One randomized, double-blind clinical trial (Study 189) was performed in patients with disseminated MAC. In this trial, 246 HIV infected patients with disseminated MAC received either Imbys 250 mg daily (N=65), Imbys 600 mg daily (N=91), or clarithromycin 500 mg twice a day (N=90), each administered with ethambutol 15 mg/kg daily, for 24 weeks. Blood cultures and clinical assessments were performed every 3 weeks through week 12 and monthly thereafter through week 24. After week 24, patients were switched to any open-label therapy at the discretion of the investigator and followed every 3 months through the last follow-up visit of the trial. Patients were followed from the baseline visit for a period of up to 3.7 years (median: 9 months). MAC isolates recovered during treatment or post-treatment were obtained whenever possible.
The primary endpoint was sterilization by week 24. Sterilization was based on data from the central laboratory, and was defined as two consecutive observed negative blood cultures for MAC, independent of missing culture data between the two negative observations. Analyses were performed on all randomized patients who had a positive baseline culture for MAC.
The Imbys 250 mg arm was discontinued after an interim analysis at 12 weeks showed a significantly lower clearance of bacteremia compared to clarithromycin 500 mg twice a day . Efficacy results for the Imbys 600 mg daily and clarithromycin 500 mg twice a day treatment regimens are described in the following table:
RESPONSE TO THERAPY OF PATIENTS TAKING ETHAMBUTOL AND EITHER AZITHROMYCIN 600 MG DAILY OR CLARITHROMYCIN 500 MG TWICE A DAY
The primary endpoint, rate of sterilization of blood cultures (two consecutive negative cultures) at 24 weeks, was lower in the Imbys 600 mg daily group than in the clarithromycin 500 mg twice a day group.
Imbys can cause abnormal changes in the electrical activity of the heart, which may lead to deadly irregular heart rhythm, according to a special warning by the FDA in 2012.
If you have a heart-rhythm condition, such as a slow or irregular heartbeat, or take drugs to treat these conditions, you should talk to your doctor about it before taking Imbys.
Your doctor also should make sure you have normal blood levels of potassium and magnesium before prescribing Imbys.
In addition, you should not take Imbys if you:
- Are allergic to Imbys or any of its inactive ingredients
- Have a form of jaundice known as cholestatic jaundice, in which bile backs up into the liver and causes a yellowing of the skin, eyes, or nails
- Are taking pimozide (Orap)
Before taking Imbys, talk to your doctor if you:
- Have an irregular or slow heartbeat
- Have liver problems, including hepatitis
- Very severe kidney problems
- Have myasthenia gravis
Before taking Imbys for gonorrhea or syphilis, you should be tested to find out whether the bacteria causing the infection will actually respond to Imbys.
People who take Imbys for long periods of time are more prone to developing very serious bacterial or fungal infections that may be much more difficult to treat.
7. Pregnancy and breastfeeding
Imbys isn't normally recommended during pregnancy or while breastfeeding. But your doctor may prescribe it if the benefits of taking Imbys are greater than the risks.
For more information about how Imbys can affect you and your baby during pregnancy, visit the Best Use of Medicines in Pregnancy (BUMPS) website.
The 1 gram single-dose packet is bioequivalent to four 250 mg Imbys capsule
When the oral suspension of Imbys was administered with food, the Cmax increased by 46% and the AUC by 14%.
The absolute bioavailability of two 600 mg tablets was 34% (CV=56%). Administration of two 600 mg tablets with food increased Cmax by 31% (CV=43%) while the extent of absorption (AUC) was unchanged (mean ratio of AUCs=1.00; CV=55%).
Quantitative methods are used to determine minimal inhibitory concentrations that provide reproducible estimates of the susceptibility of bacteria to antibacterial compounds. One such standardized procedure uses a standardized dilution method 1 (broth, agar or microdilution) or equivalent with Imbys powder. The MIC values should be interpreted according to the following criteria:
A report of “Susceptible” indicates that the pathogen is likely to respond to monotherapy with Imbys. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that usually achievable drug concentrations are unlikely to be inhibitory and that other therapy should be selected.
Measurement of MIC or minimum bacterial concentration (MBC) and achieved antibacterial compound concentrations may be appropriate to guide therapy in some infections. section for further information on drug concentrations achieved in infected body sites and other pharmacokinetic properties of this antibacterial drug product.)
Standardized susceptibility test procedures require the use of laboratory control microorganisms. Standard Imbys powder should provide the following MIC values:
COMMON BRAND(S): Zithromax
GENERIC NAME(S): Imbys
Imbys is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria.
