1.What is Clarithromycin?
Definition:
Clarithromycin is a semisynthetic 14-membered ring macrolide antibiotic used to treat a wide range of mild to moderate bacterial infections (e.g., pharyngitis, tonsillitis, respiratory tract infections, and uncomplicated skin infections).
In patients with a history of type I penicillin hypersensitivity, clarithromycin is an alternative medication for the treatment of S. pneumoniae, in addition to acute otitis media caused by H. influenzae and M. catarrhalis. Besides, in some cases, such as prophylaxis against Mycobacterium avium complex in HIV patients, clarithromycin is administered on a long-term basis.
For the treatment of Helicobacter pylori (H. pylori) infection in patients with duodenal ulcer disease, clarithromycin is also used in combination with amoxicillin and lansoprazole or omeprazole (triple therapy) or in combination with anti-ulcer medicines (dual therapy) for treatment of patients with an active duodenal ulcer associated with H. pylori infection.
Clarithromycin was approved for use in the United States in 1993. It is included on the World Health Organization's List of Essential Medicines, which includes the safest and most effective medicines required in a healthcare system.
Clarithromycin is an erythromycin derivative and is chemically known as 6-O-methylerythromycin.
Clarithromycin is a prescription medication available in various forms, including tablets and granules for oral suspension.
Chemical & Physical properties:
Chemical structure:
Molecular weight: 748.0
Molecular formula: C38H69NO13
CAS (Chemical Abstracts Service) number: 81103-11-9
IUPAC name: (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-12,13-dihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-oxacyclotetradecane-2,10-dione
DrugBank accession number: DB01211
Synonyms: O-Methylerythromycin
Powder color: White to off-white crystalline powder
Melting range: 217-220 °C
Solubility: Water solubility (0.33 mg/L), soluble in acetone
The spectrum of activity: Gram-positive bacteria (Staphylococcus aureus, S. pneumoniae, and S. pyogenes), gram-negative bacteria (Haemophilus influenzae, H. parainfluenzae, and Moraxella catarrhalis), and some other organisms including Mycoplasma, Ureaplasma, Chlamydia, Toxoplasma, and Borrelia, aerobic bacteria, and mycoplasma (Mycoplasma pneumoniae; Ureaplasma urealyticum).
Elimination half-life: 3-4 hours (250 mg), 5-7 hours (500 mg)
Brand names:
Biaxin®, Biaxin Bid®, Omeclamox®, Prevpac®
2.Clarithromycin Mechanism of action.
Clarithromycin is an antibiotic belonging to the macrolide group. It exerts its antibacterial action by inhibiting RNA-dependent protein synthesis via penetrating the cell wall and binding to 50S ribosomal subunits of the bacterial ribosome, thereby blocking the translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis.
The hepatic microsomal CYP3A and P-glycoprotein, an energy-dependent drug efflux pump, are also inhibited by clarithromycin.
3.Clarithromycin forms and specifications.
Clarithromycin API powder 99%
Sold by: Century Pharmaceuticals Limited, Vadodara, Gujarat
Product name: Clarithromycin Raw Material, API
CAS Number: 81103-11-9
API form: Powder
Color: White to off-white powder
Country of origin: India
Clarithromycin tablet（500 mg）
Clarithromycin 500 mg tablets are used to treat bacterial infections such as pharyngitis, mild to moderate community-acquired pneumonia, acute sinusitis, acute exacerbation of chronic bronchitis, mild to moderate skin infections, and mild to moderate soft tissue infections.
The extended-release tablet is only for adults diagnosed with acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, or community-acquired pneumonia.
The tablets should be swallowed whole with plenty of water and can be taken with or without food.
Clarithromycin Dry Suspension
Clarithromycin is available as granules for Oral suspension: 125 mg/5 mL and 250 mg/5 mL.
Clarithromycin oral suspension is used to treat infections in children aged 6 months to 12 years caused by clarithromycin-susceptible organisms.
