Patient Medication Information: uses, side effects, how to take - Arestin Microspheres
Serious Warnings and Precautions
Teeth may become permanently discoloured if ARESTIN MICROSPHERES is used on teeth that are developing. ARESTIN MICROSPHERES should not be used:
|
|---|
What is ARESTIN MICROSPHERES used for?
Scaling and root planning (SRP) procedures are deep cleaning procedures done by your dental professional. Scaling removes plaque, tartar and stains from the surface of the teeth. Planning smooths the rough areas on the root of teeth to promote healing. ARESTIN MICROSPHERES is used alongside SRP to reduce pocket depth (the space between your teeth and gums) in adults with:
- Chronic periodontitis
- Moderate to advance chronic periodontal disease
- ARESTIN MICROSPHERES is also used in adults, as part of periodontal maintenance program which includes good oral hygiene and SRP.
- Antibacterial drugs like ARESTIN MICROSPHERES treat only bacterial infections. They do not treat viral infections. Although you may feel better early in your treatment, ARESTIN MICROSPHERES should be used exactly as directed. Misuse or overuse of ARESTIN MICROSPHERES could lead to the growth of bacteria that will not be killed by ARESTIN MICROSPHERES (resistance). This means that ARESTIN MICROSPHERES may not work for you in the future. Do not share your medicine.
How does ARESTIN MICROSPHERES work?
Harmful bacteria can infect the gums and form spaces or gaps around the teeth. These gaps are called periodontal pockets. While SRP has been shown to remove many of the bacteria, the instruments used during SRP sometimes can’t reach stubborn bacteria that hide in the bottom of pockets. ARESTIN MICROSPHERES is placed by your healthcare professional into the periodontal pockets. ARESTIN MICROSPHERES contain minocycline hydrochloride, a tetracycline antibiotic. It stops the growth of bacteria. ARESTIN MICROSPHERES will reduce the amount of bacteria in these pockets and helps reduce the depth of pockets around your teeth.
What are the ingredients in ARESTIN MICROSPHERES?
Medicinal ingredients: Minocycline Hydrochloride
Non-medicinal ingredients: Poly (glycolide-co-dl-lactide) or PGLA.
ARESTIN MICROSPHERES comes in the following dosage forms:
- Powder (microspheres); 1 mg per cartridge
Do not use ARESTIN MICROSPHERES if:
- You are allergic to minocycline hydrochloride or any of the other ingredients in ARESTIN MICROSPHERES.
- You are sensitive to tetracycline, doxycycline, minocycline, or any other tetracycline drug.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive ARESTIN MICROSPHERES. Talk about any health conditions or problems you may have, including if you:
- are taking oral contraceptives. Antibiotics may decrease the effectiveness of your birth control pills.
are pregnant or planning on becoming pregnant.
- are breastfeeding or planning to breastfeed.
- are taking penicillin or other antibiotics.
- have a history of thrush (a yeast infection in your mouth).
- have diabetes or HIV infection.
- are receiving chemotherapy or radiation treatment.
- have systemic lupus erythematosus.
- have acute abscess (pocket of pus caused by a bacterial infection) in the periodontal pocket.
- have dental implants or are going to be getting dental implants.
Other warnings you should know about:
Minocycline can cause the development of autoimmune syndromes. Symptoms can include fever, rash, joint stiffness, swollen lymph nodes and restlessness. If you have any of these symptoms, tell your healthcare professional immediately.
ARESTIN MICROSPHERES can cause swelling of the face, fever, itching and swelling of the lymph nodes. This may be a sign of hypersensitivity reactions. If you have any of these symptoms, tell your healthcare professional immediately.
Sun Sensitivity
ARESTIN MICROSPHERES can cause your skin to become sensitive to the sun and UV light. While taking ARESTIN MICROSPHERES, use sunscreen and protective clothing if you are going to be in direct sunlight. Avoid tanning beds and other sources of UV light. If you notice skin redness after being in the sun, avoid further sun exposure.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
It is unlikely drugs may interact with ARESTIN MICROSPHERES since it is placed in small pockets around your teeth from which small amounts of antibiotic are released over several weeks.
The following may interact with ARESTIN MICROSPHERES:
- Anticoagulants (medicine used to thin the blood and prevent blood clots).
- Beta-lactam antibiotics (such as penicillin, amoxicillin, cefaclor) and aminoglycoside antibiotics (such as gentamycin, and tobramycin).
- Hormonal birth control.
- Methoxyflurane anesthesia (medicine to control pain in emergency settings).
How to take ARESTIN MICROSPHERES:
- Your healthcare professional will administer ARESTIN MICROSPHERES.
- After you leave your dentist's or periodontist's office, don't brush your teeth for 12 hours.
- Don't touch the parts of your mouth where they put the medicine for 1 week.
- Don't eat hard, crunchy, or sticky foods, such as apples, raw carrots, and caramel candy for 1 week.
- Don't use dental floss, dental tape, or toothpicks around the area where they put the medicine for 10 days.
- It is important for you to continue with a good oral hygiene regimen as recommended by your dentist.
Overdose:
| If you think you, or a person you are caring for, have been given too much ARESTIN MICROSPHERES, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
What are possible side effects from using ARESTIN MICROSPHERES?
These are not all the possible side effects you may have when taking ARESTIN MICROSPHERES. If you experience any side effects not listed here, tell your healthcare professional.
- gum discomfort / pain / soreness, gum swelling
- bleeding gums
- mouth sores and Mouth pain
- toothache
- tooth and tongue discoloration
- upset stomach
- headache
- infection
- flu-like symptoms
- pain
- diarrhea
- inflammation of the sinuses (sinusitis), trachea and bronchi (bronchitis), back of the throat (pharyngitis)
- muscle pain
- joint stiffness
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY RARE | |||
| Angioedema and Serious Allergic Reactions (including local allergic reactions): swelling of the face, eyes, lips, tongue or throat, trouble breathing or swallowing, itching, hives, small raised red pimples, or rash (papules), redness, rash, fever, abdominal cramps | √ | ||
| UNKNOWN | |||
| Acute febrile neutrophilic dermatosis (Sweet’s syndrome): painful bumps or small blisters filled with pus on the face, neck, arms, or legs, skin and mouth sores, skin discoloration, fever, muscle and joint pain, headache, and fatigue | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store between 15°C to 30°C.
- Avoid exposure to excessive heat.
- Keep out of reach and sight of children.
If you want more information about ARESTIN MICROSPHERES:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-ARESTIN (273-7846).
Manufactured by:
OraPharma, Inc.
Bridgewater, New Jersey, USA
Distributed by:
HANSAmed Limited
2830 Argentia Road, Units 7-9
Mississauga, Ontario
L5N 8G4