Overdose
With systemic use of Artrum (extended-release tablets, solution for intravenous and intramuscular administration), the main symptoms of overdose are headache, melena, nausea, abdominal pain, vomiting (including blood), respiratory depression, impaired consciousness, convulsions , renal failure, impaired renal function.
Therapy: gastric lavage and activated charcoal; symptomatic and supportive treatment. The effect of ketoprofen on the gastrointestinal tract can be reduced by using drugs that reduce the secretion of gastric glands (in particular, proton pump inhibitors) and prostaglandins. It is necessary to monitor the activity of the respiratory and cardiovascular systems. Hemodialysis is ineffective, and a specific antidote is unknown.
The main symptoms of an overdose of ketoprofen with intrarectal administration of Artrum (suppositories) are drowsiness, nausea, vomiting, abdominal pain, bleeding, impaired renal and liver function. To relieve the condition, symptomatic treatment is recommended.
Cases of overdose of Artrum in the form of a gel for external use have not been registered.
Side effects
- digestive system: dyspeptic disorders (nausea, vomiting, heartburn, increased or decreased appetite, flatulence, constipation or diarrhea), NSAID gastropathy, dry mouth, change in taste, stomatitis, impaired liver function, abdominal pain; with long-term treatment in high doses - ulceration of the mucous membrane of the gastrointestinal tract, exacerbation of Crohn's disease, perforation of the walls of the gastrointestinal tract, melena, various bleedings (gingival, hemorrhoidal, gastrointestinal);
- cardiovascular system: peripheral edema, tachycardia, increased blood pressure;
- hematopoietic system: leukopenia, anemia and hemolytic anemia;
- central nervous system: fatigue, insomnia or drowsiness, dizziness, asthenia, nightmares, headache, depression, agitation, forgetfulness, nervousness, migraine, confusion or loss of consciousness, hallucinations, peripheral polyneuropathy, speech disorder, disorientation;
- sense organs: change in taste, dryness of the mucous membrane of the eyes, conjunctival hyperemia, blurred vision, tinnitus, eye pain, vertigo, hearing loss;
- urinary system: interstitial nephritis, urethritis, renal dysfunction, nephrotic syndrome, cystitis, hematuria;
- laboratory parameters: decreased platelet aggregation, anemia, purpura, transient increase in liver enzyme activity, agranulocytosis, thrombocytopenia;
- allergic reactions: skin itching, rash, shortness of breath, exfoliative dermatitis, anaphylactoid reactions, rhinitis, bronchospasm, angioedema;
- other reactions: menometrorrhagia, myalgia, hemoptysis, thirst, nosebleeds, muscle twitching, photosensitivity, increased sweating; with long-term treatment in high doses – vaginal bleeding;
- local reactions: when using the gel - rash on the skin and itching at the site of application; when using suppositories - painful defecation, irritation of the rectal mucosa.
Artrum, instructions for use: method and dosage
Long-acting tablets
Artrum tablets are taken orally with meals. The recommended dose is 1 tablet 2 times a day. The maximum daily dose is 300 mg.
Solution for intravenous and intramuscular administration
The recommended dose for intramuscular administration is 100 mg 1-2 times a day. Artrum is administered intravenously only in a hospital setting. For a short intravenous infusion, ketoprofen is administered over 30–60 minutes, repeated administration is possible after 8 hours. With prolonged intravenous infusion, Artrum is administered over 8 hours, repeated administration is possible after 8 hours. The maximum daily dose is 200 mg.
To prepare a solution for short-term infusion, 1-2 ampoules (100-200 mg) of ketoprofen are diluted in 100 ml of isotonic sodium chloride solution. To prepare a solution for continuous infusion, 1-2 ampoules (100-200 mg) of ketoprofen are diluted in 500 ml of one of the infusion solutions (5% dextrose solution, isotonic sodium chloride solution or lactated Ringer's solution).
Parenteral administration of Artrum can be combined with taking tablets or administering rectal suppositories. The drug in solution form is used for no more than 3 days. If further use of ketoprofen is necessary, the patient is transferred to other dosage forms of Artrum (tablets, suppositories, gel).
Rectal suppositories
Artrum suppositories are injected deep into the rectum. The recommended dose is 1 suppository 2 times a day (morning and evening).
Gel for external use
Gel Artrum is used externally. A single dose is 3–5 g (the volume corresponds to one large cherry). The gel is applied to the damaged area 2-3 times a day and gently rubbed until completely absorbed. Without consulting a doctor, the duration of treatment should not exceed 10 days.
