Methylprednisolone/ Lidocaine [Discontinued in SA Market]

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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• Inflammatory joint and soft tissue conditions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to other local anaesthetics of the amide type
• Patients with systemic infection unless specific anti-infective therapy is employed
• Intrathecal use
• Intravenous use
• Administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Intranasal, intra-ocular use, or any other unapproved route of administration
• Intrathecal/epidural routes of administration
• Achilles tendon use
• Prolonged use
• Large doses
• Abrupt withdrawal
• Unstable joints
• Local injection of a steroid into a previously infected joint
• Latent tuberculosis or tuberculin reactivity
• History of drug allergy
• Cushing's disease
• Hypothyroidism
• Diabetes mellitus
• Existing or previous history of severe affective disorders or family history thereof
• Seizure disorders
• Myasthenia gravis
• Ocular herpes simplex
• Patients with existing cardiovascular risk factors
• Congrestive cardiac failure
• Hypertension
• Patients with predisposition to thromboembolic events
• Nonspecific ulcerative colitis
• Probability of impending perforation
• Abscess
• Pyogenic infection
• Diverticulitis
• Fresh intestinal anastomoses
• Active or latent peptic ulcer
• Predisposition to thrombophlebitis
• Premature or low birth weight infants
• Preterm or full term neonates

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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

Rheumatoid arthritis
Osteoarthritis
Bursitis
Tendinitis
Tenosynovitis

Methylprednisolone/ Lidocaine
40/10 (mg/ml)

• Intra-articular (inj): Dose depends on size of the joint and severity of the condition; Repeat at 1-5 week intervals

Size of joint	Examples	Dosing range
Large	Knee/ Ankle/ Shoulder	0.5-2ml (20-80mg)
Medium	Elbow/ Wrist	0.25-1ml (10-40mg)
Small	Metocarpo-phalangeal/ Interphalangeal/ Sternoclavicular/ Acromioclavicular	0.1-0.25ml (4-10mg)

Subdeltoid bursitis
Prepatellar bursitis
Olecranon bursitis

• Intrabursal/Tendon sheath (inj): 0.1-0.75ml

Ganglia

• Tendon sheath (inj): 0.1-0.5ml (4-20mg)

Epicondylitis

• Intra-articular (inj): 0.1-1ml (4-40mg)

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Do not dilute or mix with other solutions

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Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints

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See additional prescribing points for administration directions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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

Inflammatory joint and soft tissue conditions

• Administered by specialist only

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For infants and children, use should be reserved for only the most serious indications, and the recommended dosage should be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Pregnancy

• Caution
• Methylprednisolone: The ability of corticosteroids to cross the placenta varies between individual agents, however, methylprednisolone does cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. In humans, the risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses
• Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important
• Although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids, those exposed to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women
• Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy
• Lidocaine: The use of local anaesthetics such as lidocaine during labour and delivery may be associated with adverse effects on mother and foetus
• Methylprednisolone acetate with lidocaine: Since adequate human reproductive studies have not been done with methylprednisolone acetate with lidocaine, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and foetus. Lidocaine readily crosses the placenta. Benzyl alcohol can cross the placenta

Breastfeeding

• Caution
• Corticosteroids are distributed in small amounts in breast milk and may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. However, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression
• Lidocaine: Lidocaine is excreted in human breast milk
• Methylprednisolone acetate with lidocaine: This medicinal product should be used during breastfeeding only after a careful assessment of the benefit-risk ratio to the mother and infant

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Methylprednisolone
Central Nervous System Disorders

• Affective disorders
• Psychotic disorders
• Personality change
• Mood swings
• Confusion
• Anxiety
• Insomnia
• Irritability
• Convulsions
• Raised intracranial pressure
• Amnesia
• Cognitive disorder
• Dizziness
• Headache
• Epidural lipomatosis

Cardiovascular Disorders

• Cardiac arrest
• Congestive cardiac failure
• Myocardial rupture post myocardial infarction
• Hypertension
• Hypotension
• Thromboembolic events
• Cardiac arrhythmias

Respiratory Disorders

• Pulmonary embolism
• Hiccups
• Bronchospasm

Gastrointestinal Disorders

• Peptic ulcer
• Intestinal perforation
• Gastrointestinal haemorrhage
• Pancreatitis
• Ulcerative oesophagitis
• Abdominal distention
• Abdominal pain
• Diarrhoea
• Nausea

