Roxithromycinum Uses, Dosage, Side Effects, Food Interaction and all others data.

Roxithromycinum inhibits protein synthesis by irreversibly binding to the 50s ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.

Roxithromycinum has the following antibacterial spectrum in vitro: Streptococcus agalactiae, Streptococcus pneumoniae (Pneumococcus), Neisseria meningitides (Meningococcus), Listeria monocytogenes, Mycoplasma pneumoniae, Chlamydia trachomatis, Ureaplasma urealyticum, Legionella pneumophila, Helicobacter (Campylobacter), Gardnerella vaginalis, Bordetella pertussis, Moraxella catarrhalis (Branhamella Catarrhalis), and Haemophilus ducreyi. Roxithromycinum is highly concentrated in polymorphonuclear leukocytes and macrophages, achieving intracellular concentrations greater than those outside the cell. Roxithromycinum enhances the adhesive and chemotactic functions of these cells which in the presence of infection produce phagocytosis and bacterial lysis. Roxithromycinum also possesses intracellular bactericidal activity.

Trade Name Roxithromycinum
Generic Roxithromycin
Roxithromycin Other Names Roxithromycin, Roxithromycine, Roxithromycinum, Roxitromicina
Formula C41H76N2O15
Weight Average: 837.0465
Monoisotopic: 836.524569772
Protein binding

96%, mainly to alpha1-acid glycoproteins

Groups Approved, Investigational, Withdrawn
Therapeutic Class Macrolides
Available Country
Last Updated: September 19, 2023 at 7:00 am


Roxithromycinum is used for the treatment of infections caused by susceptible microorganisms;

Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia

ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.

Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.

Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.

Roxithromycinum, is a macrolide with antibacterial properties similar to erythromycin. It is active against Gram-positive bacteria like staphylococci, streptococci, listeria, corynebacteria; Gram-negative bacteria such as gonococci, Haemophilus influenzae, Haemophilus ducreyi, Legionella, campylobacter, and atypical pathogens like Mycoplasma and Chlamydia. Roxithromycinum has been found useful in the treatment of upper and lower respiratory tract infection, otorhinolaryngological, skin, dental and genital infections. It is well tolerated by adults and children.

Roxithromycinum is also used to associated treatment for these conditions: Lower Respiratory Tract and Lung Infections, Respiratory Tract Infections (RTI), Skin Infections, Ear, nose, and throat infections

How Roxithromycinum works

Roxithromycinum prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.


Roxithromycinum dosage

Adult dose: The usual dose for adults is one 300 mg tablet once daily or one 150 mg tablet twice a day for at least two days after resolution of symptoms, a normal course of therapy is between 5 and 10 days. Roxithromycinum is best administered on empty stomach. In severe hepatic impairment the dose is 150 mg once daily.

Pediatric dose: The dose for children is 2.5 to 5 mg/kg body weight twice a day. The following general guidelines can be followed

  • 6 to 11 Kg: 25 mg Roxithromycinum 12 hourly.
  • 12 to 23 Kg: 50 mg Roxithromycinum 12 hourly.
  • 24 to 40 Kg: 100 mg Roxithromycinum 12 hourly.

A normal course of therapy is between 5 and 10 days.

Side Effects

Roxithromycinum is well tolerated by patients of all age groups. Less than 4% of treated patients complain of side effects mainly nausea, abdominal pain, diarrhoea and hypersensitivity rash. Other side effects reported include vomiting, dizziness, headache, pruritus, dyspepsia, flatulence, tinnitus, vertigo and constipation. These are in general minor and do not necessitate withdrawal of therapy.


Roxithromycinum primarily causes gastrointestinal adverse events, such as diarrhoea, nausea, abdominal pain and vomiting. Less common adverse events include headaches, rashes, abnormal liver function values and alteration in senses of smell and taste.


Roxithromycinum should not be used in patients with a history of hypersensitivity to the drug. In patients with hepatic diseases the dose of Roxithromycinum should not exceed 150 mg twice a day.


Roxithromycinum does not have any affinity for cytochrome P-450 binding sites and thus is unlikely to produce drug interaction mediated by this enzymatic system. Roxithromycinum shows mild interaction with theophylline though this has not been found to produce clinically relevant effects. Alteration in the pharmacokinetics of carbamazepine or warfarin has not been found. Antacids, H2- receptor antagonists and food has no effect on the absorption of Roxithromycinum.

