Azithromycin is also used sometimes to treat H. It is also used to prevent heart infection in people having dental or other procedures, and to prevent STD in victims of sexual assault.
Talk to your doctor about the possible risks of using this medication for your condition. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
Do not take a double dose to make up for a missed one. Azithromycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children. Store azithromycin tablets, suspension, and extended-release suspension at room temperature and away from excess heat and moisture not in the bathroom. Do not refrigerate or freeze the extended-release suspension. Discard any azithromycin suspension that is left over after 10 days or no longer needed.
Discard any unused extended-release azithromycin suspension after dosing is complete or 12 hours after preparation. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily.
To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to azithromycin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the azithromycin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
In multiple-dose clinical trials involving more than patients, four patients discontinued therapy because of treatment-related liver enzyme abnormalities and one because of a renal function abnormality. In multiple-dose clinical trials involving approximately pediatric patients, no patients discontinued therapy because of treatment-related laboratory abnormalities.
Coadministration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted [see Adverse Reactions 6 ].
Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin.
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, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes see 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 mg based on body surface area.
Decreased viability and delayed development were observed in the 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 mg based on body surface area see Data. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U. Available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. Limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications.
Based on body surface area, this dose is approximately 4 rats and 2 mice times an adult human daily dose of mg. Maternal toxicity reduced food consumption and body weight gain; increased stress at parturition was observed at the higher dose. Azithromycin is present in human milk see Data.
Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin see Clinical Considerations. There are no available data on the effects of azithromycin on milk production. Azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. Breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing.
In another study, a single dose of azithromycin mg was administered intravenously to 8 women prior to incision for cesarean section.
Breastmilk colostrum samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established.
Use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients 6 months of age or greater is supported by adequate and well-controlled trials in adults. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see Warnings and Precautions 5. Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting.
In the event of overdosage, general symptomatic and supportive measures are indicated as required. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Azithromycin Tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either mg or mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide.
Azithromycin is a macrolide antibacterial drug [see Microbiology QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in healthy subjects who received either chloroquine mg alone or in combination with oral azithromycin mg, mg, and mg once daily. Coadministration of azithromycin increased the QTc interval in a dose- and concentration-dependent manner.
Two azithromycin mg tablets are bioequivalent to a single mg tablet. In a two-way crossover study, 12 adult healthy volunteers 6 males, 6 females received mg of azithromycin administered in single daily doses over either 5 days two mg tablets on day 1, followed by one mg tablet on days 2 to 5 or 3 days mg per day for days 1 to 3.
The antibacterial activity of azithromycin is pH related and appears to be reduced with decreasing pH. However, the extensive distribution of drug to tissues may be relevant to clinical activity. Azithromycin has been shown to penetrate into human tissues, including skin, lung, tonsil, and cervix. Extensive tissue distribution was confirmed by examination of additional tissues and fluids bone, ejaculum, prostate, ovary, uterus, salpinx, stomach, liver, and gallbladder.
As there are no data from adequate and well-controlled studies of azithromycin treatment of infections in these additional body sites, the clinical significance of these tissue concentration data is unknown.
Following a regimen of mg on the first day and mg daily for 4 days, very low concentrations were noted in cerebrospinal fluid less than 0. In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route of elimination.
Azithromycin pharmacokinetics was investigated in 42 adults 21 to 85 years of age with varying degrees of renal impairment. Following the oral administration of a single 1. The pharmacokinetics of azithromycin in subjects with hepatic impairment has not been established. There are no significant differences in the disposition of azithromycin between male and female subjects.
No dosage adjustment is recommended based on gender. Pharmacokinetic parameters in older volunteers 65 to 85 years old were similar to those in young adults 18 to 40 years old for the 5 day therapeutic regimen. Dosage adjustment does not appear to be necessary for older patients with normal renal and hepatic function receiving treatment with this dosage regimen [see Geriatric Use 8.
In this study, azithromycin concentrations were determined over a 24 hr period following the last daily dose. Patients weighing above Seventeen patients weighing Drug interaction studies were performed with azithromycin and other drugs likely to be coadministered. The effects of coadministration of azithromycin on the pharmacokinetics of other drugs are shown in Table 1 and the effects of other drugs on the pharmacokinetics of azithromycin are shown in Table 2.
Coadministration of azithromycin at therapeutic doses had a modest effect on the pharmacokinetics of the drugs listed in Table 1. No dosage adjustment of drugs listed in Table 1 is recommended when coadministered with azithromycin. Coadministration of azithromycin with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. Nelfinavir significantly increased the C max and AUC of azithromycin. No dosage adjustment of azithromycin is recommended when administered with drugs listed in Table 2 [see Drug Interactions 7.
Table 1. Table 2. Azithromycin acts by binding to the 23S rRNA of the 50S ribosomal subunit of susceptible microorganisms inhibiting bacterial protein synthesis and impeding the assembly of the 50S ribosomal subunit. Azithromycin demonstrates cross resistance with erythromycin. The most frequently encountered mechanism of resistance to azithromycin is modification of the 23S rRNA target, most often by methylation. Ribosomal modifications can determine cross resistance to other macrolides, lincosamides, and streptogramin B MLS B phenotype.
Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage 1 ]. Staphylococcus aureus Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes. Haemophilus ducreyi Haemophilus influenzae Moraxella catarrhalis Neisseria gonorrhoeae.
Chlamydophila pneumoniae Chlamydia trachomatis Mycoplasma pneumoniae. The following in vitro data are available, but their clinical significance is unknown.
At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration MIC less than or equal to the susceptible breakpoint for azithromycin against isolates of similar genus or organism group. However, the efficacy of azithromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.
Bordetella pertussis Legionella pneumophila. Prevotella bivia Peptostreptococcus species. Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. The relevance of these findings to patients being treated with azithromycin at the doses and durations recommended in the prescribing information is uncertain.
Phospholipidosis intracellular phospholipid accumulation has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems e. This effect has been shown to be reversible after cessation of azithromycin treatment. The significance of these findings for animals and for humans is unknown.
Acute Bacterial Exacerbations of Chronic Bronchitis. In a randomized, double-blind controlled clinical trial of acute exacerbation of chronic bronchitis AECB , azithromycin mg once daily for 3 days was compared with clarithromycin mg twice daily for 10 days. The primary endpoint of this trial was the clinical cure rate at Days 21 to The following outcomes were the clinical cure rates at the Days 21 to 24 visit for the bacteriologically evaluable patients by pathogen:. Acute Bacterial Sinusitis.
Clinical response assessments were made at Day 10 and Day The primary endpoint of this trial was prospectively defined as the clinical cure rate at Day For the patients analyzed in the modified intent to treat analysis at the Day 28 visit, the clinical cure rate for 3 days of azithromycin was In an open label, non-comparative study requiring baseline transantral sinus punctures, the following outcomes were the clinical success rates at the Day 7 and Day 28 visits for the modified intent to treat patients administered mg of azithromycin once daily for 3 days with the following pathogens:.
From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. Days 11 to 14 data are provided for clinical guidance. Days 24 to 32 evaluations were considered the primary test of cure endpoint. Azithromycin was clinically and microbiologically statistically superior to penicillin at Day 14 and Day 30 with the following clinical success i.
For the patients who were evaluated for clinical efficacy, the clinical success rate i. The combined clinical success rate i. Microbiologic determinations were made at the pre-treatment visit.
Microbiology was not reassessed at later visits. The following clinical success rates were obtained from the evaluable group:. For this reason, Protocol 3 was not considered to be an independent study. Ninety-two 92 patients were evaluable for clinical and microbiologic efficacy. At the Day 11 and Day 30 visits, the following clinical success rates were obtained from the evaluable group:.
You could also ask your pharmacist for other ways to remember your medicine. Taking an extra dose of azithromycin 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, azithromycin can cause side effects, although not everyone gets them.
These common side effects of azithromycin happen in more than 1 in people. Keep taking the medicine, but talk to your doctor or pharmacist if these side effects bother you or don't go away:. In rare cases it's possible to have a serious allergic reaction anaphylaxis to azithromycin.
These aren't all the side effects of azithromycin. For a full list, see the leaflet inside your medicine packet. Azithromycin isn't normally recommended during pregnancy or while breastfeeding. But your doctor may prescribe it if the benefits of taking azithromycin are greater than the risks. Tell your doctor if you're taking these medicines before you start azithromycin:.
You should also let your doctor know if you're taking any medicines for an irregular heartbeat arrhythmia , such as amiodarone or sotalol. Azithromycin 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. Check the leaflets that come with your medicines and talk to a pharmacist or your doctor if you have any worries.
There are no known problems with taking herbal remedies or supplements alongside azithromycin. Tell your doctor or pharmacist if you're taking any other medicines, including herbal medicines, vitamins or supplements. Azithromycin is from a group of medicines called macrolide antibiotics. Macrolide antibiotics work by killing the bacteria that cause the infection. There are other macrolide antibiotics that work in the same way as azithromycin.
They include erythromycin and clarithromycin. It's usual to take azithromycin once a day. For erythromycin, it's usually 4 times a day, and twice a day for clarithromycin. Erythromycin is more likely to cause diarrhoea than either azithromycin or clarithromycin. All macrolides can be used to treat chest and skin infections. Azithromycin and erythromycin can also be used to treat sexually transmitted infections. Clarithromycin can also be used to treat Helicobacter pylori, bacteria that can cause stomach ulcers.
Azithromycin and other macrolide antibiotics kill similar types of bacteria to penicillin antibiotics, such as amoxicillin. Some people are allergic to penicillin antibiotics - they can take macrolides like azithromycin instead. It's very important that you keep taking azithromycin until your course is finished. Do this even if you feel better. It'll help stop the infection coming back. Tell your doctor if you don't start feeling better after taking azithromycin for 3 days. Also tell them if, at any time, you start to feel worse.
Some people get a fungal infection called thrush after taking a course of antibiotics like azithromycin. Antibiotics kill the normal harmless bacteria that help to protect you against thrush. Symptoms of thrush in the mouth include redness and itching. Women may get vaginal itching. Azithromycin doesn't stop contraceptive pills, including the combined pill and emergency contraception.
But if azithromycin makes you vomit or have severe diarrhoea 6 to 8 watery poos in 24 hours for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do.
Read more about what to do if you're on the pill and you're being sick or have diarrhoea.
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