Tetracycline


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Susceptible infections 250-500 mg 6 hourly. Dosage and treatment duration vary depending on the type of infection. Acne vulgaris; Rosacea 250-500 mg/day as a single or in divided doses for at least 3 months. Brucellosis 500 mg 4 times/day for 3 weeks in combination with streptomycin. Uncomplicated genital infections due to Chlamydia trachomatis; Uncomplicated gonorrhoea; Nongonococcal urethritis 500 mg 4 times/day for 7 days. Epididymo-orchitis 500 mg 4 times/day for 10 days. Syphilis 500 mg 4 times/day. Duration: 15 days for early syphilis (<1 year’s duration) or 30 days for syphilis of >1 year (except neurosyphilis). Topical Minor skin infections As 3% ointment: Apply a small amount to affected area 1-3 times/day. Ophthalmic Bacterial conjunctivitis; Trachoma As 1% ointment: Apply bid. Duration: 7 days (bacterial conjunctivitis); 6 weeks (trachoma).
Dosage Details
Ophthalmic
Bacterial conjunctivitis, Trachoma
Adult: As 1% ointment: Apply thinly unto conjunctival sac bid. Treatment duration: 7 days (bacterial conjunctivitis); 6 weeks (trachoma).

Ophthalmic
Prophylaxis of neonatal conjunctivitis
Child: As 1% ointment: 1 single application into each eye immediately after birth.

Oral
Susceptible infections
Adult: 250-500 mg 6 hourly. Dosage and treatment duration vary depending on the type of infection.
Child: ≥8 years 25-50 mg/kg daily, in divided doses 6 hourly.

Oral
Acne vulgaris, Rosacea
Adult: 250-500 mg daily as a single or in divided doses for at least 3 months.

Oral
Brucellosis
Adult: 500 mg 4 times daily for 3 weeks in combination with streptomycin.

Oral
Nongonococcal urethritis, Uncomplicated genital infections due to Chlamydia trachomatis, Uncomplicated gonorrhoea
Adult: 500 mg 4 times daily for 7 days.

Oral
Syphilis
Adult: 500 mg 4 times daily. Treatment duration: 15 days for early syphilis (<1 year’s duration) or 30 days for syphilis of >1 year (except neurosyphilis).

Oral
Epididymo-orchitis
Adult: 500 mg 4 times daily for 10 days.

Topical/Cutaneous
Minor skin infections
Adult: As 3% ointment: Apply a small amount to affected area 1-3 times daily.
Renal Impairment
Oral
Acne vulgaris; Rosacea; Brucellosis; Uncomplicated genital infections due to Chlamydia trachomatis; Uncomplicated gonorrhoea; Nongonococcal urethritis; Epididymo-orchitis; Syphilis
Severe: Contraindicated.
Hepatic Impairment
Oral
Susceptible infections; Acne vulgaris; Rosacea; Brucellosis; Uncomplicated genital infections due to Chlamydia trachomatis; Uncomplicated gonorrhoea; Nongonococcal urethritis; Epididymo-orchitis; Syphilis
Max: 1 g daily.
Administration
Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals w/ a full glass of water, in upright position. May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to tetracyclines. Children <8 years. Severe renal impairment. Pregnancy and lactation.  Concurrent use of methoxyflurane, retinoids or vitamin A.
Special Precautions
Patient with myasthenia gravis, SLE. Children. Hepatic and mild to moderate renal impairment.
Adverse Reactions
Significant: Photosensitivity, intracranial hypertension, increased BUN. Enamel hypoplasia or permanent tooth discolouration in children, tissue hyperpigmentation in children <8 years.
Blood and lymphatic system disorders: Rarely, agranulocytosis, aplastic or haemolytic anaemia, eosinophilia, neutropenia, thrombocytopenia.
Gastrointestinal disorders: Oesophagitis, oesephageal ulceration, epigastric distress, glossitis, gastrointestinal irritations, dysphagia, nausea, vomiting, diarrhoea, abdominal discomfort, pancreatitis.
Hepatobiliary disorders: Rarely, transient increases in LFT, hepatitis, hepatic failure, jaundice.
Metabolism and nutrition disorders: Anorexia.
Skin and subcutaneous tissue disorders: Erythematous or maculopapular rash, pruritus, bullous dermatoses, skin discolouration.
Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, exacerbation of SLE). Clostridium difficile-associated disease (CDAD), hepatotoxicity.
Patient Counseling Information
Avoid exposure to sunlight; wear protective clothing and use sunscreen. Use of eye ointment may cause transient blurring of vision and other eye disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor renal, hepatic and haematopoietic functions periodically; mental status. Obtain CBC and temperature. Assess culture and sensitivity prior to starting therapy.
Overdosage
Symptoms: Nausea, vomiting, hypersensitivity. Crystalluria and haematuria may occur following very large dose. Management: Symptomatic and supportive treatment. Oral fluids may be given in case of severe vomiting and diarrhoea.
Drug Interactions
Absorption may be impaired by divalent and trivalent cations (e.g. Al, Ca, Mg, Fe, Zn), Na bicarbonate, bismuth subsalicylate, kaolin-pectin, sucralfate, colestipol and colestyramine. May form a complex with strontium ranelate, resulting in decreased absorption of tetracycline. May interfere with the bactericidal action of penicillin. May prolong the effect of anticoagulants. May reduce plasma-atovaquone concentration. May decrease the efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with diabetes mellitus. May increase the toxic effects of ergot alkaloids and methotrexate. May increase lithium and digoxin levels. May diminish therapeutic effects of BCG, BCG vaccine, typhoid vaccine.
Potentially Fatal: Increased risk of benign intracranial hypertension when given concurrently with retinoids (e.g. acitretin, tretinoin, isotretinoin). Concurrent use of methoxyflurane may result in renal toxicity.
Food Interaction
Absorption may be impaired by food, milk or milk products.
Lab Interference
May interfere with diagnostic tests including determination of urinary catecholamines or glucose.
Action
Description: Tetracycline exhibits its bacteriostatic action by reversibly binding to the 30S subunits of the ribosome, thereby preventing the binding of aminoacyl transfer RNA and inhibiting protein synthesis, thus arresting cell growth.
Pharmacokinetics:
Absorption: Incompletely absorbed from the gastrointestinal tract. Bioavailability: Approx 60-80%. Time to peak plasma concentration: Approx 1-4 hours.
Distribution: Widely distributed in body tissues and fluids e.g. ascitic, synovial and pleural fluids. Crosses the placenta and enters breast milk. Plasma protein binding: 55-64%.
Excretion: Via urine (up to 55% as unchanged drug) and faeces. Elimination half-life: 8 hours (range: 6-12 hours).
Chemical Structure

Chemical Structure Image
Tetracycline

Source: National Center for Biotechnology Information. PubChem Database. Tetracycline, CID=54675776, https://pubchem.ncbi.nlm.nih.gov/compound/Tetracycline (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C. Protect from light.
MIMS Class
ATC Classification
S01AA09 - tetracycline ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
J01AA07 - tetracycline ; Belongs to the class of tetracyclines. Used in the systemic treatment of infections.
D06AA04 - tetracycline ; Belongs to the class of topical tetracycline and derivatives agents used in the treatment of dermatological diseases.
References
Anon. Tetracycline (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/10/2019 .

Buckingham R (ed). Tetracycline. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/10/2019 .

Tetracycline 3% First Aid Antibiotic Ointment (Sample Solutions, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/10/2019 .

Tetracycline Hydrochloride Capsule (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/10/2019 .

Disclaimer: This information is independently developed by MIMS based on Tetracycline from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Tetracycline Kunming Zhenhua
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