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Scelto Injeksi

11:02
SCELTO®
INJEKSI

Scelto® 10
Each ampoule contains : Ketorolac tromethamine 10 mg
Scelto® 30
Each ampoule contains : Ketorolac tromethamine 30 mg

DESCRIPTION
Scelto (Ketorolac tromethamine/ketorolac trometamol) is a member of the pyrollo-pyrrole group of non-steroidal anti-inflammatory drugs. The Chemical name for ketorolac tromethamine is a (±) 5-benzoyl-2,3-dihydro-1H-pyrolizine-1-carboxylic acid, 2-amino-2-(hydroxymethyl)-1,3-propanediol. Ketorolac tromethamine is soluble in water and has a pKa of 3.54. The molecular weight of ketorolac tromethamine is 376.41.
Scelto injection is available for intramuscular (IM) and intavenous (IV) administration 30 mg and 10 mg ketorolac tromethamine per ml sterile solution.
Excipients include : sodium chloride, ethanol, and water for injection.

CLINICAL PHARMACOLOGY
Pharmocodynamics
Ketorolac tromethamine is a non-narcotic analgesic. It is nonsteroidal anti-inflammatory and weak antipyretic activity. Ketorolac tromethamine inhibits synthesis of prostaglandins and may be considered a peripherally acting analgesic since it does not have any known effect on opiate receptors.

CLINICAL STUDIES
The analgesic efficacy of intramuscularly administered Scelto was investigated in several studies in two acute post-operative pain models, general surgery (orthopedic, gynecologic and abdominal) and oral surgery (removal of impacted third molars), The studies were primary single-dose, parallel trial designs, in which Scelto was compared to meperidine (pethidine) or morphine administered intramuscularly. In each pain model, patients had moderate to severe pain at baseline. When compared to meperidine 50 and 100 mg, or morphine 6 and 12 mg in patients with post-operative pain. Scelto 10, 30 and 90 mg gave pain relief similar to meperidine 100 mg and morphine 12 mg.
The time to on set of analgesic action was comparable to morphine. The duration of analgesia with Scelto 30 mg and 90 mg was longer than with narcotics. Based on consideration of efficacy and safety after refeated doses, the 30 mg dose demonstrates the best therapeutic index.
In a multicentre, multi-dose (20 doses given over 5 days), post-operative (general surgery) trial of Scelto 30 mg versus morphine 6 and 12 mg each drug given on as needed basis, the overall analgesic effect of Scelto 30 mg was in between that of morphine 6 mg and 12 mg, although the differences between Scelto 30 and morphine 12 mg were not statistically significant. No evidence of respiratory depression has been observed after administration of Scelto in controlled clinical trials. Scelto did not cause constriction. Scelto cause no more drowsiness than morphine in post-operative patients.

PHARMOKINETICS
Ketorolac tromethamine is rapidly and completely absorbed following intramuscular administration with a mean peak plasma concentration of 2.2 mcg/ml occurring an average of 50 minutes after a single 30 mg dose. The terminal plasma half-life is 5.3 hours in young adults and 7 hours in elderly subjects (mean age 72). More than 99 % of the ketorolac in patient bound over a wide concentration range. The pharmacokinetics of ketorolac mean following single or multiple intramuscular doses are linear. Steady state plasma levels are achieved after dosing every 6 hours for one day. No changes in clearance occur with chronic dosing. Following a single intravenous dose, the volume of distribution averages 0.25 L/kg, the ketorolac and its metabolites (conjugates and a parahydroxy metabolite) is in the urine (mean 91.4 %) and the reminder (mean 6.1 %) is excreted in the faeces.
Haemodynamics of patients are not altered by parenteral administration of Scelto. The mean apparent volume (VB) following complete distribution after single dose was approximately 13 litres.

INDICATIONS AND USAGE
Scelto is indicated for short therm management moderately severe, acute pain following surgical procedures. The total duration of ketorolac used should not exceed five days. It is recommended that ketorolac parenteral be used in immediate post-operative period. Patients should be switch ed to alternative analgesics as soos as possible, but Scelto therapy is not exceed 5 days. Scelto is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in the circumstances and because the known effects of drugs that inhibit prostaglandin bio synthesis or uterine contraction and foetal circulation.

