Benadryl topical product poses danger if swallowed
Benadryl topical product poses
danger if swallowed
From the January 29, 2009 issue
Over the holidays, our
consumer website (www.ConsumerMedSafety.org) featured a warning about BENADRYL ITCH STOPPING
GEL (diphenhydrAMINE), an over-the-counter (OTC) topical product used to
relieve itching. The FDA adverse event reporting system has collected at least seven
reports of people who have swallowed the product, which has led to serious
adverse reactions requiring hospitalization or emergency treatment.
&Benadryl Gel contains diphenhydramine as well
as camphor, which is known to be toxic if swallowed. Camphor can cause a variety
of symptoms including burning of the mouth and throat, nausea and vomiting,
irritability, confusion, seizures, coma, and irregular respirations. Its
ingestion has occasionally led to fatalities. Camphorated oil, another topical product,
was removed from the market in the 1980s after multiple incidents of accidental
ingestion (www.fda.gov/ cder/otcmonographs/Camphorated_Oil/
camphorted_oil_human_use_.pdf). But it&s not clear whether the adverse
reactions experienced by people who swallowed Benadryl Gel were due to the
camphor component of the product or the Benadryl itself, since the symptoms can
be similar.
The packaging and labeling of Benadryl
Gel is one of the key contributing factors associated with these errors.
Benadryl is an antihistamine that has been on the market for many years. Its
line of products has grown over the years, and it now includes many combination
products to treat various symptoms. These products are widely available as a topical
cream, oral liquid, capsule, and injectable product. Although the topical cream
has long been available, all the other Benadryl products are intended for oral
or parenteral administration. Further, instead of being packaged in a tube,
like many topical products, the Benadryl Gel is available in a 4 ounce bottle.
The clear gel, which has a consistency more like liquid than a gel, can easily
be mistaken as an oral liquid, particularly since the bottle has the same shape
and size as other oral liquid products.
In our opinion, the labeling of the product
(see the photo on page 1) does not sufficiently warn consumers not to ingest
the product. You will notice that the label states in very small print, &Topical
Analgesic,& but this statement is nestled among other product information and
easily missed. If it is seen, it&s also possible that consumers won&t understand
this medical terminology. &External Use Only,& &Apply ONLY to the skin,& or &Do
NOT swallow& would be better statements on the front label panel. &External&
use is mentioned on the other side of the bottle under the Drug Facts section,
but that information was apparently missed in the abovementioned cases.
We spoke with a company representative to
ask them to make the changes suggested above. The company spokesman agreed that
his team would look into our suggestions and get back to us. We also hope they
will consider adding a picture on the label that implies topical use for
non-English speaking consumers.
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& 2017 Institute for Safe Medication Practices. All rights reserved要列出原料药的内在稳定性信息（例如强制降解试验和；不需要；2.3.PDRUGPRODUCT药物产品；2.3.P.1DescriptionandCom；Whatarethecomponentsandc；Howshouldthecompositionb；Foreachstrength,listtheq；2.3.P.4(ControlofExcipie；对于每一规
要列出原料药的内在稳定性信息（例如强制降解试验和降解途径识别）吗？ No, this information may affect the design, performance or manufacture of the drug product and should be discussed in the QOS at 2.3.P.2.1.1. The data should be included in module 3 of the application.
不需要。这些信息可能会影响药物产品的设计、性能或生产，应在QOS2.3.P.2.1.1中进行讨论。这些数据应包含在申请资料的模块3中。
2.3.P DRUG PRODUCT 药物产品
2.3.P.1 Description and Composition of the Drug Product 药物产品的说明和配方
What are the components and composition of the final product? What is the function of each excipient? 终产品的成分和配方是什么？每种辅料的功能是什么？
How should the composition be presented? 配方应如何表示？
For each strength, list the quantitative composition and function of each component in the drug product. Include solvents and processing aids removed during processing. Indicate which components are compendial. Excipient grade should be discussed in
2.3.P.4 (Control of Excipients). The total amount of material in exhibit and production batches goes in [2.3.P.3]
对于每一规格，列出药品中各成分的定量组成与功能。包括在生产过程中除去的溶剂和加工助剂。指出哪些成分是法定的。辅料的级别应在2.3.P.4（辅料的控制）中进行讨论。物料的总量和生产批次列在[2.3.P.3]中。
For modified release products with multiple processing steps, the composition of the significant intermediates (for example: tablet cores or beads) should be presented, in addition to the composite composition statement.
