Yes

Antibiotic, Ophthalmic; Antibiotic, Tetracycline Derivative; Antibiotic, Topical

Dental: Treatment of periodontitis associated with presence of Actinobacillus actinomycetemcomitans (AA). As adjunctive therapy in recurrent aphthous ulcers

Medical: Treatment of susceptible bacterial infections of both gram-positive and gram-negative organisms; also infections due to Mycoplasma, Chlamydia, and Rickettsia; indicated for acne, exacerbations of chronic bronchitis, and treatment of gonorrhea and syphilis in patients that are allergic to penicillin; used concomitantly with metronidazole, bismuth subsalicylate and an H₂-antagonist for the treatment of duodenal ulcer disease induced by H. pylori

D/B (topical)

Breast-feeding/lactation: Excreted in breast milk; avoid use if possible in lactating mothers

Hypersensitivity to tetracycline or any component; do not administer to children less than or equal to 8 years of age

Use of tetracyclines during tooth development may cause permanent discoloration of the teeth and enamel, hypoplasia and retardation of skeletal development and bone growth with risk being the greatest for children <4 years and those receiving high doses; use with caution in patients with renal or hepatic impairment (eg, elderly) and in pregnancy; dosage modification required in patients with renal impairment since it may increase BUN as an antianabolic agent; pseudotumor cerebri has been reported with tetracycline use (usually resolves with discontinuation); outdated drug can cause nephropathy; superinfection possible; use protective measure to avoid photosensitivity

>10%: Gastrointestinal: Discoloration of teeth and enamel hypoplasia (young children)

1% to 10%:

Dermatologic: Photosensitivity

Gastrointestinal: Nausea, diarrhea

<1%: Pericarditis, increased intracranial pressure, bulging fontanels in infants, pseudotumor cerebri, dermatologic effects, pruritus, pigmentation of nails, exfoliative dermatitis, diabetes insipidus syndrome, vomiting, esophagitis, anorexia, abdominal cramps, antibiotic-associated pseudomembranous colitis, staphylococcal enterocolitis, hepatotoxicity, thrombophlebitis, paresthesia, acute renal failure, azotemia, renal damage, superinfections, anaphylaxis, hypersensitivity reactions, candidal superinfection

Symptoms of overdose include nausea, anorexia, diarrhea; following GI decontamination

Supportive care only

Decreased effect: Calcium-, magnesium-, or aluminum-containing antacids, oral contraceptives, iron, zinc, sodium bicarbonate, penicillins, cimetidine may decrease tetracycline absorption

Although no clinical evidence exists, may bind with bismuth or calcium carbonate, an excipient in bismuth subsalicylate, during treatment for H. pylori

Increased toxicity: Methoxyflurane anesthesia when concurrent with tetracycline may cause fatal nephrotoxicity; warfarin with tetracyclines may result in increased anticoagulation; tetracyclines may rarely increase digoxin serum levels

Outdated tetracyclines have caused a Fanconi-like syndrome; protect oral dosage forms from light

Inhibits bacterial protein synthesis by binding with the 30S and possibly the 50S ribosomal subunit(s) of susceptible bacteria; may also cause alterations in the cytoplasmic membrane

Absorption: Oral: 75%

Distribution: Small amount appears in bile

Relative diffusion of antimicrobial agents from blood into cerebrospinal fluid (CSF): Good only with inflammation (exceeds usual MICs)

Ratio of CSF to blood level (%): Inflamed meninges: 25

Protein binding: 20% to 60%

Half-life:

Normal renal function: 8-11 hours

End-stage renal disease: 57-108 hours

Time to peak serum concentration: Oral: Within 2-4 hours

Elimination: Primary route is the kidney, with 60% of a dose excreted as unchanged drug in the urine; concentrated by liver in bile and feces in biologically active form

Children >8 years: Oral: 25-50 mg/kg/day in divided doses every 6 hours

Children >8 years and Adults:

Ophthalmic:

Ointment: Instill every 2-12 hours

Suspension: Instill 1-2 drops 2-4 times/day or more often as needed

Topical: Apply to affected areas 1-4 times/day

Adults: Oral: 250-500 mg/dose every 6 hours

Helicobacter pylori: Clinically effective treatment regimens include triple therapy with amoxicillin or tetracycline, metronidazole, and bismuth subsalicylate; amoxicillin, metronidazole, and H₂-receptor antagonist; or double therapy with amoxicillin and omeprazole. Adult dose: 850 mg 3 times/day to 500 mg 4 times/day

Dosing interval in renal impairment:

Cl_cr 50-80 mL/minute: Administer every 8-12 hours

Cl_cr 10-50 mL/minute: Administer every 12-24 hours

Cl_cr <10 mL/minute: Administer every 24 hours

Dialysis: Slightly dialyzable (5% to 20%) via hemo- and peritoneal dialysis nor via continuous arteriovenous or venovenous hemofiltration (CAVH/CAVHD); no supplemental dosage necessary

Dosing adjustment in hepatic impairment: Avoid use or maximum dose is 1 g/day

Food: Dairy products decrease effect of tetracycline

Renal, hepatic, and hematologic function test, temperature, WBC, cultures and sensitivity, appetite, mental status

False-negative urine glucose with Clinistix®

None reported

Tetracycline may decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity although the clinical significance is likely minimal; monitor serum lithium levels

No information available to require special precautions

Opportunistic "superinfection" with Candida albicans; tetracyclines are not recommended for use during pregnancy or in children less than or equal to 8 years of age since they have been reported to cause enamel hypoplasia and permanent teeth discoloration. The use of tetracyclines should only be used in these patients if other agents are contraindicated or alternative antimicrobials will not eradicate the organism. Long-term use associated with oral candidiasis.

