Drugs List

Therapeutic Indications

Uses

Relief of pain and inflammation in osteoarthritis
Relief of pain and inflammation in rheumatoid arthritis
Short term use in musculoskeletal disorders

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Gastritis
Gastrointestinal haemorrhage
History of peptic ulcer
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Surgery
Asthma
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Nephrotic syndrome
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Uncontrolled hypertension

May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
NSAIDs may provoke or exacerbate asthma
Consider the need for combination therapy with gastroprotective agents
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
If visual disturbances occur, perform ophthalmic evaluation
May affect platelet function
Monitor cardiac function in elderly patients
Monitor hepatic function in elderly patients
Monitor renal function in elderly patients
Discontinue if abnormal liver function tests persist or worsen
High dose/long term use may increase risk of arterial thrombotic events
May prolong bleeding time
Discontinue if symptoms of peptic ulcer occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Maintain treatment for the shortest possible duration
May cause impaired fertility

Due to the high plasma protein-binding of tenoxicam, caution is required when plasma albumin concentrations are markedly reduced or when bilirubin concentrations are high.

In acute musculoskeletal disorders the length of the treatment should not exceed more than 7 days, but in severe cases it can be extended up to a maximum of 14 days.

In the presence of serious skin reactions tenoxicam should not be initiated or should be discontinued.

Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered in patients with history of ulcer, particularly if complicated with hemorrhage or perforation, in the elderly and in patients requiring concomitant low dose of aspirin, or other drugs likely to increase gastrointestinal risk.

There may be an increased risk of aseptic meningitis in patients with systemic lupus erythematous and mixed connective tissue disorders.

In patients planned for major surgery, the increased bleeding time caused by the use of tenoxicam should be considered.

Pregnancy and Lactation

Pregnancy

Tenoxicam is contraindicated during the third trimester of pregnancy but may be used with caution during the first and second trimester.

The use of tenoxicam in the third trimester is contraindicated by the manufacturer and the manufacturer advises, that tenoxicam should only be used in the first and second trimesters if clearly necessary.

In early pregnancy there may be an increased risk of foetal cardiovascular malformation. In late pregnancy there may be an increased risk of premature closure of the ductus arteriosus and renal dysfunction. At the end of pregnancy labour may be delayed due to inhibition of uterine contractions, and prolonged bleeding times may affect both mother and neonate.

Animal studies have shown some teratogenic effects of prostaglandin synthesis inhibitors during organogenetic period.

Lactation

Tenoxicam is contraindicated during breastfeeding.

Manufacturer advises the discontinuation of tenoxicam or, if not possible, stopping breastfeeding.

Tenoxicam passes into breast milk after single dose administration.

Side Effects

Abdominal pain
Abnormal liver function tests
Agranulocytosis
Allergic reaction
Alopecia
Anaemia
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Asthma
Blurred vision
Bronchospasm
Confusion
Congestive cardiac failure
Constipation
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Eosinophilia
Epigastric pain
Epistaxis
Erythema
Eye irritation
Flatulence
Fluid retention
Gastro-intestinal symptoms
Gastro-intestinal ulceration and bleeding
Glomerulonephritis
Haemolytic anaemia
Headache
Hepatitis
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Increase in blood urea or creatinine
Increase in serum transaminases
Indigestion
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Malaise
Nail disorders
Nausea
Nephrotic syndrome
Nephrotoxicity
Nervousness
Non-thrombocytopenic purpura
Palpitations
Papillary necrosis
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Rash
Renal failure
Renal impairment
Somnolence
Stevens-Johnson syndrome
Stomatitis
Swollen eyes
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vesiculo-bullous reactions
Weight changes

Presentation

Oral formulation of tenoxicam.

Drugs List

Therapeutic Indications

Uses

Relief of pain and inflammation in osteoarthritis
Relief of pain and inflammation in rheumatoid arthritis
Short term use in musculoskeletal disorders

Dosage

Adults

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Gastritis
Gastrointestinal haemorrhage
History of peptic ulcer
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Females attempting to conceive
Risk factors for cardiovascular disorder
Surgery
Asthma
Cardiac impairment
Cerebrovascular disorder
Congestive cardiac failure
Connective tissue disorder
First trimester of pregnancy
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
History of gastrointestinal disorder
Hypertension
Hypovolaemia
Ischaemic heart disease
Lactose intolerance
Nephrotic syndrome
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Uncontrolled hypertension

May mask symptoms or signs of infections
May precipitate bronchospasm in patients with asthma or allergy
NSAIDs may provoke or exacerbate asthma
Consider the need for combination therapy with gastroprotective agents
Contains lactose
Discontinue if signs of gastro-intestinal bleeding occur
Elderly: Monitor for gastrointestinal bleeding
If visual disturbances occur, perform ophthalmic evaluation
May affect platelet function
Monitor cardiac function in elderly patients
Monitor hepatic function in elderly patients
Monitor renal function in elderly patients
Discontinue if abnormal liver function tests persist or worsen
High dose/long term use may increase risk of arterial thrombotic events
May prolong bleeding time
Discontinue if symptoms of peptic ulcer occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Maintain treatment for the shortest possible duration
May cause impaired fertility

Due to the high plasma protein-binding of tenoxicam, caution is required when plasma albumin concentrations are markedly reduced or when bilirubin concentrations are high.

In acute musculoskeletal disorders the length of the treatment should not exceed more than 7 days, but in severe cases it can be extended up to a maximum of 14 days.

In the presence of serious skin reactions tenoxicam should not be initiated or should be discontinued.

Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered in patients with history of ulcer, particularly if complicated with hemorrhage or perforation, in the elderly and in patients requiring concomitant low dose of aspirin, or other drugs likely to increase gastrointestinal risk.

There may be an increased risk of aseptic meningitis in patients with systemic lupus erythematous and mixed connective tissue disorders.

In patients planned for major surgery, the increased bleeding time caused by the use of tenoxicam should be considered.

Pregnancy and Lactation

Pregnancy

Tenoxicam is contraindicated during the third trimester of pregnancy but may be used with caution during the first and second trimester.

The use of tenoxicam in the third trimester is contraindicated by the manufacturer and the manufacturer advises, that tenoxicam should only be used in the first and second trimesters if clearly necessary.

In early pregnancy there may be an increased risk of foetal cardiovascular malformation. In late pregnancy there may be an increased risk of premature closure of the ductus arteriosus and renal dysfunction. At the end of pregnancy labour may be delayed due to inhibition of uterine contractions, and prolonged bleeding times may affect both mother and neonate.

Animal studies have shown some teratogenic effects of prostaglandin synthesis inhibitors during organogenetic period.

Lactation

Tenoxicam is contraindicated during breastfeeding.

Manufacturer advises the discontinuation of tenoxicam or, if not possible, stopping breastfeeding.

Tenoxicam passes into breast milk after single dose administration.

Side Effects

Abdominal pain
Abnormal liver function tests
Agranulocytosis
Allergic reaction
Alopecia
Anaemia
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arterial thrombosis
Asthma
Blurred vision
Bronchospasm
Confusion
Congestive cardiac failure
Constipation
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dyspepsia
Dyspnoea
Eosinophilia
Epigastric pain
Epistaxis
Erythema
Eye irritation
Flatulence
Fluid retention
Gastro-intestinal symptoms
Gastro-intestinal ulceration and bleeding
Glomerulonephritis
Haemolytic anaemia
Headache
Hepatitis
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Increase in blood urea or creatinine
Increase in serum transaminases
Indigestion
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Malaise
Nail disorders
Nausea
Nephrotic syndrome
Nephrotoxicity
Nervousness
Non-thrombocytopenic purpura
Palpitations
Papillary necrosis
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Rash
Renal failure
Renal impairment
Somnolence
Stevens-Johnson syndrome
Stomatitis
Swollen eyes
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Vesiculo-bullous reactions
Weight changes

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: November 2021

Reference Sources

Summary of Product Characteristics: Mobiflex tablets 20mg. Meda Pharmaceuticals. Revised November 2020.