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MEPIVACAINE HYDROCHLORIDE 20MG/ML SOLUTION FOR INJECTION

Active substance(s): MEPIVACAINE HYDROCHLORIDE

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Package Leaflet: Information for the user

Mepivacaine hydrochloride
10 mg/ml solution for injection
Mepivacaine hydrochloride
20 mg/ml solution for injection
Mepivacaine 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,
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet (see section 4).
What is in this leaflet:
1. What Mepivacaine hydrochloride solution for injection is and
what it is used for
2. What you need to know before you use Mepivacaine
hydrochloride solution for injection
3. How to use Mepivacaine hydrochloride solution for injection
4. Possible side effects
5. How to store Mepivacaine hydrochloride solution for
injection
6. Contents of the pack and other information

1. What Mepivacaine hydrochloride
solution for injectionis and what it is
used for
Local anaesthetic.
This medicine is used for the temporary localalised elimination
of pain sensation by local infiltration and regional nerve block
injection.

2. What you need to know before you are
given Mepivacaine hydrochloride
solution for injection
Do not use Mepivacaine hydrochloride solution for
injection
• if you are allergic to active substance(s) or any of the other
ingredients of this medicine (listed in section 6),
• if you suffer from severe heart rhythm disturbances (severe
disturbances of the electrical conduction system of the
heart),
• if you have an acute weakness of the heart muscle which
cannot be controlled by treatment (acute decompensated
heart failure),
• for anaesthesia of the neck of the womb (cervix) during
childbirth (paracervical anaesthesia) In addition, special
contraindications for epidural anaesthesia are
• Increased pressure inside the skull.
• Acute CNS (brain or spinal) disease including inflammation,
tumours, infectious viral or bacterial disease, narrowing of
the open spaces within your spine, active spinal disease
(such as spondylitis, tuberculosis and tumour) and spinal
trauma (such as fracture)
• Septicaemia (blood poisoning),
• Infection at the injection site
• Coagulation disorder or anticoagulant treatment (except
low-dose heparin)
• Heart attack and severe blood and fluid loss.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using
Mepivacaine hydrochloride solution for injection
If you suffer from:
• kidney or liver diseases,
• blockage of the blood vessels,
• calcification of the blood vessels (arteriosclerosis)
• nerve damage caused by diabetes.
• porphyria (disorder of the blood-producing system)
Other medicines and Mepivacaine hydrochloride solution
for injection
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Please tell your doctor or pharmacist if you are taking one of
the following medicines:
• Some strong medicines used to treat pain (e.g.
centrally-acting or opioid analgesics)
• Medicines used in anaesthesia (e.g. ether)
• Medicines used for muscle relaxation (e.g. non-depolarising
muscle relaxants)
• Medicines used to treat cardiac arrhythmias
(anti-arrhythmics)
• Other local anaesthetic agents
Pregnancy, breast-feeding and fertility
On the basis of long-standing use, anaesthetics of the
mepivacaine type are considered to be reasonably safe for
use on pregnant women.
Mepivacaine hydrochloride crosses the placenta, but
retrospective studies of pregnant women receiving local
anaesthetics for emergency surgery early in pregnancy have
not shown that local anaesthetics cause birth defects.
However, no controlled studies have been carried out in
pregnant women. Moreover, inadequately investigated animal
reproduction studies have been performed with mepivacaine.
Therefore, caution should be taken before administering this
anaesthetic during early pregnancy.
One possible complication of using Mepivacaine hydrochloride
solution for injection in obstetrics is the occurrence of arterial
hypotension in the mother.
It is not known whether local anaesthetics are excreted in
human milk. Because many drugs are excreted in human milk,
caution should be exercised when mepivacaine is
administered to a nursing woman.
It is not known whether local anaesthetics are excreted in
human milk. Because many drugs are excreted in human milk,
caution should be exercised when mepivacaine is
administered to a nursing woman. Should administration be
necessary during lactation, breast-feeding can be resumed
approximately 24 hours after the end of treatment.
Driving and using machines
Depending on the dose and route of administration
mepivacaine have a transient effect on mobility and
coordination.
When Mepivacaine hydrochloride solution for injection is used,
the doctor must decide in each individual case whether the
patient can drive or use machines.
Mepivacaine hydrochloride solution for injection contains
Sodium
Each ml of Mepivacaine 10 mg/ml solution for injection
contains 0.14 mmol (3.2 mg) of sodium.
Each 10 ml ampoule of Mepivacaine 10 mg/ml solution for
injection contains 1.4 mmol (32 mg) of sodium.

