On this page
- About Abbotic
- Key facts
- Who can and can't take Abbotic
- How and when to take it
- Side effects
- How to cope with side effects
- Pregnancy and breastfeeding
- Cautions with other medicines
- Common questions
BIAXIN Granules For Oral Suspension In Pediatric Patients
Abbotic penetrates into the middle ear fluid of pediatric patients with secretory otitis media.
Table 10: Middle Ear Fluid and Serum Concentrations of Abbotic and 14-OH-Abbotic in Pediatric Patients
When pediatric patients (n = 10) were administered a single oral dose of 7.5 mg/kg BIAXIN as an oral suspension, food increased mean peak plasma Abbotic concentrations from 3.6 (± 1.5) mcg/mL to 4.6 (± 2.8) mcg/mL and the extent of absorption from 10.0 (± 5.5) hr•mcg/mL to 14.2 (± 9.4) hr•mcg/mL.
In pediatric patients requiring antibacterial therapy, administration of 7.5 mg/kg every 12 hours of BIAXIN as an oral suspension generally resulted in steady-state peak plasma concentrations of 3 mcg/mL to 7 mcg/mL for Abbotic and 1 mcg/mL to 2 mcg/mL for 14-OH Abbotic.
In HIV-infected pediatric patients taking 15 mg/kg of BIAXIN as an oral suspension every 12 hours, steady-state Abbotic peak concentrations generally ranged from 6 mcg/mL to 15 mcg/mL.
Steady-state concentrations of Abbotic and 14-OH Abbotic observed following administration of 500 mg doses of Abbotic every 12 hours to adult patients with HIV infection were similar to those observed in healthy volunteers. In adult HIV-infected patients taking 500-mg or 1000-mg doses of Abbotic every 12 hours, steady-state Abbotic Cmax values ranged from 2 mcg/mL to 4 mcg/mL and 5 mcg/mL to 10 mcg/mL, respectively.
The steady-state concentrations of Abbotic in subjects with impaired hepatic function did not differ from those in normal subjects; however, the 14-OH Abbotic concentrations were lower in the hepatically impaired subjects. The decreased formation of 14-OH Abbotic was at least partially offset by an increase in renal clearance of Abbotic in the subjects with impaired hepatic function when compared to healthy subjects.
The pharmacokinetics of Abbotic was also altered in subjects with impaired renal function .
How should Abbotic be stored?
- Store Abbotic tablets at room temperature, 68°F to 77°F (20°C to 25°C). Protect the tablets from light.
- Store Abbotic granules for oral suspension below 77ºF ( 25ºC). After mixing Abbotic granules with water as instructed by your health care provider or pharmacist, do not refrigerate the mixture (also called an oral suspension). Store the oral suspension between 59ºF and 86ºF (15ºC to 30ºC) and use within 14 days.
- Keep Abbotic in the container that it came in and keep the container tightly closed.
- Do not use Abbotic if the original seal over the container opening is broken or missing.
- Throw away Abbotic that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Abbotic and all medicines out of reach of children.
How to use Abbotic
Take this medication by mouth with or without food as directed by your doctor, usually every 12 hours. If stomach upset occurs, you may take it with food or milk.
For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.
The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage may also be based on weight.
If you are using this medication to treat an infection, continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition persists or worsens.
If you are taking this medication to prevent certain bacterial infections, take it exactly as directed by your doctor. Do not stop taking the medication without your doctor's approval. Tell your doctor if you develop signs of infection such as fever or night sweats.
Following administration of fluconazole 200 mg daily and Abbotic 500 mg twice daily to 21 healthy volunteers, the steady-state Abbotic Cmin and AUC increased 33% and 18%, respectively. Abbotic exposures were increased and steady-state concentrations of 14-OH Abbotic were not significantly affected by concomitant administration of fluconazole.
What Is Abbotic (Biaxin)?
Abbotic is the generic form of the brand-name prescription drug Biaxin, an antibiotic used to treat bacterial infections.
Abbotic is often used for pneumonia, bronchitis, and infections of the ears, sinuses, skin and throat. It is also used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection, which is a type of lung infection that often occurs in patients with HIV.
The drug may also be used in combination with other medicines to eliminate H. pylori - a bacterium that causes ulcers. It is sometimes used to treat other types of infections including Lyme disease, cryptosporidiosis, cat scratch disease, Legionnaires' disease, and pertussis (whooping cough). It is occasionally used to prevent heart infections in people having dental or other procedures.
Abbotic is in a class of medications known as macrolide antibiotics. It works by stopping the growth of bacteria. Like all antibiotics, it cannot kill viruses that cause colds, flu or other viral infections.
Researchers from the Japanese drug company Taisho Pharmaceutical developed Abbotic in the 1970s. In 1985, Taisho partnered with the American company Abbott Laboratories for the international rights, and Abbott gained FDA approval for Biaxin in October, 1991. The drug went generic in the United States in 2005.
You should continue to take Abbotic until your prescription is finished, even if you feel better. Stopping this medication too soon or skipping doses can prevent your infection from being treated completely, and the bacteria may become resistant to antibiotics.
