Doxycyclin-Zentiva is a tetracycline antibiotic that fights bacteria in the body.
Doxycyclin-Zentiva 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.
Doxycyclin-Zentiva is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doxycyclin-Zentiva will not treat facial redness caused by rosacea.
Some forms of Doxycyclin-Zentiva are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.
Doxycyclin-Zentiva may also be used for purposes not listed in this medication guide.
Doxycyclin-Zentiva 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
Doxycyclin-Zentiva® and Doxycyclin-Zentiva® 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
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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 Doxycyclin-Zentiva, culture and susceptibility testing are recommended.
Doxycyclin-Zentiva 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
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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 Doxycyclin-Zentiva, culture and susceptibility testing are recommended.
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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)
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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, Doxycyclin-Zentiva and Doxycyclin-Zentiva CAP may be a useful adjunct to amebicides.
In severe acne, Doxycyclin-Zentiva and Doxycyclin-Zentiva CAP may be useful adjunctive therapy.
Prophylaxis of Malaria
Doxycyclin-Zentiva and Doxycyclin-Zentiva 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 Doxycyclin-Zentiva and Doxycyclin-Zentiva CAP and other antibacterial drugs, Doxycyclin-Zentiva and Doxycyclin-Zentiva 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 Doxycyclin-Zentiva?
Use Doxycyclin-Zentiva kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Doxycyclin-Zentiva kit kit contains antibiotic capsules, eyelid cleansing pads, and a moisturizing spray.
To use the eyelid cleansing pad:
Remove contact lenses before you use Doxycyclin-Zentiva kit.
Wash your hands before using Doxycyclin-Zentiva kit. Close the eyes and gently cleanse the eyelids using side to side strokes. Avoid touching the eyes directly. Rinse or leave on as directed by your doctor. Discard after use.
To use the moisturizing spray:
Hold the spray tip 4 to 6 inches away from the eye. Close the eye and spray directly onto the eyelid surface. Gently massage into the eyelids and lashes. If directed to do so by your doctor, repeat this procedure with the other eye.
If you prefer, you may spray onto the inner side of the finger and then gently massage onto the eyelids and lashes. Do not spray directly into the eyes.
To take the antibiotic:
Take Doxycyclin-Zentiva kit by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Take Doxycyclin-Zentiva kit with a full glass of water (8 oz/240 mL) and drink plenty of fluids to prevent ulcers and reduce throat irritation.
Do not eat or drink calcium-rich foods (eg, milk or other dairy products, calcium-enriched juices), or take an antacid that has aluminum, calcium, or magnesium in it; bismuth subsalicylate; iron; or urinary alkalinizers (eg, sodium bicarbonate) within 2 hours before or 2 hours after you take Doxycyclin-Zentiva kit.
Use Doxycyclin-Zentiva kit on a regular schedule to get the most benefit from it. It may take several days to see the full effect of Doxycyclin-Zentiva kit.
To clear up your infection completely, take Doxycyclin-Zentiva kit for the full course of treatment. Keep taking it even if your condition improves in a few days.
Do not use Doxycyclin-Zentiva kit if it is past the expiration date on the bottle.
If you miss a dose of Doxycyclin-Zentiva kit, 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 Doxycyclin-Zentiva kit.
Uses of Doxycyclin-Zentiva 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 [Periostat (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 (Doxycyclin-Zentiva 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 (Oracea, 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 Doxycyclin-Zentiva 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 (Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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 Doxycyclin-Zentiva 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 Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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, Doxycyclin-Zentiva 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, Doxycyclin-Zentiva is effective and recommended as antimicrobial prophylaxis for uterine evacuation procedures for induced abortion or pregnancy loss.
Doxycyclin-Zentiva description
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Doxycyclin-Zentiva is a broad-spectrum antibiotic synthetically derived from oxytetracycline and is available as Doxycyclin-Zentiva monohydrate and Doxycyclin-Zentiva hyclate (hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is α-6-deoxy-5-oxytetracycline. Doxycyclin-Zentiva has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycyclin-Zentiva will not degrade into an epianhydro form.
The molecular formula for Doxycyclin-Zentiva hydrochloride hemiethanolate hemihydrate is (C22H24N2O8·HCl)2·C2H6O·H2O and the molecular weight is 1025.89. Doxycyclin-Zentiva is a light-yellow crystalline powder. Doxycyclin-Zentiva hyclate is soluble in water, while Doxycyclin-Zentiva monohydrate is very slightly soluble in water.
Doxycyclin-Zentiva dosage
Usual Dosage And Administration
The usual dosage and frequency of administration of Doxycyclin-Zentiva differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.
Adults
The usual dose of oral Doxycyclin-Zentiva is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily.
The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
Pediatric Patients
For all pediatric patients weighing less than 45 kg with severe or life threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage of Doxycyclin-Zentiva is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose.
For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule of Doxycyclin-Zentiva is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg per kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline-class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration.
If gastric irritation occurs, Doxycyclin-Zentiva may be given with food or milk.
When used in streptococcal infections, therapy should be continued for 10 days.
Uncomplicated urethral, endocervical, or rectal infection caused by Chlamydia trachomatis: 100 mg by mouth twice a day for 7 days. As an alternate dosing regimen for uncomplicated urethral or endocervical infection caused by Chlamydia trachomatis, administer 200 mg by mouth once-a-day for 7 days.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice-a-day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
Nongonococcal urethritis (NGU) caused by U. urealyticum: 100 mg by mouth twice-aday for 7 days.
Syphilis – early: Patients who are allergic to penicillin should be treated with Doxycyclin-Zentiva 100 mg by mouth twice-a-day for 2 weeks.
Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with Doxycyclin-Zentiva 100 mg by mouth twice-a-day for 4 weeks.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice-a-day for at least 10 days.
For Prophylaxis Of Malaria
For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 or 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Inhalational Anthrax (post-exposure)
Adults: 100 mg, of Doxycyclin-Zentiva, by mouth, twice-a-day for 60 days. Children: weighing less than 45 kg, 2.2 mg/kg of body weight, by mouth, twice-a-day for 60 days. Children weighing 45 kg or more should receive the adult dose.
Sprinkling The Tablet Over Applesauce
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets may also be administered by carefully breaking up the tablet and sprinkling the tablet contents (delayed-release pellets) on a spoonful of applesauce. The delayed-release pellets must not be crushed or damaged when breaking up the tablet. Any loss of pellets in the transfer would prevent using the dose. The applesauce/Doxycyclin-Zentiva Hyclate Delayed-Release Tablets mixture should be swallowed immediately without chewing and may be followed by a glass of water if desired. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/Doxycyclin-Zentiva Hyclate Delayed-Release Tablets cannot be taken immediately, the mixture should be discarded and not stored for later use.
How supplied
Dosage Forms And Strengths
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 75 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|5” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 75 mg of Doxycyclin-Zentiva.
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 100 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|0” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 100 mg of Doxycyclin-Zentiva.
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 150 mg are white, rectangular, dual scored tablets containing yellow pellets and debossed with “D|I|I” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 150 mg of Doxycyclin-Zentiva.
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 200 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|D” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 200 mg of Doxycyclin-Zentiva.
Storage And Handling
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 75 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|5” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 75 mg of Doxycyclin-Zentiva.
Bottles of 60 tablets NDC 68308-775-60
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 100 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|0” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 100 mg of Doxycyclin-Zentiva.
Bottles of 100 tablets NDC 68308-710-10
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 150 mg are white, rectangular, dual scored tablets containing yellow pellets and debossed with “D|I|I” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 150 mg of Doxycyclin-Zentiva.
Bottles of 100 tablets NDC 68308-715-10
Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 200 mg are white, oval, scored tablets containing yellow pellets and debossed with “D|D” on one face and plain on the other. Each tablet contains specially coated pellets of Doxycyclin-Zentiva hyclate equivalent to 200 mg of Doxycyclin-Zentiva.
Bottles of 60 tablets NDC 68308-716-60
Store at 25° C (77° F); excursions permitted to 15 – 30° C (59 – 86° F). Dispense in a tight, light-resistant container (USP).
Medications containing metal ions (antacids, products containing iron, magnesium, calcium) form inactive chelates with Doxycyclin-Zentiva, 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 Doxycyclin-Zentiva).
Absorption of Doxycyclin-Zentiva is reduced by cholestyramine and colestipol (observe the interval between the reception of at least 3 h).
Due to suppression of intestinal microflora Doxycyclin-Zentiva reduces prothrombin index which requires dose adjustment of indirect anticoagulants.
Alti-Doxycyclin-Zentiva reduces the reliability of contraception and increases the frequency of breakthrough bleeding while taking estrogen-containing oral contraceptives.
Simultaneous administration of Alti-Doxycyclin-Zentiva with:
barbiturates, carbamazepine, phenytoin concentrations of Doxycyclin-Zentiva 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 Doxycyclin-Zentiva Hyclate Delayed-Release Tablets, 200 mg as a single daily dose was evaluated in a multicenter, randomized, double-blind, active-controlled study. Doxycyclin-Zentiva Hyclate Delayed-Release Tablets 200 mg was given orally once-a-day for 7 days and compared to Doxycyclin-Zentiva 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 Doxycyclin-Zentiva 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 Doxycyclin-Zentiva. 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 Doxycyclin-Zentiva'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.
Doxycyclin-Zentiva 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 Doxycyclin-Zentiva.
You should not take this medicine if you are allergic to Doxycyclin-Zentiva or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
Before taking Doxycyclin-Zentiva, 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 Doxycyclin-Zentiva.
Children should not use Doxycyclin-Zentiva. Doxycyclin-Zentiva 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.
Doxycycline (Australia, Austria, Bulgaria, Canada, Ethiopia, Greece, Hong Kong, Indonesia, Ireland, Japan, Lithuania, Malaysia, Netherlands, Oman, Philippines, Romania, Serbia, Switzerland, Thailand, United Kingdom, United States)
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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