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PerioChip, 2.5 mg (Chlorhexidine Gluconate)
Overview
What is PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
What does PerioChip, 2.5 mg (Chlorhexidine Gluconate) look like?
What are the available doses of PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
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What should I talk to my health care provider before I take PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
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How should I use PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
PerioChip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing.
One PerioChip is inserted into a periodontal pocket with probing pocket depth (PD) ≥ 5 mm. Up to 8 PerioChips may be inserted in a single visit. Treatment is recommended to be administered once every three months in pockets with PD remaining ≥ 5 mm.
The periodontal pocket should be isolated and the surrounding area dried prior to chip insertion. The PerioChip should be grasped using forceps (such that the rounded end points away from the forceps) and inserted into the periodontal pocket to its maximum depth. If necessary, the PerioChip can be further maneuvered into position using the tips of the forceps or a flat instrument. The PerioChip does not need to be removed since it biodegrades completely.
In the unlikely event of PerioChip dislodgement (in the two pivotal clinical trials, only 8 chips were reported lost), several actions are recommended, depending on the day of PerioChip loss. If dislodgement occurs 7 days or more after placement, the dentist should consider the subject to have received a full course of treatment. If dislodgement occurs within 48 hours after placement, a new PerioChip should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the PerioChip, but reevaluate the patient at 3 months and insert a new PerioChip if the pocket depth has not been reduced to less than 5 mm.
What interacts with PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
PerioChip should not be used in any patient who has a known sensitivity to chlorhexidine.
What are the warnings of PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
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What are the precautions of PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
General
The use of PerioChip in an acutely abscessed periodontal pocket has not been studied and therefore is not recommended. Although rare, infectious events including abscesses and cellulitis, which have been reported after scaling and root planing alone, have also been reported with the adjunctive placement of the PerioChip post scaling and root planing. Management of patients with periodontal disease should include consideration of potentially contributing medical disorders, such as cancer, diabetes, and immunocompromised status.
Information for Patients
Patients should avoid dental floss at the site of PerioChip insertion for 10 days after placement, because flossing might dislodge the chip. All other oral hygiene may be continued as usual. No restrictions regarding dietary habits are needed. Dislodging of the PerioChip is uncommon; however, patients should be instructed to notify the dentist promptly if the PerioChip dislodges. Patients should be also be advised that, although some mild to moderate sensitivity is normal during the first week after placement of PerioChip, they should notify the dentist promptly if pain, swelling, or other problems occur.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chlorhexidine gluconate has not been evaluated for carcinogenic potential in connection with the PerioChip. No evidence that chlorhexidine gluconate has potential to cause genetic toxicity was obtained in a battery of mutagenicity studies, including () an Ames assay, a chromosome aberration assay in CHO cells, and () a micronucleus assay conducted in mice.
Pregnancy
Teratogenic Effects:
Pregnancy Category C
Pediatric Use:
Geriatric Use:
What are the side effects of PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months.
Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinical trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups.
Array
* Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity
** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns,or fillings
| N | % | N | % | ||||
| All patients with Adverse Events | 193 | 85.8 | 189 | 85.1 | |||
| Toothache* | 114 | 50.7 | 92 | 41.4 | |||
| Upper resp tract infection | 64 | 28.4 | 58 | 26.1 | |||
| Headache | 61 | 27.1 | 61 | 27.5 | |||
| Sinusitis | 31 | 13.8 | 29 | 13.1 | |||
| Influenza-like symptoms | 17 | 7.6 | 21 | 9.5 | |||
| Back pain | 15 | 6.7 | 25 | 11.3 | |||
| Tooth disorder** | 14 | 6.2 | 15 | 6.8 | |||
| Bronchitis | 14 | 6.2 | 7 | 3.2 | |||
| Abscess | 13 | 5.8 | 13 | 5.9 | |||
| Pain | 11 | 4.9 | 11 | 5.0 | |||
| Allergy | 9 | 4.0 | 13 | 5.9 | |||
| Myalgia | 9 | 4.0 | 9 | 4.1 | |||
| Gum hyperplasia | 8 | 3.6 | 5 | 2.3 | |||
| Pharyngitis | 8 | 3.6 | 5 | 2.3 | |||
| Arthralgia | 7 | 3.1 | 13 | 5.9 | |||
| Dysmenorrhea | 7 | 3.1 | 13 | 5.9 | |||
| Dyspepsia | 7 | 3.1 | 6 | 2.7 | |||
| Rhinitis | 6 | 2.7 | 11 | 5.0 | |||
| Coughing | 6 | 2.7 | 7 | 3.2 | |||
| Arthrosis | 6 | 2.7 | 4 | 1.8 | |||
| Hypertension | 5 | 2.2 | 6 | 2.7 | |||
| Stomatitis ulcerative | 5 | 2.2 | 1 | 0.5 | |||
| Tendinitis | 5 | 2.2 | 1 | 0.5 |
What should I look out for while using PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
PerioChip should not be used in any patient who has a known sensitivity to chlorhexidine.
