Tropin

Tropin

atropine

Manufacturer:

NingboTisun Medic

Distributor:

2 World Traders
Full Prescribing Info
Contents
Atropine sulfate.
Description
Each mL contains: Atropine (sulfate) 1 mg.
Action
Pharmacology: Pharmacokinetics: Atropine is readily absorbed from the gastrointestinal tract; it is also absorbed from mucous membranes, the eye, and to some extent through intact skin, it is rapidly cleared from the blood and is distributed throughout the body. It crosses the blood-brain barrier. It is incompletely metabolized in the liver and is excreted in the urine as unchanged drug and metabolites. A half-life of about 4 hours has been reported. Atropine crosses the placenta and traces appear in breast milk. Quaternary ammonium salts of atropine such as the methonitrate, are less readily absorbed after oral doses.
Indications/Uses
For the treatment of sinus bradycardia and as an adjunct in reversal of neuromuscular blockade.
Dosage/Direction for Use
As anti-arrhythmic (sinus bradycardia or cardiopulmonary resuscitation): Premedication: See table.

Click on icon to see table/diagram/image

As adjunct in reversal of neuromuscular blockade 0.6-1.2 mg IV for each 0.5-2.5 mg neostigmine, 10-20 mg pyridostigmine, or 10-20 edrophoniums dose.
Contraindications
Known hypersensitivity to atropine or other anticholinergic agents. Patients with obstructive disease of the gastrointestinal tract (e.g. pyloroduodenal stenosis), cardiospasm, paralytic ileus or intestinal atony (especially in geriatric or debilitated patients). Megacolon complicating ulcerative colitis. Prostatic enlargement. Unstable cardiovascular status in acute haemorrhage. Tachycardia secondary to cardiac insufficiency of thyrotoxicosis. Toxaemia of pregnancy.
It is also contraindicated in patients with obstructive uropathy (e.g. bladder neck obstruction caused by prostatic hypertrophy). Due to risk of provoking hyperpyrexia, atropine should not be given to patients, especially children, where the ambient temperature is high.
Atropine should not be given to patients with closed angle glaucoma.
Special Precautions
Patients Over 40 Years: Atropine should be used cautiously in patients over 40 years old as they may be more susceptible to adverse effect, particularly those with any severe heart disease, hypertension, ulcerative colitis, ileus, chronic lung disease, hyperthyroidism, autonomic neuropathy, hepatic or renal disease or prostatic hypertrophy, esophageal reflux or hiatus hernia.
Elderly patients may react with excitement, agitation, drowsiness or confusion to even small doses of atropine. Changes in dosage should be gradual.
Debilitated Patients: Atropine should be used with caution in debilitated patients. These patients, especially those with chronic pulmonary disease, may be susceptible to the formation of bronchial mucous plugs due to decreased bronchial secretions.
Glaucoma: In patients over years, conventional parenteral doses of atropine may precipitate acute glaucoma in susceptible individuals.
Myasthenia Gravis: Atropine should be used with extreme caution in patients with myasthenia gravis.
Cardiovascular Status: In conditions characterized by tachycardia, such as cardiac insufficiency or failure, extreme caution must be exercised (see Contraindications). Care is also required in patients with acute myocardial infarction or ischaemia as atropine may worsen the symptoms.
Patients with known cardiac problems have developed angina following administration of atropine.
Atropine has been associated with the development of arrhythmias in adult and paediatric patients. Accelerated heart rate and intraventricular conduction delays have been associated with the development of ventricular fibrillation.
Use in Pregnancy: Category A: Although atropine has been taken by a large number of pregnant women and women of child-bearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the foetus being observed, the safety of atropine in pregnancy has not been positively established. As with all other drugs, caution must be exercised in the use of atropine in pregnant women and women of child-bearing age.
Use in Lactation: Small amounts of atropine have been found in human breast milk; therefore atropine should only be administered to nursing mothers if absolutely necessary.
Use in Children: Atropine should be used with caution in infants and small children.
Use In Pregnancy & Lactation
Use in Pregnancy: Category A: Although atropine has been taken by a large number of pregnant women and women of child-bearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the foetus being observed, the safety of atropine in pregnancy has not been positively established. As with all other drugs, caution must be exercised in the use of atropine in pregnant women and women of child-bearing age.
Use in Lactation: Small amounts of atropine have been found in human breast milk; therefore atropine should only be administered to nursing mothers if absolutely necessary.
Adverse Reactions
Most side effects are directly related to the antimuscarinic actions of atropine. Adverse effects following single or repeated doses are most often the result of excessive dosage.
More Common: Cardiovascular: Tachycardia and palpitations.
Central Nervous System: Dryness of the mouth, thirst (due to the reduction of salivary, bronchial and sweat secretions and are dose related).
Gastrointestinal: Urinary difficulty and retention, and constipation; due to inhibition of parasympathetic control of the bladder and GI tract respectively.
Ocular: Dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia can occur with increasing doses of atropine.
Skin: Flushing and dryness of the skin.
Less Common: Cardiovascular: Development of angina in patients with known cardiac problems has been reported.
Central Nervous System: Tremor, fatigue, drowsiness, ataxia, vomiting, mental confusion and/or excitement, dizziness. Anhidrosis also may occur and produce heat intolerance in patients living in a hot environment.
Gastrointestinal: Vomiting, retrosternal pain due to increased gastric reflux.
Skin: Hypersensitivity reactions may manifest as conjunctivitis or skin rash which, in some instances, progresses to exfoliation.
Drug Interactions
The effects of atropine and other antimuscarinics may be enhanced by use with other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants. Inhibition of drug metabolising enzymes by MAOIs may possibly enhance the effects of antimuscarinics. The reduction in gastric motility caused by antimuscarinics may affect the absorption of the drugs. Antimuscarinics may also antagonise the gastrointestinal effects of cisapride, domperidone, and metoclopramide. Antimuscarinics and parasympathomimetics may counteract each other's effects.
Storage
Store at temperature not exceeding 30°C. Protect from light.
ATC Classification
A03BA01 - atropine ; Belongs to the class of belladonna alkaloids, tertiary amines. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Soln for inj (amp) 1 mg/mL x 1 mL x 10's.
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