These include lower respiratory tract infections (e.g., bronchitis, pneumonia), upper respiratory tract infections (e.g., pharyngitis, sinusitis), skin and skin structure infections (e.g., folliculitis, cellulitis, erysipelas), and acute otitis media.
4.Amoxicillin / Clarithromycin / Lansoprazole
In combination with amoxicillin and lansoprazole, Clarithromycin is indicated as triple therapy for patients with H. pylori infection and duodenal ulcer disease.
Lansoprazole is a proton pump inhibitor, which exerts its anti-ulcer effect by reducing the amount of acid produced in the stomach. In contrast, amoxicillin, like Clarithromycin, works by stopping the growth of bacteria by inhibiting bacterial protein synthesis.
Lansoprazole is available as a delayed-release capsule (releases the medication in the intestine to avoid stomach acids breaking it down), clarithromycin is available as a tablet, and amoxicillin is available as a capsule, all of which are to be taken by mouth.
5.Clarithromycin vs. Azithromycin
Azithromycin and clarithromycin are structurally modified derivatives of the older macrolide antibiotic erythromycin, which resulted in changes in the spectrum of activity, dosing, and administration.
They treat a wide range of infections, including community-acquired respiratory tract infections and mycobacterial infections.
Azithromycin, like Clarithromycin, works by stopping the growth of bacteria by inhibiting bacterial protein synthesis.
Clarithromycin has the same 14-membered macrolide lactone ring as erythromycin; the only difference is that at position six, a methoxy group replaces the hydroxyl group.
On the other hand, Azithromycin has a 15-membered ring and a methyl-substituted nitrogen group in place of the 9A carbonyl group. As a result, azithromycin is more precisely referred to as an azalide rather than a macrolide.
6.Clarithromycin vs. Clindamycin
Clarithromycin and clindamycin both are antibiotics that work by binding to the 50s ribosomal subunit of bacteria and disrupting protein synthesis; however, they may compete at the binding site.
Clarithromycin is used to treat bacterial infections and is the first-line treatment for most common respiratory infections. In contrast, clindamycin is used to treat acne by preventing acne-causing bacteria from growing and reproducing.
The most common side effects of clarithromycin are nausea, vomiting, and diarrhea, whereas dryness and oily skin are the most common problems of clindamycin.
7.Clarithromycin uses
Clarithromycin for sinus infection
Clarithromycin is prescribed to treat mild to moderate infections, such as acute maxillary sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumonia.
The adult dose is 500 mg taken orally every 12 hours for 14 days, while the pediatric dose is 15 mg/kg taken orally every 12 hours for ten days.
Clarithromycin for urinary tract bacterial infections
Although macrolides, such as clarithromycin, are not commonly used for treating urinary tract infections (UTIs), clarithromycin is more commonly indicated for some sexually transmitted disease-caused urinary problems.
clarithromycin for pneumonia
Clarithromycin is used to treat community-acquired pneumonia caused by Mycoplasma pneumoniae, Streptococcus pneumoniae, and Chlamydophila pneumoniae.
Clarithromycin is also used as an alternative medication to treat S. pneumoniae in patients with a history of type I penicillin hypersensitivity.
8.Clarithromycin dosage
Clarithromycin comes in tablet form (250 mg-500mg), extended-release tablet form (ER) in 500mg strength, and oral suspension form (125mg/5mL and 250mg/5mL).
Adult Dosage:
Acute Exacerbation of Chronic Bronchitis
250-500 mg orally every 12 hours for 7-14 days
ER: 1000 mg orally once daily for 7 days
Acute Maxillary Sinusitis
500 mg orally every 12 hours for 14 days
ER: 1,000 mg orally once daily for 14 days
Mycobacterial Infection
500 mg orally every 12 hours for 7-14 days
Peptic Ulcer Disease
500 mg orally every 8-12 hours for 10-14 days
Pharyngitis, Tonsillitis
250 mg orally every 12 hours for 10 days
Community-Acquired Pneumonia
250 mg orally every 12 hours for 7-14 days
ER: 1,000 mg orally once daily for 7 days
Skin/Skin Structure Infection
250 mg orally for every 12 hours for 7-14 days
Pediatrics dosage:
The recommended daily dose is 15 mg/kg/day, divided orally every 12 hours for ten days.
