Azithromycin 3 Day Dose Pack Actions

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Actions of Azithromycin 3 Day Dose Pack in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Like other macrolides, Azithromycin 3 Day Dose Pack inhibits RNA-dependent protein synthesis by binding to the 50S ribosomal sub unit of the 70S ribosome of susceptible bacteria. The site of action appears to be the same as that of the macrolides, clindamycin, lincomycin, and chloramphenicol. Azithromycin 3 Day Dose Pack is bactericidal for Streptococcus pyogenes, Streptococcus pneumoniae, and Haemophilus influenzae. It is bacteriostatic for staphylococci and most aerobic gram-negative species. The spectrum of activity of Azithromycin 3 Day Dose Pack is broader than erythromycin, clarithromycin, or clarithromycin. Azithromycin 3 Day Dose Pack generally is more active in vitro against gram-negative organism than erythromycin or clarithromycin and has activity comparable to erythromycin against most gram-positive organisms. Beta-lactamases produced by Haemophilus influenzae or Moraxella catarrhalis do not inactivate Azithromycin 3 Day Dose Pack.

Pharmacokinetics: Following oral intake, Azithromycin 3 Day Dose Pack is widely distributed throughout the body except to cerebrospinal fluid. Bioavailability ranges from 34-52% and was generally maintained when Azithromycin 3 Day Dose Pack tablets were administered with a meal. Peak plasma levels are reached in 2-3 hours. Plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2-4 days.

After oral administration, Azithromycin 3 Day Dose Pack is rapidly and widely distributed throughout the body. Unique properties of Azithromycin 3 Day Dose Pack include extensive tissue distribution and high drug concentrations, within cells (including phagocytes) resulting in much tissue concentrations. Azithromycin 3 Day Dose Pack concentrates intracellularly, resulting in tissue concentrations 10 to 100 times higher than those found in plasma or serum. Azithromycin 3 Day Dose Pack is high concentrated in fibroblasts and phagocytic cells, contributing to the distribution of the drug into inflamed and infected tissues. Because of extensive tissue sequestration and binding, the usual elimination half-life of 40-68 hours is prolonged. Penetration of the drug into phagocytic cells is necessary for activity against intracellular pathogens (e.g. Staphylococcus aureus). Only very low concentrations of Azithromycin 3 Day Dose Pack have been detected in cerebrospinal fluid in patients with non-inflamed meninges.

Following a single oral dose, plasma concentrations of Azithromycin 3 Day Dose Pack declined with a polyphasic pattern. Azithromycin 3 Day Dose Pack undergoes some hepatic metabolism to inactive metabolites but more than 50% of Azithromycin 3 Day Dose Pack is eliminated through biliary secretion as unchanged drug. Azithromycin 3 Day Dose Pack is excreted in feces primarily as unchanged drug. Approximately 4.5-6% of a dose is eliminated in urine as unchanged drug within 72 hours.

How should I take Azithromycin 3 Day Dose Pack?

Your doctor will tell you how much of Azithromycin 3 Day Dose Pack to use and how often. Do not use more medicine or use it more often than your doctor tells you to. Azithromycin 3 Day Dose Pack is not for long-term use.

To use the eye drops:

To help clear up your eye infection completely, keep using Azithromycin 3 Day Dose Pack for the full treatment time, even if your symptoms disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of Azithromycin 3 Day Dose Pack will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Azithromycin 3 Day Dose Pack. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Azithromycin 3 Day Dose Pack, apply 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 dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the unopened bottle in the refrigerator. Do not freeze. Once the medicine is opened, you may store it in the refrigerator or in a closed container at room temperature, away from heat, moisture, and direct light for up to 14 days.

Ask your doctor how you should dispose of any medicine you do not use. Throw away any unused medicine after 14 days.

Azithromycin 3 Day Dose Pack administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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IV: Infuse over 1 hour (2 mg/ml infusion) or over 3 hours (1 mg/ml infusion). Not for IM or IV bolus administration.

