Drug Presentation Atropine

“DRUG
PRESENTATION”
(ATROPINE)
SUBMITTED TO: SUBMITTED BY:

INTRODUCTION
Monitoring the safety of medicine use in children is of paramount importance since, during the
clinical development of medicines, only limited data on this aspect are generated through clinical
trials. Use of medicines outside the specifications described in the licence (e.g. in terms of
formulation, indications, contraindications or age) constitutes off-label and off-licence use and
these are a major area of concern. These guidelines are intended to improve awareness of
medicine safety issues among everyone who has an interest in the safety of medicines in children
and to provide guidance on effective systems for monitoring medicine safety in the paediatric
populations. The document will be of interest to all health-care professionals, medicine
regulatory authorities, pharmacovigilancecentres, academia, the pharmaceutical industry and
policy-makers. Systems for monitoring medicine safety are described in Annex 1 -
Pharmacovigilance methods and some examples of recent information on adverse reactions to
marketed medicines are discussed in Annex 2. Pharmacovigilance is the science and activities
relating to the detection, assessment, understanding and prevention of adverse effects or any
other possible medicine-related problems (1). For the purposes of this document, an adverse
reaction to a medicine (ADR) includes not only reactions occurring during normal use of
medicines, but also reactions due to errors in medicine administration, non-adherence, overdose,
off-label use, drug abuse and adverse effects due to the use of traditional and complementary
medicines.
CONSEQUENCES OF THE CURRENT STATUS OF THE USE OF

MEDICINES IN CHILDREN:-
The consequences of the current status of the use of medicines in children include the following:-
• Wrong dosage causes short-term toxicity or treatment failure. For example, a standard
dose of phenobarbital of 15 mg/kg daily will most likely be inappropriate for a newborn
with seizures as often a loading dose of more than 20 mg/kg is needed and a
maintenancedose of 5 mg/kg might already be more than enough.
• Non-availability of appropriate paediatric formulations forces health care providers to

resort to administering crushed tablets, dissolving tablets in solvents or administering the
powder contained inside the capsule. Consequently, these formulations are administered
without any data regarding their bio-availability, efficacy and toxicity.
• Formulations of strengths suitable for administration to neonates, infants and young
children are not always available. Adult formulations therefore need to be diluted or
administered in miniscule volumes over a period of time. This leads to administration
errors (intravenous drips running fast, errors in dosage calculation and dilution),
especially in circumstances that require urgent action (as in emergency units, premature
units and paediatric and neonatal intensive care units)
• Inappropriate packages and lack of awareness among parents and caregivers about the
methods to be used for prevention of injuries, accidents and poisoning lead to accidental
poisoning in infants and small children.
• Adolescents may ingest medicines with suicidal intent or may experience health
problems from illicit drug abuse.
• Medicines can interact with traditional and herbal medicines.
• Medicines may have long-term safety problems. For example, etanercept may increase
susceptibility to tuberculosis, or long-term use of inhaled corticosteroids in early infancy
may increase the risk of growth retardation and/or osteoporosis.
• In public health programmes in resource-poor countries, co-morbidity or malnutrition

may exacerbate the toxicity. Dehydration is frequently associated with ibuprofen-induced
renal failure and malnutrition with paracetamol hepatotoxicity.
• Cultural differences can lead to misunderstanding of medicine instructions especially of

package insert information and information on promoting rational use of medicines.
• A simple process of reconstitution of nonsterile oral powder can be a risk for stability or
even safety. Some medicines for oral use need to be reconstituted with water before
ingestion. It is important to remind health-care providers that the water must be clean and
filtered, and that after reconstitution, the product has a strict expiration date. This
recommendation is fundamental especially in developing countries.
ATROPINE
CLASS AND CATEGORY:
Chemical class: Belladonna alkaloid
Therapeutic class: Anticholinergic, antimuscarinic
Pregnancy category: C
THERAPEUTIC ACTION:
Parasympatholytic, antispasmodic
INDICATIONS:
 Premedication in anaesthesia
 Spasms of the gastrointestinal tract
 Organophosphoruspesticide poisoning
AVAILABLITY:
 1 mg atropine sulfate in 1 ml ampoule (1 mg/ml) for SC, IM, IV injection
 Also comes in 0.25 mg/ml and 0.5 mg/ml ampoule
DOSAGE& DURATION:
 Premedication in anaesthesia
Child: 0.01 to 0.02 mg/kg by SC or IV injection

