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MEPTID INJECTION 100MG/ML

Active substance(s): MEPTAZINOL HYDROCHLORIDE / MEPTAZINOL HYDROCHLORIDE / MEPTAZINOL HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Meptid 100mg/ml Solution for injection

2.

QUANTITATIVE AND QUALITATIVE COMPOSITION
Each 1 ml of solution contains 100mg of meptazinol (as hydrochloride).
For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution free from particulate matter.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of moderate to severe pain, including post-operative pain,
obstetric
pain and the pain of renal colic.

4.2

Posology and method of administration
Adults
Intramuscular dosage: 75-100mg Meptid. The injection may be repeated 2-4
hourly as required. For obstetric pain a dose of 100-150mg should be used
according to weight. This dose should approximate 2mg/kg.

Intravenous dosage: 50-100mg Meptid by slow intravenous injection. The
injection may be repeated 2-4 hourly as required. If vomiting occurs, a suitable
antiemetic should be given.
Epidural/intrathecal use: This formulation is not suitable for these routes.
Elderly
The adult dosage schedule can be used in the elderly.
Children
Meptid injection has not been evaluated for use in children.

4.3

Contraindications
Patients with the following conditions:
- known hypersensitivity to the active ingredient or to any of the excipients
- acute alcoholism and where there is a risk of paralytic ileus
- raised intracranial pressure or head injury (in addition to interfering with respiration,
affect pupillary responses vital for neurological assessment)
- phaeochromocytoma (risk of pressor response to histamine release)
- acute respiratory depression
- during an asthma attack
- patients on monoamine-oxidase inhibitors (MAOIs) and for 14 days after
discontinuing an MAOI. (see section 4.5)

4.4

Special warnings and special precautions for use
Caution should be exercised in patients whose respiratory system is already
compromised.
Patients with moderate to severe renal impairment should be given a reduced dose as
the effect in these patients may be prolonged and increased. Cerebral sensitivity may
also be increased. Patients with hepatic impairment should be given a reduced dose as
opioid analgesics may precipitate coma in these patients.
Since safety in long term use is not known, it is recommended that this drug be used in
the treatment of acute pain only, apart from appropriate therapy in malignant
conditions. Repeated administration of opioid analgesics may cause dependence and
tolerance (severe withdrawal symptoms if withdrawn abruptly).
Safety for use in myocardial infarction has not been established.

Meptazinol should also be used with caution in patients with the following conditions:
hypotension, hypothyroidism, asthma (avoid during an attack), prostatic hypertrophy
and convulsive disorders.

4.5

Interaction with other medicinal products and other forms of interaction
The following undesirable effects could occur as a result of possible interaction with
meptazinol hydrochloride.
Antidepressants: CNS excitation or depression manifesting as hypertension or
hypotension may occur if meptazinol is administered to patients receiving MAOIs
(including moclobemide). Avoid concomitant use for 14 days after an MAOI is
discontinued (see section 4.3). Possible increased sedation if meptazinol is used with
tricyclic antidepressants.
Antipsychotics: enhanced sedative and hypotensive effect.
Antivirals: avoid concomitant use with ritonavir as plasma concentration of meptazinol
may be increased.
Alcohol: enhanced sedative and hypotensive effect.
Quinolones (ciprofloxacin): Avoid premedication with meptazinol as a reduced plasma
ciprofloxacin concentration may be experienced.
Anxiolytics and hypnotics: enhanced sedative effect.
Drugs used in nausea and vomiting: Concomitant use of metoclopramide or
domperidone may result in antagonism of gastrointestinal side-effects.
Ulcer healing drugs: cimetidine may inhibit metabolism of meptazinol resulting in
increased plasma concentration.

4.6

Pregnancy and lactation
Reproduction studies in animals have shown no evidence of teratogenic effect.
No experience is available in human beings. Meptazinol should not be used
during pregnancy (apart from labour) unless considered essentially by the
physician.
Meptid should not be given to lactating women unless considered essential by
the physician.

