Ibuprofen/ Codeine

Registered South African indications:

• Pain

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Previous hypersensitivity reactions to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Patients with acute attacks of asthma or bronchospasm
• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Active or history of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs
• Active or history of recurrent ulcer, haemorrhage, or perforations
• Respiratory depression
• Chronic constipation
• Severe cardiovascular disease and/or heart failure
• Paediatric patients who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome
• CYP2D6 ultra-rapid metabolisers
• Nasal polyps associated with aspirin-induced bronchospasm
• History of bronchospasm, rhinitis, or urticaria associated with aspirin or other NSAIDs
• Patients on warfarin
• Concurrent use with monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping them
• Acute alcoholism
• Head injuries and conditions with increased intracranial pressure
• Diarrhoea associated with pseudomembranous colitis

Cautions

• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Elderly
• History of bronchial asthma
• History of allergic disease
• Systemic lupus erythematosus
• Mixed connective tissue disease 
• Hypertension
• History of heart failure 
• Congestive heart failure
• Established ischaemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease 
• Hyperlipidaemia
• Diabetes mellitus
• Smoking
• Hypotension
• Hypothyroidism
• Raised intracranial pressure or head injury
• History of gastrointestinal disease 
• Children with compromised respiratory function
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Relief of pain of inflammatory origin - mild to moderate
Fever

Ibuprofen/ Codeine
200/10 (mg)

• Oral (tab): 1-2 tab, 8hrly; Max: 6 tab/24hrs

200/ 12.8 (mg)

• Oral (tab): 1-2 tab, 4 hrly; Max: 6 tab/24hrs

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

Relief of pain of inflammatory origin - mild to moderate
Fever

Ibuprofen/ Codeine
200/ 12.8 (mg)

• Younger than 12 years: Not established for use
• Older than 12 years: See adult dosage

Pregnancy

• Contraindicated
• Whilst no teratogenic effects have been demonstrated in animal experiments, the use of this combination product should, if possible, be avoided during the first 6 months of pregnancy
• During the last trimester, ibuprofen is contraindicated as there is there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child

Breastfeeding

• Contraindicated
• Codeine should not be used during breastfeeding
• At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to affect the breastfed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal

Renal Impairment

• Mild to moderate: Caution; no information available
• Severe: Contraindicated 

Hepatic Impairment 

• Mild to moderate: Caution; no information available
• Severe: Contraindicated

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Aseptic meningitis
• Drowsiness
• Restlessness
• Irritability

Cardiovascular Disorders

• Oedema
• Cardiac failure
• Arterial thrombotic events 
• Myocardial infarction
• Hypertension

Respiratory Disorders

• Respiratory depression
• Cough suppression

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Dyspepsia
• Abdominal pain
• Flatulence
• Constipation
• Peptic ulcer
• Melaena
• Haematemesis
• Gastrointestinal haemorrhage or perforation
• Ulcerative stomatitis
• Crohn's disease 

Hepatobiliary Disorders

• Liver disorders

Genitourinary Disorders

• Acute renal failure
• Papillary necrosis

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritus
• Bullous reactions
• Stevens-Johnsons Syndrome
• Erythema multiforme
• Toxic epidermal necrolysis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Leukopenia
• Thrombocytopenia
• Anaemia

• Aspirin 
• Non-steroidal anti-inflammatory drugs
• Monoamine oxidase inhibitors
• Anticoagulants
• Warfarin
• Antihypertensives
• Diuretics
• Corticosteroids
• Antiplatelet agents 
• Selective serotonin reuptake inhibitors
• Cardiac glycosides
• Lithium
• Methotrexate
• Ciclosporin
• Mifepristone
• Tacrolimus
• Zidovudine
• Quinolone antibiotics

None routine. Specific cases may require

• Renal function
• Hepatic function
• Respiratory function

Ibuprofen
Ibuprofen inhibits prostaglandin synthesis by inhibition of cyclooxygenase.

Codeine
Codeine is a centrally acting weak analgesic. It exerts its effect through mu opioid receptors. It resembles morphine in its pharmacodynamic actions although much weaker in its effects.

COMBINATIONS PREPARATIONS

Ibuprofen/ Codeine

Tablet 200mg/10mg

• Ibucod (Pharmacre) originator

Tablet 200mg/12.8mg

• Nurofen Plus (Reckitt Benckiser) originator