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Clarithromycin 500 mg Tablet, Film Coated, 20-count

by NuCare Pharmaceuticals, Inc. · 20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2)
NDC 68071-3116-02
🏷️ FDA NDC (as labeled) 68071-3116-2 billing pads the package segment with a zero
This package
Contains20-count Pack sizes4 compare ↓
Also comes in: 14 tablets 68071-3116-04 28 tablets 68071-3116-08 30 tablets 68071-3116-03
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68071-3116-2
Product NDC 68071-3116
11-digit billing NDC 68071311602
RxCUI 197517
UNII H1250JIK0A
UPC 0368071311686
Application # ANDA203584
SPL Set ID 4a3febd5-8cf4-5306-e054-00144ff8d46c
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 Discontinued
FDA listing status Discontinued by firm (certified through Apr 2023)
Marketing start 2015-12-04
Route ORAL
Dosage form TABLET, FILM COATED
Substance CLARITHROMYCIN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-3116-2 — 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 → 68071-3116-02. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals, Inc.
Application holderHEC PHARM USA INC
FDA applicationANDA203584 (ANDA)
Labeler code68071
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio362 products on file
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

📗 Our plain-language guide HelloPharmacist
  • Clarithromycin is used for a range of bacterial infections — things like community-acquired pneumonia, sinus infections, flare-ups of chronic bronchitis, strep throat, skin infecti...
  • What kind of infections does clarithromycin treat?
  • It depends on which form you have. Regular clarithromycin tablets can be taken with or without food — your stomach contents don't affect how much of the drug gets absorbed. However...
  • Do I need to take clarithromycin with food?
📖 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 tablets 28 tablets 30 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clarithromycin 500 mg 00527-1932-06 Lannett 60 tablets $0.456 AB Availability likely —
Clarithromycin 500 mg 00904-6872-04 Major 1 tablet $0.456 AB Availability likely —
Clarithromycin 500 mg 50268-0179-13 AvPAK 1 tablet $0.456 AB Availability likely —
Clarithromycin 500 mg 57237-0045-60 Rising 60 tablets $0.456 AB Availability likely —
Clarithromycin 500 mg 60687-0435-21 American 1 tablet $0.456 AB Availability likely —
Clarithromycin 500 mg 62135-0615-60 Chartwell 60 tablets $0.456 AB Availability likely —
Clarithromycin 500 mg 68002-0104-04 American 1 tablet $0.456 AB Availability likely —
Clarithromycin 500 mg 73473-0910-60 Solaris 60 tablets $0.456 AB Availability likely —
Clarithromycin 500 mg 00781-1962-60 Sandoz 60 tablets $0.488 AB Availability likely —
Clarithromycin 500 mg 43063-0530-14 PD-Rx 14 tablets — AB FDA listed —
Clarithromycin 500 mg 43063-0752-14 PD-Rx 14 tablets — AB FDA listed —
Clarithromycin 500 mg 43063-0823-20 PD-Rx 20 tablets — AB FDA listed —
Clarithromycin 500 mg 46708-0345-30 Alembic 30 tablets — AB FDA listed —
Clarithromycin 500 mg 50090-1830-00 A-S 20 tablets — AB FDA listed —
Clarithromycin 500 mg 50090-5282-00 A-S 20 tablets — AB FDA listed —
Clarithromycin 500 mg 51655-0668-20 Northwind 20 tablets — AB FDA listed —
Clarithromycin 500 mg 62332-0345-30 Alembic 30 tablets — AB FDA listed —
Clarithromycin 500 mg 63187-0376-20 Proficient 20 tablets — AB FDA listed —
Clarithromycin 500 mg 63187-0625-14 Proficient 14 tablets — AB FDA listed —
Clarithromycin 500 mg 65862-0226-10 Aurobindo 10 tablets — — FDA listed —
Clarithromycin 500 mg 67046-1515-03 Coupler 30 tablets — AB FDA listed —
Clarithromycin 500 mgthis 68071-3116-02 NuCare 20 tablets — AB Discontinued —
Clarithromycin 500 mg 68071-5045-02 NuCare 20 tablets — AB FDA listed —
Clarithromycin 500 mg 68788-8480-02 Preferred 20 tablets — AB FDA listed —
Clarithromycin 500 mg 70518-0204-00 REMEDYREPACK 30 tablets — AB FDA listed —
Clarithromycin 500 mg 71335-0017-01 Bryant 20 tablets — AB FDA listed —
Clarithromycin 500 mg 71335-1493-01 Bryant 20 tablets — AB FDA listed —
Clarithromycin 500 mg 72189-0299-20 DirectRx 20 tablets — AB FDA listed —
Clarithromycin 500 mg 72189-0639-10 Direct_Rx 10 tablets — AB FDA listed —
Clarithromycin 500 mg 76420-0051-14 Asclemed 14 tablets — AB FDA listed —
Clarithromycin 500 mg 82804-0069-20 Proficient 20 tablets — AB FDA listed —
Clarithromycin 500 mg 82804-0141-14 Proficient 14 tablets — AB FDA listed —
Clarithromycin 500 mg 82868-0085-20 Northwind 20 tablets — AB FDA listed —
Clarithromycin 500 mg 85766-0198-01 Sportpharm 100 tablets — AB FDA listed —
Clarithromycin 500 mg 85766-0203-01 Sportpharm 100 tablets — AB 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