Release form and composition
Artrum is available in the following forms:
- extended-release tablets: biconvex, round, white (20 pieces in dark glass bottles, one bottle in a cardboard box);
- solution for intravenous and intramuscular administration: transparent, with a slight yellowish tint or colorless (2 ml in dark glass ampoules, 5 ampoules in a blister pack, two packs in a cardboard pack; 2 ml in dark glass ampoules, 10 in a cardboard pack ampoules);
- rectal suppositories: torpedo-shaped, white with a yellowish or creamy tint (5 pieces in a blister pack, 1 or 2 packs in a cardboard box);
- gel for external use: colorless, non-greasy, with a specific odor (30 g or 50 g in aluminum tubes, one tube in a cardboard pack).
Each pack also contains instructions for using Artrum.
Composition of 1 tablet:
- active ingredient: ketoprofen – 150 mg;
- auxiliary components: povidone, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate.
Composition of 1 ml solution:
- active ingredient: ketoprofen – 50 mg;
- auxiliary components: benzyl alcohol, 96% ethanol, sodium hydroxide to maintain a pH level of 6.0–7.5, propylene glycol, water for injection.
Composition of 1 suppository:
- active ingredient: ketoprofen – 100 mg;
- auxiliary components: polysorbate-80, vitepsol W-35, distilled monoglycerides, solid fat or vitepsol N-15.
Composition of 1 g gel:
- active ingredient: ketoprofen – 25 mg or 50 mg (calculated as 100% substance);
- auxiliary components: trolamine, ethanol, rare cross-linked polyacrylate, propylene glycol, purified water.
Indications for use
- symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (tendinitis, bursitis, periarthritis, tenosynovitis, arthrosynovitis, lumbago);
- articular syndrome (osteoarthritis, gout, rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, psoriatic arthritis, osteoarthritis, pseudogout);
- pain syndrome (headache, algodismenorrhea, neuralgia, myalgia, radiculitis, pain due to cancer, post-traumatic and postoperative pain);
- inflammatory diseases of lymphatic vessels, veins and lymph nodes (lymphangitis, phlebitis, superficial lymphadenitis, periphlebitis);
- uncomplicated injuries (including dislocations, bruises, sports injuries, sprains or ruptures of tendons and ligaments, post-traumatic pain).
For liver dysfunction
Long-acting tablets, solution for intravenous and intramuscular administration:
- severe liver failure: therapy is contraindicated;
- moderate and mild severity of liver failure, alcoholic cirrhosis of the liver, hyperbilirubinemia: Artrum should be used under medical supervision.
Rectal suppositories:
- severe liver failure: therapy is contraindicated;
- liver failure, alcoholic cirrhosis of the liver, hyperbilirubinemia: Artrum should be used under medical supervision.
Artrum gel for external use should be used with caution in severe renal impairment and exacerbation of hepatic porphyria.
Use during pregnancy and lactation
Long-acting tablets, solution for intravenous and intramuscular administration, gel for external use:
- III trimester of pregnancy and breastfeeding: therapy is contraindicated;
- I and II trimester of pregnancy: Artrum should be used under medical supervision only in cases where the expected benefit is higher than the possible risk to the fetus.
When inhibiting the synthesis of prostaglandins, an undesirable effect on the course of pregnancy and/or embryonic development is possible. There is information about an increase in the likelihood of spontaneous abortion and the formation of heart defects (~ 1–1.5%).
In the third trimester, the use of Artrum is contraindicated due to the possibility of developing the following conditions:
- increased bleeding time;
- weakness of labor activity of the uterus and/or premature closure of the ductus arteriosus;
- renal failure and oligohydramnios.
There is no information about the excretion of ketoprofen into breast milk.
Artrum rectal suppositories are not prescribed during pregnancy/lactation.
For impaired renal function
Long-acting tablets, solution for intravenous and intramuscular administration:
- severe renal failure (in patients with creatinine clearance less than 30 ml/min): therapy is contraindicated;
- chronic renal failure (in patients with creatinine clearance 30–60 ml/min): Artrum should be used under medical supervision.
Rectal suppositories:
- severe renal failure: therapy is contraindicated;
- renal failure: Artrum should be used under medical supervision.
Artrum gel for external use should be used with caution in severe renal impairment.
special instructions
During treatment with the drug, it is necessary to systematically monitor the functions of the kidneys and liver.
With long-term use of Artrum and other non-steroidal anti-inflammatory drugs, it is necessary to monitor blood counts, especially in elderly patients.
In patients with hypertension and cardiovascular diseases leading to fluid retention, regular monitoring of blood pressure is required.
Artrum can mask the symptoms of infectious diseases.
Impact on the ability to drive vehicles and complex mechanisms
Patients taking ketoprofen should be careful when driving vehicles and performing work that requires quick reaction and increased concentration.
