Teva-ketoprofen gel 2.5% 50g tube

Description

Composition
Active substance:
Ketoprofen 2.500 g;
Excipients:
Carbomer (Carbopol 980) – 2.000 g ethanol 96% – 28,500 g, lavender flavor – 0.028 g Triethanolamine – 3.700 g (to pH 6.5) Purified water – 100 g
Description:
homogeneous transparent gel with the scent of lavender and alcohol.
Product form:
Gel for topical application of 2.5%.
50 g in the aluminum tube, covered with aluminum foil for controlling the first opening, a screw with a polyethylene cap. The tube together with instructions for use in a cardboard package.
Contraindications
– Hypersensitivity to ketoprofen and other ingredients, acetylsalicylic acid or other NSAIDs (indicating a history of bronchospasm, urticaria and rhinitis caused by the intake of acetylsalicylic acid) to tiaprofenic acid, fenofibrate;
– increased sensitivity of the skin to sunlight exposure (photosensitivity) history;
– skin history of allergy to ketoprofen, tiaprofenic acid, fenofibrate, sunscreens or perfumes;
– full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (history);
– the impact of the sun on the treated areas, including a sun deck, while use of the drug, and 2 weeks after;
– moist dermatitis, eczema, infected abrasions, sores at the site of gel; pregnancy and lactation;
– Children under 12 years (no efficacy and safety data).
Carefully
Severe renal insufficiency, hepatic porphyria (exacerbation), erozivnoyazvennye lesions of the gastrointestinal tract, severe liver problems, congestive heart failure, asthma, older age.
Dosage
25 mg / g
Indications
Acute and chronic inflammatory diseases of the musculoskeletal system (joint syndrome in exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammation of tendons and ligaments, bursitis, sciatica, lumbago).
Muscular pain of rheumatic and rheumatic origin.
Post-traumatic inflammation of soft tissue and musculoskeletal system (damages and torn ligaments, bruises).
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
ketoprofen interaction with other drugs is unlikely because when used topically by application to the skin surface of ketoprofen concentration in plasma is very low. May increase the action of drugs that cause photosensitivity. Other interactions have not been established.
However, patients taking coumarin anticoagulants, it is advisable to carry out regular monitoring of the international normalized ratio.
Overdose
Extremely low systemic absorption with topical ketoprofen makes it virtually impossible to overdose. Accidental use inside a large number of drug may cause systemic side effects.
Treatment should be symptomatic
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Ketoprofen – propionic acid derivative, has a local anti-inflammatory and analgesic action. Inhibits the enzyme activity of cyclooxygenase-1 and cyclooxygenase-2, involved in the synthesis of prostaglandins (PGs).
Ketoprofen penetrates through the skin, reaching the hearth of inflammation, thus providing the possibility of local treatment of lesions (joints, tendons, ligaments and muscles), accompanied by pain syndrome.
Pharmacokinetics:
When applied topically, it is absorbed slowly through the skin, hardly accumulates.
gel bioavailability of about 5%. After application of a dose of 50-150 mg of the plasma concentration after 5-8 hours of 0.08-0.15 g / ml. Plasma protein binding is approximately 99%. It is metabolized by conjugation with glucuronic acid. Active metabolites are not formed. The half-life of 1-3 hours.
Excreted through the kidneys in the form of conjugated metabolites.
Pregnancy and breast-feeding
As is well known adverse effects of NSAIDs which inhibit the synthesis of PG on cardio-pulmonary system of the fetus (pulmonary hypertension, premature closure of the ductus arteriosus) and renal function (renal failure, in conjunction with oligohydramnios) ketoprofen, should be avoided during pregnancy.
Adequate and well-controlled clinical studies in pregnant women have not performed. Use in pregnancy is contraindicated.
Women planning a pregnancy should refrain from using ketoprofen as against the background of his admission may reduce the likelihood of implantation of the egg.
It is not known whether ketoprofen in human milk, therefore it is not recommended to use ketoprofen during breastfeeding is highlighted.
Conditions of supply of pharmacies
Available without prescription.
side effects
Possible side effects are classified in accordance with the following frequency: very often (> 10%), frequent (> 1%, 0.1%,
0.01%
For the skin:
rarely – itching, erythema, eczema;
rarely – photosensitivity, bullous dermatitis, urticaria;
very rarely – contact dermatitis, angioedema.
On the part of the gastrointestinal tract:
very rarely – peptic ulcer, bleeding, diarrhea.
Immune system:
very rarely – anaphylactic reactions, hypersensitivity reactions.
From the urinary system:
very rarely – worsening course of renal failure
special instructions
After application of the gel to the skin must thoroughly wash their hands.
It is unacceptable application of the gel to the affected (open wounds) and inflamed skin.
Avoid contact with the mucous membranes of the eye (conjunctiva irritation hazard). Should not be used with occlusive dressing. Do not use air-tight clothes when using the drug-Ketoprofen Teva.
Long-term use of topical agents can lead to increased sensitivity or local irritation. In order to prevent any manifestations of hypersensitivity or photosensitivity should avoid exposure to sunlight during the treatment and 2 weeks after the end of treatment. It is recommended to cover the drug treated areas of skin clothing.
Caution should be exercised when using the drug-Ketoprofen Teva in patients with severe renal insufficiency.
It should stop using the product Ketoprofen-Teva in case of any skin reaction, including reaction with simultaneous application to the skin or other sunscreen cosmetics containing organic sunscreen octocrylene.
Using the drug in large quantities in very rare cases may develop systemic side effects (hypersensitivity, asthma, disorders of the gastrointestinal tract, worsening course of renal failure). The risk of systemic side effects increases depending on the amount of gel applied, the area of ​​the treated skin area, skin condition, the duration of treatment.
Effect on the ability to drive mechanisms and
The drug has no effect on the ability to drive and use machines.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Outwardly. A strip of the gel or the gel dose is applied with light massaging movements in the region over the affected body portion.
Adults and children over 12 years of age applied by 2-4 g of gel (gel strip is about 5-10 cm long, respectively), 2 times a day. Quantity of gel applied depends on the area to be treated. Duration of treatment is not more than 10 days.
With the lack of effectiveness of the drug should contact your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist