Hemomycin is a group of antibiotics. Suspension "Hemomycin" for children: instructions for use

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases must be carried out under the supervision of a specialist. All drugs have contraindications. Consultation with a specialist is required!

Antibiotic Hemomycin

Hemomycin- a drug from the group antibiotics-azalides, which have a pronounced bacteriostatic effect. The active ingredient of the drug is azithromycin. Its effect on microorganisms leads to a stop in protein synthesis in the microbial cell. If the protein is not synthesized, the microbe cannot grow and reproduce. In high doses, Chemomycin can have a bactericidal (destructive to bacteria) effect.

Staphylococci, streptococci, gonococci, meningococci, and listeria are sensitive to Hemomycin. The drug is active against intrapulmonary microorganisms that cause atypical pneumonia: legionella, mycoplasma, chlamydia. The antibacterial activity of Hemomycin is 4 times higher than the activity of Erythromycin. If a microorganism is resistant to Erythromycin, it will also be resistant to Hemomycin.

Hemomycin can also destroy intracellular pathogens and Haemophilus influenzae.

Chemomycin is well absorbed from the digestive tract, its bioavailability reaches 37%. After taking the medicine orally, the concentration of the drug in the blood reaches its maximum after 3 hours. The antibiotic easily penetrates the tissues of the respiratory and genitourinary organs. Blood cells, macrophages, capture the active substance of the drug, transfer it directly to the site of inflammation and release it there. A third of the drug is metabolized in the liver, the remaining amount is excreted unchanged in bile and urine within 3 days.

Release forms

Chemomycin is available in film-coated tablets, in blue capsules, in powder in bottles for the preparation of a suspension, in lyophilized powder in bottles for the preparation of an infusion solution.

• 1 capsule of Hemomycin contains 250 mg of azithromycin, as well as excipients.
• 1 tablet of the drug contains 500 mg of active ingredient, MCC, magnesium stearate, talc, etc.
• 5 ml of the finished suspension contains azithromycin dihydrate in the amount of 100 or 200 mg.
• A vial of azithromycin lyophilisate for infusion contains 500 mg of the drug.

Dosage forms for oral administration are available in blisters: tablets - three pieces, capsules - six pieces in a blister. The blister is packed in a cardboard box. Lyophilisate and powder for preparing the suspension are available in bottles packaged in carton boxes. A measuring spoon is included with the bottle of suspension powder.

Instructions for use of Hemomycin

Indications for use

The antibiotic Hemomycin is used for the following diseases:

• infections of the upper and lower respiratory tract: tonsillitis, sinusitis, otitis, pneumonia, bronchitis;
• urogenital infections (urethritis, cervicitis);
• skin infections;
• soft tissue infections;
• borreliosis (Lyme disease);
• mycoplasmosis, chlamydia;
• stomach diseases associated with the presence of Helicobacter pylori, etc.

Contraindications

Hemomycin is contraindicated in:

• serious arrhythmias;
• hypersensitivity to macrolides;
• women during lactation.

For children, the possibility of prescribing the drug is determined depending on age. A suspension at a dose of 100 mg/5 ml is contraindicated in newborns under the age of 6 months, a suspension at a dose of 200 mg/5 ml is contraindicated in children under the age of one year, tablets and capsules are contraindicated in children under the age of 12 years.

Side effects

Chemomycin is one of the least toxic antibiotics.

• Most often it side effects manifest themselves in the form of mild dyspeptic disorders: nausea, vomiting, constipation or diarrhea, flatulence, loss of appetite. Due to stagnation of bile, jaundice may occur.
• Possible allergic reactions from the skin (dermatoses, itching, urticaria); from the eyes: conjunctivitis; very rarely anaphylaxis or angioedema.
• The cardiovascular system can react with tachycardia, rhythm disturbances, and pain in the heart area.
• Nervous system – dizziness, headache, irritability, excitability or lethargy, sleep disturbances, anxiety.
• Occasionally, candidiasis (fungal diseases) of the mucous membranes occurs.

Hemomycin has photosensitizing activity, so you should avoid direct sunlight while taking it.

Treatment with Hemomycin

How to take Hemomycin?
The antibiotic is taken between meals and at a two-hour interval before and after taking antacid medications. The tablet or capsule is swallowed whole with water.

To prepare the suspension, add boiled water to the mark in the bottle, shake the mixture well. After taking the suspension, the oral cavity should be rinsed, getting rid of any remaining antibiotic to prevent the occurrence of thrush on the mucous membrane.

If you miss another dose, you must take the medicine as quickly as possible. The next medication intake should be on schedule as usual - at 12-hour or daily intervals.

An infusion solution is prepared and administered to patients in the form of intravenous drips into medical institutions trained personnel.

When treating with Hemomycin, you should not drink alcohol.

Dosage
For respiratory tract infections, the dose of Hemomycin for adults and children over 12 years of age is 500 mg (1 tablet or 2 capsules) 1 time per day orally for 3-6 days, depending on the severity of the disease.

For infections of the skin and soft tissues, for borreliosis (Lyme disease), take 4 capsules (1 g) on ​​the first day, then 2 capsules (500 mg) per day for 4 days.

For uncomplicated urethritis and cervicitis, 1 g (2 tablets or 4 capsules) is prescribed once.

For severe pelvic infections it is used in complex treatment once, administering 500 mg of the active substance intravenously.

