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Zithromax azithromycin dihydrate 200 mg/5mL Powder, For Suspension

by Pfizer Laboratories Div Pfizer Inc · 1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE

NDC 00069-3140-19

🏷️ FDA NDC (as labeled) 0069-3140-19 billing pads the labeler segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0069-3140-19

Product NDC 0069-3140

11-digit billing NDC 00069314019

NCPDP billing unit ML — per mL (volume)

RxCUI 105260, 141963, 211307, 212446, 226827, 248656, 308459, 308460,

UNII 5FD1131I7S

UPC 0300693060306, 0300693070305

Application # NDA050710

SPL Set ID db52b91e-79f7-4cc1-9564-f2eee8e31c45

Established class (EPC) Macrolide Antimicrobial

Chemical class Macrolides

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1995-10-19

Route ORAL

Dosage form POWDER, FOR SUSPENSION

Substance AZITHROMYCIN DIHYDRATE

GCN Seq No 018544

GCN 61199

HICL code 006334

Ingredient (HICL) Azithromycin

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W1

Therapeutic class — intermediate (HIC2) Antibiotics

HIC3 code W1D

Therapeutic class — specific (HIC3) Macrolide Antibiotics

AHFS code 08:12.12.08

AHFS class Other Macrolide Antibiotics

FDB label name ZITHROMAX 200 MG/5 ML SUSP

FDB brand name Zithromax

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 0069-3140-19 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00069-3140-19. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Macrolide Antimicrobial class.

Pharmacologic class Macrolide Antimicrobial

Drug family (ATC) Macrolides, Antibiotics

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPfizer Laboratories Div Pfizer Inc

Application holderPFIZER CHEMICALS DIV PFIZER INC

FDA applicationNDA050710 (NDA)

Labeler code00069

First marketedOct 1995

Product typeHuman Prescription Drug

Portfolio242 products on file

🔎 All NDCs from Pfizer Laboratories Div Pfizer Inc

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ZITHROMAX 200 MG/5 ML SUSP Ingredient Azithromycin

📖 What it is MedlinePlus · NLM

Azithromycin is used to treat infections caused by bacteria. It is also used to treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that affects people with a suppressed immune system). Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as azithromycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

📖 Read our full Azithromycin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Azithromycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion VITAMIN B12 Insignificant Depletion +2 more

🧪 Full Azithromycin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink

ShapeOval

Imprintpfizer;ZTM;250

Size13 mm

ScoringNot scored

FlavorBanana

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII SX01TZO3QZ
A mineral salt made from sodium and phosphate. It acts as a buffer to maintain the medicine's pH level and can help bind ingredients together in solid dosage forms.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$1.36	$40.70 / 30 ml
Medicare drug plans payPart D · Q2 2026	$0.8718	$26.15 / 30 ml
Medicare Part B allowsASP · Q0144	No ASP payment limit on file for Q0144 this quarter.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0069-3140-19

11-digit billing NDC00069-3140-19

Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)

HCPCS J-codeQ0144

DescriptorAZITHROMYCIN DIHYDRATE, ORAL, CAPSULES/POWDER, 1 GRAM

Billing units / pkg0.04 units

Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Azithromycin 200 mg/5mL 24658-0708-34	PURACAP	30 ml	$0.210	AB	Availability likely	—
Azithromycin 200 mg/5mL 42806-0151-34	Epic	30 ml	$0.210	AB	Availability likely	—
Azithromycin 200 mg/5mL 62135-0705-43	Chartwell	30 ml	$0.210	AB	Availability likely	—
Azithromycin 200 mg/5mL 70710-1460-02	Zydus	1 bottle	$0.210	AB	Availability likely	—
azithromycin dihydrate 200 mg/5mL 70436-0222-36	Slate	1 bottle	$0.219	AB	Availability likely	—
Azithromycin 200 mg/5mL 24658-0707-33	PURACAP	22.5 ml	$0.231	AB	Availability likely	—
Azithromycin 200 mg/5mL 42806-0150-33	Epic	22.5 ml	$0.231	AB	Availability likely	—
Azithromycin 200 mg/5mL 70710-1459-02	Zydus	1 bottle	$0.231	AB	Availability likely	—
azithromycin dihydrate 200 mg/5mL 70436-0228-49	Slate	1 bottle	$0.238	AB	Availability likely	—
Azithromycin 200 mg/5mL 00093-2026-23	Teva	15 ml	$0.298	AB	Availability likely	—
Azithromycin 200 mg/5mL 11788-0129-13	AiPing	1 bottle	$0.298	AB	Availability likely	—
Azithromycin 200 mg/5mL 24658-0706-32	PURACAP	15 ml	$0.298	AB	Availability likely	—
Azithromycin 200 mg/5mL 42806-0149-32	Epic	15 ml	$0.298	AB	Availability likely	—
Azithromycin 200 mg/5mL 59651-0008-15	Aurobindo	1 bottle	$0.298	AB	Availability likely	—
Azithromycin 200 mg/5mL 70710-1458-02	Zydus	1 bottle	$0.298	AB	Availability likely	—
azithromycin dihydrate 200 mg/5mL 70436-0221-34	Slate	1 bottle	$0.325	AB	Availability likely	—
Zithromax 200 mg/5mL 00069-3120-19	Pfizer	1 bottle	—	AB	FDA listed	—
Zithromax 200 mg/5mL 00069-3130-19	Pfizer	1 bottle	—	AB	FDA listed	—
Zithromax 200 mg/5mLthis 00069-3140-19	Pfizer	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 50090-4458-00	A-S	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 50090-6226-00	A-S	22.5 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 50090-6267-00	A-S	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 50090-6296-00	A-S	15 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 55695-0003-00	STATE	30 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 63187-0093-15	Proficient	15 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 67296-2141-01	Redpharm	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68071-3897-02	NuCare	22.5 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68071-4773-05	NuCare	15 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68071-4779-03	NuCare	30 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68071-4795-03	NuCare	30 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68788-7549-03	Preferred	30 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 68788-8246-03	Preferred	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 70771-1423-02	Zydus	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 70771-1424-02	Zydus	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 70771-1425-02	Zydus	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 71205-0216-30	Proficient	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 71205-0253-30	Proficient	30 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 71205-0566-15	Proficient	15 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 72189-0314-22	DirectRx	22.5 ml	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 72673-0081-60	Zhejiang	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 72673-0082-90	Zhejiang	1 bottle	—	AB	FDA listed	—
Azithromycin 200 mg/5mL 72673-0083-12	Zhejiang	1 bottle	—	AB	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

1995

On the market since

Oct 1995

📍

2026

Currently FDA-listed

31 years listed

🔓

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00069-3140-19, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

109

Units reimbursed last 4 qtrs

3.9K

Gross reimbursed last 4 qtrs

$5.2K

Avg / prescription

$48.00

Avg / unit

$1.3568

Latest quarter Q4 2025

14Rx

Fee-for-service vs managed care ⓘ

70% FFS 30% MCO

Fee-for-service · 76 Rx Managed care · 33 Rx

State Medicaid map

Units reimbursed · per 100k residents

3.6340

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Alaska 340 /100k

2 Montana 47.8 /100k

3 Florida 3.6 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zithromax — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zithromax. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$2.2K

Claims incl. refills

111

Beneficiaries

Spend / beneficiary

$25.01

Spend / claim

$20.06

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zithromax (this brand).

Top reported reactions

Drug Hypersensitivity1,996

Dyspnoea1,450

Nausea1,128

Pain1,085

Diarrhoea1,033

Fatigue1,007

Pneumonia982

Reporter sex

Serious outcomes

Hospitalization6,438

Death1,452

Life-threatening839

Disabling617

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00069-3140-19 You're viewing this	1 BOTTLE in 1 CARTON (0069-3140-19) / 30 mL in 1 BOTTLE	1995-10-19	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0069-3140-19, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00069-3140-19, written without dashes as 00069314019. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00069-3140-19, the first segment (00069) is the labeler code FDA assigned to Pfizer Laboratories Div Pfizer Inc; the middle segment (3140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (19) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pfizer Laboratories Div Pfizer Inc. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Pfizer Laboratories Div Pfizer Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code Q0144 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE ZITHROMAX is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) • Acute bacterial sinusitis in adults ( 1.1 ) • Uncomplicated skin and skin structure infections in adults ( 1.1 ) • Urethritis and cervicitis in adults ( 1.1 ) • Genital ulcer disease in men ( 1.1 ) • Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) • Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) • Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use: ZITHROMAX is not recommended in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors.

( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.4 )

1.1Indications in Adult Patients ZITHROMAX is indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae . • Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis . or Streptococcus pneumoniae . • Community‑acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , or Streptococcus pneumoniae in patients appropriate for oral therapy. • Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first‑line therapy in individuals who cannot use first‑line therapy. • Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae . • Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae . • Genital ulcer disease in men due to Haemophilus ducreyi (chancroid).

Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

1.2Indications in Pediatric Patients ZITHROMAX is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: [see Use in Specific Populations (8.4) and Clinical Studies (14.2) ] . • Acute otitis media caused by Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae , in pediatric patients 6 months of age and older. • Community‑acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , or Streptococcus pneumoniae in pediatric patients 6 months of age and older appropriate for oral therapy. • Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy in pediatric patients 2 years of age and older.

1.3Limitations of Use Azithromycin is not recommended in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: • patients with cystic fibrosis, • patients with nosocomial infections, • patients with known or suspected bacteremia, • patients requiring hospitalization, • elderly or debilitated patients, or • patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

1.4 Usage T…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage for Adult Patients ( 2.1 ) Infection Recommended Dose/Duration of Therapy Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days.

Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. Recommended Dosage for Pediatric Patients ( 2.2 ) Infection Recommended Dose/Duration of Therapy Acute otitis media (6 months of age and older) 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis (6 months of age and older) 10 mg/kg once daily for 3 days. Community-acquired pneumonia (6 months of age and older) 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis (2 years of age and older) 12 mg/kg once daily for 5 days.

2.1Recommended Dosage for Adult Patients Recommended dosages and durations of therapy in adult patient populations vary by indications [see Indications and Usage (1.1) and Clinical Pharmacology (12.3) ]. ZITHROMAX tablets and ZITHROMAX for oral suspension can be taken with or without food. Table 1.

Recommended dosage for Adult Patients by Indication Infection Due to the indicated microorganisms [see Indications and Usage (1.1) ]. Recommended Dose/Duration of Therapy Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial exacerbations of chronic obstructive pulmonary disease 500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial sinusitis 500 mg once daily for 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose

2.2Recommended Dosage for Pediatric Patients Recommended dosages and durations of therapy in pediatric patient populations vary by indications [see Indications and Usage (1.2) and Clinical Pharmacology (12.3) ] . ZITHROMAX for oral suspension can be taken with or without food. Table 2.

Recommended dose for Pediatric Patients by Indication Infection Due to the indicated microorganisms [see Indications and Usage (1.2) and Use in Specific Populations (8.4) ]. Recommended Dose/Duration of Therapy see dosing tables below for maximum doses evaluated by indication. Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.

Acute bacterial sinusitis 10 mg/kg once daily for 3 days. Community-acquired pneumonia 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, [see Use in Specific Populations (8.4) ] ) Based on Body Weight Table 3. Otitis Media and Community-Acquired Pneumonia: (5-Day Regimen) Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established [see Use in Specific Populations (8.4) ] . Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.

Weight 100 mg/5 mL 200 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course Kg Day 1 Days 2-5 Da…

💊 Dosage Forms and Strengths 148 words ▾

3 DOSAGE FORMS AND STRENGTHS ZITHROMAX 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. ZITHROMAX 250 mg tablets are engraved with "PFIZER" on one side and "306" on the other, or "Pfizer" on one side and "ZTM 250" on the other. ZITHROMAX 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin.

ZITHROMAX 500 mg tablets are engraved with "Pfizer" on one side and "ZTM500" on the other. ZITHROMAX for oral suspension after constitution contains a flavored suspension. ZITHROMAX for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles. • ZITHROMAX tablets 250 mg and 500 mg ( 3 ) • ZITHROMAX for oral suspension 100 mg/5 mL and 200 mg/5 mL ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS • Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. ( 4.1 ) • Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2 )

4.1Hypersensitivity ZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug.

4.2Hepatic Dysfunction ZITHROMAX is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious (including fatal) allergic and skin reactions: Discontinue ZITHROMAX if reaction occurs. ( 5.1 ) • Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue ZITHROMAX immediately if signs and symptoms of hepatitis occur.

( 5.2 ) • Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. ( 5.3 ) • Prolongation of QT interval and cases of torsades de pointes have been reported.

This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. ( 5.4 ) • Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing ZITHROMAX.

( 5.5 ) • Clostridioides difficile -Associated Diarrhea: Evaluate patients if diarrhea occurs. ( 5.6 ) • ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. ( 5.7 )

5.1Hypersensitivity Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy. [see Contraindications (4.1) ] Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.

These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is presently unknown. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.

Physicians should be aware that allergic symptoms may reappear when symptomatic therapy has been discontinued.

5.2Hepatotoxicity Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.

5.3Infantile Hypertrophic Pyloric Stenosis (IHPS) Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

5.4QT Prolongation Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: • patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure • patients on drugs known to prolong the QT interval • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Clas…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Hypersensitivity [see Warnings and Precautions (5.1) ] • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions (5.3) ] • QT Prolongation [see Warnings and Precautions (5.4) ] • Cardiovascular Death [see Warnings and Precautions (5.5) ] • Clostridioides difficile- Associated Diarrhea (CDAD) [see Warnings and Precautions (5.6) ] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Potentially serious adverse reactions of angioedema and cholestatic jaundice were reported.

Approximately 0.7% of the patients (adults and pediatric patients) from the 5-day multiple-dose clinical trials discontinued ZITHROMAX therapy because of treatment-related adverse reactions. In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related adverse reactions was 0.6%. In clinical trials in pediatric patients given 30 mg/kg, either as a single dose or over 3 days, discontinuation from the trials due to treatment-related adverse reactions was approximately 1%.

Most of the adverse reactions leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. [see Clinical Studies (14.2) ] Clinical Trials Experience in Adults Multiple-dose regimens: Overall, the most common treatment-related adverse reactions in adult patients receiving multiple-dose regimens of ZITHROMAX were related to the gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and abdominal pain (2 to 3%) being the most frequently reported.

No other adverse reactions occurred in patients on the multiple-dose regimens of ZITHROMAX with a frequency greater than 1%. Adverse reactions that occurred with a frequency of 1% or less included the following: Cardiovascular: Palpitations, chest pain. Gastrointestinal: Dyspepsia, flatulence, vomiting, melena, and cholestatic jaundice.

Genitourinary: Monilia, vaginitis, and nephritis. Nervous System: Dizziness, headache, vertigo, and somnolence. General: Fatigue.

Allergic: Rash, pruritus, photosensitivity, and angioedema. Single 1-gram dose regimen: Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of ZITHROMAX were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen. Adverse reactions that occurred in patients on the single 1-gram dosing regimen of ZITHROMAX with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).

Single 2-gram dose regimen: Overall, the most common adverse reactions in patients receiving a single 2-gram dose of ZITHROMAX were related to the gastrointestinal system. Adverse reactions that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%), and dizziness (1%). The majority of these complaints were mild in nature.

Clinical Trials Experience in Pediatric Patients Single and Multiple-dose regi…

🔄 Drug Interactions 219 words ▾

7 DRUG INTERACTIONS • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. ( 7.1 ) • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ( 7.2 )

7.1Nelfinavir Co-administration 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) ]

7.2Warfarin 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.

7.3Potential Drug-Drug Interaction with Macrolides 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. ( 8.5 )

8.1Pregnancy Risk Summary 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 500 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 500 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.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data 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.

Animal Data Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. In rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area.

In a pre- and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. Maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. Effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks).

These effects were not observed in a pre- and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning.

