l CONTRA-INDICATIONS Use in child less than 37 weeks

corrected gestational age

l CAUTIONS

FORTACIN ® Acquired methaemoglobinaemia . anaemia . congenital methaemoglobinaemia

l INTERACTIONS → Appendix 1: anaesthetics, local . antiarrhythmics

l SIDE-EFFECTS

▶ Common or very common Sexual dysfunction (in adults)

▶ Uncommon Fever (in adults). headache (in adults). penis

disorder (in adults)

▶ Rare or very rare Methaemoglobinaemia . skin reactions

SIDE-EFFECTS, FURTHER INFORMATION When applied to

the glans penis, side-effects for sexual partners should be

considered. Side-effects reported in female partners

include vaginal candidiasis and dysuria.

l CONCEPTION AND CONTRACEPTION

FORTACIN ® Deterioration of polyurethane-based female

and male condoms has been observed. Manufacturer

advises avoid in patients planning to conceive, or if it is

essential to achieve penetration, then the glans penis

should be washed thoroughly 5 minutes after application

but before intercourse.

l PREGNANCY

FORTACIN ® Manufacturer advises preferably avoid unless

an effective male barrier contraceptive is used—limited

information available.

l HEPATIC IMPAIRMENT

FORTACIN ® Manufacturer advises caution in severe

impairment (no information available).

l DIRECTIONS FOR ADMINISTRATION

FORTACIN ® Manufacturer advises when using the spray

for the first time, shake and prime the unit with 3 sprays,

and before each subsequent use, shake and prime the unit

with 1 spray.

l PATIENT AND CARER ADVICE

Medicines for Children leaflet: EMLA cream for local anaesthesia

www.medicinesforchildren.org.uk/emla-cream-localanaesthesia

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Cream

▶ Denela (Teva UK Ltd)

Lidocaine 25 mg per 1 gram, Prilocaine 25 mg per 1 gram Denela

5% cream | 5 gram p £2.84–£3.29 | 25 gram p £12.99 | 30 gram p £14.75 DT = £12.30

▶ Emla (Aspen Pharma Trading Ltd)

Lidocaine 25 mg per 1 gram, Prilocaine 25 mg per 1 gram Emla

5% cream | 5 gram p £2.25–£2.99 | 25 gram p £11.70 | 30 gram p £12.30 DT = £12.30

▶ Nulbia (Glenmark Pharmaceuticals Europe Ltd)

Lidocaine 25 mg per 1 gram, Prilocaine 25 mg per 1 gram Nulbia

5% cream | 5 gram p £1.58 | 25 gram p £7.88 | 30 gram p

£8.61 DT = £12.30

Cutaneous spray solution

▶ Fortacin (Recordati Pharmaceuticals Ltd)

Prilocaine 50 mg per 1 ml, Lidocaine 150 mg per 1 ml Fortacin

150mg/ml / 50mg/ml cutaneous spray | 5 ml P £59.99

Mepivacaine hydrochloride 05-Aug-2018

l INDICATIONS AND DOSE

Infiltration anaesthesia and nerve block in dentistry

▶ Child 3–17 years: Consult expert dental sources

▶ Adult: Consult expert dental sources

DOSES AT EXTREMES OF BODY-WEIGHT

▶ To avoid excessive dosage in obese patients, dose

should be calculated on the basis of ideal body-weight.

IMPORTANT SAFETY INFORMATION

Should only be administered by, or under the direct

supervision of, personnel experienced in their use, with

adequate training in anaesthesia and airway

management, and should not be administered

parenterally unless adequate resuscitation equipment is

available.

l CONTRA-INDICATIONS Application to the middle ear (can

cause ototoxicity). avoid injection into infected tissues . avoid injection into inflamed tissues . complete heart block . preparations containing preservatives should not be used

for caudal, epidural, or spinal block, or for intravenous

regional anaesthesia (Bier’s block). should not be applied

to damaged skin

CONTRA-INDICATIONS, FURTHER INFORMATION

▶ Injection site Local anaesthetics should not be injected into

inflamed or infected tissues nor should they be applied to

damaged skin. Increased absorption into the blood

increases the possibility of systemic side-effects, and the

local anaesthetic effect may also be reduced by altered

local pH.

