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Clarithromycin 250 mg/5mL For Suspension, 50 mL — NDC 50090-0994-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clarithromycin 250 mg/5mL For Suspension, 50 mL — NDC 50090-0994-0 (Billing 50090-0994-00)

by A-S Medication Solutions · 50 mL in 1 BOTTLE

This is a package of 50 mL of Clarithromycin 250 mg/5mL For Suspension from A-S Medication Solutions, marketed since Sep 2007 and currently FDA-listed. It is this product's only package size.

NDC 50090-0994-00
🏷️ FDA NDC (as labeled) 50090-0994-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

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

NDC database record

One package, one record: these facts belong to NDC 50090-0994-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50090 labeler · 0994 product · 0 package
Package marketed since
Nov 28, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
50 mL per package
Barcode (UPC-A, from the NDC)
3 5009009940 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-0994-0
Product NDC 50090-0994
11-digit billing NDC 50090099400
NCPDP billing unit ML — per mL (volume)
RxCUI 309322
UNII H1250JIK0A
Application # ANDA065283
SPL Set ID fad1e5a3-59f9-4868-9937-d3b061ab8f00
Established class (EPC) Macrolide Antimicrobial
Mechanism of action Cytochrome P450 3A4 Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors
Chemical class Macrolides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-04
Route ORAL
Dosage form FOR SUSPENSION
Substance CLARITHROMYCIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 03500010001920
GPI class Clarithromycin
GCN Seq No 021735
GCN 11671
HICL code 006228
Ingredient (HICL) Clarithromycin
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 CLARITHROMYCIN 250 MG/5 ML SUS
FDB brand name Clarithromycin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021735
  • GCN: 11671
  • GPI-14 (Medi-Span): 03500010001920
  • HICL (First Databank): 006228
  • AHFS class code: 08:12.12.08
  • RxCUI (RxNorm): 309322
Why two NDCs? The FDA registers this code as 50090-0994-0 — a 5-4-1 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 package segment → 50090-0994-00. 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
How it works Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors
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.

Clinical

Label name CLARITHROMYCIN 250 MG/5 ML SUS Ingredient Clarithromycin
📖 What it is MedlinePlus · NLM

Clarithromycin is used to treat certain bacterial infections. treat and prevent disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that affects people with a weakened immune system. eliminate H. pylori, a bacterium that causes ulcers. Clarithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as clarithromycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibioti...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for mild to moderate bacterial infections, such as bronchitis flare-ups, sinus infections, pneumonia, throat, skin and ear infections. Some forms are also used...
  • Take it by mouth exactly as your prescriber directed. Tablets can be taken with or without food. Extended-release tablets should be taken with food and swallowed whole. Finish the...
  • Stomach upset, nausea, vomiting, diarrhea, belly pain, headache and a strange taste in your mouth are the most common. Call your doctor if you get a severe rash, yellow skin or eye...
  • It interacts with many drugs, so give me your full list. Some, like simvastatin, lovastatin, colchicine in certain people, and pimozide, should not be combined with it. Blood thinn...
📖 Read our full Clarithromycin guide →
7
Nutrient depletion considerations

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

🧪 Full Clarithromycin 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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.01 $50.71 / 50 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-0994-00 You're viewing this Main listing 50 mL in 1 BOTTLE 2014-11-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clarithromycin 250 mg/5mL 00781-6023-46 Sandoz 100 ml $1.345 — Availability likely —
Clarithromycin 250 mg/5mLthis 50090-0994-00 A-S 50 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

🧪 Avoiding an ingredient? See Clarithromycin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • 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.

15 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.

Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderSANDOZ INC
FDA applicationANDA065283 (ANDA)
Labeler code50090
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio2,811 products on file

More NDCs from A-S Medication Solutions labeler code 50090

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: • Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1 ) • Acute Maxillary Sinusitis ( 1.2 ) • Community-Acquired Pneumonia ( 1.3 ) • Pharyngitis/Tonsillitis ( 1.4 ) • Uncomplicated Skin and Skin Structure Infections ( 1.5 ) • Acute Otitis Media in Pediatric Patients ( 1.6 ) • Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7 ) Limitations of Use: To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.9 )

1.1Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin is indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [ see Indications and Usage ( 1.9 ) ].

1.2Acute Maxillary Sinusitis Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [ see Indications and Usage (1.9) ].

1.3Community-Acquired Pneumonia Clarithromycin is indicated [ see Indications and Usage ( 1.9 ) ] for the treatment of mild to moderate infections caused by susceptible isolates due to: • Haemophilus influenzae (in adults) • Mycoplasma pneumoniae , Streptococcus pneumoniae , Chlamydophila pneumoniae clarithromycin [in adults and pediatric patients]

1.4Pharyngitis/Tonsillitis Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.

1.5Uncomplicated Skin and Skin Structure Infections Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus , or Streptococcus pyogenes .

