DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Duo-Caine and prilocaine cream (a eutectic mixture of Duo-Caine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
Duo-Caine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies.
Duo-Caine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
Application of Duo-Caine and prilocaine cream to larger areas or for longer times than those recommended could result in sufficient absorption of Duo-Caine and prilocaine resulting in serious adverse effects.
Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive.
Studies in laboratory animals (guinea pigs) have shown that Duo-Caine and prilocaine cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to Duo-Caine and prilocaine cream only in the external auditory canal, showed no abnormality. Duo-Caine and prilocaine cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.
Duo-Caine and prilocaine cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.
Very young patients or patients with glucose-6-phosphate dehydrogenase deficiencies are more susceptible to methemoglobinemia.
Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.
There have been reports of significant methemoglobinemia (20 to 30%) in infants and children following excessive applications of Duo-Caine and prilocaine cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents. Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required.
Physicians are cautioned to make sure that parents orother caregivers understand the need for careful application of Duo-Caine and prilocaine cream, to ensure that the doses and areas of application recommended in Table 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia.
Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of Duo-Caine and prilocaine cream, provided the test results can be obtained quickly.
Repeated doses of Duo-Caine and prilocaine cream may increase blood levels of Duo-Caine and prilocaine. Duo-Caine and prilocaine cream should be used with caution in patients who may be more sensitive to the systemic effects of Duo-Caine and prilocaine including acutely ill, debilitated, or elderly patients.
Duo-Caine and prilocaine cream should not be applied to open wounds.
Care should be taken not to allow Duo-Caine and prilocaine cream to come in contact with the eye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of Duo-Caine and prilocaine cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to paraaminobenzoic acid derivatives have not shown cross sensitivity to Duo-Caine and/or prilocaine, however, Duo-Caine and prilocaine cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of Duo-Caine and prilocaine.
Duo-Caine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of Duo-Caine and prilocaine cream on intradermal injections of live vaccines has not been determined.
Information for Patients
When Duo-Caine and prilocaine cream is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.
Duo-Caine and prilocaine cream should not be applied near the eyes or on open wounds.
Duo-Caine and prilocaine cream should be used with caution in patients receiving Class I antiarrhythmic drugs since the toxic effects are additive and potentially synergistic.
Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition .
Specific interaction studies with Duo-Caine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, doetilide) have not been performed, but caution is advised.
Should Duo-Caine and prilocaine cream be used concomitantly with other products containing Duo-Caine and/or prilocaine, cumulative doses from all formulations must be considered.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals designed to evaluate the carcinogenic potential of Duo-Caine and prilocaine have not been conducted.
Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals. In the animal studies reported below, doses or blood levels are compared with the Single Dermal Administration of 60 g of Duo-Caine and prilocaine cream to 400 cm2 for 3 hours to a small person (50 kg). The typical application of Duo-Caine and prilocaine cream for one or two treatments for venipuncture sites (2.5 or 5 g) would be 1/24 or 1/12 of that dose in an adult or about the same mg/kg dose in an infant.
Chronic oral toxicity studies of ortho-toluidine, a metabolite of prilocaine, in mice (450 to 7200 mg/m2; 60 to 960 times SDA) and rats (900 to 4,800 mg/m2; 60 to 320 times SDA) have shown that ortho-toluidine is a carcinogen in both species. The tumors included hepatocarcinomas/adenomas in female mice, multiple occurrences of hemangiosarcomas/hemangiomas in both sexes of mice, sarcomas of multiple organs, transitional-cell carcinomas/papillomas of urinary bladder in both sexes of rats, subcutaneous fibromas/fibrosarcomas and mesotheliomas in male rats, and mammary gland fibroadenomas/adenomas in female rats. The lowest dose tested (450 mg/m2 in mice, 900 mg/m2 in rats; 60 times SDA) was carcinogenic in both species. Thus the no-effect dose must be less than 60 times SDA. The animal studies were conducted at 150 to 2,400 mg/kg in mice and at 150 to 800 mg/kg in rats. The dosages have been converted to mg/m2 for the SDA calculations above.