To combat Helicobacter in peptic ulcers and chronic gastritis, the drug is used for 3 days, taking 1 gram daily.

To treat pneumonia, the drug is most often used intravenously by drip for several days at the beginning of treatment, and then the course is extended to 10 days using tablets or capsules.

Hemomycin for children

A suspension of 100 mg/5 ml is prescribed to children from 6 months, a suspension of 200 mg/kg from one year, tablets and capsules from 12 years. The dose is calculated taking into account the child’s weight.

• For infections of the respiratory system and diseases of the ENT organs, the dose is calculated at 10 mg/kg of the child’s weight per day. The course of treatment is 3 days.
• For skin diseases, on the first day, Hemomycin is prescribed at a dose of 20 mg per 1 kg of the child’s weight, and then over the next 4 days, 10 mg/kg of the child’s weight.
• For genitourinary pathology, the drug is prescribed at a dose of 10 mg/kg body weight once.
• If the child weighs more than 45 kg, an adult dose is prescribed.

Use during pregnancy and lactation

The drug is allowed to be used during pregnancy, but the question of its prescription must be decided by the doctor on an individual basis. When taking Hemomycin during

Warfarin and Hemomycin, when administered together, may enhance the anticoagulant effect, so it is necessary to carefully monitor prothrombin and blood clotting.

Antacids reduce the activity of the drug.

The drug is incompatible with Heparin and alcohol.

Hemomycin or Sumamed?

Hemomycin and Sumamed are synonyms: both drugs contain the same active ingredient - azithromycin. The choice, perhaps, can depend only on the price - Hemomycin is cheaper than Sumamed, as well as individual sensitivity and tolerability.

Both drugs are much better than the cheaper generics that have flooded the market, since the former use not only original formulas of the active substance, but also original shells that allow the drug to be delivered to Right place at the right time. In addition, the purification of branded drugs, as opposed to drugs manufactured by pharmaceutical companies under an acquired patent, is a level higher.

All this determines that Hemomycin and Sumamed, in comparison with cheaper drugs, are much more effective in their action and are better tolerated.

Hemomycin analogs

Analogues (synonyms) of Hemomycin, which is produced by the Serbian company Hemofarm, include:

• Sumamed;
• Azivok;
• Azimed;
• Azitrocin;
• Zomax;
• Zikax;
• Z-factor;
• Sumamox;
• Ecomed;
• Tremak-Sanovel;
• Azicide and others.

Every mother does everything possible to ensure that her child is healthy and happy. But, unfortunately, this is not always possible. Often present in kindergarten A child with a runny nose can cause a cold in your little one. The drug market today is overflowing with various offers. But you should always approach the choice of medicine very carefully. If we are talking about antibiotics, then your care should be maximum.

Today I want to find out what are the main indications and spectrum of action of the antibiotic Hemomycin. It is quite popular among mothers. Let's find out its composition, evaluate the side effects and draw conclusions whether it is really that good. Or perhaps it would be better to choose some analogue. The price for Hemomycin suspension 200 mg for children varies from 126 rubles or 63 hryvnia. Of course, there are cheaper and more expensive drugs that are similar in composition. But for now, let's find out why Hemomycin is effective.

Hemomycin is available in four types:

• Capsules. Externally, they have a hard gelatinous light blue shell, and inside there is a white powder. There are 6 capsules in a blister, 1 blister in a package.

• Pills. Covered with a film shell, gray-blue in color, biconvex. There are usually 3 tablets in a blister, and 1 blister in a cardboard package.

• The powder from which the suspension is made. Its color is white or very close to it, with a fruity smell. The package contains a dark bottle, the weight of the powder is 10-12 g. A measuring spoon is included.

• Special form of the drug for injections.

Compound

The main active ingredient is azithromycin in the form of dihydrate. Auxiliary components are also added - corn starch, fruit flavors, sodium saccharin, calcium carbonate, sorbitol, etc.

Operating principle

Chemomycin is a broad-spectrum bactericidal antibiotic. Azithromycin inhibits protein synthesis at the cellular level in pathogenic microorganisms. As a result, it helps block the proliferation of many bacteria.

It is active in the fight against aerobic gram-positive bacteria. These include streptococci, gonococci, staphylococci, listeria. It is also active against aerobic gram-negative bacteria, anaerobic bacteria. Given medicine active against intracellular microorganisms - chlamydia trachomatis, mycoplasma, ureaplasma, etc. Improvement is observed in patients whose disease was caused by obligate intrapulmonary microorganisms, for example, mycoplasma, chlamydia, legionella.

The drug does not act on gram-positive bacteria that are resistant to erythromycin.

Indications

Inflammatory and infectious diseases caused by microorganisms that are sensitive to this drug:

• Infections of the ENT organs and upper respiratory tract. These include sinusitis, otitis media and tonsillitis.

• Infections of the urogenital tract.
• Infections of the skin and soft tissues, such as impetigo, secondary infected dermatitis.
• Scarlet fever.
• Diseases of the intestines and duodenum caused by the bacterium Helicobacter pylori.
• Lower respiratory tract infections (bronchitis, bacterial pneumonia).
• Treatment for early stages of Lyme disease.

At what age can the following be allowed for use? Hemomycin can be used from six months of age.

