Artrocol (ketoprofen) solution for injections 100 mg/2 ml. ampoules 2 ml. №5

$17.50

Manufacturer: Romania

Artrocol (ketoprofen) solution is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic effects. It is used for:

  • Joint diseases : rheumatoid arthritis; seronegative spondyloarthritis (ankylosing spondylitis, psoriatic arthritis, reactive arthritis); gout, pseudogout; osteoarthritis; extra-articular rheumatism (tendinitis, bursitis, capsulitis of the shoulder joint).
  • Pain syndrome : lumbago, post-traumatic pain in the joints, muscles; postoperative pain; pain with metastases of tumors in the bone; algomenorrhea.
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Description

Artrocol solution for injections 100mg/2ml, 2 ml ampoules, 5 pcs. – Instructions for use

Ingredients

active ingredient : ketoprofen;

1 ampoule (2 ml) of the solution contains ketoprofen 100 mg;

excipients : propylene glycol, ethanol 96%, benzyl alcohol, sodium hydroxide, sodium hydroxide solution or hydrochloric acid, water for injection.

Dosage form

Injection.

Basic physical and chemical properties : clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Ketoprofen. ATX code M01A E03.

Pharmacodynamics

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory and antipyretic effects.

In inflammation, ketoprofen inhibits the synthesis of prostaglandins and leukotrienes, inhibiting the activity of cyclooxygenase and partially lipoxygenase, it also inhibits the synthesis of bradykinin and stabilizes lysosomal membranes.

It has a central and peripheral analgesic effect and eliminates the manifestations of symptoms of inflammatory and degenerative diseases of the musculoskeletal system.

In women, ketoprofen reduces the symptoms of primary dysmenorrhea due to inhibition of prostaglandin synthesis.

Indications

  • Joint diseases : rheumatoid arthritis; seronegative spondyloarthritis (ankylosing spondylitis, psoriatic arthritis, reactive arthritis); gout, pseudogout; osteoarthritis; extra-articular rheumatism (tendinitis, bursitis, capsulitis of the shoulder joint).
  • Pain syndrome : lumbago, post-traumatic pain in the joints, muscles; postoperative pain; pain with metastases of tumors in the bone; algomenorrhea.

Contraindications

  • Hypersensitivity to the active substance and / or to other excipients of Artrocol (ketoprofen) solution.
  • A history of allergic conditions such as bronchospasm, asthma attacks, urticaria, angioedema, acute rhinitis, after taking acetysalicylic acid or other NSAIDs.
  • Chronic dyspepsia in history.
  • A stomach or duodenal ulcer in the acute stage or gastrointestinal bleeding, peptic ulcers or perforations in history.
  • Cerebrovascular or other bleeding.
  • Tendency to hemorrhage; hemorrhagic diathesis.
  • Hemostatic disturbances or simultaneous use of anticoagulants.
  • Severe heart failure.
  • Severe liver dysfunction.
  • Severe renal impairment.
  • Bronchial asthma and rhinitis in history.
  • Treatment of perioperative pain during coronary artery bypass surgery.

Dosage and administration

Artrocol (ketoprofen) solution is intended for intravenous and intramuscular administration.

The dosage should be selected individually, depending on the patient’s condition and his response to treatment.

Intramuscular administration.

Artrocol (ketoprofen) solution is used at a dose of 100 mg (1 ampoule) 1-2 times a day. The maximum daily dose should not exceed 200 mg.

If necessary, intramuscular administration can be supplemented by the use of oral or rectal forms of ketoprofen.

Intravenous administration.

The drug should be administered as an infusion only in a hospital setting. Infusion is carried out within 0.5 – 1 hour, the course of treatment with intravenous administration is no more than 48 hours. The maximum daily dose is 200 mg.

Intermittent intravenous infusion : 100-200 mg of ketoprofen should be dissolved in 100 ml of 0.9% sodium chloride solution and administered over 0.5-1 hour. The maximum daily dose is 200 mg.

Continuous intravenous infusion : dissolve 100-200 mg of ketoprofen in 500 ml of solution for infusion (0.9% sodium chloride solution, lactated Ringer’s solution, glucose solution) and inject within 8 hours. The maximum daily dose is 200 mg.

Caution : Vials with solution for infusion should be wrapped in dark paper or aluminum foil, since ketoprofen is sensitive to light.

Tramadol and ketoprofen should be administered separately, as a precipitate may form when they are mixed.

The duration of treatment depends on the severity and course of the disease, however, adverse reactions of ketoprofen can be minimized by using the lowest effective dose for the shortest possible time (see section “peculiarities of use”).

To prevent the negative effect of ketoprofen on the mucous membranes of the digestive tract, antacids can be taken simultaneously.

Simultaneous use with other drugs.

Ketoprofen can be used together with centrally acting analgesics; it can be mixed with morphine in one bottle: 10-20 mg of morphine and 100-200 mg of ketoprofen are dissolved in 500 ml of solution for infusion (0.9% sodium chloride solution or Ringer’s solution with lactate). The maximum daily dose is 200 mg.

Special categories of patients.

Elderly patients.

In elderly patients, the risk of adverse reactions with ketoprofen increases. After 4 weeks from the start of treatment, the patient’s condition should be monitored for manifestations of gastrointestinal bleeding. The use of the drug is recommended to start with the lowest dose in order to keep patients on the lowest effective dose.

Patients with impaired renal function.

In patients with moderate renal impairment with creatinine clearance less than 0.33 ml / s (20 ml / min), the dose of ketoprofen should be reduced. The use of ketoprofen is contraindicated in patients with severe renal impairment.

Patients with impaired liver function.

In patients with chronic liver disease and reduced plasma albumin levels, the dose of ketoprofen should be reduced. The use of ketoprofen is contraindicated in patients with severe hepatic impairment.