What is Binozyt?
Binozyt, Azithromycin is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).
Binozyt belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Binozyt will not work for colds, flu, or other virus infections. Binozyt injection may be used for other problems as determined by your doctor.
Binozyt is available only with your doctor’s prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Binozyt is used in certain patients with the following medical condition:
- Trachoma (treatment).
What can Azithromycin be used for?
Azithromycin is an antibiotic. It’s widely used to treat chest infections such as pneumonia, infections of the nose and throat such as sinus infection (sinusitis), skin infections, Lyme disease, and some sexually transmitted infections.
Why azithromycin is given for 3 days?
Co-amoxiclav is frequently given as treatment for LRTI in children. Compliance is often a problem as it is usually given three times a day for 10 days. Because of the pharmacokinetic profile it is possible to administer azithromycin in a once-daily dose for 3 days.
Binozyt extended-release granules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of designated microorganisms in the specific conditions listed as follows.
Adults: Acute uncomplicated bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumonia.
Mild to moderate community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis. Binozyt is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to Binozyt, susceptibility tests should be performed when patients are treated with Binozyt). Data establishing efficacy of Binozyt in subsequent prevention of rheumatic fever are not available.
Pediatrics: Mild to moderate community-acquired pneumonia in pediatric patients 6 months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Binozyt and other antibacterial drugs, Binozyt should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Binozyt. Therapy with Binozyt may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.
How should I use Binozyt?
Use Binozyt drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Binozyt drops. Talk to your pharmacist if you have questions about this information.
- Binozyt drops is for use in the eye only. Do not swallow it.
- Wash your hands immediately before you use Binozyt drops.
- To use Binozyt drops, turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
- If a drop does not come out of the bottle when using your dose, repeat these steps.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- Do not wear contact lenses while you are using Binozyt drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
- To clear up your infection completely, use Binozyt drops for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Binozyt drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Binozyt drops.
Uses of Binozyt in details
Binozyt is an antibiotic used to treat bacterial infections of the nose, throat, lungs, bronchitis, ear, skin, soft tissues, and sexually transmitted genital and urinary infections.
How long does it take for azithromycin to work?
It takes 7 days for the medicine to work in your body and cure Chlamydia infection. If you have sex without a condom during the 7 days after taking the medicine, you could still pass the infection to your sex partners, even if you have no symptoms.
Can you drink on azithromycin 500mg?
Azithromycin is generally a safe drug. Drinking moderate amounts of alcohol (three drinks or fewer per day) doesn’t seem to reduce the effectiveness of this drug. However, combining azithromycin with alcohol could intensify your side effects. Remember, treatment with this drug is not very long.
Each film-coated tablet contains Azithromycin equivalent to Binozyt 500 mg.
Binozyt is a nitrogen-containing macrolide or azalide with actions and uses similar to those of erythromycin. Binozyt is derived from erythromycin. However, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Patients are advised to take Binozyt extended-release granules on an empty stomach (at least 1 hour before or 2 hours following a meal).
Adults: The recommended dose for adults is a single 2.0 g dose of Binozyt extended-release granules.
In the Phase 3 studies, no patient vomited within 5 minutes of dosing Binozyt extended-release granules. In the event that a patient vomits within 5 minutes of administration, additional antibiotic treatment can be considered since there would be minimal absorption of Binozyt. Since insufficient data exist on absorption of Binozyt if a patient vomits between 5 and 60 minutes following administration, alternative therapy should be considered. Neither a second dose of Binozyt extended-release granules nor alternative treatment is warranted if vomiting occurs ≥60 minutes following administration, in patients with normal gastric emptying. In patients with delayed gastric emptying, alternative therapy should be considered.
Pediatric Patients: For pediatric patients 6 months and older, Binozyt should be taken as a single dose of 60 mg/kg (equivalent to 27 mg/lb) body weight. The Binozyt dose in mL is equivalent to the child’s weight in lb (1 mL/lb dose, see Table 7), for a body weight of less than 75 lb (34 kg). It is recommended that Binozyt be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).
Pediatric patients weighing 75 lb (34 kg) or more should receive the adult dose (2 g).
Safety and effectiveness in the treatment of pediatric patients under 6 months of age have not been established.
Additional Treatment After Vomiting with Binozyt: In the event that a patient vomits within 5 minutes of administration, the health care provider should consider additional antibiotic treatment since there would be minimal absorption of Binozyt. Since insufficient data exist on absorption of Binozyt if a patient vomits between 5 and 60 minutes following administration, alternative therapy should be considered. Neither a second dose of Binozyt nor alternative treatment is warranted if vomiting occurs ≥60 minutes following administration, in patients with normal gastric emptying. In patients with delayed gastric emptying, alternative therapy should be considered.
Special Populations: In the
Elderly: No dosage adjustment is necessary in elderly patients requiring Binozyt therapy. Elderly patients may be more susceptible to the development of torsades de pointes arrhythmia than younger patients.
