Ibuprofen/ Pseudoephedrine

Registered South African indications: 

• Relief of symptoms of colds and flu
  - Including aches and pains, headaches, fever, sore throat, blocked nose and sinuses

Registered South African contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drug (NSAIDs)
• Use in children under the age of 12 years
• Pregnancy
  - Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus
• Breastfeeding
• Renal failure
• Hepatic failure
• Heart failure
• Active or history of recurrent ulcer, haemorrhage or perforations
• History of gastrointestinal bleeding or perforation (PUBs), related to previous non-steroidal anti-inflammatory drug therapy
• Severe coronary heart disease and cardiovascular disorders
• Severe hypertension
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drug (NSAIDs)
• Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
• Severe coronary heart disease and cardiovascular disorders
• Severe hypertension
• Severe heart failure, renal failure or hepatic failure
• Last trimester of pregnancy
• Children under the age of 12 years
• Coadministration with monoamine oxidase inhibitors or within 14 days of their use

• First and second trimester of pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Women of childbearing potential (Recommendations in other jurisdictions)
• Elderly
• Bronchial asthma
• Allergic disease
• Systemic lupus erythematosus 
• Mixed connective tissue disease 
• High doses
• Congestive cardiac failure 
• Established ischaemic heart disease
• Peripheral arterial disease
• Cerebrovascular disease
• Risk factors for cardiovascular events
• Females attempting to conceive
• Prostatic hypertrophy
• Hypercholesterolaemia
• History of gastrointestinal disease
• History of ulcer
• History of gastrointestinal toxicity

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

South African registered indications and dosages

Relief of symptoms of colds and flu
- Including aches and pains, headaches, fever, sore throat, blocked nose and sinuses

Ibuprofen/ Pseudoephedrine
200/ 30 (mg)

• Oral (fct, tab): Initial: 2 tab, taken with water; Then: 1-2 tab, 4-6hrly if needed; Max: 6 tab/24hrs

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If symptoms persist for more than 3 days, the patient must be advised to seek medical advice

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Lowest possible dose should be used, for the shortest possible duration of treatment

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

South African registered indications and dosages

Relief of symptoms of colds and flu
- Including aches and pains, headaches, fever, sore throat, blocked nose and sinuses

Ibuprofen/ Pseudoephedrine
200/ 30 (mg)

• Younger than 12 years: Contraindicated
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Contraindicated
• Ibuprofen/ pseudoephedrine is contraindicated in pregnancy
• Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus

Recommendations in other jurisdictions

• First and second trimester: Caution; not recommended
• Last trimester: Contraindicated
• No teratogenic effects observed in animal experiments. Avoid using ibuprofen/ pseudoephedrine during the first 6 months of pregnancy
• Starting from the 20th week, it may cause oligohydramnios due to foetal renal dysfunction. Oligohydramnios can arise shortly after starting treatment and is often reversible upon stopping. Reports exist of ductus arteriosus constriction after treatment in the second trimester; most resolved after stopping the treatment
• During the first and second trimesters, only use ibuprofen/ pseudoephedrine when absolutely necessary. If a woman trying to conceive or in the first two trimesters uses it, keep the dose low and treatment duration short. Consider antenatal monitoring for oligohydramnios and ductus arteriosus constriction if exposed to the drug from the 20th week
• Discontinue ibuprofen/ pseudoephedrine if oligohydramnios or ductus arteriosus constriction is detected. In the last trimester, ibuprofen is contraindicated due to the risk of premature constriction/closure of the foetal ductus arteriosus and potential pulmonary hypertension. The drug can delay the start of labour, extend its duration, and increase bleeding risk in both mother and child

Breastfeeding

South African recommendations

• Contraindicated
• Ibuprofen/ pseudoephedrine is contraindicated in breastfeeding women
• Although ibuprofen appears in breast milk in very low concentrations, significant amounts of pseudoephedrine are secreted into breast milk and the use of ibuprofen/ pseudoephedrine during lactation should be avoided

