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ZDOX 100/200 ( Doxycycline )


Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline has bacteriostatic activity against a broad range of Gram -positive and Gram-negative bacteria. Cross-resistance of these organisms to tetracycline is common.

Pharmacodynamics:

Bacteria3

Minimal Inhibitory Concentration (mcg/mL)

Zone Diameter (mm)

Agar Dilution (mcg/mL)

S

I

R

S

I

R

S

I

R

Acinetobacter spp.

  Doxycycline

≤ 4

8

≥ 16

≥ 13

10-12

≤ 9

  Tetracycline

≤ 4

8

≥ 16

≥ 15

12-14

≤ 11

Anaerobes

  Tetracycline

≤ 4

8

≥ 16

Bacillus anthracisb

  Doxycycline

≤ 1

  Tetracycline

≤ 1

Brucella speciesb

  Doxycycline

≤ 1

  Tetracycline

≤ 1

Enterobacteriaceae

  Doxycycline

≤ 4

8

≥ 16

≥ 14

11-13

≤ 10

  Tetracycline

≤ 4

8

≥ 16

≥ 15

12 -14

≤ 11

Francisella tularensisb

  Doxycycline

≤ 4

  Tetracycline

≤ 4

Haemophilus influenzae

  Tetracycline

≤ 2

4

≥ 8

≥ 29

26-28

≤ 25

Mycoplasma pneumoniaeb

  Tetracycline

≤ 2

Nocardiae and other aerobic Actinomyces speciesab

  Doxycycline

≤ 1

2-4

≥ 8

Neisseria gonorrhoeaec

  Tetracycline

≥ 38

31-37

≤ 30

≤ 0.25

0.5-1

≥ 2

Streptococcus pneumoniae

  Doxycycline

≤ 0.25

0.5

≥ 1

≥ 28

25-27

≤ 24

  Tetracycline

≤ 1

2

≥ 4

≥ 28

25-27

≤    24

Vibrio cholerae

  Doxycycline

≤ 4

8

≥ 16

  Tetracycline

≤ 4

8

≥ 16

Yersinia pestis

  Doxycycline

≤ 4

8

≥ 16

  Tetracycline

≤ 4

8

≥ 16

Ureaplasma urealyticum

  Tetracycline

≤ 1

≥ 2

a Organisms susceptible to tetracycline are also considered susceptible to doxycycline. However, some organisms that are intermediate or resistant to tetracycline may be susceptible to doxycycline

 Pharmacokinetics: Doxycycline–metal ion complexes are unstable at acid pH, therefore more doxycycline enters the duodenum for absorption than the earlier tetracycline compounds. In addition, food has less effect on absorption than on absorption of earlier drugs with doxycycline serum concentrations being reduced by about 20% by test meals compared with 50% for tetracycline

 Dosage

Adults: The usual dose of doxycycline is 200 mg loading dose(administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg OD(For severe infections 100mg Bid).

For children above eight years of age: In  Children <45kg loading dose is 4mg/kg/day and main tenance dose is 2mg/kg/day.

Indications:

·         CAP & Atypical pneumonia

·         LRTI

·         Fever of unknown origin (Scrub typhus)

Stability:

Doxycycline is stable for 4hrs in solution when diluted with sodium chloride Injection,or 5%dextrose Injection to concentrations between 1mg/ml and 0.1mg/ml  and stored at 25°c.Doxycycline in these solutions is stable under flourescent light for 4hrs.but must be protected from direct sunlight during storage and infusion if refrigerated and protected from sunlight and artificial light.Infusion must then be completed within 4hrs.Solutions must be used within these time periods or discarded.

When diluted with Lactated Ringer’s Injection,or Dextrose 5%in   Lactated Ringer’s Infusion of the solution(ca 1mg/ml)or lower concentrations.(not less than 0.1mg/mL)must be completed within 4hrs after reconstitution into adequate stability.During infusion ,solution must be protected from direct sunlight.Solutions must be used within time period or discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration when ever solution and container permit.

Contraindications:

The drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Adverse Effects:

An erythematous rash in sun-exposed parts of the body has been reported to occur in 7.3–21.2% of persons taking doxycycline for malaria prophylaxis. One study examined the tolerability of various malaria prophylactic regimens and found doxycycline did not cause a significantly higher percentage of all skin events (photosensitivity not specified) when compared with other antimalarials. The rash resolves upon discontinuation of the drug.

Unlike some other members of the tetracycline group, it may be used in those with renal impairment. Doxycycline is contraindicated in the pediatric treatment of acute bacterial rhinosinusitis

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