Take this medication exactly as directed. Take all of the prescription even if you see an improvement in your condition. Do not use more or more often than recommended.

Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication - effectiveness of oral contraceptives may be reduced; use appropriate barrier contraceptive measures. Breast-feeding is not recommended.

Ophthalmic: Sit down, tilt head back, instill solution or drops inside lower eyelid, and roll eyeball in all directions. Close eye and apply gentle pressure to inner corner of eye for 30 seconds. Do not touch tip of applicator to eye or any contaminated surface. May experience temporary stinging or blurred vision. Inform prescriber if condition worsens or does not improve in 3-4 days.

Topical: Wash area and pat dry (unless contraindicated). Avoid getting in mouth or eyes. You may experience temporary stinging or burning which will resolve quickly. Treated skin may turn yellow; this will wash off. May stain clothing (permanent). Report rash. Inform prescriber if condition worsens or does not improve in a few days.

Do not administer I.M. injection I.V., or I.V. injection I.M. (specific products available for each). I.V. should be infused over at least 2 hours

Capsule, as hydrochloride: 100 mg, 250 mg, 500 mg

Ointment:

Ophthalmic: 1% [10 mg/mL] (3.5 g)

Topical, as hydrochloride: 3% [30 mg/mL] (14.2 g, 30 g)

Solution, topical: 2.2 mg/mL (70 mL)

Suspension:

Ophthalmic: 1% [10 mg/mL] (0.5 mL, 1 mL, 4 mL)

Oral, as hydrochloride: 125 mg/5 mL (60 mL, 480 mL)

Tablet, as hydrochloride: 250 mg, 500 mg

American Academy of Pediatrics. Committee on Drugs. "Requiem for Tetracyclines," Pediatrics, 1975, 55(1):142-3.

Coronado BE, Opal SM, and Yoburn DC, "Antibiotic-Induced D-Lactic Acidosis," Ann Intern Med, 1995, 122(11):839-42.

Cuddihy J, "Case Report of Benign Intra-cranial Hypertension Secondary to Tetracycline," Ir Med J, 1994, 87(3):90.

Fox SA, Berenyi MR, and Straus B, "Tetracycline Toxicity Presenting as a Multisystem Disease," Mt Sinai J Med, 1976, 43(2):129-35.

Gardner K, Cox T, and Digre KB, "Idiopathic Intracranial Hypertension Associated With Tetracycline Use in Fraternal Twins: Case Reports and Review," Neurology, 1995, 45(1):6-10.

Gordon JM and Walker CB, "Current Status of Systemic Antibiotic Usage in Destructive Periodontal Disease," J Periodontol, 1993, 64(8 Suppl): 760-71.

Lee AG, "Pseudotumor Cerebri After Treatment With Tetracycline and Isotretinoin for Acne," Cutis, 1995, 55(3):165-8.

Maroon JC and Mealy J Jr, "Benign Intracranial Hypertension. Sequel to Tetracycline Therapy in a Child," JAMA, 1979, 216(9):1479-80.

Rams TE and Slots J, "Antibiotics in Periodontal Therapy: An Update," Compendium, 1992, 13(12):1130, 1132, 1134.

Sargent E, "Tetracycline for Seal Finger," JAMA, 1980, 244(5):437.

Seymour RA and Heasman PA, "Pharmacological Control of Periodontal Disease. II. Antimicrobial Agents," J Dent, 1995, 23(1):5-14

Seymour RA and Heasman PA, "Tetracyclines in the Management of Periodontal Diseases. A Review," J Clin Periodontol, 1995, 22(1):22-35.

Smilack JD, Wilson WR, and Cockerill FR 3d, "Tetracyclines, Chloramphenicol, Erythromycin, Clindamycin, and Metronidazole," Mayo Clin Proc, 1991, 66(12):1270-80.

Walters BN and Gubbay SS, "Tetracycline and Benign Intracranial Hypertension: Report of Five Cases," Br Med J (Clin Res Ed), 1981, 282(6257):19-20.

Wandstrat TL and Phillips J, "Pseudotumor Cerebri Responsive to Acetazolamide," Ann Pharmacother, 1995, 29(3):318.

Yoshikawa TT, "Antimicrobial Therapy for the Elderly Patient," J Am Geriatr Soc, 1990, 38(12):1353-72.