Cyclobenzaprine Hydrochloride

Registered South African indications:

• Muscle spasm

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Dysrhythmias
• Conduction disturbances
• Congestive heart failure
• Recent myocardial infarction
• Hyperthyroidism
• Coadministration with monoamine oxidase inhibitors or use within 14 days of their use

Cautions

• Pregnancy
• Breastfeeding
• Hepatic impairment
• Elderly
• Urinary retention
• Angle-closure glaucoma
• Increased intraocular pressure
• History of epilepsy
• May impair the ability to drive and operate machinery

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

Muscle spasm associated with acute musculoskeletal conditions

• Oral (cap): 15mg; dly; Max: 30mg/24hrs

Do not use longer than 2-3 weeks 

Not established for use in children

Pregnancy

• Caution; no evidence of risk in studies
• The safe use of cyclobenzaprine hydrochloride has not been established in pregnancy.  Animal studies have not demonstrated a foetal risk 

Breastfeeding

• Caution; not recommended
• Excretion of cyclobenzaprine in breast milk is unknown. The potential risk of adverse effects to breastfeeding infants cannot be excluded, therefore,  caution is recommended when administering to breastfeeding mothers

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment 

• Caution; no dose adjustment recommended
  Not recommended; regardless of the severity of hepatic impairment (mild, moderate, severe)

Elderly 

• Caution; no dose adjustment recommended
  Not recommended; regardless of the severity of hepatic impairment (mild, moderate, severe)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Seizures 
• Ataxia
• Vertigo 
• Dysarthria 
• Tremors 
• Hypertonia 
• Muscle twitching 
• Disorientation 
• Insomnia
• Depressed mood 
• Abnormal sensations 
• Anxiety 
• Agitation 
• Psychosis
• Abnormal thinking and dreaming 
• Hallucinations
• Excitement 
• Paresthesia 
• Diplopia 
• Tinnitus 
• Decreased or increased libido 
• Abnormal gait 
• Delusions
• Aggressive behaviour 
• Paranoia 
• Peripheral neuropathy 
• Bell’s palsy
• Alteration in EEG patterns 
• Extrapyramidal symptoms

Cardiovascular Disorders

• Tachycardia 
• Dysrhythmia 
• Vasodilatation 
• Palpitation 
• Hypotension 
• Syncope 
• Chest pain 
• Myocardial infarction 
• Heart block 
• Stroke 
• Hypertension 
• Oedema

Respiratory Disorders 

• Dyspnoea

Gastrointestinal Disorders 

• Vomiting 
• Anorexia 
• Diarrhoea 
• Gastrointestinal pain 
• Gastritis 
• Thirst 
• Flatulence 
• Ageusia 
• Paralytic ileus 
• Tongue discolouration
• Stomatitis 
• Parotid swelling

Hepatobiliary Disorders 

• Abnormal hepatic function tests
• Hepatitis 
• Jaundice 
• Cholestasis

Genitourinary Disorders  

• Urinary frequency
• Urinary retention 
• Impaired urination
• Dilatation of urinary tract 
• Impotence 
• Testicular swelling 
• Gynaecomastia 
• Breast enlargement 
• Galactorrhea

Endocrine & Metabolic Disorders 

• Disturbances of blood glucose levels 
• Weight gain or loss 
• Syndrome of inappropriate antidiuretic hormone  secretion

Musculoskeletal Disorders 

• Local weakness 
• Myalgia

Skin and Subcutaneous Tissue Disorders 

• Photosensitisation
• Alopecia
• Pruritus 
• Facial oedema
• Urticarial 
• Rash

Immune, Blood and Lymphatic System Disorders 

• Purpura 
• Bone marrow depression 
• Leucopenia 
• Eosinophilia 
• Thrombocytopenia 
• Anaphylaxis 
• Angioedema

• Monoamine oxidase inhibitors
• Central nervous system depressants
• Guanethidine
• Tramadol
• Anticholinergic medication

None routine

Cyclobenzaprine acts primarily within the central nervous system at the level of the brain stem. However, it does seem to act to some degree at the level of the spinal cord, which may contribute to its overall skeletal muscle relaxant activity. The net effect of cyclobenzaprine is a reduction of tonic somatic motor activity

Capsule 15mg

• Myprocam (Adcock) originator

Capsule 30mg

• Myprocam (Adcock) originator