Contraindications in children

• Hypersensitivity to macrolide antibiotics.
• Kidney and liver failure.
• Age category up to 12 years (for capsules and tablets).
• Children under 12 months of age (for a solution with a concentration of 200 mg/5 ml).
• Age up to 6 months (for a suspension with a concentration of 100 mg/5 ml).
• This drug should be prescribed and used with caution by pregnant women, with arrhythmia, and children with impaired renal and liver function.

Adverse reactions

• Allergic: itching, urticaria, conjunctivitis.
• In the central nervous system: insomnia, headache, anxiety, sleep disturbance, neurosis.
• In the digestive system: stomach pain, nausea, gastritis, flatulence, vomiting, cholestatic jaundice, candidiasis of the oral mucosa, increased liver enzymes, diarrhea or constipation, change in taste.
• From the urinary and reproductive system: nephritis, vaginal candidiasis.
• IN cardiovascular system: chest pain, rapid heartbeat.

Hemomycin 250: instructions for use and dosage for children

The instructions imply the use of this medicine once a day in between meals. Ideally, 1 hour before or 2 hours after meals. Such requirements were formed due to the fact that the active substances of the antibiotic are poorly absorbed with food.

Capsules Hemomycin 250

The recommended antibiotic dosage for children over 12 years of age for infections of the lower and upper respiratory tract, as well as soft tissues and skin, is 10 mg/kg once a day. The recommended duration of treatment is 3 days. Considering the peculiarities of the course of the disease, it is worth relying on the doctor’s prescription.

Hemomycin tablets

Can be prescribed to adults and children over 12 years of age for infections of the lower and upper respiratory tract at a dosage of 500 mg/day for 3 days.

• For acute uncomplicated urethritis, the doctor may prescribe the drug in a single dose of 1 g.
• For stomach diseases caused by the bacterium Helicobacter pylari, 1 g per day is prescribed for 3 days.

Instructions for use of Hemomycin suspension for children 200 mg/5 ml and 100 mg/5 ml

The suspension is prepared as follows: First you need to prepare the water - boil it and cool it. Pour prepared water into the bottle (or you can use distilled water) to the desired level and shake thoroughly until smooth. The suspension must be shaken before each use.

The diluted medicine can be stored at room temperature for up to 5 days. The instructions also ask you to pay attention to the fact that after using the medicine, the baby must be given a few sips of water or other liquid to completely wash it off from the mouth and get it inside.

Overdose

Symptoms of overdose may include: temporary hearing loss, nausea, vomiting, diarrhea.
In this case, it is necessary to perform gastric lavage and symptomatic therapy.

How does it interact with other drugs?

• With the simultaneous use of magnesium and aluminum containing drugs with Hemomycin, absorption of azithromycin is observed.
• The process of absorption of azithromycin is slowed down by ethanol and food.
• The combined use of digoxin and azithromycin significantly increases the concentration of the former.
• The drug struggles with lincosamides, cephalosporins, and antibiotics of the penicillin group.
• The main component of the antibiotic, azithromycin, is incompatible with heparin.
• But it enhances the effects of tetracyclines, sulfonamides, and streptomycin.

Conditions of storage and sale

The drug should be stored at a temperature of 15° to 25°, protected from children and direct sun rays place. The shelf life is 2 years.

The drug is sold only with a doctor's prescription.

Reviews of Hemomycin suspension for children

Most often you can find positive reviews about the drug on pharmaceutical websites. This helps to form a good assessment of its effectiveness and quality. Most often, young parents write about work failures gastrointestinal tract, and this is its only disadvantage. Therefore, if any symptoms appear, you should immediately contact your doctor to adjust the dosage or even change the medication.

Zhanna:

On the 4th day of taking the antibiotic, the child showed no improvement. Sometimes they write that the effect can occur after finishing the entire course, but we did not wait for it. We went to the pediatrician for a new prescription and prescribed injections. Based on my personal experience, I can say that this antibiotic does not help everyone.

Natalia:

My daughter refused to take Hemomycin, despite the fact that she diluted it with tea and compote, and constantly spat it out. As a result, she did not drink the full portion. But I can note that in combination with other drugs there was an effect, and the cough subsided.

Alina:

He helped my child more than once in the treatment of scarlet fever, bronchitis and purulent sore throat. In addition, the price is reasonable, and you only need to use it for 3 days, and then only once a day. We had no side effects. I can confidently recommend it only after prior consultation with a doctor. One piece of advice: if you are offered Sumamed in a pharmacy, then know that there is no difference in effectiveness, but the price of the latter is almost twice as high.

Victoria:

A very effective drug. We drank it twice and were satisfied, since it did not cause any side effects, and improvement occurred by the middle of the second day. And the price is quite reasonable.

Irina:

The downside of this antibiotic for me is that after shaking, the product remains on the walls, and after that it does not reach the desired level. In this regard, it turns out that by the last dose only half the dose remains. And given that the course of administration is short, I am worried that its action will not be enough to defeat viruses. But while taking it I overcame my cold, leaving only a slight cough and runny nose. Its advantage is that Hemomycin does not affect the intestines, as happens when taking antibiotics.

Analogues

• Suprax. This is a potent third-generation antibiotic; it can be used from 6 months. It has a fairly wide spectrum of action. But it is prescribed by doctors only when less powerful drugs do not work. Its price is an order of magnitude higher than that of Hemomycin. But, at the same time, this antibiotic copes with any kind of disease, including sore throat in children.
• Zinnat. It is allowed to be used from the age of three months. This drug acts on the causative agent of infections selectively: on some people more strongly, on others less, it may not work at all.
• Amoxicillin. This drug is prescribed for any age. However, it is not very effective in the fight against certain types of staphylococci and a number of other viruses, but this antibiotic is most often prescribed for bronchitis in children.