1.6Acute Otitis Media Clarithromycin is indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Moraxella catarrhalis , or Streptococcus pneumoniae [ see Clinical Studies ( 14.2 ) ].

1.7Treatment and Prophylaxis of Disseminated Mycobacterial Infections Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection [ see Clinical Studies ( 14.1 ) ].

1.9Limitations of Use There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus . Susceptibility testing should be performed when clinically indicated.

1.10Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Pediatric Patients: Clarithromycin 15 mg/kg/day divided every 12 hours for 10 days ( 2.4 ) • Mycobacterial Infections: Clarithromycin 500 mg every 12 hours; Clarithromycin 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients ( 2.5 ) • Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment ( 2.6 )

2.1Important Administration Instructions Clarithromycin for oral suspension may be given with or without food.

2.4Pediatric Dosage The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information [ see Dosage and Administration ( 2.5 ) ].

2.5Dosage Regimens for Mycobacterial Infections For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), clarithromycin is recommended as the primary agents. Clarithromycin should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment [ see Clinical Studies ( 14.1 ) ]. Adult Patients For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of clarithromycin is 500 mg every 12 hours.

Pediatric Patients For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours. [ see Use in Specific Populations ( 8.4 ) and Clinical Studies ( 14.1 ) ]. Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

2.6Dosage Adjustment in Patients with Renal Impairment See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [ see Drug Interactions ( 7) ]. Table 2. Clarithromycin Dosage Adjustments in Patients with Renal Impairment Recommended ClarithromycinDosage Reduction Patients with severe renal impairment (CL cr of <30 mL/min) Reduce the dosage of Clarithromycin by 50% Patients with moderate renal impairment (CL cr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of Clarithromycin by 50% Patients with severe renal impairment (CL cr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens Reduce the dosage of Clarithromycin by 75%

2.7Dosage Adjustment Due to Drug Interactions Decrease the dose of clarithromycin by 50 % when co-administered with atazanavir [ see Drug Interactions ( 7 ) ]. Dosage adjustments for other drugs when co-administered with clarithromycin may be recommended due to drug interactions [ see Drug Interactions ( 7 ) ].

2.8Reconstitution of Clarithromycin for Oral Suspension The supplied clarithromycin granules must be reconstituted with water prior to administration of clarithromycin for oral suspension. Table 3 below indicates the volume of water to be added when reconstituting. To reconstitute: a.

Add half the volume of water to the bottle containing the clarithromycin granules and shake vigorously. b. Add the remainder of water to the bottle and shake. Shake well before each use.

After mixing, store at 15° to 30°C (59° to 86°F) and use within 14 days. Do not refrigerate. Table 3.

Volume of Water to be Added When Reconstituting Clarithromycin Granules Total Volume After Reconstitution Clarithromycin Concentration After Reconstitution Amount of Water to be Added 50 mL 125 mg/5 mL 29.5 mL 100 mL 125 mg/5 mL 59 mL 50 mL 250 mg/5 mL 28.5 mL 100 mL 250 mg/5 mL 57 mL

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS Clarithromycin is available as: • Clarithromycin for oral suspension (white to off-white granules before reconstitution; white to off-white opaque suspension after reconstitution): ◦ 125 mg/5 mL concentration available in 50 mL and 100 mL bottles ◦ 250 mg/5 mL concentration available in 50 mL and 100 mL bottles • Granules for Oral Suspension: 125 mg/5 mL and 250 mg/5 mL ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS • Hypersensitivity to clarithromycin or any macrolide drug ( 4.1 ) • Cisapride and pimozide ( 4.2 ) • History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ( 4.3 ) • Colchicine in renal or hepatic impairment ( 4.4 ) • Lomitapide, lovastatin, and simvastatin ( 4.5 ) • Ergot alkaloids (ergotamine or dihydroergotamine) ( 4.6 ) • Lurasidone ( 4.7 )

4.1Hypersensitivity Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [ see Warnings and Precautions ( 5.1 ) ].

4.2Cisapride and Pimozide Concomitant administration of clarithromycin with cisapride and pimozide is contraindicated [ see Drug Interactions ( 7 ) ]. There have been postmarketing reports of drug interactions when clarithromycin is co‑ administered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin. Fatalities have been reported.

4.3Cholestatic Jaundice/Hepatic Dysfunction Clarithromycin is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

4.4Colchicine Concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment.

4.5Lomitapide, Lovastatin, and Simvastatin Concomitant administration of clarithromycin with lomitapide is contraindicated due to potential for markedly increased transaminases [ see Warnings and Precautions ( 5.4 ) and Drug Interactions ( 7 ) ]. Concomitant administration of clarithromycin with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [ see Warnings and Precautions ( 5.4 ) and Drug Interactions ( 7 ) ].

4.6Ergot Alkaloids Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [ see Drug Interactions ( 7 ) ].

4.7Lurasidone Concomitant administration of clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see Drug Interactions ( 7 )].

