Tetracycline (oral)

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# Overview
Tetracycline (oral) is an antibiotic that is FDA approved for the treatment of upper respiratory tract infections, lower respiratory tract infections, skin and soft tissue infections, granuloma inquinale, bartonellosis, and chancroid.   Common adverse reactions include anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of Achromycin V (Tetracycline HCl Capsules, USP) and other antibacterial drugs, Achromycin V (Tetracycline HCl Capsules, USP) should be used only to treat or prevent 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.
- Achromycin V (Tetracycline HCl Capsules, USP) 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.
- 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 aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)
- Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
- Psittacosis of ornithosis caused by Chlamydia psittaci.
- Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
- Granuloma inguinale caused by Calymmatobacterium granulomatis.
- Relapsing fever caused by Borrelia sp.
- Bartonellosis caused by Bartonella bacilliformis.
- Chancroid caused by Hemophilus ducreyi.
- Tularemia caused by Francisella tularensis.
- Plaque caused by Yersinia pestis.
- Cholera caused by Vibrio cholerae.
- Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).
- Infections due to Campylobacter fetus.
- Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
- Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
- In severe acne, adjunctive therapy with Achromycin V (Tetracycline HCl Capsules, USP) may be useful.
- When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
- Syphilis and yaws caused by Treponema pallidum and Treponema pertenue, respectively,
- Vincents infection caused by Fusobacterium fusiforme,
- Infections caused by Neisseria gonorrhoeae,
- Anthrax caused by Bacillus anthracis,
- Infections due to Listeria monocytogenes,
- Actinomycosis caused by Actinomyces species,
- Infections due to Clostridium species.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tetracycline (oral) in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Tetracycline (oral) in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tetracycline (oral) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tetracycline (oral) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Tetracycline (oral) in pediatric patients.

# Contraindications
- This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

# Warnings
- 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 has been observed following repeated short-term courses.
- Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
- All tetracyclines form a stable calcium complex in any bone forming tissue. - A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
- Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development).
- Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
- If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
- Tetracycline drugs should not be used during pregnancy unless absolutely necessary.
- If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity.
- Under such conditions, lower than usual total doses are indicated, and, if therapy is prolonged, serum level determinations of the drug may be advisable.
- Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
- Patients apt to be exposed to direct sunlight or ultraviolet lights should be advised that this reaction can occur with tetracycline drugs. Treatment should be discontinued at the first evidence of skin erythema.
- The antianabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia and acidosis.

# Adverse Reactions

## Clinical Trials Experience
- Anorexia, nausea, epigastric distress, vomiting, diarrhea, glossitis, black hairy tongue, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region.
- Rare instances of 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.
- Permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported.
- Maculopapular and erythrematous rashes. Exfoliative dermatitis has been reported but is uncommon. Onycholysis and discoloration of the nails have been reported rarely. Photosensitivity is also an adverse effect
- Rise in BUN has been reported and is apparently dose related.
- Hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment.
- Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions, as fever, rash, and arthralgia.
- Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia and eosinophilia have been reported.
- Bulging fontanels in infants and intracranial pressure in adults.
- When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands.
- No abnormalities of thyroid function studies are known to occur.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tetracycline (oral) in the drug label.

# Drug Interactions
- Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Achromycin V (Tetracycline HCl Capsules, USP) in conjunction with penicillin or other bactericidal antibiotics.
- 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.
- The concurrent use of Achromycin V (Tetracycline HCl Capsules, USP) and methoxyflurane has been reported to result in fatal renal toxicity.
- Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate.
- Concurrent use of Achromycin V (Tetracycline HCl Capsules, USP) may render oral contraceptives less effective.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): D
Pregnant women with renal disease may be more prone to develop tetracycline-associated liver failure.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tetracycline (oral) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Tetracycline (oral) during labor and delivery.

### Nursing Mothers
- Because of potential for serious adverse reaction in nursing infants from tetracyclines, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother

### Pediatric Use
There is no FDA guidance on the use of Tetracycline (oral) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Tetracycline (oral) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Tetracycline (oral) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Tetracycline (oral) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Tetracycline (oral) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Tetracycline (oral) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tetracycline (oral) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Tetracycline (oral) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Tetracycline (oral) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Tetracycline (oral) in the drug label.

# Overdosage
There is limited information regarding Tetracycline (oral) overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
There is limited information regarding Tetracycline (oral) Mechanism of Action in the drug label.

## Structure
There is limited information regarding Tetracycline (oral) Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tetracycline (oral) in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tetracycline (oral) in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tetracycline (oral) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Tetracycline (oral) in the drug label.

# How Supplied
- Achromycin V (Tetracycline HCl Capsules, USP) are available as follows.
- 250 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 17 in Black Ink.
- Available in bottles of following names.
- 100 NDC 23155-487-01
- 1000 NDC 23155-487-10
- 500 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 18 in Black Ink.
- Available in bottles of following.
- 100 NDC 23155-488-01
- 500 NDC 23155-488-05
- Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).

## Storage
There is limited information regarding Tetracycline (oral) Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tetracycline (oral) in the drug label.

# Precautions with Alcohol
- Alcohol-Tetracycline (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ACHROMYCIN V

# Look-Alike Drug Names
There is limited information regarding Tetracycline (oral) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price