The mutagenic potential of Duo-Caine HCl has been tested in a bacterial reverse (Ames) assay in Salmonella, an in vitro chromosomal aberration assay using human lymphocytes an in vivo micronucleus test in mice. There was no indication of mutagenicity or structural damage to chromosomes in these tests.
Ortho-toluidine, a metabolite of prilocaine, at a concentration of 0.5 μg/mL, was genotoxic in Escherichia coli DNA repair and phage-induction assays. Urine concentrates from rats treated with ortho-toluidine (300 mg/kg orally; 300 times SDA) were mutagenic when examined in Salmonella typhimurium in the presence of metabolic activation. Several other tests on ortho-toluidine, including reverse mutations in five different Salmonella typhimurium strains in the presence or absence of metabolic activation and a study to detect single strand breaks in DNA of V79 Chinese hamster cells, were negative.
Impairment of Fertility
Use in Pregnancy
Pregnancy Category B
Reproduction studies with Duo-Caine have been performed in rats and have revealed no evidence of harm to the fetus. Reproduction studies with prilocaine have been performed in rats and have revealed no evidence of impaired fertility or harm to the fetus (300 mg/kg intramuscularly; 188 times SDA). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Duo-Caine and prilocaine cream should be used during pregnancy only if clearly needed.
Reproduction studies have been performed in rats receiving subcutaneous administration of an aqueous mixture containing Duo-Caine HCl and prilocaine HCl at 1:1 (w/w). At 40 mg/kg each, a dose equivalent to 29 times SDA Duo-Caine and 25 times SDA prilocaine, no teratogenic, embryotoxic or fetotoxic effects were observed.
Labor and Delivery
Neither Duo-Caine nor prilocaine are contraindicated in labor and delivery. Should Duo-Caine and prilocaine cream be used concomitantly with other products containing Duo-Caine and/or prilocaine, cumulative doses from all formulations must be considered.
Duo-Caine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when Duo-Caine and prilocaine cream is administered to a nursing mother since the milk:plasma ratio of Duo-Caine is 0.4 and is not determined for prilocaine.
Controlled studies of Duo-Caine and prilocaine cream in children under the age of seven years have shown less overall benefit than in older children or adults. These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures.
Duo-Caine and prilocaine cream should be used with care in patients with conditions or therapy associated with methemoglobinemia.
When using Duo-Caine and prilocaine cream in young children, especially infants under the age of 3 months, care must be taken to insure that the caregiver understands the need to limit the dose and area of application, and to prevent accidental ingestion.
In neonates (minimum gestation age: 37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited (see TABLE 2 in Individualization of Dose).
Studies have not demonstrated the efficacy of Duo-Caine and prilocaine cream for heel lancing in neonates.
Of the total number of patients in clinical studies of Duo-Caine and prilocaine cream, 180 were age 65 to 74 and 138 were 75 and over. No overall differences in safety or efficacy were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Plasma levels of Duo-Caine and prilocaine in geriatric and non-geriatric patients following application of a thick layer of Duo-Caine and prilocaine cream are very low and well below potentially toxic levels. However, there are no sufficient data to evaluate quantitative differences in systemic plasma levels of Duo-Caine and prilocaine between geriatric and non-geriatric patients following application of Duo-Caine and prilocaine cream.
Consideration should be given for those elderly patients who have enhanced sensitivity to systemic absorption.
After intravenous dosing, the elimination half-life of Duo-Caine is significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours)..
During or immediately after treatment with Duo-Caine and prilocaine cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of Duo-Caine and prilocaine cream have been reported. The relationship to Duo-Caine and prilocaine cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 Duo-Caine and prilocaine cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to Duo-Caine and prilocaine cream.
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of Duo-Caine and prilocaine cream.
