BNF for Children (BNFC) 2018-2019

(singke) #1

worsening heartburn, pain on swallowing or retrosternal
pain.
lPREGNANCYAvoid.


lBREAST FEEDINGManufacturer advises avoid—no
information available.


lRENAL IMPAIRMENTAvoid if estimated glomerular
filtration rate is less than 35 mL/minute/ 1. 73 m^2.


lMONITORING REQUIREMENTSCorrect disturbances of
calcium and mineral metabolism (e.g. vitamin-D
deficiency, hypocalcaemia) before starting treatment.
Monitor serum-calcium concentration during treatment.


lDIRECTIONS FOR ADMINISTRATIONTablets should be
swallowed whole and oral solution should be swallowed as
a single 100 mL dose. Doses should be taken with plenty of
water while sitting or standing, on an empty stomach at
least 30 minutes before breakfast (or another oral
medicine); patient should stand or sit upright for at least
30 minutes after administration.
lPATIENT AND CARER ADVICEPatients or their carers should
be given advice on how to administer alendronic acid
tablets and oral solution.
Oesophageal reactionsPatients (or their carers) should be
advised to stop taking alendronic acid and to seek medical
attention if they develop symptoms of oesophageal
irritation such as dysphagia, new or worsening heartburn,
pain on swallowing or retrosternal pain.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral solution
Oral solution
▶Alendronic acid (Non-proprietary)
Alendronic acid 700 microgram per 1 mlAlendronic acid
70 mg/ 100 ml oral solution unit dose sugar free sugar-free| 4 unit
doseP£ 28. 56 DT = £ 28. 56
Effervescent tablet
▶Binosto(Internis Pharmaceuticals Ltd)
Alendronic acid (as Alendronate sodium) 70 mgBinosto 70 mg
effervescent tablets sugar-free| 4 tabletP£ 22. 80 DT = £ 22. 80
Tablet
▶Alendronic acid (Non-proprietary)
Alendronic acid (as Alendronate sodium) 10 mgAlendronic acid
10 mg tablets| 28 tabletP£ 3. 25 DT = £ 1. 38
Alendronic acid (as Alendronate sodium) 70 mgAlendronic acid
70 mg tablets| 4 tabletP£ 22. 80 DT = £ 0. 41
▶Fosamax Once Weekly(Merck Sharp & Dohme Ltd)
Alendronic acid (as Alendronate sodium) 70 mgFosamax Once
Weekly 70 mg tablets| 4 tabletP£ 22. 80 DT = £ 0. 41
eiiiiF 468


Pamidronate disodium


(Formerly called
aminohydroxypropylidenediphosphonate
disodium (APD))

lINDICATIONS AND DOSE
Osteoporosis (due to osteogenesis imperfecta and other
causes) (specialist use only)|Hypercalcaemia (specialist
use only)
▶BY INTRAVENOUS INFUSION
▶Child:(consult product literature)

lUNLICENSED USENot licensed for use in children.


lCAUTIONSAtypical femoral fractures.cardiac disease.
ensure adequate hydration.previous thyroid surgery (risk
of hypocalcaemia)


lINTERACTIONS→Appendix 1 : bisphosphonates


lSIDE-EFFECTS
▶Common or very commonAppetite decreased.chills.
decreased leucocytes.drowsiness.electrolyte imbalance.


flushing.hypertension.insomnia.paraesthesia.tetany.
thrombocytopenia
▶UncommonAgitation.dyspnoea.eye inflammation.
hypotension.muscle cramps.osteonecrosis.seizure
▶Rare or very rareConfusion.glomerulonephritis.
haematuria.heart failure.nephritis tubulointerstitial.
nephrotic syndrome.oedema.pulmonary oedema.
reactivation of infections.renal disorder exacerbated.
renal tubular disorder.respiratory disorders.visual
hallucinations.xanthopsia
▶Frequency not knownAtrialfibrillation
lPREGNANCYAvoid—toxicity inanimalstudies.
lBREAST FEEDINGAvoid.
lHEPATIC IMPAIRMENTCaution in severe hepatic
impairment—no information available.
lRENAL IMPAIRMENT
MonitoringMonitor renal function in renal disease or
predisposition to renal impairment (e.g. in tumour-
induced hypercalcaemia).
lDIRECTIONS FOR ADMINISTRATIONForslow intravenous
infusion(Aredia®;Pamidronate disodium, Hospira, Medac,
Wockhardt), give intermittently in Glucose 5 % or Sodium
chloride 0. 9 %; give at a rate not exceeding 1 mg/minute;
not to be given with infusionfluids containing calcium.
ForAredia®, reconstitute initially with water for injections
( 15 mg in 5 mL, 30 mg or 90 mg in 10 mL), then dilute with
infusionfluid to a concentration of not more than 90 mg in
250 mL. ForPamidronate disodium(Medac, Hospira,
Wockhardt) dilute with infusionfluid to a concentration of
not more than 90 mg in 250 mL
lPATIENT AND CARER ADVICEA patient reminder card
should be provided (risk of osteonecrosis of the jaw).
Driving and skilled tasksPatients should be warned against
performing skilled tasks (e.g. cycling, driving or operating
machinery) immediately after treatment (somnolence or
dizziness can occur).

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for infusion
▶Pamidronate disodium (Non-proprietary)
Pamidronate disodium 3 mg per 1 mlPamidronate disodium
15 mg/ 5 ml solution for infusion vials| 1 vialP£ 27. 50 (Hospital
only)| 5 vialP£ 149. 15 (Hospital only)
Pamidronate disodium 30 mg/ 10 ml solution for infusion vials|
1 vialP£ 55. 00 – £ 59. 66 (Hospital only)
Pamidronate disodium 60 mg/ 20 ml solution for infusion vials|
1 vialP£ 110. 00 (Hospital only)
Pamidronate disodium 90 mg/ 30 ml solution for infusion vials|
1 vialP£ 165. 00 (Hospital only)
Pamidronate disodium 9 mg per 1 mlPamidronate disodium
90 mg/ 10 ml solution for infusion vials| 1 vialP£ 170. 45 (Hospital
only)
Pamidronate disodium 15 mg per 1 mlPamidronate disodium
60 mg/ 4 ml solution for infusion ampoules| 1 ampouleP£ 119. 32
Pamidronate disodium 15 mg/ 1 ml solution for infusion ampoules|
4 ampouleP£ 119. 32
Pamidronate disodium 90 mg/ 6 ml solution for infusion ampoules|
1 ampouleP£ 170. 46
Pamidronate disodium 30 mg/ 2 ml solution for infusion ampoules|
2 ampouleP£ 119. 32

eiiiiF 468

Risedronate sodium 28-Sep-2017


lINDICATIONS AND DOSE
Osteoporosis (due to osteogenesis imperfecta and other
causes) (specialist use only)|Hypercalcaemia (specialist
use only)
▶BY MOUTH
▶Child:(consult local protocol)

lUNLICENSED USENot licensed for use in children.

BNFC 2018 – 2019 Disorders of bone metabolism 469


Endocrine system

6

Free download pdf