Analogues of Hemomycin active substance speakers:

• Sumamed– sold both in tablets and capsules, and in granules for dilution with water and preparation of a suspension. Recommended for use from 6 months. As for the price, it is slightly inferior to Hemomycin.
• Ecomed. This antibiotic is also available in three of the same forms as Sumamed or Hemomycin. Can be recommended for use from 6 months.

Features of antibiotic use in children

There are several rules that must be followed when using them:

• you cannot decide to prescribe them or stop using them on your own; this must be discussed with your doctor;
• you must strictly follow the indicated dosage;
• you should not stop using the drug before the permissible period, even if you see minor improvements;
• provide the baby with bed rest;

• ventilate the room regularly;
• carry out wet cleaning;
• exclude spicy, fried, salty foods from his diet.

After taking antibiotics, you need to help restore the intestinal microflora and immunity with the help of drugs with live bacteria - probiotics. Usually the body needs 5-10 days to return to normal.

Video review of the drug

Maintaining the health of your child is one of the most important tasks of every parent. Nowadays on the pharmaceutical market you can find a huge variety of medicines. But how do you know which of them is effective and which will really help your baby? I suggest watching a video in which a specialist answers important questions and talks about all the intricacies of taking a drug such as Hemomycin.

A very important point in the formation of health and immunity in a baby is not only the correct lifestyle and habits, but also the period of his intrauterine life. After all, the fact that the body was saturated with essential vitamins and microelements also plays a significant role. Many doctors recommend avoiding citrus fruits during pregnancy, as they are a product that can cause allergies during this period.

Of course, 99% of mothers will not, under any circumstances, risk their health and the health of their baby. However, I can say with absolute certainty that if you feel an irresistible craving to eat a certain product, do it. Perhaps this is what your baby needs right now, and will play an important role in strengthening the health and immunity of your baby.

Share your observations on the use of the drug Hemomycin. How did your baby react to taking it, were there any side effects - tell us about it in the comments on the site! And I wish you and your baby good health!

Chemomycin is a drug from the group of azalide antibiotics that has a pronounced bacteriostatic effect.

The active ingredient of the drug is azithromycin. Its effect on microorganisms leads to a stop in protein synthesis in the microbial cell. If the protein is not synthesized, the microbe cannot grow and reproduce. In high doses, Chemomycin can have a bactericidal (destructive to bacteria) effect.

In this article we will look at why doctors prescribe Hemomycin, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Hemomycin can be read in the comments.

Composition and release form

Clinical and pharmacological group: macrolide antibiotic – azalide.

1. The antibiotic in the form of tablets (500 mg) has a round shape and is blue in color. Take one tablet per day. This release form is for adults only. There are 3 tablets in one package.
2. Capsules 250 mg. They have a pleasant blue color, with white powder inside. There are 6 pieces in a pack. Drink orally (inside) before meals once a day.
3. Powder for dilution. Children's suspension of 100 mg is suitable for small children (from 6 months to one year). The diluted powder should be drunk once a day, the calculated dosage for children is 10 mg per kg of weight. After preparation, the suspension is white in color with a pleasant odor. The powder is available in darkened bottles. Sealed in cardboard packaging.

What is Hemomycin used for?

Hemomycin is used for diseases caused by pathogens sensitive to azithromycin:

1. Scarlet fever;
2. Infections of the respiratory tract and ENT organs (sore throat, otitis media, acute bronchitis, pneumonia, sinusitis, exacerbation of chronic bronchitis);
3. Soft tissue/skin infections (impetigo, secondary infected dermatoses, erysipelas);
4. Infections of the genitourinary system (uncomplicated urethritis, uncomplicated cervicitis, including those caused by mycoplasma, chlamydia, gonococcal, ureaplasma infections).

Hemomycin is also indicated for the initial stage of Lyme disease. As part of complex therapy, it is used for diseases of the stomach/duodenum associated with Helicobacter pylori.

Pharmaceutical action

Chemomycin is a broad-spectrum antibiotic. Azithromycin is a representative of a subgroup of macrolide antibiotics – azalides. In high concentrations it has a bactericidal effect.

• The drug is active against intracellular microorganisms: Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Borrelia burgdorferi, as well as against Treponema pallidum.
• Chemomycin is active against aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus spp. groups C, F and G, Streptococcus viridans, Staphylococcus aureus; aerobic gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Helicobacter pylori, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; anaerobic bacteria: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp.

Gram-positive bacteria that are resistant to erythromycin are resistant to the drug.

Instructions for use

The instructions for Hemomycin recommend taking the antibiotic orally (tablets, suspension, capsules) once a day 1 hour before or 2 hours after eating, since taking Hemomycin together with food reduces the bioavailability of the drug.

