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Indications

The preparation is an azalide antibiotic from the macrolide group that inhibits the growth of susceptible bacteria.

It is used to treat the following infections caused by azithromycin-sensitive pathogens:

• mild to moderate community-acquired pneumonia, particularly pneumonia caused by Mycoplasma pneumoniae, Chlamydophila psittaci (ornithosis), or Chlamydophila pneumoniae.
• acute exacerbation of chronic bronchitis
• acute bacterial sinusitis (inflammation of the nasal sinuses)
• pharyngitis (inflammation of the throat), tonsillitis (inflammation of the tonsils), and acute otitis media (middle ear infection) in patients with hypersensitivity to ß-lactam antibiotics or when such treatment is otherwise unsuitable.
• skin and soft tissue infections, such as furunculosis (painful inflammation of the hair follicle and surrounding tissue), pyoderma (burning, purulent inflammation of the skin), impetigo (highly infectious bacterial skin infection), and erysipelas (bacterial infection of the upper skin layers) in patients with hypersensitivity to ß-lactam antibiotics or when such treatment is otherwise unsuitable.
• uncomplicated genital infections caused by Chlamydia trachomatis

Azithromycin in dental practice

Azithromycin is widely used in dental practice for the treatment and prevention of various bacterial infections. This antibiotic, a macrolide, effectively combats infections caused by anaerobic and aerobic bacteria. In dentistry, it is applied in the following cases:

• Acute and chronic infections: Azithromycin is prescribed for infections of the teeth and gums, such as periodontitis, periapical abscess, gingivitis, and stomatitis.
• Postoperative use: Following oral surgeries, including tooth extractions and implant procedures, azithromycin can be used to prevent infections.
• Alternative for penicillin-allergic patients: Azithromycin serves as a good alternative for patients allergic to penicillin-based drugs, such as amoxicillin.
• Systemic infections: In cases where oral infections might spread to other areas, azithromycin helps prevent the development of complications.
• Periodontal therapy: It is sometimes prescribed as an adjunct in the comprehensive treatment of periodontal diseases, especially when there is a significant bacterial load.

Azithromycin is convenient for dental use due to its long half-life, allowing patients to take it only once a day, typically over a three-day course.

Chlamydia Treatment with Azithromycin

Azithromycin is a macrolide antibiotic that doctors prescribe to treat bacterial infections, such as infections caused by Chlamydia. The active ingredient, azithromycin, inhibits the growth of susceptible bacteria. The medication has also proven effective for treating acute traveler's diarrhea caused by bacteria.

In general, the recommended dose of azithromycin is 500 mg once daily for three days, or 500 mg on the first day followed by 250 mg once daily for the next four days. For a Chlamydia infection, the recommended treatment is a single dose of 1000 mg of azithromycin.

Contraindications

• This medication should not be taken:
  • if you are allergic to azithromycin, erythromycin, any other macrolide or ketolide antibiotic, or any of the other ingredients in this medication.
  • if you suffer from a severe liver disease.

Mode of Action

How does the active ingredient of the medication work?

The active ingredient is an antibiotic that combats certain bacteria by disrupting the formation of essential proteins. These proteins are crucial for bacterial growth and reproduction; without them, the bacterial cell dies.

