Tetracycline Hydrochloride 250 mg/1
Tetracycline Hydrochloride · CAPSULE · Breckenridge Pharmaceutical, Inc.
Tetracycline Hydrochloride is a capsule containing tetracycline hydrochloride at 250 mg/1, taken oral. Manufactured by Breckenridge Pharmaceutical, Inc..
Key Facts
- Brand Name
- Tetracycline Hydrochloride
- Generic Name
- Tetracycline Hydrochloride
- NDC Code (Product)
51991-906- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210662
- Marketing Start
- 01/18/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Upper respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae and Hemophilus influenzae . Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp. ). Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus…
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults Usual daily dose, 1 gram as 500 mg twice a day or 250 mg four times a day. Higher doses such as 500 mg four times a day may be required for severe infections or for those infections which do not respond to the smaller doses. For pediatric patients above eight years of age Usual daily dose, 10 mg/lb to 20 mg/lb (25mg/kg to 50 mg/kg) body weight divided in four equal doses. Administration of adequate amounts of fluid with the capsule formulation of tetracycline is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration (see ADVERSE REACTIONS ). Absorption of tetracycline is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc or sodium bicarbonate. Food and some dairy products also interfere with absorption. When used in streptococcal infections, therapy should be continued for 10 days. For treatment of brucellosis, 500 mg tetracycline four times a day for three weeks accompanied by streptomycin, 1 gram intramuscularly twice daily the first week and once daily the second week. For the treatment of syphilis in patients allergic to penicillin, the following dosage of …
Warnings
WARNINGS Tooth Development The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drugs but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs should not be used in this age group, except for anthrax, unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tetracyclines, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C . difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in…
Contraindications
CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Drug Interactions
Drug Interactions Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibacterials. Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate. Concurrent use of tetracycline may render oral contraceptives less effective.
Adverse Reactions
ADVERSE REACTIONS Gastrointestinal: anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with Candida overgrowth) in the anogenital region. Esophagitis and esophageal ulceration have been reported in patients receiving particularly the capsule and also the tablet forms of tetracyclines. Most of the patients were reported to have taken medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Teeth : permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has been reported (see WARNINGS ). Skin : fixed drug eruption, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Onycholysis and discoloration of the nails have been reported. Photosensitivity is discussed in WARNINGS . Renal Toxicity : an increase in BUN has been reported and is dose related. Liver : hepatotoxicity and liver failure have been observed in patients receiving tetracycline and in tetracycline-treated patients with renal impairment. Hypersensitivity Reactions : urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacer…
Frequently Asked Questions
What is Tetracycline Hydrochloride used for?
Tetracycline Hydrochloride contains Tetracycline Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.
Is Tetracycline Hydrochloride a controlled substance?
Tetracycline Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Tetracycline Hydrochloride?
The generic name for Tetracycline Hydrochloride is Tetracycline Hydrochloride. There are 6 other brand versions of Tetracycline Hydrochloride.
What is the NDC code for Tetracycline Hydrochloride 250 mg/1?
The NDC (National Drug Code) for Tetracycline Hydrochloride 250 mg/1 is 51991-906, listed by Breckenridge Pharmaceutical, Inc..