Fresenius Glycopyrrolate 0,2 mg/1 ml/0,4 mg/2 ml Injection

Fresenius Glycopyrrolate Injection is used pre-operatively to decrease salivary, tracheobronchial and pharyngeal secretions; decrease gastric secretions and acidity and block the effects of vagal stimulation during anaesthesia and surgery. It also antagonises the peripheral muscarinic effects, such as bradycardia and excessive secretions of cholinergic agents used to reverse neuromuscular blockade due to non-depolarising muscle relaxants e.g. neostigmine and pyridostigmine.

Fresenius Glycopyrrolate Injection may be administered intramuscularly, intravenously or subcutaneously, without dilution, in the following indications:

Adults :

• Pre-anaesthetic dose: 4 u03bcg (0,02 ml) per kg body mass given by intramuscular injection, 30 minutes to one hour before induction of anaesthesia. Maximum dose is 400 u03bcg.
• Intraoperative dose: 100 u03bcg (0,5 ml) given intravenously as a single dose, and repeated as needed at intervals of 2 u2013 3 minutes.
• To reverse neuromuscular blockade: 200 u03bcg (1 ml) IV for each 1 mg neostigmine or for each 5 mg pyridostigmine.

Children up to 12 years of age:

• Pre-anaesthetic dose: 4 u03bcg (0,02 ml/kg) given by intravenous or intramuscular injection. Maximum dose is 200 u03bcg.
• For intraoperative use: Similar dose as the pre-anaesthetic dose above may be given during operation if required.
• For reversal of neuromuscular blockade: 10 u03bcg/kg IV with neostigmine 50 u03bcg/kg IV [200 u03bcg (1 ml) IV for each 1 mg neostigmine or for each 5 mg pyridostigmine].

Fresenius Glycopyrrolate Injection can be mixed and injected with the following: 5 % and 10 % glucose in water or saline; pethidine injection; morphine sulphate; fentanyl plus droperidol injection; hydroxyzine injection. It can also be administered through tubing of an infusion of 0,9 % Sodium chloride or lactated Ringeru2019s solution.

Fresenius Glycopyrrolate Injection is contraindicated in:

• Patients with known hypersensitivity to glycopyrrolate or any of the ingredients of Fresenius Glycopyrrolate Injection.
• Patients with prostatic enlargement (in whom it may lead to urinary retention).
• Patients with paralytic ileus or pyloric stenosis.

Use with extreme caution in patients suffering from glaucoma or asthma. Fresenius Glycopyrrolate Injection should be used with caution in children and the elderly.

It should also be used with caution in the following conditions: ulcerative colitis, diarrhoea, myasthenia gravis, in patients with a fever or where the ambient temperature is high (as it can provoke hyperthermia), conditions characterised by tachycardia (thyrotoxicosis, heart failure and in cardiac surgery), myocardial infarction and hypertension as well as in coronary artery disease.

The effect of Fresenius Glycopyrrolate Injection may be enhanced by the concomitant administration of other medicines with antimuscarinic properties, e.g. amantadine, antihistamines, phenothiazine antipsychotics and tricyclic antidepressants. Chemical incompatibilities: Fresenius Glycopyrrolate Injection is incompatible with alkalis.

Safety in pregnancy and lactation has not been established.

Fresenius Glycopyrrolate Injection may cause blurred vision and dizziness that may impair a patientu2019s ability to drive vehicles and operate machinery.

Psychiatric disorders

Frequency unknown: mental confusion.

Nervous system disorders

Frequency unknown: headache, nervousness, drowsiness, insomnia, dizziness.

Eye disorders

Frequency unknown: dilation of pupils (mydriasis), loss of accommodation (cycloplegia), photophobia.

Cardiac disorders

Frequency unknown: transient bradycardia followed by tachycardia, palpitations and dysrhythmias.

Respiratory, thoracic and mediastinal disorders

Frequency unknown: decreased bronchial secretions.

Gastrointestinal disorders

Frequency unknown: dry mouth with difficulty swallowing and talking, thirst, decreased tone and motility of the gastrointestinal tract leading to constipation, nausea and vomiting.

Skin and subcutaneous tissue disorders

Frequency unknown: flushing and dryness of the skin.

Renal and urinary disorders

Frequency unknown: difficulty in micturition.

Reproductive system and breast disorders

Frequency unknown: impotence and suppression of lactation.

General disorders and administrative site conditions

Frequency unknown: weakness.

In overdose, symptoms such as hyperthermia, hypertension, increased respiratory rate, nausea and vomiting may occur. A rash may appear on the face or upper trunk. Neostigmine methylsulphate may be administered at a dose of 1,0 mg for each 1,0 mg of Fresenius Glycopyrrolate Injection that has been administered. Treatment is symptomatic and supportive.