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68071-3116-02 You're viewing this 20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2) 2017-03-08 Discontinued by firm
68071-3116-03 30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3) 2017-03-08 Discontinued by firm
68071-3116-04 14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4) 2017-03-08 Discontinued by firm
68071-3116-08 28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8) 2017-03-08 Discontinued by firm

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68071-3116-02?
NDC 68071-3116-02 is a 20-count package — 20 tablet, film coated in 1 bottle.
What is the difference between NDC 68071-3116-02 and NDC 68071-3116-04?
Both are Clarithromycin 500 mg Tablet, Film Coated — the drug itself is identical. NDC 68071-3116-02 is the 20-count package, while NDC 68071-3116-04 is the 14 tablets package.
What NDC number is used to bill for this package of Clarithromycin 500 mg Tablet, Film Coated?
Bill NDC 68071-3116-02 — the 11-digit billing format is 68071311602. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 68071-3116-2, 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: 68071-3116-02, written without dashes as 68071311602. 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 68071-3116-02, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals, Inc.; the middle segment (3116) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 14 tablets (68071-3116-04), 28 tablets (68071-3116-08), 30 tablets (68071-3116-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NuCare Pharmaceuticals, 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.
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 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) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8) 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 tablets, USP are 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 tablets, USP are 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 tablets, USP are 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

1.4Pharyngitis/Tonsillitis Clarithromycin tablets, USP are 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 tablets, USP are 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 tablets, USP are 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 tablets, USP are 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) ] .

1.8Helicobacter pylori Infection and Duodenal Ulcer Disease Clarithromycin tablet, USP is given in combination with other drugs in adults as described below to eradicate H. pylori . The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.3) ] . Clarithromycin tablets, USP in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori .

Clarithromycin tablets, USP in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain clarithromycin tablets, USP as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adults: clarithromycin 250 mg or 500 mg every 12 hours for 7–14 days (2.2) H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin 500 mg every 8 or 12 hours for 10–14 days. See full prescribing information (FPI) for additional information. (2.3) 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 tablets may be given with or without food.

2.2Adult Dosage The recommended dosages of clarithromycin for the treatment of mild to moderate infections in adults are listed in Table 1. Table 1. Adult Dosage Guidelines Clarithromycin tablets Infection Dosage (every 12 hours) Duration (days) Acute bacterial exacerbation of chronic bronchitis 250 to 500 mg a 7 b -14 Acute maxillary sinusitis 500 mg 14 Community-acquired pneumonia 250 mg c 7 d -14 Pharyngitis/Tonsillitis 250 mg 10 Uncomplicated skin and skin structure infections 250 mg 7-14 Treatment and prophylaxis of disseminated Mycobacterium avium disease [see Dosage and Administration (2.5) ] 500 mg e - H.pylori eradication to reduce the risk of duodenal ulcer recurrence with amoxicillin and omeprazole or lansoprazole [see Dosage and Administration (2.3) ] 500 mg 10-14 H.pylori eradication to reduce the risk of duodenal ulcer recurrence with omeprazole [see Dosage and Administration (2.3) ] 500 mg every 8 hours 14 a For M. catarrhalis and S. pneumoniae use 250 mg.

For H. influenzae and H. parainfluenzae , use 500 mg. b For H parainfluenzae , the duration of therapy is 7 days. c For H. parainfluenzae and M. catarrhalis use clarithromycin extended-release tablets only. d For H. influenzae , the duration of therapy is 7 days. e Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

2.3Combination Dosing Regimens for H. pylori Infection Triple therapy: clarithromycin/lansoprazole/amoxicillin The recommended adult dosage is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days [see Indications and Usage (1.8) and Clinical Studies (14.3) ] . Triple therapy: clarithromycin/omeprazole/amoxicillin The recommended adult dosage is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage (1.8) and Clinical Studies (14.3) ] .

Dual therapy: clarithromycin/omeprazole The recommended adult dosage is 500 mg clarithromycin given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage (1.8) and Clinical Studies (14.3) ] .