l CAUTIONS Cardiovascular disease . children (consider dose

reduction). debilitated patients (consider dose reduction). elderly (consider dose reduction)(in adults) . epilepsy . hypovolaemia . impaired cardiac conduction . impaired

respiratory function . myasthenia gravis . shock

l INTERACTIONS → Appendix 1: anaesthetics, local

l SIDE-EFFECTS

▶ Common or very common Arrhythmias . dizziness . hypertension . hypotension . nausea . paraesthesia . vomiting

▶ Uncommon Neurotoxicity

▶ Rare or very rare Arachnoiditis . cardiac arrest. diplopia . nerve disorders .respiratory depression

SIDE-EFFECTS, FURTHER INFORMATION Toxic effects after

administration of local anaesthetics are a result of

excessively high plasma concentrations; severe toxicity

usually results from inadvertent intravascular injection or

too rapid injection. The systemic toxicity of local

anaesthetics mainly involves the central nervous and

cardiovascular systems. The onset of toxicity can be

unpredictable and delayed. Monitor as per local protocol

for at least 30 minutes after administration.

l ALLERGY AND CROSS-SENSITIVITY

▶ Hypersensitivity and cross-sensitivity Hypersensitivity

reactions occur mainly with the ester-type local

anaesthetics, such as tetracaine; reactions are less

frequent with the amide types, such as articaine,

bupivacaine, levobupivacaine, lidocaine, mepivacaine,

prilocaine, and ropivacaine. Cross-sensitivity reactions

may be avoided by using the alternative chemical type.

l PREGNANCY Use with caution in early pregnancy.

l BREAST FEEDING Use with caution.

l HEPATIC IMPAIRMENT Manufacturer advises caution;

increased risk of toxic plasma concentrations in severe

impairment.

l RENAL IMPAIRMENT Use with caution; increased risk of

side-effects.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

▶ Scandonest plain (Septodont Ltd)

Mepivacaine hydrochloride 30 mg per 1 ml Scandonest plain 3%

solution for injection 2.2ml cartridges | 50 cartridge P £21.95

BNF 78 Local anaesthesia 1355

Anaesthesia

15

Mepivacaine with adrenaline

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, mepivacaine hydrochloride p. 1355,

adrenaline/epinephrine p. 222.

l INDICATIONS AND DOSE

Infiltration anaesthesia and nerve block in dentistry

▶ BY LOCAL INFILTRATION

▶ Adult: (consult product literature)

IMPORTANT SAFETY INFORMATION

Adrenaline/epinephrine must be used in a low

concentration when administered with a local

anaesthetic. The total dose of adrenaline should not

exceed 500 micrograms and it is essential not to exceed a

concentration of 1 in 200 000 (5 micrograms/mL) if more

than 50 mL of the mixture is to be injected.

l INTERACTIONS → Appendix 1: anaesthetics, local . sympathomimetics, vasoconstrictor

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Solution for injection

EXCIPIENTS: May contain Sulfites

▶ Scandonest special (Septodont Ltd)

Adrenaline 10 microgram per 1 ml, Mepivacaine hydrochloride

20 mg per 1 ml Scandonest special 2% solution for injection 2.2ml

cartridges | 50 cartridge P £21.95

Prilocaine hydrochloride

l INDICATIONS AND DOSE

DOSES AT EXTREMES OF BODY-WEIGHT

To avoid excessive dosage in obese patients, dose should

be calculated on the basis of ideal body-weight.

