Arketal Romparm - instructions for use, doses, side effects, contraindications

Excipients: ethanol 96% 100.0 mg, propylene glycol 400.0 mg, benzyl alcohol 20.0 mg, sodium hydroxide 8.5 mg, 10% sodium hydroxide solution or hydrochloric acid up to pH = 7.2 ± 0.2, water for injection up to 1 ml.

Description:

A clear, colorless or slightly yellow solution.

Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Ketoprofen has anti-inflammatory, analgesic and antipyretic effects associated with inhibition of cyclooxygenase activity (COX1 and COX2) regulating the synthesis of prostaglandins (Pg).

Pharmacokinetics:

Absorption - fast, bioavailability - more than 90%. The connection with plasma proteins is 99%. Time to reach the maximum concentration (TCmax) - 15-30 minutes.

The therapeutic concentration in the synovial fluid is maintained for 6-8 hours.

In a significant amount does not penetrate the blood-brain barrier (BBB).

Virtually completely metabolized in the liver by glucuronation, has the effect of "first passage" through the liver.

It is excreted by the kidneys, 60-80% - in the form of glucuronide for 24 hours.

Indications:Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, Bechterew's disease (ankylosing spondylitis), gouty arthritis, osteoarthritis. Designed for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Pain syndrome: myalgia, ossalgia, neuralgia, tendonitis, arthralgia, bursitis, radiculitis, adnexitis, otitis media, headache and toothache, with oncological diseases, post-traumatic and postoperative pain syndrome, accompanied by inflammation.

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

Contraindications:Hypersensitivity (including other NSAIDs), complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in anamnesis), peptic ulcer and 12 duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer; hemophilia and others.disorders of blood clotting, active gastrointestinal bleeding; severe renal failure (QC less than 30 ml / min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after aortocoronary bypass grafting, confirmed hyperkalaemia, inflammatory bowel disease, children's age (up to 15 years).

Carefully:

Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic liver cirrhosis, hyperbilirubinemia, liver failure, dehydration, sepsis, chronic heart failure (CHF), edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, ischemic heart disease (IHD), cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, chronic renal failure (CRF) (KK 30-60 ml / min), ulcerative lesions of the gastrointestinal tract (gastrointestinal tract) in an ana Veronese, the presence of infection Helicobacter pylori, long-term use of NSAIDs, severe physical illnesses; simultaneous application of oral glucocorticosteroid agents (GCS) (including prednisolone), anticoagulants (incl.warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), elderly age.

Pregnancy and lactation:

Arketal Rompharm is contraindicated for use in the third trimester of pregnancy.

In the first and second trimesters of pregnancy Arketal Rompharm is possible in cases when the potential benefit to the mother exceeds the potential risk for the fetus, to be used only under the supervision of a doctor.

If you need Arketal Rompharm during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Intravenous (drip) (in / in), intramuscularly (in / m).

Adults

In / m - 100 mg 1-2 times a day.

In / in, drip 100-200 mg in 100-500 ml of 0.9% solution of sodium chloride. Infusions are performed only in a hospital, not more than 300 mg for 0.5-1 h.

Treatment with the drug is carried out for a short period (2-3 days). If necessary, continue treatment with other dosage forms.

The maximum daily dose is 300 mg of ketoprofen.

Elderly patients the minimum effective dose is recommended. Patients should be observed regularly.possibly gastrointestinal bleeding during therapy with NSAIDs.

Patients with renal insufficiency the minimum effective dose is recommended, then adapted depending on renal tolerance.

Method of administration

Intramuscularly:

Arketal Rompharm is injected deep, slowly into the upper outer square of the buttocks, under strictly aseptic conditions. Subsequent injections are injected alternately into both buttocks.

Intravenously:

- short-term infusion: from 100 to 200 mg of ketoprofen diluted in 100 ml of 0.9% solution for infusion of sodium chloride and injected for 0.5-1 h; the administration can be repeated every 8 hours for no more than 48 hours.

- prolonged infusion: from 100 to 200 mg of ketoprofen is diluted in 500 ml of the infusion solution (0.9% sodium chloride, Ringer lactate, dextrose) and injected for 8 hours; administration can be repeated every 8 hours, for no more than 24 hours.

Due to the fact that ketoprofen is sensitive to light, the bottle or the infusion bag should be covered with black paper or aluminum foil.

Side effects:

From the digestive system: NSAIDs-gastropathy, abdominal pain dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), stomatitis, impaired liver function, change in taste.

From the nervous system: Headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, fatigue, confusion or loss of consciousness, headache, peripheral neuropathy.

From the sense organs: noise or ringing in the ears, blurred vision, conjunctivitis, mucous membranes dry eyes, eye pain, conjunctival hyperemia, hearing loss, vertigo.

From the side of the cardiovascular system (SSS): increased blood pressure (BP), tachycardia.

On the part of the organs of hematopoiesis: agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.

From the urinary system: edematous syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria.

Allergic reactions: Skin rash (including erythematous), urticaria, skin pruritus, rhinitis, angioedema, bronchoconstriction, exfoliative dermatitis, anaphylactic shock.

Local Reactions: burning or pain at the injection site.

Other: increased sweating; hemoptysis, epistaxis, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity,with prolonged use in large doses - vaginal bleeding.

Overdose:

Overdose was detected at doses greater than 2.5 g of ketoprofen.

Symptoms manifest themselves in the form of increased dose-dependent side effects: cramps, a feeling of heaviness in the legs; increased arterial tension, ringing in the ears, blurred vision, rash, nausea, vomiting, epigastric pain, diarrhea, gastrointestinal bleeding, headache, dizziness, incoherence, confusion, drowsiness, convulsions, coma, respiratory depression .

Treatment symptomatic, a specific antidote for ketoprofen is unknown. Conduct appropriate hydration, observe renal clearance and correct acidosis. If necessary, apply hemofiltration.

Interaction:

Pharmaceutically incompatible with tramadol solution.

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, fibrinolytics, ethanol, side effects of GCS and ISS, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Joint use with other NSAIDs, GCS, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, an increased risk of kidney dysfunction.

Co-administration with indirect anticoagulants, heparin, thrombolytic agents, antiaggregants, cefoperazone, cefamandol and cefotetan increases the risk of bleeding.

Increases hypoglycemic action of insulin and oral hypoglyca(it is necessary to recalculate the dose).

Inductors of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

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

Increases the concentration in the plasma of verapamil and nifedipine, lithium preparations, methotrexate.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

During treatment, control, picture, peripheral blood and functional state of the liver and kidneys.

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

The use of ketoprofen can mask the signs of an infectious disease.

If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with a minimal short course.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for infusion and intramuscular injection 50 mg / ml.

Packaging:

By 2.0 ml of the drug in ampoules of dark glass hydrolytic class I with a ring for kink with a capacity of 2 ml. A label is affixed to each ampoule.

5 ampoules are placed in a contour mesh package.

For 1 or 2 contour packagings together with the instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

In a place inaccessible to children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:PL-000888

Date of registration:18.10.2011

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspROMFARM COMPANY ROMFARM COMPANY Romania

Information update date: & nbsp18.10.2011

Illustrated instructions

Instructions

Arketal Rompharm (Arketal Romfarm)