Benzalkonium chloride/benzyl alcohol/chlorhexidine gluconate

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Benzalkonium chloride/benzyl alcohol/chlorhexidine gluconate Medicine

Contraindications

See also:
What is the most important information I should know about Benzalkonium chloride?

Use in occlusive dressings, casts and anal or vaginal packs.

See also:
What is the most important information I should know about Benzyl alcohol?

Benzyl alcohol topical is used to treat head lice in people between the ages of 6 months and 60 years old. This medicine will not treat lice on other body areas.

Do not use this medication on a child or infant younger than 6 months old.

If the medicine gets in your eyes or on your skin, rinse with water. Call your doctor at once if you have severe stinging, itching, or irritation of the eyes or skin after rinsing.

Avoid head to head contact with others. Avoid sharing hair brushes, combs, hair accessories, hats, scarves, and pillows. Lice infections are highly contagious.

See also:
What is the most important information I should know about Chlorhexidine gluconate?

You should not use this medication if you are allergic to Chlorhexidine gluconate gluconate.

If you have periodontal disease, you may need special treatments while you are using Chlorhexidine gluconate gluconate.

Chlorhexidine gluconate is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.

Do not give this medication to a child or teenager without a doctor's advice.

Do not add water to Chlorhexidine gluconate. Do not rinse your mouth with water or other mouthwashes right after using Chlorhexidine gluconate gluconate.

Avoid eating, drinking, or brushing your teeth just after using this medication.

Do not use any other mouthwash unless your doctor has told you to.

Chlorhexidine gluconate gluconate can stain teeth, dentures, tooth restorations, your tongue, or the inside of your mouth. Talk with your dentist about ways to remove staining from these surfaces. Stains may be harder to remove from false teeth that have scratches in their surfaces.

Visit your dentist at least every 6 months for preventive tooth and gum care.



Undesirable effects

See also:
What are the possible side effects of Benzalkonium chloride?

Paralysis of respiratory muscle, Allergic contact dermatitis, Apprehension, Collapse, Coma, Convulsion, Cyanosis (bluish discoloration of the skin), Death, Shortness of breath, Muscle weakness, Restlessness, Vomiting

See also:
What are the possible side effects of Benzyl alcohol?

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The rates of adverse reactions below were derived from two randomized, multi-center, vehicle-controlled clinical trials and one open-label study in subjects with head lice infestation.

Skin, scalp, and ocular irritation were monitored in the clinical trials. All subjects were queried about the presence of skin and scalp symptoms; the results are presented in Table 2.

The subset of subjects who did not have pruritus, erythema, edema or pyoderma of skin and scalp, or ocular irritation prior to treatment were assessed for these signs and symptoms after treatment; the results are presented in Table 3.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation.

See also:
What are the possible side effects of Chlorhexidine gluconate?

The most common side effects associated with Chlorhexidine gluconate 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 Chlorhexidine gluconate 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 Chlorhexidine gluconate 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 Chlorhexidine gluconate.

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

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Topical/Cutaneous

As antiseptic and disinfectant

Adult: As soln: Cleansing of skin, mucous membrane and wounds: 0.01-0.1%. Irrigation of deep wounds: 0.005%. Irrigation of bladder and urethra: 0.005-0.02%. Retention lavage of the bladder: 0.0025-0.005%. Disinfection and storage of surgical instruments: 0.13%; may be used w/ Na nitrite to avoid corrosion. As preservative: 0.01%-0.02% (ophth preparation); 0.002-0.2% (nasal and otic preparation). As shampoo: Seborrhoeic dermatitis: 0.2-0.5%. As cream: Napkin rash and other dermatoses: 0.13%. As vaginal douche: 0.02-0.05%. Refer to product information for specific directions for use.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.1.1 Indication

Benzyl alcohol® Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

1.2 Limitation of Use

Benzyl alcohol® Lotion does not have ovocidal activity.

1.3 Adjunctive Measures

Benzyl alcohol® Lotion should be used in the context of an overall lice management program:

  • Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels.

  • Wash personal care items such as combs, brushes and hair clips in hot water.

  • A fine-tooth comb or special nit comb may be used to remove dead lice and nits.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Chlorhexidine gluconate® (Chlorhexidine gluconate Gluconate

Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Treating cold sores and fever blisters. It may also be used for other conditions as determined by your doctor.

Benzalkonium chloride is a topical antiseptic. It works by killing sensitive germs.

Benzyl alcohol (benzyl alcohol topical) is an anti-parasite medication.

Benzyl alcohol is used to treat head lice in people between the ages of 6 months and 60 years old.

Benzyl alcohol is for treating head lice only. It will not treat lice on other body areas.

Benzyl alcohol may also be used for purposes not listed in this medication guide.

Chlorhexidine gluconate gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Chlorhexidine gluconate is used to treat gingivitis (swelling, redness, bleeding gums). Chlorhexidine gluconate gluconate is usually prescribed by a dentist.

Chlorhexidine gluconate is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.

Chlorhexidine gluconate gluconate may also be used for purposes not listed in this medication guide.

