Rodogyl Sanofi medicine for sinus infections (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Metronidazole, Spiramycin

Ingredient

Composition information	Content
Metronidazole	125mg
Spiramycin	750,000iu

Uses

indications

Rodogyl drugs are indicated in the following cases:

Treatment of acute, chronic or recurrent oral sinus infections: tip - tooth truck, inflammation, lower skin tissue inflammation, inflammation around the body of the tooth, gingivitis, stomatitis, periodontitis, ear salivary glands, under the lower jaw. Minh.

Dynamic pharmacokinetics

spiramycin

absorption

Spiramycin is quickly absorbed but not completely. Food does not affect this absorption. After drinking 6 miu, the maximum concentration in the serum is 3.3 μg/ml.

Distribution

Spiramycin does not go into the cerebrospinal fluid. The drug is secreted into breast milk. Low plasma protein binding ratio (10%). The drug is well distributed in saliva and tissues (lungs: 20 - 60 μg/g, tonsils: 20 - 80 μg/g, sinuses are inflamed: 75 - 110 μg/g, bone: 5 - 100 μg/g). Ten days after stopping treatment, the active ingredient is still present in the liver, spleen and kidneys is 5 - 7 μg/g. Macrolide penetrates and accumulates in macrophages (neutral leukocytes, single -blood leukocytes, peritoneal macrophages and alveoli). In humans, the drug has high concentrations in the phagocytes. These properties explain the effects of macrolide on intracellular bacteria.

Metabolism

Spiramycin is metabolized in the liver, resulting in the formation of active metabolites but unknown chemical structure.

Elimination

The amount of excretion in urine accounts for 10% of the dose. The rate of excretion in bile is high, the concentration is 15-40 times the concentration in plasma. A significant amount of spiramycin can be found in the feces. Selling time in plasma is about 8 hours.

metronidazole

absorption

After drinking, Metronidazole is absorbed quickly, at least 80% within an hour. The peak concentration in plasma is measured after drinking similar to the concentration after intravenous injection at the equivalent dose. Oral bioavailability is 100% and not affected by food. About an hour after taking a single dose of 500 mg, the maximum concentration in serum average is 10 μg/ml. After three hours, the average concentration in serum is 13.5 μg/ml.

Distribution

The ratio of plasma protein binding is less than 20%. The volume of apparent distribution is large (about 40 l or 0.65 l/kg). The drug is rapidly distributed at a high rate, with concentrations in the lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, semen and vaginal secretions similar to serum concentration. Metronidazole passes through the placenta and is secreted into breast milk.

Metabolism

occurs mainly in the liver. There are two main compounds formed by oxidation:

Metabolic substances "main metabolites) have bactericidal, anti -anaerobic bacteria that are approximately 30% of the activity of Metronidazole, the half -life is about 11 hours.

Acid metabolites with less amounts, with bactericidal activity approximately 5% of the activity of Metronidazole.

Elimination

High levels of liver and bile. Low intestinal concentration. Excretion in stool is also low. The drug is excreted mainly through the urinary tract because Metronidazole and oxidative metabolites in urine account for about 35-65% of the dose. The half -life of Metronidazole in plasma is 8 - 10 hours.

Before taking Rodogyl Sanofi medicine for sinus infections (2 blisters x 10 tablets)

How to use

oral medication.

Dosage

Treatment of acute, chronic oral sinus infections or recurring

Adults

4 - 6 capsules/day (3 - 4.5 million IU Spiramycin and 500 - 750 mg of metronidazole), divided into 2 or 3 drinks at meals. In severe cases, the dose can be increased to 8 capsules a day.

Children

6 - 10 years old: 2 capsules/day (1.5 million IU Spiramycin and 250 mg Metronidazole).

10 - 15 years old: 3 tablets/day (2.25 million Lu Spiramycin and 375 mg of metronidazole).

Preventive prophylaxis of complications of infections after dental surgery - mouth

Adults

4 - 6 capsules/day, divided into 2 or 3 drinks at meals.

Children

6 - 10 years old: 2 capsules/day.

10 - 15 years old: 3 capsules/day.

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 do

do when overdose? If an overdose occurs, symptomatic treatment should be treated.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

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

spiramycin

Gastrointestinal: stomach pain, nausea, vomiting, diarrhea and some very rare cases of fake colitis.

Skin: Rash, urticaria, itching. Very rare cases of Quincke, anaphylaxis, red pus skin.

Central and peripheral nerves: Sometimes it occurs.

Liver: Very rare cases of abnormal liver function test results.

