Stafilex Uses

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What is Stafilex?

Stafilex is used to help treat periodontal disease (a disease of your gums), which is caused by bacteria growing beneath the gum line. Stafilex works by killing the bacteria. Up to eight Stafilex implants are placed between your teeth and gums in places where the gum has a deep pocket. Your dentist will place the Stafilex implants after your teeth have been thoroughly cleaned.

Stafilex is available only with your dentist's prescription.

Stafilex indications

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For local use of Stafilex ICPA Health Products: trichomonas coleitis, cervical erosion, itching of the vulva, prevention of sexually transmitted diseases (including gonorrhea, syphilis, trichomoniasis, chlamydia, ureaplasmosis); gingivitis, stomatitis, aphthae, paradont, alveolitis, disinfection of removable dentures, sore throat; postoperative care for patients in ENT and dentistry.

Treatment of wounds, burn wounds and surfaces, disinfection of the patient's skin.

Treatment of surgeons', nurses' hands and operating field before diagnostic manipulation operation.

Disinfection of work surfaces of devices (including thermometers) and equipment which heat treatment is not desirable.

How should I use Stafilex?

Use Stafilex liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Stafilex liquid.

Uses of Stafilex in details

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Garlic has been used for hardening of the arteries (atherosclerosis) and high blood pressure (hypertension). Consult your doctor for more information if you have heart disease or high blood pressure. Garlic has also been used to prevent tick bites.

Some herbal/dietary supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Stafilex

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Stafilex description

Stafilex mouthwash contains Chlorhexidine digluconate 1% v/v, equivalent to Stafilex gluconate solution 0.2% w/v. It also contains ethanol, macrogolglycerol hydroxystearate, sorbitol, flavour and water.

Stafilex dosage

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Usual Adult Dose for Gingivitis

15 mL twice daily after brushing.

Oral rinse should be retained for 30 seconds then expectorated after rinsing.

Usual Adult Dose for Mucositis

15 mL twice daily after brushing.

Oral rinse should be retained for 30 seconds then expectorated after rinsing.

Usual Adult Dose for Periodontitis

Initial: One 2.5 mg chip inserted into a periodontal pocket with probing pocket depth greater than or equal to 5 mm, up to 8 chips in one visit.

Maintenance: Administration is recommended once every 3 months in pockets with remaining probing depth greater than or equal to 5 mm.

Usual Adult Dose for Skin Disinfection, Preoperative

Stafilex gluconate 2% cloth:

Patient preoperative skin preparation:

Hold package in one hand and lift flap on backside of package with the other hand. Grasp flap at top and pull down to tear flap away and expose foam. Alternatively, using sterile scissors, cut off end seal of package. Transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination. Use the first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use the second cloth to prepare larger areas.

DRY SURGICAL SITES: (such as the abdomen or arm): Use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one minute. Do not rinse.

MOIST SURGICAL SITES: (such as the inguinal fold): Use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Do not rinse.

Stafilex gluconate 4% solution:

SURGICAL HAND SCRUB: Do not dilute. Wet hands and forearms with water and scrub for 3 minutes with about 5 ml and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces. Wash for an additional 3 minutes with 5 ml and rinse under running water. Dry thoroughly.

HEALTHCARE PERSONNEL HANDWASH: Do not dilute. Wet hands with water. Dispense about 5 ml into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

PATIENT PREOPERATIVE SKIN PREPARATION: Do not dilute. Apply liberally to surgical site and swab for at least 2 minutes. Dry with a sterile towel. Repeat procedure for an additional 2 minutes and dry with a sterile towel.

SKIN WOUND AND GENERAL SKIN CLEANSING: Do not dilute. Thoroughly rinse the area to be cleaned with water. Apply a minimum amount necessary to cover the skin or would area and wash gently. Rinse again thoroughly.

Usual Pediatric Dose for Gingivitis

The safety and efficacy of Stafilex gluconate has not been established in patients less than 18 years old. However, the use of Stafilex gluconate may be appropriate in some situations.

15 mL twice daily after brushing.

Oral rinse should be retained for 30 seconds then expectorated after rinsing.

Usual Pediatric Dose for Mucositis

The safety and efficacy of Stafilex gluconate has not been established in patients less than 18 years old. However, the use of Stafilex gluconate may be appropriate in some situations.

15 mL twice daily after brushing.

Oral rinse should be retained for 30 seconds then expectorated after rinsing.

Usual Pediatric Dose for Periodontitis

The safety and efficacy of Stafilex gluconate has not been established in patients less than 18 years old. However, the use of Stafilex gluconate may be appropriate in some situations.

Initial: One 2.5 mg chip inserted into a periodontal pocket with probing pocket depth greater than or equal to 5 mm, up to 8 chips in one visit.

Maintenance: Administration is recommended once every 3 months in pockets with remaining probing depth greater than or equal to 5 mm.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dialysis

No adjustment recommended

Other Comments

Stafilex topical cloths are not sterile.

Stafilex topical cloths should not be microwaved.

Stafilex solution should be used with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Stafilex topical cloths should not be used in premature or low birthweight infants, infants receiving phototherapy, or infants less than 2 months of age. Stafilex topical cloths and Stafilex 4% solution should not be used for lumbar punctures or in contact with the meninges, or on open wounds or as a general skin cleanser.

Stafilex topical cloths and Stafilex 4% solution should not make contact with the eyes, nose, or mouth. If contact occurs, the affected area should be washed with cold water and a doctor should be contacted.

Stafilex 4% solution should not be diluted.

Repeated general cleansing of large areas of the body with Stafilex 4% topical solution should be avoided except when the underlying condition makes it necessary to reduce the bacterial population of the skin.

Stafilex interactions

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Stafilex is incompatible with the soap, and detergents containing anionic group (saponins, sodium lauryl sulfate, sodium carboxymethyl cellulose).

Stafilex ICPA Health Products is compatible with any medication containing cationic group (cetrimonium bromide, benzalkonium chloride).

Stafilex side effects

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What are the possible side effects of Stafilex?

The most common side effects associated with Stafilex gluconate oral rinses 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.

Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of Stafilex gluconate rinse.

The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: 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 Stafilex gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Stafilex gluconate oral rinse.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Stafilex gluconate oral rinse.

Stafilex contraindications

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What is the most important information I should know about Stafilex?

Stafilex gluconate oral rinse should not be used by persons who are known to be hypersensitive to Stafilex gluconate or other formula ingredients.

Active ingredient matches for Stafilex:

Chlorhexidine in Netherlands.


List of Stafilex substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Liquid; Topical; Chlorhexidine Gluconate 20% (Omega)
Liquid; Topical; Chlorhexidine Gluconate 0.5%
Liquid; Topical; Chlorhexidine Gluconate 2%
Stat Touch 2 Antimicrobial Skin Cleanser liquid 2 % (Coloplast Corp. (Canada))
Stel 4% SCRUB / 500ml (SPPL)$ 2.97
4 % x 500ml (SPPL)$ 2.97
STEL scrub 4 % x 500ml (SPPL)$ 2.97
Stel Prep Mouth/Throat 500 ml Mouth Wash/Gargle (Shalaks Pharmaceuticals Pvt. Ltd.)$ 1.21
Stel Scrub Mouth/Throat 500 ml Mouth Wash/Gargle (Shalaks Pharmaceuticals Pvt. Ltd.)$ 3.19
Swab; Isopropyl Alcohol 70%; Chlorhexidine Acetate 0.5% (Seton)
Solution; Topical; Chlorhexidine Gluconate 0.05%
Solution; Topical; Chlorhexidine Gluconate 2%
Solution; Topical; Chlorhexidine Gluconate 20%
Solution; Topical; Chlorhexidine Gluconate 4%
Solution; Topical; Chlorhexidine Gluconate 0.05%
Sterixin 0.05% solution 0.05 % (Laboratoires Sterigen Inc (Canada))
Liquid; Topical; Chlorhexidine Acetate 0.5%

References

  1. DailyMed. "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "chlorhexidine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "chlorhexidine". http://www.drugbank.ca/drugs/DB00878 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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