CAUTIONARY AND ADVISORY LABELS 2, 21
Ketotifen (as Ketotifen fumarate) 1 mg Zaditen 1mg tablets | 60 tablet P £7.53 DT = £7.53
Symptomatic relief of allergy such as hay fever and
urticaria | Insomnia associated with urticaria and
▶ Child 2–4 years: 5 mg twice daily, alternatively 5–15 mg
once daily, dose to be taken at night
▶ Child 5–9 years: 5–10 mg twice daily, alternatively
10–25 mg once daily, dose to be taken at night
▶ Child 10–17 years: 10–20 mg 2–3 times a day,
alternatively 25 mg once daily, dose to be taken at
night, increased if necessary to 25 mg twice daily
▶ Adult: 10–20 mg 2–3 times a day
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 25–50 mg (max. per dose 100 mg)
Emergency treatment of anaphylactic reactions
▶ BY SLOW INTRAVENOUS INJECTION
▶ Adult: 25–50 mg, to be administered as a solution
containing 2.5 mg/mL in water for injections;
▶ BY DEEP INTRAMUSCULAR INJECTION
Nausea | Vomiting | Vertigo | Labyrinthine disorders |
▶ Child 2–4 years: 5 mg, to be taken at bedtime on night
before travel, repeat following morning if necessary
▶ Child 5–9 years: 10 mg, to be taken at bedtime on night
before travel, repeat following morning if necessary
286 Allergic conditions BNF 78
▶ Child 10–17 years: 20–25 mg, to be taken at bedtime on
night before travel, repeat following morning if
▶ Adult: 20–25 mg, to be taken at bedtime on night
before travel, repeat following morning if necessary
MHRA/CHM ADVICE (MARCH 2008 AND FEBRUARY 2009) OVERTHE-COUNTER COUGH AND COLD MEDICINES FOR CHILDREN
Children under 6 years should not be given over-thecounter cough and cold medicines containing
l CONTRA-INDICATIONS Should not be given to children
under 2 years, except on specialist advice, because the
safety of such use has not been established
GENERAL CAUTIONS Epilepsy . prostatic hypertrophy (in
adults). pyloroduodenal obstruction . severe coronary
artery disease . susceptibility to angle-closure glaucoma . urinary retention
▶ With intravenous use Avoid extravasation with intravenous
l INTERACTIONS → Appendix 1: antihistamines, sedating
▶ With parenteral use Appetite decreased . epigastric
SIDE-EFFECTS, FURTHER INFORMATION Elderly patients are
more susceptible to anticholinergic side-effects.
l PREGNANCY Most manufacturers of antihistamines advise
avoiding their use during pregnancy; however, there is no
evidence of teratogenicity. Use in the latter part of the
third trimester may cause adverse effects in neonates such
as irritability, paradoxical excitability, and tremor.
l BREAST FEEDING Most antihistamines are present in
breast milk in varying amounts; although not known to be
harmful, most manufacturers advise avoiding their use in
mothers who are breast-feeding.
l HEPATIC IMPAIRMENT Manufacturer advises caution.
l RENAL IMPAIRMENT Use with caution.
Driving and skilled tasks Drowsiness may affect the
performance of skilled tasks (e.g. cycling or driving);
sedating effects enhanced by alcohol.
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Promethazine Hydrochloride Tablets 10 mg or 25 mg may
Promethazine Hydrochloride Oral Solution (elixir)
l LESS SUITABLE FOR PRESCRIBING Promethazine is less
suitable for prescribing for sedation.
l EXCEPTIONS TO LEGAL CATEGORY Prescription only
medicine restriction does not apply to promethazine
hydrochloride injection where administration is for saving
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
EXCIPIENTS: May contain Sulfites
Promethazine hydrochloride 25 mg per 1 ml Phenergan 25mg/1ml
solution for injection ampoules | 10 ampoule P £6.74
CAUTIONARY AND ADVISORY LABELS 2
EXCIPIENTS: May contain Sulfites
ELECTROLYTES: May contain Sodium
Promethazine hydrochloride 1 mg per 1 ml Phenergan 5mg/5ml
elixir sugar-free | 100 ml p £2.85 DT = £2.85
CAUTIONARY AND ADVISORY LABELS 2
▶ Promethazine hydrochloride (Non-proprietary)
Promethazine hydrochloride 10 mg Promethazine hydrochloride
10mg tablets | 56 tablet P £3.56 DT = £3.41
Promethazine hydrochloride 25 mg Promethazine hydrochloride
25mg tablets | 56 tablet p £4.65 DT = £4.65
Promethazine hydrochloride 25 mg Phenergan 25mg tablets | 56 tablet p £4.65 DT = £4.65
Promethazine hydrochloride 20 mg Sominex 20mg tablets | 8 tablet p £1.89 | 16 tablet p £2.69
VACCINES › ALLERGEN-TYPE VACCINES
▶ Adult: (consult product literature)
In view of concerns about the safety of desensitising
vaccines, it is recommended that they are used by
specialists and only for the following indications:
. seasonal allergic hay fever (caused by pollen) that has
not responded to anti-allergic drugs;
. hypersensitivity to wasp and bee venoms.