4.8Contraindications for Co-administered Drugs For information about contraindications of other drugs indicated in combination with clarithromycin, refer to their full prescribing information (contraindications section).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Severe acute hypersensitivity reactions: Discontinue clarithromycin if occurs ( 5.1 ) • QT prolongation: Avoid clarithromycin in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia ( torsades de pointes ), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics ( 5.2 ) • Hepatotoxicity: Discontinue if signs and symptoms of hepatitis occur ( 5.3 ) • Serious adverse reactions can occur due to drug interactions of clarithromycin with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs ( 5.4 ) • Risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease.

Balance this potential risk with the treatment benefits when prescribing clarithromycin in these patients ( 5.5 ) • Clostridium difficile associated diarrhea (CDAD): Evaluate if diarrhea occurs ( 5.6 ) • Embryo-fetal Toxicity: Based on animal findings, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate ( 5.7 ) • Exacerbation of myasthenia gravis has been reported in patients receiving clarithromycin therapy ( 5.8 )

5.1Severe Acute Hypersensitivity Reactions In the event of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, and acute generalized exanthematous pustulosis, discontinue clarithromycin therapy immediately and institute appropriate treatment.

5.2QT Prolongation • Clarithromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving clarithromycin. Fatalities have been reported.

Avoid clarithromycin in the following patients: • patients with known prolongation of the QT interval, ventricular cardiac arrhythmia, including torsades de pointes • patients receiving drugs known to prolong the QT interval [ see also Contraindications ( 4.2 )] • patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia and in patients receiving Class IA (e.g., quinidine, procainamide, disopyramide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Elderly patients may be more susceptible to drug-associated effects on the QT interval [ see Use in Specific Populations ( 8.5 ) ].

5.3Hepatotoxicity Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.

Symptoms of hepatitis can include anorexia, jaundice, dark urine, pruritus, or tender abdomen. Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur.

5.4Serious Adverse Reactions Due to Concomitant Use with Other Drugs Drugs metabolized by CYP3A4: Serious adverse reactions have been reported in patients taking clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; markedly increased transaminases with lomitapide; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; hypoglycemia and cardiac arrhythmias (e.g., torsades de pointes ) with disopyramide; and hypotension and acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine).

Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 involved elderly patients 65 years of age or… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Acute Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] • QT Prolongation [ see Warnings and Precautions ( 5.2 ) ] • Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] • Serious Adverse Reactions Due to Concomitant Use with Other Drugs [ see Warnings andPrecautions ( 5.4 ) ] • Clostridium difficile Associated Diarrhea [ see Warnings and Precautions ( 5.6 ) ] • Exacerbation of Myasthenia Gravis [ see Warnings and Precautions ( 5.8 ) ] Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Based on pooled data across all indications, the most frequent adverse reactions for both adult and pediatric populations observed in clinical trials are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. Also reported were dyspepsia, liver function test abnormal, anaphylactic reaction, candidiasis, headache, insomnia, and rash.

The subsequent subsections list the most common adverse reactions for prophylaxis and treatment of mycobacterial infections and duodenal ulcer associated with H. pylori infection. In general, these profiles are consistent with the pooled data described above. Prophylaxis of Mycobacterial Infections In AIDS patients treated with clarithromycin over long periods of time for prophylaxis against M. avium , it was often difficult to distinguish adverse reactions possibly associated with clarithromycin administration from underlying HIV disease or intercurrent illness.

Median duration of treatment was 10.6 months for the clarithromycin group and 8.2 months for the placebo group. Table 4. Incidence Rates (%) of Selected Adverse Reactions* in Immunocompromised Adult Patients Receiving Prophylaxis Against M. avium Complex Body System † Adverse Reaction Clarithromycin (n=339) % Placebo (n=339) % Body as a Whole Abdominal pain 5% 4% Headache 3% 1% Digestive Diarrhea 8% 4% Dyspepsia 4% 3% Flatulence 2% 1% Nausea 11% 7% Vomiting 6% 3% Skin & Appendages Rash 3% 4% Special Senses Taste Perversion 8% ‡ 0.3% Discontinuation due to adverse reactions occurred in 18% of patients receiving clarithromycin compared to 17% of patients receiving placebo in this trial.

Primary reasons for discontinuation in clarithromycin treated patients include headache, nausea, vomiting, depression, and taste perversion. Changes in Laboratory Values Selected laboratory adverse experiences that were reported during therapy in greater than 2 % of adult patients treated with clarithromycin in a randomized double-blind clinical trial involving 682 patients are presented in Table 5 . In immunocompromised patients receiving prophylaxis against M. avium , evaluations of laboratory values were made by analyzing those values outside the seriously abnormal value (i.e., the extreme high or low limit) for the specified test.