• For infectious and inflammatory diseases of the respiratory tract, soft tissues and skin, children over 12 years of age are prescribed the drug at a rate of 10 mg/kg once a day for 3 days, when treating the initial stage of Lyme disease - 20 mg/kg on the first day and 10 mg/kg from the second to the fifth day.
• For infectious and inflammatory diseases of the respiratory system, adults are prescribed Hemomycin at a dosage of 500 mg per day for three days.
• For infectious and inflammatory diseases of soft tissues and skin, as well as at the initial stage of Lyme disease, 1 gram is prescribed on the first day, then 500 mg once a day from the second to the fifth day.
• For diseases of the duodenum and stomach associated with Helicobacter pylori, take 1 gram per day for 3 days as part of multicomponent anti-Helicobacter pylori therapy.
• For acute urethritis or cervicitis, 1 gram of azithromycin is recommended once.

Suspension 200 mg/5 ml and 100 mg/5 ml. For children over 12 months, a suspension of 200 mg/5 ml is used, for children over 6 months, a suspension of 100 mg/5 ml is used.

• For children with infections of the upper and lower respiratory tract, infections of the skin and soft tissues (with the exception of chronic migratory erythema), Chemomycin in the form of a suspension is prescribed at the rate of 10 mg/kg body weight 1 time/day for 3 days (course dose - 30 mg/kg body weight). kg).

Rules for preparing the suspension:

1. Water (distilled or boiled and cooled) is gradually added to the bottle containing the powder to the mark.
2. The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained.
3. If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.
4. The prepared suspension is stable at room temperature for 5 days.
5. The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to wash off and swallow the suspension remaining in the mouth.

Contraindications

The drug or analogues of Hemomycin are contraindicated:

• with liver and kidney failure;
• with hypersensitivity to macrolide antibiotics;
• in childhood up to six months (for a suspension of 100 mg);
• in childhood up to one year (for a suspension of 200 mg);
• in children under twelve years of age (for tablets and capsules).

According to reviews, Hemomycin should be prescribed with caution when:

• arrhythmias;
• pregnancy.

Caution should also be exercised when using Hemomycin or its analogue in children with severe renal or hepatic impairment.

Side effects

According to reviews, Hemomycin sometimes causes the following side effects: palpitations, chest pain, nausea, diarrhea, vomiting, dyspepsia, abdominal pain, cholestatic jaundice, melena, increased activity of liver enzymes.

In addition, the drug can cause: hyperkinesia, headache, vertigo, neurosis, dizziness, insomnia or drowsiness, anxiety, vaginal candidiasis, Quincke's edema, skin rash, nephritis, photosensitivity, increased fatigue.

According to reviews of Hemomycin, children may experience: gastritis, candidiasis of the oral mucosa, constipation, changes in taste, itching, urticaria, conjunctivitis.

Pregnancy and lactation

During pregnancy, Chemomycin is prescribed only when the expected benefit of therapy for the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during lactation, the issue of stopping it should be decided. breastfeeding while using the drug.

Analogues

There are analogues of Hemomycin, among them: Azivok, Azithromycin Azitral, AzitRus, Azitrox, Azimicin, Azicide, Retard, Zetamax ZI-Factor, Zitrolide, Zitrocin, Zitnob, Sumaklid, Sumazid, Sumamed, Sumamox, Sumametsin, Sumatrolide solutab, Ecolab, Tremak- Sanovel.

Attention: the use of analogues must be agreed with the attending physician.

Photo of the drug

Latin name: Hemomycin

ATX code: J01FA10

Active substance: Azithromycin Dihydrate (Azithromycin)

Manufacturer: HEMOFARM, A.D., Serbia

Description is valid on: 19.12.17

Chemomycin is an antibacterial, bactericidal drug.

Active substance

Azithromycin.

Release form and composition

Available in the form of film-coated tablets, capsules, powder for the preparation of a suspension for oral use and lyophilisate for the preparation of an infusion solution.

Tablets and capsules are sold in blisters (3 tablets and 6 capsules each), placed in cardboard packs of 1 pc.

The lyophilisate for preparing the infusion solution is sold in glass bottles (500 mg of the drug each), placed in cardboard packages of 1 piece.

The powder is sold in glass bottles (10 g of the drug in each), placed in cardboard packs of 1 piece. The set includes a measuring spoon (volume 5 ml).

Capsules: azithromycin dihydrate 262.03 mg (which corresponds to the content of azithromycin - 250 mg). Excipients: anhydrous lactose, corn starch, sodium lauryl sulfate, magnesium stearate. Shell composition: titanium dioxide (E171), patented blue V dye (E131), gelatin.

Film-coated tablets: azithromycin (in dihydrate form) - 500 mg. Excipients: microcrystalline silicate cellulose, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone, magnesium stearate, talc, colloidal silicon dioxide. Shell composition: titanium dioxide, talc, copovidone, ethylcellulose, macrogol 6000, indigo carmine (indigotine) E132, green lacquer dye 8% (indigo carmine (indigotine) E132, quinoline yellow E104).

Indications for use

• scarlet fever;
• infections of the ENT organs and upper respiratory tract;
• lower respiratory tract infections;
• Lyme disease – for the purpose of treatment of the initial stage (erythema migrans);
• infections of soft tissues and skin;
• diseases of the duodenum and stomach associated with Helicobacter pylori (for capsules and tablets);
• urogenital tract infections;
• infectious and inflammatory diseases of the pelvic organs caused by Neisseria gonorrhoeae, Chlamydia trachomatis or Mycoplasma hominis (for lyophilisate).

Contraindications

• liver and kidney failure;
• hypersensitivity to macrolide antibiotics;
• children's age up to 16 years (for lyophilisate), up to 12 years (for tablets and capsules), up to 12 months (for a suspension of 200 mg/5 ml), up to 6 months (for a suspension of 100 mg/5 ml).

