2010/09/21

Arthrotec

Composition, structure and packing

Tablets are white or nearly white, round, biconvex, on one side and embossed in the form of arranged in a circle four characters "A", on the other - "Searle" and "1411".

1 tab. - Diclofenac sodium 50 mg - 200 micrograms misoprostol

Excipients: methylhydroxypropylcellulose, aerosil, microcrystalline cellulose, krospovidon, hydrogenated castor oil, lactose, corn starch, povidone (K-30), magnesium stearate, cellulose acetate phthalate, diethyl phthalate.

Tablets are white or nearly white, round, biconvex, on one side and embossed in the form of four characters "A" surrounding the number "75", on the other - "Searle" and "1421".

1 tab. - Diclofenac sodium -75 mg misoprostol 200 micrograms

Excipients: methylhydroxypropylcellulose, aerosil, microcrystalline cellulose, krospovidon, hydrogenated castor oil, lactose, corn starch, povidone (K-30), magnesium stearate, cellulose acetate phthalate, diethyl phthalate.

Clinico-pharmacological group

NSAIDs in combination with a synthetic analogue of prostaglandin E1.

Pharmacological action

Artrotek is a combination of diclofenac sodium - NSAID, which has anti-inflammatory and analgesic properties, and misoprostol - a synthetic analogue of prostaglandin E1, which protects the mucous membrane of the digestive tract. The mechanism of action of diclofenac sodium is linked to its ability to selectively inhibit COX-1 and COX-2.

Misoprostol is a synthetic analogue of prostaglandin E1, the reinforcing effect of factors involved in the protection of the mucous membrane of the stomach and duodenum. Misoprostol supports blood flow to the stomach, reduces the secretion of pepsin and hydrochloric acid in the stomach, promotes the formation of bicarbonate in the duodenum.

Pharmacokinetics

Pharmacokinetics of diclofenac and misoprostol in combination is similar to the pharmacokinetics of these drugs while taking in the form of individual tablets.

Pharmacokinetic interaction between these two substances was observed. After receiving multiple Artroteka cumulation of diclofenac, misoprostol, or misoprostol acid does not occur.

Indications for use of the drug

Expectant treatment
rheumatoid arthritis;
osteoarthritis;
ankylosing spondylitis;
acute joint-muscle pain.

Dosage regimen

Inside during the meal, not liquid, tablets can not crush or dissolve.

Artrotek recommended in the following doses:

Osteoarthritis, rheumatoid arthritis:

Tablets containing a dose of 50 mg/200 mg - 1 tablet 2-3; tablets containing a dose of 75 mg/200 mg - 1 tablet 2.

Ankylosing spondylitis:

Tablets containing a dose of 50 mg/200 mg - 1 tablet 2-3; tablets containing a dose of 75 mg/200 mg - 1 tablet 2.

Acute joint-muscle pain syndrome:

Tablets containing a dose of 50 mg/200 mg - 1 tablet 2-3; tablets containing a dose of 75 mg/200 mg - 1 tablet 2.

Side effect

Registered in major adverse reactions from the gastrointestinal tract, whose frequency is> 1%: abdominal pain, constipation, diarrhea, duodenitis, dyspepsia, eructation, esophagitis, flatulence, gastritis, nausea and vomiting.

Abdominal pain and diarrhea are usually transient in nature and are mild or moderate.

In addition, have been reported such side effects as dizziness, headache, insomnia, itchy skin, hemorrhagic rash, gastrointestinal bleeding and perforation. Also, changes in laboratory parameters were detected: elevated levels of alkaline phosphatase, decrease in hematocrit and increases in ALT.

Among women who received Artrotek, there have been adverse reactions from the breast and genital organs: breast pain, dysmenorrhea, intermenstrual bleeding in the period, menorrhagia, irregular menstruation, cramping abdominal pain, bloody discharge from the vagina (including bleeding in women postmenopausal), vaginitis.

During the observation period after the registration of the drug were additionally identified the following adverse reactions: Allergic reactions (including anaphylaxis and angioedema), skin reactions (including rash and bullous eruptions), mood changes, shortness of breath, hepatitis, interstitial nephritis, pancreatitis, acute renal failure, stomatitis , thrombocytopenia, rash, anemia, epidermal necrolysis.

In very rare cases, during therapy with diclofenac / misoprostol were reported blurred vision, heavy dreams, as well as reaction from the skin and mucous membranes.

In cases of administration of misoprostol by pregnant women revealed the following side effects: abnormal uterine contractions, uterine bleeding, uterine rupture / perforation, delay in separation of the placenta, amniotic fluid embolism, incomplete abortion, premature birth, fetal death, congenital malformations.

Contraindications to the use of the drug
active gastrointestinal bleeding;
pregnancy and lactation;
hypersensitivity to diclofenac sodium, misoprostol, or any other ingredients of the drug to other NSAIDs, including acetylsalicylic acid, as well as other prostaglandins;
"Aspirin" bronchial asthma, hemodyscrasia.

Data on the safety and efficacy Artroteka in children aged under 18 years of absence.

Precautions: anemia, asthma, congestive heart failure, hypertension, porphyria, old age, erosive and ulcerative lesions of the gastrointestinal tract of a history of liver or kidney failure, heart disease, fluid retention in the body, dehydration.

Pregnancy and lactation

Artrotek contraindicated in pregnant women, because misoprostol causes uterine contractions and may result in miscarriages, premature birth and fetal death. In the application of misoprostol may have malformations of the fetus. Diclofenac may cause premature closure of Botallova duct.

