Dorogyne f domesco medicine treats acute and chronic dental infections (2 blisters x 5 tablets)

Dosage form Box of 2 blisters x 5 tablets
Specifications Spiramycin, metronidazole

Ingredient

Composition information	Content
Spiramycin	1,500,000iu
Metronidazole	250mg

Uses

indications

Drogyne f is indicated in the following cases:

Acute, chronic or recurrent dental infections such as tooth abscess, inflammation, cellar inflammation around the jaw bone, inflammation around the body of the tooth, gingivitis, periodontitis, stomatitis, otitis gland inflammation, jaw inflammation. Combination between antibiotic spiramycin macrolid and metronidazole antibiotic group 5-nitroimidazol, special treatment of dental infections.

spiramycin

Spiramycin is an antibiotic macrolid. The drug has the effect of pliers in bacteria that are dividing cells. The mechanism of action of the drug is the effect on the subuniters of 50S of bacterial ribosom and prevent protein synthetic bacteria. In serum concentrations, the drug has the main effect of bacteria, but when high concentration, the drug can kill slowly for sensitive bacteria

In places where the drug level is very low, Spiramycin has a resistance to Gram -positive strains, coccus strains such as Staphylococcus, Pneumococcus, Meningoccus, most Gonococcus strains, 75 % Streptococcus and Enteroccus. The strains of Bordetella Perussis, Coryenebacteria, Chlamydia, Actinomyces, some Mycoplasma and Toxoplasma strains are also sensitive to Spiramycin. Spiramycin does not work with Gram -negative intestinal bacteria. There has also been a notice of bacterial resistance to spiramycin, including cross -resistance between Spiramycin, erythromycin and oleandomycin.

metronidazol

Metronidazol is a 5-nitroimidazol derivative, with a broad spectrum on protozoa such as amoeba, giardia and anaerobic bacteria.

The mechanism of action of Metronidazol is not very clear. In bacterial or protozoa cells, the 5-nitro group of the drug is reduced by nitroreductuctase of bacteria into toxic mediators to the cell. These substances are associated with the twisted structure of the DNA molecule to stop the copy process, eventually causing the cell to die. In vitro research shows a few factors that affect the sensitivity of bacteria with drugs, especially anaerobic conditions of the culture medium. Metronidazol may inhibit E. coli in the presence of B. Fragilis and increase the bactericidal rate with B. Fragilis when the environment has E. coli.

Metronidazol has an anti -inflammatory effect with an unknown mechanism.

Effective spectrum: In general, Metronidazol works with most anaerobic bacteria and many types of protozoa. The drug is also toxic to both oxygen -deficient cells or reducing oxygen consumption. Metronidazole does not work with fungi, viruses and most anaerobic and anaerobic bacteria (arbitrary).

pharmacokinetic

spiramycin

absorption

Spiramycin is not completely absorbed from the digestive tract and is reduced when used with food. Oral dose is absorbed about 20-50 %. Food reduces about 70% of the maximum concentration of the drug in serum and makes the peak time from 2 hours later than when they are hungry.

Distribution

After taking 6 M.I.U Spiramycin, the plasma peak concentration is 3.3mcg/ml after 1.5 - 3 hours. The drug attaches to plasma proteins ranges from 10 - 28%. Selling time is about 5 - 8 hours. If 8 hours for 1 dose of 1.5 M.I.U, the stable state is achieved at the end of the second day. Peak concentration (CPEAK): 3MCG/ml; Ctrough (bottom concentration): about 0.5mcg/ml.

widely distributed drugs into tissues (lungs: 20 - 60mcg/g, tonsils: 20 - 80mcg/g, sinusitis: 75 - 110mcg/g, bone: 5 - 100mcg/g). The drug reaches high concentrations in the lungs, tonsils, bronchial and sinuses. The drug does not go through the blood -brain barrier, but through the placenta and the breast milk. 10 days after stopping treatment, the spleen, liver and kidneys are about 5 - 7mcg/g of active medicine. Macrolid antibiotics penetrate and accumulate in cells (neutral polymorphic leukocytes, single -blood leukocytes, peritoneal, lungs). High concentration in humans. This property explains the effects of macrolids on intracellular bacteria.