Table 5. Percentage of Patients* Exceeding Extreme Laboratory Values in Patients Receiving Prophylaxis Against M. avium Complex Clarithromycin 500 mg twice a day Placebo WBC Count <1 x 10 9 /L 2/103 (4%) 0/95 SGOT >5 x ULN † 7/196 (4%) 5/208 (2%) SGPT >5 x ULN † 6/217 (3%) 4/232 (2%) * Includes only patients with baseline values within the normal range or borderline high (hematology variables) and within normal range or borderline low (chemistry variables) † ULN= Upper Limit of Normal Treatment of Mycobacterial Infections The adverse reaction profiles for both the 500 mg and 1000 mg twice a day… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Co-administration of clarithromycin is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug. Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme.

Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin. Table 8: Clinically Significant Drug Interactions with Clarithromycin Drugs That Are Affected By Clarithromycin Drug(s) with Pharmacokinetics Affected by Clarithromycin Recommendation Comments Antiarrhythmics Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or disopyramide.

Electrocardiograms should be monitored for QTc prolongation during coadministration of clarithromycin with these drugs [ see Warnings and Precautions ( 5.2 )]. Serum concentrations of these medications should also be monitored. There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with disopyramide and quinidine.

There have been postmarketing reports of hypoglycemia with the concomitant administration of clarithromycin and disopyramide. Therefore, blood glucose levels should be monitored during concomitant administration of clarithromycin and disopyramide. Digoxin Use With Caution Digoxin: Digoxin is a substrate for P-glycoprotein (Pgp) and clarithromycin is known to inhibit Pgp.

When clarithromycin and digoxin are co‑ administered, inhibition of Pgp by clarithromycin may lead to increased exposure of digoxin. Elevated digoxin serum concentrations in patients receiving clarithromycin and digoxin concomitantly have been reported in postmarketing surveillance. Some patients have shown clinical signs consistent with digoxin toxicity, including potentially fatal arrhythmias.

Monitoring of serum digoxin concentrations should be considered, especially for patients with digoxin concentrations in the upper therapeutic range. Oral Anticoagulants Warfarin Use With Caution Oral anticoagulants: Spontaneous reports in the postmarketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants. Prothrombin times should be carefully monitored while patients are receiving clarithromycin and oral anticoagulants simultaneously [ see Warnings and Precautions ( 5.4 )].

Antiepileptics Carbamazepine Use With Caution Carbamazepine: Concomitant administration of single doses of clarithromycin and carbamazepine has been shown to result in increased plasma concentrations of carbamazepine. Blood level monitoring of carbamazepine may be considered. Increased serum concentrations of carbamazepine were observed in clinical trials with clarithromycin.

There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with carbamazepine. Antifungals Itraconazole Use With Caution Itraconazole: Both clarithromycin and itraconazole are substrates and inhibitors of CYP3A, potentially leading to a bi-directional drug interaction when administered concomitantly (see also Itraconazole under “Drugs That Affect Clarithromycin” in the table below). Clarithromycin may increase the plasma concentrations of itraconazole.

Patients taking itraconazole and clarithromycin concomitantly should be monitored closely for signs or symptoms of increased or prolonged adverse reactions. Fluconazole No Dose Adjustment Fluconazole: [ see Pharmacokinetics ( 12.3 ) ] Anti-Gout Agents Colc… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric: Increased risk of torsades de pointes ( 8.5 )

8.1Pregnancy Risk Summary Based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.7 )] . Limited data from a small number of published human studies with clarithromycin use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison. Fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population 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 Animal Data Animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin.

In pregnant mice, clarithromycin was administered during organogenesis (gestation day [GD] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. Reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [MRHD] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. At ≥500 mg/kg/day, increases in the incidence of post-implantation loss and cleft palate in the fetuses were observed.

No adverse developmental effects were observed in mice at ≤250 mg/kg/day (≤1 times MRHD based on body surface area comparison). In pregnant Sprague Dawley rats, clarithromycin was administered during organogenesis (GD 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. Reductions in body weight and food consumption was observed in dams at 150 mg/kg/day.

Increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. Additionally, at 150 mg/kg/day (1 times MRHD based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, IV septal defect) was observed in the fetuses. Clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times MRHD based on body surface area comparison).

Intravenous dosing of clarithromycin during organogenesis in rats (GD 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤1 times MRHD based on body surface area comparison). In pregnant Wistar rat, clarithromycin was administered during organogenesis (GD 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. Reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤1 times MRHD based on body surface area comparison).

In pregnant rabbits, clarithromycin administered during organogenesis (GD 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dos… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.7 )] . Limited data from a small number of published human studies with clarithromycin use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison. Fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population 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 Animal Data Animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin.

In pregnant mice, clarithromycin was administered during organogenesis (gestation day [GD] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. Reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [MRHD] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. At ≥500 mg/kg/day, increases in the incidence of post-implantation loss and cleft palate in the fetuses were observed.