Prescribed with extreme caution in the following conditions:

• arrhythmia;
• pregnancy;
• children with severe functional disorders kidney or liver;
• simultaneous use of Warfarin, Terfenadine, Digoxin.

Instructions for use Chemomycin (method and dosage)

Capsules, film-coated tablets

Orally, without chewing, 1 hour before or 2 hours after meals. Frequency of use: 1 time per day.

• For infections of soft tissues and skin - 500 mg/day for 3 days (course dose - 1.5 g).
• For infections of the ENT organs of the upper and lower respiratory tract - 500 mg/day for 3 days (course dose - 1.5 g).
• For uncomplicated cervicitis and/or urethritis - 1 g once.
• For acne vulgaris of moderate severity - 500 mg of the drug on days 1, 2, 3 of treatment. Frequency of use: 1 time per day for 3 days. Then they take a break from days 4 to 7. Starting from the 8th day of treatment, the patient is prescribed 500 mg once a week (with an interval of 7 days). Treatment is carried out for 9 weeks. The course dose is 6 g.
• For Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans), 1 g is prescribed on day 1 and 500 mg every day from days 2 to 5 (course dose is 3 g).

Children over 12 years of age with infections of the upper and lower respiratory tract, skin and soft tissues are usually prescribed at a rate of 10 mg/kg 1 time/day for 3 days or on the first day - 10 mg/kg, then 4 days - 5- 10 mg/kg/day.

If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken at intervals of 24 hours.

Powder for preparing suspension

Orally, 1 hour before or 2 hours after meals. frequency of use - 1 time per day.

Add water (boiled and cooled or distilled) to the bottle to the mark. The contents of the bottle are shaken until a homogeneous suspension is obtained. If the level of the resulting suspension is below the mark on the bottle label, add water again to the desired mark and shake.

At room temperature, the prepared suspension is stable for 5 days.

For children with infections of the skin, soft tissues, upper and lower respiratory tract, Hemomycin is prescribed at the rate of 10 mg/kg body weight. Dosage regimen: 1 time per day for 3 days (course dose: 30 mg/kg). Suspension 100 mg/5 ml is indicated for use in children over 6 months of age. Suspension 200 mg/5 ml - for children over 12 months.

For adults with upper and lower respiratory tract infections, 500 mg of the drug is prescribed once a day. Treatment is carried out for 3 days (course dose - 1.5 g). For infections of soft tissues, skin, as well as Lyme disease for the treatment of the initial stage (erythema migrans) - 1 g per day for 1 dose. Then 0.5 g per day is prescribed daily from days 2 to 5 (course dose is 3 g).

For chronic migratory erythema - 1 time per day for 5 days. In this case, on day 1 a dose of 20 mg/kg is taken, and from days 2 to 5 - 10 mg/kg.

Body weight, kg	Daily dose (suspension 100 mg/5 ml), ml		Daily dose (suspension 200 mg/5 ml), ml
	1 day	2 - 5 day	1 day	2 - 5 day
<8	5 (100 mg) - 1 spoon	2.5 (50 mg) - 1/2 spoon	-	-
8–14	10 (200 mg) - 2 spoons	5 (100 mg) - 1 spoon	5 (200 mg) - 1 spoon	2.5 (100 mg) - 1/2 spoon
15–24	20 (400 mg) - 4 spoons	10 (200 mg) - 2 spoons	10 (400 mg) - 2 spoons	5 (200) - 1 spoon
25–44	(500 mg) - 5 spoons	12.5 (250 mg) - 2.5 spoons	12.5 (500 mg) - 2.5 spoons	6.25(250) - 1.25 spoons

The suspension must be shaken before use.

After taking the suspension, the child should be given a few sips of liquid to wash off and swallow the drug remaining in the mouth.

If you miss 1 dose, it is recommended to take the missed dose as soon as possible, and subsequent doses at intervals of 24 hours.

Lyophilisate

The drug should be used only in a hospital setting.

Community-acquired pneumonia - 500 mg/day, once for at least 2 days. It is recommended to replace intravenous administration with oral azithromycin at a dose of 500 mg/day once until the 7-10-day total course of treatment is completed.

Infectious and inflammatory pathologies of the pelvic organs - 500 mg/day, once for at least 2 days. IV administration should be followed by oral azithromycin at a dose of 250 mg/day once until the 7-day total course of treatment is completed.

The solution for infusion is prepared in 2 stages:

• Stage 1 - preparation of the reconstituted solution. 4.8 ml of sterile water for injection is taken into a bottle with 500 mg of the drug and shaken until the powder is completely dissolved. At room temperature, the prepared solution remains stable for 24 hours. 1 ml of solution contains 100 mg of azithromycin.
• Stage 2 - dilution of the reconstituted solution (100 mg/ml). It is carried out immediately before administration in accordance with the data below.

To obtain a concentration of azithromycin in an infusion solution of 1 mg/ml, 500 ml of solvent is required. To obtain a concentration of azithromycin in an infusion solution of 2 mg/ml - 250 ml.

The reconstituted solution is taken into a vial with a solvent (Ringer's solution, 5% dextrose solution or 0.9% sodium chloride solution) to obtain a final concentration of azithromycin of 1-2 mg in 1 ml of infusion solution.

The solution cannot be administered intramuscularly or intravenously. It is recommended to administer the prepared solution dropwise over at least 1 hour.

