Nise GEL

Nise GEL is a relatively COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity, Nise GEL has been withdrawn from market in many countries.

Tablet/Suspension: Adults: Treatment of a variety of painful inflammatory conditions including those associated with osteoarthritis, postoperative trauma, sports injuries, ear, nose and throat disorders, dental surgery, bursitis/tendinitis, thrombophlebitis, pharyngitis and gynaecological disorders.

Children: Suspension: Fever and inflammatory symptoms associated with upper respiratory tract infections (viral or bacterial origin) and in reducing pain of various origin in children eg, postoperative pain, pain due to musculoskeletal injury, pain due to minor soft tissue injury, etc.

Gel: For local application in the treatment of acute and chronic musculoskeletal disorders characterized by pain and inflammation including non-articular rheumatic disorders and soft-tissue injuries. These conditions include backache, tendonitis, tenosynovitis, sprains and strains.

Tablet/Suspension: Adults: Usual

Oral Dose: 100-mg tab twice daily.

Children: 1.5 mg/kg body weight, twice or thrice daily.

Gel: For external use only. Adults: Apply approximately 3 cm or 1¼ inches of Nise GEL gel lightly in a thin layer to the affected site and surrounding areas 3-4 times/day, or as directed by the physician. Clean and dry the affected areas thoroughly before treating with the gel. Patients should be advised to avoid occlusive dressing. Hands should be washed before and after using this medicine.

Nise GEL: Hypersensitivity to Nise GEL or any of the excipients of Nise GEL. It should not be administered to patients in whom aspirin or other NSAIDs induced the symptoms of asthma, bronchospasm, rhinitis, angioedema, nasal polyps or urticaria by prostaglandin synthesis inhibition. It should not be used on injured or abraded skin or in the presence of local infection. It should not be used simultaneously with other topical products.

Use in Children: It should not be used in children <12 years.

Sulidin Thermo: Hypersensitivity to Nise GEL, Nise GEL or any of the excipients of Sulidin Thermo. In patients with hypersensitivity to aspirin and other NSAIDs that induce symptoms of asthma, rhinitis, angioedema, urticaria or nasal polyposis. In injured, damaged and sensitive skin, pruritic conditions eg, eczema and prurigo or open wounds.

Use in Pregnancy: Pregnancy Category C.

Sulidin Thermo is not recommended for use during pregnancy. Especially, it should not be used in 3rd trimester because of the risk of premature ductal constriction and uterine atony.

Use in Children: Dosage recommendations and indications for use in children have not been established. Thus, it should not be used in children.

Nise GEL is used to treat acute pain, osteoarthritis (pain and swelling of joints due to degeneration) and pain during periods.

Clinically important interactions involving interference with drug metabolism have not been described with Nise GEL.

Gel: No clinically significant interactions involving interference with drug metabolism have been reported with topical application of Nise GEL.

Nise GEL: Adverse effects possibly related to local treatment have been infrequently reported. In clinical trials, the majority of adverse effects are local reactions at the application site eg, mild or moderate local irritation, erythema, rash, desquamation, pruritus. Staining of clothing has been noted.

The frequency of adverse events listed as follows is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, erythema. Not Known: Desquamation, pruritus, rash, mild or moderate local irritation.

When Nise GEL is applied topically, the possibility of occurrence of systemic adverse effects is less in comparison to oral administration. However, when Nise GEL is applied long-term and in high doses, the occurrence of systemic adverse effects should not be neglected.

Sulidin Thermo: Adverse effects possibly related to local treatment have been infrequently reported. In clinical studies, the majority of adverse effects are local reactions at the application area eg, mild or moderate local irritation, erythema, rash, desquamation, pruritus.

The frequency classification of adverse effects are listed as following: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

İmmune System Disorders: Very Rare: Allergic reactions (anaphylactic shock may be seen in severe events).

Nervous System Disorders: Uncommon: Dyschezia, hypoesthesia. Very Rare: Nervousness, restlessness, euphoria, confusion, tinnitus, somnolence, blurred or double vision, chill, tremor, loss of consciousness.

Eye Disorders: Uncommon: Eye irritation.

Vascular Disorders: Uncommon: Hypertension.

Respiratory, Thoracic or Mediastinal Disorders: Uncommon: Cough, throat irritation, dyspnea, labored breathing and asthma exacerbation.

Gastrointestinal Disorders: Uncommon: Nausea.

Musculoskeletal Disorders, Connective Tissue and Bone Disorders: Uncommon: Pain in extremities, muscle spasms.

General Disorders and Administration Site Conditions: Very Common: Pain in the administration area, erythema. Common: Pruritus in the administration area, papule, vesicle, edema, swelling, dryness. Uncommon: Urticaria in the administration area, paresthesia, dermatitis, hyperesthesia, inflammation, irritation, cyanosis, peripheral edema.

When Nise GEL and Nise GEL is applied topically, the possibility of occurrence systemic adverse effects is less in comparison to oral administration of Nise GEL and Nise GEL. However, when Sulidin Thermo is applied long-term and in high doses, the occurrence of systemic adverse effects should not be neglected.