对于具有多个工艺步骤的修饰释放产品，除复合成分表外，还应标明其重要中间
Identify and justify any formulation overages or overfills that appear in the final product. Manufacturing overages should be discussed in 2.3.P.3. Overfills are discussed in the appropriate USP sections on Pharmaceutical Dosage Forms.
确定并论证在最终产品中出现的任何超处方量或过量充填。生产中的过量投料应在2.3.P.3中讨论。过量充填在USP的药物剂型（Pharmaceutical Dosage Forms）的适当部分已有论述。
Note that, in general, the only acceptable justification for an overage in the final drug
product formulation is the demonstration of the same overage in the RLD
需要注意的是，在一般情况下，在最终的药物产品中超处方量的唯一可接受的理由是在RLD中存在同样的超量。
Does any excipient exceed the IIG limit for this route of administration? 是否有任一辅料超出这一给药途径的IIG限度？
How should the composition be compared to the IIG limits? 配方应该如何与IIG限度进行比较？
List IIG limits for each excipient in a table. 在一张表格中列出所有辅料的IIG限
Please note that the publicly available IIG database
http://www.accessdata.fda.gov/scripts/cder/iig/ provides the highest level for a single unit.
请注意，公开可用的IIG数据库http://www.accessdata.fda.gov/scripts/cder/iig/可提供每单位的最高标准。
In the OGD review of this question, reviewers may compare the maximum daily dose of an excipient to the maximum daily dose of that excipient found in a previously approved drug product with the same route of administration.
OGD在审核这个问题时，评审员可能会将某一辅料的每日最大剂量与以前批准的相同给药途径药品中这一辅料的每日最大剂量进行比较。
If the maximum daily dose of an excipient exceeds the IIG level (for single unit) in the public database, then it is prudent for an ANDA sponsor to identify an example use of this excipient in an approved drug product at a higher daily dose than in the proposed ANDA product.
如果某个辅料的每日最大剂量超过在公共数据库中查得的IIG标准（每单位），那么谨慎的做法是：ANDA申请者应在一个比拟申报ANDA产品更高的每日剂量下考察一个使用该辅料生产的已批准上市的药物产品样品。
What details are expected for an excipient that is not specifically listed in the IIG, especially colors or flavors? 对于未在IIG中具体列出的预期的辅料细目应如何处理，特别是颜色或味道？
For colors or flavors, indicate the compositions or have the manufacturer fax the composition to OGD if it is not available to the sponsor.
对于颜色或味道，请指出它们的组分，或者让供应商将其组分传真给OGD（如果申请者无法获取）。
What about elemental iron? 对于铁元素有何规定？
In the QOS, a sponsor should indicate that their product meets the 21 CFR 73.1200 requirement of NMT 5-mg elemental iron/day. We encourage sponsors to include the
detailed calculation of iron content/day in Module 3.
申请者应在QOS中表明他们的产品符合21 CFR73.1200中规定的NMT 5毫克铁元素/天的要求。我们鼓励申请者在模块3中加入铁含量/天的详细计算。
Do the differences between this formulation and the RLD present potential concerns with respect to therapeutic equivalence? 您的处方和RLD目前可能涉及的治疗等效性之间存在差异吗？
What comparisons does OGD recommend? 对此OGD建议哪些比较项？ The ANDA drug product must be pharmaceutically equivalent to the RLD. Compare the formulation of the RLD to the proposed generic drug product ANDA药品与RLD必须具有药学等效性。
Can an ANDA product use different excipients than the RLD? ANDA产品可以使用与RLD不同的辅料吗？
Differences in inactive ingredients are generally acceptable. For more complex dosage forms please provide justifications for differences in inactive ingredients. In addition, note that several specific dosage forms have stricter requirements indicated in the CFR.
