Nise ointment contraindications for use. Nise gel: instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

Registration number:

P N012824/02

Trade name: Nise ®

International nonproprietary name:

nimesulide

Chemical name: N-(4-nitro-2-phenoxyphenyl) methanesulfonanilide

Dosage form:

gel for external use

Compound:

1 g of gel contains:

active substance: nimesulide 10 mg;

excipients: N-methyl-2-pyrrolidone 250 mg, propylene glycol 100 mg, macrogol 315.5 mg, isopropanol 100 mg, purified water 200 mg, carbomer-940 20 mg, butylated hydroxyanisole 0.2 mg, thiomersal 0.1 mg, potassium dihydrogen phosphate 0 .2 mg, flavor (Narcissus-938) 4 mg.

Description: transparent gel light yellow or yellow, free from foreign particles.

Pharmacotherapeutic group:

non-steroidal anti-inflammatory drug (NSAID)

ATX Code: M01AX17

Pharmacological action

Nise ® gel is a new generation non-steroidal anti-inflammatory drug (NSAID) from the sulfonamide class. It has a local analgesic and anti-inflammatory effect.

Nimesulide - selective competitive reversible inhibitor cyclooxygenase type II (endoperoxide-prostaglandin-H 2 synthetase). Reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated synthesis of prostaglandin E2, at the site of inflammation and in the ascending pathways of pain impulses in spinal cord. A decrease in the concentration of prostaglandin E 2 (a mediator of inflammation and pain) reduces the activation of EP type prostanoid receptors, which is manifested by analgesic and anti-inflammatory effects.

When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Helps increase range of motion.

Pharmacokinetics

When applying the gel, the concentration of the active substance in the systemic circulation is extremely low. The maximum concentration after a single application is observed at the end of the first day; its value is more than 300 times lower than that for oral dosage forms nimesulide. No traces of the main metabolite of nimesulide, 4-hydroxynimesulide, are found in the blood.

Indications

Local symptomatic treatment inflammatory and degenerative diseases musculoskeletal system(articular syndrome during exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory lesion ligaments, tendons, bursitis, sciatica, lumbago).

Muscle pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and the musculoskeletal system (damage and rupture of ligaments, bruises).

Contraindications

Hypersensitivity to nimesulide and the components of the drug; erosive and ulcerative lesions gastrointestinal tract in the acute stage, bleeding from the gastrointestinal tract, dermatosis, damage to the epidermis and infection skin in the field of application; severe renal (creatinine clearance less than 30 ml/min.) or liver failure, a history of bronchospasm associated with the use of acetyl salicylic acid or other NSAIDs, pregnancy and lactation, childhood up to 7 years.

With caution

Liver failure; renal failure; severe heart failure; arterial hypertension; diabetes mellitus 2 types; elderly and children's age.

Directions for use and doses

Externally. Before applying the gel, wash and dry the skin surface. Apply a uniform thin layer of gel approximately 3 cm long to the area of ​​maximum pain, without rubbing, 3-4 times a day.

The amount of gel and the frequency of its use (no more than 4 times a day) may vary depending on the size of the treated area and the patient’s response.

Do not use the gel for more than 10 days without consulting a doctor.

Side effect

Local reactions: itching, urticaria, peeling, transient change in skin color (not requiring discontinuation of the drug).

If any adverse reactions occur, you should stop using the drug and consult your doctor.

When applying the gel to large areas of the skin or with prolonged use, the development of systemic adverse reactions is possible: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of “liver” transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Overdose

Cases of drug overdose have not been described. However, when applied large quantities gel (exceeding 50 g) on ​​large areas of the skin, the development of an overdose cannot be ruled out. There is no specific antidote. You need to see a doctor.

Interaction with other drugs

Pharmacokinetic interactions with drugs that compete for binding to plasma proteins cannot be ruled out.

Caution should be exercised when using Nise ® simultaneously with digoxin, phenytoin, lithium preparations, diuretics, cyclosporine, methotrexate, other NSAIDs, antihypertensive and antidiabetic agents.

Before using the gel, you should consult your doctor if you are using these products or are under medical supervision.

Special instructions

It is recommended to apply the drug only to intact areas of the skin, avoiding contact with open wounds. Avoid getting the gel into the eyes and other mucous membranes. Do not use the gel under airtight dressings. After applying the gel, wash your hands with soap. Close the tube tightly after using the gel.

Thomas release

Gel for external use 1%. 20 g or 50 g in a laminated aluminum tube equipped with a membrane to control the first opening. The tube is packed in a cardboard box with instructions for use.

