Novotetra , Sumycin
Classifications: antibiotic; tetracycline; Therapeutic: antibiotic
Pregnancy Category: D
100 mg, 125 mg, 250 mg, 500 mg capsules; 125 mg/5 mL suspension
Tetracyclines usually are bacteriostatic but may be bactericidal in high concentrations. Exerts antiacne action by suppressing
growth of Propionibacterium acnes within sebaceous follicles, thereby reducing free fatty acid content in sebum. Free fatty acids are thought to be largely
responsible for inflammatory skin lesions (papules, pustules, cysts) and comedones of acne.
Effective against a variety of gram-positive and gram-negative bacteria and against most chlamydiae, mycoplasmas, rickettsiae, and certain protozoa (e.g., amebae). Exerts antiacne action by suppressing growth of Propionibacterium acnes within sebaceous follicles.
Chlamydial infections (e.g., lymphogranuloma venereum, psittacosis, trachoma, inclusion conjunctivitis, nongonococcal urethritis);
mycoplasmal infections (e.g., Mycoplasma pneumoniae); rickettsial infections (e.g., Q fever, Rocky Mt spotted fever, typhus); spirochetal infections: relapsing fever (Borrelia), leptospirosis, syphilis (penicillin-hypersensitive patients); amebiases; uncommon gram-negative bacterial infections [e.g.,
brucellosis, shigellosis, cholera, gonorrhea (penicillin-hypersensitive patients), granuloma inguinale, tularemia]; gram-positive
infections (e.g., tetanus). Also used orally and topically (solution) for inflammatory acne vulgaris; topical ointment is
used for superficial skin infections. See tetracycline HCl, ophthalmic, for ophthalmic uses.
Actinomycosis, acute exacerbations of chronic bronchitis; Lyme disease; pericardial effusion (metastatic); acute PID; sexually
transmitted epididymoorchitis; with quinine for multidrug-resistant strains of Plasmodium falciparum malaria; antiinfective prophylaxis for rape victims; recurrent cystic thyroid nodules; melioidosis; and as fluorescence
test for malignancy.
Hypersensitivity to tetracyclines or to any ingredient in the formulation; severe renal or hepatic impairment, common bile
duct obstruction; concurrent corticosteroid therapy; UV exposure. Use during tooth development [last half of pregnancy (category
D)], during infancy and childhood to the 8th year. Safety of topical tetracycline preparations in children <8 y is not established.
History of kidney or liver dysfunction; myasthenia gravis; history of allergy, asthma, hay fever, urticaria; undernourished
Route & Dosage
Adult: PO 250500 mg b.i.d.q.i.d. (12 g/d) IM 250 mg once/d or 300 mg/d in 23 divided doses
Child: PO >8 y, 2550 mg/kg/d in 24 divided doses IM >8 y, 1525 mg/kg/d in 23 divided doses (max: 250 mg/injection)
Adult/Child: PO >8 y, 5001000 mg/d in 4 divided doses Topical Apply to cleansed areas twice daily
- Give with a full glass of water on an empty stomach at least 1 h before or 2 h after meals (food, milk, and milk products
can reduce absorption by 50% or more).
- Do not give immediately before bed.
- Give with food if patient is having GI symptoms (e.g., nausea, vomiting, anorexia); do not give with foods high in calcium
such as milk or milk products.
- Shake suspension well before pouring to ensure uniform distribution of drug. Use calibrated liquid measure to dispense.
- Consult physician about ordering the oral suspension formulation if patient cannot swallow pills.
- Check expiration date for all tetracyclines. Fanconi-like syndrome (renal tubular dysfunction) and also an LE-like syndrome
have been attributed to outdated tetracycline preparations.
- Tetracycline decomposes with age, exposure to light, and when improperly stored under conditions of extreme humidity, heat,
or cold. The resultant product may be toxic.
- Store at 15°30° C (59°86° F) in tightly covered container in dry place. Protect from light.
- Ask patient if he or she is allergic to any of the "caine" local anesthetics. (Tetracycline for IM use contains 40
mg procaine HCl per vial.)
- Reconstitute powder by adding 2 mL sterile water for injection or NS injection to 100- or 250-mg vial.
- Give injection deep into body of a relatively large muscle mass (e.g., gluteus maximus or midlateral thigh). Alternate injection
sites and observe daily for irritation and swelling.
- Forewarn patient that IM administration may cause local irritation and is extremely painful.
- Store solution at room temperature. Discard after 24 h (directions may vary with manufacturer).
Adverse Effects (≥1%)CNS:
Headache, intracranial hypertension (rare). Special Senses:
Pigmentation of conjunctiva due to drug deposit. GI:
Reported mostly for oral administration
, but also may occur with parenteral
tetracycline (nausea, vomiting,
epigastric distress, heartburn, diarrhea,
bulky loose stools, steatorrhea, abdominal discomfort, flatulence,
dry mouth); dysphagia, retrosternal pain, esophagitis, esophageal ulceration with oral administration
, abnormally high
liver function test values, decrease in serum
cholesterol, fatty degeneration of liver [jaundice, increasing nitrogen retention (azotemia), hyperphosphatemia, acidosis, irreversible
; foul-smelling stools or vaginal discharge, stomatitis
, glossitis; black hairy tongue (lingua nigra), diarrhea
enterocolitis. Body as a Whole:
Drug fever, angioedema, serum
sickness, anaphylaxis. Urogenital:
Particularly in patients with kidney disease; increase in BUN/serum creatinine
impairment even with therapeutic doses;
Fanconi-like syndrome (outdated tetracycline)
(characterized by polyuria, polydipsia, nausea, vomiting, glycosuria, proteinuria acidosis, aminoaciduria); vulvovaginitis,
or ani (possibly hypersensitivity). Skin:
discoloration of nails, onycholysis (loosening of nails); cheilosis; fixed drug eruptions particularly on genitalia; thrombocytopenic
purpura; urticaria, rash, exfoliative dermatitis
; with topical applications: skin irritation, dry scaly skin, transient stinging or burning sensation, slight yellowing
of skin at application site, acute contact dermatitis. Other: Pancreatitis
, local reactions: pain and irritation (IM site), Jarisch-Herxheimer reaction (see Nursing Implications).
Diagnostic Test Interference
tetracyclines may cause false increases in urinary catecholamines (by fluorometric methods), and false decreases in urinary urobilinogen. Parenteral tetracyclines containing ascorbic acid reportedly may produce false-positive urinary glucose determinations by copper reduction methods (e.g., Benedict's reagent, Clinitest); tetracyclines may cause false-negative results with glucose oxidase methods (e.g., Clinistix, TesTape).
, and magnesium
bind tetracycline in gut and decrease absorption. oral anticoagulants
potentiate hypoprothrombinemia. antidiarrheal agents
and pectin may decrease absorption. Effectiveness of oral contraceptives
may produce fatal nephrotoxicity. Food:
Dairy products and iron, zinc
supplements decrease tetracycline absorption.
7580% of dose absorbed. Peak:
24 h. Distribution:
Widely distributed, preferentially binds to rapid growing tissues; crosses placenta; enters breast milk. Metabolism:
Not metabolized; enterohepatic cycling. Elimination:
5060% in urine within 72 h. Half-Life:
Assessment & Drug Effects
- Lab tests: Obtain baseline and periodic C&S tests to confirm susceptibility of infecting organism to tetracycline. Also,
preform initial and periodic kidney, liver, and hematopoietic function tests, particularly during high-dose, long-term therapy.
Determine serum tetracycline levels in patients at-risk for hepatotoxicity (sometimes associated with pancreatitis and occurs
most frequently in patients receiving other hepatotoxic drugs or with history of renal or hepatic impairment).
- Report GI symptoms (e.g., nausea, vomiting, diarrhea) to physician. These are generally dose-dependent, occurring mostly
with oral forms in patients receiving 2 g/d or more and during prolonged therapy. Frequently, symptoms are controlled by
reducing dosage or administering with compatible foods.
- Be alert to evidence of superinfections (see Appendix F). Regularly inspect tongue and mucous membrane of mouth for candidiasis
(thrush). Suspect superinfection if patient complains of irritation or soreness of mouth, tongue, throat, vagina, or anus,
or persistent itching of any area, diarrhea, or foul-smelling excreta or discharge.
- Withhold drug and notify physician if superinfection develops. Superinfections occur most frequently in patients receiving
prolonged therapy, the debilitated, or those who have diabetes, leukemia, systemic LE, or lymphoma. Women taking oral contraceptives
reportedly are more susceptible to vaginal candidiasis.
- Obtain follow-up cultures from all gonococcal infection sites 37 d after completion of tetracycline therapy to verify
eradication of infection.
- Monitor I&O in patients receiving parenteral tetracycline. Report oliguria or any changes in appearance of urine or in I&O.
Patient & Family Education
- Report onset of diarrhea to physician. It is important to determine whether diarrhea is due to irritating drug effect or
superinfections or pseudomembranous colitis (caused by overgrowth of toxin-producing bacteria: Clostridium difficile) (see Appendix F). The latter two conditions can be LIFE THREATENING and require immediate withdrawal of tetracycline and prompt initiation of symptomatic and supportive therapy.
- Reduce incidence of superinfection (see Appendix F) by meticulous care of mouth, skin, and perineal area. Rinse mouth of
food debris after eating; floss daily and use a soft-bristled toothbrush. Wash hands several times a day, particularly after
each bowel movement and before eating.
- Avoid direct exposure to sunlight during and for several days after therapy is terminated to reduce possibility of photosensitivity
reaction (appearing like an exaggerated sunburn, it begins a few minutes to hours following sun exposure, often with tingling,
- Report onset of severe headache or visual disturbances immediately. These are possible symptoms of increased intracranial
pressure and necessitate prompt withdrawal of tetracycline to prevent irreversible loss of vision.
- Note: Tetracycline therapy for brucellosis or spirochetal infections may cause a Jarisch-Herxheimer reaction. The reaction is
usually mild and appears abruptly within 624 h after initiation of therapy. It is manifested by malaise, fever, chills,
headache, adenopathy, leukocytosis, exacerbation of skin lesions, arthralgia, transient hypotension. Treatment is symptomatic;
recovery generally occurs within 24 h.
- Report immediately sudden onset of painful or difficult swallowing (dysphagia) to physician. Esophagitis and esophageal
ulceration have been associated with bedtime administration of tetracycline capsules or tablets with insufficient fluid,
particularly to patients with hiatal hernia or esophageal problems.
- Do not allow topical medication to contact eyes, nose, or mouth. Be aware that tetracycline may stain clothing.
- Clean affected skin area with soap and water; rinse and dry well before application of topical drug.
- Report a worsening infection or stinging and burning sensation with topical applications to physician if pronounced.
- Skin treated with topical drug will exhibit bright yellow to green fluorescence under ultraviolet light and "black light."
- Be aware that topicycline contains a sulfite that can cause an allergic reaction (itching, wheezing, anaphylaxis) in susceptible
persons (e.g., asthmatics or allergic individuals).
- Response to acne therapy usually requires 28 wk, maximal results may not be apparent for up to 12 wk.