Elimination Route

Very rapidly absorbed and diffused into most tissues and phagocytes.

Half Life

12 hours

Pregnancy & Breastfeeding use

The safety of Roxithromycinum in pregnancy has not been established. It appears in breast milk in small amounts and dose not produce adverse effects in the breast fed infant.


Roxithromycinum should not be administered simultaneously with ergotamine or its derivatives as it may provoke arterial spasm and severe ischaemia.

Innovators Monograph

You find simplified version here Roxithromycinum

Roxithromycinum contains Roxithromycin see full prescribing information from innovator Roxithromycinum Monograph, Roxithromycinum MSDS, Roxithromycinum FDA label


What is Roxithromycinum used for?

Roxithromycinum is used to treat infections such as infections of the chest, tonsils, skin or genitals.

How safe is Roxithromycinum?

There were no toxic effects. Roxithromycinum should be considered as an effective and safe oral antibiotic to treat children with upper and lower respiratory tract and skin infections due to common pathogens.

How does Roxithromycinum work?

Roxithromycinum works by killing or stopping the growth of bacteria .

What are the common side effects of Roxithromycinum?

The common side effects of Roxithromycinum are;nausea, vomiting, stomach pain, diarrhoea, flatulence, loss of appetite. red or itchy skin, skin rash. headache, tiredness, dizziness, pins and needles, ringing in the ears.

Is Roxithromycinum safe during pregnancy?

Roxithromycinum a macrolide antibiotic, is regarded as inadvisable to use during pregnancy due to lack of safety data.

Is Roxithromycinum safe during breastfeeding?

Roxithromycinum is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Because of the low levels of Roxithromycinum in breastmilk, it would not be expected to cause adverse effects in breastfed infants.

Can I drink alcohol with Roxithromycinum?

Drinking alcohol while taking antibiotics can raise your risk of these harmful effects. If the label on your drug says not to drink alcohol during treatment, follow that advice.

Can I drive after taking Roxithromycinum?

You should not drive or operate machinery if you're taking an antibiotic that makes you drowsy.

When is the best time to take Roxithromycinum?

Roxithromycinum should be taken at least 15 minutes before food or on an empty stomach (i.e. more than 3 hours after a meal).Roxithromycinum works best if you take it on an empty stomach.

What happen If I missed Roxithromycinum?

If you forget to take your dose, remember to take it as soon as possible. However, if your next dose is approaching, simply take it at the scheduled time. Do not take two doses at once as it can increase the chance of getting some unwanted side effects.

What happen if I overdose of Roxithromycinum?

Overdose of a drug can be accidental. If you have taken more than the prescribed Roxithromycinum tablets there is a chance of getting a harmful effect on your body’s functions. Overdose of a medicine can lead to some medical emergency.

Can Roxithromycinum treat urine infection?

Roxithromycinum works as an antibacterial agent by binding to the bacterial ribosome and disrupting protein synthesis. It's used for the treatment of infections related to the respiratory tract, urinary tract, and soft tissues.

What happens if I take Roxithromycinum with food?

Taking it at the same time each day will have the best effect. It will also help you remember when to take it. Take your medicine on an empty stomach, for example, at least 15 minutes before food or at least 3 hours after food. Food can interfere with the absorption of this medicine.

How long do the effects of Roxithromycinum last?

The effect of Roxithromycinum tablets lasts for an average duration of 12 hours.

How long does it take for Roxithromycinum to take effect?

You will start to feel better in 3 to 5 days after taking the Roxithromycinum tablet. Finish your entire course of treatment, even if the condition gets better.

Can Roxithromycinum causes diarrhoea?

Roxithromycinum can cause diarrhoea because it may also kill the helpful bacteria in your stomach or intestine. Get emergency medical help if you experience severe diarrhoea that is watery or bloody. Call your pharmacist/doctor before taking anti-diarrhoeal medication.

Can Roxithromycinum causes vaginal thrush?

Roxithromycinum Tablet can cause itching and burning sensations in the vagina and may cause an abnormal discharge as well. Contact your doctor if such symptoms are experienced while using this medicine.

Can Roxithromycinum causes mouth sores?

Roxithromycinum can cause mouth sores that may appear while using or soon after discontinuing the use. Contact your doctor if have sores in the mouth or swelling of the lips or tongue.

What happens if I overdose on Roxithromycinum?

Seek emergency medical attention.

*** Taking medicines without doctor's advice can cause long-term problems.