Treating Adult Periodontal Disease
Helping to Restore the Health of Your Teeth and Gums
For more information about Periostat®, visit our website at www.periostat.com.
You should read this information before you start taking PERIOSTAT®. This only provides a summary of certain information about PERIOSTAT. Your dentist or pharmacist can give you more complete information that is written for health professionals. This does not replace the careful discussions you should have with your dentist before taking PERIOSTAT and during your regular checkups.
What is PERIOSTAT?
PERIOSTAT is a medicine used together with a deep cleaning of your teeth (known as scaling and root planing) by your dentist.
PERIOSTAT plus scaling and root planing improve the stability and health of the gums and teeth in adults with periodontitis (gum disease).
PERIOSTAT works by reducing the activity of certain enzymes produced in gum and bone tissues around teeth in individuals with adult periodontal disease.
PERIOSTAT is available as a tablet that you take twice a day by mouth. Each PERIOSTAT tablet contains doxycycline hyclate equivalent to 20 mg doxycycline.
Who should not take PERIOSTAT?
Do not take PERIOSTAT if you
- have had an allergic reaction to any of the tetracycline antibiotics, including doxycycline and minocycline. If you are unsure about any of these medications, talk to your dentist or pharmacist.
- are pregnant or plan to become pregnant, because it may harm the unborn. If you suspect or learn that you are pregnant while taking PERIOSTAT, immediately stop taking it and contact your dentist or medical doctor.
- are nursing an infant, because this medication is passed through breast milk and may cause harm to the infant.
PERIOSTAT should not be given to infants or children, because it may cause permanent discoloration of the teeth or problems with tooth development.
What should I tell my dentist before and during treatment with PERIOSTAT?
Tell your dentist if you
- have a history of allergic reactions to doxycycline or other tetracycline antibiotics.
- are pregnant or plan to become pregnant, because PERIOSTAT may harm the unborn.
- have kidney or liver disease.
- have a history of or are currently experiencing an oral or vaginal yeast or fungal infection.
- often expose your skin to sunlight or artificial sunlight, because more severe sunburns may occur in some people taking doxycycline.
- are taking any other medications, including those that you can get without a prescription (over-the-counter products).
Tell your dentist if you develop
- any skin rash, redness, or an unusual or severe sunburn.
- any allergic reactions, which may include skin rash, swelling, and difficulty swallowing or a feeling of tightness in your throat. If any of these symptoms occurs, you should contact your dentist or medical doctor immediately.
- any other possible side effects (see listing of possible side effects below).
How should I take PERIOSTAT?
PERIOSTAT should be taken twice a day by mouth, one tablet in the morning and one in the evening. If PERIOSTAT is taken close to meal times, allow at least one hour before, or two hours after meals. PERIOSTAT should be taken with a full glass of water in a sitting or standing position to avoid any irritation to your throat. You should not take more or less than the recommended daily dose of PERIOSTAT. Taking more than the recommended dose may increase the occurrence of side effects. You should continue to take PERIOSTAT until your dentist tells you to stop.
How long should I take PERIOSTAT?
PERIOSTAT has been shown in studies to be effective for up to nine months of continuous use. In addition, PERIOSTAT has been safely used for up to 12 months. The amount of time that you will take PERIOSTAT is different for each person and depends on the severity of your gum disease and the time needed for your bodyÕs healing process to take place. During your checkups, your dentist will determine if you should stop or continue to take PERIOSTAT based on your response to treatment and the level of improvement of your gum disease.
Can I take PERIOSTAT with other medications?
PERIOSTAT and certain other medications may not work properly when taken together. So tell your dentist about medications that you are taking or plan to take while you are taking PERIOSTAT. Your dentist may need to talk to or refer you to your medical doctor.
- There is a possibility that PERIOSTAT may interfere with the effectiveness of oral contraception, resulting in pregnancy.
- If you take antacids or vitamins that contain calcium, aluminum, magnesium, iron, or bismuth subsalicylate (active ingredient of Pepto-Bismol®), avoid taking them at the same time you take PERIOSTAT, because they may reduce the effectiveness of PERIOSTAT.
- If you are taking blood thinners such as Coumadin®, your medical doctor may need to make changes to the dose of your blood thinner.
- PERIOSTAT may make certain antibiotics, including penicillins, less effective.
- Taking barbiturates (such as phenobarbital), carbamazepine (Tegretol®), or phenytoin (Dilantin®) may reduce the time that PERIOSTAT stays active in your system.
- Using PERIOSTAT with the general anesthetic Penthrane® (methoxyflurane) may cause serious harm to the kidneys.
What are the possible side effects of PERIOSTAT?
In studies, the side effects reported by individuals taking PERIOSTAT or placebo (sugar pill) were largely similar. Headache, the common cold, and flu symptoms were the most commonly reported side effects in individuals receiving PERIOSTAT and placebo. Nausea and stomach discomfort may also occur (these side effects may be avoided by taking PERIOSTAT with a full glass of water). The following side effects were not reported in the PERIOSTAT studies but have been reported by individuals taking tetracyclines, including doxycycline:
- Gastrointestinal — anorexia, vomiting, glossitis (inflamed tongue), dysphagia (difficulty swallowing), and inflamed tissues (with vaginal yeast infection) in the anogenital area. Liver toxicity has rarely been reported. Inflammation or ulceration of the esophagus has rarely been reported with capsule forms of these medications (these side effects can be avoided by taking PERIOSTAT with a full glass of water).
- Skin — raised red rash, severe rash with skin peeling (uncommon), photosensitivity (severe sunburn).
- Other — increased blood urea nitrogen (BUN — an indicator of kidney function), hypersensitivity (allergic reactions that can be life threatening), exacerbation of systemic lupus erythematosus (in people with this disease), anemia, and blood-related abnormalities.
If you develop any of the side effects listed above or have a medical problem that you think may be related to PERIOSTAT, talk to your dentist or medical doctor.
What else should I know about PERIOSTAT?
This provides a summary of certain information about PERIOSTAT. If you have any questions or concerns about PERIOSTAT, you should talk to your dentist. Your pharmacist can give you an additional leaflet that is written for health professionals.
- Keep PERIOSTAT out of the reach of children.
Inactive ingredients include: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
PERIOSTAT is a registered trademark of CollaGenex Pharmaceuticals, Inc.,
Newtown, PA 18940. U.S. Patents 4,666,897 and RE 34,656
©2001 CollaGenex Pharmaceuticals, Inc., Newtown, PA 18940 1841-00 (PPI) 04/01
