Doksazosin Lek is a tetracycline antibiotic that fights bacteria in the body.
Doksazosin Lek 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.
Doksazosin Lek is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doksazosin Lek will not treat facial redness caused by rosacea.
Some forms of Doksazosin Lek are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.
Doksazosin Lek may also be used for purposes not listed in this medication guide.
Doksazosin Lek indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Rickettsial Infections
Doksazosin Lek® and Doksazosin Lek® 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
Doksazosin Lek and Doksazosin Lek CAP are indicated for treatment of the following sexually transmitted infections:
Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.
Nongonococcal urethritis caused by Ureaplasma urealyticum.
Lymphogranuloma venereum caused by Chlamydia trachomatis.
Granuloma inguinale caused by Klebsiella granulomatis.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
Chancroid caused by Haemophilus ducreyi.
Respiratory Tract Infections
Doksazosin Lek and Doksazosin Lek CAP are indicated for treatment of the following respiratory tract infections:
Respiratory tract infections caused by Mycoplasma pneumoniae.
Psittacosis (ornithosis) caused by Chlamydophila psittaci.
Because many strains of the following groups of microorganisms have been shown to be resistant to Doksazosin Lek, culture and susceptibility testing are recommended.
Doksazosin Lek is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Respiratory tract infections caused by Haemophilus influenzae.
Respiratory tract infections caused by Klebsiella species.
Upper respiratory infections caused by Streptococcus pneumoniae.
Specific Bacterial Infections
Doksazosin Lek and Doksazosin Lek CAP are indicated for treatment of the following specific bacterial infections:
Relapsing fever due to Borrelia recurrentis.
Plague due to Yersinia pestis.
Tularemia due to Francisella tularensis.
Cholera caused by Vibrio cholerae.
Campylobacter fetus infections caused by Campylobacter fetus.
Brucellosis due to Brucella species (in conjunction with streptomycin).
Bartonellosis due to Bartonella bacilliformis.
Because many strains of the following groups of microorganisms have been shown to be resistant to Doksazosin Lek, culture and susceptibility testing are recommended.
Doksazosin Lek and Doksazosin Lek CAP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
Escherichia coli
Enterobacter aerogenes
Shigella species
Acinetobacter species
Urinary tract infections caused by Klebsiella species.
Ophthalmic Infections
Doksazosin Lek and Doksazosin Lek CAP are indicated for treatment of the following ophthalmic infections:
Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
Inclusion conjunctivitis caused by Chlamydia trachomatis.
Anthrax Including Inhalational Anthrax (Post-Exposure)
Doksazosin Lek and Doksazosin Lek 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
Doksazosin Lek and Doksazosin Lek CAP are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated:
Syphilis caused by Treponema pallidum.
Yaws caused by Treponema pallidum subspecies pertenue.
Listeriosis due to Listeria monocytogenes.
Vincent’s infection caused by Fusobacterium fusiforme.
Actinomycosis caused by Actinomyces israelii.
Infections caused by Clostridium species.
Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne
In acute intestinal amebiasis, Doksazosin Lek and Doksazosin Lek CAP may be a useful adjunct to amebicides.
In severe acne, Doksazosin Lek and Doksazosin Lek CAP may be useful adjunctive therapy.
Prophylaxis of Malaria
Doksazosin Lek and Doksazosin Lek 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 Doksazosin Lek and Doksazosin Lek CAP and other antibacterial drugs, Doksazosin Lek and Doksazosin Lek 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 Doksazosin Lek?
Use Doksazosin Lek tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Doksazosin Lek tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Do not take an antacid that has aluminum, calcium, or magnesium in it; bismuth subsalicylate; iron; zinc; or multivitamins with minerals within 2 hours before or 2 hours after you take Doksazosin Lek tablets.
Do not eat or drink dairy products within 1 hour before or 2 hours after you take Doksazosin Lek tablets.