In Patients with Renal Impairment: No dosage adjustment is recommended for patients with mild-to-moderate renal impairment (GFR 10-80 mL/min). Caution should be exercised when Binozyt extended-release granules are administered to patients with severe renal impairment (GFR <10 mL/min).
In Patients with Hepatic Impairment: The pharmacokinetics of Binozyt in patients with hepatic impairment have not been established for Binozyt extended-release granules. Based on studies with immediate release-formulations, no dosage adjustment is recommended for patients with mild to moderate hepatic impairment. Binozyt should be used with caution in patients with severe hepatic impairment.
Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Binozyt, no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 24%. In patients receiving both Binozyt and antacids, the drugs should not be taken simultaneously. Co-administration of Binozyt extended-release granules for oral suspension with a single dose of 20 mL co-magaldrox (aluminum hydroxide and magnesium hydroxide) did not affect the rate and extent of Binozyt absorption.
Cetirizine: In healthy volunteers, co-administration of a 5-day regimen of Binozyt with 20 mg cetirizine at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.
Didanosine (Dideoxyinosine): Co-administration of 1,200 mg/day Binozyt with 400 mg/day didanosine in six HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared to placebo.
Digoxin: Concomitant administration of macrolide antibiotics, including Binozyt, with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if Binozyt and P-glycoprotein substrates such as digoxin are administered concomitantly, the possibility of elevated serum digoxin concentrations should be considered. Clinical monitoring, and possibly serum digoxin levels, during treatment with Binozyt and after its discontinuation are necessary.
Ergot: There is a theoretical possibility of interaction between Binozyt and ergot derivatives.
Zidovudine: Single 1,000 mg doses and multiple 1,200 mg or 600 mg doses of Binozyt had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Binozyt increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.
Binozyt does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with Binozyt.
Pharmacokinetic studies have been conducted between Binozyt and the following drugs known to undergo significant cytochrome P450-mediated metabolism.
Atorvastatin: Co-administration of atorvastatin (10 mg daily) and Binozyt (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). However, post-marketing cases of rhabdomyolysis in patients receiving Binozyt with statins have been reported.
Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Binozyt.
Cimetidine: In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before Binozyt, on the pharmacokinetics of Binozyt, no alteration of Binozyt pharmacokinetics was seen.
Oral Anticoagulants: In a pharmacokinetic interaction study, Binozyt did not alter the anticoagulant effect of a single dose of 15 mg warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of Binozyt and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when Binozyt is used in patients receiving coumarin-type oral anticoagulants.
Cyclosporin: In a pharmacokinetic study with healthy volunteers who were administered a 500 mg/day oral dose of Binozyt for 3 days and were then administered a single 10 mg/kg oral dose of cyclosporin, the resulting cyclosporin Cmax and AUC0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.
Efavirenz: Co-administration of a single dose of 600 mg Binozyt and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.
Fluconazole: Co-administration of a single dose of 1,200 mg Binozyt did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of Binozyt were unchanged by the co-administration of fluconazole; however, a clinically insignificant decrease in Cmax (18%) of Binozyt was observed.
Indinavir: Co-administration of a single dose of 1,200 mg Binozyt had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Binozyt had no significant effect on the pharmacokinetics of methylprednisolone.
Midazolam: In healthy volunteers, co-administration of 500 mg/day Binozyt for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam.
Nelfinavir: Co-administration of Binozyt (1,200 mg) and nelfinavir at steady-state (750 mg three times daily) resulted in increased Binozyt concentrations. No clinically significant adverse effects were observed and no dose adjustment was required. Although no dosage adjustment of Binozyt is recommended when administered with nelfinavir, close monitoring for known side effects of Binozyt, such as liver enzyme abnormalities and hearing impairment, is warranted.
Rifabutin: Co-administration of Binozyt and rifabutin did not affect the serum concentrations of either drug.
Neutropenia was observed in subjects receiving concomitant treatment of Binozyt and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Binozyt has not been established.
Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of Binozyt (500 mg daily for 3 days) on the AUC and Cmax of sildenafil or its major circulating metabolite.
Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Binozyt and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred.
Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when Binozyt and theophylline are co-administered to healthy volunteers.
Triazolam: In 14 healthy volunteers, co-administration of 500 mg Binozyt on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.
Trimethoprim/Sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with 1,200 mg Binozyt on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Binozyt serum concentrations were similar to those seen in other studies.
Incompatibilities: Not applicable.
Binozyt side effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Binozyt in 728 adult patients. All patients received a single 2 g oral dose of Binozyt. The population studied had community-acquired pneumonia and acute bacterial sinusitis.
In controlled clinical trials with Binozyt, the majority of the reported treatment-related adverse reactions were gastrointestinal in nature and mild to moderate in severity.
Overall, the most common treatment-related adverse reactions in adult patients receiving a single 2 g dose of Binozyt were diarrhea/loose stools (12%), nausea (4%), abdominal pain (3%), headache (1%), and vomiting (1%). The incidence of treatment-related gastrointestinal adverse reactions was 17% for Binozyt and 10% for pooled comparators.