CONTRAINDICATIONS
Scelto is contraindicated in patients who have previously established allergy to it. Because of the possibility of cross-sensitivity, Scelto is also contraindicated in patients in whom aspirin or other non steroidal anti inflammatory drugs induce serious allergic manifestation. Scelto is contraindicated in patients with active peptic ulcer.
  • Suspected or confirmed cerebrovascular disease 
  • Haemorrhagic diatheses including coagulant disorders
  • The complete or partial syndrome of nasal polyps, angio oedema or bronchospasm
  • Concurrent treatment with other NSAIDs and ASA
  • Hipovolaemia from any cause or dehydration
  • Moderate or severe renal impairment (serum creatine › 160 micromol/L)
  • A history of asthma
  • Patient who have had operations with a high risk of haemorrhage or incomplete haemostatis, patients on anticoagulants including low dose of Heparin (2500 - 5000 Unit 12 hourly).
  • Concurrent treatment with oxpentyfilline, probenecid or lithium salt. 
  • During pregnancy, labour, delivery or lactation
  • Children ‹ 16 years of age
  • Patients with a prior history of Steven-Johnson syndrome or vesicular bullous rash.
  • Neuraxial (epidural or intrathecal) administration
  • Prophylactic administration before major surgery or intraoperatively when haemostatis is critical because of the increased risk of bleeding.

WARNINGS
As with nonsteroidal anti-inflammatory analgesic agents, Scelto can cause gastrointestinal irritation, ulcers, perforation or bleeding with or without previous symptoms and should be given under close supervision to patients with a history of gastrointestinal tract disease.

PRECAUTIONS
Renal Effects: As with other drugs that inhibit prostaglandin biosynthesis, elevations of serum urea nitrogen and creatinine have been reported in clinical trials with ketorolac tromethamine.
The disposition of ketorolac in dialysis patients has not been studied. Patients who are volume depleted volume by virtue of blood loss or severe dehydration may be dependent on renal prostaglandin production to maintain renal perfusion and therefore glomerular filtration rate, volume depletion should be corrected. In such situations the use of drugs which inhibit prostaglandin synthesis might be expected to further decrease renal blood flow. Caution is advised if Scelto is used in such circumstances. Close monitoring of urine output, serum urea and serum creatinine is recommended until the patient is normovolaemic.
Haemotological Effects: Ketorolac inhibits platelet aggregation and may prolong bleeding time. Ketorolac does not affect platelet count, prothrombin time (PT) or partial thromboplastin time (PTT). Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostatis should be carefully observed when Scelto is administered. Unlike the prolonged effects from aspirin, the inhibition of platelet function by ketorolac is normalized within 24 to 48 hours after the drugs is discontinued. In controlled clinical studies, the incidence of clinically significant post-operative bleeding was 5/1170 (0.4 %) compared to 1/570 (0.2 %) in the control groups receiving opiates. Hepatic Effects: Borderline elevations of one of more liver test may occur, These abnormalities may progress, may remain unchanged, or may be transient with discontinued therapy. Meaningful elevations of serum glutamic oxaloacetic transaminase (SGOT or AST) occurred in controlled clinical trials in less than 1 % of patients. If clinical signs and sympthoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc), Scelto should be discontinued. Patients with impaired hepatic function from cirrhosis do not have any clinically important changes in ketorolac clearance. Ketorolac tromethamine is not recommended for use as a pre-operative medication, for support of anesthesia or in obstetrical analgesia.
There are no clinical data available dealing with the safety or efficacy of concomitant use of ketorolac tromethamine with other non steroidal anti-inflammatory drugs. It is not recommended that Scelto be routinely used with other non steroidal anti-inflammatory drugs, because of potential for additive side effects.
For patient with mild renal impairment: see Dosage and Administration.
Renal function should be monitored in patients who have had more than a single i.m dosage of ketorolac, particularly in elderly patients.
Fluid retention and oedema : Fluid retention and oedema have been reported with the use of Scelto, therefore it should be used with caution in patients with cardiac decompensation, hypertension or similar conditions.

DRUG INTERACTIONS
In another study of 12 healthy subjects, co-administration of heparin 5000 U s.c. and Scelto did not show any phamacodynamic effects of the combination on template bleeding time or kaolin cephalin clotting time. Ketorolac is highly bound to human plasma protein (mean 99.2 %), and binding is independent of concentration.
The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac (99.5 % control vs 99.3 % binding with ketorolac). Ketorolac does not alter digoxin protein binding. In vitro studies indicated that at therapeutic concentrations of salicylate (300 mcg/ml), the binding of ketorolac was reduced from approximately 99.2 % to 97.5 %). Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, acetaminophen, phenytoin, tolbutamide and piroxicam did not alter ketorolac protein binding. Because ketorolac is a highly potent drug and present in low concentration in plasma, it would not be expected to displace other protein-bound drugs significantly.
There is no evidence in animal or human studies that ketorolac induces or inhibits the hepatic enzymes capable of metabolizing, itself or other drugs. Hence ketorolac tromethamine would not be expected to alter the pharmacokinetics of other drugs due to enzymes induction or inhibition mechanism.
Inhibition of renal lithium clearance leading to an increase in plasma lithium concentration and potential lithium toxicity has been reported with some prostaglandin synthesis inhibiting drugs.
Ketorolac tromethamine has not been studied in this respect.
Concomitant administration of ketorolac tromethamine and methotrexate should be done with caution since some prostaglandin synthesis inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus possibly enhance the toxicity of methotrexate.

-Warfarin
The concurrent use of NSAIDs and warfarin has been associated with severe, sometime fatal, haemorrhage. The exact interaction mechanism is unknown, but may involve enhanced bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of anticoagulation by warfarin and inhibition of platelet function by NSAIDs. Scelto should be used in combination with warfarin only if absolute necessary, and patients taking this is combination of drugs should be closely monitored.
-ACE inhibitor
As with other NSAIDs, ketorolac may increase the risk of renal impairment associated with the use of ACE inhibitors, particularly in patients that are actually or effectively volume depleted.
-Diuretics
Scelto reduces the diuretic response to furosemide in normovalaemic healthy subjects by approximately 20%.
-Nephrotoxic Agents
The use of drugs with nephrotoxic activity should be avoided when using Scelto aminoglycoside antibiotics.
-Anti epileptic drugs
Sporadic cases of seizures have been reported during concomitant use of Scelto and anti epileptic drugs (phenytoin, carbamazepin)
-Psychoactive drugs
Hallucination have been reported when Scelto was used in patients taking psychoactive drugs.

Carcinogenesis, Mutagenesis, and Impairment of Fertility
In animals studies, ketorolac tromethamine was not associated with tumorigenicity or mutagenicity and did not demonstrate teratogenic potential.

Pregnancy
Scelto is not recommended during pregnancy, labor or delivery.

Nursing Mothers
Scelto is not recommended for treatment of nursing mothers. Secretion of ketorolac in human milk after ingestion of scelto is limited. The milk to plasma ratio of ketorolac concentrations ranged between 0.015 and 0.037 in a study of 10 women.

Pediatric Use
Safety and efficacy in children have not been established. Therefore, Scelto is not recommended for use in children under 16 years of age.

Elderly
Patients over 65 years may be at greater risk than younger patients for adverse events. This age related risk is common to drugs that inhibit prostaglandin synthesis. As with all drugs, the lowest effective dose should be used in elderly patients.

ADVERSE REACTlONS
The adverse reactions listed below were reported to be probably related to Scelto in clinical trials in which patients received up to 20 doses in up to five days of intramuscularly administrated Scelto 30 mg.
Incidence Between 3 and 9 %
Gastrointestinal: dyspepsia, gastrointestinal pain, nausea
Central Nervous System: headache
Incidence Between 1 and 3 %
Gastrointestinal: diarrhoea
Central Nervous System: dizziness, drowsiness, sweating Body as a whole: oedema
Injection site pain was reported by 2 % of patients in multi doses studies (vs 5% for morphine control group).
Incidence 1 % or Less
Gastrointestinal: constipation, gastrointestinal fullness, liver function abnormalities, melaena, peptic ulcer, rectal bleeding, stomatitis, vomiting, flatulence.
Body as a whole: asthenia, myalgia
Hemic ad lymphatic: purpura
Central nervous system: abnormal thinking, depression, dry mouth, euphoria, excessive thirst, inability to concentrate, nervousness, paraesthesia, stimulation, vertigo.
Respiratory : asthma, dyspnoea
Dermatologic: pruritus, urticaria
Special Senses : abnormal vision
Cardiovascular : vasidillation; pallor
Urogenital: increased urinary frequency, oliguria

Drugs Abuse and Physical Dependence
Ketorolac tromethamine is not a narcotic agonist or antagonist. Subjects did not show any subjective symptoms or objective signs of drugs withdrawal upon abrupt discontinuation of intravenous or intramuscular dosing.

OVERDOSAGE
The absence of experience with acute overdosage precludes characterisation of sequalae and assessment of antidotal efficacy at this time. In a gastroscopic study of healthy subjects daily doses of 350 mg given over at 8 hour interval for each of five consecutive days (3 times the highest recommended dose) caused abdominal pain and peptic ulcers which recovered after discontinuation of dosing.

DOSAGE AND ADMINISTRATION
Scelto ampoules are for administration by intramuscular or bolus intravenous injection. Bolus intravenous doses should be given over no less than 15 seconds. Scelto ampoules should not be used, for epidural or spinal administration. The time to onset of analgesic effect 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 median duration analgesia is generally 4 to 6 hours. Dosage should be adjusted according to the severity of the pain and patients response.

Duration of treatment: The administration of continuous multiple daily doses of Scelto intramusculary and intravenously should not exceed 2 days because adverse events may increase with prolonged usage.
Adults
Ampoules : The recommended initial dose of Scelto is 10 mg followed by 10-30 mg every 4 hours to 6 hours as required. The lowest effective dose should be given. A total daily doses of 90 mg for non-elderly and 60 mg for the elderly, renally-impaired patients and patients less than 50 kg should not be exceeded. The maximum duration of treatment should not exceed 2 days. The lowest effective dose should be used for the shortest possible time in all patient population.

For patients receiving Scelto ampoules, the total combined daily dose should not exceed 90 mg (60 mg for the elderly, renally impaired patients and patients less than 50 kg).

Special dosage instructions
Elderly patients: Ampoules : For patients over 65 years, the lower end of the dosage range is recommended a total daily dose of 60 mg should not be exceeded (see Precautions).

Children: Safety and efficacy in children have not been established. Therefore, Scelto is contraindicated for use in children under 16 years of age.

Renal impairment : Since ketorolac tromethamine and its metabolites are excreted primarily by the kidney, Scelto is contraindicated in moderate to severe impairment (serum creatinine › 160 m mol/l); patients with less renal impairment should receive a reduce dose (not exceeding 60 mg/day i.v. or i.m., and their status should be closely monitored

Combination treatment (See also Incompatibilities).
Opiod analgesics (e.g. morphine, phetidine) may be used concomitantly, and may be required for optimal analgesic effect in the early post-operative period when pain is most severe. Ketorolac tromethamine does not interfere with opioid binding and exacerbate opioid-related respiratory depression or sedation. When used in association with Scelto ampoules, the daily dose of opioid is usually less than that normally required. However, opioid side effects should still be considered, especially in day-case surgery.

Special remarks
Incompatibilities:
Scelto ampoules should not be mixed in a small volume (e.g. in a syringe) with morphine sulphate, pethidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride as precipitation of ketorolac tromethamine will occur.

Scelto ampoules are compatible with normal saline, 5 % dextrose, Ringer's solution, Ringer-lactate solution, or Plasmalyte solution. Compatibility with other drugs is unknown.

Store at room temperaturs (25 - 30 °C). Protect from light.

On medical prescription only
HARUS DENGAN RESEP DOKTER
Medicine, keep out of reach of children

Package
Scelto Injection 10 mg/ml
Box of 5 ampoules
Reg. No.DKL0321628043A1

Scelto Injection 30 mg/ml
Box of 5 ampoules
Reg. No.DKL0321628043B1

Manufactured by :
PHAROS
JAKARTA - INDONESIA

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