title: Adverse reactions - Neonatal Intensive Care Drug Manual
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  Neonatal Intensive Care Drug Manual
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  bet | 283/654 | Sana | 03.01.2022 | Hajmi | 1,5 Mb. | | #14803 |
  Adverse reactions
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  Prophylactic use of ibuprofen is associated increased risks for oliguria, increase in serum creatinine levels, and increased risk of gastrointestinal haemorrhage.[5]. [LOE I]
  Ibuprofen for treatment of a PDA was associated with increased oliguria and increased creatinine. [LOE I]
  Compared to treatment of a PDA with indomethacin, ibuprofen was associated with reduced NEC, reduced oliguria and was associated with lower creatinine levels 72 hours after initiation of treatment.[6].[LOE I]
  Compared to paracetamol (acetaminophen), ibuprofen was associated with a high rate of gastrointestinal bleeding, higher creatinine and bilirubin levels, and lower platelet counts and daily urine output. [7].
  There have been reports of pulmonary hypertension with use of ibuprofen, [5, 6] although the rate may be similar to that reported for indomethacin.[8].
  Ibuprofen may displace bilirubin from albumin at high concentrations in vitro (200 micromol/L), [9] although this does not appear to occur in vivo at the concentrations associated with recommended doses (up to 100 micromol/L). [10].
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  Compatibility
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  Fluids: Pedea, neoprofen, caldolor - Sodium chloride 0.9%, glucose 5%. NeoProfen only- sterile water for injection.36
  Y site: Pedea : Not tested.
  Y site: Neoprofen: Ceftazidime, epinephrine hydrochloride, furosemide, heparin sodium, insulin, phenobarbital sodium, potassium chloride, sodium bicarbonate
  Y site: Caldolor: Metoprolol tartrate
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  Incompatibility
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  Caldolor (ibuprofen arginine), Neoprofen (ibuprofen lysine) and Pedea (ibuprofen sodium) - regard all other IV solutions and drugs as incompatible.
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  Stability
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  Caldolor: Diluted solutions are stable for up to 24 hours at room temperature (20−25° C) and room lighting.
  Neoprofen and Pedea: Discard unused portion once opened.
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  Storage
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  IV − store unopened vials at room temperature (20−25°C).
  Oral liquid − store below 25°C.
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  Excipients
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  PEDEA - Each 1 ml of PEDEA contains the following inactive ingredients: trometamol (3.78 mg), sodium hydroxide (0.14 mg), sodium chloride (7.3 mg), hydrochloric acid and water for injections. The headspace within the ampoules is filled with nitrogen.
  Caldolor – Each 1 mL of Caldolor also contains 78 mg of arginine at a molar ratio of 0.92:1 arginine: ibuprofen. Hydrochloric acid is added for pH adjustment.
  Neoprofen - Each mL of NeoProfen contains 17.1 mg of ibuprofen lysine (equivalent to 10 mg of (±)-ibuprofen) in Water for Injection. The pH is adjusted to 7.0 with sodium hydroxide or hydrochloric acid.
  Fenpaed - contains glycerol, xanthan gum, maltitol, polysorbate 80, saccharin sodium, citric acid monohydrate, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, purified water and strawberry flavour.
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