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 S…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS Clarithromycin tablets USP, 250 mg are white to off-white oval film-coated tablets debossed with "S39" on one side and blank on the other side. Clarithromycin tablets USP, 500 mg are white to off-white oval film-coated tablets debossed with "S4" on one side and blank on the other side. Tablets: 250 mg and 500 mg (3)

⛔ Contraindications ~2 min read ▾

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

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) ] .

4.2Cardiac Arrhythmias 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.

4.5HMG-CoA Reductase Inhibitors Do not use clarithromycin concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), 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) ] .

4.7Contraindications for Co-administered Drugs For information about contraindications of other drugs indicated in combination with clarithromycin, refer to their full prescribing information (contraindications section).

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) ] .

4.2Cardiac Arrhythmias 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.

4.5HMG-CoA Reductase Inhibitors Do not use clarithromycin concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), 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) ] .

4.7Contraindications 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 ~2 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 (torsade 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 HMG CoA reductase inhibitors, some calcium channel blockers, and other drugs (5.4) Clostridium difficile associated diarrhea (CDAD): Evaluate if diarrhea occurs (5.5) Embryofetal toxicity: Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate (5.6) Exacerbation of myasthenia gravis (5.7)

5.1Acute 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), and Henoch-Schonlein purpura, 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 (quinidine, procainamide) or Class III (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 Serious adverse reactions have been reported in patients taking clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; ; hypotension and with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem, ). . Use clarithromycin with caution when administered concurrently with medications that induce the cytochrome CYP3A4 enzyme.

The use of clarithromycin with simvastatin, lovastatin, ergotamine, or dihydroergotamine is contraindicated . Drugs metabolized by CYP3A4: Serious adverse reactions have been reported in patients taking clarithromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; hypoglycemia with disopyramide; 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 elder…

🤒 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 and Precautions (5.4) ] Clostridium difficile Associated Diarrhea [see Warnings and Precautions (5.5) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.7) ] 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 Lannett Company, Inc. at 1-844-834-0530 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 a in Immunocompromised Adult Patients Receiving Prophylaxis Against M. avium Complex Body System b Clarithromycin (n=339) % Placebo (n=339) % Adverse Reaction 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% c 0.3% a Includes those events possibly or probably related to study drug and excludes concurrent conditions b 2% or greater Adverse Reaction Incidence Rates for either treatment group c Significant higher incidence compared to the placebo-treated group 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 a 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 b 7/196 (4%) 5/208 (2%) SGPT >5 x ULN b 6/217 (3%) 4/232 (2%) a Includes only patients with baseline values within the normal range or borderline high…

🔄 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 (5.3) ] . 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: Colch…

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Teratogenic Effects Pregnancy Category C Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6) ] . Four teratogenicity studies in rats (three with oral doses and one with intravenous doses up to 160 mg/kg/day administered during the period of major organogenesis) and two in rabbits at oral doses up to 125 mg/kg/day (approximately twice the recommended maximum human dose based on mg/m 2 ) or intravenous doses of 30 mg/kg/day administered during gestation days 6 to 18 failed to demonstrate any teratogenicity from clarithromycin.

Two additional oral studies in a different rat strain at similar doses and similar conditions demonstrated a low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6 to 15. Plasma levels after 150 mg/kg/day were twice the human serum levels. Four studies in mice revealed a variable incidence of cleft palate following oral doses of 1000 mg/kg/day (2 and 4 times the recommended maximum human dose based on mg/m 2 , respectively) during gestation days 6 to 15.

Cleft palate was also seen at 500 mg/kg/day. The 1000 mg/kg/day exposure resulted in plasma levels 17 times the human serum levels. In monkeys, an oral dose of 70 mg/kg/day produced fetal growth retardation at plasma levels that were twice the human serum levels.

8.3Nursing Mothers Caution should be exercised when clarithromycin is administered to nursing women. The development and health benefits of human milk feeding should be considered along with the mother’s clinical need for clarithromycin and any potential adverse effects on the human milk fed child from the drug or from the underlying maternal condition. Clarithromycin and its active metabolite 14-hydroxy clarithromycin are excreted in human milk.

Serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin 250 mg orally twice daily. Based on the limited data from this study, and assuming milk consumption of 150 mL/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. This is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age.

A prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. Adverse reactions were comparable in both groups. Adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence.

8.4Pediatric Use The safety and effectiveness of clarithromycin tablets 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 tablets 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…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category C Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6) ] . Four teratogenicity studies in rats (three with oral doses and one with intravenous doses up to 160 mg/kg/day administered during the period of major organogenesis) and two in rabbits at oral doses up to 125 mg/kg/day (approximately twice the recommended maximum human dose based on mg/m 2 ) or intravenous doses of 30 mg/kg/day administered during gestation days 6 to 18 failed to demonstrate any teratogenicity from clarithromycin.