CITANEST 1% ®

Infiltration anaesthesia | Nerve block

▶ BY REGIONAL ADMINISTRATION

▶ Adult: 100–200 mg/minute, alternatively may be given

in incremental doses; dose adjusted according to site of

administration and response, and in elderly and

debilitated patients (smaller doses may be required);

maximum 400 mg per course

PRILOTEKAL ®

Spinal anaesthesia

▶ BY INTRATHECAL INJECTION

▶ Adult: Usual dose 40–60 mg (max. per dose 80 mg),

dose may need to be reduced in elderly or debilitated

patients, or in late pregnancy

IMPORTANT SAFETY INFORMATION

Should only be administered by, or under the direct

supervision of, personnel experienced in their use, with

adequate training in anaesthesia and airway

management, and should not be administered

parenterally unless adequate resuscitation equipment is

available.

l CONTRA-INDICATIONS Acquired methaemoglobinaemia . anaemia . application to the middle ear (can cause

ototoxicity). avoid injection into infected tissues . avoid

injection into inflamed tissues . complete heart block . congenital methaemoglobinaemia . preparations

containing preservatives should not be used for caudal,

epidural, or spinal block, or for intravenous regional

anaesthesia (Bier’s block). should not be applied to

damaged skin

CONTRA-INDICATIONS, FURTHER INFORMATION

▶ Injection site Local anaesthetics should not be injected into

inflamed or infected tissues nor should they be applied to

damaged skin. Increased absorption into the blood

increases the possibility of systemic side-effects, and the

local anaesthetic effect may also be reduced by altered

local pH.

l CAUTIONS Cardiovascular disease . debilitated patients

(consider dose reduction). elderly (consider dose

reduction). epilepsy . hypovolaemia . impaired cardiac

conduction . impaired respiratory function . myasthenia

gravis . severe or untreated hypertension . shock

l INTERACTIONS → Appendix 1: anaesthetics, local

l SIDE-EFFECTS

▶ Common or very common Arrhythmias . dizziness . hypertension . hypotension . nausea . paraesthesia . vomiting

▶ Uncommon Neurotoxicity

▶ Rare or very rare Cardiac arrest. methaemoglobinaemia . nerve disorders

▶ Frequency not known Diplopia .respiratory depression

SIDE-EFFECTS, FURTHER INFORMATION Toxic effects Toxic

effects after administration of local anaesthetics are a

result of excessively high plasma concentrations; severe

toxicity usually results from inadvertent intravascular

injection or too rapid injection. The systemic toxicity of

local anaesthetics mainly involves the central nervous and

cardiovascular systems. The onset of toxicity can be

unpredictable and delayed. Monitor as per local protocol

for at least 30 minutes after administration.

Methaemoglobinaemia Methaemoglobinaemia can be

treated with an intravenous injection of methylthioninium

chloride.

l ALLERGY AND CROSS-SENSITIVITY

▶ Hypersensitivity and cross-sensitivity Hypersensitivity

reactions occur mainly with the ester-type local

anaesthetics, such as tetracaine; reactions are less

frequent with the amide types, such as articaine,

bupivacaine, levobupivacaine, lidocaine, mepivacaine,

prilocaine, and ropivacaine. Cross-sensitivity reactions

may be avoided by using the alternative chemical type.

l PREGNANCY Large doses during delivery can cause

neonatal respiratory depression, hypotonia, and

bradycardia after epidural block. Avoid paracervical or

pudendal block in obstetrics (neonatal

methaemoglobinaemia reported).

Dose adjustments Use lower doses for intrathecal use

during late pregnancy.

l BREAST FEEDING Present in milk but not known to be

harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution.

Dose adjustments ▶ With intrathecal use Manufacturer

advises consider dose reduction.

l RENAL IMPAIRMENT Use with caution.

Dose adjustments Lower doses may be required for

intrathecal anaesthesia.

l NATIONAL FUNDING/ACCESS DECISIONS

PRILOTEKAL ®

Scottish Medicines Consortium (SMC) decisions

▶ With intrathecal use The Scottish Medicines Consortium has

advised (December 2010) that prilocaine 2% hyperbaric

solution for injection (Prilotekal ®) is accepted for

restricted use within NHS Scotland for use in spinal

anaesthesia in ambulatory surgery settings.

1356 Local anaesthesia BNF 78

Anaesthesia

15

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