Oral: Immediate release suspension and tablet may be taken without regard to food; extended release suspension should be taken on an empty stomach (at least 1 hour before or 2 hours following a meal), within 12 hours of reconstitution.

Azithromycin 3 Day Dose Pack pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Mechanism of Action

Azithromycin 3 Day Dose Pack is a macrolide antibacterial drug.

Azithromycin 3 Day Dose Pack concentrates in phagocytes and fibroblasts as demonstrated by in vitro incubation techniques. Using such methodology, the ratio of intracellular to extracellular concentration was > 30 after one hr of incubation. In vivo studies suggest that concentration in phagocytes may contribute to drug distribution to inflamed tissues.

Pharmacodynamics

Based on animal models of infection, the antibacterial activity of Azithromycin 3 Day Dose Pack appears to correlate with the ratio of area under the concentration-time curve to minimum inhibitory concentration (AUC/MIC) for certain pathogens (S. pneumoniae and S. aureus). The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with Azithromycin 3 Day Dose Pack.

Cardiac Electrophysiology

QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in 116 healthy subjects who received either chloroquine (1000 mg) alone or in combination with oral Azithromycin 3 Day Dose Pack (500 mg, 1000 mg, and 1500 mg once daily). Coadministration of Azithromycin 3 Day Dose Pack increased the QTc interval in a dose- and concentration-dependent manner. In comparison to chloroquine alone, the maximum mean (95% upper confidence bound) increases in QTcF were 5 (10) ms, 7 (12) ms and 9 (14) ms with the coadministration of 500 mg, 1000 mg and 1500 mg Azithromycin 3 Day Dose Pack, respectively.

Pharmacokinetics

The pharmacokinetic parameters of Azithromycin 3 Day Dose Pack in plasma after dosing as per labeled recommendations in healthy young adults and asymptomatic HIV-positive adults (age 18 to 40 years old) are portrayed in the following chart:

MEAN (CV%) PK PARAMETER
*
AUC0-24;
0-last.

DOSE/DOSAGE FORM (serum, except as indicated)

Subjects

Day No.

Cmax (mcg/mL)

Tmax (hr)

C24 (mcg/mL)

AUC (mcg•hr/mL)

T1/2 (hr)

Urinary Excretion (% of dose)

500 mg/250 mg capsule

12

1

0.41

2.5

0.05

2.6*

4.5

and 250 mg on Days 2 to 5

12

5

0.24

3.2

0.05

2.1*

6.5

1200 mg/600 mg tablets

12

1

0.66

2.5

0.074

6.8†

40

%CV

(62%)

(79%)

(49%)

(64%)

(33%)

600 mg tablet/day

7

1

0.33

2.0

0.039

2.4*

%CV

25%

(50%)

(36%)

(19%)

7

22

0.55

2.1

0.14

5.8*

84.5

%CV

(18%)

(52%)

(26%)

(25%)

600 mg tablet/day (leukocytes)

7

22

252

10.9

146

4763*

82.8

%CV

(49%)

(28%)

(33%)

(42%)

With a regimen of 500 mg on Day 1 and 250 mg/day on Days 2 to 5, Cmin and Cmax remained essentially unchanged from Day 2 through Day 5 of therapy. However, without a loading dose, Azithromycin 3 Day Dose Pack Cmin levels required 5 to 7 days to reach steady state.

In asymptomatic HIV-positive adult subjects receiving 600 mg Azithromycin 3 Day Dose Pack Tablets once daily for 22 days, steady state Azithromycin 3 Day Dose Pack serum levels were achieved by Day 15 of dosing.

The high values in adults for apparent steady-state volume of distribution (31.1 L/kg) and plasma clearance (630 mL/min) suggest that the prolonged half-life is due to extensive uptake and subsequent release of drug from tissues.

Absorption

The 1 gram single-dose packet is bioequivalent to four 250 mg Azithromycin 3 Day Dose Pack capsule

When the oral suspension of Azithromycin 3 Day Dose Pack 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%).

Distribution

The serum protein binding of Azithromycin 3 Day Dose Pack is variable in the concentration range approximating human exposure, decreasing from 51% at 0.02 mcg/mL to 7% at 2 mcg/mL.

The antibacterial activity of Azithromycin 3 Day Dose Pack 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 3 Day Dose Pack has been shown to penetrate into tissues in humans, 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 3 Day Dose Pack treatment of infections in these additional body sites, the clinical importance of these tissue concentration data is unknown.

Following oral administration of a single 1200 mg dose (two 600 mg tablets), the mean maximum concentration in peripheral leukocytes was 140 mcg/mL. Concentration remained above 32 mcg/mL, for approximately 60 hr. The mean half-lives for 6 males and 6 females were 34 hr and 57 hr, respectively. Leukocyte-to-plasma Cmax ratios for males and females were 258 (± 77%) and 175 (± 60%), respectively, and the AUC ratios were 804 (± 31%) and 541 (± 28%), respectively. The clinical relevance of these findings is unknown. Following oral administration of multiple daily doses of 600 mg (1 tablet/day) to asymptomatic HIV-positive adults, mean maximum concentration in peripheral leukocytes was 252 mcg/mL (± 49%). Trough concentrations in peripheral leukocytes at steady-state averaged 146 mcg/mL (± 33%). The mean leukocyte-to-serum Cmax ratio was 456 (± 38%) and the mean leukocyte to serum AUC ratio was 816 (± 31%). The clinical relevance of these findings is unknown.

Metabolism

In vitro and in vivo studies to assess the metabolism of Azithromycin 3 Day Dose Pack have not been performed.

Elimination

Plasma concentrations of Azithromycin 3 Day Dose Pack 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 Azithromycin 3 Day Dose Pack, 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.

Specific Populations

Renal Insufficiency

Azithromycin 3 Day Dose Pack 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 1.0 g dose of Azithromycin 3 Day Dose Pack (4 × 250 mg capsules), the mean Cmax and AUC0-120 increased by 5.1% and 4.2%, respectively, in subjects with GFR 10 to 80 mL/min compared to subjects with normal renal function (GFR > 80 mL/min). The mean Cmax and AUC0-120 increased 61% and 35%, respectively, in subjects with end-stage renal disease (GFR < 10 mL/min) compared to subjects with normal renal function (GFR > 80 mL/min).

Hepatic Insufficiency

The pharmacokinetics of Azithromycin 3 Day Dose Pack in subjects with hepatic impairment has not been established.

Gender

There are no significant differences in the disposition of Azithromycin 3 Day Dose Pack between male and female subjects. No dosage adjustment is recommended on the basis of gender.

Geriatric Patients

Pharmacokinetic parameters in older volunteers (65 to 85 years old) were similar to those in younger volunteers (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.

Pediatric Patients

For information regarding the pharmacokinetics of Azithromycin 3 Day Dose Pack for oral suspension in pediatric patients, see the prescribing information for Azithromycin 3 Day Dose Pack for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.

Drug-drug Interactions

Drug interaction studies were performed with Azithromycin 3 Day Dose Pack and other drugs likely to be coadministered. The effects of coadministration of Azithromycin 3 Day Dose Pack on the pharmacokinetics of other drugs are shown in Table 1 and the effects of other drugs on the pharmacokinetics of Azithromycin 3 Day Dose Pack are shown in Table 2.

Coadministration of Azithromycin 3 Day Dose Pack 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 3 Day Dose Pack.

Coadministration of Azithromycin 3 Day Dose Pack with efavirenz or fluconazole had a modest effect on the pharmacokinetics of Azithromycin 3 Day Dose Pack. Nelfinavir significantly increased the Cmax and AUC of Azithromycin 3 Day Dose Pack. No dosage adjustment of Azithromycin 3 Day Dose Pack is recommended when administered with drugs listed in Table 2.

Table 1. Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of Azithromycin 3 Day Dose Pack
*
- 90% Confidence interval not reported

Coadministered Drug

Dose of Coadministered Drug

Dose of Azithromycin 3 Day Dose Pack

n

Ratio (with/without Azithromycin 3 Day Dose Pack) of Coadministered Drug Pharmacokinetic Parameters (90% CI); No Effect = 1.00

Mean Cmax

Mean AUC

Atorvastatin

10 mg/day for 8 days

500 mg/day orally on days 6 to 8

12

0.83

(0.63 to 1.08)

1.01

(0.81 to 1.25)

Carbamazepine

200 mg/day for 2 days, then 200 mg twice a day for 18 days

500 mg/day orally for days 16 to 18

7

0.97

(0.88 to 1.06)

0.96

(0.88 to 1.06)

Cetirizine

20 mg/day for 11 days

500 mg orally on day 7, then 250 mg/day on days 8 to 11

14

1.03

(0.93 to 1.14)

1.02

(0.92 to 1.13)

Didanosine

200 mg orally twice a day for 21 days

1,200 mg/day orally on days 8 to 21

6

1.44

(0.85 to 2.43)

1.14

(0.83 to 1.57)

Efavirenz

400 mg/day for 7 days

600 mg orally on day 7

14

1.04*

0.95*

Fluconazole

200 mg orally single dose

1,200 mg orally single dose

18

1.04

(0.98 to 1.11)

1.01

(0.97 to 1.05)

Indinavir

800 mg three times a day for 5 days

1,200 mg orally on day 5

18

0.96

(0.86 to 1.08)

0.90

(0.81 to 1.00)

Midazolam

15 mg orally on day 3

500 mg/day orally for 3 days

12

1.27

(0.89 to 1.81)

1.26

(1.01 to 1.56)

Nelfinavir

750 mg three times a day for 11 days

1,200 mg orally on day 9

14

0.90

(0.81 to 1.01)

0.85

(0.78 to 0.93)

Sildenafil

100 mg on days 1 and 4

500 mg/day orally for 3 days

12

1.16

(0.86 to 1.57)

0.92

(0.75 to 1.12)

Theophylline

4 mg/kg IV on days 1, 11, 25

500 mg orally on day 7, 250 mg/day on days 8 to 11

10

1.19

(1.02 to 1.40)

1.02

(0.86 to 1.22)

Theophylline

300 mg orally BID x 15 days

500 mg orally on day 6, then 250 mg/day on days 7 to 10

8

1.09

(0.92 to 1.29)

1.08

(0.89 to 1.31)

Triazolam

0.125 mg on day 2

500 mg orally on day 1, then 250 mg/day on day 2

12

1.06*

1.02*

Trimethoprim/ Sulfamethoxazole

160 mg/800 mg/day orally for 7 days

1,200 mg orally on day 7

12

0.85

(0.75 to 0.97)/

0.87

(0.80 to 0.95)/

0.90

(0.78 to 1.03)

0.96

(0.88 to 1.03)

Zidovudine

500 mg/day orally for 21 days

600 mg/day orally for 14 days

5

1.12

(0.42 to 3.02)

0.94

(0.52 to 1.70)

Zidovudine

500 mg/day orally for 21 days

1,200 mg/day orally for 14 days

4

1.31

(0.43 to 3.97)

1.30

(0.69 to 2.43)

Table 2. Drug Interactions: Pharmacokinetic Parameters for Azithromycin 3 Day Dose Pack in the Presence of Coadministered Drugs.
*
- 90% Confidence interval not reported

Coadministered Drug

Dose of Coadministered Drug

Dose of Azithromycin 3 Day Dose Pack

n

Ratio (with/without coadministered drug) of Azithromycin 3 Day Dose Pack Pharmacokinetic Parameters (90% CI); No Effect = 1.00

Mean Cmax

Mean AUC

Efavirenz

400 mg/day for 7 days

600 mg orally on day 7

14

1.22

(1.04 to 1.42)

0.92*

Fluconazole

200 mg orally single dose

1,200 mg orally single dose

18

0.82

(0.66 to 1.02)

1.07

(0.94 to 1.22)

Nelfinavir

750 mg three times a day for 11 days

1,200 mg orally on day 9

14

2.36

(1.77 to 3.15)

2.12

(1.80 to 2.50)

Microbiology

Azithromycin 3 Day Dose Pack has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in.

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes

NOTE: Azithromycin 3 Day Dose Pack demonstrates cross-resistance with erythromycin-resistant gram-positive strains. Most strains of Enterococcus faecalis and methicillin-resistant staphylococci are resistant to Azithromycin 3 Day Dose Pack.

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae
Moraxella catarrhalis

Other Microorganisms

Chlamydia trachomatis

Beta-lactamase production should have no effect on Azithromycin 3 Day Dose Pack activity.

Azithromycin 3 Day Dose Pack has been shown to be active in vitro and in the prevention and treatment of disease caused by the following microorganisms:

Mycobacteria

Mycobacterium avium complex (MAC) consisting of:
Mycobacterium avium
Mycobacterium intracellulare

The following in vitro data are available, but their clinical significance is unknown.

Azithromycin 3 Day Dose Pack exhibits in vitro minimal inhibitory concentrations (MICs) of 2.0 mcg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of Azithromycin 3 Day Dose Pack in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.

Aerobic Gram-Positive Microorganisms

Streptococci (Groups C, F, G)
Viridans group streptococci

Aerobic Gram-Negative Microorganisms

Bordetella pertussis
Campylobacter jejuni
Haemophilus ducreyi
Legionella pneumophila

Anaerobic Microorganisms

Bacteroides bivius
Clostridium perfringens
Peptostreptococcus species

Other Microorganisms

Borrelia burgdorferi
Mycoplasma pneumoniae
Treponema pallidum
Ureaplasma urealyticum

Susceptibility Testing of Bacteria Excluding Mycobacteria

The in vitro potency of Azithromycin 3 Day Dose Pack is markedly affected by the pH of the microbiological growth medium during incubation. Incubation in a 10% CO2 atmosphere will result in lowering of media pH (7.2 to 6.6) within 18 hr and in an apparent reduction of the in vitro potency of Azithromycin 3 Day Dose Pack. Thus, the initial pH of the growth medium should be 7.2 to 7.4, and the CO2 content of the incubation atmosphere should be as low as practical.

Azithromycin 3 Day Dose Pack can be solubilized for in vitro susceptibility testing by dissolving in a minimum amount of 95% ethanol and diluting to working concentration with water.

Dilution Techniques

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 method1 (broth, agar or microdilution) or equivalent with Azithromycin 3 Day Dose Pack powder. The MIC values should be interpreted according to the following criteria:

MIC (mcg/mL)

Interpretation

≤ 2

Susceptible (S)

4

Intermediate (I)

≥ 8

Resistant (R)

A report of “Susceptible” indicates that the pathogen is likely to respond to monotherapy with Azithromycin 3 Day Dose Pack. 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 Azithromycin 3 Day Dose Pack powder should provide the following MIC values:

Microorganism

MIC (mcg/mL)

Escherichia coli ATCC 25922

2.0 to 8.0

Enterococcus faecalis ATCC 29212

1.0 to 4.0

Staphylococcus aureus ATCC 29213

0.25 to 1.0

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antibacterial compounds. One such standardized procedure2 that has been recommended for use with disks to test the susceptibility of microorganisms to Azithromycin 3 Day Dose Pack uses the 15 mcg Azithromycin 3 Day Dose Pack disk. Interpretation involves the correlation of the diameter obtained in the disk test with the MIC for Azithromycin 3 Day Dose Pack.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 15 mcg Azithromycin 3 Day Dose Pack disk should be interpreted according to the following criteria:

Zone Diameter (mm)

Interpretation

≥ 18

Susceptible (S)

14 to 17

Intermediate (I)

≤ 13

Resistant (R)

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 mcg Azithromycin 3 Day Dose Pack disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism

Zone Diameter (mm)

Staphylococcus aureus ATCC 25923

21 to 26

In Vitro Activity of Azithromycin 3 Day Dose Pack Against Mycobacteria

Azithromycin 3 Day Dose Pack has demonstrated in vitro activity against MAC organisms. While gene probe techniques may be used to distinguish between M. avium and M. intracellulare, many studies only reported results on MAC isolates. Azithromycin 3 Day Dose Pack has also been shown to be active against phagocytized MAC organisms in mouse and human macrophage cell cultures as well as in the beige mouse infection model.

Various in vitro methodologies employing broth or solid media at different pHs, with and without oleic acid-albumin-dextrose-catalase (OADC), have been used to determine Azithromycin 3 Day Dose Pack MIC values for MAC strains. In general, Azithromycin 3 Day Dose Pack MIC values decreased 4 to 8 fold as the pH of Middlebrook 7H11 agar media increased from 6.6 to 7.4. At pH 7.4, Azithromycin 3 Day Dose Pack MIC values determined with Mueller-Hinton agar were 4 fold higher than that observed with Middlebrook 7H12 media at the same pH. Utilization of oleic OADC in these assays has been shown to further alter MIC values. The relationship between Azithromycin 3 Day Dose Pack and clarithromycin MIC values has not been established. In general, Azithromycin 3 Day Dose Pack MIC values were observed to be 2 to 32 fold higher than clarithromycin independent of the susceptibility method employed.

The ability to correlate MIC values and plasma drug levels is difficult as Azithromycin 3 Day Dose Pack concentrates in macrophages and tissues.

Drug Resistance

Complete cross-resistance between Azithromycin 3 Day Dose Pack and clarithromycin has been observed with MAC isolates. In most isolates, a single-point mutation at a position that is homologous to the Escherichia coli positions 2058 or 2059 on the 23S rRNA gene is the mechanism producing this cross-resistance pattern.3,4 MAC isolates exhibiting cross-resistance show an increase in Azithromycin 3 Day Dose Pack MICs to ≥ 128 mcg/mL with clarithromycin MICs increasing to ≥ 32 mcg/mL. These MIC values were determined employing the radiometric broth dilution susceptibility testing method with Middlebrook 7H12 medium. The clinical significance of Azithromycin 3 Day Dose Pack and clarithromycin cross-resistance is not fully understood at this time but preclinical data suggest that reduced activity to both agents will occur after MAC strains produce the 23S rRNA mutation.

Susceptibility Testing for MAC

The disk diffusion techniques and dilution methods for susceptibility testing against gram-positive and gram-negative bacteria should not be used for determining Azithromycin 3 Day Dose Pack MIC values against mycobacteria. In vitro susceptibility testing methods and diagnostic products currently available for determining MIC values against MAC organisms have not been standardized or validated. Azithromycin 3 Day Dose Pack MIC values will vary depending on the susceptibility testing method employed, composition and pH of media, and the utilization of nutritional supplements. Breakpoints to determine whether clinical isolates of M. avium or M. intracellulare are susceptible or resistant to Azithromycin 3 Day Dose Pack have not been established.

The clinical relevance of Azithromycin 3 Day Dose Pack in vitro susceptibility test results for other mycobacterial species, including Mycobacterium tuberculosis, using any susceptibility testing method has not been determined.


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References

  1. DailyMed. "AZITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. NCIt. "Azithromycin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
  3. EPA DSStox. "Azithromycin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).

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