Hematology: A very rare case of hemolytic anemia.

metronidazole

Gastrointestinal: benign digestive disorders (epigastric pain, nausea, vomiting, diarrhea), tongue inflammation with a feeling of dry mouth, stomatitis, mouth with metal taste, anorexia, rare, pancreatitis can recover when stopped treatment.

Skin: Fire, itching, rashes, sometimes fever, urticaria, railing, rare can occur anaphylactic shock.

Central and peripheral nerves: headache, peripheral sensory nerve, convulsions, dizziness, ventricular.

Mental: confused, hallucinations.

Hematology: Very rare cases of neutropenia, grain leukemia and thrombocytopenia.

Liver: A very rare number of cases of liver dysfunction but can recover, bile hepatitis.

Urine can be reddish brown because of water -soluble pigments due to drug metabolism.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

contraindicated

Rodogyl drugs contraindicated in the following cases:

allergies to drugs IMidazole, Spiramycin and/or any excipients.

Children under 6 years old, because they are not suitable for this form of preparation.

Rodogyl is often not recommended in combination with disulfiram, alcohol and alcoholic drugs.

Be cautious when using

If the skin is suspected of red pus skin in a patient with a body red, fever combined with pustules occurs at the beginning of treatment, it is necessary to stop treatment and later do not use Spiramycin, whether it is lonely or combined.

Avoid alcoholic beverages (because of the disulfiram effect).

Must stop treatment if there is a ventricular, dizziness or mental confusion.

Because the drug contains metronidazole, it is necessary to consider the risk of severe nervous condition in patients with serious, chronic or progressive patients in the central or peripheral nervous system.

Because the drug contains sorbitol, it should not be used in patients with fructose intolerance.

Very rare cases of hemolytic anemia have been reported in patients with glucose - 6 - phosphate dehydrogenase, spiramycin is not recommended in these patients.

On patients with a history of hematological disorders, patients are taking high doses and/or prolonged treatment, should regularly test blood tests, especially leukocytes.

In case of leukopenia, the continued treatment depends on the severity of the infection.

In the case of prolonged treatment, it is necessary to monitor the appearance of signs that suggest adverse effects of central or peripheral neuropathy (abnormal, ventricular, dizziness, convulsions).

The ability to drive and operate machinery

should warn patients about the risk of dizziness, confusion, hallucinations or convulsions and advice not to drive or operate machinery if these disorders occur.

Pregnancy

If necessary, this drug can be used during pregnancy, regardless of the stage.

metronidazole

Clinically, analyzing a large number of cases of exposure pregnancy indicates that it does not have the effect of giving birth or toxic to any specific pregnancy due to Metronidazole. However, only epidemiological studies can verify that it is not at risk. Animal studies do not show evidence of monitoring effects on metronidazole.

spiramycin

If necessary, it is possible to consider using Spiramycin during pregnancy. Indeed, the use of spiramycin is spacious during pregnancy does not show the effect of monster or toxicity for any associated with this drug.

The period of breastfeeding

Because Metronidazole and Spiramycin are excreted in breast milk, do not use this medication during breastfeeding.

Drug interaction

Spiramycin

The coordinates need to consider

Levodopa (in combination with Carbidopa): Carbidopa's absorption is inhibited with reduced levodopa levels in plasma. Clinical parameters should be followed and adjusted the levodopa dose, if necessary.

metronidazole

The combination should not be used

disulfiram: acute, confused state.

Alcohol: The effect is like disulfiram (hot, blushing, vomiting, fast heartbeat). Avoid using alcoholic drinks and alcoholic drugs.

Cautions should be cautious when using

Oral anticoagulant: Increases the effects of oral anticoagulants and/or increases the risk of bleeding, due to hypothermia. Prothrombin should be checked more often and monitor Inr. Adjusting the oral anticoagulant dose should be adjusted during this treatment and 8 days after the treatment.

The coordinates need to consider

fluorouracil: Increased fluorouracil toxicity due to clearance reduction.

Special issues associated with Inr imbalance

Many cases of increased oral anticoagulant activity have been reported in patients who are treating antibiotics. Infections and severe inflammation, age and total patient's condition seem to be risk factors. In these cases, it is difficult to determine where the infection or the treatment of infections affect Inr imbalance. However, there are a number of antibiotic groups or more related to this issue, especially fluoroquinolone, macrolide, cycline, cotrimoxazole and some cephalosporins.

interact with subclinical tests

Metronidazole can make treponema motionless and lead to false positive in Nelson test.

Storage

Store at a temperature not exceeding 30ºC.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.