Composition, form of production and packaging
Gel dental yellow-brown, soft, homogeneous, with a characteristic odor, free from grains, lumps and foreign particles.
1 g
lidocaine hydrochloride 3.3 mg
cetylpyridinium chloride 1 mg
Auxiliary substances: sorbitol solution 70% non-crystallizing - 210 mg, xylitol - 140 mg, ethanol 96% - 93.6 mg, glycerol - 70 mg, gietellose - 25 mg, macrogol glycerol hydroxy stearate - 10 mg, lauromacrogol 600-3.3 mg, macrogol 300-3.3 mg mg, sodium saccharinate - 1 mg, levomentol - 0.6 mg, herbal flavor 17.42.5490 - 4.8 mg, caramel (E150) - 1 mg, sodium citrate - 8.3 mg, citric acid monohydrate - 1.05 mg, water up to 1000 mg.
10 g - aluminum tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Kalgel В® is an anesthetic used to apply to the oral mucosa. Lidocaine has a local anesthetic effect when applied to the mucosa. Cetylpyridinium chloride has antiseptic properties.
PHARMACOKINETICS
Suction
Lidocaine is rapidly absorbed from the mucous membrane. Cetylpyridinium chloride is poorly absorbed through the mucosa of the oral cavity.
Distribution
Lidocaine binds to blood plasma proteins, incl. with alpha1-acid glycoprotein (ACHA). The degree of binding varies and is about 66%. The binding of lidocaine to plasma proteins depends on the concentrations of lidocaine and ACHA. Any change in the concentration of ACHA can greatly affect the concentration of lidocaine in the blood plasma.
Metabolism
Lidocaine is largely metabolized in the liver. Metabolism in the liver is rapid. About 90% of the lidocaine received is dealkylated to form monoethylglycinexylidide and glycinexylidide.
Excretion
Metabolites of lidocaine are excreted by the kidneys, while less than 10% of lidocaine is excreted unchanged.
INDICATIONS
- for rapid relief of pain with teething and reduction of gingival irritation.
Kalgel В® also has a weak antiseptic effect.
DOSING MODE
For application to the mucous membrane.
The preparation Kalgel В® is intended for children from the age of 3 months .
A small amount of gel (about 7.5 mm) is applied to the tip of a clean finger and gently rubbed into the inflamed portion of the baby's gum. If necessary, the gel can be applied repeatedly at intervals of 20 minutes, but not more than 6 times / day.
The use of the drug in patients with impaired renal and / or liver function has not been studied.
SIDE EFFECT
When using Calgel В® in accordance with the instructions for use, undesirable reactions are unlikely. However, single cases of hypersensitivity to lidocaine following local injections in adults and children over the age of 12 have been reported. Hypersensitivity occurred in these cases, expressed as a localized edema, accompanied by a minor difficulty in breathing or generalized rash.
A slight amount of chamomile in the herbal fragrance can cause allergic reactions, which is documented. Hypersensitivity to substances that are contained in the chamomile, manifests itself in the form of difficulty breathing in people predisposed to atopy. Anaphylactic reactions have been reported with the intake of herbal tea containing chamomile. In persons with hypersensitivity, a positive skin reaction can occur with the use of drugs containing chamomile.
In case of any undesirable reactions, it is necessary to stop using Calgel В® and consult a doctor for advice.
CONTRAINDICATIONS
- hypersensitivity to lidocaine, other amide anesthetics, cetylpyridinium or any other component of the drug;
- rare hereditary intolerance to fructose;
- Children under 3 months.
PREGNANCY AND LACTATION
Fertility
Not applicable.
Pregnancy
Not applicable.
Breastfeeding period
Not applicable.
APPLICATION FOR FUNCTIONS OF THE LIVER
The use of the drug in patients with impaired renal function has not been studied.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The use of the drug in patients with impaired liver function has not been studied.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in childhood to 3 months.
SPECIAL INSTRUCTIONS
Do not exceed recommended doses.
Impact on the ability to drive vehicles and manage mechanisms
Not applicable.
OVERDOSE
Symptoms: As a result of excessive use of Calgel ® , a decrease in pharyngeal sensitivity may occur with a concomitant effect on swallowing. This effect was registered in an adult who swallowed 5 ml of a 2% solution of lidocaine hydrochloride (equivalent to 100 mg of lidocaine) when the throat was rinsed. If the body surface area is related to the surface area of ​​the pharynx of the child at the age of 3 months, this dose will be equivalent to 5.4 g of Calgel ® .
Even with improper or excessive use of Calgel В®, it is unlikely to achieve those large amounts of lidocaine hydrochloride or cetylpyridinium chloride that could cause clinically significant toxic effects.
Treatment: In case of an overdose, stop using Calgel В® and consult a doctor.
DRUG INTERACTION
There is no data on the interaction of Calgel В® with other drugs.
There are data on the interaction of lidocaine (with intravenous infusion) with the following drugs when taken internally: procainamide, phenytoin as monotherapy or in combination with phenobarbital, primidone or carbamazepine, propranolol and potassium-sparing diuretics, including bumetanide, furosemide, and thiazide diuretics .
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years. Do not use after the expiration date stated on the package.
