Doxapram Hydrochloride 2mg/ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxapram hydrochloride

Available from:

MercuryPharm Ltd

ATC code:

R07AB; R07AB01

INN (International Name):

Doxapram hydrochloride

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Respiratory stimulants; doxapram

Authorization status:

Not marketed

Authorization date:

1980-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOXAPRAM HYDROCHLORIDE 2 MG/ML SOLUTION FOR INFUSION
DOXAPRAM HYDROCHLORIDE
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, ask your doctor or nurse
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Doxapram Hydrochloride is and what it is used for
2.
What you need to know before you are given Doxapram Hydrochloride
3.
How Doxapram Hydrochloride is given to you
4.
Possible side effects
5.
How to store Doxapram Hydrochloride
6.
Contents of the pack and other information
1.
WHAT DOXAPRAM HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Doxapram Hydrochloride 2 mg/ml Solution for infusion (also referred to
Doxapram
Hydrochloride in the remained of this leaflet) is used to help you
breathe after you have been
given an anaesthetic, when your breathing may not be as good as it
should be. Also some
pain-killers used in anaesthesia have the side effect of decreasing
your breathing and
Doxapram Hydrochloride can prevent this problem.
Your doctor can also use Doxapram Hydrochloride to speed up your
recovery after an
anaesthetic and also from associated sleepiness. Doxapram
Hydrochloride works by
increasing the amount of air that goes in and out of your lungs and
increases your rate of
breathing.
Doxapram Hydrochloride is therefore useful in conditions where
breathing properly may be
difficult.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOXAPRAM HYDROCHLORIDE
YOU SHOULD NOT BE GIVEN DOXAPRAM HYDROCHLORIDE:
• if you are allergic to
Doxapram Hydrochloride
or any of the ingredients of this medicine (listed
in section 6).
• if you have very high blood pressure
• if you are suffering from a state of sudden severe wheezing known
as status asthmaticus
• if you have heart disease
• if you suffer from ep

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2021
CRN00C77C
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxapram Hydrochloride 2mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxapram Hydrochloride 2mg/ml Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxapram Hydrochloride 2 mg/ml.
Each 500ml bag contains 1000mg Doxapram Hydrochloride.
Each ml of solution contains 2mg doxapram hydrochoride.
Excipient(s) with known effect
Each ml contains 50mg glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxapram Hydrochloride 2mg/ml Solution for Infusion acts as a
ventilatory stimulant and is used 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and Elderly :
For the treatment of respiratory failure recommended dosage is 1.5 to
4mg 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 mins 4.0 mg/min
15 – 30 mins 3.0 mg/min
30 – 60 mins 2.0 mg/min
60 mins onwards 1