Two additional oral studies in a different rat strain at similar doses and similar conditions demonstrated a low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6 to 15. Plasma levels after 150 mg/kg/day were twice the human serum levels. Four studies in mice revealed a variable incidence of cleft palate following oral doses of 1000 mg/kg/day (2 and 4 times the recommended maximum human dose based on mg/m 2 , respectively) during gestation days 6 to 15.

Cleft palate was also seen at 500 mg/kg/day. The 1000 mg/kg/day exposure resulted in plasma levels 17 times the human serum levels. In monkeys, an oral dose of 70 mg/kg/day produced fetal growth retardation at plasma levels that were twice the human serum levels.

🧒 Pediatric Use 168 words ▾

8.4Pediatric Use The safety and effectiveness of clarithromycin tablets 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 tablets 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 193 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 The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%. For a single 500 mg dose of clarithromycin, food slightly delays the onset of clarithromycin absorption, increasing the peak time from approximately 2 to 2.5 hours. Food also increases the clarithromycin peak plasma concentration by about 24%, but does not affect the extent of clarithromycin bioavailability.

Food does not affect the onset of formation of the active metabolite, 14-OH clarithromycin or its peak plasma concentration but does slightly decrease the extent of metabolite formation, indicated by an 11% decrease in area under the plasma concentration-time curve (AUC). Therefore, clarithromycin tablets may be given without regard to food. In non-fasting healthy human subjects (males and females), peak plasma concentrations were attained within 2 to 3 hours after oral dosing.

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

1.7Metabolism and Elimination Steady-state peak plasma clarithromycin concentrations were attained within 3 days and were approximately 1 mcg/mL to 2 mcg/mL with a 250 mg dose administered every 12 hours and 3 mcg/mL to 4 mcg/mL with a 500 mg dose administered every 8 hours to 12 hours. The elimination half-life of clarithromycin was about 3 hours to 4 hours with 250 mg administered every 12 hours but increased to 5 hours to 7 hours with 500 mg administered every 8 hours to 12 hours. The nonlinearity of clarithromycin pharmacokinetics is slight at the recommended doses of 250 mg and 500 mg administered every 8 hours to 12 hours.

With a 250 mg every 12 hours dosing, the principal metabolite, 14-OH clarithromycin, attains a peak steady-state concentration of about 0.6 mcg/mL and has an elimination half-life of 5 hours to 6 hours. With a 500 mg every 8 hours to 12 hours dosing, the peak steady-state concentration of 14-OH clarithromycin is slightly higher (up to 1 mcg/mL), and its elimination half-life is about 7 hours to 9 hours. With any of these dosing regimens, the steady-state concentration of this metabolite is generally attained within 3 days to 4 days.

After a 250 mg tablet every 12 hours, approximately 20% of the dose is excreted in the urine as clarithromycin, while after a 500 mg tablet every 12 hours, the urinary excretion of clarithromycin is somewhat greater, approximately 30%. In comparison, after an oral dose of 250 mg (125 mg/5 mL) suspension every 12 hours, approximately 40% is excreted in urine as clarithromycin. The renal clearance of clarithromycin is, however, relatively independent of the dose size and approximates the normal glomerular filtration rate.

The major metabolite found in urine is 14-OH clarithromycin, which accounts for an additional 10% to 15% of the dose with either a 250 mg or a 500 mg tablet administered every 12 hours. Specific Populations 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 incre…

🧬 Mechanism of Action 15 words ▾

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

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Clarithromycin tablets, USP are supplied as white to off-white oval film-coated tablets in the following packaging sizes: 500 mg tablets: (debossed with the S4 on one side) Bottles of 14 NDC 68071-3116-4 Bottles of 20 NDC 68071-3116-2 Bottles of 28 NDC 68071-3116-8 Bottles of 30 NDC 68071-3116-3 Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

📋 Description 110 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. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.

Chemical structure for clarithromycin

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Provide the following instructions or information about clarithromycin tablets to patients: Counsel patients that antibacterial drugs including clarithromycin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clarithromycin tablet 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 tablets or other antibacterial drugs in the future. Advise patients that diarrhea is a common problem caused by antibacterials including clarithromycin tablets 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. Advise patients that clarithromycin tablets may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications. Advise patients that clarithromycin tablets can be taken with or without food and can be taken with milk.

There are no data on the effect of clarithromycin tablets 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 medication. The potential for these adverse reactions should be taken into account before patients drive or use machines.

Advise patients that if pregnancy occurs while taking this drug, there is a potential hazard to the fetus [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1) ] .

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