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Pronunciation |
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(oks
i tet ra SYE
kleen) |
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U.S. Brand
Names |
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Terramycin® I.M. Injection;
Terramycin®
Oral |
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Generic
Available |
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Yes |
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Synonyms |
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Oxytetracycline Hydrochloride |
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Pharmacological Index |
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Antibiotic, Tetracycline Derivative |
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Use |
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Treatment of susceptible bacterial infections; both gram-positive and
gram-negative, as well as, Rickettsia and Mycoplasma
organisms |
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Pregnancy Risk
Factor |
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D |
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Contraindications |
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Hypersensitivity to tetracycline or any component |
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Warnings/Precautions |
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Avoid in children less than or equal to 8 years of age, pregnant and nursing
women; photosensitivity can occur with oxytetracycline |
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Adverse
Reactions |
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>10%: Miscellaneous: Discoloration of teeth and enamel hypoplasia
(infants)
1% to 10%:
Dermatologic: Photosensitivity
Gastrointestinal: Nausea, diarrhea
<1%: Pericarditis, increased intracranial pressure, bulging fontanels in
infants, pseudotumor cerebri, pruritus, exfoliative dermatitis, dermatologic
effects, diabetes insipidus syndrome, vomiting, esophagitis, anorexia, abdominal
cramps, antibiotic-associated pseudomembranous colitis, staphylococcal
enterocolitis, hepatotoxicity, thrombophlebitis, paresthesia, renal damage,
acute renal failure, azotemia, superinfections, anaphylaxis, pigmentation of
nails, hypersensitivity reactions, candidal superinfection |
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Overdosage/Toxicology |
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Symptoms of overdose include nausea, anorexia, diarrhea
Following GI decontamination, supportive care only |
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Drug
Interactions |
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Decreased effect with antacids containing aluminum, calcium or magnesium
Iron and bismuth subsalicylate may decrease doxycycline bioavailability
Barbiturates, phenytoin, and carbamazepine decrease doxycycline's half-life
Increased effect of warfarin |
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Mechanism of
Action |
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Inhibits bacterial protein synthesis by binding with the 30S and possibly the
50S ribosomal subunit(s) of susceptible bacteria, cell wall synthesis is not
affected |
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Pharmacodynamics/Kinetics |
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Absorption: Oral: Adequate (~75%); I.M.: Poor
Distribution: Crosses the placenta
Metabolism: Small amounts in the liver
Half-life: 8.5-9.6 hours (increases with renal impairment)
Time to peak serum concentration: Within 2-4 hours
Elimination: In urine, while much higher amounts can be found in bile
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Usual Dosage |
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Oral:
Children >8 years: 40-50 mg/kg/day in divided doses every 6 hours
(maximum: 2 g/24 hours)
Adults: 250-500 mg/dose every 6-12 hours depending on severity of the
infection
I.M.:
Children >8 years: 15-25 mg/kg/day (maximum: 250 mg/dose) in divided doses
every 8-12 hours
Adults: 250 mg every 24 hours or 300 mg/day divided every 8-12 hours
Syphilis: 30-40 g in divided doses over 10-15 days
Gonorrhea: 1.5 g, then 500 mg every 6 hours for total of 9 g
Uncomplicated chlamydial infections: 500 mg every 6 hours for 7 days
Severe acne: 1 g/day then decrease to 125-500 mg/day
Dosing interval in renal impairment:
Clcr <10 mL/minute: Administer every 24 hours or avoid use if
possible
Dosing adjustment/comments in hepatic impairment: Avoid use in
patients with severe liver disease |
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Mental Health: Effects
on Mental Status |
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Case reports of tetracyclines report memory disturbances, mood stabilizing
and antidepressant effects |
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Mental Health:
Effects on Psychiatric
Treatment |
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Barbiturates and carbamazepine may decrease the effects of oxytetracycline;
may decrease lithium clearance resulting in an increase in serum lithium levels
and potential lithium toxicity; monitor serum lithium
levels |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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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. 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. |
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Patient
Information |
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Take as directed, around-the-clock. Finish all doses; do not skip doses. May
take with food to reduce GI upset. Do not take with antacids, iron products, or
dairy products. You may be sensitive to sunlight; use sunblock, wear protective
clothing, or avoid direct sun. If diabetic, drug may cause false tests with
Clinitest® urine glucose monitoring; use of glucose
oxidase methods (Clinistix®) or serum glucose monitoring
is preferable. Report rash, difficulty breathing, yellowing of skin or eyes,
change in color of urine or stool, easy bruising or bleeding, fever, chills,
perianal itching, purulent vaginal discharge, white plaques in mouth, or
persistent diarrhea. Pregnancy/breast-feeding precautions: Do not get
pregnant while taking this medication - Oral contraceptives effectiveness may be
reduced; use appropriate barrier contraceptive measures. Breast-feeding is not
recommended. |
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Nursing
Implications |
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Injection for intramuscular use only; reduce dose in renal
insufficiency |
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Dosage Forms |
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Capsule, as hydrochloride: 250 mg
Injection, as hydrochloride, with lidocaine 2%: 5% [50 mg/mL] (2 mL, 10 mL);
12.5% [125 mg/mL] (2 mL) |
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