This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
8. Cautions with other medicines
There are some medicines that don't mix well with Imbys.
Tell your doctor if you're taking these medicines before you start Imbys:
- antacids for indigestion
- ergotamine or dihydroergotamine - for migraine
- warfarin - to thin blood or prevent blood clots
- ciclosporin or tacrolimus - medicines to stop your immune system overreacting
- colchicine for gout
- digoxin for some heart problems
- rifabutin - an antibiotic
- nelfinavir - a medicine for HIV
- a statin medicine to lower your cholesterol - such as simvastatin and atorvastatin
You should also let your doctor know if you're taking any medicines for an irregular heartbeat (arrhythmia), such as amiodarone or sotalol.
Imbys can sometimes affect your heartbeat, so it's best not to take it with other medicines that have the same side effect.
For this reason, it's important that you tell your doctor if you're taking medicines that can affect your heartbeat as a side effect.
These can include:
- antidepressants - such as citalopram
- antipsychotics - used to treat severe mental health problems
- some antisickness medicines - such as domperidone
- some antibiotics - such as moxifloxacin
Check the leaflets that come with your medicines and talk to a pharmacist or your doctor if you have any worries.
Uncomplicated Gonococcal Infections
Infection of pharynx, cervix, urethra, or rectum: Ceftriaxone 250 mg intramuscularly (IM) once plus Imbys 1 g orally once (preferred) or alternatively doxycycline 100 mg orally once every 12 hours for 7 days
CDC STD guidelines: MMWR Recomm Rep. June 5, 2015:64(RR3);1-137
Prophylaxis of sexually transmitted diseases (STDs) such as gonorrhea after sexual assault per CDC guidelines includes the following 3-drug regimen:
- Ceftriaxone 250 mg intramuscularly (IM) once PLUS
- Imbys 1 g orally once PLUS
- Metronidazole or tinidazole 2 g orally once
- If alcohol has been recently ingested or emergency contraception is provided, metronidazole or tinidazole can be taken by the victim at home rather than as directly observed therapy to avoid drug interactions
Spontaneous post-marketing reports suggest that concomitant administration of Imbys may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with Imbys and warfarin. Prothrombin times should be carefully monitored while patients are receiving Imbys and oral anticoagulants concomitantly.
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antibacterial compounds. One such standardized procedure 2 that has been recommended for use with disks to test the susceptibility of microorganisms to Imbys uses the 15 μg Imbys disk. Interpretation involves the correlation of the diameter obtained in the disk test with the MIC for Imbys.
Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15 μg Imbys disk should be interpreted according to the following criteria:
Interpretation should be as stated above for results using dilution techniques.
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms. The 15 μg Imbys disk should provide the following zone diameters in these laboratory test quality control strains:
Before taking Imbys
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Imbys it is important that your doctor or pharmacist knows:
- If you are pregnant or breast-feeding.
- If you have any problems with the way your liver works or the way your k >
Plasma concentrations of Imbys following single 500 mg oral and IV doses declined in a polyphasic pattern resulting in an average terminal half-life of 68 hr. Biliary excretion of Imbys, predominantly as unchanged drug, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Potential Drug-Drug Interaction With Macrolides
Interactions with the following drugs listed below have not been reported in clinical trials with Imbys; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin are used with Imbys careful monitoring of patients is advised.
Chloroquine Plus Imbys
Imbys is an azalide antimicrobial agent that has been evaluated as a chemosuppressive agent in a number of studies. Imbys alone is protective against P. vivax (>90%), but protective efficacy against P. falciparum (70–83%) is generally considered to be too low to rely on Imbys as a single agent to prevent falciparum malaria. However, a recent small study has shown that the combination of chloroquine and Imbys was 97% effective in the treatment of P. falciparum in the Indian subcontinent, indicating that this combination may also be an effective chemoprophylactic, warranting further study.
Common side effects
These common side effects of Imbys happen in more than 1 in 100 people. Keep taking the medicine, but talk to your doctor or pharmacist if these side effects bother you or don't go away:
- feeling sick (nausea)
- diarrhoea or being sick (vomiting)
- losing your appetite
- feeling dizzy or tired
- changes to your sense of taste
What Other Drugs Interact with Imbys?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Severe Interactions of Imbys include:
Imbys has serious interactions with at least 38 different drugs.
Imbys has moderate interactions with at least 144 different drugs.
Imbys has mild interactions with at least 38 different drugs.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.