Macromax – composition, action, dosage, indications, side effects

Proven content

Macromax contains the active substance azithromycin, which is an azalide antibiotic of the macrolide group with a broad spectrum of activity. The antibiotic is available only by prescription and is most often prescribed to patients by dermatologists, pulmonologists and otolaryngologists. What is the composition and how does the Macromax antibiotic work? What are the indications and contraindications for its use? What side effects may occur after using it? How to take Macromax and with what drugs not to combine it? What precautions should you take when using an antibiotic?

Macromax is characterized by bactericidal (killing bacteria) or bacteriostatic (inhibiting the growth of bacteria) activity. It is used, among others, in infections of the upper and lower respiratory tract, acute otitis media, infections of the skin and soft tissues.

Macromax – general characteristics of the drug

Macromax with the international name Azithromycinum is a macrolide antibiotic for use in the treatment of bacterial infections. The active substance of the preparation is azithromycin in the form of dihydrate.

Macromax is prescribed by a prescription to a specific person and cannot be passed on to other patients because it may harm another person, even though the symptoms of the disease are the same.

This preparation is available in three forms:

1. coated tablets of 500 mg, in a package containing 3 or 6 pieces;
2. orodispersible tablets 20 mg, in a package of 9, 12 or 15 pieces;
3. 100 mg orodispersible tablets, in a package of 3 or 6 pieces.

The most popular and available on the market are Macromax 500 coated tablets.

Macromax tablets are blue, oblong, biconvex tablets, engraved with a cross line. They are packed in PVC / PE / PVDC / Aluminum foil blisters in a cardboard box.

The price of the Macromax antibiotic it ranges from PLN 12 to PLN 18. The Macromax 500 mg pack containing 3 tablets is subject to reimbursement. The refund is 50% of the price, i.e. about PLN 7, and is available to people suffering from cystic fibrosis and in all other registered indications.

Keep the antibiotic out of the sight and reach of children. Macromax should be kept in the original package in order to protect it from moisture and light at temperatures below 25 degrees Celsius.

The manufacturer of Macromax is Bausch Health Poland Sp. z o. o. which is part of the international pharmaceutical concern Bausch Health Companies Inc., responsible for the provision of advertising and marketing services for products, including drugs, dietary supplements that are supposed to improve the health of patients all over the world. The company Bausch Health Poland Sp. z o. o. belongs to the group of 10 largest pharmaceutical companies in Poland. Many medicinal products, including Macromax, are manufactured in Poland in compliance with the highest world quality standards.

How do antibiotics work and when should you use them? Check: Antibiotics – types, action, use and side effects [EXPLAIN]

Macromax – composition and action of the drug

The active substance of Macromax is azithromycin, which is an antibiotic from the macrolide group, a semi-synthetic derivative of erythromycin. Azithromycin was developed to avoid some of the disadvantages of erythromycin. One Macromax 500 film-coated tablet contains 500 mg of azithromycin.

The mechanism of action of the antibiotic it is the same as for the entire group of macrolides and consists in inhibiting the synthesis of bacterial proteins.

The organisms usually sensitive to azithromycin are aerobic Gram-positive bacteria: Staphylococcus aureus susceptible to methicillin, Streptococcus pneumoniae susceptible to penicillin, Streptococcus pyogenes (group A); Gram-negative aerobes: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Escherichia coli ETEC, Escherichia coli EAEC; anaerobic bacteria: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromanas spp.; other microorganisms: Borrelia burgdorferi, Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae.

The process of action of the drug Macromax works by blocking the bacterial ribosomes, the cellular structures necessary for protein synthesis. As a result, the growth and multiplication of bacteria is prevented.

Azithromycin is well absorbed and penetrates rapidly from the serum into the tissues, accumulating in phagocytes that migrate to the site of infection, increasing the distribution of the drug to inflamed tissues. Bioavailability is approx. 37%.

The maximum plasma concentration occurs 2-3 hours after oral administration. Azithromycin reaches significantly (up to 50-fold) higher tissue concentrations than in plasma.

It is metabolized in the liver, excreted primarily with bile (unchanged and in the form of metabolites).

The other auxiliary components of the antibiotic are:

1. microcrystalline cellulose;
2. croscarmellose sodium;
3. powidon K25;
4. magnesium stearate;
5. colloidal anhydrous silica.

In addition, the tablet shell consists of:

1. basic butyl methacrylate copolymer (Eudragit E PO);
2. cleanup;
3. titanium dioxide (E 171);
4. dibutylu sebacynianu;
5. sodium lauryl sulfate;
6. polysorbate 80;
7. indigotine (E 132);
8. in demand.

Macromax – indications for use

Macromax antibiotic is indicated for the treatment of diseases caused by microorganisms sensitive to azithromycin. Among them stand out:

1. skin and soft tissue infections: erysipelas, impetigo, secondary dermatitis;
2. migrating erythema;
3. lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, mild to moderately severe pneumonia (including interstitial pneumonia);
4. upper respiratory tract infections: bacterial pharyngitis, sinusitis, tonsillitis;
5. acute otitis media;
6. moderately severe acne vulgaris in adults;
7. sexually transmitted diseases caused by Chlamydia trachomatis.

What bacterial diseases are most often diagnosed? Check: The most common bacterial diseases – overview and characteristics

Macromax – contraindications to use

The Macromax antibiotic, although there are indications for its use, may not always be used in every patient.

The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to the active substance azithromycin or excipients of the drug, erythromycin and other macrolide or ketolide antibiotics.

Contraindications to the use of Macromax also include some diseases and circumstances that may require you to completely abandon this drug or change the dosage of the preparation.

The use of an antibiotic may require specific check-ups and a thorough medical history.

The use of Macromax should be consulted with a doctor or pharmacist if:

1. you have conditions conducive to the development of arrhythmias (especially in women and the elderly) including: severe heart failure, congenital or ever existing cardiac arrhythmias seen on an ECG, very slow heartbeat (bradycardia), electrolyte disturbances especially low levels of potassium and magnesium, other drugs are taken that may prolong the QT interval of the electrocardiogram;
2. you have a sexually transmitted disease: your doctor should make sure you do not have syphilis infection;
3. the patient is taking ergotamine derivatives (ergot preparations);
4. you have severe liver problems, your doctor may monitor your liver function or stop treatment;
5. you have a new infection which may be a sign of an overgrowth of resistant microorganisms or a fungal infection;
6. you have severe kidney problems;
7. you have nervous (neurological) or mental (mental) disorders;
8. the patient has infected burn wounds.

In the case of the above circumstances or if you have any doubts, consult your doctor or pharmacist before taking an antibiotic.

What should you know about drug hypersensitivity? Check: Drugs are also allergenic

Macromax – possible side effects

Macromax, like any antibiotic, can cause side effects that do not have to occur in every person using this medicine.

After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The side effects are usually mild and transient, and the expected benefits of the drug are usually greater than the harm resulting from the side effects.

Side effects may appear while taking, but also up to several weeks after discontinuing the drug.

The most common side effect is the risk of superinfection with resistant bacteria or yeasts during long-term use of the antibiotic.

Among the possible side effects that may occur with the use of Macromax are:

1. Very common (more than 1 in 10 patients): diarrhea;
2. Common (less than 1 in 10 patients): headache, vomiting, abdominal pain, nausea, change in the number of white blood cells, decreased blood bicarbonate;
3. Uncommon (less than 1 in 100 patients): yeast infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastroenteritis, respiratory distress, rhinitis, oral yeast infection, changes in the blood count of different types of white blood cells (decreased number of white blood cells, neutrophils, increased eosinophils), angioedema (swelling of the face and throat with difficulty breathing), hypersensitivity, anorexia, nervousness, insomnia, dizziness, somnolence, taste disturbance, paraesthesia (abnormal sensation – tingling, prickling or numbness of the skin) , visual disturbance, ear and balance disorders, palpitations, hot flush, shortness of breath, nosebleed, constipation, flatulence, indigestion, gastritis, dysphagia, abdominal distension, dry mouth, belching stomach ulceration, salivation, rash, itching, hives, dermatitis , dry skin, excessive sweating, osteoarthritis, muscle pain, back pain, neck pain, painful urination, kidney pain, uterine haemorrhage, testicular dysfunction, swelling, weakness (asthenia), malaise (apathy), fatigue, face swelling, chest pain, fever, pain, peripheral edema, laboratory abnormalities (e.g. blood parameters or liver function, glucose levels, electrolytes), complications after procedures;
4. Rare (less than 1 in 1000 patients): agitation, liver dysfunction, jaundice with cholestasis (cholestatic), photosensitivity, severe skin reactions: acute generalized pustular eruption with rapid reddening of the skin with small pustules (vesicles filled with white or yellow fluid);
5. Unknown frequency of occurrence: anaphylactic reaction (a generalized allergic reaction rarely fatal; may develop with symptoms such as swelling of the lips, face or neck leading to severe difficulty breathing, skin rash or hives), aggressive behavior, anxiety, delirium, hallucinations, loss of consciousness (fainting), seizures, abnormal sensation, excessive psychomotor activity, lack of smell, taste, problems with the sense of smell, rapid muscle fatigue (myasthenia gravis), hearing problems including deafness or tinnitus, abnormal heart rhythm including severe acceleration of the heart rhythm (torsade de pointes, ventricular tachycardia), electrocardiogram QT prolonged, low blood pressure, pancreatitis, tongue discoloration, severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS), joint pain, liver failure, rarely fatal, lightning hepatitis, liver necrosis, acute kidney failure, interstitial nephritis, pseudomembranous colitis, thrombocytopenia (reduction in blood platelets), decreased number of red blood cells (haemolytic anemia).

The use of Macromax should be discontinued and the doctor should be informed immediately if the patient develops:

1. swelling of the hands, feet, ankles, lips, face or throat which may cause difficulty in swallowing or breathing;
2. drop in blood pressure;
3. itchy skin and hives.

These could be signs of a severe allergic reaction (angioedema or anaphylactic reaction).

In addition, severe skin reactions occurring during or after treatment with Macromax, such as blistering of the skin, mouth, eyes and genitals, peeling skin, rash, reddening of the skin, swelling of the skin and mucous membranes, acute generalized rash pustular eruptions require an immediate visit to the doctor.

On the other hand, the following: severe diarrhea with blood or mucus, uterine hemorrhage, rapid or irregular heartbeat and rapidly progressive weakness with simultaneous jaundice, dark-colored urine, bleeding tendency may be symptoms of liver failure, fulminant hepatitis or liver necrosis also require an immediate visit at the doctor.

What causes an antibiotic rash? Read on: Antibiotic rash – is it an allergy symptom?

Macromax – dosage and method of use

Always take Macromax being an antibiotic exactly as your doctor or pharmacist has told you. The doctor selects the dose of the drug individually, taking into account the patient’s age and weight, indications, the severity of the infection, the sensitivity of microorganisms and the patient’s condition. In some patient groups, additional dosage adjustments are necessary.

Standardly recommended is 1 dose daily, taken regardless of meals. Macromax 500 mg film-coated tablets are intended for adults and children weighing more than 45 kg.

If you are using an antibiotic:

1. in respiratory tract infection, otitis media, skin and soft tissue infections except erythema migrans and acne vulgaris, the total dose over 8 days is 1,5 g (500 mg once a day);
2. in migratory erythema, the total dose is 3 g and it should be administered according to the following schedule: the first day of treatment 1 g (2 tablets of 500 mg) and from the second to the fifth day: 500 mg (1 tablet);
3. For moderate acne vulgaris: in adults only, the total dose is 6 g and the recommended dose is as follows: 1 tablet of 500 mg once daily for 3 days, then 1 tablet of 500 mg once a week for 9 consecutive weeks. In the second week of treatment, the drug should be taken 7 days after the first dose, and the next eight doses should be taken at 7-day intervals;
4. in uncomplicated Chlamydia trachomatis infection: 1 g (2 film-coated tablets of 500 mg) as a single dose.

When Macromax is used in children and adolescents, the drug in the form of orodispersible tablets can be used at the recommended dose of 10 mg / kg body weight once a day for 3 days.

Elderly patients do not require dose reduction, but only caution in use due to a higher risk of arrhythmias.

The preparation is intended for oral use. Place the tablet on the tongue where it will dissolve in saliva, or dissolve it in a tablespoon of water before administration. The dose should be swallowed immediately after dissolving the tablet and washed down with a glass of water, regardless of the meal.

Do not exceed the recommended doses, because it does not increase the effectiveness of the drug, and may be harmful to health and life. If you have any doubts about the use of the preparation, consult your doctor.

How to take medication correctly? Check: How to take medications effectively?

Macromax – interaction with other medicinal products

The initiation of treatment with the use of Macromax antibiotic requires a detailed interview with regard to all currently and recently taken medications, including over-the-counter medications.

The use of certain drugs at the same time as Macromax can cause serious side effects.

Before taking the drug, tell your doctor or pharmacist about all the drugs you are taking, or have recently taken, and about the drugs you plan to start taking.

Macromax must not be used simultaneously with ergot alkaloids (ergotamine, dihydroergotamine), as ergotism may occur. The symptoms of poisoning are vasospasm, ischemia of the limbs and other tissues, including the central nervous system.

Particular care should be taken with drugs such as class IA and III antiarrhythmics (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol), antihistamines (e.g. terfenadine), cisapride, antipsychotics (e.g. phenothiazines, pimozide, haloperidol) ), antidepressants (e.g. citalopram), fluoroquinolones (e.g. levofloxacin, moxifloxacin).

