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Treating Adult Periodontal Disease
Don't take Periostat® if you are pregnant or breast-feeding, as it may cause harm to your unborn child or infant. Don't take Periostat® if you are allergic to tetracycline antibiotics.
For complete information on Periostat® that is prepared especially for health professionals, see Full Prescribing Information or talk to your dentist, periodontist, or pharmacist.
- What
is Periostat®?
- How
long has Periostat® been available,
and how many people with
periodontitis have used it?
- Is
Periostat® an antibiotic?
- How
does Periostat® work to treat periodontitis?
- I
thought bacteria caused gum disease, so why should I take a
medication to reduce the activity of enzymes in the gum tissue?
- Are
there other products besides Periostat®
that I can take to reduce
enzyme activity in periodontitis?
- How
do I know if Periostat® therapy
is right for me?
- If
I take Periostat®, do I still have
to brush and floss (as much)?
- When
will I begin to see improvements in the health of my gums when taking
Periostat®?
- How
long do I have to take Periostat®?
- How do I take Periostat®?
- Can
I take
Periostat®
once a day?
- What
should I do if I miss a dose of Periostat®?
- Is
Periostat® safe, and what side
effects might I experience?
- Who
should not take Periostat®?
- Can
I go out into the sunlight or use tanning beds while taking Periostat®?
- Will
Periostat® stain my teeth?
- Is
Periostat® safe to take with other
prescription and over-the-counter medications?
- Can
I take Periostat® with food or
dairy products, including milk?
- Can
I take antacids or Pepto-Bismol®
while I am taking Periostat®?
- Can
I take vitamins while I am taking Periostat®?
- If
I am taking birth control pills, can I take Periostat®?
- If
I am trying to become pregnant, can I take Periostat®?
- If
I am nursing my infant, can I take Periostat®?
- Can
Periostat® be used in children?
- Why
did my
pharmacist tell me not to lie down after taking Periostat®?
- Can I take Periostat® if I have problems with kidney or liver function?
- How much does Periostat® cost?
- Does
my dental insurance or prescription plan cover the cost of
Periostat®?
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What is Periostat®?
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Periostat® (doxycycline hyclate) 20 mg tablets is the first prescription medication that reduces the activity of certain tissue-destroying enzymes produced by the body and released in the gums. Periostat® is approved for the treatment of adult periodontitis in combination with a deep cleaning procedure known as scaling and root planing, which is performed by a dental professional. The Periostat® 20 mg tablet is taken orally twice daily and is used together with the scaling and root planing procedure. Extensive research has shown that when Periostat® is used with scaling and root planing, it significantly improves the results of this deep cleaning procedure and helps to stop progression of the disease better than scaling and root planing alone.
How long has Periostat® been available, and how many people with periodontitis have used it?
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Periostat® was approved by the US Food and Drug Administration (FDA) in September 1998. Before Periostat® was approved by the FDA, extensive research was performed to evaluate its safety and efficacy in adult patients with periodontitis. Since that time, many thousands of patients have received Periostat® for the treatment of periodontitis.
Is Periostat® an antibiotic?
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Periostat® (doxycycline hyclate) 20 mg tablets are not an antibiotic. Periostat® has no detectable effect on bacteria. Although much higher dosages of doxycycline hyclate (for example, 100 mg and 200 mg per day) are used to treat (eliminate) bacterial infections, the dosage of doxycycline in Periostat® is much too low to kill bacteria. In early research, it was discovered that Periostat® (20 mg taken twice daily) reduced the activity of the tissue-destroying enzymes released in the gum tissue without affecting bacteria. Antibiotic dosages of doxycycline hyclate (100 mg and 200 mg per day) are only used for short periods of time, usually 10 to 14 days; long-term use of antibiotics may cause them to become less effective against bacteria.
How does Periostat® work to treat periodontitis?
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Periostat® is an entirely unique approach to the treatment of periodontitis. It fights the deterioration of support tissue around the tooth. When Periostat® is prescribed in combination with deep cleaning therapies (scaling and root planing), clinical trials have shown significant reduction in tooth pocket depth and improved tooth attachment.
In untreated periodontitis, bacteria-containing plaque and calculus accumulate. This bacterial invasion triggers collagenase production to fight the bacteria; collagenase is an enzyme directly responsible for tissue destruction. Periostat® suppresses the enzymes that cause periodontal breakdown and prevents the enzymes from further breaking down the gum and bone tissue around the teeth. With Periostat® + SRP, the activity of the destructive enzymes is reduced and the body works to restore the damaged tissue.