What might happen if I take too much PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
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How should I store and handle PerioChip, 2.5 mg (Chlorhexidine Gluconate)?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. PerioChip (chlorhexidine gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 10 chips (NDC 52096-001-12) and 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.Store at controlled room temperature 15° - 25°C (59° - 77°F) (see USP).Rx only. PerioChip (chlorhexidine gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 10 chips (NDC 52096-001-12) and 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.Store at controlled room temperature 15° - 25°C (59° - 77°F) (see USP).Rx only. PerioChip (chlorhexidine gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 10 chips (NDC 52096-001-12) and 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.Store at controlled room temperature 15° - 25°C (59° - 77°F) (see USP).Rx only.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
PerioChip should not be used in any patient who has a known sensitivity to chlorhexidine.Interactions between ethinyl estradiol and other substances may lead to decreased or increased serum ethinyl estradiol concentrations.
Decreased ethinyl estradiol plasma concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the combination oral contraceptive.
Reduced ethinyl estradiol concentrations have been associated with concomitant use of substances that induce hepatic microsomal enzymes, such as rifampin, rifabutin, barbiturates, phenylbutazone, phenytoin sodium, griseofulvin, topiramate, some protease inhibitors, modafinil, and possibly St. John’s wort.
Substances that may decrease plasma ethinyl estradiol concentrations by other mechanisms include any substance that reduces gut transit time and certain antibiotics (e.g. ampicillin and other penicillins, tetracyclines) by a decrease of enterohepatic circulation of estrogens. During concomitant use of ethinyl estradiol containing products and substances that may lead to decreased plasma steroid hormone concentrations, it is recommended that a nonhormonal back-up method of birth control be used in addition to the regular intake of Trivora (levonorgestrel and ethinyl estradiol tablets-triphasic regimen). If the use of a substance which leads to decreased ethinyl estradiol plasma concentrations is required for a prolonged period of time, combination oral contraceptives should not be considered the primary contraceptive.
After discontinuation of substances that may lead to deceased ethinyl estradiol plasma concentrations, use of a nonhormonal back-up method of birth control is recommended for 7 days. Longer use of a back-up method is advisable after discontinuation of substances that have led to induction of hepatic microsomal enzymes, resulting in decreased ethinyl estradiol concentrations. It may take several weeks until enzyme induction has completely subsided, depending on dosage, duration of use, and rate of elimination of the inducing substance.
Some substances may increase plasma ethinyl estradiol concentrations. These include:
Ethinyl estradiol may interfere with the mechanism of other drugs by inhibiting hepatic microsomal enzymes or by inducing hepatic drug conjugation, particularly glucuronidation. Accordingly, tissue concentrations may be either increased (e.g. cyclosporine, theophylline, corticosteroids) or decreased.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
The most frequently observed adverse events in the two pivotal clinical trials were toothache, upper respiratory tract infection, and headache. Toothache was the only adverse reaction that was significantly higher (p = 0.042) in the PerioChip group when compared to placebo. Most oral pain or sensitivity occurred within the first week of the initial chip placement following SRP procedures, was mild to moderate in nature, and spontaneously resolved within days. These reactions were observed less frequently with subsequent chip placement at 3 and 6 months.
Table 3 lists adverse events, occurring in ≥ 1% of 225 patients that received PerioChip, pooled from the two pivotal clinical trials without regard to causality. Gingival bleeding was the only dental adverse event occurring at a rate of ≤ 1% in both groups.
* Includes dental, gingival or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity
** Includes broken, cracked or fractured teeth, mobile teeth, and lost bridges, crowns,or fillings
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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