These drugs, in combination with the antibiotic Macromax, may increase the risk of developing ventricular arrhythmias, including torsades de pointes, which are immediately life-threatening.

In addition, caution should be exercised when using Macromax simultaneously with drugs such as:

1. astemizole, alfentanil, the effects of which may be increased by antibiotics;
2. digoxin (in the treatment of cardiac dysfunction) and colchicine (in the treatment of gout and familial Mediterranean fever), the antibiotic may increase the concentration and intensification of the toxic effects of the simultaneous use of digoxin and colchicine;
3. rifabutin; parallel use may reduce the number of neutrophils (neutrophils), that is, neutropenia;
4. terfenadyna;
5. theophylline; the antibiotic may increase the level of theophylline in the blood;
6. nelfinavir, may increase the levels of azithromycin;
7. cyclosporine, the toxicity may be increased under the influence of an antibiotic;
8. zidovudine, the concentration of the active metabolite zidovudine in some peripheral blood cells may increase under the influence of azithromycin;
9. statins (e.g. atorvastatin), there is a risk of rhabdomyolysis, a symptom complex of rhabdomyolysis
10. cisapride, there is a risk of prolongation of the QT interval on the ECG and the occurrence of torsades de pointes, which are immediately life-threatening;
11. oral anticoagulants from the coumarin derivative group (e.g. warfarin), azithromycin may increase the effect of anticoagulants;
12. antacids may affect the absorption of azithromycin (reduce the peak concentration without affecting the absolute bioavailability).

Which drugs should never be combined with each other? Check: Dangerous interactions

Macromax – warnings and precautions

Taking Macromax antibiotic requires special care. The use of this drug must be discussed with a physician who will individually assess the risks that may be associated with the use of this antibiotic in the treatment of the patient’s condition.

The use of an antibiotic may cause serious hypersensitivity reactions that can be life-threatening, including: angioedema, anaphylactic reactions and severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular eruption, or reaction to drugs with eosinophilia and eosinophilia. systemic symptoms.

If the above reactions appear, consult a physician immediately, who may order the preparation to be discontinued immediately and appropriate symptomatic treatment initiated.

In addition, liver dysfunction, including fulminant hepatitis, leading to life-threatening liver failure, may occur during antibiotic use. This may result in hepatitis, cholestatic jaundice, liver necrosis, and liver failure, sometimes with death. Therefore, caution should be exercised when using Macromax.

If you notice liver dysfunction (e.g. dark urine, jaundice, fatigue and weariness, bleeding tendency, itching, abdominal pain, anorexia, nausea and vomiting), consult your doctor immediately, who will test your liver function and assess whether it is necessary to stop using the preparation.

Particular caution should be exercised in people with severe liver disease and in people taking other drugs that may have a toxic effect on the liver (hepatotoxic drugs).

Caution is also recommended in cases of:

1. patients with severe renal impairment;
2. patients with conditions conducive to the development of arrhythmias (especially important in women and the elderly): decreased heart rate (bradycardia), arrhythmias, ischemic heart disease, severe heart failure, impulse conduction disturbances in the heart, electrolytes such as e.g. decreased levels of magnesium (hypomagnesaemia) or potassium (hypokalaemia), prolonged QT interval on the ECG, history of a history of ventricular arrhythmias, taking medications that prolong the QT interval, antihistamines, antidepressants,
3. patients with sexually transmitted diseases (the doctor should make sure that there is no co-infection with syphilis).

The use of antibiotics can cause the overgrowth of resistant bacteria and fungi.

It is recommended to be monitored for symptoms of new infections during the treatment period. If new bacterial or fungal infections (e.g. yeast infections) appear during the application period, a doctor should be consulted immediately.

Particular precautions should be taken if diarrhea occurs during the use of Macromax. There is a risk of pseudomembranous enteritis, sometimes severe and life-threatening. Its clinical symptoms (such as, for example, watery stools with blood and mucus, dull, diffuse or colic abdominal pain, fever, periodic urge to stool) are caused by Clostridium difficile, which can multiply when the normal intestinal flora is disturbed .

Therefore, you should not treat diarrhea yourself, but consult a doctor as soon as possible, who will apply the appropriate pharmacological treatment.

People with neurological or mental disorders and people driving vehicles should also exercise caution, as the drug may cause dizziness or convulsions.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, exercise caution and ask your doctor or pharmacist for advice before taking this medicine.

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