Dosage of Azithromycin 500 mg Film-coated Tablets

• Always take this medication exactly as described in the package leaflet or as directed by your doctor. Consult your doctor if you are unsure.
• The recommended dose is:
  • The total dose is 1500 mg of azithromycin, which can be taken either according to the 3-day or the 5-day treatment regimen.
  • For a 3-day treatment:
    • Recommended dosing schedule:
      • Children, adolescents, adults, and elderly over 45 kg:
        • Single daily dose:
          • 1 film-coated tablet (equivalent to 500 mg azithromycin)
        • Total daily dose:
          • 1 film-coated tablet (equivalent to 500 mg azithromycin)
  • For a 5-day treatment:
    • Recommended dosing schedule:
      • Children, adolescents, adults, and elderly over 45 kg:
        • Single daily dose:
          • Day 1: 1 film-coated tablet (equivalent to 500 mg azithromycin)
          • Days 2 - 5: 1/2 film-coated tablet (equivalent to 250 mg azithromycin)
        • Total daily dose:
          • Day 1: 1 film-coated tablet (equivalent to 500 mg azithromycin)
          • Days 2 - 5: 1/2 film-coated tablet (equivalent to 250 mg azithromycin)
  • For uncomplicated infections of the urethra (urethritis) and cervix (cervicitis) caused by Chlamydia trachomatis, the dose is 1000 mg of azithromycin taken as a single dose, equivalent to 2 film-coated tablets.
  • In treating pneumonia, the efficacy of azithromycin is well established. In most cases, the 3-day treatment regimen is also sufficient.
• Please speak with your doctor if you feel that the effect of the medication is too strong or too weak.
• Impaired liver and kidney function:
  • In patients with impaired kidney function, no dose adjustment is required up to a glomerular filtration rate of < 10 ml/min.
• If you have taken more than you should:
  • Side effects at doses above the recommended amount are similar to those at normal doses. Typical symptoms of macrolide antibiotic overdose include temporary hearing loss, severe nausea, vomiting, and diarrhea. In case of overdose, contact a doctor. Administration of activated charcoal and general symptomatic treatment, as well as supportive measures for vital functions, may be necessary.
• If you forget to take a dose:
  • If a smaller amount was taken than prescribed, the missed dose can be taken as soon as you remember. The next dose should then be taken at the originally scheduled time.
  • If an entire dose is missed, it should not be taken at the next scheduled time. Instead, extend the treatment by one day.
  • In any case, the total prescribed amount by your doctor should be taken (even if the total duration is extended by one day), and inform your doctor accordingly.
• If you stop taking the medication:
  • To avoid potential adverse effects, the medication should be taken in the form prescribed by your doctor until the end of the treatment and should not be discontinued prematurely without consulting your doctor.
• If you have further questions on the use of this medication, contact your doctor or pharmacist.

Method of Administration

• This medication should be taken either at least 1 hour before or at least 2 hours after a meal.
• The film-coated tablets should be swallowed whole with liquid, without chewing.

Side Effects

What unwanted effects may occur?

• Diarrhea
• Headaches
• Vomiting
• Abdominal pain
• Nausea
• Changes in blood counts
• Yeast infections
• Vaginal infections
• Pneumonia due to infection
• Fungal infection
• Bacterial infection
• Infectious pharyngitis
• Infectious inflammation of the gastrointestinal tract
• Respiratory disease
• Runny nose
• Oral candidiasis (yeast infection in the mouth)
• Spontaneous swelling of (mucous) skin (angioedema)
• Hypersensitivity reaction
• Loss of appetite
• Nervousness
• Insomnia
• Dizziness
• Drowsiness
• Taste or smell disturbances
• Paresthesia (tingling or prickling sensation)
• Visual disturbances
• Ear disorders
• Vertigo
• Palpitations
• Hot flashes
• Shortness of breath (dyspnea)
• Nosebleeds
• Constipation
• Gas (flatulence)
• Gastrointestinal discomfort
• Gastritis (stomach inflammation)
• Difficulty swallowing
• Dry mouth
• Belching
• Oral ulceration
• Excessive salivation
• Soft stools
• Skin hypersensitivity reactions, such as:
  • Rash
  • Itching
  • Hives (urticaria)
  • Dermatitis
  • Dry skin
  • Excessive sweating (hyperhidrosis) due to medication
• Joint degeneration (osteoarthritis)
• Muscle pain
• Back pain
• Neck pain
• Painful or difficult urination
• Kidney pain
• Spotting or breakthrough bleeding
• Testicular disorders
• Edema (swelling), including in the face and/or arms or legs
• Weakness or lack of strength
• Malaise
• Fatigue
• Chest pain
• Fever
• Pain
• Altered blood values
• Complications following surgery
• Joint pain
• Numbness
• Seizures

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information provided here, side effects occurring in at least one out of 1,000 treated patients are considered.