The following information is intended for healthcare
professionals only
Mepivacaine Hydrochloride 10 mg/ml solution for
injection
Mepivacaine Hydrochloride 20 mg/ml solution for
injection
Dosage
The medicinal product is for Infiltration anaesthesia, peripheral
nerve block, caudal and epidural anaesthesia use only.
The physician's experience and knowledge of the patient's
clinical condition are important when selecting the dose. The
smallest dose which leads to the desired effect has to be
administered.
The listing of recommended doses applies to adolescents
aged over 15 years and adults of average size for single use
(one dose).
1 ml Mepivacaine hydrochloride solution for injection contains
10 mg & 20 mg mepivacaine hydrochloride.

Conc Volume Dose
mg
mg/ml ml

Time to Duration
installatio hours
n/minutes

Surgical Anaesthesia
Epidural lumbar anaesthesia 20

200-300 -

-

100-200 50-240 10-20

1.5-2

10
20-30 200-300 15-30
20
10-15 200-300 Neural blocks (small peripheral nerve and infiltration)
- infiltration
10
1-20 200
- digital block
10
1-5
10-50
2-5
10
4
<400
3-5
- intercostal block (per
(Cumulsegment)-maximum number
ative
of simultaneous neural
dose of
blocks must be a maximum
each of
of 10
the
injections)
- peribulbar block
20
5-7.5 100-150 3-5
- Pudendal block
10
7-10 70-100 (on each side)

1-1.5
-

Epidural thoracic
administration
Caudal block

10-15

10
10-20
10-20 5-12

1.5-2
1-2

1.5-2
-

60

5-10

50-100

- Brachial plexus block
20
- axiliary
10
- supraclavicular, interscalene 10
and subclavicular
perivascular

3-5
25-35
30-40

60-100 250-350 300-400 15-30

1.5-2

- sciatic nerve block
- Femoral block or block
of fascia iliaca

15-20
10-20

300-400 15-30
100-200 -

2-3
-

Major peripheral neural block
- paracervical block
10
(on each side)*

20
10

* Not recommended during labour

3-5

3. How to take Mepivacaine hydrochloride
solution for injection
Mepivacaine hydrochloride solution for injection will be given
to you by a doctor. Your doctor will know the correct way to
give you this medicine.
The recommended dose that your doctor gives you will
depend on the type of pain relief that you need and the part of
your body that the medicine will be injected into. It will also
depending on type your body weight, age and physical
condition.
Mepivacaine hydrochloride solution for injection will be given
to you as an injection. The part of the body where you are
injected will depend on why you are being given Mepivacaine
hydrochloride solution for injection. Your doctor will give you
Mepivacaine hydrochloride solution for injection in one of the
following places:
• Into the skin (infiltration)
• Under the skin near a nerve (regional, plexus or nerve
blockade)
• Around the spinal cord (thoracic or lumbar epidural or caudal
anaesthesia).
Mepivacaine hydrochloride solution for injection should be
given as a slow injection. The maximum recommended dose
for single administration is:
- ENT region: 200 mg mepivacaine hydrochloride (3 mg/kg
body weight),
- Intercostal blockade: 300 mg mepivacaine hydrochloride (4
mg/kg body weight),
- Epidural anaesthesia and peripheral blockades: 400 mg
mepivacaine hydrochloride (6 mg/kg body weight),
- Plexus anaesthesia: 500 mg mepivacaine hydrochloride (7
mg/kg body weight).
- For caudal anaesthesia in children: 5 mg/kg body weight.
Individual differences are
possible:
Indications
Fracture repositioning
Sympathetic nerve blockade
Skin wheals
Lateral cutaneous nerve of
thigh blockade
Femoral nerve blockage
Median nerve blockage
Obturator nerve blockage
Phrenic nerve blockage
Radial nerve blockage
Ulnar nerve blockage
Digital nerve block, each nerve
Paracervical blockade, each side
Paravertebral blockade
Pudendal blockade, each side
Sacral blockade
Tonsillectomy, each tonsil

