Adoxa

Name: Adoxa

Uses of Adoxa

Oral/Injectable:

Doxycycline is a prescription medication used to treat certain bacterial infections and to prevent malaria infections. Doxycycline treats bacterial infections of the lungs, respiratory tract, skin, genitals, and urinary tract. Doxycycline is also used to treat Lyme disease, anthrax, and acne. It may also be used by your dentist to treat periodontitis (inflammation within the mouth).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Doak Dermatologics

  • PharmaDerm, A division of Fougera Pharmaceuticals Inc.

  • Sandoz Inc.

Before Using Adoxa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Doxycycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger (except for the treatment of exposure to inhalational anthrax or rickettsia infection), unless directed by the child's doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxycycline in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving doxycycline.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amoxicillin
  • Ampicillin
  • Bacampicillin
  • Bexarotene
  • Cholera Vaccine, Live
  • Cloxacillin
  • Dicloxacillin
  • Etretinate
  • Isotretinoin
  • Methicillin
  • Methotrexate
  • Methoxyflurane
  • Nafcillin
  • Oxacillin
  • Penicillin G
  • Penicillin G Benzathine
  • Penicillin G Procaine
  • Penicillin V
  • Piperacillin
  • Pivampicillin
  • Sultamicillin
  • Temocillin
  • Tretinoin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Aminolevulinic Acid
  • Bismuth Subsalicylate
  • Calcium
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Iron
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Rifampin
  • Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma—Vibramycin® syrup contains sodium metabisulfite, which can cause allergic and life-threatening reactions in patients with this condition.
  • Diarrhea or
  • Intracranial hypertension (pseudotumor cerebri), or history of or
  • Vaginal candidiasis (yeast) infections—Use with caution. May make these conditions worse.
  • Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

How is this medicine (Adoxa) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Keep taking Adoxa (doxycycline tablets and capsules) as you have been told by your doctor or other health care provider, even if you feel well.
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Do not take bismuth (Pepto-Bismol®), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids within 2 hours of Adoxa.
  • Take with a full glass of water.
  • Do not lie down for at least 30 minutes after taking this medicine.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Adoxa or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Adoxa (doxycycline tablets and capsules). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and Usage for Adoxa

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline is indicated for the treatment of the following infections:

  Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.   Respiratory tract infections caused by Mycoplasma pneumoniae.   Lymphogranuloma venereum caused by Chlamydia trachomatis.   Psittacosis (ornithosis) caused by Chlamydia psittaci.   Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.   Inclusion conjunctivitis caused by Chlamydia trachomatis.   Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.   Nongonococcal urethritis caused by Ureaplasma urealyticum.   Relapsing fever due to Borrelia recurrentis.

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:

  Chancroid caused by Haemophilus ducreyi.   Plague due to Yersinia pestis (formerly Pasteurella pestis).   Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).   Cholera caused by Vibrio cholerae (formerly Vibrio comma).   Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).   Brucellosis due to Brucella species (in conjunction with streptomycin).   Bartonellosis due to Bartonella bacilliformis.   Granuloma inguinale caused by Calymmatobacterium granulomatis.

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

Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

  Escherichia coli   Enterobacter aerogenes (formerly Aerobacter aerogenes)   Shigella species   Acinetobacter species (formerly Mima species and Herellea species)   Respiratory tract infections caused by Haemophilus influenzae.   Respiratory tract and urinary infections caused by Klebsiella species.

Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

  Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).   Skin and skin structure infections caused by Staphylococcus aureus.   Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:

  Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.   Syphilis caused by Treponema pallidum.   Yaws caused by Treponema pertenue.   Listeriosis due to Listeria monocytogenes.   Vincent’s infection caused by Fusobacterium fusiforme.   Actinomycosis caused by Actinomyces israelii.   Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.

In severe acne, doxycycline may be useful adjunctive therapy.

Animal pharmacology and animal toxicology

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

References

  1. M7-A7. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; Approved standard - 7th edition. Clinical and Laboratory Standards Institute (Formerly NCCLS), Wayne, PA; 2006
  2. M2-A9. Performance standards for antimicrobial disk susceptibility Tests; Approved standard - 9th edition. Clinical and Laboratory Standards Institute (Formerly NCCLS), Wayne, PA; 2006.
  3. M100-S17. Performance standards for antimicrobial susceptibility testing; 17th informational supplement. Clinical and Laboratory Standards Institute (Formerly NCCLS), Wayne, PA; 2007.
  4. M11-A7. Methods for antimicrobial susceptibility testing of anaerobic bacteria; Approved standard - 7th edition.Clinical and Laboratory Standards Institute (Formerly NCCLS), Wayne, PA; 2007.
  1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.
  2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524-528.
  3. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315-317.
  4. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.

Manufactured by:

PharmaDerm®

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747 USA

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977 USA

IL221C

R02/12



PACKAGE LABEL- PRINCIPAL DISPLAY PANEL

NDC 10337-815-06
60 CAPSULES
Adoxa®
DOXYCYCLINE
CAPSULES, USP

Adoxa 
doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10337-815
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
GELATIN  
MAGNESIUM STEARATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Adoxa;150mg
Contains     
Packaging
# Item Code Package Description
1 NDC:10337-815-06 60 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065055 06/01/2011
Labeler - PharmaDerm a division of Fougera Pharmaceuticals Inc. (043838424)
Registrant - Par Pharmaceutical Inc. (092733690)
Revised: 05/2013   PharmaDerm a division of Fougera Pharmaceuticals Inc.
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