Desensitising vaccines should generally be avoided or
used with particular care in patients with asthma.
l CONTRA-INDICATIONS Consult product literature
l CAUTIONS Consult product literature
l INTERACTIONS → Appendix 1: bee venom extract
SIDE-EFFECTS, FURTHER INFORMATION Life-threatening
hypersensitivity reactions can occur. Cardiopulmonary
resuscitation must be immediately available. Manufacturer
advises monitoring for at least 1 hour after injection.
l PRESCRIBING AND DISPENSING INFORMATION Each set of
allergen extracts usually contains vials for the
administration of graded amounts of allergen to patients
undergoing hyposensitisation. Maintenance sets
containing vials at the highest strength are also available.
Product literature must be consulted for details of
allergens, vial strengths, and administration.
BNF 78 Allergic conditions 287
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Pharmalgen® for the treatment of bee and wasp venom
allergy (February 2012) NICE TA246
. a severe systemic reaction to bee or wasp venom, or
. a moderate systemic reaction to bee or wasp venom and
who have a raised baseline serum-tryptase
concentration, a high risk of future stings, or anxiety
Treatment with Pharmalgen ® should be initiated and
monitored in a specialist centre experienced in venom
www.nice.org.uk/guidance/ta246
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder and solvent for solution for injection
▶ Pharmalgen Bee Venom (ALK-Abello Ltd)
Bee venom 120 nanogram Pharmalgen Bee Venom 120nanogram
powder and solvent for solution for injection vials | 1 vial P s
Bee venom 1.2 microgram Pharmalgen Bee Venom 1.2microgram
powder and solvent for solution for injection vials | 1 vial P s
Bee venom 12 microgram Pharmalgen Bee Venom 12microgram
powder and solvent for solution for injection vials | 1 vial P s
Bee venom 120 microgram Pharmalgen Bee Venom maintenance
set 120microgram powder and solvent for solution for injection vials | 4 vial P £150.00
Treatment of seasonal allergic hay fever due to grass
pollen in patients who have failed to respond to antiallergy drugs
▶ Adult: (consult product literature)
Treatment of seasonal allergic hay fever due to grass
▶ Adult: 1 tablet daily, treatment to be started at least
4 months before start of pollen season and continue for
In view of concerns about the safety of desensitising
vaccines, it is recommended that they are used by
specialists and only for the following indications:
. seasonal allergic hay fever (caused by pollen) that has
not responded to anti-allergic drugs;
. hypersensitivity to wasp and bee venoms.
Desensitising vaccines should generally be avoided or
used with particular care in patients with asthma.
l CONTRA-INDICATIONS Consult product literature
l CAUTIONS Consult product literature
l INTERACTIONS → Appendix 1: grass pollen extract
SIDE-EFFECTS, FURTHER INFORMATION Hypersensitivity
reactions to immunotherapy can be life-threatening;
bronchospasm usually develops within 1 hour and
anaphylaxis within 30 minutes of injection. Therefore,
cardiopulmonary resuscitation must be immediately
available and patients need to be monitored for at least
1 hour after injection. If symptoms or signs of
hypersensitivity develop (e.g. rash, urticaria,
bronchospasm, faintness), even when mild, the patient
should be observed until these have resolved completely.
l PREGNANCY Should be avoided in pregnant women—
l MONITORING REQUIREMENTS The first dose of grass pollen
extract (Grazax ®) should be taken under medical
supervision and the patient should be monitored for
l DIRECTIONS FOR ADMINISTRATION Oral lyophylisates
should be placed under the tongue and allowed to
disperse. Advise patient not to swallow for 1 minute, or eat
or drink for 5 minutes after taking the tablet. The first
should be taken under medical supervision and the patient
should be monitored for 20–30 minutes.
l PRESCRIBING AND DISPENSING INFORMATION Each set of
allergen extracts usually contains vials for the
administration of graded amounts of allergen to patients
undergoing hyposensitisation. Maintenance sets
containing vials at the highest strength are also available.
Product literature must be consulted for details of
allergens, vial strengths, and administration.
▶ With oral use Patients or carers should be given advice on
how to administer oral lyophilisates.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Pollinex Grasses + Rye (Allergy Therapeutics (UK) Ltd)
Pollinex Grasses + Rye suspension for injection treatment and
extension course vials | 4 vial P £450.00
Phleum pratense 75000 SQ-T Grazax 75,000 SQ-T oral lyophilisates
sugar-free | 30 tablet P £80.12 DT = £80.12
Treatment of seasonal allergic hay fever due to tree pollen
in patients who have failed to respond to anti-allergy
▶ Adult: (consult product literature)
In view of concerns about the safety of desensitising
vaccines, it is recommended that they are used by
specialists and only for the following indications:
. seasonal allergic hay fever (caused by pollen) that has
not responded to anti-allergic drugs;
. hypersensitivity to wasp and bee venoms.
Desensitising vaccines should generally be avoided or
used with particular care in patients with asthma.
l CONTRA-INDICATIONS Consult product literature
l CAUTIONS Consult product literature
l INTERACTIONS → Appendix 1: tree pollen extract
SIDE-EFFECTS, FURTHER INFORMATION Hypersensitivity
reactions to immunotherapy can be life-threatening.
Cardiopulmonary resuscitation must be immediately
available and patients need to be monitored for at least
1 hour after injection. If symptoms or signs of
hypersensitivity develop (e.g. rash, urticaria,
bronchospasm, faintness), even when mild, the patient
should be observed until these have resolved completely.
l PREGNANCY Should be avoided in pregnant women—
No comments:
Post a Comment
اكتب تعليق حول الموضوع