Dosage (ml)
5-20 ml
5-10 ml
0.1-2 ml
10 ml
10-20 ml
3-5 ml
10-15 ml
10-15 ml
10-20 ml
5-10 ml
1-2 ml
6-10 ml
5-10 ml
7-10 ml
10-30 ml
5-10 ml

In epidural anaesthesia, the dosage must be adjusted
according to age. The following values are a guide for the
lumbar region:
• 5-year-olds:
0.5 ml/segment
• 10-year-olds:
0.9 ml/segment
• 15-year-olds:
1.3 ml/segment
• 20-year-olds:
1.5 ml/segment
• 40-year-olds:
1.3 ml/segment
• 60-year-olds:
1.0 ml/segment
• 80-year-olds:
0.7 ml/segment
The maximum recommended dose for single administration is:
• ENT region: 200 mg mepivacaine hydrochloride (3 mg/kg
body weight),
• Epidural anaesthesia and peripheral blockades: 400 mg
mepivacaine hydrochloride (6 mg/kg body weight),
• Intercostal blockade: 300 mg mepivacaine hydrochloride
(4 mg/kg body weight),
• Plexus anaesthesia: 500 mg mepivacaine hydrochloride
(7 mg/kg body weight).
Smaller doses must in general be used in patients in impaired
general condition.

3

- Retrobulbar block

20

-

Each 20 ml vial of Mepivacaine 10 mg/ml solution for injection
contains 2.8 mmol (64 mg) of sodium.
Each ml of Mepivacaine 20 mg/ml solution for injection
contains 0.12 mmol (2.8 mg) of sodium.
Each 2 ml ampoule of Mepivacaine 20 mg/ml solution for
injection contains 0.24 mmol (5.6 mg) of sodium.
Each 5 ml ampoule of Mepivacaine 20 mg/ml solution for
injection contains 0.60 mmol (14 mg) of sodium.
Each 10 ml ampoule of Mepivacaine 20 mg/ml solution for
injection contains 1.2 mmol (28 mg) of sodium.
Each 20 ml vial of Mepivacaine 20 mg/ml solution for injection
contains 2.4 mmol (56 mg) of sodium.
To be taken into consideration by patients on a controlled
sodium diet.

1-1.5

In patients with certain pre-existing conditions (vascular
occlusion, arteriosclerosis or nerve damage due to diabetes)
the dose must be reduced by a third.
High plasma levels of the active substance can occur in
patients with impaired hepatic or renal function, in particular in
repeated use. In these cases a lower dose range is likewise
recommended.
Children aged between 1 and 15 years
For children the dosages must be calculated on an individual
basis, taking into account age and weight. The maximum dose
is 5 mg mepivacaine hydrochloride per kg body weight.
Individual differences are possible. For overweight children, a
gradual dose reduction is often necessary; the dose should be
based on ideal weight. Use of Mepivacaine hydrochloride
solution for injection in neonates should be avoided due to the
reduced metabolism of the active substance in the liver.
Instructions for use
The total dose should be administered via slow injection or
fractionated at an increasing dose, while closely monitoring
the vital functions of the patient with constant verbal contact.
When administering an epidural dose a prior test dose is

Wound care
Intravenous regional anaesthesia

Up to 30 ml
Up to 40 ml

An age-related adjustment is required for epidural anaesthesia
-

5-year-olds:
10-year-olds:
15-year-olds:
20-year-olds:
40-year-olds:
60-year-olds:
80-year-olds:

0.5 ml/segment
0.9 ml/segment
1.3 ml/segment
1.5 ml/segment
1.3 ml/segment
1.0 ml/segment
0.7 ml/segment

