Actisite

Name: Actisite

Proper Use of Actisite

When tetracycline periodontal fibers are in place in your mouth, try to avoid any actions that may knock the fibers loose. For example:

  • Do not chew hard, crusty, or sticky foods, or chewing gum.
  • Do not brush or floss near any treated areas, but continue to clean the other teeth.
  • Do not use a dental spray device (e.g., Water-Pik).
  • Do not probe or pick at the fibers with your tongue, toothpicks, or fingers.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The amount of tetracycline periodontal fibers that will be put in your gums will be determined by your dentist. The number of teeth that need treatment and the depth of the pockets in your gums will determine the amount of fiber that is used.

Precautions While Using Actisite

Check with your dentist right away if the fibers become loose or fall out before your next dental visit.

Check with your dentist right away if you have pain or swelling or other problems in the treated areas.

It is very important that your dentist check your progress and remove the tetracycline periodontal fibers after ten days. Do not miss any dental appointments.

Actisite Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Gum redness, swelling, and pain in the areas of treatment
  • tongue pain and redness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Discomfort in the area where the fibers have been placed
  • redness in the area where the fibers were removed
Rare
  • Sore throat
  • staining of the tongue
  • white patches on tongue or in mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Contraindications

Documented hypersensitivity

Severe hepatic dysfunction

Cautions

Photosensitivity may occur with prolonged exposure to sunlight or tanning equipment

Reduce dose in renal impairment

Consider drug serum level determinations in prolonged therapy

Tetracycline use during tooth development (last half of pregnancy through age 8 years) can cause permanent discoloration of teeth

Fanconilike syndrome may occur with outdated tetracyclines

IV/IM no longer commercially available

Side effects

Actisite (tetracycline periodontal) fiber has been studied in 1437 patients distributed as follows over pivotal, controlled, and open- label studies.

  Study Type
Demographics Pivotal Controlled Uncontrolled TOTAL
Gender:        
Male 113 70 455 638
Female 113 55 631 799
Age Range 25-88 25-73 13-87 13-88
Race:        
Black 13 12 41 66
Asian 4 1 10 15
Hispanic 3 3 11 17
Caucasian 206 105 964 1275
Native American 0 2 56 58
Other 0 2 5 7

The most frequently reported adverse reactions in the 226 patients in the pivotal clinical trials were discomfort on fiber placement (10%) and local erythema following removal (11%).

In controlled and open-label trials patients, the following adverse reactions have been reported in less than 1% of patients: oral candidiasis, glossitis, possible allergic response, staining of the tongue, severe gingival inflammation, throbbing pain, pain following placement in an abscessed area, and minor throat irritation.

Read the entire FDA prescribing information for Actisite (Tetracycline Periodontal)

Read More »

For the Consumer

Applies to tetracycline: capsule, capsule delayed release, capsule extended release, powder for suspension, suspension, syrup, tablet, tablet delayed release, tablet extended release

Other dosage forms:

  • implant, powder for suspension

Along with its needed effects, tetracycline (the active ingredient contained in Actisite) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking tetracycline:

For all tetracyclinesMore common
  • Increased sensitivity of skin to sunlight (rare with minocycline)
Rare
  • Abdominal pain
  • bulging fontanel (soft spot on head) of infants
  • headache
  • loss of appetite
  • nausea and vomiting
  • visual changes
  • yellowing skin
For demeclocycline onlyLess common
  • Greatly increased frequency of urination or amount of urine
  • increased thirst
  • unusual tiredness or weakness
For minocycline onlyLess common
  • Pigmentation (darker color or discoloration) of skin and mucous membranes

Some side effects of tetracycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For all tetracyclinesMore common
  • Cramps or burning of the stomach
  • diarrhea
Less common
  • Itching of the rectal or genital (sex organ) areas
  • sore mouth or tongue
For minocycline onlyMore common
  • Dizziness, light-headedness, or unsteadiness

In some patients tetracyclines may cause the tongue to become darkened or discolored. This effect is only temporary and will go away when you Stop taking tetracycline.

Usual Adult Dose for Chlamydia Infection

Uncomplicated urethral, endocervical, or rectal infection: 500 mg orally 4 times a day for at least 7 days

The patient's sexual partner(s) should also be evaluated/treated.

Oral doxycycline therapy is preferred by the Centers for Disease Control and Prevention (CDC) for the treatment of chlamydial infections in nonpregnant patients.

Usual Adult Dose for Helicobacter pylori Infection

500 mg orally every 6 hours for 14 days given in conjunction with bismuth, metronidazole, and an H2 blocker

Usual Adult Dose for Nongonococcal Urethritis

500 mg orally every 6 hours for 7 days

The patient's sexual partner(s) should also be evaluated/treated.

Usual Adult Dose for Pelvic Inflammatory Disease

Although tetracyclines in general may be useful in combination with other agents for the treatment of pelvic inflammatory disease, doxycycline is much more commonly used and is specifically recommended by the CDC as a therapy for this disease. Therefore, the use of tetracycline for the treatment of this patient with pelvic inflammatory disease is not recommended. Doxycycline may be an effective alternative.

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