Sefety Advices
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UNSAFE
It is unsafe to consume alcohol with Azilab 500.
SAFE IF PRESCRIBED
Azilab 500 is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.
SAFE IF PRESCRIBED
Azilab 500 is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
There may be a possibility of diarrhea or rash in the baby.
SAFE
Azilab 500 does not usually affect your ability to drive.
CAUTION
Azilab 500 should be used with caution in patients with severe kidney disease. Dose adjustment of Azilab 500 may be needed. Please consult your doctor.
CAUTION
Azilab 500 should be used with caution in patients with liver disease. Dose adjustment of Azilab 500 may be needed. Please consult your doctor.
Medical Overview
Introduction
Azilab 500 is an antibiotic used to treat various types of bacterial infections of the respiratory tract, ear, nose, throat, lungs, skin, and eye in adults and children. It is also effective in typhoid fever and some sexually transmitted diseases like gonorrhea.
Azilab 500 is a broad-spectrum type of antibiotic effective in killing many types of gram-positive bacteria, some types of gram-negative bacteria and other microorganisms. This medicine is taken orally, preferably either one hour before or 2 hours after a meal. It should be used regularly at evenly spaced time intervals as prescribed by your doctor. Do not skip any doses and finish the full course of treatment even if you feel better. Stopping the medicine too early may lead to the return or worsening of the infection.
Commonly seen side effects seen with this medicine include vomiting, nausea, stomach pain, and diarrhea. These are usually temporary and subside with the completion of treatment. Consult your doctor if you find these side effects worry you or persist for a longer duration.
Inform your doctor if you have any previous history of allergy or heart problems before taking this medicine. Pregnant or breastfeeding women should consult their doctor before using this medicine.
Uses of Azilab 500
- Bacterial infections
Side effects of Azilab 500
Common
- Vomiting
- Nausea
- Abdominal pain
- Diarrhea
How to use Azilab 500
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Azilab 500 may be taken with or without food, but it is better to take it at a fixed time.
How Azilab 500 works
Azilab 500 is an antibiotic. It works by preventing synthesis of essential proteins required by bacteria to carry out vital functions. Thus, it stops the bacteria from growing, and prevents the infection from spreading.
What if you forget to take Azilab 500?
If you miss a dose of Azilab 500, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- Do not skip any doses and finish the full course of treatment even if you feel better. Stopping it early may make the infection to come back and harder to treat.
- Take it 1 hour before or two hours after food.
- Do not take antacids 2 hours before or after taking Azilab 500.
- Diarrhea may occur as a side effect but should stop when your course is complete. Inform your doctor if it doesn't stop or if you find blood in your stools.
- Stop taking Azilab 500 and inform your doctor immediately if you develop an itchy rash, swelling of the face, throat or tongue or breathing difficulties while taking it.
Brief Description
Indication
Bacterial infections, bacterial endocarditis, typhoid fever, community-acquired pneumonia, uncomplicated gonorrhea, streptococcal pharyngitis/tonsillitis, COPD, acute bacterial sinusitis, acute otitis media, uncomplicated UTI, Uncomplicated gonorrhea, PID, non-gonococcal urethritis, chancroid, acute salmonellosis, cervicitis, babesiosis, chlamydial infections, pelvic inflammatory disease, PID, traveler's diarrhea,
Administration
Oral Administration
Tablet: Take tablets without regard to food; however, food may enhance tolerability
Oral suspension
Conventional oral suspension (100 mg/5 mL, 200 mg/5 mL) may be stored for 10 days after reconstitution and taken without regard to food
Conventional 1 g package must be taken immediately after reconstitution
Extended-release oral suspension must be taken on empty stomach within 12 hours of reconstitution; given only in single dose; not interchangeable with immediate release formulation
IV Preparation
Dilute 500-mg vial in 4.8 mL of SWI (100 mg/mL)
Dilute further in NS to 1 mg/mL (500 mL) or 2 mg/mL (250 mL)
IV Administration
1 mg/mL solution: Infuse over 3 hours
2 mg/mL solution: Infuse over 1 hour
Adult Dose
Adult: PO Resp tract infections; Skin and soft tissue infections
500 mg once daily for 3 days.
Chancroid; Non-gonococcal cervicitis/urethritis due to Chlamydia trachomatis; Uncomplicated genital infections due to Chlamydia trachomatis
1 g as a single dose.