Name of the medicinal product

Benzalkonium chloride/benzyl alcohol/Chlorhexidine gluconate

Qualitative and quantitative composition

A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

Each chip contains Chlorhexidine gluconate gluconate 2.5 mg in a biodegradable matrix of hydrolyzed gelatin (cross-linked with glutaraldehyde).

Chlorhexidine gluconate also contains glycerin and purified water as excipients.

Chlorhexidine gluconate gluconate, an antimicrobial agent, is 1, 1'-hexamethylenebis [5-(p-chlorophenyl)biguanide] di-D-gluconate. Molecular Formula: C22H30Cl2N10·2C6H12O7. Molecular Weight: 897.8.

Special warnings and precautions for use

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

  • Benzalkonium chloride is for external use only. Do not get it in your eyes or nose.
  • Wash the affected area with warm water and a washcloth to remove any cosmetics (eg, lipstick), lotions, ointments, or other lip preparations.
  • Prepare Benzalkonium chloride for use according to the directions on the label.
  • Apply the medicine by rubbing the affected area firmly with the applicator tip. Be careful not to damage the skin. Throw the applicator away after use.
  • Wash your hands immediately after using Benzalkonium chloride.
  • Do not brush your teeth or drink soft drinks or fruit juices for at least 1 hour after you use Benzalkonium chloride.
  • If your symptoms get better but return later, you may use another dose. Do not use more than 3 times per day.
  • If you miss a dose of Benzalkonium chloride, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Benzalkonium chloride.

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

  • An extra patient leaflet is available with Benzyl alcohol. Talk to your pharmacist if you have questions about this information.
  • Benzyl alcohol is for topical use only. Do not get Benzyl alcohol in the eyes. Keep eyes closed until Benzyl alcohol is rinsed out of the hair. If using Benzyl alcohol on a child, cover the eyes with a washcloth or towel.
  • Apply enough of Benzyl alcohol to saturate hair and scalp, especially behind the ears and on the back of the neck. Leave on hair for 10 minutes. Rinse with water. Repeat treatment after 7 days.
  • Wash your hands immediately after using Benzyl alcohol.
  • All personal headgear, scarves, coats, and bed linens should be disinfected by machine washing in hot water and drying. Use the hot cycle of a dryer for at least 20 minutes.
  • Personal articles of clothing and bedding that cannot be washed or dried by machine may be dry cleaned, sealed in a plastic bag for a period of about 2 weeks, or sprayed with a product specifically designed for this purpose.
  • Personal combs and brushes may be disinfected by soaking in hot water above 130 degrees F (54 degrees C) for 5 to 10 minutes.
  • Thoroughly vacuum rooms, including furniture, of individuals infected with lice.
  • If you miss a dose of Benzyl alcohol, use it as soon as you remember.

Continue to use it as directed by your doctor. Ask your health care provider any questions you may have about how to use Benzyl alcohol.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Rinse your mouth with Chlorhexidine gluconate gluconate twice daily after brushing your teeth.

Measure your dose using the cup provided with the medication. Swish the medicine in your mouth for at least 30 seconds, then spit it out. Do not swallow the mouthwash.

Do not add water to the oral rinse. Do not rinse your mouth with water or other mouthwashes right after using Chlorhexidine gluconate gluconate.

Chlorhexidine gluconate gluconate may leave an unpleasant taste in your mouth. Do not rinse your mouth to remove this taste after using the medication. You may rinse the medicine away and reduce its effectiveness.

Use this medication for the full prescribed length of time. Your symptoms may improve before your gingivitis is completely cleared. Chlorhexidine gluconate gluconate will not treat a viral or fungal infection such as cold sores, canker sores, or oral thrush (yeast infection).

Visit your dentist at least every 6 months for preventive tooth and gum care.

Store Chlorhexidine gluconate gluconate at room temperature away from moisture and heat.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Bladder irrigation, ear, eye, nose and throat irrigation, gingivitis, perodontal diseases, preoperative disinfection of unbroken skin, stomatitis, thrush, tonsillitis, urethral irrigation.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Head lice

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications

Gingivitis:

Oral rinse: Antimicrobial dental rinse for gingivitis treatment

Periodontitis: Periodontal chip: Adjunctive therapy to scaling and root planning procedures to reduce pocket depth in patients with periodontitis

Off Label UsesMedication-related osteonecrosis of the jaw (MRONJ), adjunctive therapy:Oral rinse:

Based on a position paper by the American Association of Maxillofacial Surgeons (AAOMS), Chlorhexidine gluconate is an effective and recommended adjunctive treatment strategy in the management of medication-related osteonecrosis of the jaw (MRONJ) (stage 1 and above [eg, patients with exposed and necrotic bone or fistulae that probes to bone]).

