Penthrox® Europe
Penthrox® Europe

This website is an information resource about Penthrox® intended for healthcare professionals only.

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Patients who have been given Penthrox® can find the Patient Information Leaflet (PIL) here.

Report adverse events

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. By reporting side effects, you can help provide more information on the safety of medicine.

Mundipharma routinely monitors the safety of all its medicines, including reviewing safety data from clinical studies and collecting reports of adverse events. If you are a patient or are aware of a patient who has experienced an adverse event, overdose or unexpected benefits with one of our products, please also contact Mundipharma by calling +44 (0) 1223 424 211 or by emailing eudrugsafety@mundipharma-rd.eu. Mundipharma will only use your details to contact you about your adverse event report.

Penthrox® is a registered trademark of Medical Developments International Limited and is used under licence. The Mundipharma network of independent associated companies has exclusive rights in 40 European countries, but excluding the UK and Ireland.

Copyright © 2020 Mundipharma International Limited. All rights reserved.

Mundipharma

Simple, fast, effective

trauma pain relief enables you to focus on your patient’s injury

Fast Onset Aids Patients

Penthrox® is inhaled, it enters the lungs in the form of a vapour and is rapidly transported into the bloodstream, giving a fast onset of analgesic action.

In the inMEDIATE study, a randomised, controlled study, the median time to first pain relief was just 3 minutes (vs. 10 minutes with standard analgesic treatment).54 Because it works so quickly, Penthrox® can help minimise patients’ suffering in the emergency room, and this may also improve patients’ satisfaction.6

Fast Onset
-
mins

vs 10 mins Standard of Care analgesia54*
* In the Standard of Care group, 70% of patients received intravenous first-step analgesics and 9.4% of patients were treated with opioids

Works within 6-10 breaths1,2

FAST OFFSET58

Psychomotor tests performed on healthy volunteers have demonstrated a return to normal 30 minutes after cessation of Penthrox® treatment.

  • Aids further clinical evaluation and diagnosis59
  • Can bridge the gap to other analgesics59
  • Avoids opioid-related monitoring or observation1,4
FAST OFFSET
-
mins

in healthy volunteers58

Median time to onset of meaningful pain relief

Intravenous
morphine sulphate
- mins12
Intranasal
fentanyl
- mins13
Oromucosal
fentanyl
- mins13

Effective in moderate-to-severe pain (≥4 on the Numerical Rating Scale [NRS])

Penthrox® provided significantly better pain relief than Standard of Care (SoC) analgesia

Randomised, head-to-head studies

inMEDIATE54

Change in NRS pain intensity from baseline

In the SoC group, 70% of patients received IV first-step analgesics and 9.4% of patients were treated with opioids.

MEDITA55

Change in Visual Analogue Scale (VAS) pain intensity from baseline

In the SoC group, 88% of patients with moderate pain received IV paracetamol and 12% received IV ketoprofen while 95% of patients with severe pain received IV morphine (one received paracetamol and one received ketoprofen in error).

EFFECTIVE IN MODERATE-TO-SEVERE PAIN (≥4 on the NRS)

Penthrox® provided significant decrease in pain intensity compared with SoC

Randomised, head-to-head studies

inMEDIATE54

Over first 20 minutes

In the SoC group, 70% of patients received IV first-step analgesics and 9.4% of patients were treated with opioids.

MEDITA55

Over first 10 minutes

In the SoC group, 88% of patients with moderate pain received IV paracetamol and 12% received IV ketoprofen while 95% of patients with severe pain received IV morphine (one received paracetamol and one received ketoprofen in error).

EFFECTIVE IN MODERATE PAIN (4-6 on the NRS)

Penthrox® provided significantly better pain relief than IV paracetamol (1 g) or IV ketoprofen (100 mg)

Randomised, head-to-head study: MEDITA55

Change in VAS pain intensity from baseline

In the SoC group, 88% of patients with moderate pain received IV paracetamol and 12% received IV ketoprofen

Greater improvement in pain intensity with Penthrox® at 3, 5 and 10 minutes

EFFECTIVE IN SEVERE PAIN (≥7 on the NRS)

Penthrox® provided significantly better pain relief than IV morphine (0.10 mg/kg) over 10 minutes

Randomised, head-to-head studies

MEDITA55

Change in VAS pain intensity from baseline

In the SoC group, 95% of patients with severe pain received IV morphine (one received paracetamol and one received ketoprofen in error)

