tetracycline hydrochloride

tetracycline hydrochloride,

an antibiotic.

indications It is prescribed in the treatment of bacterial infections.

contraindications Known hypersensitivity to this drug or to other tetracyclines prohibits its use. Use during pregnancy or in children under 8 years of age may result in discoloration of the child's teeth. It is to be administered with caution with renal or liver impairment.

adverse effects Among the most serious effects are potentially serious superinfections, allergic reactions, phototoxicity, and GI disturbances.

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tetracycline hydrochloride

Actisite, Apo-Tetra (CA), Bristacycline, Novotetra (CA), Nu-Tetra (CA), Sumycin, Sumycin Syrup

Pharmacologic class: Tetracycline

Therapeutic class: Anti-infective

Pregnancy risk category B (topical form), D (oral form)

Action

Unknown. Thought to inhibit bacterial protein synthesis at level of 30S and 50S bacterial ribosomes and to alter cytoplasmic membrane of susceptible organisms.

Availability

Capsules: 250 mg, 500 mg

Ointment: 3%

Oral suspension: 125 mg/5 ml

⊘Indications and dosages

➣ Mild to moderate infections caused by susceptible organisms

Adults: 500 mg P.O. b.i.d. or 250 mg P.O. q.i.d.

➣ Severe infections caused by susceptible organisms

Adults: 500 mg P.O. q.i.d.

Children older than age 8: 25 to 50 mg/kg P.O. q.i.d.

➣ Syphilis in penicillin-allergic patients

Adults: 500 mg P.O. q.i.d. for 14 days

➣ Late syphilis (except neurosyphilis)

Adults: 500 mg P.O. q.i.d. for 28 days

➣ Leptospirosis when penicillin is contraindicated or ineffective

Adults: 1 to 2 g P.O. daily in two to four divided doses for 5 to 7 days

➣ Yaws

Adults: 1 to 2 g P.O. daily in two to four divided doses for 10 to 14 days

➣ Gonorrhea in penicillin-allergic patients

Adults: Initially, 1.5 g P.O., followed by 500 mg P.O. q 6 hours for 4 days, up to a total of 9 g

➣ Uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis

Adults: 500 mg P.O. q.i.d for 7 days

➣ Rickettsial and mycoplasmal infections

Adults: 1 to 2 g P.O. daily in two to four divided doses for 7 days

➣Helicobacter pylori infection

Adults: In patients with active duodenal ulcer, 500 mg P.O. q.i.d. at meals and bedtime for 14 days, given with other drugs (such as metronidazole, bismuth subsalicylate, amoxicillin, or omeprazole)

➣ Brucellosis

Adults: 500 mg P.O. q.i.d. for 3 weeks, given with streptomycin I.M. b.i.d. during week 1 and streptomycin once daily during week 2

➣ Granuloma inguinale; chancroid

Adults: 1 to 2 g P.O. daily in two to four divided doses for 2 to 4 weeks

➣ Cholera

Adults: 500 mg P.O. q 6 hours for 48 to 72 hours

➣ Plague when streptomycin is contraindicated or ineffective

Adults: 2 to 4 g P.O. q.i.d. for 10 days

Children older than age 8: 30 to 40 mg/kg P.O. q.i.d. for 10 to 14 days

➣ Tularemia as an alternative to streptomycin

Adults: 1 to 2 g P.O. daily in two to four divided doses for 1 to 2 weeks

➣Campylobacter infection

Adults: 1 to 2 g P.O. daily in two to four divided doses for 10 days

➣ Relapsing fever caused by Borrelia recurrentis

Adults: 1 to 2 g P.O. daily in two to four divided doses for 7 days or until patient is afebrile

➣ Adjunctive treatment of inflammatory acne

Adults and adolescents: 500 mg to 1 g P.O. q.i.d. for 1 to 2 weeks, decreased gradually to 125 to 500 mg P.O. daily

➣ Acne vulgaris

Adults and children older than age 11: 3% ointment applied to affected area b.i.d. (morning and evening) until skin is thoroughly wet

Dosage adjustment

• Renal impairment

Off-label uses

• Rosacea
• Anthrax
• Arthritis
• Lyme disease
• Sclerosing agent to control pleural effusions

Contraindications

• Hypersensitivity to drug, other tetracyclines, bisulfites, or alcohol (in some products)

Precautions

Use cautiously in:
• renal disease, hepatic impairment, nephrogenic diabetes insipidus
• cachectic or debilitated patients
• pregnant or breastfeeding patients (except in anthrax treatment or with topical form)
• children younger than age 11 (with topical form)
• children younger than age 8 (except in anthrax treatment).