Best before date

Do not use the drug after the expiration date indicated on the package.

Storage conditions

List B.

In a dry place, protected from light, at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children!

Conditions for dispensing from pharmacies

Over the counter.

Manufacturer

Dr. Reddy's Laboratories Ltd.

Hyderabad, Andhra Pradesh, India.

Address of production place

Dr. Reddy's Laboratories Ltd.

Plot No. 41, Nasigere Village, Kasaba Hobli, KIADB, Malur-563130, Karnataka, India.

Consumer complaints should be sent to:

Representative office of Dr. Reddy and Laboratories Ltd.:

115035, Moscow, Ovchinnikovskaya embankment, 20, building 1

Nise gel contains nimesulide, a selective COX-2 inhibitor. It has an analgesic and anti-inflammatory effect due to the inhibition of COX-2, which leads to inhibition of the synthesis of prostaglandins, which are involved in the formation of edema and pain during inflammation. Nimesulide inhibits platelet activating factor, tumor necrosis factor alpha, the release of proteinases and histamine.
Methyl salicylate, a derivative of salicylic acid, has a local irritating and distracting effect.
Menthol has an analgesic effect, accompanied by a feeling of cold. The analgesic effect of menthol is associated with stimulation of cold receptors, stabilization of calcium ion flows through the channels of neuronal membranes.
Capsaicin has a local irritant effect, causes a local increase in blood flow and tissue hyperemia at the site of application, and promotes the release of endogenous biologically active substances.
Nise gel is characterized by high safety of use (virtually no side effects are noted). When applied externally, the gel is gradually absorbed through the skin into the underlying muscle or synovial fluid. Equilibrium concentrations between skin and muscle or synovial fluid are achieved quickly.
With local application of Nise gel, systemic absorption is insignificant, since the levels of nimesulide in the blood plasma remained below the detection limit of high-performance liquid chromatography and only after 5 hours very low concentrations (100 μg/l) of hydroxynimesulide in the blood plasma were detected.

Indications for use of the drug Nise gel

Osteoarthritis (including rheumatoid arthritis), osteoarthritis, tenosynovitis, bursitis, synovitis, lumbodynia; post-traumatic inflammation of tendons, ligaments, muscles, joints.

Use of the drug Nise gel

Apply a 3 cm long column of gel to the affected area of ​​skin in a thin layer 2-3 times a day and rub in lightly. Before applying the gel, thoroughly wash and dry the skin surface. Do not use the gel for more than 10 days.

Contraindications to the use of the drug Nise gel

Hypersensitivity to the components of the drug; severe dysfunction of the liver and kidneys; stomach ulcer and duodenum in the acute stage, dermatitis and infectious diseases skin; period of pregnancy and lactation; patients who have acetylsalicylic acid and other NSAIDs have caused symptoms of asthma, rhinitis, angioedema or allergic rashes on the skin.

Side effects of the drug Nise gel

At the site of application of the drug, itching, erythema, rash, redness, peeling, and skin burns may be noted.

Special instructions for the use of the drug Nise gel

The drug is intended for external use. Elderly patients with significant impairment of liver and kidney function, patients with congestive heart failure should use the drug with caution. It is recommended to apply the gel only to intact areas of the skin, avoid contact with open wounds. Do not use the gel under airtight or tight bandages. Avoid getting the gel into the eyes and mucous membranes. Wash your hands thoroughly before and after using the gel.
Indications for use of the gel in children and dosage have not been established.

Drug interactions Nise gel

Not studied.

Overdose of the drug Nise gel, symptoms and treatment

No cases described.

Storage conditions for the drug Nise gel

In a place protected from light at a temperature of 2-25 ° C. Do not freeze.

List of pharmacies where you can buy Nise gel:

• Saint Petersburg

The drug "Nise" - gel for local application. What kind of remedy is this, what are its indications, side effects, pharmacological action and other information you will find in the materials of this article.

Appearance of the medication

The drug "Nise" is a purely transparent 1% gel with a light yellow tint. This product has a uniform consistency, without foreign particles. The medication is available in aluminum tubes of 20 and 50 g, packed in cardboard boxes with detailed instructions.

Composition of the product

The medicine "Nise" is a gel containing active ingredients such as nimesulide, methyl salicylate, menthol and capsaicin. In addition, the presented drug includes auxiliary components:

• diethylene glycol ethyl ether;
• diethyl phthalate;
• polyoxyl 40 hydrogenated;
• propylene glycol;
• castor oil;
• disodium edetate;
• sodium benzoate;
• purified water;
• carbomer-980;
• trometamol;
• butylated hydroxytoluene;
• propylene glycol.

Pharmacological action

“Nise” is a gel, which is a non-steroidal anti-inflammatory drug for external use only. It has an analgesic effect, relieves swelling and inhibits platelet activation. When used, this medication first causes a weakening and then a complete disappearance of pain at the site of application of the drug, including pain in the joints and muscles (during movement and at rest). Among other things, Nise gel significantly reduces morning swelling and stiffness of the body, and also helps to increase the range of painless movements.

Action of active substances

As mentioned above, the drug "Nise" includes the following active substances, such as nimesulide, methyl salicylate, menthol and capsaicin. What role do they play in the presented medicine? You will get the answer to this question below.

• Nimesulide is a selective cyclooxygenase-2 inhibitor. It exhibits anti-inflammatory and analgesic effects.
• Methyl salicylate is a derivative of salicylic acid. It has a distracting and local irritating effect.
• Menthol promotes an analgesic effect, which is accompanied by a feeling of slight chill.
• Capsaicin has locally irritating properties, causes tissue hyperemia and increased blood flow at the site of application, and also promotes the removal of biological endogenous substances.

Pharmacokinetics

This form of the drug is characterized by fairly high safety of use (side effects from the gel are practically not detected). When used externally, Nise is gradually absorbed from the skin into the muscles and a balance between them is quickly achieved.

Indications for use of the drug

Gel for external use “Nise” (the description of the drug was presented above) is recommended for use for the following deviations:

• psoriatic arthritis;
• rheumatoid arthritis;
• osteochondrosis with radicular syndrome;
• ankylosing spondylitis;
• articular syndrome due to gout and rheumatism;
• lumbago;
• post-traumatic inflammation of the musculoskeletal system, soft tissues (various ruptures and damage to ligaments, as well as bruises);
• radiculitis;
• osteoarthritis;
• sciatica;
• inflammation of tendons and ligaments, bursitis;
• myalgia of non-rheumatic and rheumatic origin.

Contraindications to the use of the drug

Like any medicine intended for external use, Nise gel also has contraindications for use. These include the following:

• hypersensitivity to the constituent substances of the drug;
• severe impairment of kidney and liver function;
• peptic ulcer of the duodenum and stomach (especially in the acute stage);
• infectious diseases of the skin and dermatitis;
• pregnancy period;
• lactation period.

Special instructions for the use of the drug

Nise gel should be used externally only. It should be used with extreme caution in sick elderly people, as well as those who have significant impairments in kidney and liver function, and patients with congestive heart failure. It is advisable to apply this drug only to intact areas of the skin, while avoiding contact with the eyes, mucous membranes, open wounds and ulcers. Do not use the gel under tight or airtight bandages. Before and after using the drug, it is recommended to wash your hands well with soap. At the end of treatment, the tube with the gel should be tightly closed.

How to use the product

Before direct use gel, the surface of the skin must be washed and dried thoroughly. After this, a strip of the product about 3 centimeters long should be applied in a thin and even layer to the area of ​​maximum pain. In this case, it is highly not recommended to rub the gel intensively.

Dosage of the drug

The amount of Nise and the frequency of its use should vary depending on the size painful area skin, as well as the patient's reaction. However, it is not advisable to use this medication more than 4 times a day. Maximum dose gel should be about 30 g per day. The duration of treatment (pain relief) with the presented remedy is 10 days. If you need to use the drug for a longer period of time, you should definitely consult a doctor.

Overdose

Currently, cases of overdose with this drug have not been observed. But if you use the gel in an amount of more than 50 g on large areas of the skin, the patient may experience adverse reactions. In this case, you should immediately consult a doctor.

Side effects

When applying the drug "Nise" to large areas, the following side effects may develop:

• From the gastrointestinal tract: vomiting, heartburn, nausea, stomach pain, diarrhea, increased activity of liver enzymes and erosive and ulcerative lesions of the gastrointestinal tract.
• From the side of the central nervous system: dizziness and severe headaches.
• From the side of hematopoiesis: agranulocytosis, anemia, thrombocytopenia, prolongation of bleeding time and leukopenia.
• From the urinary system: hematuria and fluid retention.
• Allergic reactions: anaphylactic shock and skin rash.
• Local reactions: peeling, itching, change in skin color and urticaria.

Terms and conditions of storage

Best before date this drug is 24 months from the date of manufacture. It is recommended to store Nise gel out of the reach of children and in a cool place at a temperature not exceeding 23°C. Freeze this remedy is strictly prohibited. It should also be noted that pharmacy chains sell it without a doctor’s prescription.

Other forms of release

This drug is available not only in the form of a gel, but also in the form of a suspension for oral administration (for children younger age). The remedy “Nise” for toothache should be used in tablet form in the amount of 1 or 2 pieces (depending on the intensity).

Cost of the drug

Depending on the form of release of the drug presented, its price can vary significantly. Thus, Nise tablets in the amount of 20 pieces (pack) in different pharmacy chains cost about 140-150 Russian rubles. As for the anesthetic gel, for a 20-gram tube you will have to pay about the same amount, but for a suspension (60 ml) pharmacists ask about 230 rubles.

Nise gel is one of the options for non-steroidal anti-inflammatory drugs for topical use. The composition of this gel includes 10 mg active substance(nimesulide) per 1 gram of gel. The product itself is light yellow in color. Available in tubes of 20 and 50 grams.

Pharmacologically, nimesulide is one of last generations anti-inflammatory drugs and is a relatively selective reversible inhibitor of cyclooxygenase-2. In its action, it reduces the concentration of inflammatory cytokines, reduces the amount of synthesized pain mediators, which, in turn, leads to good analgesic and anti-inflammatory effects.

Local use of Nise gel leads to a decrease in pain (sometimes even to the relief of moderate pain), reduces swelling of inflamed joints, and helps to increase the range of active movements by reducing pain.

Pharmacokinetically, it is practically not absorbed into the blood when applied topically. The maximum concentration is detected at the end of the first day. The concentration of nimesulide in the blood is several hundred times lower than when using tablets and powders. Metabolites are not detected in the blood at all.

Indications for use

Nise gel in neurological practice indicated primarily for vertebrogenic pain syndromes. Can also be used in rheumatological practice, in the treatment next pathology:

• Exacerbation of gout with articular syndrome.
• Arthritis of various etiologies.
• Muscle pain of various origins.
• Post-traumatic inflammation of soft tissues.
• Sprain.
• Inflammatory diseases of the ligamentous apparatus.

Contraindications

Despite the fairly high safety of using Nise gel, there are a number of contraindications for the use of the drug:

• Allergic reactions.
• Erosion and ulcer in the gastrointestinal tract in the acute phase.
• Bleeding from the gastrointestinal tract, incl. according to anamnesis.
• Skin damage in the area of ​​intended use.
• Severe renal failure with low level creatinine clearance (below 30 ml per minute).
• Terminal liver failure.
• Pregnancy and lactation.
• Aspirin-dependent bronchial asthma, including a history of attacks while taking NSAIDs.
• Children under 7 years of age (under 18 years of age, use with caution).

It should also be used with caution in people with diabetes, with uncontrolled blood pressure, with end-stage heart failure, with unstable angina.

Dosage

For external use only. It is advisable to clean and dry the skin before use. Apply a thin layer to the area of ​​pain, the length of the gel column is 3-4 cm. Do not rub in, use up to 4 times a day.

You should not use Nise gel for more than 10 days without consulting a healthcare professional.

Overdose

Cases of overdose have not been described in the literature. Overdose phenomena are possible when using the gel in doses over 50 grams. There is no antidote; use symptomatic treatment.

Side effects

The following side effects are possible when using the gel:

• The most common local reactions are itching, peeling, urticaria, and changes in skin color (temporarily). Most often, treatment discontinuation is not required.
• Theoretically, systemic adverse reactions may develop when used for a long time or in high doses: vomiting, stool disturbances, heartburn, ulcerative lesions of the mucous membranes, increased transaminase activity, dizziness, anaphylactic shock, prolongation of bleeding time, changes in the blood picture.

Special instructions

• It is not advisable to apply to damaged skin or mucous membranes. Do not use in compresses or tight bandages. Wash your hands after application. Close the lid after use.
• Use carefully in combination with digoxin, lithium preparations (psychiatric practice), cytostatics, and other non-steroidal drugs, diuretics, antihypertensive and hypoglycemic drugs for uncontrolled flow of these diseases. When a patient uses these groups medicines consultation with a doctor is required.
• Store at room temperature, do not freeze. Shelf life up to two years.

Gel price

Available in pharmacies without a prescription. Prices for the drug (relevance as of December 21, 2014) vary from pharmacies’ markups and are approximately from 140 to 220 rubles per 20 gram package and from 250 to 335 rubles per 50 gram package.