COMPOSITION

Each ml contains:

Atropine Sulfate BP .......... 1 mg
Water for Injection BP ........ q.s.

THERAPEUTIC INDICATIONS

Atropine sulfate is given parenterally as a preanesthetic medication to decrease salivation and bronchial secretions.

It is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, atropine sulfate given with morphine may be indicated.

Atropine sulfate is indicated for relaxation of the upper gastrointestinal tract and colon during hypotonic radiography.

Atropine is used as an antidote for pilocarpine, physostigmine, isofluorophosphate, choline esters, certain species of Amanita, and poisoning by organophosphate cholinesterase inhibitors found in certain insecticides and chemical warfare nerve gases.

Large doses relieve the muscarine-like symptoms and some central nervous system manifestations.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

The most important therapeutic action of atropine is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves.

It also has central nervous system activity, which may be stimulating or depressing depending upon the dose.

Following administration of usual clinical doses, atropine produces stimulation of the medulla and higher cerebral centers, manifested by mild central vagal excitation and moderate respiratory stimulation.

Atropine sulfate acts peripherally as a competitive antagonist of the muscarinic actions of acetylcholine. It does not prevent the release of acetylcholine but antagonizes the effect of acetylcholine on effector cells.

These actions include:

Vasodilation
Drying of the mouth
Increased pulse rate
Inhibition of contractions of the gastrointestinal tract, ureter and bladder
Reduction of salivary, bronchial, gastric and sweat gland secretions

Following clinical and larger doses, atropine sulfate causes dilation of the pupils and paralysis of accommodation and, in narrow-angle glaucoma, can increase intraocular pressure.

CONTRAINDICATIONS

Conditions in which inhibition of postganglionic cholinergic nerves is undesirable, such as:

Also contraindicated in asthma because parenteral doses that might relieve asthma would excessively dry mucous plugs in the bronchi.

Prostatic hypertrophy, although not a contraindication, requires special attention to signs of urinary retention.

WARNINGS & PRECAUTIONS

Atropine is a highly potent drug, and due care is essential to avoid overdose, especially with intravenous administration.

Pediatric populations are more susceptible than adults to the toxic effects of anticholinergic agents.

Atropine IV decreases the rate of mexiletine absorption without altering oral bioavailability.

Delayed mexiletine absorption is reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.

Atropine is not removed by dialysis.

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

This product contains benzyl alcohol which has been associated with a fatal gasping syndrome in infants and neonates.

PRECAUTIONS

General

Doses of 0.5–1 mg atropine are mildly stimulating to the CNS.

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.

Information for Patients

Atropine causes dryness of the mouth, and when used with other drugs that can cause dryness of the mouth, the effect is additive.

Patients receiving chronic treatment can develop blurred vision and should not be involved in activities requiring good and clear vision.

PREGNANCY AND BREASTFEEDING

Pregnancy

Animal reproduction studies have not been conducted with atropine sulfate.

It is not known whether atropine sulfate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.

Atropine sulfate should be given during pregnancy only if clearly needed.

Breastfeeding

Caution should be exercised when atropine sulfate is administered to a nursing mother.

SIDE EFFECTS

Adverse effects are dose-related and usually reversible when therapy is discontinued.

In relatively small doses, atropine reduces salivary, bronchial and sweat secretions.

Dry mouth and anhidrosis may develop, these effects becoming intensified as dosage is increased.

Psychiatric disorders

Hallucinations
Mental confusion
Excitement, especially in the elderly

Nervous system disorders

Headache
Nervousness
Drowsiness
Dizziness
Insomnia

Eye disorders

Increased ocular tension
Larger doses dilate the pupil and inhibit accommodation of the eye

Cardiac disorders

Large doses block vagal impulses with consequent increase in heart rate with possible atrial arrhythmias, A-V dissociation and multiple ventricular ectopics.

ST elevation and acute myocardial infarction have been reported.

Cases have occurred where severe bradycardia due to hyperkalemia could not be resolved with atropine.

Vascular disorders

Flushing

Respiratory, thoracic and mediastinal disorders

Reduced bronchial secretion may cause dehydration of residual secretion and formation of thick bronchial plugs that are difficult to expel from the respiratory tract.

Gastrointestinal disorders

Reduction of salivary secretions
Parasympathetic inhibition of gastrointestinal tract
Constipation
Inhibition of gastric secretion
Loss of taste
Nausea
Vomiting
Bloated feeling

Skin and subcutaneous tissue disorders

Anaphylaxis
Anhidrosis
Urticaria
Rash occasionally progressing to exfoliation

Musculoskeletal, connective tissue and bone disorders

Weakness

DRUG INTERACTIONS

The effects of atropine may be enhanced by concomitant administration of drugs with anticholinergic activity, including:

Tricyclic antidepressants
Antispasmodics
Antiparkinsonian drugs
Some antihistamines
Phenothiazines
Disopyramide
Quinidine

By delaying gastric emptying, atropine may alter absorption of other drugs.

During anesthesia, responsiveness of the heart rate to IV atropine may be decreased when propofol is administered.

Extreme caution should be observed during dobutamine-atropine stress echocardiography or concomitant administration of catecholamines with atropine because of the risk of Takotsubo syndrome.

DOSAGE AND ADMINISTRATION

General Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.

Do not administer unless solution is clear and seal is intact.

Discard unused portion.

Intravenous administration is preferred, but subcutaneous, intramuscular and endotracheal routes are possible.

For endotracheal administration, dilute 1–2 mg in not more than 10 ml sterile water or normal saline.

Titrate dosage based on heart rate, PR interval, blood pressure and symptoms.

Adult Dosage

Use	Dose (Adults)	Repeat
Antisialagogue or other ant-vagal use	0.5–1 mg	Every 1–2 hours
Organophosphorus or muscarinic mushroom poisoning	2–3 mg	Every 20–30 minutes
Brady systolic cardiac arrest	1 mg	Every 3–5 minutes, maximum total dose 3 mg

Pediatric Dosage

Dosing in pediatric populations has not been well studied.

Usual initial dose:

0.01–0.03 mg/kg

Method of administration

For:

IV use
IM use
SC use only

STORAGE

Store below 30°C.
Protect from light.
Keep out of reach of children.

PACKING

ATROPINE INJECTION BP 1 MG/ML

Available in packs of:

10 × 1 ml ampoules

MANUFACTURED IN INDIA BY

CENTURION HEALTHCARE PRIVATE LIMITED

601, Atlantis Heights, Sarabhai Compound,
Vadi Wadi, Vadodara – 390007, Gujarat, India.

ATROPINE INJECTION BP 1 MG/ML