Pharington
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARINGTON (PHARYNGTON)
Composition:
Active ingredients: 1 tablet contains chlorhexidine dihydrochloride 5 mg, ascorbic acid 50 mg;
Excipients: sugar, methylcellulose, talc, magnesium stearate, quinoline yellow (E 104), Ponceau 4R (E 124), orange flavoring.
Pharmaceutical form. Effervescent tablets for sucking.
Basic physicochemical properties: flat cylindrical tablets with bevelled edges, pale orange in color. Speckles on the tablet surface are permissible.
Pharmacotherapeutic group. Preparations used in throat diseases. Antiseptics. ATC code R02A A.
Pharmacological Properties
Pharmacodynamics
Pharyngton is a combined medicinal product consisting of two components. Chlorhexidine exerts its antibacterial effect by nonspecific binding to phospholipids of the bacterial cell membrane, where chlorhexidine inhibits dehydrogenase and ATPase activity and disrupts membrane permeability for potassium, nucleotides, and amino acids.
Chlorhexidine acts as a bacteriostatic agent at low concentrations (less than 20 mg/L) and as a bactericidal agent at high concentrations. Its action is primarily directed against gram-positive microorganisms and Candida albicans, and to a lesser extent against gram-negative microorganisms. Chlorhexidine is particularly effective against Streptococcus mutans, Streptococcus salivarius, Escherichia coli, Selenomonas, anaerobic bacteria, and Candida albicans. It is less effective against Streptococcus sanguis, Proteus, Pseudomonas, Klebsiella, and Veillonella species.
Ascorbic acid reduces inflammation and edema of the mucous membranes of the mouth and nasopharynx, enhances immune response, and acts as a cofactor in collagen synthesis and tissue regeneration.
Pharmacokinetics
Chlorhexidine is practically not absorbed through mucous membranes or skin. During sucking, chlorhexidine is gradually released from the tablets into saliva and binds to the mucous membranes of the oral cavity and tongue, from where it is subsequently released back into saliva, exerting its antibacterial effect. Chlorhexidine may be swallowed with saliva, but its absorption from the gastrointestinal tract is very low. Chlorhexidine is minimally metabolized in the liver and is excreted via bile into the intestine. Typically, about 90% of ingested chlorhexidine is excreted unchanged in feces.
Chlorhexidine concentration in body fluids can be measured by high-performance liquid chromatography with a detection sensitivity of up to 1 mg/L.
Ascorbic acid is well absorbed from the gastrointestinal tract. Its degree of binding to plasma proteins is approximately 25%. Ascorbic acid is metabolized to dehydroascorbic acid and oxalic acid and is primarily excreted in urine.
Clinical characteristics.
Indications.
Local treatment of symptoms of inflammation of the mucous membrane of the throat and larynx.
Contraindications.
Hypersensitivity to chlorhexidine or to any other component of the medicinal product.
Interaction with other medicinal products and other forms of interaction.
There are no reports of interactions with other medicinal products.
Special precautions for use.
The use of the medicinal product may temporarily cause a slight change in taste sensation, but taste perception fully returns within 4 hours after taking the medicinal product. It is recommended to take the medicinal product after eating.
Pharington should not be used for more than 14 days; on average, treatment duration is 5–7 days.
Due to the presence of sugar in the composition of the medicinal product, caution is advised when treating patients with diabetes mellitus or predisposition to dental caries.
Prolonged use of Pharington may cause slight, temporary discoloration of teeth and tongue. These effects are reversible upon discontinuation of the medicinal product, but medical advice may be needed to resolve them.
Occasionally, patients with gastrointestinal disorders and/or liver diseases may experience nausea, vomiting, and belching. If these symptoms occur, the medicinal product should be discontinued.
Use during pregnancy or breastfeeding.
Studies on the effects of chlorhexidine during pregnancy have not been conducted. Animal studies using doses many times higher than those potentially received by humans during chlorhexidine use showed no embryotoxic effects. Nevertheless, pregnant women should consult a physician before using this medicinal product.
It is not known whether chlorhexidine passes into breast milk.
Ascorbic acid is excreted in breast milk. A breastfeeding woman should consult a physician before taking Pharington.
Ability to affect reaction speed when driving or operating machinery.
The medicinal product is completely safe and does not impair the ability to drive or operate complex machinery.
Dosage and Administration.
For adults and children aged 12 years and older: suck one tablet four times daily (every 6 hours).
The tablet should be taken after eating and after tooth brushing.
It is recommended not to rinse the mouth or drink large amounts of liquid within 2 hours after sucking the tablets.
Children. Recommended for children aged 12 years and older.
Overdose.
The medicinal product is practically not absorbed from the gastrointestinal tract; therefore, overdose is highly unlikely. In case of a possible overdose, clinical evaluation and symptomatic treatment are required.
Adverse reactions.
Possible allergic reactions, including nasal congestion, skin rash, oral mucosa desquamation, parotid gland swelling. Taste alterations, increased dental plaque, discoloration (brown stains) on teeth, fillings and dental prostheses, irritation or inflammation of the oral mucosa, gastric mucosa irritation and diarrhea may occur.
The medicinal product contains the dye Ponceau 4R (E 124), which may cause allergic reactions in sensitive individuals.
Shelf life. 3 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets per blister; 2 blisters per carton.
Supply category. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and place of business.
38 Kopilivska Street, Kyiv, 04073, Ukraine.
Web-site: www.vitamin.com.ua.