Drugs List

Therapeutic Indications

Uses

Short term relief of moderate to severe acute pain

Contraindications

Acute alcohol intoxication
Children under 18 years
Drug intoxication
Photoallergic or phototoxic reactions to fibrates
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Chronic dyspepsia
Coagulopathy
Crohn's disease
History of gastrointestinal bleeding
History of gastrointestinal perforation
Long QT syndrome
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Pregnancy
Renal impairment - creatinine clearance below 60ml/minute
Severe cardiac failure
Severe dehydration
Severe hepatic impairment
Severe respiratory depression
Torsade de pointes
Ulcerative colitis
Uncontrolled seizures

Precautions and Warnings

Allergic disposition
Elderly
Family history of long QT syndrome
Impaired consciousness
Predisposition to seizures
Recent major surgery
Risk factors for cardiovascular disorder
Shock
Varicella
Asthma
Cardiac disorder
Cerebrovascular disorder
Connective tissue disorder
CYP2D6 ultra-rapid metaboliser genotype
Dehydration
Drug misuse
Electrolyte imbalance
Haematopoietic disorders
Hepatic impairment
History of cardiac disorder
History of gastrointestinal disorder
History of gastrointestinal ulceration
History of torsade de pointes
Mild renal impairment
Opioid dependence
Peripheral arterial circulatory disorder
Raised intracranial pressure
Respiratory depression
Seizures
Systemic lupus erythematosus
Uncontrolled hypertension

Correct electrolyte disorders before treatment
CYP2D6 ultra-rapid metaboliser genotype: Increased risk of opioid toxicity
May mask symptoms or signs of infections
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Consider a proton pump inhibitor to prevent gastrointestinal bleeding
Ensure patient has adequate fluid intake
Consider monitoring ECG in patients at risk of QT prolongation
Discontinue if signs of gastro-intestinal bleeding occur
GI symptoms / history of GI disease: monitor for digestive disturbances
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with hepatic impairment for adverse effects
Monitor patients with pre-existing hypertension
Monitor serum electrolytes
Advise patient to report gastrointestinal signs or symptoms
Discontinue if signs of gastro-intestinal ulceration occur
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if there is a rise in liver enzymes
Maintain treatment at the lowest effective dose
Only recommended for short term use (up to 5 days)
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)

Fluid retention and oedema has been reported with NSAIDs. Treatment may be associated with a small increase in the risk of arterial thrombotic events.

Convulsions have been reported in patients receiving tramadol at the recommended dose. Patients with epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.

Whilst tramadol with dexketoprofen is not licensed for use with children, the manufacturer states that tramadol is not recommended in children at risk of impaired respiratory function including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. Extreme caution and monitoring for signs of opioid toxicity is also advised following use in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.

Pregnancy and Lactation

Pregnancy

Tramadol with dexketoprofen is contraindicated during pregnancy.

Use of tramadol with dexketoprofen during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited information regarding the use of tramadol and dexketoprofen during pregnancy. Potential risks are unknown.

Dexketoprofen
Animal studies with dexketoprofen have not shown reproductive toxicity. Wider studies of prostaglandin synthesis have shown increased pre- and post-implantation loss, embryo-foetal lethality and increased incidences of various malformations including cardiovascular. Prostaglandin synthesis inhibitors may adversely affect the pregnancy and/or embryo/foetal development. Use of a prostaglandin synthesis inhibitor in early pregnancy may increase the risk of miscarriage, cardiac malformation and gastroschisis. The risk increases with dose and duration of therapy.

During the third trimester of pregnancy, prostaglandin synthesis inhibitors may expose the foetus to: cardiopulmonary toxicity (with premature closure of the ducts arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis. Use at the end of pregnancy, may lead to prolongation of bleeding time and inhibition of uterine contractions (resulting in delayed or prolonged labour).

Tramadol
Animal studies with tramadol have shown adverse effects on the development of organs, bone formation and neonatal mortality following very large concentrations. No teratogenic effects have been observed, and fertility, reproductive performance and offspring development were unaffected.

As tramadol crosses the placenta, use during later stages of pregnancy may cause respiratory depression. Prolonged use can lead to neonate withdrawal symptoms.

Lactation

Tramadol with dexketoprofen is contraindicated during breastfeeding.

