Periostat

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking doxycycline, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking doxycycline.

Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking doxycycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Doxycycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking doxycycline.

Oral/Injectable:

Serious side effects have been reported with doxycycline. See “Doxycycline Precautions” section.

Common side effects of doxycycline include:

• nausea
• vomiting
• diarrhea
• itching of the rectum or vagina
• sore mouth
• increased sensitivity to sunlight and ultraviolet light
• mild rash

This is not a complete list of doxycycline side effects.  Ask your doctor or pharmacist for more information.

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

Tell your doctor if you are breastfeeding or plan to breastfeed.  The active ingredient in doxycycline is excreted in human breast milk. The effect of doxycycline on the nursing infant is not known, although it may affect bone and tooth development.

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

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.

This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a 9 -12 month period. The most frequent adverse reactions occurring in studies involving treatment with a bioequivalent form of doxycycline hyclate capsules or placebo are listed below:

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

1. Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol 1995; 22: 100-109.

2. Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low-dose Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase Activity in Humans. J. Periodont Res 1990; 25: 321-330.

3. Golub, L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult Periodontitis. Inflammation Research 1997; 46: 310-319.

4. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin. Pharmacokinetics 1988; 15: 355-366.

5. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy 1971; 16: 217-228.

6. Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.: Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel Forschung 1986; 36: 1705-1707.

NDC 0299-5960-02

Periostat®
(doxycycline hyclate tablets)

20 mg
100 Tablets

GALDERMA

INERT INGREDIENTS:
Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Titanium Dioxide, Triacetin.

See package insert for dosage information.

Store at controlled room temperature 15°– 30°C (59° – 86°F).

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA

Manufactured by:
PMRS, Inc.
Horsham, PA 19044 USA

GALDERMA is a registered trademark.

30182-0109

Rx only

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

Along with its needed effects, doxycycline (the active ingredient contained in Periostat) 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 while taking doxycycline:

• Bloating
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with swallowing
• dizziness
• fast heartbeat
• feeling of discomfort
• fever
• headache
• hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• hives or welts, itching, or rash
• increased thirst
• indigestion
• inflammation of the joints
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea and vomiting
• numbness or tingling of the face, hands, or feet
• pain in the stomach, side, or abdomen, possibly radiating to the back
• redness and soreness of the eyes
• redness of the skin
• sore throat
• sores in the mouth
• stomach cramps
• stomach pain or tenderness
• swelling of the feet or lower legs
• swollen lymph glands
• tightness in the chest
• unusual tiredness or weakness
• unusual weight loss
• yellow eyes or skin

Some side effects of doxycycline 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:

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• chest pain, discomfort, or burning
• cracks in the skin
• decrease in vision
• difficulty breathing
• discoloration of the thyroid glands
• double vision
• general body swelling
• heartburn
• increased sensitivity of the skin to sunlight
• loss of heat from the body
• lower back or side pain
• nosebleeds
• pain or burning in the throat
• pain with swallowing
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rash with flat lesions or small raised lesions on the skin
• red, swollen skin
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• severe nausea
• severe stomach pain
• severe sunburn
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• unusual bleeding or bruising
• vomiting blood