Misoprostol should not be prescribed for lactating mothers, since the possible allocation of misoprostol acid in milk can cause diarrhea in infants. It is not known whether this drug is released from the mother's milk. However, since many drugs are excreted with breast milk, as well as the fact that there is a possibility of development in infants adverse reactions to diclofenac / misoprostol, you should either give up breastfeeding or stop taking the drug.

Application for violations of liver function

With care apply in hepatic failure.

Application for violations of renal function

With caution used in renal insufficiency.

Cautions

In patients treated with NSAID therapy, including Artrotek were reported serious adverse reactions from the gastrointestinal tract, such as bleeding, sores and perforation.

Physicians and patients should be aware of a potential cause ulcers, even in the absence of symptoms from the gastrointestinal tract.

NSAIDs, including Artrotek should be used with caution in patients with diseases of the digestive tract in history or in the active stage, such as ulcers, bleeding, inflammatory bowel disease.

Women of childbearing age can not begin therapy until Artrotekom until pregnancy is excluded, and they should use reliable contraceptive measures during the entire period of therapy. If you are planning pregnancy, this medication should be abolished.

The therapy Artrotekom should periodically monitor liver function. If Artrotek be considered in patients with impaired liver function, the treatment should be carried out under constant medical supervision.

Patients with kidney, liver or heart diseases should also be careful, because the use of NSAIDs, including diclofenac / misoprostol, can lead to a breach of kidney function. Care must be taken in the early treatment of patients with dehydration. You should use the lowest possible dose and regular monitoring of renal function.

In patients treated with NSAIDs, including Artrotek were also marked fluid retention and swelling. Therefore, caution should be exercised in the appointment Artroteka patients with chronic heart failure in history, as well as conditions predisposing to fluid retention.

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

Artrotek reduces inflammation, it can reduce the severity of symptoms, allowing diagnosis of infectious diseases, such as fever.

Patients aged 65 years and older profile of side effects of diclofenac / misoprostol is similar to that in younger with only clinically significant difference is that patients age 65 and older are more susceptible to the adverse effects of diclofenac / misoprostol in the gastrointestinal tract.

Overdose

Toxic doses Artroteka not installed. However, describes the symptoms of overdose caused by components of the drug: nausea, vomiting, abdominal pain, bleeding, confusion, drowsiness, reduced muscle tone.

Clinical symptoms suggestive of an overdose of misoprostol are: tremors, convulsions, shortness of breath, abdominal pain, diarrhea, fever, palpitation, hypotension, bradycardia.

Treatment: acute overdose, gastric lavage is shown. It may also be effective in the forced diuresis, since metabolites of diclofenac and misoprostol is excreted with urine. Effect of dialysis on the elimination of diclofenac (the degree of binding is to plasma proteins is 99%) and misoprostol acid (the degree of plasma protein binding of less than 90%), while not determined. Ingestion of activated charcoal helps to reduce the absorption of diclofenac / misoprostol.

Drug Interactions

Diclofenac acetylsalicylic acid is displaced from its binding site from albumin, which reduces the concentration of diclofenac in plasma, as well as to reduce its maximum concentration in plasma and to decrease the value AUC. In this regard, it is not recommended the simultaneous use of diclofenac / misoprostol and acetylsalicylic acid.

In patients receiving both digoxin and diclofenac, recorded the highest levels of digoxin. Therefore, patients receiving both digoxin and diclofenac / misoprostol should be under medical supervision to identify the toxic effect of digoxin.

NSAIDs may reduce natriuretic effect of diuretics. Since the simultaneous use of potassium-sparing diuretics may increase potassium levels observed in the serum in such cases must monitor the level of this indicator. Be careful when appointing diclofenac / misoprostol in conjunction with the above mentioned drugs.

It is established that a number of NSAIDs interact with anticoagulants taken orally, although noted that diclofenac does not interact with anticoagulants such as warfarin. When you receive indirect anticoagulants (warfarin) with NPVC increases the risk of bleeding from the gastrointestinal tract. Therefore, patients receiving anticoagulants concurrently with this type of diclofenac / misoprostol should be monitored, so if necessary it was carried out adjusting the dose of anticoagulant

NPVC can reduce the effect of antihypertensive agents, including ACE inhibitors. In case of simultaneous appointment of diclofenac / misoprostol with ACE inhibitors may worsen renal function.

Diclofenac does not affect glucose metabolism in healthy people, in addition, while the use of diclofenac with antidiabetic means for oral action of the latter does not change. However, there are reports of change of such drugs at their reception at the same time NPVC. Therefore Artrotek be used with caution to patients receiving insulin or hypoglycemic means for oral administration.

Care should be exercised in the appointment while NPVC, including Artrotek, methotrexate, because NSAIDs can increase the level of methotrexate in plasma.

Diclofenac reduces the renal clearance of lithium and increase the concentration of lithium in plasma. Therefore, patients receiving lithium, Artrotek be used with caution.

Antacids may slow the absorption of diclofenac. Magnesium-containing antacids may provoke exacerbation of diarrhea associated with misoprostol.

Cyclooxygenase inhibitors, such as diclofenac, through their effects on renal prostaglandins, may increase the nephrotoxicity of cyclosporine.

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Drug prescription.

Terms and Conditions of storage

List B. In dry, the reach of children, at a temperature not exceeding 25 ° C.

Shelf life - 3 years. Do not use later than the date specified on the package.