Ketonal 5% cream 50g tube

Description

Composition
Active substance:
1 g of cream contains: ketoprofen – 50.0 mg ;.
Excipients:
Methyl parahydroxybenzoate (methyl hydroxybenzoate) 2.0 mg propyl parahydroxybenzoate (propyl) 0.5 mg propyleneglycol 70.0 mg, 50.0 mg isopropyl myristate, petrolatum (white) 320.0 mg elfakos ST 9 30.0 mg, propylene glycol glyceryl oleate 90.0 mg, magnesium sulfate 5.0 mg purified water 382.5 mg.
Description:
White or almost white uniform cream.
Product form:
Cream for external use, 5%.
Primary packaging
30, 50 or 100 g were placed in an aluminum tube, sealed at the neck of the membrane tubes, screw-capped plastic cap provided with a cone-shaped device to puncture the membrane.
secondary packaging
1 tube together with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to ketoprofen or other components of the drug as well as the salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, blockers of ultraviolet (UV) rays, perfumes; specify a history of asthma attacks or allergic rhinitis after application of NSAIDs and salicylates; III trimester of pregnancy; children’s age (15 years); violation of integrity of the skin in the area of ​​application of the cream (eczema, acne, dermatitis, weeping, infected wound or open); a history of photosensitivity reactions; exposure to sunlight, including indirect sun rays and UV radiation in the solarium during the entire treatment period and 2 weeks after cessation of treatment.
It should consult a physician before using the cream Ketonal® if you have: dysfunction of liver and / or kidney; erosive and ulcerative lesions of the gastrointestinal tract; blood diseases; bronchial asthma; chronic heart failure.
Dosage
50 mg / g
Indications
Symptomatic therapy – reduction of pain and inflammation – in the following conditions: osteoarthritis of different localization; periarthritis, tendinitis, bursitis, myalgia, neuralgia, sciatica; injuries of the musculoskeletal system (including sports), bruised muscles and ligaments, sprains, torn ligaments and muscle tendons.
Interaction with other drugs
Patients taking coumarin anticoagulants, it is advisable to carry out regular monitoring of the international normalized ratio (INR).
Ketoprofen, like other NSAIDs, may reduce the excretion of methotrexate and help to increase its toxicity.
Interaction with other medicinal products and the impact on their removal are not significant.
Overdose
Overdosing is unlikely with topical preparation.
In case of overdose, the skin should be thoroughly rinsed with running water. You must discontinue use Ketonal® and contact your doctor.
In case of contact of the drug may develop into systemic adverse reactions.
In this case, symptomatic treatment and supportive therapy as an overdose forms for oral administration.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Ketoprofen is one of the most effective inhibitors of cyclooxygenase. It also inhibits lipoxygenase activity and bradykinin. Stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.
The main properties of ketoprofen are analgesic, anti-inflammatory and anti-edematous action. Ketoprofen has no negative impact on the status of the articular cartilage.
Pharmacokinetics:
Ketoprofen when applied topically in a cream hardly accumulates in the body. Bioavailability cream – about 5%. Penetrates into the tissue of the joints, including in synovial fluid, and there reaches therapeutic concentrations. Plasma concentration of the drug is extremely low.
Ketoprofen is metabolized in the liver to form conjugates that are derived mainly kidneys. Metabolism of ketoprofen not dependent on age, presence of severe renal failure or liver cirrhosis. Excretion of ketoprofen kidney is slow.
Pregnancy and breast-feeding
Pregnancy
Application in I and II trimesters
Since the safety of ketoprofen in pregnant women has not been evaluated, it should avoid the use of ketoprofen in I and II trimesters of pregnancy.
Application in the III trimester of pregnancy
The drug Ketonal® Cream is contraindicated in the III trimester of pregnancy.
During the III trimester of pregnancy, all prostaglandin inhibitors, including ketoprofen, may have toxic effects on the heart, lungs and kidneys of the fetus.
In late pregnancy, may increase bleeding time in mother and child. NSAIDs may delay the onset of labor.
Breast-feeding
To date, no data on the allocation of ketoprofen into breast milk, therefore the use of the drug Ketonal® cream during breastfeeding is not recommended.
Conditions of supply of pharmacies
Without a prescription.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (by> 1/100 to
special instructions
It is necessary to avoid getting the cream in the eyes or on the skin around the eyes, mucous membranes.
When the skin reactions, including those that develop when used together with octocrylene-containing drugs should stop treatment immediately.
Patients suffering from bronchial asthma combined with chronic rhinitis, chronic sinusitis and / or nasal polyposis, or paranasal sinuses, have a higher risk of allergic reactions with the use of aspirin and / or NSAIDs than the rest of the population.
To reduce the risk of photosensitivity is recommended to protect the treated skin with a cream dress by exposure to UV radiation during the treatment period and 2 weeks after cessation of use. Should not exceed the recommended duration of treatment is due to increased risk of developing contact dermatitis and photosensitivity reactions over time.
It is necessary to wash hands thoroughly after each application of the drug.
Information about the negative impact of cream Ketonal® on ability to drive and engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions, no.
Storage conditions
At a temperature not exceeding 25 C. Keep out of reach of children.
Dosing and Administration
For outdoor applications.
A small amount of cream (3-5 cm) Light rubbing movements applied thinly to the skin inflamed or painful body part in accordance with its area 2-3 times a day. The duration of treatment without consulting a doctor should not exceed 14 days.
If necessary Ketonal® cream may be combined with other medicinal forms Ketonal® formulation (capsules, tablets, rectal suppositories, solution for intravenous and intramuscular administration).
The maximum dose of ketoprofen is 200 mg / day.
Occlusive dressing is not recommended.
If you forgot to put the cream, apply it at a time when the next dose, do not double but it should be applied.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist