Pafedin spray

Pafedin

INTERNATIONAL NONPROPRIETARY NAME:

Absent

DRUG FORM: Topical Spray, (2mg+0.5mg)/ml

DESCRIPTION:

- Pafedin (lemon-flavored): clear, colorless homogeneous solution with lemon and alcohol aroma, sweet to taste.

- Pafedin (menthol): clear, colorless homogeneous solution with menthol, eucalyptus and alcohol aroma, taste sweet.

COMPOSITION:

1 ml of Pafedin spray (lemon flavor) contains:

Active substance: chlorhexidine digluconate (in a form of chlorhexidine digluconate solution) - 2 mg, lidocaine hydrochloride - 0.5 mg.

Excipients: glycerin, anhydrous ethanol, sucralose, citric acid monohydrate, flavoring agent “Lemon”, purified water.

1 ml of Pafedin spray (with menthol) contains:

Active substance: chlorhexidine digluconate (in a form of chlorhexidine digluconate solution) - 2 mg, lidocaine hydrochloride-0.5 mg.

Excipients: glycerin, anhydrous ethanol, sucralose, citric acid monohydrate, eucalyptus oil, levomenthol, purified water.

PHARMACOTHERAPEUTIC GROUP

Products for treatment of larynx and pharynx disorders. Antiseptics.

ATX code: R02AA20

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Lidocaine hydrochloride is a peripheral local amide type anesthetic. It possesses a superficial analgesic effect.

Chlorhexidine is a cationic bisbiguanide antiseptic. It is active against Gram-positive (Micrococcus spp., Staphylococcus spp., Streptococcus spp., Bacillus spp.) and to a lesser extent - against Gram-negative microorganisms, mainly on their vegetative form (it has no effect on spores at normal temperatures). It also has antimycotic effect against dermatophytes and fungi. It rapidly reduces infectivity of some lipophilic viruses (e.g., influenza virus, herpes virus, HIV). At low concentrations the drug product is bacteriostatic and at high concentrations - bactericidal.

PHARMACOKINETICS:

Chlorhexidine

In case of oral and topical use chlorhexidine absorption is low. Chlorhexidine binds well with proteins in saliva. Chlorhexidine does not accumulate in the body. It is metabolized at a very little extent.

Lidocaine

Lidocaine absorption is variable; it depends on place and method of its application. In healthy adults after application of 2% solution for the mouth lidocaine is not detected in plasma. In children, as well as in immunocompromised adults, lidocaine is reabsorbed into plasma through the oral mucosa.

At local application Lidocaine anesthetic effect appears in 2-5 minutes and lasts for 30-45 minutes.

Lidocaine is well distributed in tissues (kidneys, lungs, liver, heart, adipose tissue). Lidocaine penetrates through the blood-brain barrier and the placenta and is excreted into breast milk.

Lidocaine undergoes primary metabolism in the liver.

INDICATIONS FOR USE:

For short-term symptomatic and local pain treatment in infectious-inflammatory diseases of oral cavity and pharynx (pharyngitis, tonsillitis, stomatitis, gingivitis) in adults and children above 6 years old

CONTRAINDICATIONS:

- Hypersensitivity to the active or auxiliary substances of the drug product or amide local anesthetics;

- Significant area of lesions (ulcers, erosions) of oral cavity and pharynx mucous membrane;

- Children under 6 years old.

Menthol spray is not recommended for patients with bronchial asthma or other respiratory diseases with marked respiratory tract hypersensitivity due to the risk of bronchospasm.

UNDESIRABLE EFFEC*:

When applied topically in oral cavity and throat for short period and in recommended doses, the drug product is well tolerated. Gastrointestinal tract disorders: nausea, vomiting, abdominal pain, etc.

Immune system disorders: hypersensitivity skin reactions or other skin reactions, as well as their combination.

Other undesirable reactions are also possible (for more detailed information please refer to the drug product instructions for use).

METHOD OF ADMINISTRATION AND DOSAGE*:

Adults: 3 to 5 consecutive nebulizer button presses; repeat 6 to 10 times daily.

Children above 12 years old: 3-5 consecutive nebulizer button presses; repeat 6 to 10 times a day.

Children 6 to 12 years old: 2-3 consecutive nebulizer button presses; repeat 3 to 5 times a day.

PRECAUSIONS*:

Cross-allergy to lidocaine hydrochloride may occur in case of allergy to other amide local anesthetics.

In case of serious allergy, this drug product should be stopped. In case of mucosal lesions, the drug product should not be used, because it may interfere with the healing process of these lesions. Repeated use of this drug product may cause numbness in the area of the tongue root area and pharynx and difficulty in swallowing.

Caution should be exercised when using this drug product in patients with congestive heart disease or impaired liver function, as well as in concomitant use with lidocaine analogs (class I antiarrhythmic drugs), as in such cases there may be an increase in undesirable effect of lidocaine.

EFFECT ON ABILITY TO DRIVE AND OPERATE MACHINERY:

The drug product does not affect or very slightly affects the ability to drive and operate machinery.

USE IN PREGNANCY AND LACTATION*:

Disturbances of pharmacokinetics and (or) pharmacodynamics of lidocaine in pregnancy may be the cause of toxic effects. There have been no reliable and controlled studies of chlorhexidine use during pregnancy.

Use of the spray during pregnancy and lactation is not recommended unless the expected benefit outweighs the risk.

INTERACTION WITH OTHER DRUG PRODUCTS*:

Lidocaine should not be used in combination with other disinfectant solutions containing heavy metals. Clinically insignificant interactions of lidocaine with the following drugs have been described: myorelaxants, other antiarrhythmic drugs, hydantoins (antiepileptic agents), epinephrine, opioid drugs, betablockers, cimetidine, and the antiarrhythmic drug mexiletine. Non-significant interactions have also been noted in patients with myocardial infarction caused by cocaine ingestion.

Pafedin should not be used concomitantly with cholinesterase inhibitors (e.g., neostigmine, distigmine, pyridostigmine) or with other medications used for the treatment of myasthenia gravis.

Solutions contained chlorhexidine are incompatible with certain soaps and other anionic substances such as alginates, tragacanth, insoluble powders such as kaolin and insoluble calcium, magnesium compounds that are often included in toothpastes. Due to this effect, at least 30 minutes gap should be maintained between the use of toothpaste and Pafedin chewable tablets intake.

STORAGE CONDITIONS:

Store at temperature not above 25°C. Keep out of reach of children!

SHELF LIFE:

5 years. Do not use after the expiration date indicated on the package.

PRESCRIPTION STATUS

Without prescription

*For more detailed information please refer to the instructions for medical use.

Manufacturer information

Foreign Production and Trade Unitary Enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, Smilovichi, Sadovaya street, 1, tel./fax: (+375) 17 240 26 35, е-mail: rebpharma@rebpharma.by, http://www.rebpharma.by.