АРТРОТЕК

Active material: Diclofenac, Misoprostol
When ATH: M01AB55
CCF: NSAIDS in combination with a synthetic analogue of prostaglandin E1₁
ICD-10 codes (testimony): M05, M15, M25.5, M45, M79.1
When CSF: 05.01.01.03.01
Manufacturer: PHARMACIA Ltd. (Great Britain)

Pharmaceutical form, composition and packaging

Pills white or nearly white, round, lenticular, embossed on one side as on the circle of four characters “A”, another – “Searle” and “1411”.

Excipients: methylhydroxypropylcellulose, aэrosyl, microcrystalline cellulose, krospovydon, Castor oil, hydrogenated, lactose, corn starch, povidone (K-30), magnesium stearate, tsellyulozы acetate phthalate, diethyl phthalate.

10 PC. – blisters (2) – packs cardboard.

Pills white or nearly white, round, lenticular, embossed on one side as four characters “A”, surrounding the figure “75”, another – “Searle” and “1421”.

Excipients: methylhydroxypropylcellulose, aэrosyl, microcrystalline cellulose, krospovydon, Castor oil, hydrogenated, lactose, corn starch, povidone (K-30), magnesium stearate, tsellyulozы acetate phthalate, diethyl phthalate.

10 PC. – blisters (2) – packs cardboard.

Pharmacological action

Artrotek is a combination of diclofenac sodium – NSAIDs, having anti-inflammatory and analgesic properties and misoprostol – synthetic analogue of prostaglandin e₁ protects the mucous membranes of the DIGESTIVE TRACT. The mechanism of action of diclofenac sodium is linked to its ability to inhibit neselektivno ziklooksigenzu-1 and ziklooksigenzu-2.

Misoprostol is a synthetic analogue of prostaglandin E1₁ reinforcing factors, involved in the protection of gastric mucosa and duodenal ulcer. Misoprostol supports blood supply of the stomach mucosa, decreases the secretion of pepsin and hydrochloric acid in the stomach, contributes to the formation of bicarbonate in the duodenum.

Pharmacokinetics

Pharmacokinetics of diclofenac and misoprostol, in combination, similar to the pharmacokinetics of these drugs, When taken as separate pills.

C_max – maximum concentration

T_max – time to maximum concentration

AUC – area under the curve "concentration – time»

Pharmacokinetic interaction between these two substances are not observed. After repeated admission Artroteka cumulation diclofenac, misoprostol or concentrations of misoprostol acid does not occur.

Testimony

Symptomatic treatment

-Rheumatoid arthritis;

-osteoarthritis;

- Ankylosing spondylitis;

— acute joint-muscle pain.

Dosage regimen

Inside during meals, without chewing, tablets also can crush or dissolve.

Artrotek is recommended for use in the following doses:

Osteoarthritis, rheumatoid arthritis:

Preparation 50 mg/200 mcg – by 1 tab. 2-3 times / day, 75 mg/200 mcg – by 1 tab. 2 times / day.

Ankiloziruyushtiy spondylitis:

Preparation 50 mg/200 mcg – by 1 tab. 2-3 times / day; by 75 mg/200 mcg – by 1 tab. 2 times / day.

Acute joint-muscle pain syndrome:

Preparation 50 mg/200 mcg – by 1 tab. 2-3 times / day; by 75 mg/200 mcg – by 1 tab. 2 times / day.

Side effect

Registered in mostly adverse reactions from the blood, the frequency of which is >1%: abdominal pains, constipation, diarrhea, duodenitis, dyspepsia, belching, esophagitis, flatulence, gastritis, nausea and vomiting.

Abdominal pain and diarrhea are usually transitory, and there may be mild or medium.

Besides, such adverse reactions were recorded as dizziness, headache, insomnia, itching, Hemorrhagic rash, gastrointestinal bleeding and perforation. Also identified changes in laboratory parameters: increased alkaline phosphatase decrease in hematocrit and increased ALT.

Women, receiving Artrotek, observed adverse reactions from the mammary glands and sexual organs: pain in the milk glands, dysmenorrhoea, bleeding in the mežmenstrual′nyj period, menorragija, menstrual irregularities, cramping in the abdomen, bleeding from the vagina (including bleeding in postmenopausal women), vaginitis.

In the course of monitoring after product registration further identified the following adverse reactions: allergic reactions (including anaphylaxis and angioedema), skin reactions (including rashes and Bullous rashes), mood changes, breathlessness, hepatitis, interstitial nephritis, pancreatitis, acute renal failure, stomatitis, thrombocytopenia, hives, anemia, epidermal necrolysis. In very rare cases, while therapy diclofenac/misoprostol were reported blurred vision, heavy dreaming, as well as reaction from the skin and mucous membranes.

Where, When pregnant women received misoprostol, the following were noted side effects: Abnormal Uterine reduction, uterine bleeding, uterine rupture/perforation, delay departure of the placenta, embolism of amniotic fluid, incomplete abortion, miscarriage, Fetal death, congenital malformations.

Contraindications

- Active gastrointestinal bleeding;

-pregnancy and lactation;

-hypersensitivity to diclofenac sodium, misoprostol, or any other ingredient preparation, other nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, as well as other prostaglandins;

- “Aspirin” bronchial asthma, hemodyscrasia.

Data on the safety and efficacy of Artroteka in children under the age of 18 missing years.

Carefully: anemia, bronchial asthma, congestive heart failure, arterial hypertension, porphyria, advanced age, erosivno-azwenne defeat gastrointestinal tract disorder, liver or kidney failure, Heart Disease, fluid retention, degidratatsiya.

