Doxycycline 3DDD Uses

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What is Doxycycline 3DDD?

Doxycycline 3DDD is a tetracycline antibiotic that fights bacteria in the body.

Doxycycline 3DDD is used to treat many different bacterial infections, such as acne, urinary tract infections, intestinal infections, eye infections, gonorrhea, chlamydia, periodontitis (gum disease), and others.

Doxycycline 3DDD is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doxycycline 3DDD will not treat facial redness caused by rosacea.

Some forms of Doxycycline 3DDD are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.

Doxycycline 3DDD may also be used for purposes not listed in this medication guide.

Doxycycline 3DDD indications

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Rickettsial Infections

Doxycycline 3DDD® and Doxycycline 3DDD® CAP are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae.

Sexually Transmitted Infections

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for treatment of the following sexually transmitted infections:

Respiratory Tract Infections

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for treatment of the following respiratory tract infections:

Specific Bacterial Infections

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for treatment of the following specific bacterial infections:

Because many strains of the following groups of microorganisms have been shown to be resistant to Doxycycline 3DDD, culture and susceptibility testing are recommended.

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:

Ophthalmic Infections

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for treatment of the following ophthalmic infections:

Anthrax Including Inhalational Anthrax (Post-Exposure)

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Alternative Treatment for Selected Infections when Penicillin is Contraindicated

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated:

Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne

In acute intestinal amebiasis, Doxycycline 3DDD and Doxycycline 3DDD CAP may be a useful adjunct to amebicides.

In severe acne, Doxycycline 3DDD and Doxycycline 3DDD CAP may be useful adjunctive therapy.

Prophylaxis of Malaria

Doxycycline 3DDD and Doxycycline 3DDD CAP are indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline 3DDD and Doxycycline 3DDD CAP and other antibacterial drugs, Doxycycline 3DDD and Doxycycline 3DDD CAP 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.

How should I use Doxycycline 3DDD?

Use Doxycycline 3DDD tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Doxycycline 3DDD tablets.

Uses of Doxycycline 3DDD in details

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Use: Labeled Indications

Acne: Adjunctive therapy in severe acne.

Actinomycosis: Treatment of actinomycosis caused by Actinomyces israelii when penicillin is contraindicated.

Acute intestinal amebiasis: Adjunct to amebicides in acute intestinal amebiasis.

Anthrax, including inhalational anthrax (postexposure): Treatment of anthrax caused by Bacillus anthracis, including inhalational (postexposure) prophylaxis; to reduce the incidence or progression of disease following exposure to aerosolized B. anthracis.

Cholera: Treatment of cholera infections caused by Vibrio cholerae.

Clostridium: Treatment of infections caused by Clostridium spp. when penicillin is contraindicated.

Gram-negative infections: Treatment of infections caused by Escherichia coli, Enterobacter aerogenes, Shigella spp., Acinetobacter spp., Klebsiella spp. (respiratory and urinary infections), and Bacteroides spp.; Neisseria meningitidis (when penicillin is contraindicated).

Gram-positive infections: Treatment of infections caused by Streptococcus spp., when susceptible.

Listeriosis: Treatment of listeriosis due to Listeria monocytogenes when penicillin is contraindicated.

Malaria prophylaxis: Prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (under 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine-resistant strains.

Mycoplasma pneumoniae: Treatment of infections caused by Mycoplasma pneumoniae.

Ophthalmic infections:

Treatment of inclusion conjunctivitis or trachoma caused by Chlamydia trachomatis.

Periodontitis (20 mg tablet and capsule [Doxycycline 3DDD (Canadian product)] only): Adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Relapsing fever: Treatment of relapsing fever caused by Borrelia recurrentis.

Respiratory tract infections: Treatment of respiratory infections caused by Haemophilus influenzae, Klebsiella spp., or Mycoplasma pneumoniae; treatment of upper respiratory tract infections caused by Streptococcus pneumoniae; respiratory infections caused by Staphylococcus aureus (Doxycycline 3DDD is not the drug of choice in the treatment of any type of staphylococcal infection).

