Gel for external use Dr. Reddy's Nise, 1%, 20 g

Release form, composition and packaging

Gel for external use 1% light yellow or yellow, transparent, free from foreign particles.

1 g

nimesulide 10 mg

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, butylhydroxyanisole - 0.2 mg, thiomersal - 0.1 mg, potassium dihydrogen phosphate - 0.2 mg, flavor (Narcissus-938) - 4 mg.

20 g - tubes made of laminated aluminum (1) - cardboard packs.

50 g - tubes made of laminated aluminum (1) - cardboard packs.

pharmachologic effect

NSAIDs of a new generation from the sulfonanilide class. It has a local anesthetic and anti-inflammatory effect. Nimesulide is a selective competitive reversible inhibitor of COX-2 (endoperoxide prostaglandin H2 synthetase). Reduces the concentration of short-lived prostaglandin H2, a substrate for kinin-stimulated synthesis of prostaglandin E2, in the focus of inflammation and in the ascending pathways of pain impulses in the spinal cord. A decrease in the concentration of prostaglandin E2 (a mediator of inflammation and pain) reduces the activation of prostanoid receptors of the EP type, which manifests itself in analgesic and anti-inflammatory effects. When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, incl. joint pain at rest and during movement, reduces morning stiffness and swelling of the joints. Promotes increased range of motion.

Pharmacokinetics

When the gel is applied, the concentration of the active substance in the systemic circulation is extremely low.

Cmax after a single application is noted by the end of the first day, its value is more than 300 times lower than that for oral dosage forms of nimesulide.

No traces of the main metabolite of nimesulide, 4-hydroxynimesulide, are found in the blood.

Indications for use

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system: - articular syndrome with exacerbation of gout

- rheumatoid arthritis

- psoriatic arthritis

- ankylosing spondylitis

- osteoarthritis

- osteochondrosis with radicular syndrome

- sciatica

- inflammatory lesions of ligaments, tendons, bursitis

- sciatica, lumbago

- muscle pains of rheumatic and non-rheumatic origin

- post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

Contraindications for use

- hypersensitivity to nimesulide and drug components

- erosive and ulcerative lesions of the gastrointestinal tract in the acute phase

- bleeding from the gastrointestinal tract

- dermatoses, epidermal damage and skin infections in the area of ​​application

- severe renal failure (CC < 30 ml / min)

- severe liver failure

- an indication in the history of the phenomenon of bronchospasm in connection with the use of acetylsalicylic acid or other NSAIDs

- pregnancy

- lactation period (breastfeeding)

- children up to age 7 years.

With care: liver failure

renal failure

severe heart failure

arterial hypertension

type 2 diabetes mellitus

old age, children.

Dosage regimen

Outwardly.

Before applying the gel, wash and dry the skin surface.

Apply a column of gel about 3 cm long in a uniform thin layer to the area of ​​maximum pain, without rubbing, 3-4 times / day.

The amount of gel and the frequency of its application (no more than 4 times / 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.

Overdose

Cases of drug overdose are not described.

However, when a large amount of gel (more than 50 g) is applied to large areas of the skin, an overdose may develop.

There is no specific antidote.

You need to see a doctor.

Side effect

Local reactions: itching, urticaria, peeling, transient discoloration to

Name ENG

NISE

Clinical and pharmacological group

NSAIDs for external use

ATX code

Nimesulide

Dosage

1% x 20g

Structure

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, butylhydroxyanisole - 0.2 mg, thiomersal - 0.1 mg , potassium dihydrogen phosphate - 0.2 mg, flavor (Narcissus-938) - 4 mg.

Indications

Local symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system:

articular syndrome with exacerbation of gout

rheumatoid arthritis

psoriatic arthritis

ankylosing spondylitis

osteoarthritis

osteochondrosis with radicular syndrome

radiculitis

inflammatory lesions of ligaments, tendons, bursitis

sciatica, lumbago

muscle pains of rheumatic and non-rheumatic origin

post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

INN / Active ingredient

Nimesulide

Contraindications

hypersensitivity to nimesulide and drug components

erosive and ulcerative lesions of the gastrointestinal tract in the acute phase

bleeding from the gastrointestinal tract

dermatoses, epidermal damage and skin infections in the area of ​​application

severe renal failure (CC < 30 ml / min)

severe liver failure

an indication of a history of bronchospasm in connection with the use of acetylsalicylic acid or other NSAIDs

pregnancy

lactation period (breastfeeding)

children under 7 years of age.

With care: liver failure

renal failure

severe heart failure

arterial hypertension

type 2 diabetes mellitus

old age, children.

Storage conditions and periods

At a temperature not exceeding 25 degrees (do not freeze).

Expiration date: 2 years

Specifications

Category

Bruises, sprains

Scope of the medicinal product

General

Release form

Gel

Manufacturer country

India

Package quantity, pcs

one

Scope of application

Orthopedics

Minimum age from

7 years

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

Dr.

Reddy's

The amount of the dosage form in the primary package

20 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M01AX17 Nimesulide

Dosage form

Gel for external use

The target audience

Children

Drug action

Pain reliever

,

Anti-inflammatory

Expiration date in days

730

Dosage (volume) of the substance in the preparation

1 g of gel contains: nimesulide 10 mg

Package weight, g

twenty

Mode of application

:

Before applying the gel, wash and dry the skin surface.

A column of gel approximately 3 cm long is applied to the area of ​​maximum pain, rubbing with an even thin layer (do not rub) 3-4 times / day.

The maximum dose is 5 mg / kg of body weight / day.

The duration of the drug is 10 days.

Information on technical characteristics, delivery set, country of manufacture