非活性成分的差异通常是可以接受的。对于更复杂的剂型，请对非活性成分的差异提供合理性证明。另外请注意，CFR对一些特定的剂型作出了更为严格的要求。 ● Parenteral, ophthalmic, and otic solutions must have the same inactive ingredients (see 21 CFR 314.127(a)(8) and 21 CFR 314.94(a)(9) for requirements and exceptions )注射用、眼用和耳用溶液必须具有相同的非活性成分（见21 CFR314.127(a)(8)和21 CFR314.94(a)(9)的要求和特例）
Inactive ingredient changes permitted in drug product [21 CFR 314.94(a)(9)]. 允许在药品中存在的非活性成分的变化 [21 CFR314.94(a)(9)]：
（iii）- Parenteral use: Should be Q1[1]and Q2[2] except for preservative, buffer or
antioxidant 注射用：应该是除防腐剂、缓冲液或抗氧化剂之外的Q1和Q2。
（iv）- Ophthalmic & Otic use: Should be Q1 and Q2 except for preservative, buffer,
thickening agent or tonicity adjuster. 眼用和耳用：应该是除防腐剂、缓冲液、增稠剂或渗透压调节剂之外的Q1和Q2。
（v）Topical use (including aerosol & nasal solutions): Should contain same
inactive ingredients (Q1). However, an abbreviated application may include different inactive ingredients 局部用（包括气溶胶和滴鼻剂）：应包含相同的非活性成分（Q1）。不过对于简化申请（仿制药）可以包含不同的非活性成分。
[1] [2]: Q1= the same inactive ingredients 相同非活性成分
Q2= the same concentration of inactive ingredients 相同浓度的非活性成分
The allowable changes described in the CFR are only allowable “provided that the applicant identifies and characterizes the differences and provides information
demonstrating that the differences do not affect the safety or efficacy of the proposed drug product.” Allowable changes may require justification by additional
bioequivalence studies.
根据CFR的描述，许可的辅料变化只限于“仅当申请者识别和鉴别了这些差异，并提供信息论证这些差异不会影响药品的安全性和有效性时。”许可的变化可能需要额外的生物等效性研究来支持合理性证明。
● For solutions, differences in inactive ingredients may affect eligibility for
biowaivers (see 21 CFR 320.22(b)(3)(iii) ) and thus the differences should be justified here. 对于溶液而言，非活性成分的差异可能会影响其生物等效豁免试验的适用性（见21CFR320.22(b)(3)(iii)），因此必须对这些差异进行论证。
Examples 例如：
Amount of sorbitol or mannitol in an oral solution 山梨醇或甘露醇在口服溶液中的用量
Amount of penetration enhancer in a topical product 促渗剂在外用产品中的用量 Any Q1 or Q2 difference in an ophthalmic solution 滴眼液中存在的任何Q1或Q2差异
Any Q1 or Q2 difference in inhalation and nasal spray products 吸入剂和喷鼻剂产品中存在的任何Q1或Q2差异
● For suspensions please always justify differences in inactive ingredients especially with respect to their effect on viscosity and resuspendability 对于混悬剂，无论何种情况都应对其非活性成分的差异进行论证，尤其是关于这些差异对粘度和再悬浮能力的影响。
Can an ANDA product use a different release mechanism than the RLD? ANDA产品可以采用与RLD不同的释放机制吗？
An ANDA product may have a different mechanism as long as the product
performance and safety will be equivalent to the RLD. OGD can reject an application with a passing bioequivalence study if the difference in mechanism poses a safety or efficacy risk to the public (see 21 CFR 314.127(a)(8)(ii)(A)(5)).
只要ANDA产品的性能和安全性等同于RLD，那么就可以采用不同机制。OGD有权拒绝一个已通过生物等效性研究的申请，如果该申请在释放机制上的改变会对公众造成安全性或有效性风险（见21 CFR314.127(a)(8)(ii)(A)(5)）。
For modified release products, please explain any difference in release mechanism from the RLD. It is recommended that comparative dissolution between the RLD and ANDA products in multiple dissolution media be provided. If there are differences, please explain the differences in terms of the release mechanism.
对于修饰释放产品，请说明它与RLD在释放机制上存在的任何差异。建议提供RLD与ANDA产品在多个溶出介质中的比较溶出度。如果存在差异，请从释放机制的角度解释该差异。
Will OGD fail to approve a product that is bioequivalent to the RLD and meets
specifications based on the answer to this question? 基于这个问题的答案，OGD会不批准一个与RLD具有生物等效性并符合质量标准的产品吗？
If the differences between RLD and ANDA product can affect safety or efficacy when used according to the label, then OGD has the authority under the CFR to not approve the ANDA product.
如果按照说明书使用时RLD和ANDA产品之间的差异可影响安全性或疗效，那么OGD根据CFR有权不批准ANDA产品。
For modified release products, it is possible for two products with very different plasma concentration profiles (such as different shape or different Tmax) to have
equivalent AUC and Cmax. In such cases, the sponsor should identify the formulation and/or release mechanism attributes that are responsible for this difference in profiles and provide a justification as to why the difference in plasma concentration profiles does not affect therapeutic equivalence.
对于修饰释放产品，血浆浓度分布（如不同的形态或不同的峰时间（Tmax））差异很大的两种产品可能会具有相同的AUC和Cmax。在这种情况下，申请者应辨别造成这种分布差异的处方和/或释放机制属性，并对为什么在血浆中的浓度分布差异不影响治疗等效性进行论证。
2.3.P.2 Pharmaceutical Development 药物研发
How long should the development report be? 研发报告多长合适？
A complete development report should be included in Module 3. It should include development from the initial planning for an ANDA for this RLD. It should tell the development story that led to the final formulation and include the identification of critical formulation and process variables for this product. See ICH Q8 for details. 模块3中应包括一个完整的研发报告。它应包括来自该原研药的仿制药的最初规划的研发信息。应叙述最终处方的开发过程，包括确认该产品的的关键处方和工艺变量。详情见ICH Q8。
The Module 3 development report should summarize the development process and should not include raw study reports. It should present the results of the development pathway using summary charts and tables. The reader should be able to see how the formulation evolved in development and what the sponsor learned from each change. 模块3的研发报告应总结研发过程，但不应包含原始研究报告。用汇总图表或表格的形式表示研发路径的结果。应让审阅者看到在整个研发过程中处方是怎样进行改进的以及申请者从每一项变化中得到了什么。
How long should the summary of the development report in the QOS be? 在质量综述（QOS）中研发报告综述写多长合适？
The QOS of the development report should be guided by the questions provided by OGD.
研发报告的QOS应由OGD提出的问题来引导。
How far back should development history go? 研发史应追溯到多久以前？ To the initial planning for an ANDA for this RLD.
追溯到该RLD的ANDA最初计划。
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ensearchwebFrom Wikipedia, the free encyclopedia
This article is about topical medications. For other uses, see .
This article needs additional citations for . Please help
by . Unsourced material may be challenged and removed. (December 2008) ()
A topical medication is a
that is applied to a particular place on or in the body, as opposed to . (The word topical derives from Greek .) Most often this means application to
such as the
to treat ailments via a large range of classes including , , , , and ointments.
Many topical medications are epicutaneous, meaning that they are applied directly to the skin. Topical medications may also be , such as , or applied to the surface of tissues other than the skin, such as
applied to the , or
placed in the ear, or medications applied to the surface of a . As a , the topical route is contrasted with the
route (in the digestive tract), the
route (injected into veins), and others.
A topical effect, in the
sense, may refer to a local, rather than , target for a medication. However, many topically administered drugs have systemic effects, because they reach the
after being absorbed by the .
Topical medications differ from many other types of drugs because mishandling them can lead to certain complications in a patient or administrator of the drug.
chemicals, such as , can be
into the body after being applied to the skin in the form of a , , or .
have become a popular means of administering some drugs for , , and prevention of . One example of an
that may be applied topically is .
A medication's potency often is changed with its base. For example, some
will be classified one or two strengths higher when moving from cream to ointment. As a rule of thumb, an ointment base is more occlusive and will drive the medication into the skin more rapidly than a solution or cream base.
The manufacturer of each topical product has total control over the content of the base of a medication. Although containing the same active ingredients, one manufacturer's cream might be more acidic than the next, which could cause skin irritation or change its absorption rate. For example, a vaginal formulation of
antifungal cream might irritate the skin less than an athlete foot formulation of miconazole cream. These variations can, on occasion, result in different , even though the active ingredient is the same. No comparative potency labeling exists to ensure equal efficacy between brands of topical steroids (percentage of oil vs water dramatically affect the potency of topical steroid). Studies have confirmed that the potency of some topical steroid products may differ according to manufacturer or brand. An example of this is the case of brand name
cream in clinical studies have demonstrated significantly better vasoconstrictions than some forms of this drug produced by generic drug manufacturers. However, in a simple base like an ointment, much less variation between manufacturers is common.
In , the base of a topical medication is often as important as the medication itself. It is extremely important to receive a medication in the correct base, before applying to the skin. A pharmacist should not substitute an ointment for a cream, or vice versa, as the potency of the medication can change. Some physicians use a thick ointment to replace the waterproof barrier of the inflamed skin in the treatment of eczema, and a cream might not accomplish the same clinical intention
There are many general classes, with no clear dividing line between similar formulations. As a result, what the manufacturer's marketing department chooses to list on the label of a topical medication might be completely different from what the form would normally be called. For example,
"cream" is more appropriately described as an ointment than as a cream.
Topical solutions are of low viscosity and often use water or alcohol in the base. The solution can cause drying of the skin if alcohol is used in the base. These are usually a powder dissolved in water, alcohol, and sometimes oil. Alcohol in topical steroids can frequently cause drying if it is used as a base ingredient. There is significant variability between brands. There is a risk of irritation, depending on the preservative(s) and fragrances used in the base. Some examples of topical solutions are given below:
Aluminium acetate topical solution: This is colorless, with a faint acetous odour and sweetish taste. It is applied topically as an astringent after dilution with 10-40 parts of water. This is used in many types of dermatologic lotions, creams, and pastes. Commercial premeasured and packed tablets and powders are available for this preparation.
Povidone iodine topical solution: This is a chemical complex of iodine with polyvinylpyrrolidone, the agent being a polymer having an average molecular weight of 40,000. The povidone iodine contains 10% available iodine, slowly released when applied to skin. This preparation is employed topically as a surgical scrub and non irritating antiseptic solution, with its effectiveness being directly attributed to the presence and release of iodine from the complex. Commercial product:
are similar to solutions but are thicker and tend to be more
in nature than solution. They are usually an oil mixed with water, and more often than not have less alcohol than solutions. Lotions can be drying if they contain a high amount of alcohol. There is a significant variability in the ingredients between different lotions.
A mixture that separates into two or three parts with time. Frequently an oil mixed with a water-based solution needs to be shaken into suspension before use. "Shake well before use".
is an emulsion of oil and water in approximately equal proportions. It penetrates the
outer layer of skin wall. Cream is thicker than lotion, and maintains its shape when removed from its container. It tends to be moderate in moisturizing tendency. For topical steroid products, oil-in-water emulsions are common. Creams have a significant risk of causing
due to . It has a high rate of acceptance by patients. There is a great variation in ingredients, composition, pH, and tolerance among generic brands.
Metal case for Cruz Roja ointment from Mexico (beginning of the 20th century) from the permanent collection of the .
An ointment is a homogeneous, viscous, semi-solid preparation, most commonly a greasy, thick oil (oil 80% - water 20%) with a high viscosity, that is intended for external application to the skin or mucous membranes. Ointments have a
that defines the maximum amount of water that it can contain.They are used as
or for the application of active ingredients to the skin for protective, therapeutic, or prophylactic purposes and where a degree of occlusion is desired.
Ointments are used topically on a variety of body surfaces. These include the
(an eye ointment), , , , and . An ointment may or may not be medicated.
Ointments are usually very moisturizing, and good for dry skin. They have a low risk of sensitization due to having few ingredients beyond the base oil or fat, and low irritation risk. There is typically little variability between brands of drugs. They are often disliked by patients due to greasiness.