Oropharyngeal decontamination to reduce the risk of ventilator-associated or hospital-acquired pneumonia, Cardiac surgical patients:Oral rinse:

Data from a prospective, randomized, double-blind, placebo-control trial and a prospective, randomized, case-controlled trial in patients undergoing coronary artery bypass grafting, valve, or other open heart surgical procedures who received Chlorhexidine gluconate gluconate 0.12% oral rinse during the perioperative period showed a decreased rate in hospital-acquired pneumonia. However, the trials used in both meta-analyses were heterogeneous and included patients in a variety of settings (eg, cardiothoracic, general ICU, mixed medical-surgical ICU, trauma ICU). The trials also displayed significant variability with Chlorhexidine gluconate treatment regimens. Chlorhexidine gluconate concentration varied from 0.12%, 0.2%, or 2% across studies. Frequency of administration, Chlorhexidine gluconate dosage form (oral rinse, gel, paste, foam), and technique of application also varied across studies. In the US, Chlorhexidine gluconate gluconate for use in the oral cavity is commercially available only as 0.12% solution. Additional trials may be necessary to further define the role of Chlorhexidine gluconate in this condition.

Dosage (Posology) and method of administration

Topical/Cutaneous

As antiseptic and disinfectant

Adult: As soln: Cleansing of skin, mucous membrane and wounds: 0.01-0.1%. Irrigation of deep wounds: 0.005%. Irrigation of bladder and urethra: 0.005-0.02%. Retention lavage of the bladder: 0.0025-0.005%. Disinfection and storage of surgical instruments: 0.13%; may be used w/ Na nitrite to avoid corrosion. As preservative: 0.01%-0.02% (ophth preparation); 0.002-0.2% (nasal and otic preparation). As shampoo: Seborrhoeic dermatitis: 0.2-0.5%. As cream: Napkin rash and other dermatoses: 0.13%. As vaginal douche: 0.02-0.05%. Refer to product information for specific directions for use.

Benzyl alcohol® Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guidelines in Table 1, apply sufficient Benzyl alcohol® Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat application after 7 days. Avoid contact with eyes.

Table 1: Benzyl alcohol® Lotion Usage Guideline

Hair Length Amount of Benzyl alcohol® Lotionper Application
Ounces 8 oz bottle Size
Short 0-2 inches 4-6 oz ½ to ¾ bottle
2-4 inches 6-8 oz ¾-1 bottle
Medium 4-8 inches 8-12 oz 1-1½ bottles
8-16 inches 12-24 oz 1½-3 bottles
Long 16-22 inches 24-32 oz 3-4 bottles
Over 22 inches 32-48 oz 4-6 bottles
How suppliedDosage Forms And Strengths

Benzyl alcohol® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion).

Storage And Handling

Benzyl alcohol® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion)

NDC 59212-780-08 as an 8 fl oz (227 g) in a polypropylene bottle

NDC 59212-780-88 as a package containing two individual 8 fl oz (NDC 59212-780-08) polypropylene bottles with a nit comb

Store at 20° C - 25° C (68° F - 77° F); excursions permitted to 15° C - 30° C (59° F - 86° F).

Do not freeze.

MANUFACTURED FOR: Concordia Pharmaceuticals Inc., Bridgetown, Barbados BB11128. BY: Contract Pharmaceuticals Limited, Mississauga, Ontario L5N 6L6, Canada. Revised: 09/2013

One Chlorhexidine gluconate is inserted into a periodontal pocket with probing pocket depth (PD) 5 mm or greater. Up to 8 chips may be inserted in a single visit. Treatment is recommended to be administered once every three months in pockets with PD remaining 5 mm or greater. The periodontal pocket should be isolated and the surrounding area dried prior to chip insertion.

The Chlorhexidine gluconate 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 Chlorhexidine gluconate can be further maneuvered into position using the tips of the forceps or a flat instrument. The Chlorhexidine gluconate does not need to be removed since it biodegrades completely.

In the unlikely event of Chlorhexidine gluconate dislodgement (in the two pivotal clinical trials, only 8 chips were reported lost), several actions are recommended, depending on the day of Chlorhexidine gluconate 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 Chlorhexidine gluconate should be inserted. If dislodgement occurs more than 48 hours after placement, the dentist should not replace the Chlorhexidine gluconate, but reevaluate the patient at 3 months and insert a new Chlorhexidine gluconate if the pocket depth has not been reduced to less than 5 mm.

How supplied

Chlorhexidine gluconate (Chlorhexidine gluconate gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack.

Store at 20° - 25°C with excursions permitted to 15° - 30° C (59° - 86°F).

Manufactured by: Dexcel® Pharma Technologies Ltd, HaMarpeh 7 St.,Jerusalem 91237, Israel. Distributed by: Adrian Pharmaceuticals, Spring Hill, Florida 34606. Iss. 01/10

Interaction with other medicinal products and other forms of interaction

See also:
What other drugs will affect Benzalkonium chloride?

Increased risk of corneal toxicity when used as preservative in anaesthetic eye drops.

See also:
What other drugs will affect Benzyl alcohol?

Drug interaction studies were not conducted with Benzyl alcohol® Lotion.

See also:
What other drugs will affect Chlorhexidine gluconate?

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

Chlorhexidine gluconate Pharmaniaga is compatible with any medication containing cationic group (cetrimonium bromide, Chlorhexidine gluconate).