Paroex Chlorhexidine 0.12% Mouthwash Without Alcohol, 300 ml

Product Information

Clinical effectiveness and safety of Paroex® have not been established in children under the age of 18. Nonclinical Toxicology Carcinogenesis, Mutagenesis, And Impairment Of Fertility Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trails: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivits, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse. This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used by people with weakened immune systems to decrease mouth sores (mucositis). It may also be used to help hospitalized patients breathing through a ventilator not get pneumonia. how to use Instruct patients to not rinse with water or other mouthwashes and to not brush their teeth or eat immediately after using the topical oral solution. Subgingival Administration The cap on the original container of chlorhexidine can be used to measure the 15 mL (½ fluid ounce) dose of this medicine. Fill the cap to the ``fill line.'' If you do not receive the dental rinse in its original container, make sure you have a measuring device to measure out the correct dose. Your pharmacist can help you with this.

Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020.Our Paroex (chlorhexidine gluconate rinse) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Contraindication

The most common side effects associated with chlorhexidine gluconate oral rinse are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. APO-Chlorhexidine; Chlorhexidine Alcohol Free [DSC]; DentiCare Rinse; EURO-Chlorhexidine; GUM Paroex Oral Rinse; Oro Clear; Oro-Clense; Perichlor; Perichlor Without Alcohol; Peridex; Periogard Alcohol Free; Periogard [DSC] What is this drug used for? Chlorhexidine may have a bitter aftertaste. Do not rinse your mouth with water immediately after using chlorhexidine, since doing so will increase the bitterness. Rinsing may also decrease the effect of the medicine.

Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out. Your dentist has prescribed Paroex ® to treat your gingivitis - to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups. Geriatric 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

NDC Codes

topical oral solution: 15 mL as a mouthwash or oral rinse twice daily for 30 seconds (morning and evening after toothbrushing). Periodontitis Subgingival https://www.ada.org/en/publications/ada-news/2020-archive/november/prescription-oral-rinse-product-recalled-due-to-microbial-contamination