Prophylaxis of disseminated MAC infections 1.2 g once wkly.
Treatment or secondary propjhylaxis: 500 mg once daily w/ other antimycobacterials.
Uncomplicated gonorrhoea 2 g as a single dose. Granuloma inguinale Initial: 1 g, then 500 mg/day until all lesions have healed completely.
Active immunisation against typhoid fever caused by Salmonella typhi 1 g once daily for 5 days.
IV Community-acquired pneumonia 500 mg as a single IV daily dose for 2 days, then 500 mg single oral dose daily to complete 7-10 days of therapy.
Pelvic inflammatory disease 500 mg as a single IV daily dose for 1-2 days, then 250 mg single oral dose daily to complete a 7-day therapy.
Elderly: No dosage adjustment needed.
Hepatic impairment: No dosage adjustment needed.
Child Dose
Child: PO: q24h
Otitis: 10 mg/kg/day for 1 day, then 5 mg/kg for 4 days; or 10 mg/kg/day for 3 days; or 30 mg/kg once.
Pharyngitis: 12 mg/kg/day for 5 days.
Sinusitis: 10 mg/kg/day for 3 days.
CABP: 10 mg/kg for 1 day, then 5 mg/kg/day for 4 days or 60 mg/kg once of ER susp
MAC/PCP prophylaxis: 5 mg/kg/day
IV: 10 mg/kg q24h
>6 mth 10 mg/kg;
15-25 kg: 200 mg;
26-35 kg: 300 mg;
36-45 kg: 400 mg.
All doses to be taken once daily for 3 days.
Renal Dose
Renal impairment: No dosage adjustment needed.
Contraindication
Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Coadministration w/ pimozide. History of cholestatic jaundice/hepatic dysfunction associated w/ prior use of azithromycin.
Mode of Action
Azithromycin is a semisynthetic azalide antibiotic. It blocks transpeptidation by binding to 50s ribosomal subunit of susceptible organisms and disrupting RNA-dependent protein synthesis at the chain elongation step.
Precaution
May increase the risk of Torsades de pointes and fatal heart arrhythmias in patients w/ prolonged QT interval, low K or Mg blood levels, slow heart rate and medication treating abnormal heart rhythms. Impaired hepatic and renal function. Pregnancy and lactation. Monitoring Parameters Liver function tests, CBC w/ differential.
Lactation: Unknown whether drug is excreted into breast milk; use with caution
Side Effect
>10%
High single dose therapy
Diarrhea (52.8%),Nausea (32.6%),Abdominal pain (27%),Loose stool (19.1%)
1-10%
Cramping (2-10%),Vaginitis (2-10%),Dyspepsia (9% with single high dose therapy),Flatulence (9% with single high dose therapy),Vomiting (6.7% with single high dose therapy),Malaise (1.1%)
<1%
Agitation,Allergic reaction,Anemia,Anorexia,Candidiasis,Chest pain,Conjunctivitis,Constipation,Dermatitis (fungal),Dizziness,Eczema,Edema,Enteritis,Facial edema,Fatigue,Gastritis,Headache,Hyperkinesia,Hypotension,Increased cough,Insomnia,Leukopenia,Malaise,Melena,Mucositis,Nervousness,Oral candidiasis,Pain,Palpitations,Pharyngitis,Pleural effusion,Pruritus,Pseudomembranous colitis,Rash,Rhinitis,Seizures,Somnolence,Urticaria,Vertigo
Potentially Fatal: Angioedema and cholestatic jaundice.
Pregnancy Category Note
Pregnancy
Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data); data do not suggest embryofetal risk (Developmental and Reproductive Toxicology Database [DART]; https://toxnet.nlm.nih.gov/newtoxnet/dart.htm)
Animal data
Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area; decreased viability and delayed development were observed in offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area
Lactation
Drug is present in human milk; non-serious adverse reactions reported in breastfed infants after maternal administration of therapy; there are no available data on effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed infant from drug or underlying maternal condition; advise women to monitor breastfed infant for diarrhea, vomiting, or rash.
Interaction
Increases serum concentrations of digoxin, ciclosporin, terfenadine, hexobarbital and phenytoin. Decreased rate of absorption w/ antacids containing aluminium and magnesium. Increased risk of ergot toxicity.
Potentially Fatal: Increased risk of cardiotoxicity w/ pimozide.
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Disclaimer
The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.