Treatment-related adverse reactions following Binozyt treatment that occurred with a frequency of <1% included the following:
Cardiovascular: Palpitations, chest pain
Gastrointestinal: Constipation, dyspepsia, flatulence, gastritis, oral moniliasis
Nervous system: Dizziness, vertigo
Allergic: Rash, pruritus, urticaria
Special senses: Taste perversion
The data described below reflect exposure to Binozyt in 907 pediatric patients. The population was 3 months to 12 years of age. All patients received a single 60 mg/kg oral dose of Binozyt.
As in adults, the most common treatment-related adverse reactions in pediatric subjects were gastrointestinal in nature. The pediatric subjects all received a single 60 mg/kg dose (equivalent to 27 mg/lb) of Binozyt.
In a trial with 450 pediatric subjects (ages 3 months to 48 months), vomiting (11%), diarrhea (10%) loose stools (9%), and abdominal pain (2%) were the most frequently reported treatment-related gastrointestinal adverse reactions. Many treatment related gastrointestinal adverse reactions with an incidence greater than 1% began on the day of dosing in these subjects [43% (68/160)] and most [53% (84/160)] resolved within 48 hr of onset. Treatment-related adverse events that were not gastrointestinal, occurring with a frequency ≥ 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).
In a second trial of 337 pediatric subjects, ages 2 years to 12 years, the most frequently reported treatment-related adverse reactions also included vomiting (14%), diarrhea (7%), loose stools (2%), nausea (4%) and abdominal pain (4%).
A third trial investigated the tolerability of two different concentrations of Binozyt oral suspension in 120 pediatric subjects (ages 3 months to 48 months), all of whom were treated with Binozyt. The study evaluated the hypothesis that a more dilute, less viscous formulation (the recommended 27 mg/mL concentration of Binozyt) is less likely to induce vomiting in young children than a more concentrated suspension used in other pediatric studies. The vomiting rate for subjects taking the dilute concentration Binozyt was 3% (2/61). The rate was numerically lower but not statistically different from the vomiting for the more concentrated suspension Across both treatment arms, the only treatment-related adverse events with a frequency of ≥ 1% were vomiting (6%, 7/120) and diarrhea (2%, 2/120).
Treatment-related adverse reactions with a frequency of < 1% following Binozyt treatment in all 907 pediatric subjects in the Phase 3 studies were:
Body as a whole: Chills, fever, flu syndrome, headache;
Digestive: Abnormal stools, constipation, dyspepsia, flatulence, gastritis, gastrointestinal disorder, hepatitis;
Hematologic and lymphatic: Leukopenia;
Nervous system: Agitation, emotional liability, hostility, hyperkinesia, insomnia, irritability, paresthesia, Somnolence;
Respiratory: Asthma, bronchitis, cough, dyspnea, pharyngitis, rhinitis;
Skin and appendages: Dermatitis, fungal dermatitis, maculopapular rash, pruritus, urticaria;
Special senses: Otitis media, taste perversion;
Postmarketing Experience with Other Binozyt Products
Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Adverse events reported with Binozyt immediate release formulations during the postmarketing period for which a causal relationship may not be established include:
Allergic: Arthralgia, edema, urticaria and angioedema
Cardiovascular: Palpitations and arrhythmias including ventricular tachycardia and hypotension
There have been reports of QT prolongation and torsades de pointes.
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis
Genitourinary: Interstitial nephritis, acute renal failure and vaginitis
Hematopoietic: Thrombocytopenia, mild neutropenia
Liver/biliary: Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with Binozyt.
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope
Psychiatric: Aggressive reaction and anxiety
Skin/appendages: Pruritus, rash, photosensitivity, serious skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss
In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Binozyt clinical trials in adults and pediatric patients:
Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible.
Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.
You should not use this medication if you have ever had jaundice or liver problems caused by taking Binozyt. You should not use Binozyt if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).
There are many other medicines that can interact with Binozyt. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Binozyt will not treat a viral infection such as the common cold or flu.
Avoid taking an antacid within 2 hours before or after you take Binozyt. Some antacids can make it harder for your body to absorb Binozyt.
Active ingredient matches for Binozyt:
Azithromycin in Bulgaria, Costa Rica, El Salvador, Greece, Guatemala, Indonesia, Nicaragua, Panama, Thailand, Venezuela, Vietnam.
Azithromycin dihydrate in Thailand.
Unit description / dosage (Manufacturer)Price, USD Capsule; Oral; Azithromycin 250 mg Capsule; Oral; Azithromycin 500 mg Binozyt 200 mg/5 mL x 15 mL x 1’s Binozyt 200 mg/5 mL x 20 mL x 1’s Binozyt 200 mg/5 mL x 22.5 mL x 1’s Binozyt 200 mg/5 mL x 30 mL x 1’s Binozyt 200 mg/5 mL x 37.5 mL x 1’s Binozyt 500 mg x 3’s$ 11.13 Binozyt 500 mg x 1 Blister 3 Tablet Binozyt 250