I thought bacteria caused gum disease, so why should I take a medication to reduce the activity of enzymes in the gum tissue?
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Bacteria are certainly a cause of gum disease, and it is important to remove bacteria to improve gum health. Bacteria, however, are not the direct cause of gum and dental bone tissue damage and eventual tooth loss. Gum and bone tissue damage are actually caused by the body‘s own defense against bacterial infection. How could this be? Well, as a natural infection-fighting mechanism, your body sends white blood cells to the infection site. One of the functions of the white blood cells is to release enzymes to facilitate the passage into the gum and bone tissue. Once there, the white blood cells will destroy the bacteria. In periodontitis, however, there is an overproduction of these enzymes by these cells — an overproduction that results in a greater destruction of the gum and bone tissue than the body can repair or replace. Therefore, treatment of periodontitis involves a two-pronged approach: reduce the bacteria in the tooth pockets (the space between the gum and tooth) with a deep cleaning (known as scaling and root planing) of the teeth, and reduce the activity of the enzymes released in the gum tissue with Periostat®. Extensive studies have shown that when used with scaling and root planing, Periostat® significantly improved the results of this deep cleaning procedure and helped to stop progression of the disease better than scaling and root planing alone.
Are there other products besides Periostat® that I can take to reduce enzyme activity in periodontitis?
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Periostat® (20 mg taken twice daily) is the first FDA-approved product available that specifically reduces the activity of tissue-destroying enzymes associated with periodontitis. You should know that there are other products available that contain higher dosages of doxycycline (50 mg and 100 mg). These products are used to fight infection, but there are no studies that show that dosages of 50 mg and 100 mg of doxycycline are safe or effective in reducing enzyme activity in periodontitis. Exceeding the recommended dosage for Periostat® may increase side effects, including the development of resistant organisms. When your doctor prescribes Periostat®, you should make sure that your prescription bottle says Periostat® on the label. If not, please contact your prescribing professional. If your dentist, periodontist, or pharmacist has any questions about Periostat®, please have him or her contact our Professional Affairs Department at 1-888-339-5678.
How do I know if Periostat® therapy is right for me?
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You should discuss your dental health status with your dentist, periodontist, or hygienist to determine if Periostat® is right for you. There are a few things you should know about Periostat® when discussing your dental health status with your dental professional. First, it was shown in research with Periostat® that patients with both mild-to-moderate and severe periodontitis who received Periostat® therapy with a deep tooth cleaning (scaling and root planing) had significantly better treatment results than those individuals who received scaling and root planing without Periostat®. So, if you have either mild-to-moderate or severe periodontitis, you may be a candidate for Periostat® therapy.
Second, if you have had a previous scaling and root planing performed by a dental professional and your gum disease is not getting any better or it is getting worse, you are certainly a candidate for receiving Periostat®.
Third, be aware that certain individuals should not take Periostat®, including those who have shown allergic reactions to any of the tetracycline antibiotics, or women who are pregnant, breast-feeding, or attempting to become pregnant, as Periostat® may cause harm to the unborn child or infant. (See "Can Periostat® be used in children?") Also, Periostat® should not be used in children. If your dental professional has any questions about Periostat®, please have him or her contact our Professional Affairs Department at 1-888-339-5678.
If I take Periostat®, do I still have to brush and floss (as much)?
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Absolutely yes, as the key to good oral and dental health is regular and proper flossing and brushing of your teeth and tongue to reduce the buildup of plaque (soft buildup of food and bacteria) on your teeth. If you fail to brush and floss while taking Periostat®, you may not see much improvement in your gum disease.
When will I begin to see improvements in the health of my gums when taking Periostat®?
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In the Periostat® studies, significant improvements in gum pocket depths and reduced gum bleeding (when the gums were examined with a probe, a dental instrument) were observed after 3 months of Periostat® treatment. Keep in mind that Periostat® treatment allows the body to begin the healing process, so it takes time for the changes in your damaged gum and bone tissue to become apparent.
How long do I have to take Periostat®?
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The duration of Periostat® therapy is different for each person and depends on the severity of your gum disease and the time needed for your body‘s healing process to take place. During your checkups, your dentist or periodontist will determine if you should stop therapy or continue to take Periostat® based on your response to treatment and the level of improvement of your gum disease. Periostat® has been shown in studies to be effective for up to 9 months of continuous use; in addition, Periostat® has been safely used for up to 12 months.
How do I take Periostat®?