Before administration, the solution is visually inspected. If it contains particles of a substance, it is unsuitable for use.

At room temperature, the prepared solution is stable for 24 hours.

Side effects

The use of Hemomycin may cause the following side effects:

• Central nervous system: vertigo, headache, drowsiness, dizziness; in children - headache (in the treatment of otitis media), anxiety, hyperkinesia, sleep disturbance, neurosis.
• Cardiovascular system: chest pain, palpitations.
• Digestive system: abdominal pain, attacks of nausea, diarrhea, dyspepsia, flatulence, vomiting, melena, increased activity of liver transaminases, cholestatic jaundice; in children - gastritis, anorexia, constipation.
• Reproductive and urinary systems: nephritis, vaginal candidiasis.
• Allergic manifestations: Quincke's edema, rashes; in children - urticaria, itchy skin, conjunctivitis.
• Other: photosensitivity, increased fatigue.

Additionally for the lyophilisate for the preparation of infusion solution:

• Central nervous system: convulsions, asthenia, paresthesia, insomnia, aggressiveness, anxiety, increased excitability, fainting.
• Cardiovascular system: arrhythmia (including bidirectional ventricular tachycardia), increased QT interval, decreased blood pressure.
• Digestive system: abdominal cramps and pain, indigestion, hepatitis, pseudomembranous colitis, discoloration of the tongue, liver necrosis, pancreatitis, liver failure (risk of death).
• Genitourinary system: acute renal failure.
• Musculoskeletal system: arthralgia.
• Lymphatic and circulatory systems: leukopenia, neutropenia, thrombocytopenia, neutrophilia.
• Sense organs: visual impairment, tinnitus, impaired perception of smell and taste, reversible hearing impairment (including the development of deafness).
• Local reactions: inflammation and pain at the injection site.
• Allergic manifestations: toxic epidermal necrolysis, angioedema, anaphylactic reaction, Stevens-Johnson syndrome, erythema multiforme.
• Other: candidiasis (including genital and oral cavity), malaise, vaginitis.

Overdose

• temporary hearing loss;
• diarrhea;
• nausea;
• vomit.

Analogues

Analogs by ATC code: Azivok, Azithromycin, Zitnob, Safotsid, Sumamed.

Do not decide to change the drug on your own; consult your doctor.

pharmachologic effect

Antibacterial, bactericidal.

special instructions

• The drug in the form of capsules, tablets and powder for suspension is not recommended to be taken with food.
• There must be a break of at least 2 hours between taking antacids and drugs.
• After cessation of therapy, hypersensitivity reactions may persist in some patients. In this regard, specific treatment and careful medical monitoring are required.
• When taking the drug (as with any antibiotic therapy), there is a risk of superinfection (including fungal infection).
• The lyophilisate should not be administered in longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin are designed for a short dosing regimen.
• Considering the likelihood of side effects from the central nervous system, care must be taken when working with complex mechanisms and driving vehicles.

During pregnancy and breastfeeding

Use during pregnancy is permissible only in cases where the benefits of its use for the mother outweigh the possible risk to the fetus.

Registration number LSR-002215/07-150807

Tradename: Hemomycin

International nonproprietary name:

Azithromycin

Dosage form:

powder for the preparation of suspension for oral administration.

Compound
5 ml of the finished suspension contains: active substance azithromycin (in the form of azithromycin dihydrate 104.809 mg) 100 mg, excipients - xanthan gum - 20.846 mg, sodium saccharinate - 4.134 mg, calcium carbonate - 162.503 mg, colloidal silicon dioxide - 26.008 mg, sodium phosphate anhydrous - 17.259 mg, sorbitol - 2145.682 mg, apple flavor - 3.303 mg, strawberry flavor - 8.159 mg, cherry flavor - 12.096 mg.

Description
White or almost white powder with a fruity odor.
Description of the finished suspension: an almost white suspension with a fruity odor.

Pharmacotherapeutic group:

Antibiotic, azalide

CODE ATX

Pharmacological properties

Broad-spectrum antibiotic. It is a representative of the subgroup of macrolide antibiotics - azalides. In high concentrations it has a bactericidal effect.

Gram-positive cocci are sensitive to azithromycin: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, streptococci of groups C, F and O, Staphylococcus aureus, Streptococcus viridans; gram negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, Bordetella parapertussis, Legionella pneumophila, Haemophilus ducreyi, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnereila vaginalis; some anaerobic microorganisms: Bacleroides bivius, Clostridium perfringens, Peptostreptococcus spp; and Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdorferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.

Pharmacokinetics
Azithromycin is rapidly absorbed from the gastrointestinal tract due to its stability in an acidic environment and lipophilicity. After oral administration of 500 mg, the maximum concentration of azithromycin in the blood plasma is reached after 2.5 - 2.96 hours and is 0.4 mg/l. Bioavailability is 37%.

Azithromycin penetrates well into the respiratory tract, organs and tissues of the urogenital tract (in particular the prostate gland), skin and soft tissues. The high concentration in tissues (10-50 times higher than in plasma) and the long half-life are due to the low binding of azithromycin to plasma proteins, as well as its ability to penetrate eukaryotic cells and concentrate in the low pH environment surrounding lysosomes. This, in turn, determines the large apparent volume of distribution (31.1 l/kg) and high plasma clearance. The ability of azithromycin to accumulate predominantly in lysosomes is especially important for the elimination of intracellular pathogens. It has been proven that phagocytes deliver azithromycin to sites of infection, where it is released during the process of phagocytosis. The concentration of azithromycin in foci of infection is significantly higher than in healthy tissues (on average by 24-34%) and correlates with the degree of inflammatory edema. Despite its high concentration in phagocytes, azithromycin does not have a significant effect on their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which has made it possible to develop short (3-day and 5-day) courses of treatment.

It is demethylated in the liver, the resulting metabolites are not active. The elimination of azithromycin from blood plasma occurs in 2 stages: the half-life is 14-20 hours in the range from 8 to 24 hours after taking the drug and 41 hours in the range from 24 to 72 hours, which allows the drug to be used once a day. Food intake significantly changes pharmacokinetics (depending on the dosage form): suspension - Cmax increases (by 46%) and AUC (by 14%)

Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of the upper respiratory tract and ENT organs (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media);
• scarlet fever;
• infections of the lower respiratory tract (bacterial and atypical pneumonia, bronchitis);
• infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);
• Lyme disease (borreliosis), for the treatment of the initial stage (erythema migrans).

Contraindications
Hypersensitivity (including to other macrolides); liver and/or kidney failure; lactation period (suspended during treatment), children up to 6 months.
Carefully- pregnancy, arrhythmia (ventricular arrhythmias and prolongation of the QT interval are possible), children with severe impairment of liver or kidney function.

Use during pregnancy and lactation
Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Directions for use and doses
The drug is taken orally 1 time/day. 1 hour before meals or 2 hours after meals. Add water (distilled or boiled and cooled) to the bottle to the mark. The contents of the bottle are thoroughly shaken until a homogeneous suspension is obtained.

If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.

The prepared suspension is stable at room temperature for 5 days.

For infections of the upper and lower respiratory tract, skin and soft tissues (except for chronic migratory erythema)

Children: at the rate of 10 mg/kg body weight 1 time per day for 3 days (course dose 30 mg/kg). Depending on the child’s body weight, the following dosage regimen is recommended:

Adults: 500 mg 1 time per day for 3 days (course dose 1.5 g)

For infections of the urogenital tract, the drug is prescribed to adults: 1 g once.

For chronic migratory erythema - once a day for 5 days: on the 1st day at a dose of 20 mg/kg body weight, and then from the 2nd to the 5th day - 10 mg/kg body weight. The following dosage regimen for the CHEMOMYCIN suspension in children with Erythema migrans is recommended:

From 2nd to 5th day

The suspension should be shaken before use.

Immediately after taking the suspension, the child should be given a few sips of liquid (water, tea) to drink and swallow the suspension remaining in the mouth.

If a dose of the drug is missed, it should be taken immediately, if possible, and then subsequent doses should be taken at intervals of 24 hours.

Side effect
From the digestive system: diarrhea (5%), nausea (3%), abdominal pain (3%); 1% or less - dyspepsia, flatulence, vomiting, melena, cholestatic jaundice, increased activity of “liver” transaminases; in children - constipation, anorexia, gastritis.
In extremely rare cases: oral candidiasis.
From the cardiovascular system: palpitations, chest pain (1% or less).
From the nervous system: dizziness, headache, vertigo, drowsiness; in children - headache (during treatment of otitis media), hyperkinesia, anxiety, neurosis, sleep disturbance (1% or less).
From the genitourinary system: vaginal candidiasis, nephritis (1% or less).
Allergic reactions: rash, photosensitivity, Quincke's edema.
Other: increased fatigue; in children - conjunctivitis, itching, urticaria.

Overdose
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: symptomatic; gastric lavage.

Interaction with other drugs
Antacids (aluminum and magnesium), ethanol and food slow down and reduce absorption. When warfarin and azithromycin were co-administered (in usual doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may enhance the anticoagulation effect, patients need careful monitoring of prothrombin time. Digoxin: increased digoxin concentrations. Ergotamine and dihydroergotamine: increased toxic effects (vasospasm, dysesthesia). Triazolam: decreased clearance and increased pharmacological action of triazolam.

Slows down the elimination and increases the plasma concentration and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, as well as drugs subject to microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic agents, theophylline and other xanthine derivatives) - due to inhibition of microsomal oxidation in hepatocytes by azithromycin. Lincosamines weaken the effectiveness, tetracycline and chloramphenicol enhance it. Pharmaceutically incompatible with heparin.

special instructions
It is necessary to observe a break of 2 hours while using antacids. After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under medical supervision. If you miss 1 dose of the drug, the missed dose should be taken as soon as possible, and subsequent doses should be taken 24 hours apart.

Release form
Powder for the preparation of suspension for oral administration 100 mg/5 ml. 11.43 g of powder in a dark glass bottle, sealed with a metal cap with first-opening control. The bottle along with a measuring spoon (volume 5 ml, with a line for the volume 2.5 ml) and instructions for use in a cardboard box.

Storage conditions:

List B.
Store in a dry place, protected from light, at a temperature of 15 to 25 °C.
Keep out of the reach of children.

Best before date
3 years. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies
On prescription.

Manufacturer:

Hemofarm A.D., Serbia
26300 Vršac, Beogradski put bb, Serbia

Consumer complaints should be sent to:
Russia, 603950, Nizhny Novgorod
GSP-458, st. Salganskaya, 7