Arquethal Rompharm, 50 mg/ml 2 ml 10 pcs

Inflammatory and degenerative diseases of the musculoskeletal system:

– rheumatoid arthritis;

– psoriatic arthritis;

– Bechterew’s disease (ankylosing spondylitis);

– gouty arthritis;

– osteoarthritis.

Prescribed for symptomatic therapy, reducing pain and inflammation at the time of use, has no effect on the progression of the disease.

Pain syndrome:

– myalgia;

– ossalgia;

– neuralgia;

– tendonitis, bursitis;

– arthralgia;

– sciatica;

– adnexitis;

– otitis media;

p> – headache;

– toothache;

– pain in cancer;

– post-traumatic and postoperative pain syndrome accompanied by inflammation.

Algodysmenorrhea, childbirth (as an analgesic and tocolytic agent).

Active ingredient

Composition

1 ml contains ketoprofen 50 mg

Supplementary substances:

ethanol 96% – 100 mg,

propylene glycol – 400 mg,

benzyl alcohol – 20 mg,

sodium hydroxide – 8.5 mg,

Sodium hydroxide solution – 10% or hydrochloric acid – to pH 7.2±0.2,

water d/i – up to 1 ml.

How to take, the dosage

The drug is administered to adults by IV drops or intravenously. V/m – 100 mg 1-2 times/day, v/v drops – 100-200 mg in 100-500 ml of 0.9% sodium chloride solution. Infusions are carried out only in hospital, not more than 300 mg for 0.5-1 h.

The maximum daily dose is 300 mg.

The drug is treated briefly (2-3 days). If necessary, treatment is continued with other dosage forms.

In elderly patients, it is recommended that the drug be used in the lowest effective dose. Patients should be monitored regularly, as gastrointestinal bleeding is possible during NSAID therapy.

In patients with renal impairment, the drug is recommended in the lowest effective dose, which should then be adjusted according to the state of renal function.

Principles of administration

The drug is administered deeply, slowly, in the upper outer quadrant of the buttock, under strictly aseptic conditions. Subsequent injections are administered alternately in both buttocks.

In/v: 1) short-term infusion – 100 to 200 mg of ketoprofen diluted in 100 ml of 0.9% sodium chloride solution and administered for 0.5-1 h; the injection can be repeated every 8 h, for not more than 48 h; 2) long-term infusion – 100 to 200 mg of ketoprofen diluted in 500 ml of solution for infusion (09% sodium chloride solution, Ringer’s lactate solution, dextrose solution) and administered for 8 h; administration can be repeated every 8 h, for not more than 24 h.

Because ketoprofen is sensitive to light, the vial or infusion bag should be covered with black paper or aluminum foil.

Interaction

Pharmaceutically incompatible with tramadol solution.

Decreases the effectiveness of uricosuric drugs.

It enhances the effect of anticoagulants, antiaggregants, fibrinolytics, ethanol, the side effects of gluco- and mineralocorticoids, estrogens.

Limits the effectiveness of hypotensive drugs and diuretics.

Mixed use with other NSAIDs, GCS, ethanol, corticotropin may lead to ulceration and gastrointestinal bleeding, increased risk of renal dysfunction.

The co-administration with indirect anticoagulants, heparin, thrombolytics, antiaggregants, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

Enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Hepatic microsomal enzyme inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase production of hydroxylated active metabolites.

Co-administration with valproic acid causes impairment of platelet aggregation.

Enhances plasma concentrations of verapamil and nifedipine, lithium drugs, methotrexate.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special Instructions

During treatment, monitoring of peripheral blood counts and functional status of the liver and kidneys is necessary.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

The use of ketoprofen may mask the signs of infectious disease.

Dose reduction and close monitoring are necessary if renal and hepatic function is impaired.

To reduce the risk of gastrointestinal adverse events, the lowest effective dose should be used in the shortest possible course.

Impact on driving and operating machinery

At the time of treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions

Contraindications

– complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (incl. In anamnesis);

– gastric and duodenal ulcer in the acute phase;

p> – ulcerative colitis in the acute phase;

– Crohn’s disease;

– diverticulitis;

– Peptic ulcer;

– hemophilia and other blood clotting disorders;

– active gastrointestinal bleeding;

– severe renal failure (CK less than 30 ml/min);

– advanced renal disease;

– severe hepatic insufficiency or active liver disease;

– condition after aortocoronary bypass surgery;

– confirmed hyperkalemia;

– inflammatory bowel disease;

– childhood under 15 years of age;

– hypersensitivity to the components of the drug;

– hypersensitivity to other NSAIDs.

With caution: anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis, hyperbilirubinemia, liver failure, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, CHD, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, chronic renal failure (CK 30-60 ml/min), history of peptic ulcers, Helicobacter pylori infection, long-term use of NSAIDs, severe medical conditions, simultaneous use of oral GCS (including prednisolone), and other medical conditions.Prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), advanced age.

Side effects

Digestive system disorders: NSAID gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), stomatitis, liver function disorders, change in taste.

Nervous system disorders: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, migraine, peripheral neuropathy.

Sensory organs: tinnitus or ringing in the ears, blurred vision, conjunctivitis, dry mucous membrane of the eye, eye pain, conjunctival hyperemia, decreased hearing, vertigo.

Cardiovascular system: increase in BP, tachycardia.

Hematopoietic disorders: agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.

Urinary system disorders: edema syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria.

Allergic reactions: skin rash (including erythematous), urticaria, skin itching, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock.

Local reactions: burning or pain at the injection site.

Others: increased sweating, hemoptysis, nasal bleeding, myalgia, muscle twitching, shortness of breath, thirst, photosensitization, with prolonged use in high doses – vaginal bleeding.

Overdose

Overdose has been detected at doses greater than 2.5 g of ketoprofen.

Symptoms: intensification of dose-dependent side effects: seizures, feeling heavy in the legs, increased BP, tinnitus, blurred vision, rash, nausea, vomiting, epigastric pain, diarrhea, gastrointestinal bleeding, headache, dizziness, incoherence (incoherence), confusion, drowsiness, seizures, coma, respiratory depression.

Treatment: symptomatic therapy is carried out. A specific antidote is unknown. Adequate hydration is carried out, renal clearance is monitored and acidosis is corrected. Hemofiltration is used if necessary.

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