Doxapram Hydrochloride 2mg/ml Solution for Infusion Ref.[2766] Active ingredients: Doxapram

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: MercuryPharm Ltd 4045, Kingswood Road City West Business Park Co Dublin Ireland

Therapeutic indications

Doxapram acts as a ventilatory stimulant and is specifically indicated in the following situations:

Acute Respiratory failure:

  1. To stimulate ventilation in patients whose blood gas status or clinical condition suggests that severe carbon dioxide retention would occur during controlled oxygen therapy.
  2. To stimulate ventilation in patients showing a progressive increase in PCO2 with mental status changes during or after controlled oxygen therapy.

Following anaesthesia:

  1. To stimulate ventilation in the post-operative period as an aid to the reduction of post-operative pulmonary complications
  2. To permit use of effective doses of narcotic analgesics without associated problems of ventilatory depression.

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 of the patient. Administer concurrently with oxygen. Whenever possible the condition of the patient should be monitored by frequent measurement of blood gas tensions.

The following dosage regimen has been shown to result in the rapid production of a steady state plasma concentration of doxapram:

0-15 mins4.0 mg/min
15-30 mins3.0 mg/min
30-60 mins2.0 mg/min
60 mins onwards1.5 mg/min

Following anaesthesia recommended dosage is 2-3 mg per minute, and appropriate adjustments to the administration rate should be made according to the response of the patient.

Children

Dopram is not recommended for use in children due to insufficient data on safety and efficacy.

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 clonic and generalized seizures. Intravenous diazepam, phenytoin, and short-acting barbiturates, oxygen and resuscitative equipment should be readily available to manage overdoses.

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 the air inlet tube is always clamped off.

  1. Remove the protective overpouch by tearing down from notch and remove container.
  2. Carefully straighten hanger and ports if necessary
  3. Squeeze container and inspect for minute leaks and examine solution for visible particles or cloudiness by viewing along seam. Discard unit if leaks, particles or cloudiness are evident.
  4. Suspend container from base eyelet support.
  5. Using aseptic technique prepare administration set.
  6. Remove blue protector from outlet port and insert set connector well into port.
  7. Prime set and regulate administration as required. If administration set becomes blocked do not pump contents back into container but replace equipment.
  8. Discard all containers and equipment after use. Do not store partly used containers.

Cautions:

  1. Do not vent.
  2. Do not administer unless the solution is clear and container is undamaged.
  3. Do not use in series connections as this could result in air embolism due to residual air being drawn from the primary container before administration of fluid from the secondary container is completed.
  4. Discontinue infusion if adverse reaction occurs.
  5. It is recommended that the intravenous administration set be replaced at least once every 24 hours.

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