1 ml ampoule: ৳ 5.00 (50's pack: ৳ 250.00)

Indications

Injection:
Cardiovascular disorders: It is used in a variety of disorders or circumstances in which bradyarrhythmias occur. It is frequently used in sudden onset bradyarrhythmias and although it may also be employed for the initial treatment of chronic arrhythmias, cardiac pacing is generally preferred for long-term control. Examples of acute use include the prevention and treatment of arrhythmias associated with anaesthesia, the treatment of other drug-induced arrhythmias, and in cardiac arrest due to asystole. It has been used in the management of bradycardia of acute myocardial infarction; however, caution is required, as it may exacerbate ischaemia or infarction in these patients.

Anaesthetic premedication: It is given before the induction of general anaesthesia to diminish the risk of vagal inhibition of the heart and to reduce the salivary and bronchial secretions

Anticholinesterase and mushroom poisoning.

For control of muscarinic side-effects of neostigmine in reversal of competitive neuromuscular block.

1% Eye drops: As a cycloplegic or mydriatic for refraction or for desired dilatation of the iris or uveal tract during acute infammatory conditions.

0.01% Eye drops: It reduces the rate of unwanted changes in the eye which may slow the progression of near sightedness (myopia). It Prevents or delay the progression of myopia in young children (4-14 years).

Composition

Atropine Injection: Each mL contains Atropine Sulphate BP 0.6 mg.

Atropine 1% eye drops: Each ml sterile eye drops contains Atropine Sulphate BP 10 mg. Preservative: Benzalkonium Chloride 0.01%

Atropine 0.01% eye drops: Each ml sterile eye drops contains Atropine Sulphate USP 0.1 mg. Preservative: Sodium Perborate 0.01%

Pharmacology

Injection: Atropine binds to and inhibit muscarinic acetylcholine receptors, producing a wide range of anticholinergic effects. Atropine is an anticholinergic agent which competitively blocks the muscarinic receptors in peripheral tissues such as the heart, intestines, bronchial muscles, iris and secretory glands. Some central stimulation may occur. Atropine abolishes bradycardia and reduces heart block due to vagal activity. Smooth muscles in the bronchi and gut are relaxed while glandular secretions are reduced. It also has mydriatic and cycloplegic effect.

Eye drops: Atropine is a belladonna alkaloid. Atropine Sulphate acts in the eye to block the action of acetylcholine, relaxing the cholinergically innervated sphincter muscle of the iris. This results in dilation of the pupil (mydriasis). The cholinergic stimulation of the accommodative ciliary muscle of the lens is also blocked. This results in paralysis of accommodation (cycloplegia). Efects on accommodation may last 6 days; mydriasis may persist for 12 days.

Dosage & Administration

Injection-

In cardiovascular disorders
: Typical initial doses are in the range of 0.5 to 1.0 mg intravenously. In less severe cases doses may be repeated, as necessary, upto a total dose of 0.03 mg per kg body-weight (about 2 mg); suggested dosage intervals have ranged from 3 to 5 minutes to 1 to 2 hours. In severe instances, as in asystole, a total dose of 0.04 mg per kg (about 3 mg) may be given; some authorities have recommended that the total amount should be given in three divided doses of 1 mg at 3 to 5 minute intervals whereas others consider that 3 mg should be given as a single dose.

As anaesthetic premedication: 300 to 600 mcg may be given by subcutaneous (S.C.) or intramuscular (I.M.) injection, usually 30 to 60 minutes before anaesthesia. Alternatively 300 to 600 mcg may be given intravenously immediately before induction of anaesthesia. It may also be given in combination with upto 10 mg morphine sulphate by S.C. or I.M. injection about an hour before anaesthesia.

Suitable paediatric premedication doses are:
  • Children weighing upto 3 kg: 100 mcg subcutaneously.
  • Children weighing 7-9 kg: 200 mcg subcutaneously.
  • Children weighing 12-16 kg: 300 mcg subcutaneously.
  • Children weighing 20-27 kg: 400 mcg subcutaneously.
  • Children weighing 32 kg: 500 mcg subcutaneously.
  • Children weighing 41 kg: 600 mcg subcutaneously.
In anticholinesterase and mushroom poisoning: It is used in very large doses, e.g. beginning with a dose of 2 mg intravenously or intramuscularly and repeating every 5 to 15 minutes as necessary until signs and symptoms disappear. Doses of up to 100 mg may be needed in the first 24 hours, and lower oral doses should be continued to prevent reappearance of symptoms.

For control of muscarinic side-effects of neostigmine: 0.6 to 1.2 mg by intravenous injection in conjunction with neostigmine methylsulphate.

Infants and children are particularly susceptible to toxic effects of atropine.

1% Eye drops-
  • For uveitis: One drop three times daily
  • For refraction: One drop in the eyes twice daily for one or two days before examination, and one hour before examination. Pressure should be maintained over lacrimal sac, occluding lacrimal duct for one minute after instillation.
0.01% Eye drops- Use one drop in the affected eye(s) once daily. Use The Product as advised by physician. The doctor will decide the correct dose and duration for the child depending upon their age, body weight and health condition.

Interaction

Injection: Peripheral and central nervous system anticholinergic action is additive with other drugs which have anticholinergic activity for example, tricyclic antidepressants, other antispasmodics and antiparkinsonian drugs, some antihistamines, phenothiazines, disopyramide and quinidine. By delaying gastric emptying, atropine may delay the onset of action of other drugs and in some cases increase absorption. Addition of metoclopramide accentuates the reduction of lower oesophageal pressure produced by atropine premedication, and may thus protect against aspiration of gastric contents.

Eye drops: Atropine should not be used with the following medications because very serious interactions may occur Anticholinergics, Antiglaucoma agents (cholinergic, long-acting, and ophthalmic), Antimyasthenics, Potassium citrate, and Potassium supplements, Carbachol, Physostigmine or Pilocarpine.

Contraindications

Injection: It is contraindicated in patients with glaucoma, chronic lung disease, unstable cardiac rhythm, prostatic hypertrophy, reflux oesophagitis, paralytic ileus or pyloric stenosis, and generally, in the elderly.

Eye drops: Atropine is contraindicated in the presence of angle closure glaucoma or where angle closure glaucoma is suspected. If used in glaucoma susceptible patients, an estimation of the depth of the angle of the anterior chamber should be performed prior to the initiation of therapy. Hypersensitivity to any ingredient in eye drops.

Side Effects

Injection: Dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accomodation (cycloplegia) and photophobia, flushing, dryness of skin, transient bradycardia followed by tachycardia with palpitations and arrhythmias, difficulty in micturition, as well as reduction in the tone and motility of GIT leading to constipation. Occasionally vomiting may also occur.

Eye drops: Incidence common: Blurred vision. Incidence less frequent to rare: Conjuctival irritation, follicularconjunctivitis, increased intraocular pressure (especially in patients with closed-angle glaucoma), increased sensitivity to light, and swelling of eyelids. Systemic toxicity may occur in susceptible patients, particularly children.

Pregnancy & Lactation

Injection: It has negligible effects on the human uterus and is not teratogenic. Small quantities of atropine appears in breast milk when the drug is given to lactating mothers. It has also been reported to impair milk production, although this is not conclusively documented.

Eye drops: Atropine Sulphate may be systemically absorbed after ocular administration; however, signifcant efects on the fetus have not been reported. Systemically absorbed Atropine Sulphate is distributed into breast milk in very small amounts. It may cause adverse efects, such as rapid pulse, fever, or dry skin, in nursing infant of mothers using ophthalmic Atropine.

Precautions & Warnings

Injection: It should be used with caution in children, and in geriatric patients, who may be more susceptible to its adverse effects. It is generally advisable to be cautious in giving atropine to any patient with diarrhoea. Due to the risk of provoking hyperpyrexia atropine should not be given to patients, especially children when the ambient temperature is high. It should also be used cautiously in patients with fever. Persons with Down's syndrome appear to have an increased susceptibility to the actions of atropine. It should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, heart failure, and in cardiac surgery, where it may further accelerate the heart rate. Care is required in patients with acute myocardial infarction as ischaemia and infarction may be made worse. It should be given with care to patients with hypertension.

Atropine may cause mental confusion, especially in the elderly. Reduced bronchial secretion caused by systemic administration of atropine may be associated with the formation of mucous plugs.

In the treatment of parkinsonism, increases in dosage and transfer to other forms of treatment should be gradual and antimuscarinic agents should not be withdrawn abruptly. Minor reactions may be controlled by reducing the dose until tolerance has developed.

Eye drops:  Do not use if hypersensitive to any of the ingredients. Do not use in patients with primary glaucoma because atropine dilates the pupil, patient treated with ophthalmic atropine will be very sensitive to light. They should be kept out of bright light while receiving this medication.

Overdose Effects

Flush the eye with water and seek emergency medical attention. Symptoms of a atropine ophthalmic overdose include headache, fast heartbeat, dry mouth and skin, unusual drowsiness, and fushing.

Therapeutic Class

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Mydriatic and Cycloplegic agents

Storage Conditions

Store below 25°C in a dry place, away from light. Keep out of the reach of children.