The vehicle of an ointment is known as the ointment base. The choice of a base depends upon the clinical indication for the ointment. The different types of ointment bases are:
Hydrocarbon bases, e.g. , ,
Absorption bases, e.g. ,
Water-soluble bases, e.g.
200, 300, 400
Emulsifying bases, e.g. ,
Vegetable oils, e.g. , , ,
The medicaments are dispersed in the base and are divided after penetrating the living cells of the skin.
The water number of an ointment is the maximum quantity of water that 100g of a base can contain at 20 °C.
Ointments are formulated using hydrophobic, hydrophilic, or water-emulsifying bases to provide preparations that are immiscible, miscible, or emulsifiable with skin secretions. They can also be derived from hydrocarbon (fatty), absorption, water-removable, or water-soluble bases.
Evaluation of ointments
Drug content
Release of medicament from base
Medicament penetration
Consistency of the preparation
Absorption of medicament into blood stream
Irritant effect
Properties which affect choice of an ointment base are:
Penetrability
Solvent property
Irritant effects
Ease of application and removal
Methods of preparation of ointments
Trituration: In this finely subdivided insoluble medicaments are evenly distributed by grinding with a small amount of the base followed by dilution with gradually increasing amounts of the base.
Fusion: In this method the ingredients are melted together in descending order of their melting points and stirred to ensure homogeneity.
are thicker than liquids. Gels are often a semisolid
sometimes using alcohol as a solvent for the active ingredient. Some gels liquefy at body temperature. Gel tends to be cellulose cut with alcohol or acetone. Gels tend to be self-drying. Gels tend to have greatly variable ingredients between brands. Gels carry a significant risk of inducing hypersensitivity due to fragrances and preservatives. Gel is useful for hairy areas and body folds. In applying gel one should avoid fissures in the skin, due to the stinging effect of the alcohol base. Gel enjoys a high rate of acceptance due to its cosmetic elegance.
can be seen with topical steroid marketed for the scalp.
can be a very precise time released method of delivering a drug. Cutting a patch in half might affect the dose delivered. The release of the active component from a transdermal delivery system (patch) may be controlled by diffusion through the adhesive which covers the whole patch, by diffusion through a membrane which may only have adhesive on the patch rim or drug release may be controlled by release from a polymer matrix. Cutting a patch might cause rapid dehydration of the base of the medicine and affect the rate of diffusion.
A topical dosage form that is programmed with low frequencies recognized by the body and complements topical medication adhered to the backing of the chip.
is either the pure drug by itself (talcum powder), or is made of the drug mixed in a carrier such as corn starch or corn cob powder (Zeosorb AF - miconazole powder). Can be used as an inhaled topical ( powder used in nasal surgery).
Medication may be placed in a solid form. Examples are deodorant, antiperspirants, astringents, and hemostatic agents. Some solids melt when they reach body temperature (e.g. rectal suppositories).
Certain contraceptive methods rely on
as a carrier of a liquid medicine.
embedded in a sponge has been used as a primitive contraception in some cultures.
Cordran tape is an example of a topical steroid applied under
by tape. This greatly increases the potency and absorption of the topical steroid and is used to treat inflammatory skin diseases.
Some medications are applied as an ointment or gel, and reach the mucous membrane via vaporization. Examples are nasal
and smelling salt.
combines three agents - oil, water, and powder. It is an ointment in which a powder is suspended.
is a skin preparation that has a high percentage of alcohol. It would normally be used as a drug vehicle if drying of the area is desired.
Dr. David Edwards - Dentistry Microbiology Lecture series
. Medical Reference. University of Maryland Medical System. 2009.
Zaghi, D; Maibach (2007). "Survey of Safety and efficacy information in drug inserts for topical prescription medications". American Journal of Clinical Dermatology. 8 (1): 43–46. :.
Wolverton, SE. Comprehensive Dermatologic Drug Therapy. WB Saunders. 2001. pp 563-572.
ansels pharmaceutical dosage form p.g # 371
Wolverton, S. Comprehensive Dermatologic Drug Therapy. p. 13.)
American Academy of Dermatology
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