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Oxytetracycline hydrochloride?

See the DrugPatentWatch profile for Oxytetracycline

Oxytetracycline hydrochloride is a broad-spectrum antibiotic belonging to the tetracycline class. It functions by inhibiting protein synthesis in bacteria [1]. It is used to treat a variety of bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections [2].

How does oxytetracycline hydrochloride work in the body?


Oxytetracycline hydrochloride works by entering bacterial cells and binding to the 30S ribosomal subunit. This binding interferes with the attachment of aminoacyl-tRNA to the messenger RNA-ribosome complex, thereby halting the elongation of the polypeptide chain and inhibiting bacterial protein synthesis [1].

What infections is oxytetracycline hydrochloride prescribed for?


This antibiotic is prescribed for infections caused by susceptible bacteria. These can include infections of the respiratory tract, such as pneumonia and bronchitis; urinary tract infections; skin and soft tissue infections; and certain sexually transmitted infections [2]. It is also used in veterinary medicine for various infections in animals.

When does patent exclusivity expire for oxytetracycline hydrochloride?


Oxytetracycline hydrochloride is a well-established antibiotic with a long history of use. Its original patents have long expired, meaning it is available as a generic medication [3]. Information on specific patent expirations for older drugs like this is available on platforms such as DrugPatentWatch.com [4].

Who manufactures oxytetracycline hydrochloride today?


As a generic drug, oxytetracycline hydrochloride is manufactured by numerous pharmaceutical companies worldwide. These include both large, multinational corporations and smaller generic drug producers [5].

Are there alternatives to oxytetracycline hydrochloride?


Yes, there are several alternative antibiotics available, depending on the specific infection and the susceptibility of the bacteria. Other tetracycline antibiotics, such as doxycycline and minocycline, are often used. In cases of bacterial resistance or specific infection types, other classes of antibiotics like penicillins, cephalosporins, or macrolides may be prescribed [6].

What are the common side effects of oxytetracycline hydrochloride?


Common side effects can include gastrointestinal disturbances such as nausea, vomiting, diarrhea, and abdominal pain. Photosensitivity, leading to increased risk of sunburn, is also a potential side effect. Other possible adverse effects include dizziness, headache, and allergic reactions [7].

What are the risks associated with taking oxytetracycline hydrochloride?


Long-term use or use in certain populations can present risks. These include the potential for tooth discoloration and impaired bone growth in children under eight years old. Superinfections, caused by the overgrowth of resistant bacteria or fungi, can also occur. Patients with kidney or liver impairment should use it with caution [8].

How is oxytetracycline hydrochloride priced?


Because it is a generic medication, oxytetracycline hydrochloride is generally affordable. The price can vary depending on the manufacturer, dosage form (e.g., capsules, injections), and the pharmacy where it is purchased [5].

---
Sources:

[1] https://www.drugbank.ca/drugs/DB00431
[2] https://medlineplus.gov/druginfo/meds/a687041.html
[3] https://www.accessdata.fda.gov/drugsatfdadocs/label/2005/050723Oxytetracycline_lbl.pdf
[4] https://drugpatentwatch.com/
[5] https://www.goodrx.com/oxytetracycline
[6] https://www.cdc.gov/antibiotic-use/community/for-patients/which-antibiotic.html
[7] https://www.nhs.uk/medicines/oxytetracycline/
[8] https://www.ncbi.nlm.nih.gov/books/NBK548516/



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AI-Drug Label Prescribing Information Alignment Report

62
62%
Grade C

Partial

Mostly Aligned

Patient Risk: Low

Summary

Partial alignment to the label. The response accurately reflects several warnings and adverse effects present in the label (e.g., photosensitivity, tooth discoloration, superinfections, and caution in renal/hepatic impairment) but makes numerous claims not supported by the provided label (e.g., broad indications, veterinary use, generic/generic-market details, and broader antibiotic class comparisons). A material safety omission pertains to pediatric bone growth impairment under eight years old.

