Tetracycline (Sumycin) is an antibiotic that acts by inhibiting bacterial protein synthesis. It is used to treat patients with the following conditions:

• Acute intestinal amebiasis:

  • It is used as adjunctive therapy in acute intestinal amebiasis caused by Entamoeba histolytica.

• Acne:

  • It is used as adjunctive therapy for the treatment of severe acne.

• Actinomycosis:

  • It is used in the Treatment of actinomycosis caused by Actinomyces species when penicillin is contraindicated.

• Anthrax:

  • It is used in the Treatment of anthrax due to Bacillus anthracis when penicillin is contraindicated.

• Campylobacter:

  • It is used in the treatment of infections caused by Campylobacter fetus.

• Cholera:

  • It is used in the Treatment of cholera caused by Vibrio cholera.

• Clostridium:

  • It is used in the treatment of infections caused by Clostridium spp. when penicillin is contraindicated.

• Gram-negative infections:

  • It is used in the treatment of infections caused by Escherichia coli, Enterobacter aerogenes, Shigella spp., Acinetobacter spp., Klebsiella spp., and Bacteroides spp.

• Listeriosis:

  • It is used in the treatment of listeriosis due to Listeria monocytogenes when penicillin is contraindicated.

• Ophthalmic infections:

  • It is used in the treatment of inclusion conjunctivitis or trachoma caused by Chlamydia trachomatis.

• Relapsing fever:

  • It is used in the treatment of relapsing fever due to Borrelia spp.

• Respiratory tract infection:

  • It is used in the treatment of respiratory tract infections caused by Haemophilus influenzae (upper respiratory tract only), Klebsiella spp. (lower respiratory tract only), Mycoplasma pneumoniae (lower respiratory tract only), Streptococcus pneumoniae, or Streptococcus pyogenes.

• Rickettsial infections:

  • It is used in Treatment of Rocky Mountain spotted fever, typhus group infections, Q fever, and rickettsialpox caused by Rickettsiae.

• Sexually transmitted diseases:

  • It is used in the Treatment of lymphogranuloma venereum or uncomplicated urethral, endocervical, or rectal infections caused by C. trachomatis; granuloma inguinale (donovanosis) caused by Klebsiella granulomatis; chancroid caused by Haemophilus ducreyi; and syphilis caused by Treponema pallidum when penicillin is contraindicated.

• Skin and skin structure infections:

  • It is used in the treatment of skin and skin structure infections caused by Staphylococcus aureus or S. pyogenes.

• Urinary tract infections:

  • It is used in the treatment of urinary tract infections caused by susceptible gram-negative organisms (eg, E. coli, Klebsiella spp.).

• Vincent infection:

  • It is used in Treatment of Vincent infection caused by Fusobacterium fusiforme when penicillin is contraindicated.

• Yaws:

  • It is used in the treatment of yaws caused by Treponema pertenue when penicillin is contraindicated.

• Zoonotic infections:

  • It is used in the treatment of psittacosis also called ornithosis) due to Chlamydophila psittaci; tularemia due to Francisella tularensis; plague due to Yersinia pestis; brucellosis due to Brucella spp. (in conjunction with an aminoglycoside); and bartonellosis due to Bartonella bacilliformis.

• Off Label Use of Tetracycline in Adults:

  • Helicobacter pylori eradication;
  • Malaria;
  • Periodontitis associated with the presence of Actinobacillus actinomycetem comitans

Tetracycline Dose in Adults

Tetracycline usual dosage range:

• • 250 to 500 mg given every 6 to 12 hours

Dose in the treatment of Acne:

• 1 g given daily in divided doses
• reduce the dose gradually to 125 to 500 mg/day once improvement is noted (alternate day or intermittent therapy may be adequate in some patients).

Dose in the treatment of Helicobacter pylori eradication (off-label): 

• American College of Gastroenterology guidelines

  • Bismuth quadruple regimen :

    • 500 mg 4 times daily given, in combination with:
      • standard-dose proton pump inhibitor two times a day,
      • metronidazole 250 mg 4 times a day or 500 mg 3 or 4 times a day, and
      • either bismuth sub-citrate 120 - 300 mg 4 times a day or bismuth sub-salicylate 300 mg 4 times a day
    • continue regimen for 10 to 14 days.

Dose in the treatment of severe Malaria (off-label):

• 250 mg given 4 times daily for 7 days with quinidine gluconate.

Dose in the treatment of uncomplicated Malaria (off-label):

• 250 mg given 4 times daily for 7 days with quinine sulfate.

Dose in the treatment of Periodontitis (off-label):

• 250 mg given every 6 hours until improvement (usually 10 days)

Dose in the treatment of Syphilis, penicillin-allergic patients:

• Early syphilis (primary or secondary infection):

  • 500 mg given 4 times daily for 14 days.

