One bottle contains:

• active substance - lidocaine 3.8 g (4.8 mg in one dose);
• excipients: peppermint oil, propylene glycol, ethanol (96%).

Spray for external and topical use, 10 %, 38 g.

Anesthetics. Local anesthetics. Amides. Lidocaine.

ATC code  N01BВ02

Lidocaine-DF spray is used in all cases where skin or mucosal anesthesia is required.

Dental procedures and surgeries:

• anesthesia of the injection site before injecting a local anesthetic;
• during operations on opening of superficial abscesses;
• removal of a movable milk tooth or bone fragment;
• removal of sutures from the mucous membrane wound;
• gingival anesthesia prior to the application of a crown or bridge;

Manual or instrumental removal of tartar, removal (excision) of an enlarged interdental papilla;

• to reduce or suppress increased pharyngeal reflex before making an impression or applying an X-ray film (the product should be used only with elastic impression materials; due to the risk of aspiration, the use of the product is contraindicated if plaster is used to make an impression);
• in children during frenulotomy and salivary gland cysts dissection;
• when removing superficial benign tumors of mucous membranes.

Otorhinolaryngology:

• in the treatment of nasal bleeding, before electrocoagulation, septectomy and resection of nasal polyps;
• to suppress the pharyngeal reflex and anesthetize the injection sites;
• as additional anesthesia before opening a peritonsillar abscess or puncture of the maxillary sinus;
• for anesthesia when flushing the nasal sinuses.

Endoscopy and instrumental methods of investigation:

• pharyngeal anesthesia before introducing various tubes through the nose or mouth (gastro-duodenal probe or Sengstaken tube);
• in case of a tracheotomy tube change.

Gynecology and obstetrics:

• for perineal surgeries and for episiotomies;
• removal of stitches;
• anesthesia of the surrounding tissues during surgery on the vagina and cervix;
• for excision and treatment of hymenal tears or suture abscesses.

Dermatology:

• skin or mucosal anesthesia during minor surgical procedures.

• hypersensitivity to lidocaine or any other component of the product;
• due to the risk of aspiration, the use of Lidocaine-DF spray is contraindicated when casts are used for preparation.

Spray for external and topical use. The dose of the product depends on the indication and the size of the surface to be anesthetized. One pressure on the valve is accompanied by a release of 4.8 mg of lidocaine. To prevent absorption and toxic effects, Lidocaine-DF should be used in minimal doses that provide the necessary pain relief. Usually 1-3 pressings on the valve are enough, but in obstetrics the number of pressings can reach 15-20 (maximum - 40 pressings per 70 kg of body weight).

Recommended doses in various applications:

The product can be applied to large surfaces with a moistened gauze swab.

Probably:

• moderate burning and tingling sensation when applying Lidocaine topically, which disappears as the local anesthetic effect develops (after 1 minute);
• transient erythema, edema, impaired sensitivity at the site of application.

Very rare:

• urticaria, angioedema, bronchospasm, and in extremely severe cases - shock (the product should be stopped immediately in case of any hypersensitivity reaction).
• The frequency of systemic effects after using Lidocaine spray is extremely low because very little of the active product is applied that can enter the bloodstream. The following side effects may be observed in very rare cases if large doses are applied, as well as in case of rapid absorption, hypersensitivity, idiosyncrasy, poor tolerance of the product;
• symptoms of central nervous system agitation or depression (nervous agitation, dizziness, drowsiness, spasms, loss of consciousness and respiratory paralysis);
• hypotension, depressed myocardial function, bradycardia, cardiac arrest;
• bronchospasm, respiratory muscle paralysis, sore throat, hoarse voice.

Symptoms:  cardiovascular and central nervous system dysfunctions described under "Side effects".

Treatment: make sure the airway is clear, and if necessary administer oxygen therapy and/or ventilator assistance. For single spasms, 50-100mg succinylcholine and/or 5-15mg diazepam should be administered as soon as possible. Because succinylcholine can cause respiratory arrest, it should only be used by specialists experienced in tracheal intubation and management of patients with respiratory muscle paralysis. Short-acting barbituric acid derivatives (thiopental sodium) can also be used.  Atropine (0.5-1mg intravenously) and sympathomimetics are used to eliminate cardiovascular symptoms (bradycardia, conduction disorders). Ventricular fibrillation and cardiac arrest require resuscitation.

Lidocaine-DF spray, can be used during pregnancy, as it is not dangerous in the recommended doses.

Lidocaine is excreted with breast milk, but using it in normal therapeutic doses, the amount excreted with milk is too small to cause any harm to the infant.

Application to the cheek mucosa is accompanied by a risk of dysphagia and subsequent aspiration, especially in children. If the tongue and cheek mucosa are not sensitive, the risk of biting the tongue and cheek mucosa increases.

Lidocaine is well absorbed through mucous membranes (especially in the trachea) and damaged skin. This should be taken into account, especially when treating large areas of tissue in children.

In children, lower doses should be used according to age and general condition.

In children under 2 years of age, Lidocaine-DF spray is recommended to be applied with a swab soaked in the product.

If the product is used for surgical procedures in the pharynx or nasopharynx, note that lidocaine, by suppressing the pharyngeal reflex and entering the larynx and trachea, suppresses the cough reflex, which may lead to bronchopneumonia. This is especially important in children because they are more likely to have a swallowing reflex. Therefore, Lidocaine-DF spray is not recommended for local anesthesia before tonsillectomy and adenotomy in children under 8 years of age.

When applying the spray, keep the bottle upright.

Avoid getting the spray in the eyes and respiratory tract (risk of aspiration).  Particular caution is required when applying the product to the back of the pharynx.

The product is used with caution in patients with epilepsy, as well as in bradycardia, impaired cardiac conduction, hepatic dysfunction and severe shock, especially when a significant amount of the product can be expected to be absorbed when treating large tissue areas with high doses.

Lidocaine is well absorbed through mucous membranes (especially in the trachea) and damaged skin. This should be taken into account, especially when treating large areas of tissue in children.

Caution is required when applying Lidocaine-DF, spray, if mucosal integrity is compromised and/or on infected areas.

Lower doses should be used in frail and elderly patients, in acute illnesses, and in children, according to age and general condition.

Lidocaine has a porphyrogenic effect, so it can be used only in emergency indications in patients with acute porphyria.

Lidocaine spray should not get on the plastic cuff of the endotracheal tube (PVC/non-PVC), as lidocaine can damage it by forming small holes, which can lead to decreased pressure in the cuff.

The product contains ethanol. The product may modify or intensify the effects of other medicines.

The product contains propylene glycol, which may irritate the mucous membranes or skin.

Effects on ability to drive and use machines

Depending on the dose, in very rare cases, local anesthetics can cause side effects on the nervous system and thus may affect the ability to drive vehicles and operate machinery.

38 g of the product in dark glass bottles with a spray lid and a protective cap. Each bottle has a label. One bottle is with instruction for use in the state and Russian language are placed in a carton pack.

Store at 15^оС to 25^оС!

Keep out of the reach of children.

4 years

Do not use after expiration date.

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Адрес электронной почты защищен от спам-ботов. Для просмотра адреса в вашем браузере должен быть включен Javascript.