Doxypalu Uses

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What is Doxypalu?

Doxypalu is a tetracycline antibiotic that fights bacteria in the body.

Doxypalu 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.

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

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

Doxypalu may also be used for purposes not listed in this medication guide.

Doxypalu indications

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Rickettsial Infections

Doxypalu® and Doxypalu® 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

Doxypalu and Doxypalu CAP are indicated for treatment of the following sexually transmitted infections:

Respiratory Tract Infections

Doxypalu and Doxypalu CAP are indicated for treatment of the following respiratory tract infections:

Specific Bacterial Infections

Doxypalu and Doxypalu 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 Doxypalu, culture and susceptibility testing are recommended.

Doxypalu and Doxypalu 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

Doxypalu and Doxypalu CAP are indicated for treatment of the following ophthalmic infections:

Anthrax Including Inhalational Anthrax (Post-Exposure)

Doxypalu and Doxypalu 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

Doxypalu and Doxypalu 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, Doxypalu and Doxypalu CAP may be a useful adjunct to amebicides.

In severe acne, Doxypalu and Doxypalu CAP may be useful adjunctive therapy.

Prophylaxis of Malaria

Doxypalu and Doxypalu 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 Doxypalu and Doxypalu CAP and other antibacterial drugs, Doxypalu and Doxypalu 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 Doxypalu?

Use Doxypalu 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 Doxypalu tablets.

Uses of Doxypalu 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 [Doxypalu (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 (Doxypalu 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 (Doxypalu, 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 Doxypalu 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 (Doxypalu 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, Doxypalu 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, Doxypalu 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, Doxypalu 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, Doxypalu 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 Doxypalu 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 Doxypalu 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, Doxypalu 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, Doxypalu 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, Doxypalu is effective and recommended as antimicrobial prophylaxis for uterine evacuation procedures for induced abortion or pregnancy loss.

Doxypalu description

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

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

Doxypalu dosage

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

Doxypalu® (Doxypalu) 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Doxypalu® (Doxypalu) should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Doxypalu® (Doxypalu) 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

Doxypalu® (Doxypalu) (white tablet imprinted with a PS20) containing Doxypalu equivalent to 20 mg Doxypalu. 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

Doxypalu interactions

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What other drugs will affect Doxypalu?

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Medications containing metal ions (antacids, products containing iron, magnesium, calcium) form inactive chelates with Doxypalu, 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 Doxypalu).

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

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

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

Simultaneous administration of Alti-Doxypalu with:

  • barbiturates, carbamazepine, phenytoin concentrations of Doxypalu 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.

    Doxypalu side effects

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    What are the possible side effects of Doxypalu?

    Clinical Trial Experience

    The safety and efficacy of Doxypalu Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxypalu Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doxypalu 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 Doxypalu 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

    Doxypalu 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 Doxypalu. 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 Doxypalu'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.

    Doxypalu contraindications

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    What is the most important information I should know about Doxypalu?

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

    Doxypalu 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 Doxypalu.

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

    Before taking Doxypalu, 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 Doxypalu.

    Children should not use Doxypalu. Doxypalu 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 Doxypalu:

    Doxycycline in France.

    Doxycycline Hyclate


    Unit description / dosage (Manufacturer)Price, USD
    Tablet; Oral; Doxycycline Monohydrate 100 mg
    Tablet; Oral; Doxycycline Monohydrate 50 mg
    Tablets; Oral; Doxycycline Monohydrate 100 mg
    Tablets; Oral; Doxycycline Monohydrate 50 mg

    List of Doxypalu substitutes (brand and generic names):

    DOXYPAL-DR cap 100 mg x 10's (Jagsonpal)$ 0.11
    Doxyrek 100mg Capsule DR (Rekvina Laboratories Ltd)$ 0.05
    DOXYREK DR 100MG CAPSULE 1 strip / 10 capsule drs each (Rekvina Laboratories Ltd)$ 0.48
    100 mg x 20's (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.75
    Doxyric 100mg TAB / 20 (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.75
    Doxyric 500 mg Tablet (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.12
    DOXYRIC 100 MG TABLET 1 strip / 10 tablets each (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.58
    DOXYRIC 250 MG TABLET 1 strip / 10 tablets each (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.58
    DOXYRIC tab 100 mg x 20's (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.75
    Doxyric 100mg TAB / 20 (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.75
    Doxyric 100mg Tablet (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.06
    Doxyric 250mg Tablet (Euphoric Pharmaceuticals Pvt.Ltd.)$ 0.06
    Doxyrin 100 mg Tablet (Suzikem Drugs Pvt. Ltd.)$ 0.03
    Doxyrose 100 mg Capsule (Medi Rose)$ 0.03
    Doxysain 100 mg Capsule (Sain Medicaments Pvt. Ltd.)$ 0.01
    DOXYSAIN tab 100 mg x 10's (Sain Medicaments Pvt. Ltd.)$ 0.68
    Doxysain Tab 100 mg Tablet (Sain Medicaments Pvt. Ltd.)$ 0.04
    Doxysep 100+10 Tablet (West Coast Pharmaceuticals)$ 0.05
    Doxysep 100 mg/10 mg Tablet (West Coast Pharmaceuticals)$ 0.01
    Tablet; Oral; Doxycycline Hyclate 100 mg (Ecosol)
    Tablet; Oral; Doxycycline Hyclate 200 mg (Ecosol)
    Tablets; Oral; Doxycycline Hyclate 100 mg (Ecosol)
    Tablets; Oral; Doxycycline Hyclate 200 mg (Ecosol)

    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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