Active Pharmaceutical Ingredients

Oxytetracycline dihydrate is a broad-spectrum antibiotic that works by inhibiting bacterial protein synthesis.

Molecular Formula：C22H24N2O9, 2H2O

Molecular Weight：496.4

CAS No.: 6153-64-6

Description

Oxytetracycline Dihydrate is a yellow, crystalline powder. It is very slightly soluble in water. It dissolves in dilute acid and alkaline solutions.

Application

Oxytetracycline Dihydrate has broad-spectrum antibacterial effect, and also has certain inhibitory effect on sensitive bacteria including pneumococcus, Streptococcus, some Staphylococcus, Bacillus anthracis, * tetanus, Mycoplasma hydatidis, Chlamydia trachomatis, and helicoid.

Packing and Storage

Preserve in tight, light-resistant containers.

Minimum Order

One package

Oxytetracycline Dihydrate Introduction

Item	Details
Basic Information	Oxytetracycline dihydrate is a tetracycline – class antibiotic. Its chemical formula is C₂₂H₂₄N₂O₉·2H₂O. It is a yellowish – crystalline powder. The drug is derived from the fermentation of Streptomyces rimosus. It has relatively good solubility in water, which is beneficial for formulating it into various pharmaceutical products such as tablets, capsules, and injectable solutions. The dihydrate form helps in maintaining the stability of the oxytetracycline molecule.
Pharmacological Action	Oxytetracycline dihydrate acts by binding to the 30S subunit of the bacterial ribosome. This binding inhibits the binding of aminoacyl – tRNA to the ribosomal acceptor site, thereby blocking the addition of new amino acids to the growing polypeptide chain. As a result, bacterial protein synthesis is inhibited. It has a broad – spectrum antibacterial activity. It is effective against many Gram – positive bacteria, including Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus (although less effective against methicillin – resistant Staphylococcus aureus). Against Gram – negative bacteria, it shows activity against Escherichia coli, Klebsiella pneumoniae, Proteus species, and some strains of Pseudomonas aeruginosa. It also has activity against some atypical pathogens such as Mycoplasma pneumoniae, Chlamydia trachomatis, and Rickettsia species.
Clinical Applications	1. Respiratory Tract Infections: – It can be used to treat community – acquired pneumonia, targeting pathogens like Streptococcus pneumoniae, Mycoplasma pneumoniae, and Chlamydia pneumoniae. – For acute exacerbations of chronic bronchitis, it can combat bacteria such as Haemophilus influenzae and Moraxella catarrhalis. 2. Urinary Tract Infections: – Oxytetracycline dihydrate can be used to treat urinary tract infections caused by susceptible bacteria like Escherichia coli and Proteus species. 3. Gastrointestinal Tract Infections: – In some cases, it may be used for the treatment of gastrointestinal infections caused by susceptible bacteria. For example, it can be used to treat traveler’s diarrhea caused by certain strains of Escherichia coli. 4. Skin and Soft Tissue Infections: – It can treat cellulitis, impetigo, and other skin infections caused by Gram – positive bacteria. 5. Zoonotic Infections: – It is used to treat zoonotic infections such as Rocky Mountain spotted fever caused by Rickettsia rickettsii and psittacosis caused by Chlamydia psittaci.
Adverse Reactions	1. Gastrointestinal Effects: Nausea, vomiting, diarrhea, abdominal pain, and anorexia are common side effects. These symptoms are usually mild to moderate and may be due to the drug’s effect on the normal gut flora and direct irritation of the gastrointestinal mucosa. 2. Photosensitivity: Oxytetracycline dihydrate can increase the skin’s sensitivity to sunlight. Patients taking this drug are more prone to sunburns and may experience skin rashes, redness, and itching when exposed to sunlight. 3. Tooth Discoloration and Bone Growth Effects: In children, especially those under 8 years old, oxytetracycline can cause permanent tooth discoloration (yellow – gray – brown staining) as it binds to calcium in the teeth and bones. It can also affect bone growth during development. 4. Hepatotoxicity: In some cases, it can cause liver function abnormalities, presenting as elevated liver enzymes such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST). In rare cases, it can lead to more serious liver damage. 5. Allergic Reactions: Allergic reactions can occur, ranging from mild rashes, itching, and hives to severe anaphylactic shock. Patients with a history of allergic reactions to tetracycline – class antibiotics are at a higher risk.
Drug Interactions	1. With Antacids: Antacids containing aluminum, calcium, or magnesium can chelate with oxytetracycline, reducing its absorption. It is recommended to take antacids at least 2 – 3 hours before or after taking oxytetracycline dihydrate. 2. With Oral Contraceptives: Oxytetracycline may reduce the effectiveness of oral contraceptives by interfering with the normal gut flora that recycles estrogen conjugates. Women using oral contraceptives should be advised to use additional contraceptive methods during treatment with oxytetracycline. 3. With Warfarin: Concurrent use of oxytetracycline and warfarin can enhance the anticoagulant effect of warfarin. Oxytetracycline may inhibit the normal gut flora that produces vitamin K, which is necessary for the synthesis of clotting factors. Patients taking both drugs need to have their prothrombin time or international normalized ratio (INR) monitored closely. 4. With Other Nephrotoxic Drugs: Concurrent use with other nephrotoxic drugs, such as aminoglycosides or non – steroidal anti – inflammatory drugs (NSAIDs), can increase the risk of nephrotoxicity.
Special Population Considerations	1. Pregnant Women: Oxytetracycline is contraindicated during pregnancy, especially in the second and third trimesters. It can cross the placenta and may cause tooth discoloration and affect bone development in the fetus. 2. Breastfeeding Women: Oxytetracycline is excreted in breast milk. Breastfeeding should be avoided during treatment with oxytetracycline as it may cause tooth discoloration and other adverse effects in the nursing infant. 3. Children: As mentioned, oxytetracycline should not be used in children under 8 years old due to the risk of tooth discoloration and effects on bone growth. 4. Patients with Renal Impairment: In patients with renal impairment, the clearance of oxytetracycline may be affected. Dosage adjustment may be required, and close monitoring of serum drug levels and renal function is recommended.

 

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