Pregnancy and lactation

Artrotek is contraindicated for pregnant women, because misoprostol causes contractions of the uterus and can provoke miscarriage, preterm birth and fetal death. When misoprostol may occur malformations of the foetus. Diclofenac may cause premature closure of the ductus Botallo's.

Misoprostol you cannot assign breastfeeding mothers, because possible concentrations of misoprostol acid milk can cause diarrhea at the baby. Unknown, whether this drug is excreted in human milk. But, because many drugs are excreted in human milk, as well as the fact, that there is the possibility of development in infants of adverse reactions on diclofenac/misoprostol, You should either abandon breastfeeding, or stop taking this medication.

Cautions

Patients, treated with NSAIDs, including Artrotek, serious adverse reactions were reported from the stomach, such as bleeding, the appearance of ulcers and perforation.

Doctors and patients should be aware of the potential for ulcers, even in the absence of symptoms of the digestive tract.

NSAIDs, including Artrotek, It should be administered with caution to patients with gastrointestinal diseases in history or in the active stage, such as ulcer, bleeding, inflammatory bowel disease.

Women of childbearing age, you cannot start treatment until Artrotekom, until pregnancy is excluded, as well as they should use a reliable contraceptive measures during the whole period of therapy. If a pregnancy is assumed, This drug should be lifted.

Against the backdrop of Artrotekom therapy should be periodically monitored liver function. If Artrotek is prescribed for patients with compromised liver function, treatment should be under the constant supervision of a doctor.

In patients with kidney lesion, liver or heart disease should also exercise caution, Since the use of non-steroidal anti-inflammatory drugs, including diclofenac/misoprostol, can lead to renal dysfunction. Caution must be used in the treatment of patients with dehydration. You should use the lowest possible dose and regularly monitor kidney function.

Patients, treated with NSAIDS, including Artrotek, There were also marked by fluid retention and swelling. Therefore, caution must be exercised in the appointment Artroteka patients with chronic heart failure in history, as well as for conditions, predisposing to fluid retention.

NSAIDs, including diclofenac, increase the time of platelet aggregation. Misoprostol enhances not influence of diclofenac on the activity of platelets.

Artrotek attenuates inflammation, It can reduce the severity of symptoms, allowing to diagnose infectious diseases, eg, fever.

In patients aged 65 years and older profile diclofenac/misoprostol side effects similar to those of the younger with the only clinically significant difference in the, patients 65 years of age and older are more susceptible to the adverse influence of diclofenac/misoprostol on gastrointestinal tract.

Overdose

Toxic dose Artroteka not installed. However, described symptoms of overdose, due to components of the drug – nausea, vomiting, abdominal pain, bleeding, confusion, drowsiness, decreased muscle tone. Clinical symptoms, ukazыvayushtimi of misoprostol peredozirovku, are: tremor, convulsions, breathlessness, abdominal pains, diarrhea, fever, heartbeat, hypotension, bradycardia.

In acute overdose shown gastric lavage. Can be also effective forced diuresis, because metabolites of diclofenac and misoprostol stand out with urine. The effect of dialysis on excretion of diclofenac (the bonding with blood plasma is 99%) and acid misoprostol (the degree of binding to plasma proteins is less 90%) While not exactly installed. Ingestion of activated charcoal helps to reduce intake of diclofenac/misoprostol.

Drug Interactions

Diclofenac, aspirin is being ousted from his bonding with albuminami, that leads to a decrease in the concentration of diclofenac in plasma, as well as to lower its maximum concentration in plasma and to lower values of AUC. Not recommended simultaneous application of diclofenac/misoprostol and acetylsalicylic acid.

Patients, at the same time receiving Digoxin and diclofenac, recorded elevated levels of Digoxin. Therefore, patients, at the same time receiving Digoxin and diclofenac/misoprostol, should be under medical supervision to detect toxicity of Digoxin.

Non-steroidal anti-inflammatory drugs can weaken natriyureticescoe effect dioretikov. Because if you use with potassium-saving diuretics may be increasing the level of potassium in serum, in such cases, it is necessary to monitor the level of this indicator. Use caution when prescribing diclofenac/misoprostol simultaneously with the aforementioned drugs.

Established, that a number of non-steroidal anti-inflammatory drugs interacted with oral anticoagulants, Although the observed, that diclofenac does not interact with anticoagulant warfarin type. When receiving indirect anticoagulants (warfarin) with the NPVC increases the risk of bleeding from the digestive tract. In this regard, patients, receiving anticoagulants given type simultaneously with diclofenac/misoprostol, should be under the supervision of, If necessary they were adjusted doses of anticoagulant

NPVC can decrease the effect antigipertenziveh funds, including ACE inhibitors. While appointing diclofenac/misoprostol with ACE inhibitors can worsen kidney function.

Diclofenac does not disturb glucose metabolism in healthy people, Besides, together with the use of diclofenac with antidiabetic means for admission into action the past does not change. At the same time, There have been reports about changing actions of these drugs when their admission simultaneously with the NPVC. So Artrotek should be administered with caution to patients, receiving insulin or hypoglycemic funds for intake.

Caution should be exercised when prescribing simultaneously with the NPVC, including Artrotek, methotrexate, as non-steroidal anti-inflammatory drugs may increase methotrexate level in plasma. Diclofenac reduces kidney klirens lithium and increases concentration of lithium in the plasma. Therefore, patients, receiving lithium, Artrotek should be administered with caution.

Antacids can slow down the absorption of diclofenac. Magnesium – containing antacids may provoke worsening diarrhea, related to administration of misoprostol.

Cyclooxygenase inhibitors, such as diclofenac, due to their effect on prostaglandins of the kidneys, may increase the nephrotoxicity of cyclosporine.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. In a dry place inaccessible to children at a temperature of no higher than 25° c.

Storage life 3 year. Do not use after the date of, indicated on the package.