9.Clarithromycin side effects
The most common Clarithromycin side effects are nausea, vomiting, diarrhea, abnormal taste, rash, and headache.
10.Clarithromycin manufacturing process
Antibiotics, such as clarithromycin, are fermentation products isolated as unfinished products or intermediates, which are typically solid substances with limited stability. Chromatography, crystallization, and precipitation are all methods used in organic chemistry to purify them.
The excipients added during clarithromycin manufacturing include microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, and povidone (K-30).
11.Clarithromycin Active Pharmaceutical Ingredients (APIs) price
The average price is $173 (USD/kg)
12.Clarithromycin API manufacturers in China
Below are some pharmaceutical API manufacturers in China.
Arshine Pharmaceutical Co., Ltd.
Arshine Group is a China-based Top 10 life science raw materials leading company with over 2,000 products, including API, intermediates, pharmaceuticals equipment, and pharmaceutical packing materials.
Since its inception in 2007, the company has built up a strong and close working relationship with over 800 domestic manufacturers, and Arshine's marketing network has now expanded to more than 100 countries and regions across five continents, providing professional services to global customers such as leading companies in various industries and regions. The company has earned international ISO 9001 and FAMI-QS certifications.
Business Type: Clarithromycin API manufacturers
Main Product Categories: Active Pharmaceutical Ingredients
Product Name: Clarithromycin API
CAS number: 81103-11-9
Standard: USP, BP, EP
Supplier address: Block 14, No.100, Luyun Road, Changsha 410205, China.
The supplier contact number: +86-731-88503670
Main Sales Markets: North America, Central/South America, Western Europe, Eastern Europe, Australia, Middle East, Africa, East Asia (e.g., China, Korea), and South Asia (e.g., India, Malaysia).
Tianjin YiFang Science & Technology, Co., Ltd.
Business Type: Clarithromycin API manufacturers
Main Product Categories: Active Pharmaceutical Ingredient, Raw materials for pharmaceuticals
Product Name: Clarithromycin API
CAS number: 81103-11-9
Price(USD): RMB ¥16317
Supplier Address: Tianjin, China
The supplier contact number: +86-22-58613872
Zhejiang Better Pharmaceuticals Co., Ltd.
Zhejiang Better Pharmaceuticals is a joint-venture between Hong Kong, S.A.R., China Youchuang International Investment Group and Shaoxing Sunflower Investment with a registration capital amounts to $39,800,000.
Better Pharma is a leading manufacturer and supplier of active pharmaceutical ingredients API, pharmaceutical preparations, and pharmaceutical intermediates.
Better Pharma guarantees its customers the highest quality manufacturing processes and assurance of first-class quality for its products based on GMP standards.
Business Type: Clarithromycin API manufacturers
Main Product Categories: Active Pharmaceutical Ingredients (API)> Antibiotics > Macrolides
Product Name: Clarithromycin API
CAS number: 81103-11-9
Specifications: CEP/ EP/ USP/ JP/ IP
Status: GMP Certificate, US DMF NO.20501, COS/CEP 2008-07
Suppler address: Sanjiang Road, Paojiang Industrial Zone, Shaoxing 312071, P.R. China
The supplier contact number: +86-575-88959687
Main Sales Markets: The Middle East; North & Central America; Africa; East Asia (e.g., China, Korea); Europe; South America; South Asia (e.g., India, Pakistan, Sri Lanka); and South East Asia.
Zhejiang Medicines & Health Products Imp. & Exp. Co., Ltd.
ZMC has consistently adhered to the principle of “Quality First, Reputation Supreme,” and it has been listed in the Catalogue of China's Top 500 Import & Export Companies for fourteen consecutive years.
In 2009, its sales volume totaled 415.23 million US dollars, placing it first in the Chinese company for medicines and health products.
