Fam for analgesic and anti inflammatory agent

Fam                                                                                                Ketorolac Tromethamine
Analgesic  Anti-inflammatory Agent

Composition :

– each fam tablet contains 10 mg Ketorolac Tromethamine.
Inactive ingredients: Starch, AviceL Magnesium Stearate. Talc, Aerosil.
– Each Fam 2 ml ampoule contains 30 mg Ketorolac Tromethamine.
Inactive ingredients: Ethyl Alcohol, Sodium Chloride & Sterile Water.

Pharmacological Action :

– Fam is a non-steroidal anti-inflammatory (NSAlD) a potent analgesic antl-lnflamrnatory and anti-pyretic.
– Fam inhibits cyclooxygenase enzymes (COX· I and COX-2) inhibiting the biosynthesis of prostaglandins.                                         – The analgesic effect of Fam (Ketorolac) is comparable with morphine, pethidine and pentazocine without the undesirable effects of opiate. The analgesic effect starts within 30 minutes reaches the maximum level within 1-2 hours following oral or IM administration and the mean duration of analgesia is 4-6 hours.

Pharmacokinetics :

Ketorolac is completely absorbed after oral or IM administration, peak plasma concentration within 30-60 minutes, the steady state plasma level is reached after 1 day, fatty diet decrease the absorption rate, delays the peak plasma level about I hour. KetoroJac is 99% bound to plasma proteins, it does not penetrate the blood-brain barrier, and it may cross the placenta, small amounts are distributed into breast milk, Ketorolac is metabolized mainly in the liver. About 90% is excreted in unchanged urine, metabolites and the remainder is excreted in the faeces, the tenninal plasma half-life is 4-6 hours,

Indications :

– For short-term management (s; 7 days) of different painful conditions that requires analgesia at opioid level e,g,: Major abdominal operations – Orthopaedic operations – Dental operations – Gynecological operations; Therapy should be initiated with IV or IM and continuation of treatment with oral Ketorolac, if necessary,
– For management of severe painful conditions e.g.: cancer pain, Renal colic … etc.

N.B : The total combined duration of use of Ketorolac tromethamine is not to exceed s 7 days because of potential increase of severity of
adverse reactions associated with therapeutic doses. Patients should be switched to alternative analgesics as soon as possible.

Dosage and Administration :

– Oral : One tablet every 4-6 hours (maximum dose 40mg/day). Opiates can be used concomitantly.
– Injection: Loading dose 30-60 mg, then half the dose for continuing pain relief, the maximum dose is 120 mg/day.

Contraindications :

Known hypersensitivity to ketorolac or other NSAlDs, history of asthma, severe heart failure. peptic ulcer. coagulation disorders, and during pregnancy and lactation.

Side Effects :

Side effects may include: GIT upsets, Dizziness, Vertigo, Rash, Pruritus, Sweating, Tinnitus. Headache, Dyspnea, Oliguria, Insomnia, Flushing, Bradycardia. and Weight Gain.

Drug interactions :

– ketorelac should not be used with other NSAIDs and Probenecid because of the potential for additive side-effects.
– Ketorolac reduces the diuretic response to frusemide by approximately 20%. in renal impainnent.
– Caution is advised when: Methotrexate or Lithium is administered
concurrently with ketorolac.

Precautions and Warnings :

cardiovascular Risk:

NASlDs 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 disease or risk factors for cardiovascular disease may be at greater risk. NASIDs are contraindicated for the treatment of pert – operative pain in the setting of coronary artery bybass graft ( CABG ) surgery.

Gastrointestinal Risk:

NASlDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines. 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.
– In elderly: Longer dosing interval is advisable.
– History of asthma: Bronchospasm may be precipitated.
– NSAIDs can cause: GIT irritation, ulcers or bleeding with or without a history of previous symptoms.
– Renal patients: patients with moderate to severe impainnent of renal function should not receive ketorolac.
– Appropriate monitoring is required for patients with history of
hypertension and/or congestive heart failure.
– caution should be used where strict haemostasis is critical, e.g. in
cosmetic or day-case surgery.

Overdose :

– Symptoms include nausea, abdominal pain, vomiting. dizziness, hypertension.
– Supportive measures: keeping airways unobstructed, monitoring
cardiovascular function, general symptomatic and supportive measures.

Presentation :

– Tablets: carton box containing I. 2, 😉 or 5 (AL/PVC) strips, each of 10 tablets and an inner leaflet.
– Ampoules: boxes contain 1, 5 or 100 ampoules, each of 2 ml and an

Storage :

– Tablets: Store at temperature not exceeding 30°c’ in a cool dry place.
– Ampoules: Store at room temperature.

Patients’ notice :

– A medicament, it is a product that affects your health, and consumption without need or without medical consultation is dangerous for you.                                                                                          – Follow strictly the instructions of your doctor prescription, and the
instructions of the pharmacist sold the medicament, as they are
experienced with its benefits and risks, do not interrupt or repeat the treatment course by yourself.

Manufactured by :

Fam tablets: Manufactured by: AlfaCure Phannaceuticals Co. s.a.e.
Fam ampoules: Manufactured by: Sunny Pharmaceutical co.(S.A.E.)
Factory: Badr city, Cairo-Egypt