Recommendations in other jurisdictions

• Caution; not recommended
• Although ibuprofen appears in breast milk in very low concentrations, significant amounts of pseudoephedrine are secreted into breast milk and the use of ibuprofen/ pseudoephedrine during lactation should be avoided

Fertility

South African recommendations

• No information available

Recommendations in other jurisdictions

• There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment

South African recommendations

• Contraindicated

Recommendations in other jurisdictions

• Contraindicated
  In moderate to severe renal impairment, renal function may further deteriorate, especially in dehydrated children and adolescents

Recommendations below are applicable to South Africa and other jurisdictions

• Contraindicated

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no dose adjustment recommended
  The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal

Central Nervous System Disorders

• Headache
• Aseptic meningitis
• Anxiety
• Tremors
• Hallucinations
• Dizziness
• Restlessness
• Insomnia
• Anorexia
• Psychotic reactions
• Depression

Cardiovascular Disorders

• Oedema
• Hypertension
• Cardiac failure
• Arterial thrombotic events
• Cardiac arrhythmias
• Precordial pain
• Palpitations

Respiratory Disorders

• Asthma
• Bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Dyspepsia
• Diarrhoea
• Flatulence
• Constipation
• Peptic ulcer
• Perforation or gastrointestinal haemorrhage
• Melaena
• Haematemesis
• Ulcerative stomatitis
• Gastritis
• Exacerbation of ulcerative colitis and Crohn's disease
• Dry mouth
• Oesophagitis
• Pancreatitis
• Intestinal diaphragm-like stricture

Hepatobiliary Disorders

• Hepatic dysfunction

Genitourinary Disorders

• Acute renal failure
• Papillary necrosis
• Difficulty in micturition

Endocrine and Metabolic Disorders

• Thirst
• Sweating

Musculoskeletal Disorders

• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Rash
• Bullous reactions
• Stevens-Johnson Syndrome
• Erythema multiforme
• Toxic epidermal necrolysis
• Bruising pruritis
• Urticaria
• Purpura
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Exacerbation of asthma and bronchospasm
• Haematopoietic disorders
• Exacerbation of existing autoimmune disorders

Sensory Disorders

• Hearing disturbance
• Visual disturbances
• Tinnitus
• Vertigo

• Monoamine oxidase inhibitors
• Corticosteroids
• Anticoagulants
• Sympathomimetics agents
• Selective serotonin reuptake inhibitors
• Antiplatelet agents
• Non-steroidal anti-inflammatory drugs
• Tricyclic antidepressants
• Acetylsalicylic acid
• Antihypertensives
• Diuretics
• Cardiac glycosides
• Lithium
• Methotrexate
• Ciclosporin
• Mifepristone
• Tacrolimus
• Zidovudine
• Quinolone antibiotics
• Guanethidine
• Reserpine
• Methyldopa

None routine

Ibuprofen
Inhibits prostaglandin synthesis by inhibition of cyclooxygenase.

Pseudoephedrine
Pseudoephedrine acts mainly on alpha and also on beta adrenergic receptors. It produces vasoconstriction by acting on the alpha-adrenergic receptors in the mucosa of the respiratory tract. This results in the decongestant properties of pseudoephedrine.

COMBINATION PREPARATIONS

Ibuprofen/ Pseudoephedrine

Tablet 200/30mg

• Advil Cold & Sinus (GSK) originator
• Benylin for colds (Benylin Daytime)  (Johnson & Johnson) originator
• Demazin Cold and Flu (iNova Pharmaceuticals)
• Ibumax cold and flu (Cipla)
• Nurofen cold and flu (Reckitt Benckiser) originator
• Sinutab 3 Way Econo Pack (Johnson & Johnson)

Caplets 200/30mg

• Sinumax Cold & Flu (Janssen) Discontinued