Sulaydin - instructions for use, dose, side effects, contraindications

Nimesulide N- (4-nitro-2-phenoxyphenyl) methanesulfonamide is a non-steroidal anti-inflammatory drug of the sulfanilide class, a selective inhibitor of cyclooxygenase type 2 (COX-2).Virtually does not block the activity of COX-1.

Has a pronounced anti-inflammatory, analgesic and antipyretic action. It is comparable in effectiveness to indomethacin, diclofenac, ibuprofen and piroxicam, but it is much less likely to cause side effects. In addition, it inhibits the formation of superoxide radicals by stimulated polymorphonuclear leukocytes, binds free radicals, inhibits activation of integrin, inhibits factor synthesis, activates platelets, prevents the stimulation of nerve endings with bradykinin, inhibits the release of tumor necrosis factor-α (TNF-α), the release of histamine from mast cells, inhibits the activity of proteases (elastases, collagenase), prevents damage to the cartilage matrix of inhibition of metalloprotease synthesis.

Pharmacokinetics:

The gel is quickly absorbed into the underlying tissues, enters the synovial fluid.

After a single external application in a dose of 200 mg, the maximum concentration (C_max) of nimesulide in blood plasma is observed after 24 hours and reaches 9.77 ng / ml.

With prolonged external application, the concentration of nimesulide on the 8th day in blood plasma is 37.25 + 13.25 ng / ml, which is 100 times less than when ingested at an average daily dose (200 mg / day).

Five hours after the application of the gel, the concentration of the main active metabolite (4-hydroxynimidesulide) in the blood plasma does not exceed 100 μg / l.

Indications:

Local therapy for conditions characterized by pain, inflammation and muscle or joint rigidity, such as:

- osterarthritis;

- periarthritis;

- tendonitis;

- tenosynovitis;

- bursitis;

- lumbago;

- stretching of muscles, ligaments and other post-traumatic states of the supporting motor apparatus.

Contraindications:

The use of the drug Sulaidin is contraindicated:

with increased sensitivity to any component of the drug or to other NSAIDs;

in patients in whom acetylsalicylic acid preparations or other inhibitors of prostaglandin synthesis, cause allergic reactions such as rhinitis, urticaria, or bronchospasm;

If skin is damaged or if there is evidence of local infection at the site of the intended application;

while using other topical medicinal products;

in children under 12 years.

Carefully:

Bleeding from the gastrointestinal tract in an anamnesis, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, severe renal / hepatic insufficiency,severe disorders of the blood coagulation system, uncontrolled chronic heart failure.

Pregnancy and lactation:Nimesulide is not used in pregnancy and breastfeeding. Studies of the safety and efficacy of the drug during pregnancy and breastfeeding have not been conducted. There are no data on the effect on fetal development.

Dosing and Administration:

The drug is intended for external use only.

Approximately 3 cm of the gel is applied a thin layer on a clean and dry patch of skin over the painful area 3-4 times a day.

Do not rub the gel intensively or use under occlusive dressings. It is recommended that you avoid wearing crushing clothing.

Before and after the procedure, you should wash your hands.

The duration of therapy is determined individually and is an average of 7-15 days.

Use in children under 12 years old

Recommendations and indications for the use of the drug in pediatric practice children under 12 years are not established.

Side effects:

With external application nimesulide usually well tolerated.

Local reactions: moderate or severe skin irritation, hyperemia, rash, desquamation, itching.

Systemic reactions (with prolonged use or use in large areas): heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the mucous membrane of the gastrointestinal tract, headache, dizziness; fluid retention, allergic reactions (skin rash, anaphylactic shock); Thrombocytopenia, leukopenia, anemia, agranulocytosis; increased activity of "liver" transaminases; prolonged bleeding time; hematuria.

In case of adverse reactions, discontinue use and prescribe appropriate treatment.

Overdose:Cases of drug overdose with external application have not been described.

Interaction:With external application nimesulide does not cause a clinically significant effect on the metabolism of other drugs.

Special instructions:

Do not apply gel on mucous membranes, eyes, damaged and infected skin areas affected by skin diseases of the area and open wounds.

When application of the drug may occur, intense burning sensation, which disappears within a few days. During the use of the drug and before Do not touch sensitive areas of the skin.If you accidentally hit the gel on mucous membranes or sensitive areas of the skin, you should rinse these areas with plenty of water.

Gel follows with. use caution in high-risk patients development of adverse reactions caused by salicylates.

AT experimental research no mutagenic effect of nimesulide was detected, and no data were obtained on the effect of nimesulide on the chromosome of lymphocytes in ^ vitro and on the interaction with H-thymidine of cultured human lymphocytes.

Effect on the ability to drive transp. cf. and fur:

Sulaidin's intake does not affect the ability to drive vehicles and mechanisms.

Form release / dosage:

Gel for external use 1%

30 grams of gel in laminated tubes, sealed with a membrane and ukuporennyh screwed white propylene cap.

1 tuba together with instructions for use in a pack of cardboard.

Packaging:Tubes laminated (1) - packs cardboard

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000173

Date of registration:14.01.2011

The owner of the registration certificate:Embol Ilaç San. Ltd. Shti.Embol Ilaç San. Ltd. Shti.

Manufacturer: & nbsp

Embol Ilaç San. Ltd. Shti. Turkey

Representation: & nbspKOFARM, LLCKOFARM, LLC

Information update date: & nbsp14.08.2015

Illustrated instructions

Instructions

Sulaydine (Sulidin)