Administration

• Give with 8 oz of water at least 1 hour before or 2 hours after a meal (especially if it includes milk or other dairy products), antacids, laxatives, or antidiarrheal drugs.

Route	Onset	Peak	Duration
P.O.	Rapid	2-3 hr	6-12 hr
Topical	Unknown	Unknown	Unknown

Adverse reactions

CNS: paresthesia, benign intracranial hypertension

CV: pericarditis

EENT: abnormal conjunctival pigmentation, hoarseness, pharyngitis

GI: nausea, vomiting, diarrhea, loose bulky stools, esophageal ulcers, epigastric distress, enterocolitis, oral and anogenital candidiasis, stomatitis, black hairy tongue, glossitis, anorexia, pancreatitis

GU: dark yellow or brown urine, vaginal candidiasis, anogenital lesions

Hematologic: eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia, thrombocytopenia purpura

Hepatic: fatty liver

Musculoskeletal: retarded bone growth, polyarthralgia

Respiratory: pulmonary infiltrates

Skin: stinging and yellowing of skin (with topical form), photosensitivity, maculopapular or erythematous rash, increased pigmentation, urticaria, onycholysis

Other: permanent tooth discoloration (in children younger than age 8), tooth enamel defects, superinfection, hypersensitivity reactions including anaphylaxis, serum sickness-like reaction, exacerbation of systemic lupus erythematosus

Interactions

Drug-drug. Adsorbent antidiarrheals, antacids, calcium, cholestyramine, cimetidine, colestipol, iron, magnesium, sodium bicarbonate: decreased tetracycline absorption

Digoxin: increased digoxin blood level, greater risk of toxicity

Hormonal contraceptives: decreased contraceptive efficacy

Insulin: reduced insulin requirement

Lithium: increased or decreased lithium blood level

Methoxyflurane: increased risk of nephrotoxicity

Penicillin: decreased penicillin activity

Sucralfate: prevention of tetracycline absorption from GI tract

Warfarin: enhanced warfarin effects

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, blood urea nitrogen: increased levels

Hemoglobin, neutrophils, platelets, white blood cells: decreased levels

Urinary catecholamines: false elevation

Drug-food. Dairy products, foods containing calcium: decreased drug absorption

Drug-behaviors. Alcohol use: decreased drug efficacy

Sun exposure: increased risk of photosensitivity

Patient monitoring

• Monitor for signs and symptoms of superinfection and hypersensitivity reaction.
• With long-term use, monitor CBC, liver function tests, and (in prepubertal patients) bone growth.
• Assess neurologic status. Stay alert for benign intracranial hypertension (especially in children).

Patient teaching

• Tell patient to take oral form with 8 oz of water at least 1 hour before or 2 hours after eating a meal, consuming dairy products, or taking antacids, laxatives, or antidiarrheal drugs. Advise him to take last daily dose at least 1 hour before bedtime.
• Stress importance of completing entire course of therapy as ordered, even after symptoms improve.
☞ Caution patient not to use outdated tetracycline, because it may cause serious kidney disease.
• Teach patient to recognize and report signs and symptoms of yeast infection and other infections.
• With long-long therapy, tell patient he'll undergo regular blood testing. Advise parents that prepubertal child should have periodic bone X-rays.
• Instruct patient using topical form not to let drug touch eyes, nose, or mouth. Tell him drug may turn skin yellow.
• Caution patient to avoid alcohol during therapy.
• Tell parents that tetracycline use during tooth development period (last half of pregnancy, infancy, and childhood to age 8) may cause permanent yellow, gray, or brownish tooth discoloration.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.