No adverse developmental effects were observed in mice at ≤250 mg/kg/day (≤1 times MRHD based on body surface area comparison). In pregnant Sprague Dawley rats, clarithromycin was administered during organogenesis (GD 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. Reductions in body weight and food consumption was observed in dams at 150 mg/kg/day.

Increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. Additionally, at 150 mg/kg/day (1 times MRHD based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, IV septal defect) was observed in the fetuses. Clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times MRHD based on body surface area comparison).

Intravenous dosing of clarithromycin during organogenesis in rats (GD 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤1 times MRHD based on body surface area comparison). In pregnant Wistar rat, clarithromycin was administered during organogenesis (GD 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. Reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤1 times MRHD based on body surface area comparison).

In pregnant rabbits, clarithromycin administered during organogenesis (GD 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times MRHD based on body surface area comparison). Intravenously administered cl… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 181 words ▾

8.4Pediatric Use The safety and effectiveness of clarithromycin for oral suspension have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. Use in these indications is based on clinical trials in pediatric patients or adequate and well- controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: • Pharyngitis/Tonsillitis • Community-Acquired Pneumonia • Acute maxillary sinusitis • Acute otitis media [ see Clinical Studies ( 14.2 ) ] • Uncomplicated skin and skin structure infections The safety and effectiveness of clarithromycin for oral suspension have been established for the prevention of disseminated Mycobacterium avium complex (MAC) disease in pediatric patients 20 months and older with advanced HIV infection.

No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC pediatric treatment studies. Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. The safety of clarithromycin has not been studied in MAC patients under the age of 20 months.

🧓 Geriatric Use 201 words ▾

8.5Geriatric Use In a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-OH clarithromycin were increased compared to those achieved in healthy young adults. These changes in pharmacokinetics parallel known age-related decreases in renal function. In clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients.

Consider dosage adjustment in elderly patients with severe renal impairment. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [ see Warnings and Precautions ( 5.3 ) ]. Most reports of acute kidney injury with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [ see Warnings and Precautions ( 5.4 ) ].

Especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. Deaths have been reported in some patients [ see Contraindications ( 4.4 ) and Warnings and Precautions ( 5.4 ) ].

🆘 Overdosage 51 words ▾

10 OVERDOSAGE Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics Absorption Clarithromycin Granules For Oral Suspension When 250 mg doses of clarithromycin for oral suspension were administered to fasting healthy adult subjects, peak plasma concentrations were attained around 3 hours after dosing. For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively. In adults given 250 mg clarithromycin as suspension (n = 22), food appeared to decrease mean peak plasma clarithromycin concentrations from 1.2 (± 0.4) mcg/mL to 1.0 (± 0.4) mcg/mL and the extent of absorption from 7.2 (± 2.5) hr•mcg/mL to 6.5 (± 3.7) hr•mcg/mL.

Distribution Clarithromycin and the 14-OH clarithromycin metabolite distribute readily into body tissues and fluids. There are no data available on cerebrospinal fluid penetration. Because of high intracellular concentrations, tissue concentrations are higher than serum concentrations.

Examples of tissue and serum concentrations are presented below. Table 9. Tissue and Serum Concentrations of Clarithromycin CONCENTRATION (after 250 mg every 12 hours) Tissue Type Tissue(mcg/g) Serum(mcg/mL) Tonsil 1.6

0.8Lung 8.8

1.7Specific Populations for Clarithromycin Granules Formulations Clarithromycin Granules For Oral Suspension in Pediatric Patients Clarithromycin penetrates into the middle ear fluid of pediatric patients with secretory otitis media. Table 10. Middle Ear Fluid and Serum Concentrations of Clarithromycin and 14-OH-Clarithromycin in Pediatric Patients CONCENTRATION (after 7.5 mg/kg every 12 hours for 5 doses) Analyte Middle Ear Fluid (mcg/mL) Serum (mcg/mL) Clarithromycin 2.5 1.7 14-OH Clarithromycin 1.3

0.8When pediatric patients (n = 10) were administered a single oral dose of 7.5 mg/kg clarithromycin as an oral suspension, food increased mean peak plasma clarithromycin concentrations from 3.6 (± 1.5) mcg/mL to 4.6 (± 2.8) mcg/mL and the extent of absorption from 10.0 (± 5.5) hr•mcg/mL to 14.2 (± 9.4) hr•mcg/mL. In pediatric patients requiring antibacterial therapy, administration of 7.5 mg/kg every 12 hours of clarithromycin as an oral suspension generally resulted in steady-state peak plasma concentrations of 3 mcg/mL to 7 mcg/mL for clarithromycin and 1 mcg/mL to 2 mcg/mL for 14-OH clarithromycin.

