Drugs List

Therapeutic Indications

Uses

Muscle spasms
Muscular spasticity

Not all brands are licensed for all indications.

Treatment of spasticity due to neurological disorders such as multiple sclerosis, spinal cord injury or disease.

Treatment of muscle spasms caused by conditions of the spine (cervical and lumbar syndromes) or as a result of surgery on the musculoskeletal system e.g. vertebrae or hip joint.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Severe hepatic impairment
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Cardiovascular disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Renal impairment - creatinine clearance below 25 ml/minute

Correct electrolyte disorders before treatment
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Contains lactose
Some formulations contain sucrose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
Monitor renal function in patients with renal impairment
Monitor serum electrolytes
Advise patient to report if allergic reaction occurs
Discontinue if hepatitis develops
To discontinue, reduce dose gradually
Discontinue at first signs of jaundice
Discontinue if allergic reaction occurs
Discontinue if ALT or AST persistently exceed 3 x ULN
Dose adjustment required if patient starts/stops smoking during therapy
Advise patient to avoid alcohol during treatment
Advise patient grapefruit products may increase plasma level
Advise patients that hallucinations can occur

In patients who develop symptoms of hepatic dysfunction (unexplained nausea, anorexia or tiredness) liver function should be monitored. In patients taking daily doses of 12mg and above, liver function should be monitored monthly for the first 4 months.

Pregnancy and Lactation

Pregnancy

Tizanidine is contraindicated during pregnancy.

The manufacturer recommends tizanidine is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. At the time of writing the safety of tizanidine in pregnancy has not been established. Animal data suggests toxicity but no congenital defects. It is not known if tizanidine crosses the placenta, however its relatively low molecular weight suggests that passage to the embryo or foetus should be expected. Dose related hypotension could potentially be a serious adverse effect in pregnancy. This can be minimised by careful dose titration, but close monitoring of maternal blood pressure is needed. (Briggs 2015).

Lactation

Tizanidine is contraindicated during breastfeeding.

The manufacturer does not recommend the use of tizanidine while breastfeeding. The relatively low molecular weight and lipid solubility of tizanidine suggests excretion into breast milk will occur. Safety has not been established, but serious toxicity is a potential complication (Briggs 2015).

Side Effects

Abdominal pain
Allergic reaction
Anxiety
Ataxia
Bradycardia
Circulatory collapse
Decreased appetite
Dizziness
Drowsiness
Dry mouth
Dysarthria
Fatigue
Gastro-intestinal symptoms
Hallucinations (transient)
Headache
Hepatic failure
Hepatitis
Hypotension
Increases in serum transaminases (reversible)
Insomnia
Loss of consciousness (transient)
Muscle weakness
Nausea
Pruritus
Rash
Reversible confusional states
Sleep disorders
Syncope
Tachycardia
Vertigo
Vomiting

Presentation

Oral formulations of tizanidine.

Drugs List

Therapeutic Indications

Uses

Muscle spasms
Muscular spasticity

Not all brands are licensed for all indications.

Treatment of spasticity due to neurological disorders such as multiple sclerosis, spinal cord injury or disease.

Treatment of muscle spasms caused by conditions of the spine (cervical and lumbar syndromes) or as a result of surgery on the musculoskeletal system e.g. vertebrae or hip joint.

Dosage

Dosage, including timing and frequency, should be individually determined. There is considerable variation in response between patients so careful titration is necessary.

Abrupt discontinuation can cause rebound hypertension and tachycardia. Tizanidine should be stopped gradually.

Adults

Patients with Renal Impairment

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
Long QT syndrome
Pregnancy
Severe hepatic impairment
Torsade de pointes

Precautions and Warnings

Elderly
Family history of long QT syndrome
Cardiovascular disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Ischaemic heart disease
Lactose intolerance
Mild hepatic impairment
Renal impairment - creatinine clearance below 25 ml/minute

Correct electrolyte disorders before treatment
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Contains lactose
Some formulations contain sucrose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor liver function. Withdraw if evidence of hepatotoxic reaction
Monitor renal function in patients with renal impairment
Monitor serum electrolytes
Advise patient to report if allergic reaction occurs
Discontinue if hepatitis develops
To discontinue, reduce dose gradually
Discontinue at first signs of jaundice
Discontinue if allergic reaction occurs
Discontinue if ALT or AST persistently exceed 3 x ULN
Dose adjustment required if patient starts/stops smoking during therapy
Advise patient to avoid alcohol during treatment
Advise patient grapefruit products may increase plasma level
Advise patients that hallucinations can occur

In patients who develop symptoms of hepatic dysfunction (unexplained nausea, anorexia or tiredness) liver function should be monitored. In patients taking daily doses of 12mg and above, liver function should be monitored monthly for the first 4 months.

Pregnancy and Lactation

Pregnancy

Tizanidine is contraindicated during pregnancy.

The manufacturer recommends tizanidine is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. At the time of writing the safety of tizanidine in pregnancy has not been established. Animal data suggests toxicity but no congenital defects. It is not known if tizanidine crosses the placenta, however its relatively low molecular weight suggests that passage to the embryo or foetus should be expected. Dose related hypotension could potentially be a serious adverse effect in pregnancy. This can be minimised by careful dose titration, but close monitoring of maternal blood pressure is needed. (Briggs 2015).

Lactation

Tizanidine is contraindicated during breastfeeding.

The manufacturer does not recommend the use of tizanidine while breastfeeding. The relatively low molecular weight and lipid solubility of tizanidine suggests excretion into breast milk will occur. Safety has not been established, but serious toxicity is a potential complication (Briggs 2015).

Side Effects

Abdominal pain
Allergic reaction
Anxiety
Ataxia
Bradycardia
Circulatory collapse
Decreased appetite
Dizziness
Drowsiness
Dry mouth
Dysarthria
Fatigue
Gastro-intestinal symptoms
Hallucinations (transient)
Headache
Hepatic failure
Hepatitis
Hypotension
Increases in serum transaminases (reversible)
Insomnia
Loss of consciousness (transient)
Muscle weakness
Nausea
Pruritus
Rash
Reversible confusional states
Sleep disorders
Syncope
Tachycardia
Vertigo
Vomiting

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: February 2017

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Tizagelan 2mg tablets. Gerot Lannach UK Limited. Revised October 2021.
Summary of Product Characteristics: Tizagelan 4mg tablets. Gerot Lannach UK Limited. Revised October 2021.

Summary of Product Characteristics: Tizanidine 2mg tablets. Actavis UK Limited. Revised February 2016.
Summary of Product Characteristics: Tizanidine 4mg tablets. Actavis UK Limited. Revised February 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 December 2022