Tetracycline (oral)

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Tetracycline (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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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)

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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

Gastrointestinal System
  • 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.
Teeth
  • Permanent discoloration of teeth may be caused during tooth development. Enamel hypoplasia has also been reported.
Skin
  • 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
Renal Toxicity
  • Rise in BUN has been reported and is apparently dose related.
Liver
  • Hepatotoxicity and liver failure have been observed in patients receiving large doses of tetracycline and in tetracycline-treated patients with renal impairment.
Hypersensitivity Reactions
Blood
Other
  • 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

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

Tetracycline Structural Formula V.1.png
Tetracycline (oral)
Systematic (IUPAC) name
?
Identifiers
CAS number 60-54-8

64-75-5 (hydrochloride)
ATC code A01AB13 D06AA04 (WHO) J01AA07 (WHO) S01AA09 (WHO) S02AA08 (WHO) S03AA02 (WHO) Template:ATCvet Template:ATCvet Template:ATCvet
PubChem 643969
DrugBank DB00759
Chemical data
Formula C22H24N2O8 
Mol. mass 444.435 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 75%
Metabolism Not metabolised
Half life 8-11 hours, 57-108 hours (kidney impairment)
Excretion Urine (>60%), feces
Therapeutic considerations
Licence data

US

Pregnancy cat.

D(AU) D(US)

Legal status

Prescription only

Routes oral, topical (skin and eye), intramuscular, intravenous

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

Tetracycine 01.jpg
This image of the FDA label is provided by the National Library of Medicine.

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®[1]

Look-Alike Drug Names

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

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "ACHROMYCIN V - tetracycline hydrochloride capsule".

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