In HIV-infected pediatric patients taking 15 mg/kg of clarithromycin as an oral suspension every 12 hours, steady-state clarithromycin peak concentrations generally ranged from 6 mcg/mL to 15 mcg/mL. HIV Infection Steady-state concentrations of clarithromycin and 14-OH clarithromycin observed following administration of 500 mg doses of clarithromycin every 12 hours to adult patients with HIV infection were similar to those observed in healthy volunteers. In adult HIV-infected patients taking 500-mg or 1000-mg doses of clarithromycin every 12 hours, steady-state clarithromycin C max values ranged from 2 mcg/mL to 4 mcg/mL and 5 mcg/mL to 10 mcg/mL, respectively.

Hepatic Impairment The steady-state concentrations of clarithromycin in subjects with impaired hepatic function did not differ from those in normal subjects; however, the 14-OH clarithromycin concentrations were lower in the hepatically impaired subjects. The decreased formation of 14-OH clarithromycin was at least partially offset by an increase in renal clearance of clarithromycin in the subjects with impaired hepatic function when compared to healthy subjects. Renal Impairment The pharmacokinetics of clarithromycin was also altered in subjects with impaired renal function [ see Use in Specific Populations ( 8.6 ) and Dosage and Administration ( 2.5 ) ].

Drug Interactions Fluconazole Following administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers, the steady-state clarithromycin C min and AUC increased 33… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 17 words ▾

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

📦 How Supplied / Storage and Handling 14 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-0994 NDC: 50090-0994-0 50 mL in a BOTTLE

📋 Description 166 words ▾

11 DESCRIPTION Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0 ‑ methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.96.

The structural formula is: Figure 1: Structure of Clarithromycin Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Clarithromycin is available as granules for oral suspension.

After constitution, each 5 mL of clarithromycin for oral suspension, USP contains 125 mg or 250 mg of clarithromycin. Each bottle of clarithromycin granules for oral suspension contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: citric acid (anhydrous), colloidal silicon dioxide, confectioner’s sugar, fruit punch flavor, glyceryl monostearate, hypromellose, maltodextrin, methacrylic acid copolymer dispersion, poloxamer, polyethylene glycol, polysorbate 80, potassium sorbate, povidone, titanium dioxide, triethyl citrate, and xanthan gum. structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Provide the following instructions or information about clarithromycin to patients: Important Administration Instructions Advise patients that clarithromycin for oral suspension can be taken with or without food and can be taken with milk. Do not refrigerate the suspension. Drug Interactions Advise patients that clarithromycin may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications.

Diarrhea Advise patients that diarrhea is a common problem caused by antibacterials including clarithromycin 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. If this occurs, instruct patients to contact their healthcare provider as soon as possible.

Embryo-fetal Toxicity Advise females of reproductive potential that if pregnancy occurs while taking this drug, there is a potential hazard to the fetus [ see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 ) ]. Antibacterial Resistance Counsel patients that antibacterial drugs including clarithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When clarithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of 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 clarithromycin or other antibacterial drugs in the future. Potential for Dizziness, Vertigo and Confusion There are no data on the effect of clarithromycin on the ability to drive or use machines.

However, counsel patients regarding the potential for dizziness, vertigo, confusion and disorientation, which may occur with the clarithromycin. The potential for these adverse reactions should be taken into account before patients drive or use machines. Risk of Mortality in Patients with Coronary Disease Years After Clarithromycin Treatment Advise patients who have coronary artery disease to continue medications and lifestyle modifications for their coronary artery disease because clarithromycin may be associated with increased risk for mortality years after the end of clarithromycin treatment.

Manufactured in Romania by Sandoz SRL for Sandoz Inc., Princeton, NJ 08540 Rev. September 2023

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Clarithromycin Granules For Oral Suspension When 250 mg doses of clarithromycin for oral suspension were administered to fasting healthy adult subjects, peak plasma concentrations were attained around 3 hours after dosing. For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively. In adults given 250 mg clarithromycin as suspension (n = 22), food appeared to decrease mean peak plasma clarithromycin concentrations from 1.2 (± 0.4) mcg/mL to 1.0 (± 0.4) mcg/mL and the extent of absorption from 7.2 (± 2.5) hr•mcg/mL to 6.5 (± 3.7) hr•mcg/mL.

Distribution Clarithromycin and the 14-OH clarithromycin metabolite distribute readily into body tissues and fluids. There are no data available on cerebrospinal fluid penetration. Because of high intracellular concentrations, tissue concentrations are higher than serum concentrations.

