ROKAM (amp)
-
Chemical Name:
Piroxicam -
Therapeutic Category:
Anti-inflammatory drugs -
Pharmacologic Category:
Nonsteroidal Anti-inflammatory Drug (NSAID) -
Pharmaceutical Form:
Ampoule -
Composition:
Piroxicam 20mg/1ml
ROKAM
Injection (Ampoule)
Piroxicam
1.PHARMACOLOGY:
Piroxicam is a non-steroidal anti-inflammatory drug from oxicams group.
It possesses the following properties, which are all related to an inhibition of the biosynthesis of the prostaglandins: Analgesic, antipyretic, anti-inflammatory and inhibition of the platelets.
Edema, erythema, tissue proliferation, fever and pain can all be inhibited in laboratory animals by the administration of Piroxicam. It is effective regardless of the etiology of the inflammation.
It has been shown that Piroxicam interacts at several steps in the immune and inflammation responses through:
- Inhibition of prostanoid synthesis, including prostaglandins, through a inhibition of the cyclooxigenase enzyme.
- Reversible inhibition of the neutrophil aggregation.
- Inhibition of polymorphonuclear cell and monocyte migration to the area of inflammation.
- Inhibition of lysosomal enzyme release from stimulated leucocytes.
- Inhibition of superoxide anion generation by the neutrophil.
- Reduction of both systemic and synovial fluid rheumatoid factor production in patients with seropositive rheumatoid arthritis.
In clinical studies Piroxicam has been found effective as an analgesic in pain of various etiologies (post-traumatic pain and post-operative pain). The onset of analgesia is prompt.
2.PHARMACOKINETICS:
Piroxicam pharmacokinetic’s is linear and there are no age-related pharmacokinetics modifications.
Aabsorption:
Comparative pharmacokinetic study between oral and injectable forms of Piroxicam has shown the following:
- Plasmatic levels of Piroxicam after intramuscular administration are significantly higher than after oral administration.
- There is bio-equivalence between the 2 forms (IM and oral).
Distribution:
- Elimination half-life is around 50 hours.
- After IM injection of Piroxicam 40 mg, we have Cmax of 3.80 gr/ml in 45 minutes (Tmax).
- Binding to plasmatic proteins is important: 99 %.
- Piroxicam crosses rapidly the synovial membrane, the synovial levels are from 45 to 50 % of the blood levels.
- The binding to synovial liquid proteins is the same as the binding to plasma proteins.
- Piroxicam is present in the breast milk (around 1 to 3 % of the plasma level).
Metabolism and Excretion:
Piroxicam is almost entirely metabolized. It is eliminated slowly.
Less than 5 % of the administered doses is eliminated unchanged in the urine and feces. One of the important metabolic ways is the hydroxylation of the pyridine nucleus, followed by a glycuroconjugation and then urinary excretion.
3.INDICATIONS:
Piroxicam is a nonsteroidal anti-inflammatory drug indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, arthrosis, degenerative joint disease, ankylosing spondylitis, acute musculo-skeletal disorders, acute gout, pain after operative intervention and following acute trauma, and for the relief of fever and pain associated with acute upper respiratory tract inflammation.
4.CONTRAINDICATIONS:
- Hypersensitivity to Piroxicam or any other close substance as NSAIDs and Aspirin.
- Gastric ulcer in evolution.
- Severe hepatocellular and renal impairment.
- During anticoagulant therapy.
- Children less than 15 years.
5.PRECAUTIONS:
- Pregnancy and nursing mothers.
- Care should be taken in patients with asthmatic history and gastrointestinal bleeding.
- In case of any cutaneous manifestations, treatment should be interrupted.
- There is no need to reduce the dosage in elderly patients.
6.SIDE EFFECTS:
It may cause: Rash, pruritus, gastrointestinal disturbances, dizziness, and vertigo.
It may rarely cause: Slight pain at the site of injection.
7.DRUG INTERACTIONS:
- Piroxicam may potentiate the action of all drugs, which lead to a hyperkaliemia like: Potassium salts, diuretics, NSAIDs, etc…
- Caution should be taken if administered with the following products: NSAIDs (including Aspirin), oral anticoagulants, heparins, Lithium, Methotrexate, Ticlopidine, Pentoxifylline, Zidovudine.
8.DOSAGE & ADMINISTRATION:
Posology (IM Injection):
Acute Inflammatory Rheumatoid: 20 mg (1 ampoule) per day.
Acute Lombalgies and Radiculalgies: 40 mg (2 ampoules) per day in one injection for the first 2 days, and then eventually 1 ampoule (20 mg) the next day.
The total daily dose of ROKAM should not exceed 40 mg per day.
Duration of treatment:
2 to 3 days (the oral treatment could be followed if necessary).
Method of administration:
The IM injection should be deep and slow and it should be done on different side each time.
9.PACKAGING & COMPOSITION:
ROKAM – Injection: A pack of 5 or 100 ampoules of 1 mL. Each ampoule (1 mL) contains Piroxicam 20 mg.
10.STORAGE CONDITIONS:
Store ROKAM – Injection at temperature between (15-25)°C.
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