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Periostat® should be taken twice a day by mouth, at least 1 hour before or 2 hours after your morning and evening meal. There should be approximately 12 hours between doses; if your lifestyle involves working different shifts and you cannot take your first dose of Periostat® in the morning, then alter the dose schedule accordingly. Periostat® should be taken with a full glass of water (8 ounces) 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 or periodontist tells you to stop.
Can I take Periostat® once a day?
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Periostat® must be taken twice a day with approximately a 12-hour time period between doses.
What should I do if I miss a dose of Periostat®?
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Just resume taking the next scheduled dosage. Do not double up doses (take two doses at once) to make up for the missed dose. If you normally take Periostat® in the morning and realize several hours later that you forgot to take it, you should wait until your next daily dose. If you consistently miss doses, your results could be less than what you expect. It is a good idea to take Periostat® at the same time each day, before or after meal times or when you brush or floss your teeth in the morning and evening. By keeping to a schedule, you are more likely to remember your dose.
Is Periostat® safe, and what side effects might I experience?
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In the Periostat® studies, 428 patients with periodontitis received Periostat® or placebo (sugar pill) for 9 to 12 months. The frequency of side effects was similar in patients receiving Periostat® and placebo. Headache, the common cold, and flu symptoms were the most commonly reported side effects both in patients receiving Periostat® and placebo. (See Periostat® Prescribing Information for a list of side effects observed in clinical studies.)
We have received reports of nausea or stomach upset in some individuals who take Periostat®. If you experience nausea or stomach upset, these side effects may be reduced or stopped if you take Periostat® with a full glass of water (at least 8 ounces).
If you take Periostat® and spend excessive time in the sun or use tanning/sun beds, you could develop a photosensitivity reaction.
(See “Can I go out into the sunlight or use tanning beds while taking Periostat®?”)
Who should not take Periostat®?
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Individuals who should not take Periostat® include those who have shown hypersensitivity (allergic reactions) to any of the tetracycline antibiotics, or women who are pregnant, breast-feeding, or attempting to become pregnant, as Periostat® may cause harm to the unborn child or infant. Periostat® should not be used in children.
Can I go out into the sunlight or use tanning beds while
taking Periostat®?
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If you take Periostat® and spend time in the sun or use tanning/sun beds, you could develop a photosensitive reaction. If you experience this reaction, you will notice that sun-exposed skin becomes sunburned more easily or severely than usual. This reaction does not occur with everyone who takes Periostat®, but because some people may be more sensitive to the sun than others, it is advisable to take proper measures (such as using sun block lotion or cream and wearing protective hats and clothing) to protect your exposed skin from the sun. If you are taking Periostat® and notice a burning or reddening of skin, you should stop taking Periostat®, avoid further exposure to the sun (and stop using tanning beds), and contact your doctor to advise him or her of this possible photosensitivity reaction. (See "Who should not take Periostat®?")
Will Periostat® stain my teeth?
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Not with adult usage. In the Periostat® studies, there were no reports of tooth staining. You should be aware that other products that you may be using — namely products that contain chlorhexidine — do cause tooth staining. Chlorhexidine is a commonly used antiseptic dental mouthwash or rinse. (See "Can Periostat® be used in children?")
Is Periostat® safe to take with other prescription and over-the-counter medications?
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If you are taking any prescription or over-the-counter medications, you should tell your doctor. Periostat® can be taken safely with most other medications; however, there are some medications that should be taken with precautions or avoided. For example, if you are taking a blood thinner such as Coumadin®, the dosage of Coumadin® may need to be closely monitored by your medical doctor. So, if you are taking Periostat® and Coumadin®, it is important that both your dentist/periodontist and your medical doctor know that you are taking both medications.
For a woman taking birth control pills, know that Periostat® may make the birth control pills less effective. Although there is a very small risk that you could become pregnant when taking Periostat® and birth control pills, you should let your dentist/periodontist and medical doctor know that you are taking both medications. If you continue to take birth control pills while taking Periostat®, you should also use a second type of birth control as a precaution. (See “If I am taking birth control pills, can I take Periostat®?”)
The absorption of Periostat® is reduced when taken with antacids containing aluminum, calcium, or magnesium, or when taken with bismuth subsalicylate (Pepto-Bismol®). In addition, products that contain iron will reduce the absorption of Periostat®. So, if you take any of these products, you should take them at least 3 to 4 hours before or after you take Periostat®.
The use of barbiturates (such as phenobarbital), carbamazepine (Tegretol®), and phenytoin (Dilantin®) may reduce the time that Periostat® remains in the body. The use of tetracycline with Penthrane (methoxy-fluorane), a general anesthetic, has been reported to cause kidney failure and death. (Penthrane is no longer used in humans in the United States.)