Rickettsial infections: Treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

Rosacea (Doxycycline 3DDD, Apprilon [Canadian product] only): Treatment of only inflammatory lesions (papules and pustules) of rosacea in adults.

Sexually transmitted infections: Treatment of lymphogranuloma venereum and uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis; granuloma inguinale (donovanosis) caused by Klebsiella granulomatis; chancroid caused by Haemophilus ducreyi; nongonococcal urethritis caused by Ureaplasma urealyticum; when penicillin is contraindicated, uncomplicated gonorrhea caused by Neisseria gonorrhea and syphilis caused by Treponema pallidum.

Note: The CDC sexually transmitted disease guidelines recommend dual antimicrobial therapy be used for uncomplicated gonorrhea due to N. gonorrhea resistance concerns; ceftriaxone is the preferred cephalosporin and Doxycycline 3DDD is an alternative option for the second antimicrobial only in cases of azithromycin allergy (CDC [Workowski 2015]).

Skin and skin structure infections (Avidoxy only): Treatment of skin and skin structure infections caused by Staphylococcus aureus (Doxycycline 3DDD is not the drug of choice in the treatment of any type of staphylococcal infection).

Vincent infection: Treatment of Vincent infection caused by Fusobacterium fusiforme when penicillin is contraindicated.

Yaws: Treatment of yaws caused by Treponema pallidum subspecies pertenue when penicillin is contraindicated.

Zoonotic infections: Treatment of psittacosis (ornithosis) caused by Chlamydophila psittaci; plague due to Yersinia pestis; tularemia caused by Francisella tularensis; brucellosis caused by Brucella spp. (in conjunction with streptomycin); bartonellosis caused by Bartonella bacilliformis; infections caused by Campylobacter fetus.

Off Label Uses

Anaplasmosis and ehrlichiosis

Based on the IDSA guidelines for the clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis (HGA) and babesiosis and the Centers for Disease Control and Prevention (CDC) guideline for the diagnosis and management of tickborne rickettsial diseases, Doxycycline 3DDD is effective and recommended for the treatment of human anaplasmosis (also known as HGA) and human ehrlichiosis.

Bartonella infections in HIV-infected patients

Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, Doxycycline 3DDD is a recommended and effective agent for treatment of bacillary angiomatosis, peliosis hepatis, bacteremia, osteomyelitis, CNS infections, infective endocarditis, and other severe infections due to Bartonella in adolescent and adult HIV-infected patients.

Bite wound infection (animal or human bite)

Based on the IDSA guidelines for the diagnosis and management of SSTIs, Doxycycline 3DDD is an acceptable alternative agent for the prophylaxis and treatment of bite wounds (animal or human).

Cellulitis, mild to moderate

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs) and the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections, Doxycycline 3DDD is an effective and recommended treatment option for SSTIs caused by MRSA, particularly purulent cellulitis due to community-acquired MRSA (CA-MRSA).

Chronic obstructive pulmonary disease, acute exacerbation

Data from a randomized, double-blind, placebo-controlled trial support the use of Doxycycline 3DDD in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD).

Based on the American College of Chest Physicians diagnosis and management of lung cancer clinical practice guidelines, intrapleural Doxycycline 3DDD is effective and recommended in the management of recurrent, symptomatic, malignant pleural effusions.

Proctitis, acute or proctocolitis

Based on the CDC sexually transmitted diseases treatment guidelines, Doxycycline 3DDD in combination with ceftriaxone is an effective and recommended agent in the treatment of acute proctitis or proctocolitis.

Prosthetic joint infection

Based on the IDSA guidelines for the management of prosthetic joint infection, Doxycycline 3DDD is an effective and recommended agent for treatment (oral phase) of prosthetic joint infection and for chronic oral antimicrobial suppression of prosthetic joint infection due to staphylococci or Cutibacterium acnes.

Surgical prophylaxis, uterine evacuation (induced abortion or pregnancy loss)

Based on the American College of Obstetricians and Gynecologists guidelines for prevention of infection after gynecologic procedures, Doxycycline 3DDD is effective and recommended as antimicrobial prophylaxis for uterine evacuation procedures for induced abortion or pregnancy loss.

Doxycycline 3DDD description

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Doxycycline 3DDD is a broad-spectrum antibiotic synthetically derived from oxytetracycline and is available as Doxycycline 3DDD monohydrate and Doxycycline 3DDD hyclate (hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is α-6-deoxy-5-oxytetracycline. Doxycycline 3DDD has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline 3DDD will not degrade into an epianhydro form.

The molecular formula for Doxycycline 3DDD hydrochloride hemiethanolate hemihydrate is (C22H24N2O8·HCl)2·C2H6O·H2O and the molecular weight is 1025.89. Doxycycline 3DDD is a light-yellow crystalline powder. Doxycycline 3DDD hyclate is soluble in water, while Doxycycline 3DDD monohydrate is very slightly soluble in water.

Doxycycline 3DDD dosage

THE DOSAGE OF Doxycycline 3DDD® (Doxycycline 3DDD hyclate) DIFFERS FROM THAT OF Doxycycline 3DDD USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.

Doxycycline 3DDD® (Doxycycline 3DDD hyclate) 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Doxycycline 3DDD® (Doxycycline 3DDD hyclate) should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Doxycycline 3DDD® (Doxycycline 3DDD hyclate) is taken close to meal times, allow at least one hour prior to or two hours after meals. Safety beyond 12 months and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended to wash down the drug and reduce the risk of esophageal irritation and ulceration..

How supplied

Doxycycline 3DDD® (Doxycycline 3DDD hyclate) (white tablet imprinted with a PS20) containing Doxycycline 3DDD hyclate equivalent to 20 mg Doxycycline 3DDD. Bottle of 60 (NDC 64682-008-01), Bottle of 100 (NDC 64682-008-02) and Bottle of 1000 (NDC 64682-008-03).

Storage: All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).

Manufactured by: Pharmaceutical Manufacturing Research Services, Inc., Horsham, PA 19044. Marketed by: CollaGenex Pharmaceuticals, Inc., Newtown, PA, 18940. FDA revision date: 3/31/2004

Doxycycline 3DDD interactions

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What other drugs will affect Doxycycline 3DDD?

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Medications containing metal ions (antacids, products containing iron, magnesium, calcium) form inactive chelates with Doxycycline 3DDD, in connection with what it is necessary to avoid their simultaneous use.

It needed to avoid combination with penicillins, cephalosporins, bactericidal action and is an antagonist of bacteriostatic antibiotics (including Doxycycline 3DDD).

Absorption of Doxycycline 3DDD is reduced by cholestyramine and colestipol (observe the interval between the reception of at least 3 h).

Due to suppression of intestinal microflora Doxycycline 3DDD reduces prothrombin index which requires dose adjustment of indirect anticoagulants.

Alti-Doxycycline 3DDD reduces the reliability of contraception and increases the frequency of breakthrough bleeding while taking estrogen-containing oral contraceptives.

Simultaneous administration of Alti-Doxycycline 3DDD with:

  • barbiturates, carbamazepine, phenytoin concentrations of Doxycycline 3DDD in plasma decreases due to the induction of liver enzymes, which may be responsible for the decrease of its antibacterial action.
  • retinol improves intracranial pressure.

    Doxycycline 3DDD side effects

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    What are the possible side effects of Doxycycline 3DDD?

    Clinical Trial Experience

    The safety and efficacy of Doxycycline 3DDD Hyclate Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycycline 3DDD Hyclate Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doxycycline 3DDD hyclate capsules 100 mg given orally twice daily for 7 days for the treatment of men and women with uncomplicated urogenital C. trachomatis infection.

    Adverse events in the Safety Population were reported by 99 (40.2%) subjects in the Doxycycline 3DDD Hyclate Delayed-Release Tablets, 200 mg treatment group and 132 (53.2%) subjects in the doxycyclinehyclate capsules reference treatment group. Most AEs were mild in intensity. The most commonly reported adverse events in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginitis, Table 1.

