Sansvigyl

Sansvigyl

Treatment of oral diseases such as tooth acute inflammation, chronic, or recurrent: abscessed tooth, swelling, inflammation of the tissues around the jaw teeth, inflammation around the tooth, bone infections, gingivitis, stomatitis ... Department inflammation after surgery.


Damaged pipe drug use :
 

SANSVIGYL

- Drug form : Film-coated Tablets .
 

- Composition : Each film coated tablet contains :
                                       
-------------------------------------- Acetylspiramycin 100mg
                                       
( Corresponding to 100000 units )
                                       
Metronidazole 125mg --------------------------------------------

                            
Excipients qs ............................................... ....................... 1 member

    
( Excipients include : lactose , starch , wheat starch , talc , sodium starch glycolate , gelatin , silicon dioxide , magnesium stearate , povidone , hydroxy propyl methyl cellulose , titanium dioxide, Nipagin , PEG 6000 , nipasol , color Erythrosine , Ponceau 4R color , purified water , 96 % ethanol ) .
 

- The pharmacodynamic characteristics :
* Acetylspiramycin : As monoacetat derivatives of spiramycin . The macrolide antibiotic spiramycin have similar antibacterial spectrum antibacterial spectrum of erythromycin and clindamycin . Drugs bacteriostatic effect on bacteria cell division . At the concentrations of serum bacteriostatic drugs work , but when drug concentrations in tissues can kill bacteria . Mechanism of action of the drug is the effect on the 50S subunit of the bacterial ribosome and preventing bacterial protein synthesis . The bacteria that cause dental disease often sensitive to Spiramycine such as Bordetella pertussis , Actinomyces , Corynebacteria , Chlamydia , Mycoplasma ...
* Metronidazole : As a result of 5 - nitro - imidazole , has broad activity in protozoa as histolytica , Giardia and the anaerobic bacteria . Mechanism of action of metronidazole is not yet clear . In parasites , 5 - nitro group of the drug was reduced to toxic intermediates cells . These substances associated with helical structure of the DNA molecule to break the fibers and cells eventually die . The average concentration of metronidazole is effective 8 micrograms / ml or less for most of the protozoa and bacteria sensitive . The bacteria that cause dental disease often sensitive to metronidazole , such as Clostridium , C.perfringens , Bifidobacterium bifidum , Eubacterium , Bacteroides fragilis ...
 

- The pharmacokinetic characteristics :

* Acetylspiramycin :
- Absorption : Spiramycin not completely absorbed in the gastrointestinal tract . Oral absorption is about 20-50 % of the dose . Peak plasma concentrations are reached within 2-4 hours after ingestion . Peak plasma concentrations after oral dose is 1g achieve 1 micrograms / ml . Peak blood concentration after a single dose can be maintained for 4 to 6 hours .

- Distribution : Spiramycin widely distributed throughout the body . High concentrations are achieved in the lungs , tonsils , sinuses and bronchi . Spiramycin little penetration into the cerebrospinal fluid . Drug concentrations in serum bacteriostatic effect in the range from 0.1 to 3.0 micrograms / ml and the concentration of drug in the tissue bactericidal effect in about 8-64 micrograms / ml . Oral spiramycin have distributed short half-life ( 10.2 ± 3.72 min ) .

- Elimination : The average elimination half-life is 5-8 hours. Drugs primarily excreted in bile . Drug concentrations in the larger density 15-40 times the concentration in the serum . After 36 hours only about 2 % of the dose found in the urine .

Metronidazole * :
- Absorption : Metronidazole is rapidly and completely absorbed after oral administration , reaching plasma concentrations of about 10 micrograms / ml for 1 hour after taking 500mg . Linear relationship between dose and plasma concentrations occur in the dose range from 200 - 2000 mg . Repeat dose every 6-8 hours will cause accumulation of the drug. Metronidazole half-life in plasma of approximately 8 hours and the volume of distribution is approximately the volume of body water ( 0.6 to 0.8 liters / kg ) . Approximately 10-20 % of the drug associated with plasma proteins .

- Distribution : Metronidazole good penetration into tissues and body fluids in saliva and breast milk . Also achieve therapeutic concentrations in the CSF are . Metronidazole is metabolized in the liver to form the hydroxy metabolite and acid , and excreted in the urine as a glucuronide . The metabolites are still somewhat medicinal effects .

- Elimination : The average elimination half-life in plasma of about 7 hours. Half-life of the hydroxy metabolite is 9.5 to 19.2 hours in patients with normal renal function . Over 90 % of an oral dose is excreted by the kidneys within 24 hours , mainly hydroxy metabolite ( 30-40 % ) , and type of acid ( 10-22 % ) . Less than 10 % excreted mother nature . Approximately 14 % of the dose excreted in the feces.
        
In patients with impaired renal function , half-life of mother nature does not change , but the half-life of the metabolite hydroxy lasts 4 to 17 times higher . Metronidazole metabolism can be affected when severe hepatic impairment . Metronidazole can be eliminated from the body by hemodialysis efficiency .
 

- Indications : Treatment of infections of the oral acute , chronic or recurrent , especially dental abscesses , inflammation , inflammation of the tissue around the bone , inflammation around the tooth root , gum disease , inflammatory benefit , stomatitis ... preventing infection following oral surgery .
 

