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Drug overview for BACTINE (lidocaine hcl/benzalkonium chloride):
Generic name: LIDOCAINE HCL/BENZALKONIUM CHLORIDE (LYE-doe-kane)
Drug class: Topical Local Anesthetics
Therapeutic class: Dermatological
Benzalkonium chloride, a mixture of alkyldimethylbenzylammonium chlorides, Lidocaine, a nonselective voltage-gated sodium channel inhibitor, is an amide-type local anesthetic. is rapidly germicidal for many pathogenic bacteria and fungi.
Lidocaine is used topically for the treatment of pain. Various topical Properly diluted, benzalkonium chloride is used for the prophylactic disinfection of the intact skin and in the treatment of superficial lidocaine products are commercially available. Lidocaine 1.8%
and 5% injuries and infected wounds. It is also used to preserve the sterility of topical systems (i.e., patches) are FDA-labeled for the treatment of pain associated with postherpetic neuralgia (PHN). Lidocaine is also available surgical instruments and rubber articles during storage, and to preserve in various over-the-counter (OTC) topical preparations for the temporary the sterility of ophthalmic solutions. treatment of pain.
Generic name: LIDOCAINE HCL/BENZALKONIUM CHLORIDE (LYE-doe-kane)
Drug class: Topical Local Anesthetics
Therapeutic class: Dermatological
Benzalkonium chloride, a mixture of alkyldimethylbenzylammonium chlorides, Lidocaine, a nonselective voltage-gated sodium channel inhibitor, is an amide-type local anesthetic. is rapidly germicidal for many pathogenic bacteria and fungi.
Lidocaine is used topically for the treatment of pain. Various topical Properly diluted, benzalkonium chloride is used for the prophylactic disinfection of the intact skin and in the treatment of superficial lidocaine products are commercially available. Lidocaine 1.8%
and 5% injuries and infected wounds. It is also used to preserve the sterility of topical systems (i.e., patches) are FDA-labeled for the treatment of pain associated with postherpetic neuralgia (PHN). Lidocaine is also available surgical instruments and rubber articles during storage, and to preserve in various over-the-counter (OTC) topical preparations for the temporary the sterility of ophthalmic solutions. treatment of pain.
DRUG IMAGES
BACTINE SOLUTION
BACTINE PUMP SPRAY
BACTINE PAIN RELIEVING SPRAY
The following indications for BACTINE (lidocaine hcl/benzalkonium chloride) have been approved by the FDA:
Indications:
Minor skin wound pain
Prevent minor bacterial skin infection
Pruritus of skin
Skin irritation
Professional Synonyms:
Itchy skin eruption
Prevent superficial bacterial infection of skin
Pruritic dermatitis
Indications:
Minor skin wound pain
Prevent minor bacterial skin infection
Pruritus of skin
Skin irritation
Professional Synonyms:
Itchy skin eruption
Prevent superficial bacterial infection of skin
Pruritic dermatitis
The following dosing information is available for BACTINE (lidocaine hcl/benzalkonium chloride):
Tincture of benzalkonium chloride 1:750 is used for the preoperative disinfection of unbroken skin or treatment of superficial injuries. For preoperative disinfection of mucous membranes and denuded skin, benzalkonium chloride solution in concentrations of 1:10,000 to 1:2,000 is used. For irrigation of the eye, a solution 1:10,000 to 1:5,000 is used.
For preservation of ophthalmic solutions, a solution 1:7,500 to 1:5,000 is used. For vaginal douche and irrigation, benzalkonium chloride solution 1:5,000 to 1:2,000 is used. For urinary bladder and urethral irrigation, a solution 1:5,000 to 1:20,000 is used; for retention irrigation of the bladder, a solution 1:20,000 to 1:40,000 is used.
For infected, widely denuded areas, benzalkonium chloride solution should be used in concentrations of 1:2,000 to 1:5,000. For irrigation of infected deep wounds, concentrations of 1:20,000 to 1:3,000 may be employed. For the sterile storage of metallic instruments and rubber articles, benzalkonium chloride solution 1:750, with sodium nitrite 0.5% to prevent corrosion, is used.
For preservation of ophthalmic solutions, a solution 1:7,500 to 1:5,000 is used. For vaginal douche and irrigation, benzalkonium chloride solution 1:5,000 to 1:2,000 is used. For urinary bladder and urethral irrigation, a solution 1:5,000 to 1:20,000 is used; for retention irrigation of the bladder, a solution 1:20,000 to 1:40,000 is used.
For infected, widely denuded areas, benzalkonium chloride solution should be used in concentrations of 1:2,000 to 1:5,000. For irrigation of infected deep wounds, concentrations of 1:20,000 to 1:3,000 may be employed. For the sterile storage of metallic instruments and rubber articles, benzalkonium chloride solution 1:750, with sodium nitrite 0.5% to prevent corrosion, is used.
Lidocaine patches are applied topically to intact skin. Applyimmediately after removal from the protective envelope. Patches may be cut into smaller sizes with scissors prior to removal of therelease liner.