Greater improvement in pain intensity with Penthrox® over 10 minutes

FAST AND EFFECTIVE VS BASELINE IN A VARIETY OF TRAUMA TYPES

Exploratory analysis shows effect of Penthrox® was independent of injury type55

No head-to-head comparison according to injury type was performed

FAST AND EFFECTIVE IN ANTERIOR SHOULDER DISLOCATION

Penthrox® was associated with quicker recovery and faster discharge than with propofol

In an observational study, Penthrox® successfully facilitated reduction of anterior shoulder dislocation in 80% vs 98% of propofol patients57

HIGH SATISFACTION AMONG PATIENTS AND CLINICIANS

Penthrox® exceeded the expectations of patients and clinicians for efficacy and comfort

Randomised, head-to-head studies

inMEDIATE54

Ratings for pain control and comfort of treatment

MEDITA55

Rated ‘excellent’, ‘very good’ or ‘good’

Penthrox® has a well-established safety profile

Penthrox® has been used for over 40 years in Australia and New Zealand, accumulating a total of over 6 million administrations. 2,3,53

Historical risk associated with high anaesthetic doses of methoxyflurane

Nephrotoxicity caused by metabolite fluoride, is a dose-related effect associated with high anaesthetic doses3

Analgesic dose Penthrox® significantly lower than anaesthetic dose – at least 6-fold below the upper safety limit3

Dose
(MAC-hours)
Methoxyflurane Penthrox® (1 x 3mL bottle) 0.3
Methoxyflurane Upper safety limit ≤2.0
Methoxyflurane Subclinical toxicity 2.5-3.0
Methoxyflurane Clinical toxicity >5.0
MAC minimum alveolar concentration, the concentration required to produce surgical anaesthesia in 50% of healthy patients
MAC-hour determined by multiplying the MAC by the duration of administration of anaesthetic

Adapted from Dayan AD, 20163

Summary of product characteristics (PDF)

Penthrox® was well tolerated in all four randomised controlled pivotal trials with the majority of adverse events being mild and transient and no different to standard of care.1,2,11,54,55,56

Penthrox® has no clinically relevant effects on vital signs and only a low risk associated with respiratory depression1,14.

See more in-depth information
MedDRA System Organ Class Very Common Common
≥1/100 to <1/10
Uncommon
≥1/1,000 to <1/100
Not Known
Metabolism and nutrition disorders Increased appetite
Psychiatric disorders Euphoric mood Anxiety
Depression
Inappropriate affect
Affect lability§
Agitation§
Confusional state§
Dissociation§
Restlessness§
Nervous system disorders Dizziness Amnesia
Dysarthria
Dysgeusia
Headache
Somnolence
Paraesthesia
Peripheral sensory neuropathy
Altered state of consciousness§
Nystagmus§
Eye disorders Diplopia Vision blurred§
Vascular disorders Hypotension Flushing Blood pressure fluctuation§
Respiratory, thoracic and mediastinal disorders Cough Choking§
Hypoxia§
Gastrointestinal disorders Dry mouth
Nausea
Oral discomfort Vomiting§
Hepatobilary disorders Hepatic failure*
Hepatitis*
Jaundice§
Liver injury§
Skin and subcutaneous tissue disorders Hyperhidrosis
Renal and urinary disorders Renal failure§
General disorders and administration site conditions Feeling drunk Fatigue
Feeling abnormal
Chills
Feeling of relaxation
Investigations Hepatic enzyme increased§
Blood urea increased
Blood uric acid increased§
Blood creatinine increased§

*Isolated post-marketing reports that have been observed with analgesic use of methoxyflurane
§Other events linked to methoxyflurane use in analgesia found in post marketing experience and in scientific literature

Contraindications1

Use as an anaesthetic agent

Who are susceptible to malignant hyperthermia or have a relative who has had malignant hyperthermia

Altered level of consciousness due to any cause including head injury, drugs, or alcohol

Who have a history of hypersensitivity to Penthrox® or other fluorinated anaesthetics

Those who have a history of liver damage after previous Penthrox® use or halogenated hydrocarbon anaesthetics

Those with clinically significant renal impairment

Those demonstrating clinically evident cardiovascular instability

Those demonstrating clinically evident respiratory depression

Those with previous or known family history of severe adverse reactions after being administered with inhaled anaesthetics