- Usage and dosage: As directed by the physician . The average dose :
    
* Adults : Take 4-6 tablets / day , divided 2-3 times , at meal time . In severe cases , attacks can dose 8 tablets / day .
    
* Children 10-15 years: Take 3 tablets / day in 3 divided doses .
    
* Children 6-10 years: Take 2 tablets / day in 2 divided doses .
       
( This drug is only used in the physician 's prescription )
 

- Contraindications: Hypersensitivity to any of the ingredients of the medication . Children under 6 years of age . Women who are pregnant or lactating . Do not drink alcohol while taking the drug.
 

- Caution:
* Acetylspiramycin : People with liver dysfunction ( because the drug can cause liver toxicity ) .
Metronidazole * :
- Metronidazole may inhibit the enzyme alcohol dehydrogenase and other alcohol oxidation . Drugs have mild reactions such as flushing disulfiram type , headache , nausea , vomiting , abdominal cramping , and sweating .
- Metronidazole can cause Treponema pallidum estate create false positive reactions Nelson of legal experience .
- Use high-dose treatment of anaerobic infections and treat diseases caused by amoebas and giardia can cause blood disorders and visceral neuropathy can operate .
 

- Unwanted effects of drugs :
* Acetylspiramycin : Rarely cause unwanted effects seriously .
- Common : Gastrointestinal ( nausea , vomiting , diarrhea , dyspepsia ) .
- Less common : whole body ( fatigue , nosebleeds , sweating, feeling of chest compression ) . Temporary paresthesia , feeling disorders , groggy , sore , stiff muscles and joints , burning sensation . Gastrointestinal ( acute colitis ) . Skin ( The skin rash , urticaria ) .
- Rarely: Body ( anaphylactic reaction , multiple infections due to prolonged use oral spiramycin ) .
* Metronidazole : unwanted effects often depends on the dose . When high doses and long term adverse effects increases . Undesirable effects when taking metronidazole most common are nausea , headache , loss of appetite , dry mouth , metallic taste very unpleasant . The other undesirable reactions in the digestive tract of metronidazole are nausea , diarrhea , epigastric pain , abdominal pain , constipation . The undesirable effects on the gastrointestinal tract occurs approximately 5-25 % .
- Common : Gastrointestinal ( nausea , vomiting , anorexia , abdominal pain , diarrhea , unpleasant metallic taste )
- Less common : blood ( leucopenia ) .
- Rare : blood ( agranulocytosis ) . CNS ( seizure , disease peripheral polyneuropathy , headache ) . Skin ( skin blistering , skin rash , itching ) . Urology ( dark urine ) .
 

* Note : " Inform your physician about any adverse effects encountered when using drugs ."
 

- Interaction with other drugs , and other forms of interaction :
* Acetylspiramycin : Use acetylspiramycin concurrently with OCs will take effect pregnancy prevention .
Metronidazole * :
- Metronidazole pills increase the effect of anticoagulants , especially warfarin , thus avoiding at the same time .
- Metronidazole disulfiram effects model . So do not take this medicine at the same time 2 to avoid toxic effects on nerve as psychosis , confusion .
- Concomitant administration of metronidazole and phenobarbital increase the metabolism metronidazole metronidazole should be eliminated faster .
- Use metronidazole for patients who had high blood levels of lithium ( lithium is due ) will make the serum lithium concentration increases, toxicity .
- Metronidazole increases effect of vecuronium is a non- depolarizing muscle relaxants .
 

- Overdoses :
* Acetylspiramycin : No report .
* Metronidazole : Metronidazole to take a single dose of 15 g has been reported . Symptoms include nausea , vomiting and ataxia . Neurotoxic effects include convulsions , peripheral neuritis have been reported after 5 to 7 days to 2 g doses of 6 to 10.4 days / times .
- Treatment : No specific antidote . Symptomatic treatment and support .
 

- Shelf-life: 36 months from date of manufacture . Do not use the medicine after the expiry date .
* Note: When you see the pill is moldy , stained spots in the prescription label batch production , HD dim ... or other suspicious symptoms must be brought to the facility where drug sales or production at the address where in the application .
 

- Packing : Box 2 pack x10 party.
 

- Storage: dry , temperatures below 300C .
 

- Applicable standards : TCCS .

- REGISTRATION NUMBER : VD- 18731-13

No designated overdose

Keep out of reach of children.
" Read the manual before use "
If you need additional information , please consult a doctor "


 


Drugs manufactured in : pharmaceutical company in Ha Tay
La Khe - Ha Dong - Ho . Hanoi
Tel : 04.33522203-33516101 . FAX : 04.33522203

Distributed by :
Eu Medipharm France., JSC
202A - Thuy Linh - Hoang Mai - Linh Nam - Ha Noi

Business office :
No. 5 Urban Lot 4 B II - Q.Hoang Mai Den Lu , Hanoi .
:04.363.42.523 Tel - Fax : 04.363.42 . 522
 

Representative office in HCMC . HCM
No. 14/12 Cu Chinh Lan - P. 13 - Q . Tan Binh - TP . HCM
Tel : 08-62746954 Fax : 08-38130272

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