Bedoral ® Injection

BEDORAL ® 30 is used in the short-term management of moderate post-operative pain.

Contraindications

BEDORAL ® 30 should not be administered if:

• Hypersensitivity to ketorolac tromethamine or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in such patients).
• In patients with recent gastrointestinal bleeding or perforation, in patients with active peptic ulcer disease and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
• Haemorrhagic diatheses, including coagulation disorders. Patients on anti-coagulation therapy including prophylactic low-dose heparin or low molecular weight heparins or heparinoids.
• BEDORAL ® 30 inhibits platelet function and is therefore contra-indicated in patients with suspected or confirmed cerebrovascular bleeding, patients who have had operations with a high risk of haemorrhage or incomplete haemostasis and those at high risk of bleeding.
• In patients with moderate or severe renal impairment (serum creatinine > 442 μmol/l) or in patients at risk of renal failure due to volume depletion or dehydration.
• BEDORAL ® 30 is contra-indicated during pregnancy and lactation. (See: Pregnancy and Lactation).
• Safety and efficacy in children under 16 years of age have not been established. As prophylactic analgesics before surgery, due to inhibition of platelet aggregation, and also intra-operatively, because of increased risk of bleeding.
• BEDORAL ® 30 is contra-indicated for neuraxial (epidural or intrathecal) administration.
• The combination of BEDORAL ® 30 and oxpentifylline is contra-indicated.

Posology and method of administration

Children: BEDORAL ® 30 injection is not recommended for use in children under 16 years of age.

Adults: BEDORAL ® 30 injection may be used as a single or multiple dose IM or bolus IV injection, or IV infusion. BEDORAL ® 30 injection may be used for short-term IV or IM use, not exceeding two days. The maximum duration for use of the IV infusion, is not to exceed 24 hours. The lowest effective dose should be given. If further pain relief is required, opiate analgesics (e.g. morphine, pethidine) may be used concomitantly. When used in association with BEDORAL ® 30, the daily dose of morphine required is less than that normally required following major surgery. However, opioid side-effects should still be considered, especially in day-case surgery. Hypovolemia should be corrected prior to the administration of BEDORAL ® 30. BEDORAL ® 30 infusion should be used only in patients with adequate fluid and electrolyte balance. Bolus doses should be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins in approximately 30 minutes with maximum effect within 1 – 2 hours after dosing. The median duration of analgesia is generally 4 – 6 hours.

Undesirable effects

System Organ Class Frequent Less frequent Frequency Unknown

Blood and lymphatic system disorders Purpura Thrombocytopaenia, post-operative wound haemorrhage, epistaxis Haematoma, increased bleeding time

Psychiatric disorders Depression, hallucinations, psychotic reactions Nervousness, abnormal thinking, euphoria, Inability to concentrate, insomnia, abnormal dreams and anxiety.

Nervous system disorders Headache, Drowsiness, dizziness Convulsions, aseptic meningitis

Eye disorders Abnormal vision

Ear and labyrinth disorders Tinnitus, hearing loss Vertigo

Cardiac disorders Hypertension Hypotension Flushing, bradycardia, pallor, palpitations, chest pain.

Respiratory, thoracic and mediastinal disorders Dyspnoea, asthma, pulmonary oedema.

Gastrointestinal disorders Nausea, dyspepsia, gastrointestinal pain, abdominal discomfort, diarrhoea, constipation, flatulence, Melaena, peptic ulcer, rectal bleeding, hemorrhage, perforation, pancreatitis. Gastritis, eructation, esophagitis fullness, stomatitis, vomiting

Hepato-biliary disorders Hepatitis, cholestatic jaundice. Abnormal liver function tests, liver failure.

Skin and subcutaneous tissue disorders Pruritus, urticaria, Lyell’s syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash. Drug reaction with Eosinophillia and Systemic Symptoms (DRESS) [see section 4.4]

Musculoskeletal, connective tissue and bone disorders Hyperkinesia Paraesthesia and myalgia

Renal and urinary disorders Increased urinary frequency, oliguria, acute renal failure, haemolytic uraemic syndrome, flank pain (with or without haematuria), interstitial nephritis. Signs of renal impairment, leading to elevations of creatinine and potassium, can occur after one dose of BEDORAL® 30. Hyponatraemia, hyperkalaemia, raised serum urea and creatinine, urinary retention, nephritic syndrome.

General disorders and administrative site conditions sweating, excessive thirst, injection site reactions, oedema, weight gain Fever Dry mouth, abnormal taste, asthenia

Special precautions for storage

Store at or below 25 °C. Protect from light. STORE BEDORAL ® 30 OUT OF REACH OF CHILDREN.