8.2Lactation Risk Summary 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.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZITHROMAX and any potential adverse effects on the breastfed infant from ZITHROMAX or from the underlying maternal condition. Clinical Considerations Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. Data 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…

🤰 Pregnancy ~2 min read ▾

These effects were not observed in a pre- and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning.

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use [see Clinical Pharmacology (12.3) , Indications and Usage (1.2) , and Dosage and Administration (2.2) ] 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 ZITHROMAX 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.

Pharyngitis/Tonsillitis: Safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established.

🧓 Geriatric Use 98 words ▾

8.5Geriatric Use In multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. 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 (5.4) ]

🆘 Overdosage 37 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Azithromycin is a macrolide antibacterial drug. [see Microbiology (12.4) ]

12.2Pharmacodynamics Based on animal models of infection, the antibacterial activity of azithromycin 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. 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 (500 mg, 1000 mg, and 1500 mg once daily).

Co-administration of azithromycin 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 co-administration of 500 mg, 1000 mg and 1500 mg azithromycin, respectively.

12.3Pharmacokinetics Following oral administration of a single 500 mg dose (two 250 mg tablets) to 36 fasted healthy male volunteers, the mean (SD) pharmacokinetic parameters were AUC 0–72 =4.3 (1.2) mcg∙hr/mL; C max =0.5 (0.2) mcg/mL; T max =2.2 (0.9) hours. Two azithromycin 250 mg tablets are bioequivalent to a single 500 mg tablet. In a two-way crossover study, 12 adult healthy volunteers (6 males, 6 females) received 1500 mg of azithromycin administered in single daily doses over either 5 days (two 250 mg tablets on day 1, followed by one 250 mg tablet on days 2–5) or 3 days (500 mg per day for days 1–3).

Due to limited serum samples on day 2 (3-day regimen) and days 2–4 (5-day regimen), the serum concentration-time profile of each subject was fit to a 3-compartment model and the AUC 0–∞ for the fitted concentration profile was comparable between the 5-day and 3-day regimens. Table 11. Pharmacokinetic Parameters for Adult Patients Receiving a 3‑Day and 5‑Day Oral Regimen 3-Day Regimen 5-Day Regimen Pharmacokinetic Parameter [mean (SD)] Day 1 Day 3 Day 1 Day 5 C max (serum, mcg/mL) 0.44 (0.22) 0.54 (0.25) 0.43 (0.20) 0.24 (0.06) Serum AUC 0–∞ (mcg∙hr/mL) 17.4 (6.2) Total AUC for the entire 3-day and 5-day regimens.

14.9(3.1) Serum T 1/2 71.8 hr 68.9 hr Absorption The absolute bioavailability of azithromycin 250 mg capsules is 38%. In a two-way crossover study in which 12 healthy subjects received a single 500 mg dose of azithromycin (two 250 mg tablets) with or without a high fat meal, food was shown to increase C max by 23% but had no effect on AUC. When azithromycin oral suspension was administered with food to 28 adult healthy male subjects, C max increased by 56% and AUC was unchanged.

Distribution The serum protein binding of azithromycin 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 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 500 mg on the first day and 250 mg daily for 4 days, very low concentrations were noted in cerebrospinal fluid (less than 0.01 mcg/mL) in the presence of noninflamed meninges.

Elimination Metabolism In vit…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Azithromycin is a macrolide antibacterial drug. [see Microbiology (12.4) ]

Mechanism of Action 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. Resistance 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). Antimicrobial Activity 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) ] Gram-Positive Bacteria Staphylococcus aureus Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Gram-Negative Bacteria Haemophilus ducreyi Haemophilus influenzae Moraxella catarrhalis Neisseria gonorrhoeae Other Bacteria 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. Gram-Positive Bacteria Beta-hemolytic streptococci (Groups C, F, G) Viridans group streptococci Gram-Negative Bacteria Bordetella pertussis Legionella pneumophila Anaerobic Bacteria Prevotella bivia Peptostreptococcus species Other Bacteria Ureaplasma urealyticum

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZITHROMAX Tablets How Supplied ZITHROMAX tablets (azithromycin tablets, USP) are supplied in the following strengths and package configurations: Tablet strength Tablet Color/Shape Tablet Markings Package Size NDC Code 250 mg (containing azithromycin dihydrate equivalent to 250 mg of azithromycin) Pink modified capsular shaped, engraved, film-coated Engraved with "PFIZER" on one side and "306" on the other Bottles of 30 NDC 0069-3060-30 Boxes of 3 (Z-PAKS ® of 6) NDC 0069-3060-75 Unit Dose package of 50 NDC 0069-3060-86 Engraved with "Pfizer" on one side and "ZTM 250" on the other Bottles of 30 NDC 0069-4061-01 Boxes of 3 (Z-PAKS ® of 6) NDC 0069-4061-75 Unit Dose package of 50 NDC 0069-4061-89 500 mg (containing azithromycin dihydrate equivalent to 500 mg of azithromycin) Pink modified capsular shaped, engraved, film coated Engraved with "Pfizer" on one side and "ZTM500" on the other Bottles of 30 NDC 0069-3070-30 Boxes of 3 (TRI-PAKS™ of 3 tablets) NDC 0069-3070-75 Storage and Handling Store ZITHROMAX tablets between 15° to 30°C (59° to 86°F).

ZITHROMAX for Oral Suspension How Supplied ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) after constitution contains a flavored suspension. ZITHROMAX for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: Azithromycin contents per bottle NDC 300 mg 0069-3110-19 600 mg 0069-3120-19 900 mg 0069-3130-19 1200 mg 0069-3140-19 Constitution instructions are described for each bottle type elsewhere in the prescribing information [see Dosage and Administration (2) ] .

Storage and Handling Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed [see Dosage and Administration (2) ] .

📋 Description 219 words ▾

11 DESCRIPTION ZITHROMAX (azithromycin tablets, USP and azithromycin for oral suspension, USP) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3(dimethylamino-)-β-D-xylohexopyranosyl-]oxy]-1-oxa-6-azacyclopentadecan-15 one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a -methyl substituted- nitrogen atom is incorporated into the lactone ring.

Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula: Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0. ZITHROMAX tablets (azithromycin tablets, USP) is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: D&C Red #30 aluminum lake, dibasic calcium phosphate anhydrous, hypromellose, lactose, magnesium stearate, pregelatinized starch, sodium croscarmellose, sodium lauryl sulfate, titanium dioxide, and triacetin.

ZITHROMAX for oral suspension (azithromycin for oral suspension, USP) is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: FD&C Red#40, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, xanthan gum, and spray dried artificial banana, cherry, and creme de vanilla flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions ZITHROMAX tablets and oral suspension can be taken with or without food. Concomitant Administration with Aluminum and Magnesium Containing Antacids Advise patients not to take aluminum and magnesium containing antacids and azithromycin simultaneously.

Allergic Reactions Direct patients to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur [see warnings and Precautions (5.1) ] . Vomiting, Irritability, Diarrhea or Rash with Feeding in Infants Direct parents or caregivers to contact their physician if vomiting, irritability, diarrhea or rash with feeding occurs in the infant [see Warnings and Precautions (5.3) and Use in Specific Population (8.2) ] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including ZITHROMAX should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When ZITHROMAX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZITHROMAX or other antibacterial drugs in the future.

Diarrhea Diarrhea is a common problem caused by antibacterials, including ZITHROMAX which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.6) ] .

Licensed from Pliva This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com . LAB-0023-24.0 Logo

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bacteremia: The presence of bacteria in the blood, which may cause no symptoms or may lead to a more serious infection.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

diarrhea: Loose, watery bowel movements that happen more often than normal.

discontinuation rate: The share of people in a study who stopped taking a treatment before the study was finished.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postmarketing surveillance: Tracking of a medicine's safety after it is approved and being used by the general public.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

pruritus: Itching of the skin.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

torsades de pointes: A rare but dangerous fast heart rhythm that can cause fainting and, in the worst cases, become life-threatening.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 00069-3130-19 · Pfizer 00069-3150-83 · Pfizer →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Zithromax azithromycin dihydrate 200 mg/5mL Powder, For Suspension

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