1. Name of the medicinal product

Atropine Sulfate Injection USP 0.6mg/1ml Taj Pharma
Atropine Sulfate Injection USP 0.4mg/1ml Taj Pharma
Atropine Sulfate Injection USP 8mg/20ml Taj Pharma

  1. Qualitative and quantitative composition

a) Atropine Sulfate Injection USP 0.6mg/1ml
Each ml contains:
Atropine sulfate                            0.6mg
Benzyl Alcohol                               9mg
Sodium Chloride                             9mg
Water for Injection                         q.s
Sulfuric Acid for pH adjustment.

b) Atropine Sulfate Injection USP 0.4mg/1ml
Each ml contains:
Atropine sulfate                            0.4mg
Benzyl Alcohol                               9mg
Sodium Chloride                             9mg
Water for Injection                         q.s
Sulfuric Acid for pH adjustment.

c) Atropine Sulfate Injection USP 8mg/20ml
Each ml contains:
Atropine sulfate                            0.4mg
Benzyl Alcohol                               9mg
Sodium Chloride                             9mg
Water for Injection                         q.s
Sulfuric Acid for pH adjustment.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection.

Clear, Colorless Solution

  1. Clinical particulars

4.1 Therapeutic indications

Atropine Sulfate Solution for Injection is used:

  • As a preoperative medication for the reduction of salivary and bronchial secretions.
  • During cardiopulmonary resuscitation to treat sinus bradycardia or asystole.
  • For treatment of symptomatic sinus bradycardia induced by drugs or toxic substances such as pilocarpine, organophosphate pesticides, amanita muscaria mushrooms.
  • For management of bradycardia of acute myocardial infarction.
  • For prevention of cholinergic effects on the heart (e.g. arrhythmias, bradycardia) during surgery.
  • In combination with neostigmine during reversal of effect of non-depolarising muscle relaxants.

4.2 Posology and method of administration

Pre-oeprativemedication.
Adults: By the intravenous route: 300 – 600 micrograms immediately before induction of anaesthesia. By the intramuscular or subcutaneous route: 300 – 600 micrograms, one hour before induction of anaesthesia.
Children: By the subcutaneous route 30 minutes before induction of anaesthesia
Premature infants: 65 micrograms;
Children up to 3kg: 100 micrograms;
children 7-9kg:: 200 micrograms;
Children 12-16kg: 300 micrograms;
Children 20-27kg: 400 micrograms;
Children 32kg: 500 micrograms;
Children 41kg: 600 micrograms;

By the intramuscular route 30-60 minutes before induction of anaesthesia.

Alternative dosage statement for children over 1 year:

10-20 micrograms/kg 30-60 minutes before induction of anaesthesia..

As an antidote to cholinesterase inhibitors

Adults:

2mg, preferably IV.

Children:

50 micrograms/kg IV or IM.

Repeat dose every 5-10 minutes until signs of atropinisation appear.

As an antidote to organophosphate pesticides and in mushroom poisoning

Adults:

2mg IV or IM.

Children:

50 micrograms/kg IV or IM

Repeat dose every 10-30 minutes until muscarinic signs and symptoms subside.

Reversal of effects of non-depolarising muscle relaxants

Adults:

0.6 –1.2 mg given IV in conjunction with neostigmine methyl- sulfate.

In cardiopulmonary resuscitation

Adults:

3mg IV once

Children:

20 micrograms/kg IV once

In arrhythmias

Bradycardia, particularly if complicated by hypotension, 300 micrograms IV initially, increasing to 1mg if necessary.

Method of administration:

Atropine sulfate 1mg in 1ml solution for injection is administered by intravenous, intramuscular or subcutaneous injection.

4.3 Contraindications

Hypersensitivity to Atropine Sulfate or to any of the excipients listed in section 6.1.

Known hypersensitivity to the drug, closed-angle glaucoma, prostatic enlargement, myasthenia gravis (unless given in conjunction with anticholinesterase), paralytic ileus or pyloric stenosis and severe ulcerative colitis.

4.4 Special warnings and precautions for use

Atropine sulfate should be used with caution in children, the elderly and those with Down’s syndrome. It should be given with caution to patients with diarrhoea, urinary retention or fever, and when the ambient temperature is high. Care is required in patients with acute myocardial infarction as ischaemia, and infarction may be exacerbated in patients with hypertension.

Caution is also required when using the drug in patients with conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and during cardiac surgery. Paradoxical atrioventricular block or sinus arrest has been reported following administration of atropine in a few patients after heart transplantation. The use of atropine for therapeutic or diagnostic procedures in heart transplant patients should be undertaken with extreme caution, and ECG monitoring and equipment for immediate temporary pacing should be available.