4.7

Effects on ability to drive and use machines

Since dizziness and occasionally drowsiness have been reported, patients
should be cautioned against driving or operating machinery until it is
established that they do not become dizzy or drowsy whilst taking meptazinol.

4.8

Undesirable effects

System Organ Class

Very Common (≥ 1/10)

Nervous system disorders

dizziness, headache, vertigo,
somnolence, drowsiness

Vascular disorders
Respiratory, thoracic and
mediastinal disorders
Gastrointestinal disorders

Skin and subcutaneous
tissue disorders

Uncommon (≥ 1/1,000 to
≤ 1/100)
hypotension
Respiratory depression

abdominal pain, constipation,
diarrhoea, dyspepsia, nausea,
vomiting
Increased sweating, rash

For very rare reports of psychiatric disorders (hallucination, confusion, depression), causal
relationship with the use of meptazinol has not been established and therefore omitted from
the table above.
Reactions not already stated which are attributable to opioid analgesics include difficulty with
micturition, ureteric or biliary spasm, dry mouth, facial flushing, bradycardia, tachycardia,
palpitations, hypothermia, dysphoria, mood changes, miosis, decreased libido or potency,
urticaria and pruritus.
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 the Yellow
Card Scheme, Website: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Overdose with Meptid Injection has not been reported. Large doses, including seven
times the recommended therapeutic dose, have been given in balanced and total
intravenous anaesthesia without significant respiratory depressant effects.
In the event of cardiovascular and respiratory collapse, normal resuscitative procedures
should be employed. Respiratory depression caused by overdosage with meptazinol
may only be partially reversed with therapeutic doses of naloxone. Naloxone has a
short duration of action in comparison with meptazinol. Repeated administration or
administration by continuous intravenous infusion may be considered necessary.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Nervous System; Opioids; Other Opioids
ATC Code: N02AX
Meptid (meptazinol) is a centrally acting analgesic belonging to the hexahydroazepine
series, which has demonstrated mixed agonist and antagonist activity at opioid
receptors.
Receptor binding studies have shown that although meptazinol displays only a low
affinity for δ and α opioid receptor sites, it has a somewhat higher affinity for the
subpopulation of μ sites. These binding sites also display a high affinity for the
endogenous opioid peptides, and are thought to be responsible for, among other
things, analgesia, but not for the mediation of respiratory depression.
A component of its analgesic action is also attributable, in mice at least, to an effect
on central cholinergic transmission. In this respect it differs from all conventional
analgesic drugs which have been examined.
5.2

Pharmacokinetic properties
After intramuscular administration, meptazinol is rapidly absorbed and peak
plasma levels are reached within 30 minutes. The plasma half-life is
approximately 2 hours. The peak analgesic effect is seen within 30-60 minutes
and lasts about 3-4 hours.
After intravenous administration, the onset of action is immediate, occurring
within minutes, and lasts a minimum of one hour.
The major route of metabolism is via the glucuronidation pathway and
excretion occurs mainly in the urine.

5.3

Preclinical safety data
Standard toxicity tests revealed no unexpected finding of clinical significance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glucose
Water for injections.

6.2

Incompatibilities
Meptid injection should not be mixed with other drugs in the same infusion
solution or in the same syringe. Meptid injection is an acidic solution of the
hydrochloride salt of meptazinol and is therefore pharmaceutically
incompatible with injection solutions known to be strongly basic (for example
thiopentone) as precipitation of the meptazinol base may occur.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container

1 ml clear glass ampoules. The glass complies with the requirements of the European
Pharmacopoeia Type I. The ampoules will be packed in cartons of 10.
Not all pack sizes may be marketed.
6.6

7.

Special precautions for disposal
Single use only. Discard any unused contents.

MARKETING AUTHORISATION HOLDER

Almirall, S.A.
Ronda General Mitre 151

08022 Barcelona
Spain

8

MARKETING AUTHORISATION NUMBER(S)
PL 16973/0018

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/10/2005

10

DATE OF REVISION OF THE TEXT
19/06/2015

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Source: Medicines and Healthcare Products Regulatory Agency

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