clinical Determinants of Serum Indoxyl Sulfate and p-Cresyl Sulfate, Candidate Biomarkers of the Human Microbiome Enterotype.

Indoxyl sulfate and p-cresyl sulfate are unique microbial co-metabolites. Both co-metabolites have been involved in the pathogenesis of accelerated cardiovascular disease and renal disease progression...

Global Rates of Marine Sulfate Reduction and Implications for Sub-Sea-Floor Metabolic Activities.

Sulfate reduction is a globally important yet poorly quantified redox process in marine sediments. We developed an artificial neural network trained with 199 sulfate profiles, constrained with geomorp...

Heparan Sulfate Structure: Methods to Study N-Sulfation and NDST Action.

Heparan sulfate proteoglycans are important modulators of cellular processes where the negatively charged polysaccharide chains interact with target proteins. The sulfation pattern of the heparan sulf...

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Rheumatology
Latest News Clinical Trials Research Drugs Reports Corporate
Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Dictionary). It is an active area of medical research, because of the d...

Neurology - Central Nervous System (CNS)
Latest News Clinical Trials Research Drugs Reports Corporate
Neurology is the branch of medicine concerned with nerves; both the central nervous system and the peripheral nervous system. This includes strokes and disorders affecting the brain aswell as spinal cord damage and peripheral neuropathies.The complexity ...

Advertisement

Drugs and Medication Quicklinks


Searches Linking to this Drug Record