Up to 3 patches may be applied at one time as prescribed; application of more than the recommended number of patches or for longer durations than recommended can result in increased blood concentrations of lidocaine, resulting in adverse reactions. Advise patients on proper application of the patches. Clothing may be worn over the area ofapplication.
If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides. Lidocaine 5% (Lidoderm(R)) patches may not stick if they get wet. The manufacturer states to avoid contact with water, such as bathing,swimming or showering.
The manufacturer of Ztlido(R) states that the patches may be used during moderate exercise, such as biking for 30 minutes and may be exposed to water, such as showering, for 10 minutes or immersion for 15 minutes. To dry the topical system after water exposure, gently pat the skin; do not rub the skin or topical system. Do not apply external heat sources, such as heating pads or electric blankets,directly to lidocaine patches, since this may increase plasma lidocaine levels.
The manufacturer of Ztlido(R) states that the patches can beapplied to an administration site after moderate heat exposure, such as15 minutes of heating pad exposure on a medium setting. Topical lidocaine (Lidoderm(R)and generics; Ztildo(R)) patches should be stored at 20-25degreesC with excursions permitted to 15-30degreesC.
Up to 3 patches may be applied at one time as prescribed; application of more than the recommended number of patches or for longer durations than recommended can result in increased blood concentrations of lidocaine, resulting in adverse reactions. Advise patients on proper application of the patches. Clothing may be worn over the area ofapplication.
If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides. Lidocaine 5% (Lidoderm(R)) patches may not stick if they get wet. The manufacturer states to avoid contact with water, such as bathing,swimming or showering.
The manufacturer of Ztlido(R) states that the patches may be used during moderate exercise, such as biking for 30 minutes and may be exposed to water, such as showering, for 10 minutes or immersion for 15 minutes. To dry the topical system after water exposure, gently pat the skin; do not rub the skin or topical system. Do not apply external heat sources, such as heating pads or electric blankets,directly to lidocaine patches, since this may increase plasma lidocaine levels.
The manufacturer of Ztlido(R) states that the patches can beapplied to an administration site after moderate heat exposure, such as15 minutes of heating pad exposure on a medium setting. Topical lidocaine (Lidoderm(R)and generics; Ztildo(R)) patches should be stored at 20-25degreesC with excursions permitted to 15-30degreesC.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for BACTINE (lidocaine hcl/benzalkonium chloride):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Ethyl Alcohol/Disulfiram Derivatives SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Disulfiram alters the intermediary metabolism of alcohol. Acetaldehyde is produced as a result of an initial metabolism of alcohol in the liver. Acetaldehyde is normally further oxidized by aldehyde dehydrogenase. However, this step is slowed by disulfiram and results in elevated acetaldehyde levels in the blood, which produces the undesirable effects.(1-2) CLINICAL EFFECTS: Patients taking preparations that contain alcohol or using topical preparations that contain alcohol while taking disulfiram or agents related to it may experience throbbing in the head and neck, palpitations, tachycardia, hypotension, sweating, nausea, and vomiting.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer recommends that disulfiram never be administered to a patient who is in a state of alcohol intoxication. Patients should be advised that even small amounts of alcohol may trigger the reaction. U.S. manufacturer states that taking any alcohol containing products during the course of therapy with disulfiram or its derivatives is contraindicated.(2) Patients should be informed about unsuspected sources of alcohol such as elixirs and topical preparations.(2) Alcohol is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (13): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation DISCUSSION: Disulfiram is used therapeutically in the treatment of alcoholism. The quantity of alcohol required to elicit the interaction varies with individuals.(2,4-5) Consumption of even small doses (e.g., 15 ml may lead to this interaction; therefore, concomitant administration should be avoided. Patients have suffered from this interaction from ingest-ing cough mixtures(6) and using topical preparations such as aftershave lotions(7) and antipsoriatic preparations(8) that contained alcohol. The duration of this interaction varies from 30 to 60 minutes to several hours, depending on the amount of alcohol consumed.(2,9) An overdose of disulfiram and alcohol may have caused a case of severe polyneuritis in one report,(10) and another report attributes the death of a patient to this interaction.(11) This interaction has also been reported in patients who came in contact with other organic solvents (e.g., paint, "mineral spirits") through inhalation; therefore, patients should be advised of this potential hazard as well.(12) |
DISULFIRAM |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 0 moderate interactions.
The following contraindication information is available for BACTINE (lidocaine hcl/benzalkonium chloride):
Drug contraindication overview.
*Known history of sensitivity to local anesthetic of the amide type, or to any other component of the product.
*Known history of sensitivity to local anesthetic of the amide type, or to any other component of the product.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Large open wound |
| Methemoglobinemia |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Heart block |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Sepsis |
| Shock |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Respiratory depression |
| Seizure disorder |
The following adverse reaction information is available for BACTINE (lidocaine hcl/benzalkonium chloride):
Adverse reaction overview.
Common adverse effects of lidocaine 1.8 and 5% patches include mild and transient application site reactions (e.g., blisters, bruising, burning sensation, depigmentation,dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia,pruritus, vesicles). Systemic adverse reactions following topical use of lidoderm patch are unlikely due to minimal drug absorption.
