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Drug overview for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
Generic name: LIDOCAINE/PHENYLEPHRINE HCL/GLYCERIN
Drug class: Topical Local Anesthetics
Therapeutic class: Anorectal Preparations
Lidocaine, a nonselective voltage-gated sodium channel inhibitor, is an Phenylephrine hydrochloride, synthetic sympathomimetic amine, is a amide-type local anesthetic. vasoconstrictor.
Lidocaine is used topically for the treatment of pain. Various topical lidocaine products are commercially available. Lidocaine 1.8%
and 5% topical systems (i.e., patches) are FDA-labeled for the treatment of pain associated with postherpetic neuralgia (PHN). Lidocaine is also available in various over-the-counter (OTC) topical preparations for the temporary treatment of pain.
Generic name: LIDOCAINE/PHENYLEPHRINE HCL/GLYCERIN
Drug class: Topical Local Anesthetics
Therapeutic class: Anorectal Preparations
Lidocaine, a nonselective voltage-gated sodium channel inhibitor, is an Phenylephrine hydrochloride, synthetic sympathomimetic amine, is a amide-type local anesthetic. vasoconstrictor.
Lidocaine is used topically for the treatment of pain. Various topical lidocaine products are commercially available. Lidocaine 1.8%
and 5% topical systems (i.e., patches) are FDA-labeled for the treatment of pain associated with postherpetic neuralgia (PHN). Lidocaine is also available in various over-the-counter (OTC) topical preparations for the temporary treatment of pain.
DRUG IMAGES
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The following indications for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin) have been approved by the FDA:
Indications:
Hemorrhoids
Proctitis
Pruritus ani
Rectal pain
Professional Synonyms:
Proctalgia
Rectitis
Indications:
Hemorrhoids
Proctitis
Pruritus ani
Rectal pain
Professional Synonyms:
Proctalgia
Rectitis
The following dosing information is available for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
To produce decongestion of the conjunctiva, 1 or 2 drops of a 0.12-0.25% ophthalmic solution of phenylephrine hydrochloride may be applied topically to the conjunctiva every 3-4 hours (up to 4 times daily for self-medication) as needed.
Vasoconstriction for diagnosis of ocular congestion or to improve visualization of ocular blood vessels in sickle-cell disease may be achieved by application of 1 or 2 drops of a 2.5% solution. In the ''blanching test'', congestion probably is caused by conjunctivitis rather than iridocyclitis if the drug produces perilimbal blanching in the congested eye.
A 2.5 or 10% solution of the drug may also be administered prior to surgery to produce mydriasis and aid in controlling hemorrhage. (See Phenylephrine Hydrochloride 52:24.)
To produce nasal decongestion in adults and children 12 years of age or older, the usual dosage is 2 or 3 drops, 1-3 sprays, or 1-3 metered sprays instilled in each nostril. In cases of extreme nasal congestion in adults, a 1% solution may be used initially. To produce nasal decongestion in children 6-12 years of age, 2 or 3 drops or 1 or 2 sprays of a 0.25%
solution may be instilled in each nostril. Doses of the drug as drops or spray may be repeated in 4 hours if needed. Phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a physician consulted.
Intranasal application of phenylephrine should generally be used for no longer than 3-5 days.
For use with local anesthetics, phenylephrine hydrochloride may be used in concentrations of 1:2500 to 1:20,000.
Vasoconstriction for diagnosis of ocular congestion or to improve visualization of ocular blood vessels in sickle-cell disease may be achieved by application of 1 or 2 drops of a 2.5% solution. In the ''blanching test'', congestion probably is caused by conjunctivitis rather than iridocyclitis if the drug produces perilimbal blanching in the congested eye.
A 2.5 or 10% solution of the drug may also be administered prior to surgery to produce mydriasis and aid in controlling hemorrhage. (See Phenylephrine Hydrochloride 52:24.)
To produce nasal decongestion in adults and children 12 years of age or older, the usual dosage is 2 or 3 drops, 1-3 sprays, or 1-3 metered sprays instilled in each nostril. In cases of extreme nasal congestion in adults, a 1% solution may be used initially. To produce nasal decongestion in children 6-12 years of age, 2 or 3 drops or 1 or 2 sprays of a 0.25%
solution may be instilled in each nostril. Doses of the drug as drops or spray may be repeated in 4 hours if needed. Phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a physician consulted.
Intranasal application of phenylephrine should generally be used for no longer than 3-5 days.
For use with local anesthetics, phenylephrine hydrochloride may be used in concentrations of 1:2500 to 1:20,000.
Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva. Digital pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of ophthalmic solutions to minimize drainage into the nose and throat and reduce the risk of absorption and systemic reactions. Excess solution around the eye should be removed with a tissue.
For intranasal applications, phenylephrine may be administered in solution as drops or spray. Vicks Sinex(R) (with mist spray nozzle) nasal solution is administered by nasal inhalation using a special nasal inhaler that produces metered droplet sprays. Care must be taken to avoid contamination of the dropper, inhaler, or spray.
Except in young children in whom sprays are difficult to use, nasal sprays may be preferable to drops because of the lesser risk of swallowing the drug and resultant systemic absorption. Drops should be applied to the dependent (lower) nostril, with the patient in a lateral head-low position. The patient should remain in the same position for 5 minutes, then the solution should be applied to the other nostril in a similar manner.
Alternatively, drops may be instilled when the patient is reclining with the head tilted back as far as possible. Sprays should be delivered or pumped (Vicks Sinex(R) metered spray) into each nostril with the patient's head erect so that excess solution is not released. The nose should be blown thoroughly 3-5 minutes later.
Prior to initial use of the metered sprays, the nasal inhaler must be primed by depressing the pump firmly several times. To minimize the risk of spreading infections, droppers, inhalers, and spray dispensers should not be used by more than one person, and tips of the dispensers, inhalers, or droppers should be rinsed with hot water following use. Phenylephrine nasal solutions also may be applied to a tampon or nasal pack for insertion into nasal passages.
However, this method of application should be restricted to use in diagnostic or surgical procedures performed under medical supervision because mechanical injury may occur. 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.
For intranasal applications, phenylephrine may be administered in solution as drops or spray. Vicks Sinex(R) (with mist spray nozzle) nasal solution is administered by nasal inhalation using a special nasal inhaler that produces metered droplet sprays. Care must be taken to avoid contamination of the dropper, inhaler, or spray.
Except in young children in whom sprays are difficult to use, nasal sprays may be preferable to drops because of the lesser risk of swallowing the drug and resultant systemic absorption. Drops should be applied to the dependent (lower) nostril, with the patient in a lateral head-low position. The patient should remain in the same position for 5 minutes, then the solution should be applied to the other nostril in a similar manner.
Alternatively, drops may be instilled when the patient is reclining with the head tilted back as far as possible. Sprays should be delivered or pumped (Vicks Sinex(R) metered spray) into each nostril with the patient's head erect so that excess solution is not released. The nose should be blown thoroughly 3-5 minutes later.
Prior to initial use of the metered sprays, the nasal inhaler must be primed by depressing the pump firmly several times. To minimize the risk of spreading infections, droppers, inhalers, and spray dispensers should not be used by more than one person, and tips of the dispensers, inhalers, or droppers should be rinsed with hot water following use. Phenylephrine nasal solutions also may be applied to a tampon or nasal pack for insertion into nasal passages.
However, this method of application should be restricted to use in diagnostic or surgical procedures performed under medical supervision because mechanical injury may occur. 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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
There are 0 contraindications.
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 MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
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 9 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Benign prostatic hyperplasia |
| Cardiac arrhythmia |
| Coronary artery disease |
| Disease of liver |
| Hypertension |
| Hyperthyroidism |
| Nervousness |
| Respiratory depression |
| Seizure disorder |
The following adverse reaction information is available for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
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 MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
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 |
Animal reproduction studies have not been performed with phenylephrine. It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia.
(See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed. 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.
(See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed. 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.
Since it is not known whether phenylephrine is distributed into milk, the drug should be used with caution in nursing women. 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 MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MEDICATED HEMORRHOID PAIN RLF (lidocaine/phenylephrine hcl/glycerin)'s list of indications:
| Hemorrhoids | |
| K64.0 | First degree hemorrhoids |
| K64.8 | Other hemorrhoids |
| K64.9 | Unspecified hemorrhoids |
| O22.4 | Hemorrhoids in pregnancy |
| O22.40 | Hemorrhoids in pregnancy, unspecified trimester |
| O22.41 | Hemorrhoids in pregnancy, first trimester |
| O22.42 | Hemorrhoids in pregnancy, second trimester |
| O22.43 | Hemorrhoids in pregnancy, third trimester |
| O87.2 | Hemorrhoids in the puerperium |
| Proctitis | |
| K62.7 | Radiation proctitis |
| K62.89 | Other specified diseases of anus and rectum |
| Pruritus ani | |
| L29.0 | Pruritus ani |
| L29.3 | Anogenital pruritus, unspecified |
| Rectal pain | |
| K62.89 | Other specified diseases of anus and rectum |
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