Business Type: Clarithromycin API manufacturers
Category: Active Pharmaceutical Ingredients API> Antibiotics > Macrolides
Grade: Pharmaceutical grade
Product Name: Clarithromycin API
CAS number: 81103-11-9
Standard: ChP, USP, BP, EP, JP, In-house Standards
Supplier address: Hangzhou Zhejiang, China
The supplier contact number: +86-571-28935729
Main Sales Markets: North and South America, Western Europe, Eastern Europe, Australia, Asia, Middle East, and Africa
JIANGSU GTIG HUATAI CO., LTD.
The company primarily deals with chemical engineering and medicine imports and exports. It actively participates in the international market competition by expanding the import and export scale and adjusting the structure of export products and technical content.
Business Type: Clarithromycin API manufacturers
Category: Active Pharmaceutical Ingredients > Antibiotics > Other Antibiotics
Product: Clarithromycin Active Pharmaceutical ingredient (API)
CAS number: 81103-11-9
Packaging Details: 25kg drum
Factory Location: Zhangjiagang, Jiangsu, China
The supplier contact number: +86-512-58696995
HEC
HEC Pharm Group is an emerging pharmaceutical company specializing in developing, producing, and marketing high-quality, low-cost generics, APIs, and intermediates for global markets.
HEC's manufacturing facilities have all been GMP certified by both the US FDA and European authorities, and the company's products are GMP, EU GMP, COS/CEP, and FDA certified.
HEC also offers contract R&D and manufacturing services.
Business Type: Clarithromycin API manufacturers, Trading Company, Manufacturer
Main Product Categories: Active Pharmaceutical Ingredients (APIs), Finished Dosage, Bio Products
Product: Clarithromycin Active Pharmaceutical Ingredient (API)
CAS number: 81103-11-9
Standard: ChP, EP
Factory Location: Dongguan Guangdong, China
The supplier contact number: +81-03-3523-2888
13.FAQ:
What does clarithromycin treat？
Clarithromycin is used in the treatment of a wide range of infections caused by bacteria. It can also be used in conjunction with anti-ulcer medications to treat specific types of stomach ulcers.
Is clarithromycin a macrolide?
Clarithromycin is a semisynthetic macrolide antibiotic that works by stopping the growth of bacteria.
How long does clarithromycin take to work for sinusitis?
Most cases of acute sinusitis caused by bacteria respond to antibiotics, including clarithromycin, and most people feel better 3 to 4 days after starting them.
What is the market size for clarithromycin macrolides?
The global clarithromycin market is divided geographically into North America, Latin America, Europe, Asia Pacific, excluding Japan (APEJ), Japan, and the Middle East and Africa (MEA).
Because of a wide range of pharmaceutical companies, North America is expected to be dominant in the global clarithromycin market.
Because of the expansion of product offerings by key players and global demand for the drug, the global clarithromycin market in the Asia Pacific, excluding Japan, is expected to grow at a significant CAGR.
References:
1.https://pubchem.ncbi.nlm.nih.gov/compound/Clarithromycin
2.https://go.drugbank.com/drugs/DB01211
3.https://www.ncbi.nlm.nih.gov/books/NBK547886/
4.https://www.rxlist.com/consumer_clarithromycin_biaxin/drugs-condition.htm
5.https://reference.medscape.com/drug/clarithromycin-342524
6.https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050662s058,050698s038,050775s026lbl.pdf
7.http://apps.who.int/iris/handle/10665/325771
8.https://books.google.com.eg/booksid=8Vn2BwAAQBAJ&pg=PA53&redir_esc=y#v=onepage&q&f=false
9.https://www.medicines.org.uk/emc/product/6094/smpc#gref
10.https://www.indiamart.com/proddetail/clarithromycin-11641122312.html
11.https://medlineplus.gov/druginfo/meds/a601067.html
12.https://www.uptodate.com/contents/azithromycin-and-clarithromycin
13.https://www.iodine.com/compare/biaxin-vs-cleocin
14.https://www.rxlist.com/urine_infection/drugs-condition.htm
15.https://www.factmr.com/report/2869/clarithromycin-market
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