Use of tramadol with dexketoprofen when breastfeeding is contraindicated by the manufacturer. The presence of tramadol with dexketoprofen in human breast milk and the effects on exposed infants are unknown.

The presence of dexketoprofen in human breast milk is unknown. Available data indicates tramadol is expressed in human breast milk in small amounts.

Side Effects

Abdominal disorders
Abnormal liver function tests
Acne
Acute renal failure
Anaphylactic reaction
Anxiety
Asthenia
Blurred vision
Bradycardia
Bradypnoea
Bronchospasm
Chills
Circulatory collapse
Cognitive impairment
Constipation
Delirium
Dependence
Diarrhoea
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Dysuria
Exacerbation of epilepsy
Facial oedema
Fatigue
Feeling abnormal
Flatulence
Flushing
Gastric irritation
Gastritis
Haematuria
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersensitivity reactions
Hypertensive crisis
Hypoglycaemia
Hypokalaemia
Hypotension
Increased blood lactate levels
Increased blood pressure
Insomnia
Involuntary muscle contractions
Laryngeal oedema
Malaise
Menstrual disturbances
Micturition disorders
Miosis
Mood changes
Muscular coordination disorders
Mydriasis
Nausea
Nephritis
Nephrotic syndrome
Neutropenia
Orthostatic hypotension
Pain - generalised
Palpitations
Pancreatitis
Paraesthesia
Peptic ulceration with perforation and haemorrhage
Periorbital oedema
Peripheral oedema
Photosensitivity
Polyuria
Pruritus
Psychotic disorder
Rash
Respiratory depression
Retching
Sensory disturbances
Sleep disorders
Speech disturbances
Stevens-Johnson syndrome
Syncope
Tachycardia
Thrombocytopenia
Thrombocytosis
Tinnitus
Toxic epidermal necrolysis
Tremor
Urinary retention
Urticaria
Vertigo
Vomiting
Weakness
Withdrawal symptoms

Presentation

Oral formulations containing tramadol hydrochloride with dexketoprofen.

Drugs List

Therapeutic Indications

Uses

Short term relief of moderate to severe acute pain

Dosage

Adults

Elderly

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Acute alcohol intoxication
Children under 18 years
Drug intoxication
Photoallergic or phototoxic reactions to fibrates
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Chronic dyspepsia
Coagulopathy
Crohn's disease
History of gastrointestinal bleeding
History of gastrointestinal perforation
Long QT syndrome
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Pregnancy
Renal impairment - creatinine clearance below 60ml/minute
Severe cardiac failure
Severe dehydration
Severe hepatic impairment
Severe respiratory depression
Torsade de pointes
Ulcerative colitis
Uncontrolled seizures

Precautions and Warnings

Allergic disposition
Elderly
Family history of long QT syndrome
Impaired consciousness
Predisposition to seizures
Recent major surgery
Risk factors for cardiovascular disorder
Shock
Varicella
Asthma
Cardiac disorder
Cerebrovascular disorder
Connective tissue disorder
CYP2D6 ultra-rapid metaboliser genotype
Dehydration
Drug misuse
Electrolyte imbalance
Haematopoietic disorders
Hepatic impairment
History of cardiac disorder
History of gastrointestinal disorder
History of gastrointestinal ulceration
History of torsade de pointes
Mild renal impairment
Opioid dependence
Peripheral arterial circulatory disorder
Raised intracranial pressure
Respiratory depression
Seizures
Systemic lupus erythematosus
Uncontrolled hypertension

Correct electrolyte disorders before treatment
CYP2D6 ultra-rapid metaboliser genotype: Increased risk of opioid toxicity
May mask symptoms or signs of infections
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Consider a proton pump inhibitor to prevent gastrointestinal bleeding
Ensure patient has adequate fluid intake
Consider monitoring ECG in patients at risk of QT prolongation
Discontinue if signs of gastro-intestinal bleeding occur
GI symptoms / history of GI disease: monitor for digestive disturbances
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with hepatic impairment for adverse effects
Monitor patients with pre-existing hypertension
Monitor serum electrolytes
Advise patient to report gastrointestinal signs or symptoms
Discontinue if signs of gastro-intestinal ulceration occur
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if there is a rise in liver enzymes
Maintain treatment at the lowest effective dose
Only recommended for short term use (up to 5 days)
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)

Fluid retention and oedema has been reported with NSAIDs. Treatment may be associated with a small increase in the risk of arterial thrombotic events.