• Latent syphilis (late or of unknown duration):

  • 500 mg given 4 times daily for 28 days.

• Tularemia (mild to moderate):

  • 500 mg given 4 times daily for at least 14 days

• Vibrio cholerae:

  • 500 mg given 4 times daily for 3 days

Tetracycline Dose in Childrens

General dosing, susceptible infection:

• Children ≥8 years and Adolescents:
  • 25 to 50 mg/kg/day given in divided doses every 6 hours

Dose in the treatment of Acne:

• Children ≥8 years and Adolescents:
  • 500 mg/dose given twice daily

Tetracycline dose in the treatment of Malaria:

• It is used in combination with other antimalarial agents in uncomplicated chloroquine-resistant infections caused by:
  • P. falciparum,
  • P. vivax or
  • unknown species

  • Children ≥8 years and Adolescents:

    • Non-HIV-exposed/-positive: Oral:

      • 6.25 mg/kg/dose given every 6 hours for 7 days.
      • The maximum dose: 250 mg/dose

    • HIV-exposed/-positive: Oral:

      • 6 to 12.5 mg/kg/dose given every 6 hours for 7 days.
      • The maximum dose: 500 mg/dose

  • Severe infection :

    • Note: Use in combination with other antimalarial agents

      • Children ≥8 years and Adolescents:

    • Non-HIV-exposed/-positive: Oral:

      • 6.25 mg/kg/dose given every 6 hours for 7 days.
      • The maximum dose: 250 mg/dose

    • HIV-exposed/-positive: Oral:

      • 6 to 12.5 mg/kg/dose given every 6 hours for 7 days.
      • The maximum dose: 500 mg/dose

Dose in the treatment of Syphilis in penicillin-allergic patients:

• Adolescents: Oral:

  • Early syphilis (primary or secondary infection):

    • 500 mg/dose given 4 times daily for 14 days

  • Latent syphilis (late or of unknown duration):

    • 500 mg/dose given 4 times daily for 28 days

Pregnancy Risk Factor D

• Tetracycline crosses the placenta
• In utero exposure can cause permanent yellowing, graying, or browning of teeth. This is more common after repeated or long-term exposure.
• It has been reported that tetracycline can cause liver damage during pregnancy.
• Women with renal disease may be at greater risk of developing hepatic impairment from tetracycline.
• Tetracyclines, as a class, are generally second-line antibiotics for pregnant women. They should be avoided.
• Many guidelines consider tetracycline contraindicated in pregnancy. However, it is considered a relative contraindication for pregnant women.
• Other agents are often preferred when systemic antibiotics are required for dermatologic conditions in pregnant ladies.

Tetracycline use during breastfeeding:

• Breast milk contains Tetracycline.
• According to the manufacturer of the product, when deciding whether to breastfeed during therapy or not, it should consider the risks to the infant as well as the benefits to the mother.
• Tetracyclines as a class are not recommended for nursing mothers because they can permanently stain breast-feeding infants' teeth.
• Sources note that breastfeeding can be continued during tetracycline therapy, but they recommend using alternative medications whenever possible.
• Others note that some short-term exposure is acceptable. However, breast-feeding mothers should avoid long-term use (e.g., to treat acne).
• Breast milk antibiotics can cause non-dose-related changes in the bowel flora.
• Monitor infants for GI disorders.

Tetracycline dose in Kidney disease:

• Manufacturer’s labeling:

  • The manufacturer has not recommended any dose adjustment in patients with kidney disease.

• Alternative dosing 

• • GFR greater than 50 mL/minute:

    • The recommended dose based on indication should be given every 8 to 12 hours.

  • GFR 10 - 50 mL/minute:

    • The recommended dose based on the indication should be given every 12 - 24 hours.

  • GFR less than 10 mL/minute:

    • The recommended dose based on the indication should be given as once daily.

Tetracycline Dose in Liver Disease:

• The manufacturer has not recommended any dose adjustment in patients with liver disease.

Side effects of Tetracycline (Sumycin):

• Cardiovascular:

  • Pericarditis
  • Thrombophlebitis

• Central Nervous System:

  • Bulging Fontanel (Infants)
  • Increased Intracranial Pressure
  • Paresthesia
  • Pseudotumor Cerebri

• Dermatologic:

  • Exfoliative Dermatitis
  • Nail Discoloration
  • Pruritus
  • Skin Photosensitivity

• Gastrointestinal:

  • Abdominal Cramps
  • Anorexia
  • Dental Discoloration (Young Children)
  • Diarrhea
  • Enamel Hypoplasia (Young Children)
  • Esophagitis
  • Nausea
  • Pancreatitis
  • Pseudomembranous Colitis (Antibiotic-Associated)
  • Staphylococcal Enterocolitis
  • Vomiting

• Genitourinary:

  • Azotemia

• Hepatic:

  • Hepatotoxicity

• Hypersensitivity:

  • Anaphylaxis
  • Hypersensitivity Reaction

• Infection:

  • Fungal Superinfection (Candida)
  • Superinfection

• Renal:

  • Acute Renal Failure
  • Renal Insufficiency

Contraindication to Tetracycline (Sumycin) Include:

• Severe allergic reactions to any tetracyclines, or any part of the formulation.

