Lidocaine 5%

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  • ATX classification: R02A Preparations for the treatment of diseases of the throat.
  • Mnn or grouping name: Gimekromon
  • Pharmacological group: R02A – PREPARATIONS FOR THE TREATMENT OF THROAT DISEASES
  • Manufacturer: LEK
  • License Owner: SANDOZ GROUP
  • Country: Unknown

Instruction

on medical use of the drug

Angal ®

Tradename

International non-proprietary name

Dosage Form

Lozenges for sucking

Composition

One pastille contains

active ingredients: chlorhexidine dihydrochloride

excipients: levomenthol, sorbitol, magnesium stearate.

Description

Lozenges are round, from white to almost white.

Pharmacotherapeutic group

Preparations for the treatment of diseases of the throat. Antiseptics.

ATH code R02AA20

Pharmacological properties

The local anesthetic effect of lidocaine develops in 2–5 minutes and lasts for 30–45 minutes. Anesthesia is superficial and does not extend into submucosal structures.

Lidocaine penetrates the blood-brain barrier and the placenta and is excreted into human breast milk. It undergoes primary metabolism in the liver. The first two metabolites of monoethylglycinexylidide and glycinexylidite are pharmacologically active. Substance excreted

mainly in the form of metabolites through the kidneys, and 10% is excreted unchanged. The biological half-life of lidocaine is 1.5–2 hours in adults and 3 hours in newborn babies. The half-life of lidocaine metabolites can vary from 2 to 10 hours.

Chlorhexidine is practically not absorbed through the mucous membrane and skin. When resorption, chlorhexidine is gradually released from the lozenge into saliva and binds to the mucous membrane of the oral cavity and tongue, after which it re-enters the saliva, where its antibacterial effect is manifested. Chlorhexidine can be swallowed with saliva, but its absorption in the gastrointestinal tract is very low. Chlorhexidine is slightly metabolized in the liver and is excreted mainly with bile through the intestines. Usually, 90% of chlorhexidine is excreted unchanged with feces.

The preparation Angal ® has a local analgesic and antibacterial effect. The drug reduces pharyngeal inflammation, reducing the possibility of developing more severe bacterial infections of the throat, and relieves pain during irritation and swallowing.

Lidocaine hydrochloride is an anesthetic amide-type peripheral topical effect. It has a superficial analgesic effect, without blocking the conduction of a nerve impulse at the site of application.

Being a local anesthetic, lidocaine has the same mechanism of action as other drugs in this group; it blocks the generation and conduction of nerve impulses in sensory, motor, and vegetative nerve fibers. It has a direct effect on the cell membrane by inhibiting the flow of sodium ions into the nerve fibers through the membrane. Due to the progressive spread of the anesthetic effect, the threshold of electrical excitation in the peripheral nerves increases, the conduction of the nerve impulse slows down, and the reproduction of the action potential is weakened, which ultimately leads to a complete blockage of the nerve impulse. In general, local anesthetics block vegetative nerves, small non-myelinated (sense of pain) and small myelinated (sense of pain, temperature) more quickly than large myelinated fibers (sense of touch, pressure).

At the molecular level, lidocaine specifically blocks sodium ion channels in an inactive state, which prevents the generation of action potential, preventing the conduction of nerve impulses when using local lidocaine near the nerve.

Chlorhexidine is a cationic antiseptic that has an antibacterial effect on both gram-positive and gram-negative microorganisms (for example, Micrococcus sp., Staphylococcus sp., Bacillus sp., Clostridium sp., Corinebacterium sp.). It also has an anti-fungal effect on dermatophytes and fungi. The drug acts as a bacteriostatic in low concentrations, and in high concentrations has a bactericidal effect.

Chlorhexidine carries a positive charge; thus, it is absorbed on negatively charged areas of the bacterial cell wall and on extracellular structures. The absorption is specific and is localized to the corresponding phosphate-containing sections of the bacterial cell wall.

Chlorhexidine binds to the cytoplasmic membrane of bacteria. It is absorbed on the negatively charged surface of the teeth. Small amounts of active substances enter the gastrointestinal tract with saliva. Chlorhexidine is not absorbed. Lidocaine can be absorbed through the mucous membrane of the mouth and pharynx. However, most of it collapses without reaching the systemic blood flow.