Hepatobiliary Disorders

• Increased hepatic enzymes
• Hepatitis

Endocrine and Metabolic Disorders

• Cushingoid
• Hypopituitarism
• Steroid withdrawal syndrome
• Sodium retention
• Fluid retention
• Hypokalaemic alkalosis
• Impaired glucose tolerance
• Hypokalaemia
• Menstrual irregularity
• Dyslipidaemia
• Increased appetite

Musculoskeletal Disorders

• Muscular weakness
• Myopathy
• Myalgia
• Growth retardation
• Pathological fracture
• Osteoperosis
• Osteonecrosis
• Neuropathic arthropathy
• Arthralgia
• Tendon rupture
• Spinal compression fracture

Skin and Subcutaneous Tissue Disorders

• Skin atrophy
• Acne
• Erythema
• Angioedema
• Pruritus
• Urticaria
• Ecchymosis
• Petechiae
• Rash
• Hirsuitism
• Hyperhidrosis
• Skin striae
• Telangiectasia
• Impaired wound healing

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions with or without circulatory collapse
• Susceptibility to infection
• Increased severity of infections
• Recurrence of dormant tuberculosis
• Opportunistic infections
• Kaposi's sarcoma
• Leukocytosis

Sensory Disorders

• Subcapsular cataract
• Glaucoma
• Exophthalmos
• Corneal thinning
• Scleral thinning
• Chorioretinopathy
• Vertigo
• Optic nerve damage

Lidocaine
Central Nervous System Disorders 

• Dizziness
• Nervousness
• Tremor
• Circumoral paraesthesia
• Tongue numbness
• Drowsiness
• Convulsions
• Coma

Cardiovascular Disorders

• Hypotension
• Bradycardia
• Myocardial depression
• Cardiac arrhythmias
• Cardiac arrest
• Circulatory collapse

Respiratory Disorders

• Dyspnoea
• Bronchospasm
• Respiratory depression
• Respiratory arrest

Gastrointestinal Disorders

• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Oedema 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Methaemoglobinaemia

Sensory Disorders

• Tinnitus
• Hyperacusis
• Blurred vision
• Diplopia
• Amaurosis fugax
• Orbital inflammation

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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• Cardioactive agents
• Non-steroidal anti-inflammatory drugs
• CYP3A4 inducers
• CYP3A4 inhibitors
• CYP3A4 substrates
• Anticholinesterases 
• Hypoglycaemic agents
• Antihypertensives 
• Diuretics
• Acetazolamide
• Loop diuretics
• Thiazide diuretics 
• Carbenoxolone
• Oral anticoagulants
• Antiemetics
• HIV protease inhibitors
• Potassium-depleting agents 

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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None routine. Specific cases may require

• ECG

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Administration directions

Intra-articular
Using the same sterile technique as for a lumbar puncture, a sterile 20-24 gauge needle is quickly inserted into the synovial cavity. The aspiration of only a few drops of joint fluid proves the joint space has been entered by the needle. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of methylprednisolone/ lidocaine. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. Inject the methylprednisolone/ lidocaine. After injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing.

Intrabursal and into tendon sheaths
The area around the injections site is prepared in a sterile way. A 20-24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose of methylprednisolone/ lidocaine. After injection, the needle is withdrawn and a small dressing applied.

In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken, following application of a suitable antiseptic to the overlying skin, to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch.

When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and methylprednisolone/ lidocaine infiltrated into the area.

For ganglia of the tendon sheaths, the suspension is injected directly into the cyst.

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market (Effective: December 2019).

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Methylprednisolone
Methylprednisolone is a synthetic glucocorticoid that is a methyl derivative of prednisolone. It acts by binding to intracellular glucocorticoid receptors that result in changes to gene expression. It also exerts effects independently of its ability to alter gene expression. The net effect is a diverse range of alterations to multiple physiological and organ systems primarily causing a decrease in inflammation and maintaining function under stress.

Lidocaine
Lidocaine inhibits the ionic refluxes required for the initiation and conduction of impulses, thereby stabilising the neuronal membrane. After absorption lidocaine may cause stimulation of the central nervous system followed by depression, and in the cardiovascular system, it acts primarily on the myocardium where it may produce a decrease in electrical excitability, conduction rate and force of contraction.