Surgidol 10 Tablet

Presentation

Surgidol 10 Tablet: Each film coated tablet contains Ketorolac Tromethamine USP 10 mg.

Surgidol 30 IM/IV Injection: Each ml contains Ketorolac Tromethamine BP 30 mg.

Description

Surgidol (Ketorolac Tromethamine) is a non-steroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity mediated by peripheral effects. It has more pronounced analgesic activity than other available NSAIDs. Ketorolac inhibits the synthesis of prostaglandins through inhibition of the cyclo-oxygenase enzyme system. Surgidol is not an anesthetic agent and possesses no sedative or anxiolytic properties. It is not an opioid and has no known side effects of opioid analogues. Ketorolac Tromethamine is rapidly and completely absorbed when administered by the oral, intravenous or the intramuscular route. The pharmacokinetics is linear following single and multiple dosing.

Indications

Surgidol is indicated for the short-term management of moderate to moderately severe acute pain, including post-surgical pain (such as general, orthopedic and dental surgery), acute musculoskeletal trauma pain and postpartum uterine cramping pain.

Dosage and Administration

Surgidol Tablet:

Adults: The usual oral dose of Surgidol (Ketorolac Tromethamine) is 10 mg every 4 to 6 hours for pain as required. Doses exceeding 40 mg per day are not recommended. The maximum duration of treatment with the oral formulation is 5 days for post-surgical patients and 7 days for patients with musculoskeletal pain.

Patients under 50 kg, over 65 years of age: The lowest effective dose is recommended.

Surgidol Injection:

Injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Surgidol injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single Dose Treatment: The following regimen should be limited to single administration use only.

Adult Patients:

IM Dosing: Patients ≤ 65 years of age: One dose of 60 mg. Patients > 65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.

IV Dosing: Patients ≤ 65 years of age: One dose of 30 mg. Patients > 65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.

Pediatric Patients (2 to 16 years of age):

IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.

IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.

Multiple Dose Treatment (IV or IM):

Patients <65 years of age: The recommended dose is 30 mg Surgidol injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients, and patients less than 50 kg: The recommended dose is 15 mg Surgidol injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.

Conversion from Parenteral to Oral Therapy:

Surgidol tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Surgidol tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Surgidol IM should be replaced by Surgidol tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.

Contraindications

Ketorolac Tromethamine is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components of Ketorolac Tromethamine. Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding, bleeding disorders are contraindicated for this drug.

Adverse Effects

It is generally well tolerated. However, adverse effects like dry mouth, excessive thirst, psychotic reactions, convulsion, myalgia, hyponatremia, hyperkalemia, raised blood urea and creatinine, renal failure, hypertension, bradycardia, chest pain, purpura, post operative haemorrhage, haematoma, liver function change etc may occur in some cases. Gastrointestinal side-effects include abdominal discomfort, constipation, diarrhea, dyspepsia, flatulence, fullness, gastritis, gastrointestinal bleeding, gastrointestinal pain, nausea, pancreatitis, peptic ulcer, perforation, stomatitis, vomiting etc.

Precautions

Precaution should be taken in elderly, allergic disorder, renal, cardiac & hepatic impairment, porphyria, patient with low body weight (<50kg).

Pregnancy and Lactation

Pregnancy category C. Ketorolac Tromethamine is contraindicated in pregnancy and lactation.

Drug Interactions

Warfarin, digoxin, heparin and salicylate should be used carefully with Ketorolac Tromethamine.

Overdose

Over dosage of Ketorolac Tromethamine may cause abdominal pain, peptic ulcers which is healed after discontinuation of doses. Metabolic acidosis has been reported following intentional over dosage.

Storage

Store in a cool and dry place protected from light. Keep out of the reach of children.

Packaging

Surgidol 10 Tablet: Each box contains 30 tablets in Alu-Alu blister pack.

Surgidol 30 IM/IV Injection: Each box contains 1 ampoule in blister pack and a disposable syringe (3ml).