If you have given more Mepivacaine hydrochloride
solution for injection than you should
You may experience restlessness, dizziness, hearing and
visual disturbances, tingling in the region of the tongue and
mouth, slurred speech, nausea, vomiting, tremor and muscle
twitching as signs of an impending seizure, heart rhythm
disturbances, increased heart rate, raised blood pressure and
flushing. An extreme overdose can cause loss of
consciousness with respiratory and circulatory arrest.
If there are signs of overdose, the administration of
Mepivacaine hydrochloride solution for injection must be
halted immediately. Your doctor will decide what further
therapeutic measures are required, which may include an
infusion of a lipid emulsion.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The possible undesirable effects after use of Mepivacaine
hydrochloride solution for injection largely correspond to those
of other local anaesthetics. Undesirable effects caused by the
medicinal products itself are difficult to distinguish from the
physiological effects of nerve blockade (e.g. drop in blood
pressure, slow heart rate). They are also difficult to distinguish
from the consequences of the puncture, either direct (e.g.
nerve damage) or indirect (e.g. abscess at the administration
site).
In addition, any abnormal absorption characteristics or
disturbances of metabolism in the liver or disturbances in
excretion via the kidneys must be considered as a possible
cause of undesirable effects.
Possible side effects
Common (affects less than 1 in 10 people)
• pins and needles or numbness
• dizziness
• reduction in heart rate
• low blood pressure*, high blood pressure
• nausea*, vomiting.
Uncommon (affects less than 1 in 100 people)
• signs and symptoms of CNS toxicity, e.g. seizures, tingling
around the mouth, numbness of the tongue, hearing and
vision disturbances, loss of consciousness, tremor, ringing in
the ears (tinnitus), speech disturbances, suppression of the
functions of the CNS

recommended. Accidental intravascular injection can be
recognised by the specific toxicity symptoms. Accidental
intrathecal injection is recognised by the signs of spinal
blockade. If toxic symptoms occur, the injection must be
halted immediately.
Mepivacaine hydrochloride solution for injection is injected into
the space around the spinal cord for targeted anaesthesia of
individual nerves (epidural nerve block).
To anaesthetise tissue, Mepivacaine hydrochloride solution for
injection is injected into a localised area of tissue (infiltration
anaesthesia). To anaesthetise individual nerves (peripheral
nerve block), for pain therapy and sympathetic nerve
blockade, Mepivacaine hydrochloride solution for injection is
applied locally following targeted puncture, depending on
anatomical considerations.
Mepivacaine hydrochloride solution for injection should be
used only by those with the relevant knowledge of
successfully conducting the relevant anesthetic procedure.
As a general rule, low concentration solutions are applied in
continuous administration (drip).
Repeated use of this medicinal product can result in loss of
efficacy due to rapid development of tolerance to the drug
(tachyphylaxis).
For small surgical procedures, more short term anaesthesia is
desired.
In order to avoid side effects, the following points should be
noted:
• An intravenous access for an infusion (volume replacement)
should be placed in patients who are at risk and when using
high doses.
• In general an agent that causes narrowing of the blood
vessels should not be added to the therapy.
• The patient should be correctly positioned.
• Blood pressure, pulse/ECG and the size of the pupils must
be monitored.
• General and special contraindications and interactions with
other agents should be noted.
• Ensure that resuscitation equipment (e.g. to keep the airway
open and administer oxygen) and emergency medication to
treat toxic reactions are immediately available

Rare (affects less than 1 in 1,000 people)
• allergic reactions
• life threatening allergic reactionneuropathy (peripheral nerve
disease)
• peripheral nerve injury
• arachnoiditis (inflammation of one of the membranes that
cover the brain and spinal cord)
• double vision.
• heart rate disorders
• cardiac arrest
• respiratory failure
* These side effects occur more commonly after epidural
anaesthesia.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Mepivacaine
hydrochloride solution for injection
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions.
• Do not freeze.
• Do not use this medicine after the expiry date, which is
stated on the ampoule, vial and carton. The expiry date
refers to the last day of that month.
• Do not use this medicine if you notice the contents are
discoloured in any way or if particles are present.
• Mepivacaine hydrochloride solution for injection is for single
use only and should be used immediately after opening.
Discard any unused solution.
• 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.