Convulsions have been reported in patients receiving tramadol at the recommended dose. Patients with epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling circumstances.

Whilst tramadol with dexketoprofen is not licensed for use with children, the manufacturer states that tramadol is not recommended in children at risk of impaired respiratory function including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. Extreme caution and monitoring for signs of opioid toxicity is also advised following use in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.

Pregnancy and Lactation

Pregnancy

Tramadol with dexketoprofen is contraindicated during pregnancy.

Use of tramadol with dexketoprofen during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited information regarding the use of tramadol and dexketoprofen during pregnancy. Potential risks are unknown.

Dexketoprofen
Animal studies with dexketoprofen have not shown reproductive toxicity. Wider studies of prostaglandin synthesis have shown increased pre- and post-implantation loss, embryo-foetal lethality and increased incidences of various malformations including cardiovascular. Prostaglandin synthesis inhibitors may adversely affect the pregnancy and/or embryo/foetal development. Use of a prostaglandin synthesis inhibitor in early pregnancy may increase the risk of miscarriage, cardiac malformation and gastroschisis. The risk increases with dose and duration of therapy.

During the third trimester of pregnancy, prostaglandin synthesis inhibitors may expose the foetus to: cardiopulmonary toxicity (with premature closure of the ducts arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis. Use at the end of pregnancy, may lead to prolongation of bleeding time and inhibition of uterine contractions (resulting in delayed or prolonged labour).

Tramadol
Animal studies with tramadol have shown adverse effects on the development of organs, bone formation and neonatal mortality following very large concentrations. No teratogenic effects have been observed, and fertility, reproductive performance and offspring development were unaffected.

As tramadol crosses the placenta, use during later stages of pregnancy may cause respiratory depression. Prolonged use can lead to neonate withdrawal symptoms.

Lactation

Tramadol with dexketoprofen is contraindicated during breastfeeding.

Use of tramadol with dexketoprofen when breastfeeding is contraindicated by the manufacturer. The presence of tramadol with dexketoprofen in human breast milk and the effects on exposed infants are unknown.

The presence of dexketoprofen in human breast milk is unknown. Available data indicates tramadol is expressed in human breast milk in small amounts.

Side Effects

Abdominal disorders
Abnormal liver function tests
Acne
Acute renal failure
Anaphylactic reaction
Anxiety
Asthenia
Blurred vision
Bradycardia
Bradypnoea
Bronchospasm
Chills
Circulatory collapse
Cognitive impairment
Constipation
Delirium
Dependence
Diarrhoea
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Dysuria
Exacerbation of epilepsy
Facial oedema
Fatigue
Feeling abnormal
Flatulence
Flushing
Gastric irritation
Gastritis
Haematuria
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersensitivity reactions
Hypertensive crisis
Hypoglycaemia
Hypokalaemia
Hypotension
Increased blood lactate levels
Increased blood pressure
Insomnia
Involuntary muscle contractions
Laryngeal oedema
Malaise
Menstrual disturbances
Micturition disorders
Miosis
Mood changes
Muscular coordination disorders
Mydriasis
Nausea
Nephritis
Nephrotic syndrome
Neutropenia
Orthostatic hypotension
Pain - generalised
Palpitations
Pancreatitis
Paraesthesia
Peptic ulceration with perforation and haemorrhage
Periorbital oedema
Peripheral oedema
Photosensitivity
Polyuria
Pruritus
Psychotic disorder
Rash
Respiratory depression
Retching
Sensory disturbances
Sleep disorders
Speech disturbances
Stevens-Johnson syndrome
Syncope
Tachycardia
Thrombocytopenia
Thrombocytosis
Tinnitus
Toxic epidermal necrolysis
Tremor
Urinary retention
Urticaria
Vertigo
Vomiting
Weakness
Withdrawal symptoms

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2019

Reference Sources

Summary of Product Characteristics: Skudexa 75mg/25mg film-coated tablets. A.Menarini Farmaceutica Internazionale SRL. Revised August 2019.