Azithromycin 500mg 3 Tab (Zithromax)

Azithromycin 500mg 3 Tab (Zithromax)

Brand: Simi
Product Code: azithromycin_500mg_3t
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Price: $22.50$31.50
Description

Azthromycin 500 mg. 3 tablets

Patient Education - English

  • Generic Name: azithromycin
  • Pronounced: a ZITH roe MYE sin
  • Brand Names: Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax

What is the most important information I should know about azithromycin?

You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin.

What is azithromycin?

Azithromycin is an antibiotic that fights bacteria.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

Azithromycin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking azithromycin?

You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin. You should not use azithromycin if you are allergic to it or to similar drugs such as clarithromycin, erythromycin, or telithromycin.

To make sure azithromycin is safe for you, tell your doctor if you have:

  • liver disease;
  • kidney disease;
  • myasthenia gravis;
  • a heart rhythm disorder; or
  • a history of Long QT syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 6 months old.

Older adults may be more likely to have side effects on heart rhythm, including a life-threatening fast heart rate.

How should I take azithromycin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The dose and length of treatment with azithromycin may not be the same for every type of infection.

You may take most forms of azithromycin with or without food.

Take Zmax extended release liquid (oral suspension) on an empty stomach, at least 1 hour before or 2 hours after a meal.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Throw away any mixed Zmax oral suspension that has not been used within 12 hours.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use this medication 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. Azithromycin will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat. Throw away any unused liquid medicine after 10 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking azithromycin?

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. These antacids can make azithromycin less effective when taken at the same time.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking azithromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Azithromycin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of azithromycin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;
  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • mild diarrhea;
  • mild stomach pain or upset;
  • dizziness; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect azithromycin?

Many drugs can interact with azithromycin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with azithromycin, especially:

  • droperidol;
  • methadone;
  • nelfinavir;
  • another antibiotic--clarithromycin, erythromycin, moxifloxacin, pentamidine;
  • a blood thinner (warfarin, Coumadin);
  • cancer medicine--arsenic trioxide, vandetanib;
  • an antidepressant--citalopram, escitalopram;
  • anti-malaria medication--chloroquine, halofantrine;
  • heart rhythm medicine--amiodarone, disopyramide, dofetilide, flecainide, ibutilide, procainamide, quinidine, sotalol; or
  • medicine to treat a psychiatric disorder--chlorpromazine, haloperidol, mesoridazine, pimozide, thioridazine.

This list is not complete and many other drugs can interact with azithromycin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about azithromycin.

Adult Dosing .

Dosage forms:  250,500,600; 100,200/5 mL; 1 g pwdr pkt; IV

infections, bacterial

[500 mg PO x1 on day 1, then 250 mg PO q24h x4 days]

sinusitis, acute bacterial

[500 mg PO q24h x3 days]
Info: not recommended per IDSA guidelines

pharyngitis/tonsillitis, streptococcal

[500 mg PO x1 on day 1, then 250 mg PO q24h x4 days]
Alt: 500 mg PO q24h x3 days

COPD exacerbation, acute bacterial

[500 mg PO x1 on day 1, then 250 mg PO q24h x4 days]
Alt: 500 mg PO q24h x3 days

pneumonia, community-acquired

[500 mg PO x1 on day 1, then 250 mg PO q24h x4 days]
Alt: 500 mg IV q24h x2 or more days, then 500 mg PO q24h to complete 7-10 day course

infections, chlamydial

[treatment]
Dose: 1 g PO x1; Info: for uncomplicated urethritis, cervicitis only
[*prophylaxis]
Dose: 1 g PO x1; Info: for sexual assault victims

infections, uncomplicated gonococcal

[initial infection]
Dose: 1 g PO x1; Info: for infections of pharynx, cervix, urethra, rectum; use w/ ceftriaxone (preferred) or cefixime; may use 2 g PO x1 as monotherapy for pts w/ hypersens. to cephalosporin
[recurrent or persistent infection]
Dose: 2 g PO x1; Info: for infections of pharynx, cervix, urethra, rectum; use after gonococcal and chlamydial infection tx failure; use w/ gentamicin

PID, mild-mod. severe

[500 mg IV q24h x1-2 days, then 250 mg PO q24h x5-6 days]
Info: usual course 7 days total; not 1st-line agent

urethritis, non-gonococcal

[initial infection]
Dose: 1 g PO x1
[recurrent or persistent infection]
Dose: 1 g PO x1 w/ metronidazole or tinidazole; Info: for use only if single-dose azithromycin not used for initial infection

chancroid

[1 g PO x1]

MAC tx, disseminated

[500-600 mg PO q24h]
Info: not 1st-line agent; use w/ ethambutol

MAC prophylaxis, primary

[1200 mg PO qwk]
Alt: 600 mg PO 2x/wk

*MAC prophylaxis, secondary

[500-600 mg PO q24h]
Info: not 1st-line agent; use w/ ethambutol

*endocarditis prophylaxis, dental

[500 mg PO x1]
Start: 30-60min before procedure

*cervicitis, presumptive

[1 g PO x1]

*salmonellosis, acute

[1 g PO q24h x1 day, then 500 mg PO q24h x2-6 days]
Info: may extend tx x1wk if immunocompromised

*typhoid fever, adjunct tx

[10 mg/kg PO q24h x1wk]

*babesiosis, mild-mod.

[immunocompetent pts]
Dose: 500-1000 mg PO x1 on day 1, then 250 mg PO q24h x6-9 days; Info: use w/ atovaquone
[immunocompromised pts]
Dose: 600-1000 mg PO q24h x7-10 days; Info: use w/ atovaquone

renal dosing

[no adjustment]
severe impairment: caution advised; HD/PD: no supplement

hepatic dosing

[not defined]
hepatic impairment: caution advised

Peds Dosing .

Dosage forms:  250,500,600; 100,200/5 mL; 1 g pwdr pkt; IV

otitis media, acute

[2 mo-12 yo]
Dose: 10 mg/kg PO x1 on day 1, then 5 mg/kg PO q24h x4 days

sinusitis, acute bacterial

[>6 mo]
Dose: 10 mg/kg PO q24h x3 days; Info: not recommended per IDSA guidelines

pharyngitis/tonsillitis, streptococcal

[>2 yo]
Dose: 12 mg/kg PO q24h x5 days; Max: 500 mg/dose; Alt: 20 mg/kg PO q24h x3 days

community-acquired pneumonia, atypical

[mild infection, >3 mo]
Dose: 10 mg/kg PO x1 on day 1, then 5 mg/kg PO q24h x4 days; Max: 500 mg for 1st dose, 250 mg for subsequent doses
[*moderate-severe infection, >3 mo]
Dose: 10 mg/kg IV q24h x2 days, then 5 mg/kg PO q24h x3 days; Max: 500 mg/dose IV; 250 mg/dose PO

*endocarditis prophylaxis, dental

[15 mg/kg PO x1]
Start: 30-60min before procedure; Max: 500 mg/dose

*infection tx, chlamydial

[<8 yo and <45 kg]
Dose: 20 mg/kg PO x1; Max: 1 g/dose; Info: not 1st-line agent
[>8 yo or >45 kg]
Dose: 1 g PO x1

*infection prophylaxis, chlamydial

[preadolescents <45 kg]
Dose: 20 mg/kg PO x1; Info: for sexual assault victims
[preadolescents >45 kg and adolescents]
Dose: 1 g PO x1; Info: for sexual assault victims

*urethritis, non-gonococcal

[adolescents, initial infection]
Dose: 1 g PO x1
[adolescents, recurrent or persistent infection]
Dose: 1 g PO x1 w/ metronidazole or tinidazole; Info: for use only if single-dose azithromycin not used for initial infection

*chancroid

[preadolescents <45 kg]
Dose: 20 mg/kg PO x1; Max: 1 g/dose
[preadolescents >45 kg and adolescents]
Dose: 1 g PO x1

*MAC tx

[1 mo-12 yo]
Dose: 10-12 mg/kg PO q24h for at least 1mo; Max: 500 mg/day; Info: not 1st-line agent; use w/ ethambutol
[>13 yo]
Dose: 500-600 mg PO q24h; Info: not 1st-line agent; use w/ ethambutol

*MAC prophylaxis, primary

[1 mo-12 yo]
Dose: 20 mg/kg PO qwk; Max: 1200 mg/wk; Alt: 5 mg/kg PO q24h, max 250 mg/day
[>13 yo]
Dose: 1200 mg PO qwk; Alt: 600 mg PO 2x/wk

