- ATROPIN EL-SAAD 0.25: each ampoule 1ml contains 0.25mg Atropine Sulphate monohydrate.

- ATROPIN EL-SAAD 0.5: each ampoule 1ml contains  0. 5mg Atropine Sulphate monohydrate..

- ATROPIN EL-SAAD 1: each ampoule 1ml contains 1mg Atropine Sulphate monohydrate.

 

Plasma half-life is  2 to 2.30 hours.

Metabolism  occurs through hydrolysis and glucuroconjugation.   

Excretion path in through kidney ,1/3 unchanged and 2/3 glucuroconjugated  form.

Atropine crosses the placental barrier and  is excreted in the maternal milk.

 

Atropine Sulfate Injection is indicated:

-As an antisialogogue for preanesthetic medication to prevent or reduce secretions of the respiratory tract.

- To restore cardiac rate and arterial pressure during anesthesia when vagal stimulation causes a sudden decrease in pulse rate and cardiac action .

- To lessen the degree of atrioventricular (A-V) heart block when increased vagal tone is a major factor in the conduction defect.

- To overcome severe bradycardia and syncope due to a hyperactive carotid sinus reflex.

- As an antidote for cardiovascular collapse from  the use of a choline ester.

- In the treatment of anticholinesterase poisoning from organophosphorus insecticides.

- As an antidote for the “rapid” type of mushroom poisoning due to the presence of the alkaloid, muscarine, in certain species of fungus.

 

Atropine generally is contraindicated in patients with glaucoma, pyloric stenosis or prostatic hypertrophy, except in doses ordinarily used for preanesthetic medication.

 

- Atropine is a highly potent drug and due to care is essential to avoid overdosage ,especially  with intravenous administration . Children are more  susceptible than adults  to  the toxic  effects of anticholinergic agents.

- 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 secretion and formation of dangerous viscid plugs in patients with chronic lung disease .

Pregnancy: category C, it is not Known whether Atropine can cause fetal harm when given to pregnant woman or can affect reproduction capacity .Atropine should be given to pregnant woman only if clearly needed.

Use in lactation : As atropine passes into the breast milk , overdosage in neonates may occur with signs of neurological toxicity principally . Furthermore , Atropine inhibits lactation . Therefore if the drug must be used , lactation is contra- indicated  

Safety and effectiveness in pediatric population have not been established .

An evaluation of current studies revealed no clinical identifying differences in response between elderly and younger patients .In general dose selection for an elderly patient should be caution , usually starting at the low end of the dosing range , reflecting the greater frequency of decreased hepatic ,renal or cardiac function .

 

 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 person living in a hot environment .

- Constipation may occur in elderly patients.

- Hypersensitivity reactions have been observed, especially skin rashes which in some instances progressed to exfoliation.

- Adverse effect following single or repeated injection of Atropine are most often the result of excessive dosage .There 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.

 

-Atropine Sulfate Injection may be administered subcutaneously, intramuscularly or intravenously.

- The average adult dose is 0.5 mg (range 0.4—0.6 mg).

- In children, the dosage ranges from 0.1 mg in the newborn to 0.6 mg  in a child age 12 years, injected subcutaneously 30 minutes before surgery. For  intravenous dosage ranges from 0.01 to 0.03 mg per kg of body weight.

- Usual doses are used to reduce severe bradycardia and syncope associated with hyperactive carotid sinus reflex.

-  For bradyarrhythmias the usual intravenous adult dosage ranges from 0.4 to 1 mg  every one to two hours as needed; larger doses up to a maximum of 2 mg may be required.

- In anticholinesterase poisoning from exposure to insecticides, large doses of at least 2 to 3 mg should be administered parenterally and repeated until signs of Atropine intoxication appear.

- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

In the event of toxic overdosage , a short acting barbiturate or diazepam may be given as needed  to control marked excitement and convulsion . Large dose for sedative 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 to4 mg (0.5to1mg for children ),rapidly abolishes delirium and coma caused by large dose 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 ;200mg 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 over dosage may occur .These increase in severity and extent with larger doses of the drug (excitement , hallucination , delirium and coma , with a dose of 10mg or more ).

 

-  ATROPIN EL-SAAD 0.25: 5 ampoules ×1ml in carton package.

- ATROPIN EL-SAAD 0.5: 5 ampoules ×1ml in carton package.

- ATROPIN EL-SAAD 1: 5 ampoules ×1ml in carton package.

 

Store at temperature between (15-30)°C.