Instructions for use Apizartron ointment tube 20 g
Composition
active ingredients:
100 g of ointment contain 0.003 g of standardized bee venom, 10 g of methyl salicylate, 1 g of allyl isothiocyanate;
excipients: cetostearyl alcohol, sodium cetostearyl sulfate, sodium lauryl sulfate, mineral oil, purified water.
Dosage form
Ointment.
Main physicochemical properties: homogeneous ointment from white to white with a yellowish tint, with the smell of methyl salicylate.
Pharmacotherapeutic group
Other remedies for topical use for joint and muscle pain.
ATX code M02A X10.
Pharmacological properties
Pharmacodynamics
A combined preparation for external use, the pharmacological properties of which are due to the mutual potentiation of the therapeutic effects of each of the components. An important component of the ointment is venom obtained from living bees and isolated in its pure form by lyophilization. To ensure the constant effectiveness of this biological substance, bee venom is standardized and studied during biochemical and pharmacological tests. Standardized bee venom contains active ingredients that provide a multifaceted therapeutic effect. The most important of them are melittin, apamin, MSD peptide, histamine, hyaluronidase, phospholipase. The second component of the ointment, methyl salicylate, belongs to the group of non-steroidal anti-inflammatory drugs that penetrate well through the skin. It has anti-inflammatory and analgesic effects, which are enhanced due to the synergistic action of the bee venom ingredients - MSD peptide and apamin. The third component, allyl isothiocyanate, has a local irritant effect, causing local hyperthermia and hyperemia, which are enhanced by the ingredients of bee venom - histamine and melittin. Melittin also promotes the release of endothelial relaxing factor EDRF. Improved local blood circulation leads to better oxygen saturation of tissues and accelerates the removal of toxic metabolic products from the focus of inflammation, which cause a feeling of pain.
Pharmacokinetics
Not studied.
Indication
As part of complex therapy for:
inflammatory and degenerative-dystrophic diseases of the joints (arthrosis and arthritis, including rheumatism);
myalgia and pain due to traumatic injuries of muscles, tendons, ligaments;
neuralgic diseases (neuralgia, neuritis, sciatica, lumbago and radiculitis);
peripheral disorders of local blood circulation.
For warming up muscles in sports medicine.
Contraindication
hypersensitivity to salicylates, isothiocyanates, bee products;
liver failure;
acute renal failure;
skin diseases;
acute inflammation of the joints;
hemorrhagic diathesis.
Contraindicated in patients under 6 years of age.
Do not apply the drug to the skin if the integrity of the skin is broken, as well as to large areas of skin.
Special safety precautions
Avoid contact with mucous membranes, eyes and open wounds.
After applying the ointment, wash your hands thoroughly with soap and water.
In case of accidental eye contact, rinse with running water for 15 minutes. If after rinsing the patient experiences pain, irritation, or decreased visual acuity, he should consult a doctor.
Avoid prolonged use on large body surfaces in patients with renal insufficiency.
Apizartron® ointment should be used with extreme caution in children aged 6 to 12 years.
Interaction with other medicinal products and other types of interactions
No interactions with other substances have been observed so far. Methyl salicylate may enhance the effects of anticoagulants and methotrexate.
Application features
The ointment contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Apizartron® is not used during pregnancy and lactation.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
A strip of ointment 3-5 cm long (depending on the area of the affected surface) is applied to the skin surface to be treated. The ointment is evenly distributed in a thin layer and a noticeable reaction (redness, feeling of warmth) is expected, which occurs after 0.5-2 minutes, depending on the individual sensitivity of the body. After that, the ointment is slowly and intensively rubbed into the skin. It is recommended to keep the areas of the body treated with the ointment warm. As a rule, the drug is used 2-3 times a day, until the symptoms of the disease disappear.
Children
The drug is not prescribed to children under 6 years of age due to lack of experience in this category of patients.
Apizartron® ointment should be used with extreme caution in children aged 6 to 12 years.
Overdose
Methyl salicylate and allyl isothiocyanate are toxic components that are part of the Apizartron® ointment. Symptoms of methyl salicylate intoxication: bloody vomiting, tachypnea, hyperpnea, dyspnea, tinnitus, deafness, lethargy, convulsions, loss of consciousness. In case of overdose, resuscitation measures are necessary. Accidental ingestion of the ointment (in this case, apitoxin is inactivated) can cause irritation of the gastrointestinal tract (nausea, abdominal pain, vomiting). Treatment: take activated charcoal, sodium sulfate and plenty of fluids (but not milk!). In case of accidental ingestion or use in children under 6 years of age, consult a doctor.
Side effects
Skin irritation;
contact dermatitis;
Allergic reactions are possible, including skin rashes, itching, angioedema.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
Aluminum tubes of 20 g, 30 g, 50 g and 100 g of ointment. One tube in a cardboard box with instructions.
Vacation category
Without a prescription.
Producer
Passauer Pharma GmbH.
Address
Eiderstedter Weg 3, 14129 Berlin, Germany.
Applicant
Passauer Pharma GmbH, Germany.
