Doxapram Hydrochloride 2mg/ml Solution for Infusion (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Mercury Pharma Group |
|---|---|
| Διεύθυνση | No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK |
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Name of the medicinal product
Dopram Infusion. Doxapram Hydrochloride 2mg/ml Solution for Infusion.
Qualitative and quantitative composition
Dopram Infusion contains 2 mg Doxapram Hydrochloride BP per ml, in 5% Glucose intravenous infusion BP.
Pharmaceutical form
Sterile solution for intravenous infusion.
Therapeutic indications
Doxapram acts as a ventilatory stimulant and is specifically indicated in the following situations: Acute Respiratory failure: To stimulate ventilation in patients whose blood gas status or clinical condition ...
Posology and method of administration
Dopram infusion is recommended for intravenous use only. Adults and Older patients For the treatment of respiratory failure recommended dosage is 1.5 to 4 mg per minute depending on the condition and response ...
Contraindications
Hypersensitivity to any of the ingredients in the product Severe hypertension Status asthmaticus Coronary artery disease Epilepsy and other convulsive disorders Cerebral oedema Cerebrovascular accident ...
Special warnings and precautions for use
Dopram should be administered concurrently with oxygen to patients with severe irreversible airways obstruction or severely decreased lung compliance, due to the increased work of breathing in these patients. ...
Interaction with other medicinal products and other forms of interaction
Clinical data suggest that concurrent use of aminophylline/theophylline and Dopram may be associated with increased CNS stimulation, agitation, muscle fasciculation and hyperactivity. Care should thus ...
Pregnancy and lactation
Although there is no recognised hazard, this product is not recommended for use in pregnancy unless there are compelling clinical reasons to do so. The physician must weigh the benefit to the risk. It ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Nervous system disorders Dopram may produce adverse effects due to general stimulation of the central, peripheral and autonomic nervous systems: pyrexia, sweating, flushing, salivation, headache, dizziness, ...
Overdose
Overdosage may result in hypertension, tachycardia and other arrhythmias; skeletal muscle hyperactivity including enhanced deep tendon reflexes, and dyspnoea. Serious symptoms of overdosage may include ...
Pharmacodynamic properties
Pharmacotherapeutic group: Respiratory stimulants ATC code: R07AB01 The principal pharmacological action of Dopram is an increase in minute volume produced primarily by an increase in tidal volume and ...
Pharmacokinetic properties
Following an I.V. bolus injection of 1.5mg/kg doxapram, the plasma concentration of doxapram declined in a multi-exponential manner. The mean half-life from 4 – 12 hours was 3.4 hours (range 2.4 – 4.1 ...
Preclinical safety data
Reproduction studies have been performed in rats at doses of up to 1.6 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus associated with the use of doxapram. ...
List of excipients
Glucose Intravenous infusion (BP)
Incompatibilities
Dopram is incompatible with alkaline solutions such as aminophylline, frusemide and thiopentone sodium.
Shelf life
2 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Primary container: Viaflex bag in overpouch. Secondary container: Cardboard carton. Presentation: each Viaflex bag contains 500 ml.
Special precautions for disposal and other handling
The VIAFLEX Plus container has an outlet port designed for an administration set with a short single connector. If an administration set with a combined air inlet/fluid path connector has to be used, ensure ...
Marketing authorization holder
MercuryPharm Ltd 4045, Kingswood Road City West Business Park Co Dublin Ireland
Marketing authorization number(s)
PL 15372/0002
Date of first authorization / renewal of the authorization
01 October 1997
Date of revision of the text
March 2012