Adverse reactions : תופעות לוואי

4.8      Undesirable effects

The incidence of predictable undesirable side effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment (see section 4.4).

In common with other local anaesthetics, adverse reactions to lidocaine are rare and are usually the result of raised plasma concentrations due to accidental intravascular injection, excessive dosage or rapid absorption from highly vascular areas, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Systemic toxicity mainly involves the central nervous system and/or the cardiovascular system. Neurological signs of systemic toxicity include dizziness or light-headedness, nervousness, tremor, circumoral paraesthesia, tongue numbness, drowsiness, convulsions, coma.
Cardiovascular reactions are depressant and may manifest as hypotension, bradycardia, myocardial depression, cardiac arrhythmias, and possibly cardiac arrest or circulatory collapse. Blurred vision, diplopia, and transient amaurosis may be signs of lidocaine toxicity.



          MedDRA
Frequency     Adverse Drug Reactions
System Organ Class
Infections and infestations   Not Known     Opportunistic infectione; Infectione (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs),
Injection site infection; Peritonitisc,e; Recurrence of dormant tuberculosis


Blood and lymphatic system    Not Known     Leukocytosise disorders
Immune system disorders       Not Known     Drug hypersensitivity, Anaphylactic reaction, Anaphylactoid reaction
Endocrine disorders                         Cushingoide; Hypothalamic pituitary adrenal axis Not Known     suppression e; Withdrawal symptoms - Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. However,
this is more applicable to corticosteroids with an indication where continuous therapy is given (see section 4.4).
A 'withdrawal syndrome' e; may also occur including, fever, myalgia, arthralgia, rhinitis,
conjunctivitis, painful itchy skin nodules and loss of weight.
Metabolism and nutrition disorders                     Not Known     Metabolic acidosise, Sodium retentione; Fluid retentione, Alkalosis hypokalaemice;
Dyslipidaemiae, Glucose tolerance impairede;
Increased requirements for insulin (or oral hypoglycemic agents in diabetics) a,e,
Lipomatosise, Increased appetite (which may result in Weight increased)


Psychiatric disorders
Not Known     Affective disordere (including Depressed moode,
Euphoric mood, Affect labilitye, psychological dependence, Suicidal ideatione), Psychotic disordere (including Maniae, Delusione,
Hallucinatione, and Schizophreniae [aggravation of]); Confusional state; Mental disordere;
Anxiety; Personality changee; Mood swingse;
Abnormal behavioure; Insomniae, Irritabilitye,,
Nervousnessd
Nervous system disorders      Not Known     Epidural lipomatosise , Intracranial pressure increased (with Papilloedema [Benign intracranial hypertension] e); Loss of consciousnessd; Seizure; Amnesiae; Cognitive disordere; Tremord, Somnolenced,
Hypoaesthesiad, Dizziness; Headachee;



         MedDRA
Frequency   Adverse Drug Reactions
System Organ Class
Eye disorders                    Not Known   Exophthalmose; Vision blurredd (See also section 4.4); chorioretinopathy e; Cataracte; Glaucomae;
Diplopiad ; Rare instances of blindness associated with intralesional therapy around the face and head; Corneal or scleral thinning; Exacerbation of ophthalmic viral or fungal disease


Ear and labyrinth disorders      Not Known   Vertigoe, Tinnitusd
Cardiac disorders                Not Known   Cardiac arrestd , Cardiac arrhythmiasd; Cardiac failure congestive (in susceptible patients) e ,
Bradycardiad
Vascular disorders
Not Known   Circulatory collapsed; Hypertensione;
Hypotension; Embolism arterial, Thrombotic eventse; Flushing
Respiratory, thoracic and        Not Known   Respiratory arrestd, Respiratory depressiond, mediastinal disorders                        Pulmonary embolisme, Hiccupse ; Bronchospasmd; Dyspnoead
Gastrointestinal disorders                   Peptic ulcerb,e (with possible Peptic ulcer Not Known   perforation and Peptic ulcer haemorrhage)
Gastric haemorrhagee; Intestinal perforatione;
Pancreatitise; Oesophagitis ulcerativee;
Oesophagitis; Oesophageal candidiasis;
Abdominal paine; Abdominal distensione;
Diarrhoeae; Dyspepsiae; Nauseae, Vomitingd
Hepatobiliary disorders          Not Known   Hepatitis, Increase of liver enzymes Skin and subcutaneous tissue                 Angioedema; Face oedemad; Petechiae; disorders                        Not Known   Ecchymosise; Skin atrophye; Skin striaee; Skin hyperpigmentatione; Skin hypopigmentatione;
Hirsutisme; Rash; Erythemae; Prurituse; Urticaria;
Acnee; Hyperhidrosise Skin lesiond
Musculoskeletal and              Not Known   Muscular weaknesse,Osteonecrosise; connective tissue disorders                  Osteoporosise; Pathological fracturee; Muscle atrophye; Myopathye; Neuropathic arthropathye;
Growth retardatione; Arthralgia; Myalgiae;
Muscle twitchingd; Post injection pain flare
(following intra-articular, periarticular, and tendon sheath injections)a
Reproductive system and          Not Known   Menstruation irregular breast disorders
General disorders and            Not Known   Impaired healinge; Oedema peripherale; Injection administration site conditions               site reactione; Abscess sterilee; Fatiguee; Malaisee; Feeling coldd, Feeling hotd

Investigations                               Intraocular pressure increasede, Alanine Not Known   aminotransferase increasede; Aspartate aminotransferase increased; Blood alkaline phosphatase increasede; Blood potassium decreasede ; Carbohydrate tolerance decreasede;
Urine calcium increasede;; Blood urea increasede;
Nitrogen balance negative (due to protein catabolism); Suppression of reactions to skin testsa,e
          MedDRA
Frequency               Adverse Drug Reactions
System Organ Class
Injury, poisoning and             Not Known               Tendon rupturee (particularly of the Achilles procedural complications                                  tendon); Spinal compression fracturee.
Systemic corticosteroids are not indicated for,
and therefore should not be used to treat,
traumatic brain injury.
a
Not a MedDRA Preferred term.
b
Peptic ulcer perforation and Peptic ulcer haemorrhage.
c
Peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis (see section 4.4).
d
Reported for lidocaine only.e Reported for methylprednisolone acetate only.

CERTAIN SIDE EFFECTS REPORTED WITH SOME NON RECOMMENDED ROUTES OF
ADMINISTRATION:

Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache, meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, Seizure, sensory disturbances.

Extradural: Wound dehiscence, loss of sphincter control.

Intranasal: Permanent/temporary blindness, allergic reactions, rhinitis.
Ophthalmic (Subconjunctival): Redness and itching, abscess, slough at injection site, residue at injection site, increased intra-ocular pressure, decreased vision - blindness, infection.

Miscellaneous: Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/