Adult: 1 mg by SC or IV injection
 Spasms of the gastrointestinal tract
Child from 2 to 6 years: 0.25 mg by SC injection as a single dose

Child over 6 years: 0.5 mg by SC injection as a single dose
Adult:0.25to1mgbySCinjection,toberepeatedevery6hoursifnecessary,withoutexceed
ing2mg/day.
 Organophosphorus pesticide poisoning
Child: 0.02 to 0.05 mg/kg by IM.
ATROPINE MECHANISM OF ACTION:

 It competitively blocks the muscarinic receptors in peripheral tissues (heart, intestines,
bronchial muscles, iris, secretory glands) and relaxes the smooth muscles. ž
 The main action of vagus nerve of parasympathetic system on the heart is to slow it down
and atropine blocks that action and speeds up the heart rate.
CONTRA-INDICATIONS,ADVERSE EFFECTS, PRECAUTIONS:
 Do not administer to patients with urethro-prostatic disorders, cardiac disorders, glaucoma.

 Do not administer to children with high fever.
 Maycause:urinaryretention,drynessofthemouth,constipation,dizziness,headache,dilatationoft
hepupils, tachycardia.
 Administerwithcautionandunderclosesupervisiontopatientstakingotheranticholinergicdrug
s(antidepressants, neuroleptics, H-1 antihistamines, antiparkinsonians, etc.).
 Pregnancy: no contra-indication;noprolongedtreatment
 Breast-feeding: avoid; noprolongedtreatment
NURSING CONSIDERATIONS
WARNING For patient prescribed Atropine for suspected nerve gas or insecticide exposure,
dosage is determined by severity of symptoms. Mild symptoms include blurred vision, miosis,
excessive unexplained teary eyes or runny nose, increased salivation, chest tightness, difficulty
breathing, tremors, muscle twitching, nausea, vomiting, unexplained wheezing or coughing,
acute onset of stomach cramps, tachycardia, and bradycardia. Severe symptoms include
confusion or other strange behavior, severe difficulty breathing, extreme secretions from airway
or lungs, severe muscle twitching and general weakness, involuntary urination and defecation,
seizures, and unconsciousness.
• Avoid using high-dose atropine sulfate in patients with ulcerative colitis because of risk of
toxic megacolon or in patients with hiatal hernia and reflux esophagitis because of risk of
esophagitis
• Atropine has no absolute contraindications when used to treat life-threatening nerve gas or
insecticide exposure.
WARNING Assess for symptoms of toxic doses of atropine, such as excitement, agitation,
drowsiness, and confusion, which are likely to affect elderly patients even with low doses. If
symptoms occur, take safety precautions to prevent injury.
• Assess bowel and bladder elimination. Notify prescriber of diarrhea, constipation, urinary
hesitancy, or urine retention.
PATIENT TEACHING:
• For patient prescribed an AtroPen to carry because of risk of nerve gas or insecticide exposure,
explain when and how to selfadminister the drug.
• Instruct patient to take atropine sulfate 30 to 60 minutes before meals.
• Advise patient to notify prescriber if he has persistent or severe diarrhea, constipation, or
difficulty urinating.

Drug Presentation Atropine

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“DRUG

SUBMITTED TO: SUBMITTED BY:

CONSEQUENCES OF THE CURRENT STATUS OF THE USE OF

• Non-availability of appropriate paediatric formulations forces health care providers to

• Medicines can interact with traditional and herbal medicines.

• In public health programmes in resource-poor countries, co-morbidity or malnutrition

• Cultural differences can lead to misunderstanding of medicine instructions especially of

Therapeutic class: Anticholinergic, antimuscarinic

Child: 0.01 to 0.02 mg/kg by SC or IV injection

 Spasms of the gastrointestinal tract

Child from 2 to 6 years: 0.25 mg by SC injection as a single dose

 Organophosphorus pesticide poisoning

Child: 0.02 to 0.05 mg/kg by IM.

ATROPINE MECHANISM OF ACTION:

CONTRA-INDICATIONS,ADVERSE EFFECTS, PRECAUTIONS:

 Do not administer to patients with urethro-prostatic disorders, cardiac disorders, glaucoma.

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