Examples of tissue and serum concentrations are presented below. Table 9. Tissue and Serum Concentrations of Clarithromycin CONCENTRATION (after 250 mg every 12 hours) Tissue Type Tissue(mcg/g) Serum(mcg/mL) Tonsil 1.6

0.8Lung 8.8

1.7Specific Populations for Clarithromycin Granules Formulations Clarithromycin Granules For Oral Suspension in Pediatric Patients Clarithromycin penetrates into the middle ear fluid of pediatric patients with secretory otitis media. Table 10. Middle Ear Fluid and Serum Concentrations of Clarithromycin and 14-OH-Clarithromycin in Pediatric Patients CONCENTRATION (after 7.5 mg/kg every 12 hours for 5 doses) Analyte Middle Ear Fluid (mcg/mL) Serum (mcg/mL) Clarithromycin 2.5 1.7 14-OH Clarithromycin 1.3

0.8When pediatric patients (n = 10) were administered a single oral dose of 7.5 mg/kg clarithromycin as an oral suspension, food increased mean peak plasma clarithromycin concentrations from 3.6 (± 1.5) mcg/mL to 4.6 (± 2.8) mcg/mL and the extent of absorption from 10.0 (± 5.5) hr•mcg/mL to 14.2 (± 9.4) hr•mcg/mL. In pediatric patients requiring antibacterial therapy, administration of 7.5 mg/kg every 12 hours of clarithromycin as an oral suspension generally resulted in steady-state peak plasma concentrations of 3 mcg/mL to 7 mcg/mL for clarithromycin and 1 mcg/mL to 2 mcg/mL for 14-OH clarithromycin.

In HIV-infected pediatric patients taking 15 mg/kg of clarithromycin as an oral suspension every 12 hours, steady-state clarithromycin peak concentrations generally ranged from 6 mcg/mL to 15 mcg/mL. HIV Infection Steady-state concentrations of clarithromycin and 14-OH clarithromycin observed following administration of 500 mg doses of clarithromycin every 12 hours to adult patients with HIV infection were similar to those observed in healthy volunteers. In adult HIV-infected patients taking 500-mg or 1000-mg doses of clarithromycin every 12 hours, steady-state clarithromycin C max values ranged from 2 mcg/mL to 4 mcg/mL and 5 mcg/mL to 10 mcg/mL, respectively.

Hepatic Impairment The steady-state concentrations of clarithromycin in subjects with impaired hepatic function did not differ from those in normal subjects; however, the 14-OH clarithromycin concentrations were lower in the hepatically impaired subjects. The decreased formation of 14-OH clarithromycin was at least partially offset by an increase in renal clearance of clarithromycin in the subjects with impaired hepatic function when compared to healthy subjects. Renal Impairment The pharmacokinetics of clarithromycin was also altered in subjects with impaired renal function [ see Use in Specific Populations ( 8.6 ) and Dosage and Administration ( 2.5 ) ].

Drug Interactions Fluconazole Following administration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily to 21 healthy volunteers, the steady-state clarithromycin C min and AUC increased 33% and 18%, respectively. Clarithromycin exposures were increased and steady-state concentrations of 14-OH clarithromycin were not… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Mycobacterial Infections Prophylaxis of Mycobacterial Infections A randomized, double-blind clinical trial (trial 3) compared clarithromycin 500 mg twice a day to placebo in patients with CDC-defined AIDS and CD 4 counts less than 100 cells/µL. This trial accrued 682 patients from November 1992 to January 1994, with a median CD 4 cell count at entry of 30 cells/mcL. Median duration of clarithromycin was 10.6 months vs.

8.2months for placebo. More patients in the placebo arm than the clarithromycin arm discontinued prematurely from the trial (75.6% and 67.4%, respectively). However, if premature discontinuations due to Mycobacterium avium complex (MAC) or death are excluded, approximately equal percentages of patients on each arm (54.8%) on clarithromycin and 52.5% on placebo) discontinued study drug early for other reasons.

The trial was designed to evaluate the following endpoints: 1. MAC bacteremia, defined as at least one positive culture for Mycobacterium avium complex bacteria from blood or another normally sterile site 2. Survival 3.

Clinically significant disseminated MAC disease, defined as MAC bacteremia accompanied by signs or symptoms of serious MAC infection, including fever, night sweats, weight loss, anemia, or elevations in liver function tests MAC Bacteremia In patients randomized to clarithromycin, the risk of MAC bacteremia was reduced by 69% compared to placebo. The difference between groups was statistically significant (p < 0.001). On an intent- to-treat basis, the one-year cumulative incidence of MAC bacteremia was 5.0% for patients randomized to clarithromycin and 19.4% for patients randomized to placebo.

While only 19 of the 341 patients randomized to clarithromycin developed MAC, 11 of these cases were resistant to clarithromycin. The patients with resistant MAC bacteremia had a median baseline CD 4 count of 10 cells/mm 3 (range 2 cells/mm 3 to 25 cells/mm 3 ). Information regarding the clinical course and response to treatment of the patients with resistant MAC bacteremia is limited.

The 8 patients who received clarithromycin and developed susceptible MAC bacteremia had a median baseline CD 4 count of 25 cells/mm 3 (range 10 cells/mm 3 to 80 cells/mm 3 ). Comparatively, 53 of the 341 placebo patients developed MAC; none of these isolates were resistant to clarithromycin. The median baseline CD 4 count was 15 cells/mm 3 (range 2 cells/mm 3 to 130 cells/mm 3 ) for placebo patients that developed MAC.

