Doxycycline (injection)

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# Overview
Doxycycline (injection) is an antibiotic that is FDA approved for the treatment of Rickettsiae, Mycoplasma pneumoniae, psittacosis and ornithosis, lymphogranuloma venereum and granuloma inguinale, relapsing fever.   Common adverse reactions include anorexia,nausea,vomiting, diarrhea, dysphagia,edema, urticaria, hemolytic anaemia, neutropenia, eosinophilia.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxy-cycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
- Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms:
- Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers).
- Mycoplasma pneumoniae (PPLO, Eaton Agent).
- Agents of psittacosis and ornithosis.
- Agents of lymphogranuloma venereum and granuloma inguinale.
- The spirochetal agent of relapsing fever (Borelia recurrentis).
- The following gram-negative microorganisms:
- Haemophilus ducreyi (chancroid).
- Pasteurella pestis and Pasteurella tularensis.
- Bartonella bacilliformis.
- Bacteroides species
- Vibrio comma and Vibrio fetus.
- Brucella species (in conjunction with streptomycin).
- Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.
- Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Escherichia coli.
- Enterobacter aerogenes (formerly Aerobacter aerogenes).
- Shigella species.
- Mima species and Herellea species.
- Haemophilus influenzae (respiratory infections).
- Klebsiella species (respiratory and urinary infections).
- Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
- Streptococcus species:
- Up to 44% of strains of Streptococcus pyogenes and 74% of Streptococcus pyogenes and 74% of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive.
- For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.
- Diplococcus pneumoniae.
- Staphylococcus aureus, respiratory, skin and soft tissue infections. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.
- When penicillin is contraindicated, doxycycline is  and alternative drug in the treatment of infections due to:
- Neisseria gonorrhoeae and N. meningitidis.
- Treponema pallidum and Treponema pertenue (syphilis and yaws).
- Listeria monocytogenes.
- Clostridium species.
- Fusobacterium fusiforme (Vincent's infection).
- Actinomyces species.
- In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.  - Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.
- NOTE: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result.
- THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE FOR INJECTION (100 TO 200 MG/DAY) DIFFERS FROM THAT OF THE OTHER TETRACYCLINES (1 TO 2 G/DAY).  EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
- Studies to date have indicated that doxycycline hyclate at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.
- The usual dosage of doxycycline for injection is 200 mg on the first day of treatment administered in one or two infusions. Subsequent daily dosage is 100 to 200 mg depending upon the severity of infection, with 200 mg administered in one or two infusions.
- In the treatment of primary and secondary syphilis, the recommended dosage is 300 mg daily for at least 10 days.
- In the treatment of inhalational anthrax (post-exposure) the recommended dose is 100 mg of doxycycline, twice a day. Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. - Oral therapy should be instituted as soon as possible. Therapy must continue for a total of 60 days.
- For Children Above Eight Years of Age
- The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight on the first day of treatment, administered in one or two infusions.
- Subsequent daily dosage is 1 to 2 mg/lb of body weight given as one or two infusions, depending on the severity of the infection. For children over 100 pounds the usual adult dose should be used.
- In the treatment of inhalational anthrax (post-exposure) the recommended dose is 1 mg/lb (2.2 mg/kg) of body weight, twice a day in children weighting less than 100 lb (45 kg). Parenteral therapy is only indicated when oral therapy is not indicated and should not be continued over a prolonged period of time. Oral therapy should be instituted as soon as possible. Therapy must continued for a total of 60 days.
- The duration of infusion may vary with the dose (100 to 200 mg/day), but is usually one to four hours. A recommended minimum infusion time for 100 mg of a 0.5 mg/mL solution is one hour. Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided. The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
- Intravenous solutions should not be injected intramuscularly or subcutaneously. caution should be taken to avoid the inadvertent introduction of the intravenous solution into the adjacent soft tissue.
- To prepare a solution containing 10 mg/mL, the contents of the vial should be reconstituted with 10 mL (for the 100 mg/vial container) or 20 mL (for the 200 mg/vial container) of Sterile Water for Injection or any of the 10 intravenous infusion solutions listed below. Each 100 mg of doxycycline for injection (i.e., withdraw entire solution from the 100 mg vial) is further diluted with 100 mL to 1000 mL of the intravenous solutions listed below. Each 200 mg of doxycycline for injection (i.e., withdraw entire solution from the 200 mg vial) is further diluted with 200 mL to 2000mL of the following intravenous solutions:
- Sodium Chloride Injection, USP
- 5% Dextrose Injection, USP
- Ringer's Injection, USP
- Invert Sugar, 10% in Water
- Lactated Ringer's Injection, USP
- Dextrose 5% in Lactated Ringer's
- Normosol-M in D5-W (Abbott)
- Normosol-R in D5-W (Abbott)
- Plasma-Lyte 56 in 5% Dextrose (Baxter)
- Plasma-Lyte 148 in 5% Dextrose (Baxter)
- This will result in desired concentrations of 0.1 to 1 mg/mL. Concentrations lower than 0.1 mg/mL or higher than 1 mg/mL are not recommended.
- Doxycycline is stable for 48 hours in solution when diluted with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, to concentrations between 1 mg/mL and 0.1 mg/mL and stored at 25 degrees C. Doxycycline in these solutions is stable under fluorescent light for 48 hours, but must be protected from direct sunlight during storage and infusion. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion if refrigerated and protected from sunlight and artificial light. Infusion must then be completed within 12 hours. Solutions must be used within these periods or discarded.
- Doxycycline, when diluted with Ringer's Injection, USP, or Invert Sugar, 10% in Water, to a concentration between 1 mg/mL and 0.1 mg/mL, must be completely infused within 12 hours after reconstitution to ensure adequate stability.  During infusion, the solution must be protected from direct sunlight. Reconstituted solutions (1 to 0.1 mg/mL) may be stored up to 72 hours prior to start of infusion if refrigerated and protected from sunlight and artificial light. infusion must then be completed within 12 hours. Solutions must be used within these time periods or discarded.
- Diluted solutions (0.1 to 1 mg/mL) prepared using Normosol-M in D5-W (Abbott); Normosol-R in D5-W (Abbott); plasma-Lyte 56 in 5% Dextrose (Baxter); or Plasma-Lyte 148 in 5% Dextrose (Baxter) may also be stored up to 12 hours prior to start of infusion, if refrigerated and protected from sunlight and artificial light. The infusion must be completed within 12 hours. Solutions must be used within these time periods or discarded.
- When diluted with Lactated Ringer's Injection, USP, or Dextrose 5% in Lactated Ringer's, infusion of the solution (ca. 1 mg/mL) or lower concentrations (not less than 0.1 mg/mL) must be completed within six hours after reconstitution to ensure adequate stability. During infusion, the solution must be protected from direct sunlight. Solutions must be used within this time period or discarded.
- Solutions of doxycycline for injection, at a concentration of 10 mg/mL in Sterile Water for Injection, when frozen immediately after reconstitution are stable for eight weeks when stored at - 20 degrees C. If the product is warmed, care should be taken to avoid heating it after the thawing is complete. Once thawed the solution should not be refrozen.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline (injection) in adult patients.

### NonGuideline-Supported Use
- Acinetobacter infection: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided.
- Allergy to penicillin - Clostridial infection: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided.
- Allergy to penicillin - Clostridial infection: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided
- Anthrax, Inhalational Postexposure ; Prophylaxis: 100 mg IV/ORALLY every 12 hours for at least 60 days.
- Chancroid: 200 mg IV in 1 or 2 infusions on day 1, then 100 to 200 mg/day IV for at least 24 to 48 hours after symptoms and fever have subsided.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Doxycycline (injection) in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline (injection) in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Doxycycline (injection) in pediatric patients.

# Contraindications
There is limited information regarding Doxycycline (injection) Contraindications in the drug label.

# Warnings
- THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POST-EXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
- Pseudomembranous colitis has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
- Treatment with antibacterial agents alters the normal flora of the colon and may permit over growth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis."
- After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous  colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
- Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light, should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
- The anti-anabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
- Doxycycline for injection has not been studied in pregnant patients. It should not be used in pregnant women unless, in the judgment of the physician, it is essential for the welfare of the patient.
- Results of the animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
- The use of doxycycline for injection in children under 8 years is not recommended because safe conditions for its use have not been established. (See above WARNINGS about use during tooth development).
- As with other tetracyclines, doxycycline forms a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
- Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

# Adverse Reactions

## Clinical Trials Experience
- Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines.
- Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is also found.
- Rise in BUN has been reported and is apparently dose related.
- Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythematosus.
- Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving full therapeutic dosages. These conditions disappeared rapidly when the drug was discontinued.
- Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have been reported.
- When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Doxycycline (injection) in the drug label.

# Drug Interactions
There is limited information regarding Doxycycline (injection) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): D
- There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline us during pregnancy by TERIS-the Teratogen Information System-concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no risk. 1
- A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. (Sixty-three(0.19%) of the controls and 56 (0.30%) of the cases were treated with doxycycline). This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed cases.
- A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of age.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxycycline (injection) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Doxycycline (injection) during labor and delivery.

### Nursing Mothers
- Tetracycline are excreted in human milk, however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated: however, the effects of prolonged exposure to doxycycline in breast milk are unknown.4 Because of the potential for adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

### Pediatric Use
- The use of doxycycline for injection in children under 8 years is not recommended because safe conditions for its use have not been established. (See above WARNINGS about use during tooth development).
- As with other tetracyclines, doxycycline forms a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
- Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

### Geriatic Use
There is no FDA guidance on the use of Doxycycline (injection) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Doxycycline (injection) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Doxycycline (injection) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Doxycycline (injection) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Doxycycline (injection) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Doxycycline (injection) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Doxycycline (injection) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
There is limited information regarding Monitoring of Doxycycline (injection) in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Doxycycline (injection) in the drug label.

# Overdosage
There is limited information regarding Doxycycline (injection) overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action

## Structure
There is limited information regarding Doxycycline (injection) Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Doxycycline (injection) in the drug label.

## Pharmacokinetics
- Doxycycline is primarily bacteriostatic and though to exert its antimicrobial effect by the inhibition of protein synthesis. Doxycycline is active against a wide range of gram-positive and gram-negative organisms.
- The drugs in the tetracycline class have closely similar antimicrobial spectra and cross resistance among them is common. Microorganisms may be considered susceptible to doxycycline (likely to respond to doxycycline therapy) if the minimum inhibitory concentration (MIC) is not more than 4 mcg/mL. Microorganisms may be considered intermediate (harboring partial resistance) if the MIC is 4 to 12.5 mcg/mL and resistant (not likely to respond to therapy) if the MIC is greater than 12.5 mcg/mL.
- If the Kirby-Bauer method of disc susceptibility testing is used, a 30 mcg doxycycline disc should give a zone of at least 16 mm when tested against a doxycycline-susceptible bacterial strain. A tetracycline disc may be used to determine microbial susceptibility.  If the Kirby-Bauer method of disc susceptibilty testing is used, a 30 mcg tetracycline disc should give a zone of at least 19 mm when tested against a tetracycline-susceptible bacterial strain.
- Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form.
- Following a single 100 mg dose administered in a concentration of 0.4 mg/mL in a one-hour infusion, normal adult volunteers averaged a peak of 2.5 mcg/mL, while 200 mg of a concentration of 0.4mg/mL administered over two hours averaged a peak of 3.6 mcg/mL.
- Excretion of doxycycline by the kidney is about 40 percent/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage of excretion may fall as low as 1 to 5 percent/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/mon). Studies have shown no significant difference in serum half-life of doxycycline (range 18 to 22 hours) in individuals with normal and severly impaired renal function.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Doxycycline (injection) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Doxycycline (injection) in the drug label.

# How Supplied
- Product  No.    NDC No.131163323-130-11
- Doxycycline for Injection, USP (equivalent to 100 mg Doxycycline with 480 mg ascorbic acid and 300 mg mannitol),
- Lyophilized in a flip-top vial, in packages of 1016420
- 63323-164-20    Doxycycline for Injection, USP (equivalent to 200 mg Doxycycline with 960 mg ascorbic acid and 600 mg mannitol), lyophilized in a flip-top vial, packaged individually.

## Storage
- Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Doxycycline (injection) in the drug label.

# Precautions with Alcohol
- Alcohol-Doxycycline (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- DOXY 100

# Look-Alike Drug Names
There is limited information regarding Doxycycline (injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price