Sumamed

Sumamed is the trade name for an antibiotic whose active ingredient is azithromycin. Azithromycin belongs to the class of macrolide antibiotics that are used to treat various bacterial infections.

It has a broad spectrum of action and can be effective against many types of bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia trachomatis, Mycoplasma pneumoniae, Neisseria gonorrhoeae, and others.

Sumamed is often used to treat upper respiratory tract infections such as bronchitis, sinusitis, and sore throat, as well as lower respiratory tract infections, pneumonia, skin and soft tissue infections, urinary tract infections, and others.

It is available in various forms, including tablets, capsules, powder for suspension preparation and solution for injection. The dosage and duration of treatment depend on the type of infection, its severity and individual patient characteristics.

It is important to use Sumamed only as prescribed by a doctor and strictly follow the recommendations for dosage and duration of treatment to prevent the development of bacterial resistance and minimize the risk of side effects.

Indications Sumameda

1. Upper respiratory tract infections: Including bacterial bronchitis, sinusitis, pharyngitis, laryngitis, tonsillitis (sore throat) and other respiratory tract infections.
2. Lower respiratory tract infections: Including pneumonia and obstructive bronchitis.
3. Skin and Soft Tissue Infections: Including ostiophlebitis, cellulitis, impetigo, folliculitis and others.
4. Urinary tract infections: Including urethritis, cystitis, orchitis, prostatitis and others.
5. Syphilis: Including primary, secondary and early latent forms.
6. Uncomplicated bladder infections: Including urethritis caused by Chlamydia trachomatis or Neisseria gonorrhoeae.
7. Gonorrhea: In cases where sensitivity to antibiotics is confirmed or suspected.

Release form

1. Pills

• Dosage: The most common tablets are 250 mg and 500 mg azithromycin tablets.
• Packaging: Tablets are packed in blisters, which may contain different numbers of tablets depending on the dosing regimen (usually from 3 to 6 tablets per package).

2. Capsules

• Dosage: Capsules usually contain 250 mg of azithromycin.
• Packaging: Capsules, as well as tablets, are packed in blisters.

3. Powder for preparation of suspension

• Dosage: Oral suspension powder may be intended for preparation of 100 mg/5 mL or 200 mg/5 mL suspension.
• Packaging: The powder is supplied in vials, which the user should dilute with water before use. Each vial usually contains enough powder to prepare 15, 30 or 37.5 ml of suspension.

4. Powder for injection

• Dosage: Azithromycin for Injection is usually available in the form of a lyophilizate that contains 500 mg of azithromycin to be dissolved and then administered intravenously.
• Packaging: Powder for injection is packed in sterile vials.

Pharmacodynamics

Its pharmacodynamics is to inhibit protein synthesis in the bacterial cell by blocking the binding of the 50S ribosomal subunit and preventing tRNA translocation. This results in impaired bacterial growth and multiplication.

Azithromycin is active against a wide range of bacteria, including aerobic Gram-positive and Gram-negative microorganisms, as well as anaerobic bacteria and some other infectious agents. It has high activity against such pathogens as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, and others.

Pharmacokinetics

1. Absorption: Azithromycin is usually well absorbed from the gastrointestinal tract after oral administration. Food may delay its absorption, but usually does not significantly affect the total bioavailability.
2. Distribution: It penetrates well into various tissues and organs where it creates high concentrations, especially in the lungs, liver, kidneys, middle ear, and mid-skin layer.
3. Protein binding: Azithromycin binds to blood plasma proteins to an insignificant extent (about 50%).
4. Metabolism: It is hardly metabolized in the liver, making it less susceptible to interactions with other drugs metabolized through this organ.
5. Excretion: Most of azithromycin is excreted through bile and urine, mainly unchanged. A small amount is excreted through the intestine.
6. Half-excretion: Half-excretion of azithromycin from the body is long, it is about 68 hours, which allows its use in regimens with more infrequent administration compared to other antibiotics.

Dosing and administration

Methods of application and dosage:

Tablets and Capsules

• Adults and children over 12 years of age (weighing more than 45 kg):

  • Usual dosage: 500 mg once daily for 3 days.
  • Alternative regimen (for some indications): 500 mg on the first day, then 250 mg once daily for 4 days.

• Use: Tablets and capsules should be taken at least 1 hour before or 2 hours after a meal with plenty of liquid.

Powder for Preparation of Suspension

• Children weighing less than 45 kg:

  • Thedosage is usually 10 mg/kg body weight once daily for 3 days.
  • Analternative regimen for some infections may include administration of 10 mg/kg body weight on the first day, followed by 5 mg/kg per day for the next 4 days.

• Use: The suspension is prepared by adding the specified amount of water to the powder, shaking the bottle thoroughly. The suspension can be taken independently from meals.

