Atridox

Name: Atridox

Do I need a prescription for doxycycline?

Yes

Description

The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline.

The structural formula of doxycycline hyclate is:


Empirical Formula: (C22H24N2O8•HCI)2•C2H6O•H2O

Indications

ATRIDOX (doxycycline hyclate) ® is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing.

Warnings

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH. This adverse reaction is more common during long-term use of the drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, OR IN PREGNANT WOMEN, UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.

If any tetracycline is used during pregnancy, the patient should be apprised of the potential hazard to the fetus. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking doxycycline or other tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs.

Atridox Usage

  • Take doxycycline exactly as prescribed.  Do not change the dose or stop taking doxycycline without talking to your doctor. 

Oral:

  • This medication comes in tablet, capsule, and oral suspension (liquid) forms.
  • Doxycycline is typically taken once or twice a day, with a glass of water and with or without food. 
  • You should finish the entire course of treatment of the antibiotic to ensure your infection is treated appropriately. It is important not to skip doses of doxycycline.
  • If doxycycline upsets your stomach, the drug should be taken with food or milk.
  • The oral suspension should be shaken prior to taking the medication.
  • If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of doxycycline at the same time.
  • Doxycycline also comes as a gel to be applied to the the tooth pocket. It is administered by a dentist in a clinic setting.

Injectable:

  • This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Other Requirements

  • Store doxycycline at room temperature, below 86°F (30°C).
  • Keep this and all medications out of the reach of children.

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.

Drug Interactions

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 receiving 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.

  • Rifampin
  • Rifapentine

Other Interactions

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.

Side effects

In clinical trials involving a total of 1436 patients, adverse experiences from all causalities were monitored across treatment groups.

In the Circulatory System category, 10 subjects (1.6%) in the ATRIDOX (doxycycline hyclate) ® group were reported as having “unspecified essential hypertension.” Only 1 subject (0.2%) in the Vehicle group, and none in the Scaling and Root Planing or Oral Hygiene groups were reported to have “unspecified essential hypertension.” In all cases, the event occurred anywhere from 13 to 134 days post treatment. There is no known association of oral administration of doxycycline with essential hypertension.

Two patients in the polymer vehicle group and none in the ATRIDOX (doxycycline hyclate) ® group (0.2% for both groups combined) reported adverse events consistent with a localized allergic response.

Sex, age, race and smoking status did not appear to be correlated with adverse events.

The following table lists the incidence of treatment-emergent adverse events from all causalities, across all treatment groups, occurring in ≥ 1% of the entire study population.

Body System Verbatim Terms Doxycycline
n=609
Vehicle
n=413
OH
n=204
SRP
n=210
Circulatory
  High blood pressure 1.60% 0.20% 0.00% 0.00%
Digestive
  Gum discomfort, pain or soreness; loss of attachment; increased pocket depth 18.10% 23.00% 20.10% 21.00%
  Toothache, pressure sensitivity 14.30% 14.30% 10.30% 18.10%
  Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration 9.90% 10.90% 10.30% 8.60%
  Thermal tooth sensitivity 7.70% 8.50% 4.40% 6.70%
  Gum inflammation, swelling, sensitivity 4.10% 5.80% 5.40% 5.70%
  Soft tissue erythema, sore mouth, unspecified pain 4.30% 5.30% 2.70% 6.20%
  Indigestion, upset stomach, stomachache 3.60% 4.10% 2.90% 3.80%
  Diarrhea 3.30% 2.40% 1.00% 1.00%
  Tooth mobility, bone loss 2.00% 0.70% 0.50% 2.40%
  Periapical abscess, lesion 1.50% 1.90% 1.00% 0.50%
  Aphthous ulcer, canker sores 0.70% 1.70% 1.00% 1.40%
  Fistula 0.80% 1.50% 1.50% 1.00%
  Endodontic abscess, pulpitis 1.50% 1.50% 0.00% 0.50%
  Jaw pain 1.10% 0.50% 1.00% 1.90%
  Tooth loss 0.80% 1.50% 1.50% 0.00%
  Bleeding gums 1.00% 0.70% 0.00% 2.40%
Genitourinary
  Premenstrual tension syndrome 4.40% 3.10% 2.50% 3.30%
Ill-Defined Conditions
  Headache 27.30% 28.10% 23.50% 23.80%
  Cough 3.60% 6.10% 2.90% 2.40%
  Sleeplessness 3.40% 1.50% 2.00% 2.90%
  Body aches, soreness 1.60% 1.20% 1.50% 1.40%
  Nausea and vomiting 1.80% 0.70% 2.50% 0.50%
  Fever 1.00% 1.90% 1.00% 1.90%
Injury & Poisoning
  Broken tooth 5.10% 4.10% 4.90% 5.70%
Mental
  Tension headache 1.80% 0.70% 0.00% 1.00%
Musculoskeletal
  Muscle aches 6.40% 4.60% 4.90% 3.30%
  Backache 3.60% 5.30% 2.50% 6.20%
  Pain in arms or legs 1.50% 2.20% 2.00% 2.40%
  Lower back pain 1.60% 1.70% 0.50% 2.90%
  Neck pain 1.30% 1.70% 1.00% 1.90%
  Shoulder pain 1.00% 1.00% 1.50% 1.00%
Nervous System
  Ear infection 1.60% 1.90% 2.00% 0.00%
Respiratory 
  Common cold 25.50% 25.20% 18.10% 16.70%
  Flu, respiratory 6.10% 9.00% 3.90% 6.70%
  Stuffy head, post nasal drip, congestion 5.60% 7.70% 2.90% 4.80%
  Sore throat 5.70% 6.50% 2.00% 3.30%
  Sinus infection 5.30% 2.70% 1.00% 1.90%
  Flu 2.80% 2.90% 2.90% 3.30%
  Bronchitis 2.30% 1.90% 1.50% 1.00%
  Allergies 1.00% 1.00% 1.00% 1.90%
Skin & Subcutaneous Tissue
  Skin infection or inflammation 1.30% 1.00% 1.00% 1.00%

Read the entire FDA prescribing information for Atridox (Doxycycline Hyclate)

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