Indications for use

– topical treatment of inflammation of the oral mucosa (stomatitis, gingivitis) and pharynx

– eliminate pain during inflammation of the oral mucosa

– relieving symptoms of sore throat (pain when swallowing, irritation)

Dosage and administration

The dose for an adult and a teenager older than 12 years is between six and ten lozenges per day.

The dose for a child over 5 years old is half the dose of an adult, that is, from three to five lozenges per day.

Pastils are designed for sucking in the oral cavity. One pastille is gradually absorbed in the mouth.

The drug can be used for three to four days. If the patient’s condition does not improve within the specified period of time, consult a doctor.

The maximum single dose for an adult is 5 mg of chlorhexidine (0.08 mg / kg body weight) and 1 mg of lidocaine (0.02 mg / kg body weight), which corresponds to one pastille.

The maximum daily dose of chlorhexidine is 50 mg, and lidocaine is 10 mg, which corresponds to ten lozenges.

Side effects

When using the drug with the recommended dose tolerated well

– skin allergies

– gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhea)

– severe allergic reactions, anaphylactic shock

– delayed hypersensitivity reactions (contact allergies, photosensitivity reactions)

– anxiety, excitement, euphoria

– drowsiness, dizziness, loss of orientation, stupefaction (including confusion of speech), vertigo, trembling, psychosis, irritability, paresthesia, numbness, convulsions, loss of consciousness and coma

– blurred vision (misfocused and double vision)

– dyspnea, respiratory failure syndrome, respiratory arrest

– difficulty in swallowing, mouth ulcers, distortion of taste, burning sensation on the tongue

– muscle cramps, tremor

– feeling cold or hot

With prolonged and prolonged use of the drug in

a brown stain may appear temporarily in the mouth

Contraindications

– known hypersensitivity to any component of the drug

– children up to 5 years

– history of muscle cramps (including febrile convulsions)

Drug interactions

During the use of Angal® lozenges, patients are not recommended to simultaneously use other local antiseptic preparations. The exception is Angal® C spray. In this case, a single dose of lozenges is replaced with a single dose of spray.

It is not recommended to apply Angal® lozenges simultaneously with cholinesterase inhibitors (that is, with neostigmine, distigmine, pyridostigmine) and other drugs for the treatment of myasthenia.

The drug should be used with caution in patients taking type 1B antiarrhythmic drugs (tokainid).

special instructions

Lidocaine 5%

The drug contains levomenthol, that is, it should be prescribed with caution to young children, possibly reflex respiratory depression

The drug contains sorbitol, that is, their use is permissible for patients with diabetes, but is not recommended for people with hereditary fructose intolerance. Patients suffering from chronic heart failure, taking class 1B antiarrhythmic drugs, care must be taken when prescribing the drug, because of the danger of enhancing the toxic effect of lidocaine.

It should be used with caution in patients who are prone to hypersensitivity reactions.

Do not use the drug continuously for longer than 3-4 days, or too often.

Pregnancy and lactation

During pregnancy and lactation, the use of the drug is allowed, but in accordance with the instructions for use and for a short time.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

Research on the ability to drive a car or potentially dangerous machinery was not conducted.

Overdose

Symptoms: systemic intoxication, which is the result of exposure to the central nervous and cardiovascular systems.

When systemic intoxication can develop: dysfunction of the central nervous and cardiovascular systems (nervousness, yawning, agitation, tinnitus, nystagmus, muscle tremor, convulsions, depression, respiratory failure), disorders of the cardiovascular system (loss of myocardial tone , peripheral vasodilation, hypotension, arrhythmia)

If symptoms of overdose appear, treatment should be stopped immediately. It is necessary to induce vomiting and gastric lavage. In more severe cases, the patient is hospitalized to maintain breathing and blood circulation.

Release form and packaging

12 lozenges each are placed in a blister packaging made from a polyvinyl chloride film and aluminum printed lacquered foil.

On 2 blister strip packagings together with the instruction for medical application in the state and Russian languages ​​are placed in a pack from a cardboard.

Storage conditions

Lidocaine 5%

Store at a temperature not higher than 25 o C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date printed on the package.

Vacation conditions

Manufacturer / Packager

Qualifar

Registration Certificate Holder

Lek Pharmaceuticals

Address of the organization that receives claims from consumers on the quality of products (goods) in the Republic of Kazakhstan

Almaty, st. Luganskogo, 96,

Tel +7 (727) 2581048

Fax: +7 (727) 2581047

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