Ibuprofen

Registered South African indications:

• Patent ductus arteriosus 

Contraindication 

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment
• Life-threatening infection
• Active bleeding, especially intracranial or gastrointestinal haemorrhage
• Thrombocytopenia or coagulation defects
• Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta)
• Known or suspected necrotising enterocolitis

Cautions 

• Mild to moderate renal impairment
• Hepatic impairment
• Prophylactic use at any gestational age
• Presence of an infection
• Marked elevated bilirubin concentration
• Preterm newborn infants <27 weeks of gestational age

Not indicated for use in adults

Paed. forms avail. in SA and covered in this monograph: inj

Patent ductus arteriosus
- Haemodynamically significant patent ductus arteriosus in preterm newborn infants <34 weeks of gestation

• IV: Initial: 10mg/kg, infused over 15min, within the first 6 hours of life; Second dose: 5mg/kg, infused over 15min, administered 24hrs after initial dose; Third dose: 5mg/kg, infused over 15min, administered 24hrs after second dose

 Treatment should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist

If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels

If the ductus arteriosus does not close 48hrs after the last injection or if it re-opens, a second course of 3 doses may be given

If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may then be necessary

See additional prescribing points

Pregnancy

• Not indicated for use in adults

Breastfeeding

• Not indicated for use in adults

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Contraindicated

Hepatic Impairment

• Caution; no information available
  Administer with caution and stop treatment if hepatic function deteriorates

Elderly

• Not indicated for use in geriatric patients

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Intraventricular haemorrhage
• Periventricular leukomalacia

Respiratory Disorders

• Bronchopulmonary dysplasia
• Pulmonary haemorrhage
• Hypoxemia

Gastrointestinal Disorders

• Necrotizing enterocolitis
• Intestinal perforation
• Gastrointestinal haemorrhage
• Gastric perforation

Genitourinary Disorders

• Oliguria
• Fluid retention
• Haematuria
• Acute renal failure
• Increased blood creatinine
• Decreased blood sodium

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Neutropenia

• Diuretics
• Anticoagulants
• Corticosteroids
• Nitric oxide
• Other nonsteroidal anti-inflammatory drugs
• Aminoglycosides

• Renal function
• Echocardiogram
• Gastrointestinal function
• Bilirubin

None routine. Specific cases may require

• Pulmonary pressure
• Signs of bleeding

Method of administration

• Ibuprofen should be administered as a short IV infusion over 15mins, preferably undiluted. If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection
• Any unused portion of the solution should be discarded
• The total volume of solution injected should take into account the total daily fluid volume administered

Incompatibilities

• Ibuprofen solution must not be in contact with any acidic solution, such as certain antibiotics or diuretics. A rinse of the infusion line must be performed between each product administration
• Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the ibuprofen solution. Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended

Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activity.The therapeutic effect, as a non-steroidal anti-inflammatory drug (NSAID), is thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis. Since prostaglandins are involved in the persistence of the ductus arteriosus after birth, this effect is believed to be the main mechanism of action of ibuprofen in this indication.

Injection (per 2ml) 10mg

• Pedea (Equity) originator

Also available in the following forms: Suspension, capsule, tablet and gel.