Mepivacaine hydrochloride 10 mg/ml solution for injection:
10 ml red band ampoules are supplied in packs of 1 and 5
ampoules
20 ml vials with chlorobutyl rubber stopper and mist grey
flip-off seal are supplied in packs of 1, 5 and 10 vials
Mepivacaine hydrochloride 20 mg/ml solution for injection:
2 ml green band ampoules are supplied in packs of 1 and 5
ampoules
5 ml red band ampoules are supplied in packs of 1, 5, 10 and
50 ampoules
10 ml green band ampoules are supplied in packs of 1 and 5
ampoules
20 ml vials with chlorobutyl rubber stopper and lavender
flip-off seal are supplied in packs of 1, 5 and 10 vials
The ampoules are available in blister/ tray pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319, Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House
319, Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom
Wessling Hungary Kft.
Budapest, Fóti út 56 , 1047,
Hungary
This leaflet was last revised in 05/2016.

6. Contents of the pack and other
information
What Mepivacaine hydrochloride solution for injection
contains
The active substance is Mepivacaine hydrochloride.
Mepivacaine 10 mg/ml solution for injection:
Each 1 ml of solution contains Mepivacaine hydrochloride 10 mg.
Each 10 ml ampoule contains Mepivacaine hydrochloride100 mg.
Each 20 ml vial contains Mepivacaine hydrochloride 200 mg.
Mepivacaine 20 mg/ml solution for injection:
Each 1 ml of solution contains Mepivacaine hydrochloride 20 mg.
Each 2 ml ampoule contains Mepivacaine hydrochloride 40 mg.
Each 5 ml ampoule contains Mepivacaine hydrochloride 100 mg.
Each 10 ml ampoule contains Mepivacaine hydrochloride
200 mg.
Each 20 ml vial contains Mepivacaine hydrochloride 400 mg.
The other ingredients are water for injections, sodium chloride
and sodium hydroxide (for pH adjustment), hydrochloric acid
(for pH adjustment)
What Mepivacaine hydrochloride solution for injection
looks like and contents of the pack
Mepivacaine solution for injection is a clear, colourless, sterile
solution for injection. It is available in Type I clear glass
ampoules and Type I clear glass vials with rubber stopper and
flip-off seal.

• Have a lipidic emulsion available to administer in the event of
intoxication with clinical symptoms of neurotoxicity or
cardiotoxicity.
Use with caution:
• In patients receiving the anticoagulant treatment with low
molecular weight heparin
• When injecting into an inflamed (infected) area (increased
absorption accompanying reduced efficacy)
• In retrobulbar and peribulbar injections
• In epidural anaesthesia (injecting an anesthetic around the
spinal canal to achieve anaesthesia), low blood pressure and
slow heart rate can occur.
• In elderly patients (sudden arterial hypotension is one of the
possible complications of epidural anaesthesia),
• In patients in weakened general condition,
• In patients with partial or complete heart block
• In patients receiving the certain medicines to treat fever and
pain (non-steroidal anti-inflammatories) or agents to increase
the blood volume (plasma substitutes).
• Loss of cartilage tissue was reported in patients who had
received continuous infusions of local anesthetics in a joint after
surgery. In the majority of cases reported, the shoulder joint was
affected.
• Use in head and neck region is more hazardous, since the risk
for central nervous system intoxication symptoms is increased.
Method of administration
The method of administration of Mepivacaine varies according
to the method of infiltration anaesthesia, perineural
anaesthesia and epidural anaesthesia.
Handling Instructions
Only clear solutions practically free from particles should be used.
The solution for injection is intended for single withdrawal and
use only and must be used immediately after opening the
ampoule and vial. Any unused solution should be discarded.
Do not use this medicine after the expiry date, which is stated
on the ampoule, vial and carton. The expiry date refers to the
last day of that month.
Storage information
Do not freeze.
Use immediately after opening.
Shelf-life
2 years

INP021
10 00000 0 000000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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