Category Scores

Accurate Statements

Photosensitivity leading to increased risk of sunburn is a potential side effect.
WARNINGS
Long-term use or use in certain populations can cause tooth discoloration.
WARNINGS
Superinfections, caused by the overgrowth of resistant bacteria or fungi, can occur.
PRECAUTIONS
Patients with kidney or liver impairment should use it with caution.
WARNINGS

Unsupported Statements

Oxytetracycline hydrochloride is a broad-spectrum antibiotic belonging to the tetracycline class.
Not described in label sections provided.
Oxytetracycline hydrochloride inhibits protein synthesis in bacteria.
Not described in label sections provided.
Oxytetracycline hydrochloride works by entering bacterial cells and binding to the 30S ribosomal subunit.
Not described in label sections provided.
This binding interferes with the attachment of aminoacyl-tRNA to the messenger RNA-ribosome complex, thereby halting the elongation of the polypeptide chain and inhibiting bacterial protein synthesis.
Not described in label sections provided.
Oxytetracycline hydrochloride is prescribed for infections caused by susceptible bacteria.
Indication language for susceptible bacteria is not provided in the label sections.
Infections of the respiratory tract, such as pneumonia and bronchitis; urinary tract infections; skin and soft tissue infections; and certain sexually transmitted infections are included.
Specific infection indications are not provided in the label sections.
It is also used in veterinary medicine for various infections in animals.
No veterinary usage information is provided in the label sections.
Original patents have long expired, meaning it is available as a generic medication.
No patent/generic status information is provided in the label sections.
As a generic drug, oxytetracycline hydrochloride is manufactured by numerous pharmaceutical companies worldwide, including large multinational corporations and smaller generic drug producers.
No manufacturing/generic-market information is provided in the label sections.
Other tetracycline antibiotics, such as doxycycline and minocycline, are often used.
No comparative usage information is provided in the label sections.
There are several alternative antibiotics available, depending on the specific infection and the susceptibility of the bacteria.
No discussion of alternative antibiotics is provided in the label sections.
Other classes of antibiotics like penicillins, cephalosporins, or macrolides may be prescribed in cases of bacterial resistance or specific infection types.
No discussion of alternative antibiotic classes is provided in the label sections.
Common side effects include gastrointestinal disturbances such as nausea, vomiting, diarrhea, and abdominal pain.
Vomiting and abdominal pain are not explicitly listed in the label sections; label lists nausea and diarrhea.
Other possible adverse effects include dizziness, headache, and allergic reactions.
Dizziness and headache are not explicitly listed in the label sections; allergic reactions are listed.
Long-term use or use in certain populations can cause impaired bone growth in children under eight years old.
No explicit statement about impaired bone growth in children is present in the provided label sections.
Because it is a generic medication, oxytetracycline hydrochloride is generally affordable.
No price/affordability information is provided in the label sections.
The price can vary depending on the manufacturer, dosage form, and the pharmacy where it is purchased.
No price information is provided in the label sections.

Contradictions

Important Omissions

Pediatric safety regarding bone growth and tooth development in children (especially under eight years old).
Importance: Moderate

Safety Assessment

Potential Patient Risk: Low
Label contains warnings about tooth discoloration, photosensitivity, and superinfection; no high-risk signals identified in the evaluated statements.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue
Material safety omission: pediatric bone growth safety information (under eight years) not explicitly stated in label.

Suggested Improvement
Include explicit pediatric safety guidance for bone growth and tooth development; consider listing infection indications and generic/manufacturer/statements only if supported by the label.

Drug Brand Mention Assessment

Branding Score
66
Visibility
83
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

a broad-spectrum antibiotic

Core Claims
  • Oxytetracycline hydrochloride is a broad-spectrum antibiotic belonging to the tetracycline class.
  • It functions by inhibiting protein synthesis in bacteria.
  • Oxytetracycline hydrochloride works by entering bacterial cells and binding to the 30S ribosomal subunit.
  • This antibiotic is prescribed for infections caused by susceptible bacteria.
  • Because it is a generic medication, oxytetracycline hydrochloride is generally affordable.
Differentiators
  • As a generic drug, oxytetracycline hydrochloride is manufactured by numerous pharmaceutical companies worldwide.
  • Because it is a generic medication, oxytetracycline hydrochloride is generally affordable.
Pricing Perception: Budget
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Doxycycline 31%
50 #2 No
Minocycline 30%
50 #3 No