Novozithron exhibits significant intracellular penetration and concentrates within phagocytes and fibroblasts, thus the levels in tissues are much greater than in plasma. This drug has a long half-life in children (32 to 64 hours). Through selective uptake by fibroblasts and phagocytic cells, tissue concentrations may be 100 to 1000 times that of blood. 7 Novozithron is available in 250-, 500-, and 600-mg oral tablets and as a 100-mg/5 mL and 200-mg/5 mL powder for suspension. IV Novozithron is sometimes combined with an IV β-lactam when atypical pathogens are suspected for inpatients with community-acquired pneumonia. 8
The most common adverse effects in pediatric patients receiving Novozithron are GI effects which are dose-related. Novozithron is not appreciably metabolized.
What is the most important information I should know about Novozithron?
You should not use Novozithron if you have ever had an allergic reaction, jaundice, or liver problems while taking this medicine. You should not use Novozithron if you have ever had a severe allergic reaction to similar drugs such as clarithromycin, erythromycin, or telithromycin.
What should I discuss with my healthcare provider before using Novozithron?
You should not use Novozithron if you are allergic to it, or if you have ever had:
- jaundice or liver problems caused by taking Novozithron; or
- a severe allergic reaction to similar drugs such as clarithromycin, erythromycin, or telithromycin.
Novozithron oral should not be used to treat pneumonia in people who have:
- cystic fibrosis;
- an infection after being in a hospital;
- an infection in the blood;
- a weak immune system (caused by diseases such as HIV/AIDS or cancer); or
- in older adults and those who are ill or debilitated.
Tell your doctor if you have ever had:
- liver or kidney disease;
- myasthenia gravis;
- low levels of potassium in your blood;
- a heart rhythm disorder; or
- long QT syndrome (in you or a family member).
It is not known whether this medicine is effective in treating genital ulcers in women.
Tell your doctor if you are pregnant or breastfeeding. Taking Novozithron while breastfeeding may cause diarrhea, vomiting, or rash in the nursing baby.
Novozithron is not approved for use by anyone younger than 6 months old. Novozithron should not be used to treat a throat or tonsil infection in a child younger than 2 years old.
Novozithron and Alcohol
Alcohol may increase or worsen certain side effects caused by Novozithron, such as dizziness and upset stomach.
In Study 155, discontinuations for drug-related toxicity occurred in 8.2% of subjects treated with Novozithron and 2.3% of those given placebo (p=0.121). In Study 174, more subjects discontinued from the combination of Novozithron and rifabutin (22.7%) than from Novozithron alone (13.5%; p=0.026) or rifabutin alone (15.9%; p=0.209).
The most common side effects of Novozithron are:
Other possible side effects of Novozithron include:
Possible serious side effects of Novozithron include:
Antibiotics can alter the normal bacteria in the colon and encourage overgrowth of some bacteria such as Clostridium difficile, which causes inflammation of the colon (pseudomembranous colitis). Patients who develop signs of pseudomembranous colitis after starting Novozithron (diarrhea, fever, abdominal pain, and possibly shock) should contact their physician immediately.
Brand Names: Novozithron 3 Day Dose Pack, Novozithron 5 Day Dose Pack, Zithromax, Zithromax IV, Zithromax TRI-PAK, Zithromax Z-Pak
4.5 Determination in body flu > Novozithron concentrations versus time profiles in extracellular space of muscle and subcutaneous adipose tissue, also in plasma and white blood cells, were determined at days 1 and 3 of treatment as well as 2 and 7 days after end of treatment. Of all compartments, Novozithron concentrations were highest in white blood cells, attesting for intracellular accumulation. However, Novozithron concentrations in both soft tissues were markedly lower than in plasma both during and after treatment. Novozithron concentrations were measured by subinhibitory at all time points in both soft tissues and at the large majority of observed time points in plasma .
What if I take too much?
Taking an extra dose of Novozithron by accident is unlikely to harm you or your child. It may, however, increase the chance of temporary side effects, such as feeling or being sick or diarrhoea.
Talk to your pharmacist or doctor if you're worried, or if you or your child accidentally take more than 1 extra dose.
Like all medicines, Novozithron can cause side effects, although not everyone gets them.