Survival A statistically significant survival benefit of clarithromycin compared to placebo was observed (see Figure 3 and Table 13 ). Since the analysis at 18 months includes patients no longer receiving prophylaxis the survival benefit of clarithromycin may be underestimated. Figure 3.

Survival of All Randomized AIDS Patients Over Time in Trial 3 Table 13. Mortality Rates at 18 months in Trial 3 Mortality Rates Reduction in Mortality Rates on clarithromycin Placebo clarithromycin 6 month 9.4% 6.5% 31% 12 month 29.7% 20.5% 31% 18 month 46.4% 37.5% 20% Clinically Significant Disseminated MAC Disease In association with the decreased incidence of MAC bacteremia, patients in the group randomized to clarithromycin showed reductions in the signs and symptoms of disseminated MAC disease, including fever, night sweats, weight loss, and anemia.

Treatment of Mycobacterial Infections Dose-Ranging Monotherapy Trials in Adult AIDS Patients with MAC Two randomized clinical trials (Trials 1 and 2) compared different dosages of clarithromycin in patients with CDC-defined AIDS and CD 4 counts less than100 cells/mcL. These trials accrued patients from May 1991 to March 1992. Trial 500 was a randomized, double-blind trial; trial 577 was an open-label compassionate use trial.

Both trials used 500 mg and 1000 mg twice daily dosing of clarithromycin; trial 1 also had a 2000 mg twice daily clarithromycin group. Trial 1 enrolled 154 adult patients and trial 2 enrolled 469 adult patients. The majority of… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenesis The following in vitro mutagenicity tests have been conducted with clarithromycin: • Salmonella /Mammalian Microsomes Test • Bacterial Induced Mutation Frequency Test • In Vitro Chromosome Aberration Test • Rat Hepatocyte DNA Synthesis Assay • Mouse Lymphoma Assay • Mouse Dominant Lethal Study • Mouse Micronucleus Test All tests had negative results except the in vitro chromosome aberration test which was positive in one test and negative in another.

In addition, a bacterial reverse-mutation test (Ames test) has been performed on clarithromycin metabolites with negative results. Impairment of Fertility Fertility and reproduction studies have shown that daily doses of up to 160 mg/kg/day to male and female rats caused no adverse effects on the estrous cycle, fertility, parturition, or number and viability of offspring. Plasma levels in rats after 150 mg/kg/day were twice the human serum levels.

Testicular atrophy occurred in rats at doses 7 times, in dogs at doses 3 times, and in monkeys at doses 8 times greater than the maximum human daily dose (on a body surface area basis).

13.2Animal Toxicology and/or Pharmacology Corneal opacity occurred in dogs at doses 12 times and in monkeys at doses 8 times greater than the maximum human daily dose (on a body surface area basis). Lymphoid depletion occurred in dogs at doses 3 times greater than and in monkeys at doses 2 times greater than the maximum human daily dose (on a body surface area basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 179 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenesis The following in vitro mutagenicity tests have been conducted with clarithromycin: • Salmonella /Mammalian Microsomes Test • Bacterial Induced Mutation Frequency Test • In Vitro Chromosome Aberration Test • Rat Hepatocyte DNA Synthesis Assay • Mouse Lymphoma Assay • Mouse Dominant Lethal Study • Mouse Micronucleus Test All tests had negative results except the in vitro chromosome aberration test which was positive in one test and negative in another.

In addition, a bacterial reverse-mutation test (Ames test) has been performed on clarithromycin metabolites with negative results. Impairment of Fertility Fertility and reproduction studies have shown that daily doses of up to 160 mg/kg/day to male and female rats caused no adverse effects on the estrous cycle, fertility, parturition, or number and viability of offspring. Plasma levels in rats after 150 mg/kg/day were twice the human serum levels.

Testicular atrophy occurred in rats at doses 7 times, in dogs at doses 3 times, and in monkeys at doses 8 times greater than the maximum human daily dose (on a body surface area basis).

📚 References 69 words ▾

15 REFERENCES 1. Winkel P, Hilden J, Hansen JF, Kastrup J, Kolmos HJ, Kjøller E, et al. Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded clinical trial. Int J Cardiol 2015; 182:459-65. 2. Kemper CA, et al. Treatment of Mycobacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. Ann Intern Med . 1992;116:466-472.

📄 Recent Major Changes 11 words ▾

Contraindications ( 4 ) 05/2023 Drug Interactions ( 7 ) 05/2023

📄 Package Label / Principal Display Panel 3 words ▾

Clarithromycin Label Image

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

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

Medicare Part D (outpatient prescription) spending for Clarithromycin — the program that covers self-administered drugs. 4 manufacturers.
⚠️ 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 Clarithromycin. 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
$830.3K
Claims incl. refills
35.1K
Beneficiaries
32.1K
Spend / beneficiary
$25.86
Spend / claim
$23.65
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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.
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.
← 50090-0991-00 · A-S 50090-1001-00 · A-S →
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.