Metabolism

Spiramycin metabolizes the liver into active metabolites.

Elimination

Most of the excretion of bile and about 10% into the urine. Spiramycin also eliminates partially into the feces.

metronidazol

absorption

Metronidazole often absorbs fast and completely after drinking. About 80% of the dose is absorbed from the gastrointestinal tract. After taking a single dose of 500mg, the peak concentration of plasma reached about 11.5 - 13mcg/ml for 1-3 hours. There is a linear correlation between the dose and plasma concentration in the range of 200 - 2000mg.

Distribution

Metronidazole well distributed into tissues and fluid fluid, including bones, bile, saliva, amniotic fluid, peritoneal fluid, genital secretion, cerebrospinal fluid and red blood cells. The concentration of the medication in cerebrospinal fluid reaches approximately 43 % of plasma concentrations in case the meninges are not inflamed and equivalent to inflammation. The drug can be through the placenta and into the milk with a concentration of a plasma concentration. About 20% of drugs associated with plasma protein.

Metabolism

About 30-60 % of the metronidazol dose of oral metabolism in the liver. into hydroxy and glucuronid metabolites. 2-Hydroxy metabolites also have pharmacological effects on bacteria and protozoa.

Elimination

In people with normal liver and kidney function, the average selling time of Metronidazol in plasma is about 6 - 8 hours and hydroxy metabolites are about 9.5 - 19.2 hours. The sale time is not affected when the renal function is impaired, may be prolonged when the liver function is reduced (may be up to 10.3 - 29.5 hours). Over 90 % of oral doses are eliminated through the kidneys within 24 hours, mainly in the form of metabolites and less than 10 % in the form of unprocessed. About 14% of the dose of elimination through feces. Metronidazole may be removed from the body with a hemorrhage, but ineffective when the abdominal fate.

*Diffusion into the tissue tissue: Two active ingredients in the tablet concentrated in saliva, gums and alveolar bones.

Before taking Dorogyne f domesco medicine treats acute and chronic dental infections (2 blisters x 5 tablets)

How to use

Take oral, take medicine at meals.

Dosage

Adults and children over 15 years old

Take 2-3 capsules/day, divide 2-3 times. In severe cases, 4 capsules may be used.

Preventing postoperative infections

adults and children over 15 years old

Take 2-3 tablets/day, divide 2-3 times.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Related to Spiramycin: It is unknown toxic spiramycin dose. When using high doses, it may cause digestive disorders: nausea, vomiting, diarrhea. Prolonged QT can be encountered, gradually stopping when stopping treatment (encountered in newborns taking high doses or in adults intravenously at risk of extending QT).

Related to Metronidazol: The report of Metronidazol overdose when taking a single dose of 15g. Symptoms include nausea, vomiting and loss of air conditioning, peripheral neuropathy, epilepsy. Neurotic effects such as convulsions, peripheral neuropathy have been reported after 5 to 7 days of dosage 6 - 10.4g 2 days/time.

How to overdose

In case of spiramycin overdose, the electrocardiogram should be used to measure the QT interval, especially when accompanied by other risks (reducing potassium, QT interval, congenital prolonged, combined with drugs that extend the QT interval or cause torsion). There is no specific antidote for Spiramycin or Metronidazol. In case of overdose, symptomatic treatment.

What to do when you forget 1 dose? If you forget to take a dose, drink as soon as you remember. If the time is close to the next medication, skip the forgotten dose and take the next dose at the usual time. Do not use double to compensate for the forgotten dose.

Side Effects

When using Drogyne F, you may experience unwanted effects (ADR).

Gastrointestinal disorders such as stomach pain, nausea, vomiting, diarrhea.

Allergic reactions: urticaria.

