Fastum, gel 2.5% 30 g

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drugs (NSAIDs) for local use

ATX code: M02AA10
Pharmacological properties

Pharmacodynamics
The mechanism of action of the drug is associated with inhibition of prostaglandin synthesis. Ketoprofen has analgesic and anti-inflammatory effects. Ketoprofen penetrates through the skin and reaches the site of inflammation, allowing local treatment of lesions (joints, tendons, ligaments and muscles) accompanied by pain syndrome.

Pharmacokinetics
When applied topically ketoprofen penetrates into the center of inflammation through the skin, absorption of ketoprofen from the center of inflammation is extremely slow (gel bioavailability – about 5%). After application of ketoprofen in dose of 50-150 mg the concentration in plasma is 0.08-0.15 mkg/ml in 5-8 hours. It practically does not cumulate in the body. The elimination half-life is 1-3 hours. Blood plasma protein binding is 60-90%. It is eliminated mainly through the kidneys as glucuronide; about 90% of the administered dose is eliminated within 24 hours.

Indications

Active ingredient

Composition

100 g of gel contains:
Active ingredient: ketoprofen – 2.50 g.
Excipients: carbomer, ethanol 96%, neroli flavoring, lavandine flavoring, trolamine (triethanolamine), purified water.

How to take, the dosage

A 5-10 cm strip of gel is applied as a thin layer to the affected area or skin over the lesion 1 to 3 times a day and lightly rubbed.
The preparation Fastum® can be used in combination with physiotherapy (phonophoresis and ionophoresis).

Interaction

Special Instructions

Do not apply the gel on damaged (including open wounds) and inflamed skin!

Avoid getting the gel on mucous membranes and in the eyes (risk of conjunctival irritation).

Wash hands thoroughly after each use of the product. Do not use in the form of hermetic dressings. Do not exceed the recommended period of treatment because the longer the time of application increases the risk of contact dermatitis and photosensitization reactions.
To avoid any symptoms of hypersensitivity or photosensitization, avoid exposure to direct sunlight (including visits to solariums) during the treatment period.
Patients with renal, cardiac or hepatic insufficiency should be cautious during the use of the preparation Fastum®; sporadic cases of systemic adverse effects associated with renal damage have been reported.

The drug should be discontinued if any skin reactions occur, including reactions if sunscreens or other cosmetic products containing the organic sunscreen octocrylene are applied simultaneously on the skin. External use of the drug in large quantities may cause systemic side effects (hypersensitivity, bronchial asthma, gastrointestinal and renal disorders). Localized skin reactions have been reported, which may subsequently extend beyond the area where the drug was applied. Rare events include cases of more severe reactions, such as bullous or flaccid eczema, which may spread and become generalized.
The risk of systemic side effects increases depending on the amount of gel applied, the area of skin treated, the condition of the skin, the duration of treatment (so do not exceed the maximum recommended duration of treatment).

Persons who have asthma with chronic rhinitis, chronic sinusitis, and/or nasal polyps have a higher risk of developing allergic reactions to aspirin and/or NSAIDs than other people.

Influence on the ability to drive and operate vehicles

The drug Fastum® does not affect the ability to drive vehicles and operate machinery.

Synopsis

Contraindications

– hypersensitivity to ketoprofen or other components of the drug, thiaprofenic acid, fenofibrate, acetylsalicylic acid or other NSAIDs (history of asthma symptoms, urticaria or rhinitis, caused by taking the drugs);
– history of skin hypersensitivity to solar radiation (photosensitization);
– history of skin allergy to ketoprofen, thiaprofenic acid, fenofibrate, sunscreens or perfumes;
– sun exposure to the treated sites, including indirect sunlight and solarium during the course of application of the product and 2 weeks after application, pathological skin changes such as acne, eczema, infected abrasions, wounds (in the gel application site);
– children under 12 years of age (effectiveness and safety has not been studied);
– third trimester of pregnancy.

With caution
– liver and kidney function disorders;
– heart failure;
– older age (older patients are more prone to adverse reactions when using nonsteroidal anti-inflammatory drugs).

Side effects

Possible side effects of the preparation Fastum® are given according to the descending frequency of their occurrence: very common (≥ 10%), common (≥ 1%, < 10%), infrequent (≥ 0,1%, < 1%), rare (≥ 0,01%, < 0,1%), very rare (< 0,01%).

Skin disorders
Infrequent: erythema, pruritus, eczema, burning sensation;
Rare: photosensitization, bullous dermatitis, urticaria;
Very rare: contact dermatitis, angioedema.

Gastrointestinal tract disorders
Very rare: peptic ulcer, gastrointestinal bleeding, diarrhea.

The immune system
Very rare: anaphylactic reactions, hypersensitivity reactions.

Urinary system disorders
Very rare: renal failure or exacerbation of existing renal failure.

Pregnancy use

In the first and second trimesters of pregnancy

There were no teratogenic or embryotoxic effects of the drug in studies on mice and rats. In a study on rabbits, a small embryotoxic effect was noted, probably related to maternal toxicity.
Since no safety studies of ketoprofen in pregnant women have been conducted, its use in the first and second trimester of pregnancy should be avoided.

In the third trimester of pregnancy
All prostaglandin synthesis inhibitors, including ketoprofen, cause toxic damage to the fetal cardiopulmonary system and the kidneys. At the end of pregnancy, both the mother and the baby may have prolonged bleeding times. Because of this, ketoprofen is contraindicated in the third trimester of pregnancy.

Breastfeeding
There are no data on the penetration of ketoprofen into the mother’s milk. Ketoprofen is not recommended for use in breastfeeding mothers.

Similarities