Caution is required when atropine is administered systemically to patients with chronic obstructive pulmonary disease, as a reduction in bronchial secretions may lead to the formation of bronchial plugs.

Antimuscarinics such as atropine may delay gastric emptying, decrease gastric motility and relax the oesophageal sphincter. They should be used with caution in patients whose conditions may be aggravated by these effects e.g. reflux oesophagitis.

4.5 Interaction with other medicinal products and other forms of interaction

The effects of atropine may be enhanced by the concomitant administration of other drugs with antimuscarinic activity including phenothiazines, amantadine, tricyclic antidepressants, MAOI’s, some antihistamines and disopyramide.

Reduced GI motility caused by atropine may affect the absorption of other drugs such as mexilitine and ketoconazole.

Atropine induced dry mouth may prevent dissolution of sublingual preparations such as the nitrates, reducing their effectiveness.

During anaesthesia, the heart rate responsiveness to IV atropine could be decreased (and not effectively overcome by a large dose of atropine) when the subject is receiving concomitant propofol; it could be due to propofol-induced suppression of the sympathetic nervous system.

4.6 Fertility, pregnancy and lactation

Atropine sulfate crosses the placenta. There is insufficient evidence to establish the safety of atropine in human pregnancy. It should therefore be used during pregnancy only if considered essential by the physician.

Atropine sulfate is excreted in breast milk, and infants of nursing mothers may exhibit some effects of the drug. Infants are usually very sensitive to the effects of anticholinergic drugs. Atropine should therefore only be used during breast feeding if considered essential by the physician.

4.7 Effects on ability to drive and use machines

Atropine sulfate may cause drowsiness or blurred vision and patients should be used advised accordingly.

4.8 Undesirable effects

The most commonly reported adverse events are due to the action of atropine on muscarinic and, at high doses, nicotinic receptors. These effects are dose-related and usually reversible when therapy is discontinued.

Immune system disorders:

Anaphylaxis.

Nervous system/ Psychiatric disorders:

Dizziness, confusional states, especially in the elderly. At higher doses hallucinations, restlessness, delirium.

Eye disorders:

Dilatation of the pupils with loss of accommodation and photophobia, raised intraocular pressure.

Cardiac disorders:

Transient bradycardia followed by tachycardia, palpitations, arrhythmias.

There have been reports of paradoxical atrioventricular block, especially after heart transplantation (see section 4.4).

Vascular disorders:

Flushing.

Respiratory disorders:

Reduced bronchial secretion may result in the formation of thick bronchial plugs which are difficult to eject from the respiratory tract (see section 4.4).

Gastrointestinal disorders:

Dry mouth with difficulty in swallowing, nausea, vomiting, constipation. Inhibition of gastric secretion, retrosternal pain due to gastric reflux.

Skin & subcutaneous tissue disorders:

Dry skin, urticaria, rashes, skin exfoliation.

Renal & urinary disorders:

Difficulty with micturition.

General disorders:

Thirst, fever.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms

Flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, hypertension, nausea, vomiting. A rash may appear on the face or upper trunk. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, CNS depression may occur with coma, circulatory and respiratory failure and death.

Treatment

Treatment should be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of central nervous system depression should be considered. Hypoxia and acidosis should be corrected. Antiarrhythmic drugs are not recommended if dysrhythmias occur.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: anticholinergic agents

Atropine is an antimuscarinic agent which competitively antagonises acetylcholine at postganglionic nerve endings, thus affecting receptors if the exocrine glands, smooth muscle, cardiac muscle and the central nervous system.

Peripheral effects include decreased production of saliva, sweat, nasal, lachrymal and gastric secretions, decreased intestinal motility and inhibition of micturition.

Atropine increases sinus rate and sinoatrial and AV conduction. Usually heart rate is increased, but there may be an initial bradycardia.

Atropine inhibits secretions throughout the respiratory tract and relaxes bronchial smooth muscle producing bronchodilation

5.2 Pharmacokinetic properties

Following intravenous administration, the peak increase in heart rate occurs within 2 to 4 minutes. Peak plasma concentrations of atropine after intramuscular administration are reached within 30 minutes, although peak effects on the heart, sweating and salivation may occur nearer one hour after intramuscular administration.

Plasma levels after intramuscular and intravenous injection are comparable at one hour. Atropine is distributed widely throughout the body and crosses the blood brain barrier. The elimination half-life is about 2 to 5 hours. Up to 50% of the dose is protein bound. It disappears rapidly from the circulation.

It is incompletely metabolised in the liver and is excreted in the urine as unchanged drug and metabolites. About 50% of the dose is excreted within 4 hours and 90% in 24 hours.

5.3 Preclinical safety data

None stated.

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium Chloride

Water for Injections

The pH may be adjusted using Sodium Hydroxide or Sulfuric Acid.

6.2 Incompatibilities

Atropine sulfate injection is reported to be physically incompatible with bromides, iodides, alkalis, noradrenaline bitartrate, metaraminol bitartrate and sodium bicarbonate. A haze or precipitate may form within 15 minutes when atropine sulfate is mixed with methohexital sodium solutions.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

1ml (Type 1) clear glass ampoules.

Fusion sealed Packed into carton of 10 ampoules.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Atropine Sulfate Injection USP 0.6mg/1ml Taj Pharma
Atropine Sulfate Injection USP 0.4mg/1ml Taj Pharma
Atropine Sulfate Injection USP 8mg/20ml Taj Pharma

Package Leaflet: Information for the user

Atropine Sulphate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, please ask your doctor, pharmacist or nurse
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Atropine Solution for injection is and what it is used for
    2. What you need to know before you are given Atropine Solution for injection
    3. How Atropine Solution for injection is given
    4. Possible side effects
    5. How to store Atropine Solution for injection
    6. Contents of the pack and other information

 

  1. What Atropine Solution for injection is and what it is used for

Atropine Solution for injection belongs to a group of medicines known as anticholinergics. These medicines are often used:

  • before general anaesthesia to reduce saliva secretions
  • to restore normal heartbeat during a cardiac arrest
  • as an antidote to some insecticides and in mushroom poisoning.
  • In combination with other drugs to reverse the effect of muscle relaxants used during surgery.
  1. What you need to know before you are given Atropine Solution for injection

You should not be given Atropine Solution for injection if:

  • you are allergic to Atropine Sulfate or to any of the other ingredients of this medicine (listed in section 6).
  • you suffer from closed-angle glaucoma (a condition that affects your eyes).
  • you are a man with an enlarged prostate.
  • you suffer from myasthenia gravis (weakness of breathing muscles).
  • you suffer from pyloric stenosis (narrowing of the opening that takes away food from your stomach).
  • you suffer from paralytic ileus (your intestine stops functioning properly)
  • you suffer from ulcerative colitis – a disease of the colon and rectum.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Atropine Solution for injection if:

  • you have urinary difficulties
  • you have heart failure
  • you have had heart attack
  • you have a heart transplant
  • you have chronic obstructive pulmonary disease (a condition where the airflow to your lungs is restricted and you may cough and feel breathless)
  • you have an overactive thyroid
  • you have high blood pressure
  • you have a fever
  • you are suffering from diarrhoea
  • you have reflux oesophagitis (heartburn)

Other medicines and Atropine Solution for injection:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines including medicines obtained without prescription.

Other medicines which may interact with Atropine Solution for injection are:

  • medicines to treat psychosis or depression.
  • amantidine (a medicine for Parkinson’s disease)
  • antihistamines (medicines to treat hayfever and allergies)
  • medicines to regulate your heart (disopyramide and mexiletine)
  • ketoconazole (a medicine to treat fungal infections)
  • medicines that you take by allowing them to dissolve slowly in your mouth – atropine may cause your mouth to become dry, making it more difficult for these medicines to dissolve.

Pregnancy, fertility and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Driving and using machines

You should not drive or use machinery if affected by the administration of Atropine Solution for injection.

  1. How Atropine Solution for injection is given

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

If you think you have been given too much Atropine Solution for injection:

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much or you begin to feel your heart beating very fast, you are breathing quickly, have high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection immediately.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported.

Contact your doctor or nurse immediately if you get any of the following:

  • Sudden life – threatening allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Other Side effects include:

  • drowsiness
  • blurred vision
  • dry mouth with difficulty swallowing
  • thirst
  • dilation of the pupils
  • flushing
  • dryness of the skin
  • slow heart beat followed by fast heart beat
  • palpitations (you are aware of your heart beating)
  • difficulty in passing urine or constipation
  • vomiting
  • confusion especially in the elderly or severe confusion
  • coughing and bringing up phlegm ( bronchial plugs)
  • restlessness
  • hallucinations
  • changes in the way the heart beats (arrhythmias)
  • heart condition ( atrioventricular block) after heart transplantation
  • fever

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Atropine Solution for injection

Keep out of the sight and reach of children.

You should not be given this medicine if it has passed the expiry date shown on the ampoule label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

  1. Contents of the pack and other information

What Atropine Solution for injection contains:

The active ingredient is Atropine Sulfate 0.1% w/v. The other ingredients are sodium chloride and water for injections. It may also include sodium hydroxide and sulfuric acid to make a neutral solution.

What Atropine Solution for injection looks like and contents of the pack:

Atropine Solution for injection is a clear, colourless solution supplied in glass ampoules each containing 1ml. The ampoules are supplied to your pharmacist or doctor in packs of 10.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com