Aertal, cream 1.5% 60 g

Pharmacodynamics

Aceclofenac is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. The drug suppresses the development of edema and erythema regardless of the etiology of inflammation. Aceclofenac inhibits the formation of prostaglandins and leukotrienes due to reversible inhibition of cyclooxygenase types 1 and 2.

The established clinical efficacy of the drug is complemented by good tolerability. The use of Aerthal® cream is advisable in patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.

Pharmacokinetics

Intake

After application, aceclofenac is absorbed from the application area, quickly reaching saturation. It accumulates in the area of absorption, which contributes to increased anti-inflammatory activity, and gradually enters the systemic bloodstream in small amounts, so the risk of side effects, including on the gastrointestinal tract, is minimized.

Distribution

Aceclofenac is distributed throughout the body.

Elimination

Aceclofenac is metabolized in the liver and is excreted slowly by the kidneys and through the intestine, partially unchanged.

Indications

Active ingredient

Composition

1 g of cream contains:

Active substance:

aceclofenac 100% micronized 0.015 g.

Auxiliary substances:

emulsion wax 0.1 g,

liquid paraffin 0.04 g,

methyl parahydroxybenzoate 0.002 g,

propyl parahydroxybenzoate 0.0005 g,

water 0.8425 g.

Tube 60 g.

How to take, the dosage

Aertal® Cream is for external use only and should not be applied under occlusive dressings. Aertal® should be applied by gentle massaging movements to the affected area three times a day. The applied dose depends on the size of the affected area: 1.5-2 g of Aertal® cream (corresponds approximately to a 5-7 cm long strip of cream).

Pediatric use

There is no experience with Aertal® Cream in children, so Aertal® Cream is contraindicated for use in children.

Elderly patients

There is no need for dosing adjustment in elderly patients.

Interaction

Despite the lack of data on possible interactions of aceclofenac with other drugs, caution should be exercised when prescribing it to patients taking other drugs, especially those containing lithium, digoxin. Caution should also be exercised when concomitant therapy with anticoagulants, diuretics or analgesics.

Special Instructions

Impact on ability to drive vehicles and other mechanisms requiring high concentration

Aertal® cream has no effect on the ability to drive vehicles and operate machinery.

Contraindications

Side effects

The adverse events reported in clinical studies and post-marketing surveillance are listed below; adverse events are grouped according to organ system classes according to the Medical Dictionary for Regulatory Affairs (MedDRA) and frequency of occurrence:

General disorders and disorders at the injection site: infrequent photosensitivity reaction, erythema, skin itching; rare – skin irritation; very rare – bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

There have been very rare reports of severe skin reactions, sometimes leading to death, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with use of NSAIDs.

Overdose

Symptoms: cases of aceclofenac overdose are unknown. The exact symptoms of aceclofenac overdose are unknown. In case of improper use or accidental ingestion arterial hypotension, renal failure, seizures, gastrointestinal mucosa irritation and respiratory depression may develop.

Treatment: symptomatic and supportive therapy is carried out. Absorption of the drug should be prevented as soon as possible by gastric lavage and administration of activated charcoal.

Forced diuresis or hemoperfusion is ineffective due to the high degree of binding of aceclofenac to plasma proteins and its intense metabolism.

Pregnancy use

Pregnancy

Aertal® Cream is contraindicated in pregnancy. There is no information on the use of Aertal® Cream in pregnancy.

Breastfeeding

It is not known whether aceclofenac penetrates into the breast milk. Aertal® cream should not be used while breastfeeding.

Similarities