INDICATIONS
RolacĀ® ampoules are indicated for the short- term management of moderate to severe acute postoperative pain.
RolacĀ® tablets are indicated for the short-term management of moderate postoperative pain.
DOSAGE AND ADMINISTRATION
RolacĀ® ampoules are for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over not less than 15 seconds, RolacĀ® ampoules should not be used for epidural or spinal administration. The time to onset of analgesic eect following both I.V. and I.M. administration is similar and is approximately 30 minutes, with maximum analgesia occurring within 1 to 2 hours. The medium duration of analgesia is generally 4 to 6 hours dosage should be adjusted according to the severity of the pain and the patient response
CONTRAINDICATIONS
ā a history of peptic ulcer or gstrointestinal bleeding
ā suspected or conrmed cerebrovascular bleeding
ā hemorrhagic diatheses, including coagulation disorders
ā Patients with hypersensitivity to Ketorolac Tromethamine or other NSAIDs and patients in whom aspirin or other
prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in
such patients) patients with the complete or partial syndrome of nasal polyps, angio-edema or bronchospasm
ā concurrent treatment with other NSAIDs, oxpentifylline, probenecid or lithium salts
ā hypovolemia from any cause or dehydration
ā moderate or severe renal impairment (serum creatinine >160 umol/l)
ā a history of asthma
ā patients who have had operations with a high risk of hemorrhage or incomplete homeostasis
ā patients on anticoagulants including low-dose heparin
(2500- 5000 units 12 hourly)
ā during pregnancy, labor, delivery or lactation
ā children under 16 years of age.
USE IN PREGNANCY AND LACTATION
It is detected in human milk. Safety in pregnancy has not been established. It in not recommended during pregnancy, labour or delivery and in mother who are breast-feeding.
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