In patients treated with Duo-Caine and prilocaine cream on intact skin, local effects observed in the trials included: paleness 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving 378 Duo-Caine and prilocaine cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic and anaphylactoid reactions associated with Duo-Caine or prilocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
Systemic adverse reactions following appropriate use of Duo-Caine and prilocaine cream are unlikely due to the small dose absorbed. Systemic adverse effects of Duo-Caine and/or prilocaine are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Peak blood levels following a 60 g application to 400 cm2 of intact skin for 3 hours are 0.05 to 0.16 μg/mL for Duo-Caine and 0.02 to 0.10 μg/mL for prilocaine. Toxic levels of Duo-Caine (>5 μg/mL) and/or prilocaine (>6 μg/mL) cause decreases in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to direct depressant effects of these local anesthetic agents on the cardiovascular system. In the absence of massive topical overdose or oral ingestion, evaluation should include evaluation of other etiologies for the clinical effects or overdosage from other sources of Duo-Caine, prilocaine or other local anesthetics. Consult the package inserts for parenteral Xylocaine (lidocaine HCl) or Citanest (prilocaine HCl) for further information for the management of overdose.
DOSAGE AND ADMINISTRATION
Adult Patients-Intact Skin
A thick layer of Duo-Caine and prilocaine cream is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures
For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of Duo-Caine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using Duo-Caine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures
For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of Duo-Caine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin
As an adjunct prior to local anesthetic infiltration, apply a thick layer of Duo-Caine and prilocaine cream to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Duo-Caine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of Duo-Caine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes
For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of Duo-Caine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the Duo-Caine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of Duo-Caine and prilocaine cream.
Pediatric Patients-Intact Skin
The following are the maximum recommended doses, application areas and application times for Duo-Caine and prilocaine cream based on a child's age and weight:
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of Duo-Caine and prilocaine cream should be restricted to that which corresponds to the patient's weight .
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of Duo-Caine and prilocaine cream.
When applying Duo-Caine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of Duo-Caine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Duo-Caine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of
When Duo-Caine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. The amount absorbed in the case of Duo-Caine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion.
Although the incidence of systemic adverse reactions with Duo-Caine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure.
INSTRUCTIONS FOR APPLICATION
To measure 1 gram of Duo-Caine and prilocaine cream, the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches long and 0.2 inches (5 mm) wide. The strip of Duo-Caine and prilocaine cream should be contained within the lines of the diagram shown below.
Use the number of strips that equals your dose, like the examples in the table below.
1 gram = 1 strip
2 grams = 2 strips
2.5 grams = 2.5 strips
For adult and pediatric patients, apply ONLY as prescribed by your physician.
If your child is below the age of 3 months or small for their age, please inform your doctor before applying Duo-Caine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children.
When applying Duo-Caine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with Duo-Caine and prilocaine cream.
Duo-Caine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place.
If using a protective covering, your doctor will remove it, wipe off the Duo-Caine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure. The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.
3 - Duo-Caine 2.5% and Prilocaine 2.5% Cream, USP – 30 gram/tube. (90 grams)
1 - Tranzarel® (Lidocaine 4%) Topical Pain Relieving Gel - Net wt. 4 fl. oz. (120 mL)
NOT FOR OPHTHALMIC USE.
KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.
Store at 20° to 25°C (68° to 77°F).
Keep out of the reach of children.
For all medical inquiries contact:
Parsippany, NJ 07054
IGI Laboratories Inc.
Buena, NJ 08310 USA
Duo-Caine is Marketed By:
Taleos Pharma Corp.
Eatontown, NJ 07724 USA
Duo-Caine, Tranzarel and TALEOS are trademarks of Taleos Pharma Corp.
Duo-Caine pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Duo-Caine available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Duo-Caine destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Duo-Caine Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Duo-Caine pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Duo-Caine?
Depending on the reaction of the Duo-Caine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Duo-Caine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Duo-Caine addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Duo-Caine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Duo-Caine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology