Arestin

What Is Arestin?

Arestin (minocycline hydrochloride) microspheres are indicated as an antibiotic add-on to scaling and root planing (SRP) procedures for the reduction of periodontal pocket depth in adult patients with periodontal gum disease.

What Are Side Effects of Arestin?

Common side effects of Arestin include:

• headache,
• infection,
• flu-like symptoms,
• pain,
• mouth irritation,
• gum infection,
• cavities,
• dental pain,
• gum inflammation (gingivitis),
• swelling and sores inside the mouth,
• sore throat, and
• indigestion.

Dosage for Arestin

Arestin is a variable dose product, dependent on the size, shape, and number of pockets being treated.

What Drugs, Substances, or Supplements Interact with Arestin?

Arestin may interact with other drugs. Tell your doctor all medications and supplements you use.

Arestin During Pregnancy and Breastfeeding

Use of tetracycline antibiotic medications such as Arestin during tooth development may cause permanent discoloration of the teeth, and should not be used in children or in pregnant or nursing women.

Additional Information

Our Arestin Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Arestin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, severe rash; swollen glands, unusual tiredness, fever, nausea, stomach pain; lower back pain, painful urination, blood or pus in your urine; chest pain, cough with mucus, difficult breathing; jaundice (yellowing of the skin or eyes); swelling of your face, lips, tongue, or throat.

Some of these signs of allergic reaction have occurred when minocycline was taken by mouth in a pill form. It is not known whether Arestin minocycline powder would cause these same effects when used in dentistry.

Call your dentist at once if you have:

• tooth pain;
• pain or swelling in your gums;
• fever, swollen glands, rash or itching, joint pain or swelling, muscle aches, general ill feeling; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• increased tooth sensitivity;
• pain;
• headache;
• infection; or
• flu-like symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Arestin (Minocycline Hydrochloride Microspheres)

 

Arestin Professional Information

SIDE EFFECTS

The most frequently reported non-dental treatment-emergent adverse events in the 3 multicenter US trials were headache, infection, flu syndrome, and pain.

Table 5: Adverse Events (AEs) Reported in ≥ 3% of the Combined Clinical Trial Population of 3 Multicenter US Trials by Treatment Group

	SRP Alone N=250	SRP+ Vehicle N=249	SRP+ ARESTIN® N=423
Number (%) of Subjects Treatment-emergent AEs	62.4%	71.9%	68.1%
Total Number of AEs	543	589	987
Periodontitis	25.6%	28.1%	16.3%
Tooth Disorder	12.0%	13.7%	12.3%
Tooth Caries	9.2%	11.2%	9.9%
Dental Pain	8.8%	8.8%	9.9%
Gingivitis	7.2%	8.8%	9.2%
Headache	7.2%	11.6%	9.0%
Infection	8.0%	9.6%	7.6%
Stomatitis	8.4%	6.8%	6.4%
Mouth Ulceration	1.6%	3.2%	5.0%
Flu Syndrome	3.2%	6.4%	5.0%
Pharyngitis	3.2%	1.6%	4.3%
Pain	4.0%	1.2%	4.3%
Dyspepsia	2.0%	0	4.0%
Infection Dental	4.0%	3.6%	3.8%
Mucous Membrane Disorder	2.4%	0.8%	3.3%

The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN compromise clinical attachment.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Arestin (Minocycline Hydrochloride Microspheres)