Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Doxapram hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Doxapram Injection contains the active substance doxapram hydrochloride. It 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 painkillers used in anaesthesia have the side effect of decreasing your breathing and this medicine can prevent this problem. Your doctor can also use this medicine to speed up your recovery after an anaesthetic and also from associated sleepiness. Doxapram Injection works by increasing the amount of air that goes in and out of your lungs and increases your rate of breathing. This medicine is therefore useful in conditions where breathing properly may be difficult.
Doxapram Injection You should not be given Doxapram Injection:
• • • • • •
if you have what is called cerebral oedema, where there is build up of fluid in the brain if you have suffered from a stroke if you suffer from the condition known as hyperthyroidism/ thyrotoxicosis (when you have an overactive thyroid gland and your body produces too much of the hormone thyroxine) if the airways in your lungs or the muscles in the chest wall that you use to breathe are severely blocked in any way if you have an injury to the head if you suffer from a blood clot in the lung (pulmonary embolism).
Make sure your doctor knows if you suffer from any of the above. Warnings and precautions Talk to your doctor or nurse before you are given Doxapram Injection:
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. This may affect his decision about whether to give you Doxapram Injection or not.
to you Your doctor will give you Doxapram Injection by injecting it into one of your veins. The amount you are given will depend on your condition and on how well you are responding to the medicine. Adults and the elderly: The recommended dose that you would be given is between 1.0 and 1.5mg of this medicine for each kilogram that you weigh (e.g. if you weigh 70 kilograms you will probably receive between 70mg and 105mg of this medicine). This dose may be repeated hourly if necessary. Use in children and adolescents Doxapram Injection is not recommended for use in children. If you are given more Doxapram Injection than you should If your doctor accidentally gives you too much of this medicine you may feel the following: your heartbeat becomes irregular, you develop some shortness of breath and your muscle movements become more difficult. Tell your doctor immediately if you feel any of these symptoms. If you have any further questions on the use of this medicine ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. If you develop sudden and severe increase in blood pressure or difficulty in breathing your doctor will stop Doxapram Injection. The following side effects have also been reported: Not known: frequency cannot be estimated from available data • • • • • • •
feeling feverish, flushed and possibly sweating coughing shortness of breath tightening of the chest and throat increased blood pressure quicker or slower heartbeat than usual warmth at the base of the tummy
• • • • • • • • • • • • • • • • • • •
muscle twitches chest pain or chest tightness increased muscle tone/stiffness (Muscle spasticity) reflex of toe in response to foot stroke (bilateral Babinski) weakness in the limbs, slurred speech or visual disturbances which may be caused by reduced blood supply to the brain slight decrease in blood supply to brain premature contraction of heart (extrasystoles) fits headache dizziness feeling hyperactive feeling confused having hallucinations (see, hear, smell, taste, or feel something that is not there) nausea (feeling sick) and vomiting (being sick) salivation series of involuntary muscular contractions (Clonus) increased reflexes in brain function (increased deep tendon reflexes) irregular heartbeat inability to pass urine or sudden passing of urine.
Additional side effects in children, infants and pre-term newborns Although Doxapram Injection is not recommended for use in children, its use in children is known to cause the following side effects:
Doxapram Injection Your doctor, pharmacist or nurse will know how to store Doxapram Injection properly.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and ampoule label after 'EXP'. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate. Once opened use immediately. For single use only. Discard any unused contents. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Doxapram Injection contains The active substance is doxapram hydrochloride. There is 100mg of doxapram hydrochloride in 5ml of the injection (20mg in each ml of the injection). The other ingredient is water for injections. What Doxapram Injection looks like and contents of pack The name of your medicine is Doxapram Hydrochloride 20mg/ml Solution for Injection and is supplied in glass ampoules packed in a cardboard carton. Each ampoule contains 5ml of a clear colourless sterile solution for injection. Five ampoules are supplied in a carton. Marketing Authorisation Holder Mercury Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany. This leaflet was last revised in August 2023. The following information is intended for healthcare professionals only. Incompatibilities: Doxapram Injection is incompatible with alkaline solutions such as aminophylline, furosemide and thiopental sodium.
Doxapram Hydrochloride BP 20mg/ml Solution for Injection comes as injection containing 20mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Doxapram Hydrochloride BP 20mg/ml Solution for Injection is doxapram hydrochloride.
Medicines with the same active substance, strength and form include: Doxapram hydrochloride 20 mg/ml Solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Doxapram Hydrochloride BP 20mg/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Doxapram acts as a ventilatory stimulant and Dopram Injection is used following anaesthesia to stimulate ventilation in the post-operative period as an aid to the reduction of post-operative pulmonary complications, and to permit the use of effective doses of narcotic analgesics without associated problems of ventilatory depression. Dopram Injection is also used to increase CNS arousal and spontaneous respiratory activity from inhalational anaesthesia when this would be beneficial.
Posology
Adults and Elderly:
The recommended dosage is 1.0 to 1.5mg/kg body weight, administered over a period of 30 seconds or more, which may be repeated at one hour intervals, if necessary.
Hepatic impairment:
There are no studies to support dosage recommendations in patients with hepatic impairment. However, as Doxapram is metabolized primarily by liver it should be used with care in patients with hepatic dysfunction (see section 4.4).