Common adverse effects of lidocaine 1.8 and 5% patches include mild and transient application site reactions (e.g., blisters, bruising, burning sensation, depigmentation,dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia,pruritus, vesicles). Systemic adverse reactions following topical use of lidoderm patch are unlikely due to minimal drug absorption.
There are 16 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dermatitis due to topical drug |
| Rare/Very Rare |
|---|
|
Acute respiratory failure Anaphylaxis Angioedema Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia CNS toxicity Cyanosis Eyelid edema Headache disorder Hypotension Methemoglobinemia Respiratory depression Seizure disorder Unconsciousness |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Blanching of skin Edema Erythema Pruritus of skin Skin rash Stinging of skin Urticaria |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Apprehension Blurred vision Dizziness Drowsy Euphoria Muscle fasciculation Nervousness Sensation of cold Sensation of warmth Tinnitus Tremor Vomiting |
The following precautions are available for BACTINE (lidocaine hcl/benzalkonium chloride):
Safety and effectiveness in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Lidocaine 5% patch has not been studied in pregnancy. The limited human data with the 1.8% patch are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
Animal reproductionstudies found that subcutaneous administration of the drug at doses higher than recommended human doses during the period of organogenesis resulted in lower fetal weights. Some manufacturers recommend that lidocaine patches should be used during pregnancy only if clearly needed. Lidoderm patches have not been studied and are contraindicated in labor and delivery. If lidocaine patches are used concomitantly with other productscontaining lidocaine, total doses contributed by all formulations must be considered.
Animal reproductionstudies found that subcutaneous administration of the drug at doses higher than recommended human doses during the period of organogenesis resulted in lower fetal weights. Some manufacturers recommend that lidocaine patches should be used during pregnancy only if clearly needed. Lidoderm patches have not been studied and are contraindicated in labor and delivery. If lidocaine patches are used concomitantly with other productscontaining lidocaine, total doses contributed by all formulations must be considered.
Lidocaine is excreted into humanmilk in low concentrations following topical application. Caution should be exercised whenlidocaine is administered to a nursing woman, especially when administered with other local anesthetics.
Clinical studies of lidocaine 1.8% patch did not include sufficient number of patients >=65 years of age to determine whether they respond differently from younger patients. No differences in response have been identified in other clinical experience.
The following prioritized warning is available for BACTINE (lidocaine hcl/benzalkonium chloride):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for BACTINE (lidocaine hcl/benzalkonium chloride)'s list of indications:
| Pruritus of skin | |
| L29.8 | Other pruritus |
| L29.81 | Cholestatic pruritus |
| L29.89 | Other pruritus |
| L29.9 | Pruritus, unspecified |
| Skin irritation | |
| L24 | Irritant contact dermatitis |
| L24.0 | Irritant contact dermatitis due to detergents |
| L24.1 | Irritant contact dermatitis due to oils and greases |
| L24.2 | Irritant contact dermatitis due to solvents |
| L24.3 | Irritant contact dermatitis due to cosmetics |
| L24.4 | Irritant contact dermatitis due to drugs in contact with skin |
| L24.5 | Irritant contact dermatitis due to other chemical products |
| L24.6 | Irritant contact dermatitis due to food in contact with skin |
| L24.7 | Irritant contact dermatitis due to plants, except food |
| L24.8 | Irritant contact dermatitis due to other agents |
| L24.81 | Irritant contact dermatitis due to metals |
| L24.89 | Irritant contact dermatitis due to other agents |
| L24.9 | Irritant contact dermatitis, unspecified cause |
| L24.A | Irritant contact dermatitis due to friction or contact with body fluids |
| L24.A0 | Irritant contact dermatitis due to friction or contact with body fluids, unspecified |
| L24.A1 | Irritant contact dermatitis due to saliva |
| L24.A2 | Irritant contact dermatitis due to fecal, urinary or dual incontinence |
| L24.A9 | Irritant contact dermatitis due friction or contact with other specified body fluids |
| L24.B | Irritant contact dermatitis related to stoma or fistula |
| L24.B0 | Irritant contact dermatitis related to unspecified stoma or fistula |
| L24.B1 | Irritant contact dermatitis related to digestive stoma or fistula |
| L24.B2 | Irritant contact dermatitis related to respiratory stoma or fistula |
| L24.B3 | Irritant contact dermatitis related to fecal or urinary stoma or fistula |
| L25 | Unspecified contact dermatitis |
| L25.0 | Unspecified contact dermatitis due to cosmetics |
| L25.1 | Unspecified contact dermatitis due to drugs in contact with skin |
| L25.2 | Unspecified contact dermatitis due to dyes |
| L25.3 | Unspecified contact dermatitis due to other chemical products |
| L25.4 | Unspecified contact dermatitis due to food in contact with skin |
| L25.5 | Unspecified contact dermatitis due to plants, except food |
| L25.8 | Unspecified contact dermatitis due to other agents |
| L25.9 | Unspecified contact dermatitis, unspecified cause |
| L30.9 | Dermatitis, unspecified |
| R21 | Rash and other nonspecific skin eruption |
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