Can I take Periostat® with food or dairy products, including milk?
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Periostat® is best taken on an empty stomach with a full glass of water (8 ounces). Taking Periostat® with meals may reduce its absorption, so it is recommended that it be taken 1 hour before or 2 hours after a meal. Dairy products including milk may reduce the absorption of Periostat® and should be avoided around the time of your Periostat® dose. It is, however, okay to use a small amount of milk or cream in coffee or tea.
Can I take antacids or Pepto-Bismol® while I am taking Periostat®?
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You can take antacids or Pepto-Bismol® while taking Periostat®; however, you should not take them at the same time. The absorption of Periostat® is reduced when taken with antacids containing aluminum, calcium, or magnesium, or when taken with bismuth subsalicylate (Pepto-Bismol®). So, if you take any of these products, you should take them at least 3 to 4 hours before or after you take Periostat®.
Can I take vitamins while I am taking Periostat®?
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You can take vitamins while taking Periostat®, but they should not be taken at the same time. Remember that Periostat® is best taken on an empty stomach with a full glass of water. (See “How do I take Periostat®?”) If your vitamins contain minerals, including calcium, magnesium, and iron, take them at least 3 to 4 hours before or after you take Periostat®.
If I am taking birth control pills, can I take Periostat®?
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If you are taking birth control pills, Periostat® may make the birth control pills less effective. Although there is a very small risk that you could become pregnant when taking Periostat® and birth control pills, you should let your dental professional and medical doctor know that you are taking both medications. If you continue to take birth control pills while taking Periostat®, you should also use a second type of birth control as a precaution.
If I am trying to become pregnant, can I take Periostat®?
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If you are trying to become pregnant, you should not take Periostat®. Periostat® may cause harm to the unborn when taken by a pregnant woman. In animal studies, it was found that tetracyclines, including doxycycline, cross the placenta and can have toxic effects on the unborn, as well as cause abnormal bone development. There is also evidence that these medications have toxic effects on the fertilized eggs of animals.
If you are attempting to become pregnant, or suspect or know that you are pregnant, you should immediately stop taking Periostat® and contact your doctor.
If I am nursing my infant, can I take Periostat®?
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Tetracyclines, including doxycycline, are excreted in human milk. Because of the potential for serious side effects from doxycycline in nursing infants, nursing mothers should not take Periostat®.
Can Periostat® be used in children?
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Periostat® is only recommended for use in adults with periodontitis. There have been no studies to evaluate the safe and effective use of Periostat® in children or adolescents. Furthermore, the use of tetracyclines, including doxycycline, may cause permanent tooth discoloration (yellow-gray-brown) and abnormalities during tooth development from the last half of pregnancy up to the age of 8 years. In addition, growth abnormalities of the lower leg bones have occurred in premature babies who received tetracycline.
Why did my pharmacist tell me not to lie down after taking Periostat®?
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This recommendation from your pharmacist is a way of preventing possible irritation to the lining of your food canal from your mouth to your stomach caused by the medication. If you lie down right after taking a tablet or capsule, it may not get to the stomach and could cause irritation to the lining of the food canal. Therefore, like many medications, you should take Periostat® only while standing or sitting and with a full glass of water (8 ounces) to ensure that the tablet gets to the stomach.
Can I take Periostat® if I have problems with kidney or liver function?
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If you have kidney or liver problems of any kind, you should first discuss this with your dental and medical professionals before taking any medication. If your dentist/periodontist or medical doctor has any questions about using Periostat® in a person with liver or kidney function problems, he or she can contact our Professional Affairs Department at 1-888-339-5678.
How much does Periostat® cost?
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The cost for a 30-day supply of Periostat® will vary slightly depending upon the pharmacy. Your pharmacy bases the cost to you on how much it is charged by its wholesaler plus the pharmacy‘s dispensing fee.
Does my dental insurance or prescription plan cover the cost of Periostat®?
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Please contact your insurance company directly by phone or through their internet website for an explanation of your prescription benefits.
| * SRP = Scaling and root planing (a professional deep cleaning procedure) |
| Periostat®
| All About Periodontitis | Professional and Educational Resources
Resources
Insurance Information | References | Dental Resources | Take the Test Prescribing Information | Home | Site Map | Periostat® Consumer Advertisement |
| Please
see Full Prescribing Information for adverse
reactions, warnings, and contraindications. |
| ©2005
CollaGenex Pharmaceuticals, Inc. This information is intended for residents of the United States |