Renal impairment:
There are no studies to support dosage recommendations in patients with renal impairment.
Paediatric population:
Not recommended.
Method of administration
Dopram Injection is recommended for intravenous use only.
1. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
2. Severe hypertension
3. Status asthmaticus
4. Coronary artery disease
5. Epilepsy and other convulsive disorders
6. Cerebral oedema
7. Cerebrovascular accident
8. Hyperthyroidism /Thyrotoxicosis
9. Physical obstruction of the respiratory tract, or conditions resulting in restriction of chest wall, muscles of respiration or alveolar expansion.
10. Head injury
11. Proven/suspected pulmonary embolism
1. 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.
2. In patients presenting with bronchoconstriction, Dopram should always be used in conjunction with adrenoceptor bronchodilator drugs in order to reduce the amount of respiratory effort.
3. As Dopram is metabolised primarily by the liver, use with care in patients with hepatic dysfunction.
4. Dopram should be administered cautiously to patients receiving sympathomimetic agents since an additive pressor effect may occur.
5. Dopram should be used with great care in patients who are being treated concurrently with monoamine oxidase inhibiting drugs. Animal studies have shown that the action of doxapram is potentiated after pre-treatment with a MAOI.
6. In patients who have received anaesthetics known to sensitize the myocardium to catecholamines, such as halothane, cyclopropane, and enflurane, initiation of Dopram therapy should be delayed for at least 10 minutes following discontinuance of anaesthesia, since an increase in adrenaline release has been noted with Dopram administration.
7. The respiratory stimulant effect of Dopram may not outlast the residual effects of the depressant drugs. Since respiratory depression may recur after stimulation with Dopram, the patient should be closely monitored until fully alert for ½ to 1 hour. Dopram may temporarily mask the residual effects of curare-type muscle relaxant drugs.
8. Dopram should be administered with caution in patients with hypermetabolic states such as phaeochromocytoma.
9. If sudden hypertension or dyspnoea develops, Doxapram should be stopped.
10. Monitoring of the blood pressure and deep tendon reflexes is recommended to prevent overdosage.
11. To avoid side effects, it is advisable to use the minimum effective dosage.
12. Doxapram should not be used in conjunction with mechanical ventilation.
13. An adequate airway is essential and airway protection should be considered since Doxapram may stimulate vomiting.
14. Dopram should be used with caution in hypertensive patients (Dopram is contraindicated in severe hypertension, see section 4.3) and in patients with impaired cardiac reserve
15. The administration of this agent does not diminish the need for continuous monitoring of all aspects of patient response, including frequent analysis of arterial-blood gases.
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 be taken when these two drugs are used concomitantly.
Dopram should also be administered with great care to patients being treated concurrently with monoamine oxidase inhibitors (MAOIs). Animal studies have shown that the action of Dopram may be potentiated after pre-treatment with a MAOI (see section 4.4)
Dopram may potentiate the effects of sympathomimetic agents (see section 4.4).
Doxapram may temporarily mask the residual effects of curare-type muscle relaxant drugs (see section 4.4).
Pregnancy
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.
Breast-feeding
It is not known whether this drug is excreted in human milk. Therefore, caution should be exercised when Dopram is administered to a lactating mother.
Fertility
No data available.
Dopram Injection, Doxapram Hydrochloride 20mg/ml Solution for Injection has no or negligible influence on the ability to drive and use machines.
Adverse reactions listed by System Organ Class. The following adverse reactions have been observed at the frequencies defined using the following convention: Not known: cannot be estimated from the available data.
System Organ Class
Frequency
Adverse reactions
Nervous system disorders
Not known
*Pyrexia, sweating, flushing, salivation, headache, dizziness, hyperactivity, confusion, hallucinations, perineal warmth, muscle fasciculation, muscle spasticity, clonus, bilateral babinski, increased deep tendon reflexes and convulsions have been reported.
Cardiac disorders
Not known
Cardiovascular effects have been observed and include a moderate increase in blood pressure, arrhythmias, sinus tachycardia, bradycardia and extrasystoles, chest pain or chest tightness.
Respiratory, thoracic and mediastinal disorders
Not known
Respiratory problems such as dyspnoea, cough, bronchospasm and laryngospasm may occur.
Gastrointestinal disorders
Not known
Effects on the gastrointestinal tract such as nausea and vomiting may also occur.
Renal and urinary disorders
Not known
Urinary retention, stimulation of urinary bladder with spontaneous voiding.
*Dopram may produce adverse effects due to general stimulation of the central, peripheral and autonomic nervous systems.
Doxapram can induce a significant decrease in maximal cerebral blood flow velocity.
Paediatric Population:
Dopram is not recommended in children (see section 4.2). The following adverse reactions have been reported in off license use of doxapram in preterm neonates and infants:
• neurodevelopmental delay
• significant prolongation of QT interval, in some cases associated with atrioventricular block.
• bleeding in stools, abdominal distension and necrotizing enterocolitis and multiple gastric perforations
• early teeth eruption involving lower central incisors
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
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.
Management
Intravenous diazepam, phenytoin, and short-acting barbiturates, oxygen and resuscitative equipment should be readily available to manage overdoses.
Ask anything about Doxapram Hydrochloride BP 20mg/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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