Instructions Benzylbenzoate Grindeks ointment 200 mg/g tube 30 g
Composition
active ingredient: benzyl benzoate;
1 g of ointment contains 200 mg of benzyl benzoate;
Excipients: polysorbate 80, carbomer, sodium hydroxide, methylparaben (E 218), propylparaben (E 216), bronopol, purified water.
Dosage form
Ointment.
Main physicochemical properties: white or almost white ointment with a specific odor.
Pharmacotherapeutic group
Means used for ectoparasites, including scabies mites. ATX code R0ZA X01.
Pharmacological properties
Pharmacodynamics.
Benzyl benzoate is a benzyl ester of benzoic acid. It acts selectively, penetrates the chitinous cover of scabies mites Acarus scabiei and accumulates in their body in toxic concentrations, causing the death of adults. It does not affect scabies mite eggs. It also has a weak anesthetic effect.
Pharmacokinetics.
When applied topically, benzyl benzoate penetrates the upper layers of the epidermis and is not absorbed systemically.
Indication
Scabies.
Contraindication
Hypersensitivity to the components of the ointment.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Application features
The ointment is for external use only. To prevent irritation, avoid contact with eyes, mucous membranes, or broken skin.
To determine hypersensitivity to the drug, it is recommended to first apply a small amount of ointment to the skin.
The ointment contains methylparaben (E 218), propylparaben (E 216) and bronopol as excipients. Methylparaben (E 218) and propylparaben (E 216) may cause allergic reactions (possibly delayed), bronopol – local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Do not use during pregnancy. Breastfeeding should be discontinued during treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no impact.
Method of administration and doses
For external use.
Immediately before use in children aged 3 to 5 years, the ointment is diluted with warm boiled water (30‒35 ºС) in a ratio of 1:1 and mixed until a homogeneous emulsion is formed. Treatment should usually be carried out without a preliminary warm bath 2 times with an interval of 12 hours. In children aged 5 and over and adults, undiluted ointment is used.
When treating scabies, 10-15 g of ointment is applied to previously washed skin in one go and rubbed in. The ointment covers all areas of the skin, except the face and hair.
First, the ointment is applied to the palms of the hands, then to all other parts of the body in a top-down sequence. Last of all, the ointment is applied to the legs, feet and interdigital spaces. In areas with delicate skin (groin area, genitals, mammary glands), as well as in case of eczema, dermatitis or pyoderma, the ointment should be applied carefully, without rubbing.
After applying the ointment, you should not wash your hands for 3 hours. In some cases, after the applied ointment has dried (usually after 1 hour), it is recommended to apply a second layer of the drug. After the end of the treatment, patients should wear clean underwear and change their bed linen. After 24-48 hours, take a shower and change their underwear and bed linen again.
The ointment is applied to the skin 4 times over 2 weeks with an interval of 3-4 days. An average of 60-90 g of ointment is used per course of treatment.
Children
The ointment is not recommended for use in children under 3 years of age.
Overdose
Symptoms: if the ointment is accidentally swallowed or if a very large amount of ointment is applied, central nervous system stimulation (convulsions) and urinary retention may occur.
Treatment: symptomatic. The skin should be washed. If the ointment is swallowed, the stomach should be washed and activated charcoal should be taken. If necessary, anticonvulsants should be used.
Side effects
Classification of the frequency of adverse reactions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000), including isolated cases; unknown (cannot be estimated from the available data).
Skin and subcutaneous tissue disorders
Not known: contact dermatitis; allergic skin reactions: skin irritation, painful burning sensation. Skin sensitivity is particularly increased if its surface is damaged or if the ointment gets on the genital mucosa.
When rubbing the ointment into the skin, you may experience a tingling sensation, which will go away after a few minutes. If the tingling sensation persists, you should wash the skin.
Expiration date
2.5 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not store in the refrigerator or freezer.
Keep out of reach of children.
Packaging
30 g in an aluminum tube; 1 tube in a cardboard pack.
Vacation category
Without a prescription.
Producer
JSC Tallinn Pharmaceutical Plant.
Address
Krustpils Street, 53, Riga, LV-1057, Latvia.
Applicant
JSC "Grindex".
