Adolor AMPOULES Composition :
Each 1 ml contains:
Ketorolac tromethamine 15 mg
Adolor AMPOULES properties :
adolor is a highly potent injectable analgesic for management of postoperative and other types of moderate to severe acute pain adolor is a member of the non-steroidal anti inflammatory drugs with mild antipyretic effect adolor rapidly relieves pain by inhibiting thesynthesis and actions of prostaglandine and other pain mediators the analgesic efficacy of adolor is equipotent to that of morphine and superior to that of meperidine however its use is devoid of the adverse effects of narcotics such as respiratory depression, nausea, vomiting, sedation, disturbance of blood pressure and heart rate or tolerance. AOOLOR is used as monotherapy with rapid onset of analgesia ( within 1 minute after I. V. and 10 minutes after LM. ) and long duration of action (up to 6 hours). When the use of opioids is unavoidable, ADOLOR can be added
to the therapeutic regimen to improve the quality of analgesia reduce the required dose of opioids and minimize the associated adverse effects adolor is well tolerated and non irritant at the injection site
Adolor AMPOULES Pharmacokinetics :
Following ADOLOR administration, peak plasma concentrations of ketorolac are achieved immediately after I.V. and within 30 to 50 minutes after I.M. The drug is distributed to body fluids and tissues but it does not readily cross the blood brain barrier.
Ketorotac is about 99% bound to plasma proteins. It IS eliminated from the body partly unchanged in the urine and partly by hepatic metabolism. The plasma half-life ranges from 4 to 6 hours and is increased in the elderly and In patients with renal or hepatic dysfunction. Ketorolac crosses the placenta and only a small amount of the drug appears in breast milk.
Adolor potent analgesic AMPOULES Indications :
– Post-operative pain following abdominal, gynecologlcal, orthopedic or orodental surgery.
– Post-traumatic pain.
– Renal and biliary colic.
– Visceral pain associated with cancer.
Adolor AMPOULES Dosage :
Adults up to 65 year. : 15 – 30 mg every 6 hours. The maximum daily dose should not exceed 120 mg. adults over 65 years or with body weight less than 50 kg and patients with renal Impairment : 15mg every 6 hours. The maximum daily dose should not exceed 60 mg
N.B. : – I.m ketorolac should be injected slowly and deeply into alarge muscle .
– Treatment with ketorolac should not exceed 5 days.
Adolor AMPOULES Contraindications :
Pregnancy,Nursing mothers and Pediatric use:
do not administer injections preserved with benzyl alcohol has been associated with serious adverse events and death particularly in pediatric patients (it may cause Gasping Syndrome).
Injections preservative free should be used in these populations.
– hypersensitivity to ketorolac, active peptic ulcer, severe renal impairment, hemorrhagic or bleeding abnormalities, labor and delivery
– In addition, ketorolac as other NSAIDS is contraindicated during pregnancy and lactation.
Adolor AMPOULES Precautions :
NSAIDs should be used with caution in patients with impaired renal or hepatic function, hypertension and bronchial asthma.
Adolor AMPOULES Warnings :
Cardiovascular Risk·:NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular diseases or risk factors for cardiovascular diseases may be at greater risk.
NSAIDs is contraindicated for the treatment of peri-operative pain in the setting of coronary artery by pass graft (CABG) surgery.
Gastrointestinal Risk·:NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or Intestine, which can be fatal. These events can occur at any time during use and without warning symptoms elderly patients are at greater risk for serious gastrointestinal events.
– This product contains benzy1 alcohol which Is potentially toxic when administered locally to neural tissues.
Adolor AMPOULEs Side effects :
As with other NSAIDs, GIT disturbances, prolongation of bleeding time, edema or allergic skin reactions might occur.
Adolor AMPOULES Packing :
A box containing 3 ampoules, 1 ml each ( 15 mg 11 ml).
A box containing 3 ampoules, 2 ml each ( 30 mg 12 ml ).
Adolor AMPOULES Storage :
Union of Arab Pharmacists.
Keep at temperature 15 – 30′” C, away from light.
Keep out of the reach of children.
Adolor AMPOULES Produced by :
Pharco B International for Pharco Pharmaceuticals