Patient Information

• Warnings and Precautions
  • Please talk to your doctor before taking this medication:
    • If you have impaired kidney function.
    • If you have impaired liver function: Since azithromycin is metabolized in the liver and excreted via bile, it should not be taken if you suffer from severe liver disease.
    • If you are infected with erythromycin-resistant gram-positive bacteria (cross-resistance) or most strains of methicillin-resistant staphylococci.
    • If you are using ergot alkaloids: Concurrent use of ergot alkaloids and macrolide antibiotics (the group to which azithromycin belongs) has led to accelerated development of ergotism (symptoms of ergot poisoning). Therefore, azithromycin and ergot alkaloid derivatives should not be used together.
    • If you have a neurological or psychiatric disorder.
    • With QT interval prolongation (a specific interval on the ECG):
      • Patients with congenital or acquired QT prolongation should not take this medication.
      • Certain medications that may prolong the QT interval, such as those used to treat arrhythmias (class IA and III antiarrhythmics), cisapride, and terfenadine, should not be taken with azithromycin.
      • Patients with electrolyte imbalance, particularly those with low potassium (hypokalemia) or magnesium levels (hypomagnesemia) in the blood, should not take the tablets.
      • Patients with clinically relevant bradycardia (slow heart rate), arrhythmias, or severe heart failure should avoid azithromycin.
    • Secondary infections: Watch for possible symptoms of secondary infections caused by non-susceptible pathogens, such as fungi.
  • Azithromycin is not the first choice for treating pharyngitis or tonsillitis caused by Streptococcus pyogenes. In these cases, as well as for the prevention of acute rheumatic fever, penicillin is the drug of choice.
  • Azithromycin is not the first choice for treating sinusitis or otitis media (middle ear infection).
  • Azithromycin is unsuitable for treating severe infections where rapid high blood concentrations of the antibiotic are necessary.
  • Skin and soft tissue infections are commonly caused by Staphylococcus aureus and Streptococcus pyogenes, both of which are generally resistant to macrolides. When beta-lactam antibiotics are not an option (e.g., due to allergy), azithromycin is considered an alternative treatment.
  • Azithromycin may cause or worsen severe muscle weakness (myasthenia gravis) during treatment.
  • Azithromycin is not indicated for treating infected burns.
  • For sexually transmitted infections, a concurrent infection with Treponema pallidum (syphilis) should be ruled out.
  • There have been reports of serious intestinal inflammation (pseudomembranous enterocolitis) following the use of macrolide antibiotics, including azithromycin. This should be considered if patients experience diarrhea after beginning treatment with azithromycin.
  • There is no experience regarding the safety and efficacy of long-term azithromycin use in the stated indications. If infections recur quickly, treatment with a different antibiotic should be considered.
• Driving and operating machinery
  • Based on current knowledge, azithromycin generally has no impact on concentration and reaction abilities. However, the occurrence of side effects may affect your ability to react and impair your capacity to drive or operate machinery.

Pregnancy

• If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.
• Pregnancy
  • This medication should be given to pregnant women only in exceptional cases where there is a potential life-threatening situation and no alternative therapy is available, as a conclusive assessment of its safety is currently not possible.
• Breastfeeding
  • Azithromycin, the active ingredient in this medication, passes into breast milk.
  • As the effects of azithromycin on a breastfed infant have not been studied, breastfeeding should be avoided during treatment. It is recommended to pump and discard breast milk during treatment and for two days after the end of treatment. Breastfeeding may be resumed afterward.

Instructions

What should you be aware of?

• Do not discontinue the medication prematurely, as this may lead to a (recurrent) outbreak of the illness.
• Exercise caution if you are allergic to macrolide antibiotics.
• Exercise caution if you are lactose intolerant. If you are on a diabetes diet, consider the sugar content.
• There may be interactions with other medications. Therefore, before starting treatment with a new medication, inform your doctor or pharmacist about any other medications you are currently using. This also applies to medications you purchase over-the-counter, use occasionally, or have used in the past.