Rated Abbotic for Skin And Skin Structure Infections Report
Omg i will never take this again.I was bitten by a cat and my finger did swell 2x the size & within 4 hours,was weeping gloop.Nurse cleaned & strapped it & dr gave me this nasty pill. i am allergic to penicillin so this was next on list.1st & 2nd dose was ok then felt awful & felt the need2eat but that made me feel worse.That day,out of 24 hours,i slept for 19 hours.I went super cold,then melting & repeat & also then had the most disgusting taste in my mouth.I didnt take anymore-my finger may fall off lol but at least i now feel human
- Chlamydophila pneumoniae
- Helicobacter pylori
- Mycobacterium avium complex (MAC) consisting of M. avium and M. intracellulare
- Mycoplasma pneumoniae
At least 90 percent of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the Abbotic susceptible MIC breakpoint for organisms of similar type to those shown in Table 11. However, the efficacy of Abbotic in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.
Before taking this medicine
You should not use this medicine if you are allergic to Abbotic or similar medicines such as azithromycin (Zithromax, Z-Pak, Zmax), erythromycin, or telithromycin, or if:
you have had jaundice or liver problems caused by taking Abbotic; or
you have liver or kidney disease and you also take a medicine called colchicine.
Some medicines can cause unwanted or dangerous effects when used with Abbotic. Your doctor may need to change your treatment plan if you use any of the following drugs:
To make sure this medicine is safe for you, tell your doctor if you have ever had:
long QT syndrome (in you or a family member);
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).
Abbotic may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant.
In animal studies, Abbotic caused birth defects. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.
Abbotic can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.
This medicine is not approved for use by anyone younger than 6 months old.
BIAXIN Filmtab Immediate-Release Tablets
The absolute bioavailability of 250 mg Abbotic tablets was approximately 50%. For a single 500 mg dose of Abbotic, food slightly delays the onset of Abbotic absorption, increasing the peak time from approximately 2 to 2.5 hours. Food also increases the Abbotic peak plasma concentration by about 24%, but does not affect the extent of Abbotic bioavailability. Food does not affect the onset of formation of the active metabolite, 14-OH Abbotic or its peak plasma concentration but does slightly decrease the extent of metabolite formation, indicated by an 11% decrease in area under the plasma concentration-time curve (AUC). Therefore, BIAXIN Filmtab may be given without regard to food. In non-fasting healthy human subjects (males and females), peak plasma concentrations were attained within 2 to 3 hours after oral dosing.
BIAXIN XL Filmtab Extended-Release Tablets
Abbotic extended-release tablets provide extended absorption of Abbotic from the gastrointestinal tract after oral administration. Relative to an equal total daily dose of immediate-release Abbotic tablets, Abbotic extended-release tablets provide lower and later steady-state peak plasma concentrations but equivalent 24-hour AUCs for both Abbotic and its microbiologically-active metabolite, 14-OH Abbotic. While the extent of formation of 14-OH Abbotic following administration of BIAXIN XL Filmtab (2 x 500 mg tablets once daily) is not affected by food, administration under fasting conditions is associated with approximately 30% lower Abbotic AUC relative to administration with food. Therefore, BIAXIN XL Filmtab should be taken with food.
Figure 2: Steady-State Abbotic Plasma Concentration-Time Profiles
BIAXIN Granules For Oral Suspension
When 250 mg doses of Abbotic as BIAXIN as an oral suspension were administered to fasting healthy adult subjects, peak plasma concentrations were attained around 3 hours after dosing.
For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively.
In adults given 250 mg Abbotic as suspension (n = 22), food appeared to decrease mean peak plasma Abbotic concentrations from 1.2 (± 0.4) mcg/mL to 1.0 (± 0.4) mcg/mL and the extent of absorption from 7.2 (± 2.5) hr•mcg/mL to 6.5 (± 3.7) hr•mcg/mL.
What are the side effects of Abbotic?
Abbotic generally is well tolerated, and side effects usually are mild and transient. Common side effects of Abbotic are:
Other important side effects which are rare, but serious include:
Abbotic should be avoided by patients known to be allergic to Abbotic or other chemically-related macrolide antibiotics, such as erythromycin. Treatment with Abbotic and other antibiotics can alter the normal bacteria flora of the colon and permit overgrowth of C. difficile, a bacterium responsible for pseudomembranous colitis. Patients who develop pseudomembranous colitis as a result of antibiotics treatment may experience diarrhea, abdominal pain, fever, and sometimes even shock.
Rated Abbotic for Bronchitis- acute Report
Please do not take this drug. I had to end the course after 3- 500mg tablets, severe side effects, nightmares, insomnia, MUSCLE SPASMS, and these all can be PERMANENT as in forever lifelong symptoms. Many are living with life long symptoms that will SHORTEN YOUR LIFE SPAN. Serious issues such as change to rythm of the heart and CNS damage, Chronic Fatigue and a COGNITIVE IMPAIRMENTS that can be PERMANENT. I am just one of those unlucky enough to go for a doctor begging for help only to be poisned.