NEOSEPT (benzidamine) 0.15% 30ml spray
Nonsteroidal anti-inflammatory mean.
International
name: Benzydamine.
Drug form: Oral spray for local use.
Composition:
Active substance: Benzydamine hydrochloride – 0,15 g/100ml.
Excipients: ethanol, methylparaben,
menthol, saccharin, glycerine, lemon oil, distilled water.
Pharmacological
operation: Benzydamine hydrochloride is a nonsteroidal anti-inflammatory
mean of indazol group, which is characterized by expressed anti-inflammatory,
analgesic and anti swelling action.
Mechanism of action of the drug is related to cellular
membrane stabilization and inhibition of prostaglandin synthesis.
Pharmacokinetics: For local
use, Benzydamine is well
absorbed from the mucous membrane and reaches in the inflammatory nidus.
Benzydamine hydrochloride metabolises in the organism
and is excreted via kidneys and gastrointestinal tract as metabolites.
Indications:
·
Inflammatory diseases of oral cavity and the throat:
tonsillitis, pharyngitis, laryngitis, tonsillitis, stomatitis, gingivitis,
glossitis (including after chemotherapy and radiation therapy);
·
After surgery and traumas (tonsillectomy, jaw fracture and etc.);
·
Pain and inflammation in case of tooth extraction or
other medical manipulations;
·
Candidiasis (into combination therapy);
·
Inflammation of calculous salivary glands;
·
Parodontosis.
Order of
administration and dosage: Raise the spray upright before use, aim
to inflammation place in the oral cavity and spray by pressing to doser.
Note: in case of
the first use of the vial, it is necessary to press the doser 2-3 times
additionally in order to fill up the spraying pipe.
For
adults and elderly: 2 sprays 4-8 times in a day, 1,5 - 3 hours interval;
Children from 6 to 12 years: 2 sprays
in 1,5 - 3 hours interval; 4 times in a day;
Children from 3 to 6 years: 1-2
sprays on each 4 kg of the body in 1,5 - 3 hours interval; maximum 4 times in a
day;
According to doctor’s prescription,
sequence
of drug use may increase up to 5 in case of need.
Treatment duration is 4-5 days. If
desired result hasn’t come in this period, doctor’s consultation is
necessary.
If necessary to spray to tonsils, spray of the left
and right side of the throat.
Side effects: Local
reactions: dry mouth, tissue numbness and/or feeling of burning in the oral
cavity.
Allergic reactions: rash on the skin
Vary rare – laryngospasm.
Special
warnings and precautions: In case of infectious-inflammatory disease,
the preparation is used into combination therapy.
If feeling of burn develops during
the use of preparation, the preparation should be diluted with water in
advance.
The preparation should be prescribed
safely at time of pregnancy and lactation.
When using a spray avoid spraying
into the eyes.
Contraindications: Additional sensitivity toward
the components compounding in the preparation.
Pregnancy and lactation: Use of spray is recommended during lactation and pregnancy.
Interaction with other medicines or other types of interactions: not detected.
Overdose: At present there
isn’t information about the overdose of Benzydamine.
Influence of vehicle and mechanisms management: Doesn’t influence on
ability of driving vehicle and mechanism.
Drug
package: 30ml solution in a dark orange colour polymeric material vial with spray.
The vial is placed in a carton box with using instruction.
Storage: Is kept
in a dark place, not more than 250C.
Drug
release form: Group of pharmaceutical product - III (without prescription).
Shelf
life: 2 years.