    Table 1: Adverse Reactions Reported in Greater than or Equal to 2% of Subjects

    Doxycycline 3DDD Hyclate Delayed-Release Tablets, 200 mg

    N = 246

    Preferred Term n (%)
    Subjects with any AE 99 (40.2)
    Nausea 33 (13.4)
    Vomiting 20 (8.1)
    Headache 5 (2.0)
    Diarrhea 8 (3.3)
    Abdominal Pain Upper 5 (2.0)
    Vaginitis Bacterial 8 (3.3)
    Vulvovaginal Mycotic Infection 5 (2.0)

    Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not always reflect the rates observed in practice.

    Postmarketing Experience

    The following adverse reactions have been identified during post-approval use of Doxycycline 3DDD. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate a causal relationship to drug exposure.

    Due to oral Doxycycline 3DDD's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:

    Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of drugs in the tetracycline-class. Most of these patients took medications immediately before going to bed.

    Skin: Maculopapular and erythematous rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and erythema multiforme have been reported. Photosensitivity is discussed above.

    Renal: Rise in BUN has been reported and is apparently dose-related.

    Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

    Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

    Intracranial Hypertension: Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracycline

    Thyroid Gland Changes: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function are known to occur.

    Doxycycline 3DDD contraindications

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    What is the most important information I should know about Doxycycline 3DDD?

    Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

    Doxycycline 3DDD can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Doxycycline 3DDD.

    You should not take this medicine if you are allergic to Doxycycline 3DDD or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

    Before taking Doxycycline 3DDD, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

    Drink plenty of liquids while you are taking Doxycycline 3DDD.

    Children should not use Doxycycline 3DDD. Doxycycline 3DDD can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

    Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.



    Active ingredient matches for Doxycycline 3DDD:

    Doxycycline in Belgium.


    List of Doxycycline 3DDD substitutes (brand and generic names)

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    Unit description / dosage (Manufacturer)Price, USD
    Doxyday 100 mg Tablet (Acron Laboratories Pvt. Ltd.)$ 0.03
    DOXYDAY 100MG TABLET 1 packet / 100 tablets each (Acron Laboratories Pvt. Ltd.)$ 3.84
    DOXYDAY cap 8's (Acron Laboratories Pvt. Ltd.)$ 0.47
    Doxyday 100mg Tablet (Acron Laboratories Pvt. Ltd.)$ 0.04
    Tablet, Film-Coated; Oral; Doxycycline Hyclate 50 mg (Fujisawa)
    Tablets, Film-Coated; Oral; Doxycycline Hyclate 50 mg (Fujisawa)
    Capsule; Oral; Doxycycline 100 mg (Docpharm)
    Capsules; Oral; Doxycycline 100 mg (Docpharm)
    Tablet, Film-Coated; Oral; Doxycycline Hyclate 100 mg (Fujisawa)
    Tablet, Film-Coated; Oral; Doxycycline Hyclate 200 mg (Fujisawa)
    Tablets, Film-Coated; Oral; Doxycycline Hyclate 100 mg (Fujisawa)
    Tablets, Film-Coated; Oral; Doxycycline Hyclate 200 mg (Fujisawa)
    Powder; Oral; Doxycycline Hydrochloride 100%
    DOXYGATES TABLET 1 strip / 10 tablets each (Gates India Pvt Ltd)$ 0.46
    DOXYGEE 100MG TABLET 1 strip / 8 tablets each (Zydus Cadila)$ 0.10
    DOXYGEE TABLET 1 packet / 100 tablets each (Zydus Cadila)$ 0.80
    Doxygee NA Tablet (Zydus Cadila)$ 0.01
    Capsule; Oral; Doxycycline Monohydrate 100 mg (Hexal)

    References

    1. DailyMed. "DOXYCYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
    2. PubChem. "doxycycline". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
    3. DrugBank. "doxycycline". http://www.drugbank.ca/drugs/DB00254 (accessed September 17, 2018).

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    Information checked by Dr. Sachin Kumar, MD Pharmacology

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