*MAC prophylaxis, secondary

[1 mo-12 yo]
Dose: 5 mg/kg PO q24h; Max: 250 mg/day; Info: not 1st-line agent; use w/ ethambutol
[>13 yo]
Dose: 500-600 mg PO q24h; Info: not 1st-line agent; use w/ ethambutol

*cervicitis, presumptive

[adolescents]
Dose: 1 g PO x1

*salmonellosis, acute

[10 mg/kg PO q24h x3-7 days]
Max: 500 mg/day; Info: may extend tx x1wk if immunocompromised

*typhoid fever, adjunct tx

[10 mg/kg PO q24h x1wk]

*babesiosis, mild-mod.

[immunocompetent pts]
Dose: 10 mg/kg PO x1 on day 1, then 5 mg/kg PO q24h x6-9 days; Max: 500 mg on day 1; 250 mg/day on days 2-10; Info: use w/ atovaquone
[immunocompromised pts]
Dose: 12 mg/kg PO q24h x7-10 days; Max: 600 mg/day; Info: use w/ atovaquone

renal dosing

[no adjustment]
CrCl <10: caution advised; HD/PD: no supplement

hepatic dosing

[not defined]
hepatic impairment: caution advised

Contraindications/Cautions .

  • hypersens. to drug/class/compon.
  • azithromycin-assoc. cholestatic jaundice hx
  • azithromycin-assoc. hepatic impairment hx
  • caution in elderly pts
  • caution if hepatic impairment
  • caution if renal impairment
  • caution if QT prolongation
  • caution if QT prolongation risk
  • caution if QT prolongation family hx
  • caution if congenital long QT syndrome
  • caution if torsades de pointes hx
  • caution if ventricular arrhythmias
  • caution if bradycardia
  • caution if recent MI
  • caution if CHF
  • caution if electrolyte abnormalities
  • caution if myasthenia gravis
  • caution if recent abx-assoc. colitis hx

Drug Interactions .

Overview

azithromycin

macrolide

Interaction Characteristics:
  1. P-gp (MDR1) inhibitor, moderate
  2. alters GI flora
  3. binds to polyvalent cations
  4. GI absorption enhanced by GLP-2 receptor agonist
  5. prolongs QT interval, probable

Contraindicated

  • BCG live intravesical
  • cisapride
  • dronedarone
  • pimozide
  • thioridazine

Avoid/Use Alternative

  • amiodarone
  • anagrelide
  • arsenic trioxide
  • artemether/lumefantrine
  • asenapine
  • bedaquiline
  • chloroquine
  • clarithromycin
  • crizotinib
  • degarelix
  • disopyramide
  • dofetilide
  • dolasetron
  • droperidol
  • ephedra
  • ephedrine
  • erythromycin
  • flecainide
  • goserelin
  • haloperidol
  • histrelin
  • ibutilide
  • iloperidone
  • leuprolide
  • lopinavir/ritonavir
  • methadone
  • mifepristone
  • nilotinib
  • paliperidone
  • pasireotide
  • pentamidine
  • procainamide
  • quinidine (antiarrhythmic)
  • quinine
  • ranolazine
  • saquinavir
  • sotalol
  • sunitinib
  • telavancin
  • telithromycin
  • tetrabenazine
  • toremifene
  • triptorelin
  • typhoid vaccine, live
  • vandetanib
  • ziprasidone

Monitor/Modify Tx

  • acetazolamide
  • afatinib
  • albuterol
  • albuterol inhaled
  • aluminum hydroxide
  • amphotericin
  • arformoterol inhaled
  • bendroflumethiazide
  • betamethasone
  • budesonide
  • bumetanide
  • carboplatin
  • chlorothiazide
  • chlorthalidone
  • cisplatin
  • citalopram
  • cortisone
  • dexamethasone
  • digoxin
  • ethacrynic acid
  • exenatide
  • formoterol inhaled
  • foscarnet
  • furosemide
  • hydrochlorothiazide
  • hydrocortisone
  • indacaterol inhaled
  • indapamide
  • isoproterenol
  • levalbuterol inhaled
  • magnesium carbonate
  • magnesium hydroxide
  • magnesium trisilicate
  • metaproterenol
  • methazolamide
  • methyclothiazide
  • methylprednisolone
  • metolazone
  • ondansetron
  • pirbuterol inhaled
  • prednisolone
  • prednisone
  • quinidine (CYP2D6 booster)
  • romidepsin
  • salmeterol inhaled
  • sirolimus
  • sodium phosphate (bowel prep)
  • sodium phosphate rectal
  • sulfate bowel prep
  • teduglutide
  • terbutaline
  • torsemide
  • triamcinolone
  • vilanterol inhaled
  • warfarin

Caution Advised

  • alfuzosin
  • amitriptyline
  • amoxapine
  • apomorphine
  • chlorpromazine
  • ciprofloxacin
  • clomipramine
  • clozapine
  • colchicine
  • dasatinib
  • desipramine
  • desogestrel (contraceptive)
  • dienogest (contraceptive)
  • doxepin
  • drospirenone (contraceptive)
  • escitalopram
  • estradiol (contraceptive)
  • ethinyl estradiol (contraceptive)
  • ethynodiol (contraceptive)
  • etonogestrel (contraceptive)
  • fluconazole
  • fluphenazine
  • gemifloxacin
  • granisetron
  • imipramine
  • isradipine
  • lapatinib
  • levofloxacin
  • levonorgestrel (contraceptive)
  • maraviroc
  • mefloquine
  • mestranol (contraceptive)
  • moxifloxacin
  • mycophenolate mofetil
  • mycophenolic acid
  • nelfinavir
  • norelgestromin (contraceptive)
  • norethindrone (contraceptive)
  • norfloxacin
  • norgestimate (contraceptive)
  • norgestrel (contraceptive)
  • nortriptyline
  • ofloxacin
  • pazopanib
  • perphenazine
  • posaconazole
  • prochlorperazine
  • promethazine
  • propafenone
  • protriptyline
  • quetiapine
  • sodium picosulfate
  • tacrolimus
  • trifluoperazine
  • trimipramine
  • vardenafil
  • vemurafenib
  • venlafaxine
  • vismodegib
  • voriconazole

Adverse Reactions .

Serious Reactions

  • angioedema
  • anaphylaxis
  • cholestatic jaundice
  • hepatotoxicity
  • pancreatitis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Clostridium difficile associated diarrhea
  • QT prolongation
  • torsades de pointes
  • myasthenia gravis exacerbation

Common Reactions

  • diarrhea
  • nausea
  • abdominal pain
  • vaginitis
  • dyspepsia
  • dizziness
  • rash
  • vomiting
  • anorexia
  • pruritus

Safety/Monitoring .

Pregnancy: B

Lactation: Safety Unknown

Monitoring Parameters
no routine tests recommended

Look/Sound-Alike Drug Names
[from www.usp.org]
azithromycin confused with: azathioprine; aztreonam; erythromycin; vancomycin; Zaroxolyn

Pharmacology .

Metabolism: liver; CYP450: unknown

Excretion: bile primarily (>50% unchanged), urine (6% unchanged); Half-life: 68h; Info: extensive uptake and eventual release from tissues

Subclass: Macrolides

Mechanism of Action
bacteriostatic or bactericidal, depending on susceptibility and concentration; binds to 50S ribosomal subunit, inhibiting protein synthesis

Manufacturer/Pricing .

Manufacturer: generic

DEA/FDA:

Approximate Retail Price

powder, for suspension:

  • 200 mg/5 mL (1 bottle of oral susp, 15mL): $44.00
  • 100 mg/5 mL (1 bottle of oral susp, 15mL): $38.88

powder, for suspension:

  • 200 mg/5 mL (1 bottle of oral susp, 22.5mL): $40.41

 

tablet, film coated:

  • 500 mg (1 tri-pak): $51.70

tablet, film coated:

  • 250 mg (8 ea): $69.25
  • 500 mg (5 ea): $79.29
  • 600 mg (8 ea): $134.36

tablet, film coated:

  • 250 mg (1 z-pak): $51.09

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Warranty Information

AZITHROMYCIN is the Generic equivalent to the brand or patented medicine ZITHROMAX. Because of its generic form, a compulsory licence(s) were issued in numerous countries allowing their fabrication, importation, exportation and distribution where legally permitted; and are not in violation of any accords in regards to trademarks or patents. Confirm you are able to order and receive these generic pharmaceuticals into your country prior to ordering, some countries may not allow their importation. This med may be dispensed from Mexico, Switzerland, UK, EurAsia or USA.
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