KETRUM [Ketoprofen] 2.5% Gel for external use

KETRUM

instructions for medical use of the medicinal product

Tradename

Ketrum, Ketrum

International non-proprietary name

Ketoprofen, Ketoprofen
Compound

Each 100 g of gel contains:

Ketoprofen 2.5 g

Excipients: carbomer 940, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trolamine (triethanolamine), propylene glycol, lavender hydroperfume, polyoxyl 40 hydrogenated castor oil, ethanol and distilled water.

Dosage form

Gel for external use.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

Pharmacological properties

Ketoprofen belongs to the group of NSAIDs with a pronounced analgesic effect. The mechanism of action of the drug is to reduce the synthesis of prostaglandins by inhibiting the activity of cyclooxygenases (COX-1 and COX-2). Ketoprofen stabilizes lysosome membranes, inhibits the synthesis of leukotrienes and exhibits anti-bradykinin activity. Its anti-inflammatory activity is similar to that of indomethacin and naproxen and exceeds the activity of ibuprofen, phenylbutazone and acetylsalicylic acid, respectively, by 20, 80 and 160 times. The analgesic effect of ketoprofen is similar to that of indomethacin and naproxen. Passive penetration of the drug through the skin is equivalent to ingestion of ketoprofen. The time to reach plasma Cmax is 2.7–4 hours, T1 / 2 is 2–4 hours. 99% of ketoprofen binds to plasma proteins, mainly to albumins. Metabolism of ketoprofen in the liver occurs rapidly and extensively by conjugation with glucuronic acid, active metabolites are not formed.

Indications for use

To reduce the severity of pain in muscles and joints, swelling due to sports and other injuries (dislocations, sprains, bumps, rupture of ligaments and tendons). Muscle pain due to excessive exercise, back pain. To reduce the severity of pain and eliminate inflammation in degenerative rheumatic diseases.

Contraindications

Hypersensitivity to ketoprofen, as well as any of the excipients of the drug, other NSAIDs and salicylates. The presence of attacks of bronchial asthma and rhinitis after the use of NSAIDs and salicylates in history. Exacerbation of peptic ulcer of the stomach or duodenum, history of gastrointestinal bleeding, chronic dyspepsia (discomfort and pain in the upper abdomen). Severe renal failure . Skin diseases. During pregnancy and breastfeeding. Children's age up to 15 years.

Use during pregnancy or lactation

The drug should not be used during pregnancy and lactation.

Interaction with other drugs

The simultaneous use of other topical dosage forms containing ketoprofen or other NSAIDs is not recommended. With the simultaneous use of acetylsalicylic acid and ketoprofen, the binding of ketoprofen to plasma proteins decreases.

The simultaneous use of probenecid and ketoprofen leads to a decrease in the plasma clearance of ketoprofen and the degree of its protein binding. Ketoprofen, like other NSAIDs, reduces the excretion of methotrexate, which leads to an increase in its toxicity.

Special instructions and precautions

It is not allowed to apply the gel on open wounds and inflamed skin! If changes appear on the skin, treatment should be temporarily stopped. With severe skin irritation, it is not recommended to continue treatment. During the use of the drug, it is necessary to carefully protect the gel from getting into the eyes due to the risk of irritation of the mucous membrane of the conjunctiva. After using the drug, you should immediately wash your hands. Do not use under occlusive dressings (not breathable). Avoid exposure to direct sunlight and UV radiation during treatment and for 2 weeks after its completion.

Children: for use in children over 15 years of age.

The ability to influence the rate of reactions when driving vehicles or working with other mechanisms.

There are no data on the effect of ketoprofen on the ability to drive vehicles and work with potentially dangerous equipment.

Dosage and administration

3-5 cm of gel is applied and lightly rubbed into the skin at the site of the lesion 1-2 times a day. The total amount of gel applied during the day should not exceed 15 g (7.5 g corresponds to approximately 14 cm of gel).

Side effect

With prolonged use at the site of application of the gel, allergic reactions ( erythema , itching , swelling, etc.), contact dermatitis , and rarely photosensitivity can be observed . Very rarely, asthmatic attacks are noted as a variant of an allergic reaction.

Overdose

Symptoms: irritation, erythema and itching of the skin at the site of application of the gel. Treatment: Thoroughly rinse the skin surface with running water.

Storage conditions

Store at room temperature.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Package

40 g of gel in an aluminum tube along with instructions for medical use in a cardboard box.

Manufacturer

The trademark and registration certificate are owned by the company

LIV MEDICINE LIMITED, UK.

Produced

Amria Pharmaceutical Industries, Alexandria-Cairo Desert Road Km 25, Alexandria, Egypt.

KETRUM

instructions for the medical use of the medicinal product

Tradename

Ketrum, Ketrum

International non-proprietary name

Ketoprofen, Ketoprofen
composition

Each 100 g of gel contains:

Ketoprofen 2.5g

Excipients: carbomer 940, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trolamine (triethanolamine), propylene glycol, lavender hydrogen perfume, polyoxyl 40 hydrogenated castor oil, ethanol and distilled water.

Dosage form

Gel for external use.

pharmaceutical group

Non-steroidal anti-inflammatory drug (NSAID).

pharmaceutical properties

Ketrum belongs to the group of NSAIDs with a pronounced analgesic effect. The mechanism of action of the drug is to reduce the synthesis of prostaglandins by inhibiting the activity of cyclooxygenases (COX-1 and COX-2). Ketoprofen stabilizes lysosomal membranes, inhibits the synthesis of leukotrienes and exhibits anti-bradykinin activity. Its anti-inflammatory activity is similar to that of indomethacin and naproxen and exceeds the activity of ibuprofen, phenylbutazone and acetylsalicylic acid by 20, 80 and 160 times, respectively. The analgesic effect of ketoprofen is similar to that of indomethacin and naproxen. Passive penetration of the drug through the skin is equivalent to the ingestion of ketoprofen. Time to reach plasma Cmax - 2.7-4 hours, T1 / 2 - 2-4 hours. 99% of ketoprofen binds to plasma proteins, mainly albumin. Metabolism of ketoprofen in the liver occurs rapidly and extensively by conjugation with glucuronic acid, no active metabolites are formed.

Indications for use

To reduce the severity of pain in muscles and joints, edema due to sports and other injuries (dislocations, sprains, blows, rupture of ligaments and tendons). Muscle pain due to excessive physical exertion, lower back pain. To reduce the severity of pain and eliminate inflammation in degenerative rheumatic diseases.

Contraindications

Hypersensitivity to ketoprofen, as well as any of the excipients of the drug, other NSAIDs and salicylates. The presence of attacks of bronchial asthma and rhinitis after the use of NSAIDs and salicylates in history. Exacerbation of peptic ulcers of the stomach or duodenum, history of gastrointestinal bleeding, chronic dyspepsia (discomfort and pain in the upper abdomen). Severe renal failure. Diseases of the skin. During pregnancy and breastfeeding. Children under 15 years of age.

Use during pregnancy or lactation

The drug should not be used during pregnancy and lactation.

Interaction with other medicinal products

The simultaneous use of probenecid and ketoprofen leads to a decrease in the plasma clearance of ketoprofen and the degree of its binding to proteins. Ketoprofen, like other NSAIDs, reduces the excretion of methotrexate, which leads to an increase in its toxicity.

Special instructions and precautions

It is not allowed to apply the gel to open wounds and inflamed skin! If changes appear on the skin, you need to temporarily stop treatment. In case of severe skin irritation, it is not recommended to continue treatment. During the use of the drug, you must carefully protect against contact with the gel in the eyes due to the danger of irritation of the conjunctival mucosa. After using the drug, wash your hands immediately. Do not use under occlusive dressings (impermeable). Avoid exposure to direct sunlight and UV radiation during treatment and for 2 weeks after its completion.

Children: used in children over the age of 15.

The ability to influence the speed of reactions when driving or working with other mechanisms.

There are no data on the effect of ketoprofen on the ability to drive vehicles and work with potentially dangerous equipment.

Method of administration and dosage

side effects

With prolonged use at the site of application of the gel, allergic reactions (erythema, itching, edema, etc.), contact dermatitis, rarely photosensitization may occur. Asthmatic attacks are very rarely noted as a variant of an allergic reaction.

Overdose

Symptoms: irritation, erythema and itching of the skin at the site of application of the gel. Treatment: Thoroughly rinse the skin surface with running water.

storage conditions

Store at room temperature.

Keep out of the reach of children!

Shelf life

3 years old Do not use after the expiration date printed on the package.

Release form

40 g of gel in an aluminum tube together with instructions for medical use in a cardboard box.