To clear up your infection completely, take Doksazosin Lek tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
Drink plenty of nondairy fluid with Doksazosin Lek tablets to wash it down and avoid the risk of sore throat.
Take Doksazosin Lek tablets twice daily (every 12 hours), preferably in the morning and evening.
Continue to take Doksazosin Lek tablets even if you feel well. Do not miss any doses.
If you miss a dose of Doksazosin Lek tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Doksazosin Lek tablets.
Uses of Doksazosin Lek in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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 [Doksazosin Lek (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 (Doksazosin Lek 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 (Doksazosin Lek, 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 Doksazosin Lek 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 (Doksazosin Lek 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, Doksazosin Lek 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, Doksazosin Lek 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, Doksazosin Lek 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, Doksazosin Lek is an effective and recommended treatment option for SSTIs caused by MRSA, particularly purulent cellulitis due to community-acquired MRSA (CA-MRSA).
Data from a randomized, double-blind, placebo-controlled trial support the use of Doksazosin Lek 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 Doksazosin Lek 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, Doksazosin Lek 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, Doksazosin Lek 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, Doksazosin Lek is effective and recommended as antimicrobial prophylaxis for uterine evacuation procedures for induced abortion or pregnancy loss.
Doksazosin Lek description
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Doksazosin Lek is a broad-spectrum antibiotic synthetically derived from oxytetracycline and is available as Doksazosin Lek monohydrate and Doksazosin Lek hyclate (hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is α-6-deoxy-5-oxytetracycline. Doksazosin Lek has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doksazosin Lek will not degrade into an epianhydro form.
The molecular formula for Doksazosin Lek hydrochloride hemiethanolate hemihydrate is (C22H24N2O8·HCl)2·C2H6O·H2O and the molecular weight is 1025.89. Doksazosin Lek is a light-yellow crystalline powder. Doksazosin Lek hyclate is soluble in water, while Doksazosin Lek monohydrate is very slightly soluble in water.
Doksazosin Lek dosage
THE DOSAGE OF Doksazosin Lek® (Doksazosin Lek hyclate) DIFFERS FROM THAT OF Doksazosin Lek USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT MICROORGANISMS.
Doksazosin Lek® (Doksazosin Lek hyclate) 20 mg twice daily as an adjunct following scaling and root planing may be administered for up to 9 months. Doksazosin Lek® (Doksazosin Lek hyclate) should be taken twice daily at 12 hour intervals, usually in the morning and evening. It is recommended that if Doksazosin Lek® (Doksazosin Lek 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
Doksazosin Lek® (Doksazosin Lek hyclate) (white tablet imprinted with a PS20) containing Doksazosin Lek hyclate equivalent to 20 mg Doksazosin Lek. 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
Medications containing metal ions (antacids, products containing iron, magnesium, calcium) form inactive chelates with Doksazosin Lek, 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 Doksazosin Lek).
Absorption of Doksazosin Lek is reduced by cholestyramine and colestipol (observe the interval between the reception of at least 3 h).
Due to suppression of intestinal microflora Doksazosin Lek reduces prothrombin index which requires dose adjustment of indirect anticoagulants.
Alti-Doksazosin Lek reduces the reliability of contraception and increases the frequency of breakthrough bleeding while taking estrogen-containing oral contraceptives.
Simultaneous administration of Alti-Doksazosin Lek with:
barbiturates, carbamazepine, phenytoin concentrations of Doksazosin Lek in plasma decreases due to the induction of liver enzymes, which may be responsible for the decrease of its antibacterial action.
The safety and efficacy of Doksazosin Lek Hyclate Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doksazosin Lek Hyclate Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doksazosin Lek 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 Doksazosin Lek 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
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 Doksazosin Lek. 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 Doksazosin Lek'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.
Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.
Doksazosin Lek 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 Doksazosin Lek.
You should not take this medicine if you are allergic to Doksazosin Lek or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
Before taking Doksazosin Lek, 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 Doksazosin Lek.
Children should not use Doksazosin Lek. Doksazosin Lek 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.
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).
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