Powder for Injection

• Adults:
  • Dosage: 500 mg intravenously once daily for 2-5 days (depending on the doctor's instructions and severity of the condition).
  • Administration: The solution for injection is prepared immediately before administration. Infusion should last at least 60 minutes.

Special Instructions

• Theduration of the course of treatment must be strictly adhered to, even if the symptoms have disappeared earlier.
• Alcohol intake is not recommended during treatment with azithromycin because of possible increased side effects.
• Interactions with other medications may affect the effectiveness of azithromycin, so it is important to notify your doctor of all medications you are taking.
• Allergic reactions: You should seek immediate medical attention if signs of allergies such as rash, itching, swelling, difficulty breathing occur.

Use Sumameda during pregnancy

The use of azithromycin, such as Sumamed, during pregnancy is usually considered with extreme caution by your doctor. It is important to consider the potential risks to the baby and benefits to the mother when using any medicine during pregnancy.

Most animal studies have shown no direct harmful effects of azithromycin on fetal development. However, human studies are not extensive enough to draw definitive conclusions about the safety of azithromycin during pregnancy.

Contraindications

1. Hypersensitivity: People with known hypersensitivity to azithromycin, other macrolide antibiotics, or any of the excipients of the drug should not use Sumamed because of the risk of allergic reactions, including anaphylaxis.
2. Drugs that interact with azithromycin: Sumamed may interact with other drugs such as ergotamine and digoxin. You should discuss possible interactions with other drugs with your doctor before starting treatment.
3. Liver diseases: In patients with severe hepatic dysfunction Sumamed use may be contraindicated due to possible aggravation of liver condition.
4. Heart diseases: In the presence of cardiovascular diseases, such as arrhythmias, Sumamed should be used with caution due to the possibility of prolongation of the QT interval and increased cardiotoxic effect.
5. Myasthenia gravis: In patients with myasthenia gravis, the use of Sumamed may lead to increased muscle weakness and worsening of the condition.
6. Pregnancy and breastfeeding: The use of azithromycin during pregnancy and breastfeeding should be performed only under doctor's prescription and under strict control.
7. Children: Sumamed may not be advisable for use in children depending on their age, weight, and medical condition.

Side effects Sumameda

1. Gastrointestinal disorders: Including diarrhea, nausea, vomiting, abdominal pain, and dyspepsia. Taking Sumamed with food may help reduce the risk of these symptoms.
2. Gastrointestinal tract disorders: Dysbacteriosis, superinfections including candidiasis, pseudomembranous colitis, as well as increased aminotransferase and alkaltine phosphatase activity may occur.
3. Allergic reactions: Including urticaria, pruritus, skin rash, angioedema, anphylactic reactions.
4. Nervous system disorders: Headache, including migraine, dizziness, drowsiness, insomnia, and possible development of peripheral neuropathy.
5. Cardiovascular disorders: Cardiac rhythm disturbances, including QT interval prolongation and arrhythmias may occur.
6. Liver and kidney disorders: Increased activity ofliver enzymes, hepatitis, cholestasis.
7. Other reactions: Anorexia, auditory hallucinations, taste disturbances, oral candidiasis, eosinophilia, allopenia, arthralgias, myalgias may occur.

Overdose

Symptoms of Sumamed overdose may include:

• Nausea and vomiting.
• Diarrhea.
• Gastrointestinal disorders.
• Headache.
• Temporary hearing loss.
• Changes in heart rhythm.

Interactions with other drugs

1. QT-prolonging drugs: Azithromycin may increase the risk of arrhythmias, especially torsades de pointes, when used concomitantly with QT-prolonging drugs such as antiarrhythmic drugs (e.g., amidarone, sotalol), certain antibiotics (e.g., chloramphenicol, levofloxacin), antimycotics (e.g., fluconazole), and others.
2. Cytochrome P450 inhibitors: The use of azithromycin together with cytochrome P450 inhibitors such as erythromycin, clarithromycin may increase the concentration of azithromycin in the blood and increase its toxic effects.
3. Antifungals: Azithromycin may increase the effect of azole antimycotic drugs such as ketoconazole or itraconazole, which may lead to an increased risk of arrhythmias.
4. Drugs that increase hyperkalemia: The use of azithromycin with drugs that increase hyperkalemia, such as spironolactone or potassium preparations, may lead to an increase in blood potassium levels and the development of hyperkalemia.
5. Acidosis-reducing drugs: Azithromycin may increase the toxic effects of acidosis-reducing drugs such as acetazolamide or diuretics, which may lead to the development of metabolic acidosis.
6. Drugs that increase liver toxicity: Use of azithromycin with drugs that increase liver toxicity, such as tetracyclines or protease inhibitors, may increase the risk of liver damage.