Summary of unwanted reactions:

Agencies frequency (*) Unwanted reactions

Digestive common nausea, diarrhea, indigestion Meet tired, nosebleed, sweating, feeling pressed chest. Temporary, disturbing, staggering, painful, muscular and joints. Heart rare extends the range of qt blood rarely leukopenia rarely DA rare Blister, skin, itchy, itchy Unexpectedly defined as follows: Very common (ADR> 1/10), common (1/100

Instructions on how to handle ADR

Stop treatment when dizzy, confused, loss of air conditioning. Check the white blood cell formula in people with hematopoietic disorders or high doses and prolonged treatment. Reduce the dose in people with severe liver failure. Symptomatic treatment if the reaction cannot be controlled.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Drogyne f anti -contraindications in the following cases:

Hypersensitivity to imidazol or spiramycin or any other ingredient of the drug.

Children under 15 years old.

disulfiram, alcohol (see in the drug interaction).

Caution should be used when used This case must be contraindicated to use Spiramycin.

Do not drink alcohol (effect like disulfiram).

Stop treatment when air conditioning, dizziness, mental disorders.

The drug contains metronidazol, the risk can worsen a mental state in people with central or peripheral, stable or progressive mental illness.

The very rare case of hemolytic anemia has been reported in patients with glucose-6-phosphate-dehydrogenase. Should not use Spiramycin for these patients.

Monitor the white blood cell formula in the event of a history of blood organs or treatment at high and prolonged doses. If leukopenia, the continuation of treatment depends on the level of infection.

Be cautious when using Spiramycin for people with liver dysfunction that can be toxic to the liver.

Be cautious for people with heart disease, arrhythmia (including people who tend to extend QT).

The ability to drive and operate machinery

The drug can cause potential risks such as dizziness, confusion, hallucinations or convulsions. Patients should not use drugs when driving, operating machinery, working on high and other cases.

Pregnancy

may consider taking drugs for pregnant women if necessary.

Metronidazol: Clinically, research on many pregnant women using metronidazol does not show teratogenic or toxic to embryos. Animal research shows that Metronidazol has no teratogenic effect.

Spiramycin: Spiramycin may be considered for use during pregnancy if necessary. So far, the use of spiramycin for pregnant women has not shown teratogenic or toxic to the embryo.

Breastfeeding period

metronidazol and Spiramycin through breast milk, thus avoiding the use of drugs during breastfeeding.

Drug interaction

involving Spiramycin:

Using Spiramycin simultaneously with oral contraceptive medicine will lose the effect of contraception.

spiramycin reduces the concentration of levodopa in the blood if used simultaneously.

Spiramycin is small or does not affect the cytochrom P450 enzyme system in the liver, so compared to erythromycin, Spiramycin has less interactive with drugs metabolized by this enzyme.

Related to Metronidazol:

With anticoagulants Coumarin: Metronidazole can increase the effect of oral anticoagulants, especially warfarin that extends prothrombin time, so avoid simultaneous use or must monitor prothrombin time or adjust the dose of anticoagulants if needed.

Alcohol and drugs containing alcohol: Metronidazole inhibits alcohol oxidation enzymes and alcohol dehydrogenase causing Disulfiram reaction. Therefore, do not drink alcohol or simultaneously use alcohol -containing drugs during treatment with metronidazol. Do not simultaneously use metronidazol with disulfiram or medication must be used at the distance.

Phenobarbital: simultaneously use Metronidazol and Phenobarbital, increasing metronidazol metabolism, which is faster.

lithium: There have been a report on some toxic signs of lithium when taking Metronidazol for patients who are treating high doses of lithium and can cause lithium levels, so they need to be cautious and monitor the level of lithium when used simultaneously.

terfenadin and astemisol: Metronidazol can interact with terfenadin and astemisol when used simultaneously increases serious adverse reactions on the cardiovascular drugs of these drugs such as extending QT, arrhythmia, tachycardia ...

Therefore, it is necessary to be very careful and should not be used simultaneously these antihistamines for patients who are taking drugs with Itraconazole structure, ketoconazole, including metronidazol.

Fluorouracil: Increasing the toxicity of fluorouracil due to reduction of clearance.

cimetidin inhibits metronidazol's liver metabolism, increasing the half -life of metronidazol, leading to ADR increase, so it is necessary to consider when used simultaneously.

Storage

In a dry place, temperatures below 30 ° C, avoid light.

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