Warnings and precautions

• BUN Increased

  • Patients with impaired renal function should be cautious when using it as it can raise serum BUN levels due to its antianabolic properties.

• Intracranial hypertension (pseudotumor Cerebri):

  • It may cause headaches, diplopias, blurred vision, vision loss, blurred vision, vision impairment, and/or even papilledema.
  • Patients on oral contraceptives, obese women, pregnant women and people with a history or intracranial hypertension are at highest risk for pseudotumor cerebri.
  • Concomitant use of isotretinoin (known to cause pseudotumor cerebri [PTC]) and tetracycline is avoided.
  • If the drug is not stopped promptly, permanent vision loss is possible.
  • It is important to seek prompt medical attention if you experience visual symptoms.
  • Patients should be monitored until intracranial pressure stabilizes.

• Photosensitivity

  • Photosensitivity patients who experience skin erythema or photosensitivity should stop using it.
  • Avoid using tanning equipment.
  • Patients should avoid prolonged sun exposure and should be encouraged to use sunscreens.

• Superinfection

  • Long-term use of the drug can lead to superinfections, especially fungal or bacterial.
  • Possible complications include bacterial superinfection, including clostridioides difficile -associated diarrhea (CDAD), and pseudomembranous collitis.
  • Clostridioides difficile -associated diarrhea (CDAD), can occur up to 2 months after the end of antibiotics.

• Hepatic impairment

  • Patients with preexisting liver or renal disease are at risk of developing hepatic impairment.

• Renal impairment

  • It should be used with caution by patients with impaired renal function.
  •  Recommendations for adjustment of the dos

Tetracycline: Drug Interaction

Monitor:

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

How to administer Tetracycline (Sumycin)?

• Administer on an empty stomach (ie, 1 hour prior to, or 2 hours after meals) to increase total absorption and with an adequate amount of fluid to reduce the risk of esophageal irritation and ulceration.
• Give at least 1 to 2 hours prior to, or 4 hours after antacid because aluminum and magnesium cations may chelate with tetracycline and reduce its total absorption.

Mechanism of action of Tetracycline (Sumycin):

• It inhibits the synthesis of bacterial proteins by binding to the 30S or 50S ribosomal (subunits) of the susceptible bacteria.
• It can also alter the cytoplasmic layer.

Absorption:

• Oral: 77% to 88%
• Intramuscular absorption is poor, with less than 60% of dose absorbed

Distribution:

• It is Widely distributed to most body fluids and tissues including ascitic, synovial and pleural fluids; bronchial secretions; poor penetration into CSF

Protein binding:

• 55% to 64%

Half-life elimination:

• 6 to 11 hours

Time to peak, serum:

• Oral: 2 to 4 hours

Excretion:

• Via Urine (30%) & feces (20% to 60%) (Agwuh 2006 

International Brands of Tetracycline:

• A tetra
• Achromycin
• Achromycin V
• Aclocin
• Acromicina
• Alexcyclin
• Ambramicina
• Apocyclin
• Atron
• Beatacycline
• Berciclina
• Biotine
• Bocycline
• Cadicycline
• Ciclotetryl
• Cinatrex
• Clincor
• Cyclabid
• Dhatracin
• Dicyclin Forte
• Dumocycline
• Eapatet
• Emcycline
• Erifor
• Florocycline
• Hexacycline
• Hostacyclin
• Hostacycline
• Hostacycline-P
• Hydromycin
• Ibicyn
• Imex
• Latycin
• Lenocin
• Medocycline
• Mephicycline
• Metacycline
• Ophth-tetracil
• Opticyclin
• Oricyclin
• Panmycin
• Pantocycline
• Quemiciclina-S
• Recycline
• Resteclin
• Rimatet
• Servitet
• Steclin V
• Subamycin
• Tc
• Tefilin
• Teracin
• Tetrabiotico
• Tetrachem
• Tetracid
• Tetraciklins
• Tetracilin
• Tetracin
• Tetracyclinum
• Tetracyklin
• Tetradar
• Tetralan
• Tetramed
• Tetramig
• Tetramin
• Tetran
• Tetrana
• Tetrarco
• Tetras
• Tetraseptin
• Tetrasuiss
• Tetrecu
• Tetret-250
• Tetrex
• Tetrm
• Tetrop
• Tevacycline
• Traxetrine
• Ttmycin
• Wintel
• Xepacycline

Tetracycline Brands in Pakistan: