DOCSLIB.ORG

357 Subpart D—Records and Reports PART 436—TESTS AND

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
357 Subpart D—Records and Reports PART 436—TESTS AND Food and Drug Administration, HHS Pt. 436 from the requirements of section 502(l) (e) The quantity shipped is limited to and from the certification require- an amount reasonable for the purpose ments of section 512(n) of the act if of patch testing in the normal course shipped or sold to, or in the possession of the practice of medicine and is used of, persons regularly and lawfully en- solely for such patch testing. gaged in instruction in pharmacy, (f) The manufacturer or distributor chemistry, or medicine not involving maintains records of all shipments for clinical use; or in law enforcement; or this purpose for a period of 2 years in research not involving clinical use; after shipment and will make them or in chemical analysis or physical available to the Food and Drug Admin- testing, provided they are to be used istration upon request. only for such instruction, law enforce- ment, research, analysis, or testing, [43 FR 11151, Mar. 17, 1978] and provided further that their labels bear the statement ``Not for drug use.'' Subpart DÐRecords and Reports § 433.25 [Reserved] § 433.30 Records retention. § 433.26 Neomycin sulfate ointment in- At the option of the person having tended for hypersensitivity testing. control of records required to be kept Neomycin sulfate ointment subject by any regulation in this part 433, pho- to sections 502(l) and 507 of the act and tostatic or other permannnt reproduc- packaged for use as an allergen for skin tions may be substituted for such patch testing of hypersensitivity shall records after the first 2 years of the be exempt from the certification re- holding period. quirements of section 502(l) and 507 of the act if it complies with all the fol- PART 436ÐTESTS AND METHODS OF lowing conditions: ASSAY OF ANTIBIOTIC AND AN- (a) It contains neomycin sulfate equivalent to 200 milligrams of neomy- TIBIOTIC-CONTAINING DRUGS cin per gram in petrolatum. (b) The neomycin sulfate used in pre- Sec. paring the neomycin sulfate ointment Subpart AÐDefinitions; Interpretations; conforms to the standards prescribed Requirements by § 444.42(a)(1) of this chapter except § 444.42(a)(1)(ii). 436.1 Sterility requirements of items (c) The shipment of neomycin sulfate packaged with sterile antibiotic drugs. is made as a result of a specific request 436.2 Alternative assay methods. made to the manufacturer or distribu- tor by a practitioner licensed by law to Subpart BÐSterility Test Methods administer such drug, and the use of 436.20 Sterility test methods and proce- neomycin sulfate ointment for patch dures. testing is not promoted by the manu- facturer or distributor. Subpart CÐBiological Test Methods (d) Each package shall bear on its outside wrapper or container and on 436.31 Equipment and diluents for use in bi- the immediate container, in addition ological testing. to other labeling information required 436.32 Pyrogen test. by the act and regulations, the follow- 436.35 Depressor substances test. ing statements in lieu of adequate di- rections for use: Subpart DÐMicrobiological Assay (1) The statement, ``Caution: Federal Methods law prohibits dispensing without pre- 436.100 Laboratory equipment. scription''. 436.101 Solutions. (2) The statement, ``For use only in 436.102 Culture media. patch testing''. 436.103 Test organisms. (3) The potency of the ointment. 436.104 Penicillin activity. (4) The expiration date as prescribed 436.105 Microbiological agar diffusion assay. by § 432.5(a)(3) of this chapter. 436.106 Microbiological turbidimetric assay. 357 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00352 Fmt 8010 Sfmt 8010 C:\CFR\21V5.000 pfrm13 Pt. 436 21 CFR Ch. I (4±1±96 Edition) Subpart EÐGeneral Chemical Tests for 436.322 High±pressure liquid Antibiotics chromatographic assay for anthracycline antibiotics. 436.200 Loss on drying. 436.323 Continuous flow thin layer chroma- 436.201 Moisture determination. tography identity test for cefamandole 436.202 pH. nafate. 436.203 Crystallinity. 436.324 Polarographic analysis of 436.204 Iodometric assay. cefamandole. 436.205 Hydroxylamine colorimetric assay. 436.325 High pressure liquid chroma- 436.206 Test for metal particles in ophthal- tography assay for vidarabine. mic ointments. 436.326 Thin layer chromatographic identity 436.207 Residue on ignition. test for cefoxitin sodium. 436.208 Heavy metals determination. 436.327 Thin layer chromatographic identity 436.209 Melting range or temperature. test for cyclacillin. 436.210 Specific rotation. 436.328 High pressure liquid 436.211 Identity tests by infrared chromatographic assay for sulfisoxazole spectrophotometry. acetyl content. 436.212 Disintegration test. 436.329 High-pressure liquid 436.213 Nonaqueous titrations. chromatographic assay for meclocycline. 436.214 Heat stability. 436.330 Thin layer chromatographic identity 436.215 Dissolution test. test for bacampicillin. 436.216 High±performance liquid 436.331 High-pressure liquid chromatographic assay. chromatographic assay for 436.217 Film-coat rupture test. dactinomycin. 436.332 High-pressure liquid Subpart FÐChemical Tests for Specific chromatographic assay for moxalactam. Antibiotics 436.333 Thin layer chromatographic identity test for moxalactam. 436.300 Polarimetric assay of carbenicillin 436.334 High-pressure liquid indanyl sodium. chromatographic assay for piperacillin. 436.301 Thin layer chromatography identity 436.335 High-pressure liquid test for carbenicillin indanyl. chromatographic assay for chlor- 436.302 Clindamycin vapor phase chroma- amphenicol palmitate. tography. 436.336 Thin layer chromatographic identity 436.303 Clindamycin content of clindamycin test for azlocillin. palmitate hydrochloride by vapor phase 436.337 High-pressure liquid chromatography. chromatographic assay for cephradine. 436.304 Clindamycin phosphate vapor phase 436.338 High-pressure liquid chromatography. chromatographic assay for cefoperazone. 436.305 Thin layer chromatographic identity 436.339 High-pressure liquid test for hetacillin. chromatographic assay for bleomycin 436.306 Lincomycin gas liquid chroma- fractions. tography. 436.340 High-pressure liquid 436.307 Spectinomycin vapor phase chroma- chromatographic assay for tetracycline tography. hydrochloride content and 4± 436.308 Paper chromatography identity test epitetracycline hydrochloride content. for tetracyclines. 436.341 High-pressure liquid 436.309 Anhydrotetracyclines and 4-epian- chromatographic assay for plicamycin. hydrotetracycline. 436.342 High-pressure liquid 436.310 Thin layer chromatography identity chromatographic assay for cefazolin. test for mitomycin. 436.343 High-pressure liquid 436.311 Thin layer chromatography identity chromatographic assay for cefuroxime. test for amoxicillin. 436.344 Thin layer chromatographic identity 436.312 Atomic absorption method for deter- test for cefuroxime. mining the zinc content of zinc baci- 436.345 High-pressure liquid tracin. chromatographic assay for ceftizoxime. 436.316 Determination of penicillin G con- 436.346 High-pressure liquid tent. chromatographic assay for cyclosporine. 436.317 Solubility characteristic test for 436.347 High-pressure liquid griseofulvin (ultramicrosize) tablets. chromatographic assay for cefoxitin. 436.318 Continuous flow thin layer chroma- 436.348 High-pressure liquid tography identity test. chromatographic assay for ceforanide. 436.319 Thin layer chromatography identity 436.349 High-pressure liquid test for bacitracin and bacitracin zinc. chromatographic assay for L-lysine in 436.320 Ferric chloride colorimetric assay. ceforanide for injection. 436.321 Griseofulvin gas liquid chroma- 436.350 High-performance liquid tography. chromatographic assay for cefonicid. 358 VerDate 17<JUL>96 11:55 Jul 29, 1996 Jkt 167069 PO 00000 Frm 00353 Fmt 8010 Sfmt 8010 C:\CFR\21V5.000 pfrm13 Food and Drug Administration, HHS Pt. 436 436.351 High-performance liquid 436.505 Penicillin-streptomycin-bacitracin chromatographic assay for amoxicillin ointment; penicillin-dihydrostrepto- and clavulanic acid. mycin-bacitracin ointment; penicillin- 436.352 High-performance liquid streptomycin-bacitracin methylene disa- chromatographic assay for determining licylate ointment; penicillin-dihydro- clavam-2-carboxylate content in streptomycin-bacitracin methylene disa- clavulanate potassium. licylate ointment. 436.353 High-performance liquid 436.506 Benzathine penicillin G and buffered chromatographic assay for amdinocillin. crystalline penicillin for aqueous injec- 436.354 High-performance liquid tion. chromatographic assay for ceftriaxone. 436.507 Benzathine-procaine-buffered crys- 436.355 High±performance liquid talline penicillins for aqueous injection. chromatographic assay for ticarcillin± 436.508 Penicillin - bacitracin - neomycin clavulanic acid. ointment; penicillin-bacitracin-neomycin 436.356 High±performance liquid in oil. chromatographic assay for ceftazidime. 436.509 Procaine penicillin-streptomycin- 436.357 Atomic absorption test for sodium polymyxin in oil; procaine penicillin-di- carbonate content. hydrostreptomycin-polymyxin in oil; 436.358 High±performance liquid procaine penicillin-streptomycin- chromatographic assay for pyridine. polymyxin ointment; procaine penicillin- dihydrostreptomycin-polymyxin oint- 436.360 Gel permeation chromatographic ment. assay for high molecular weight polymer. 436.510 Penicillin - streptomycin - erythro- 436.361 High±performance liquid mycin ointment; penicillin-dihydro- chromatographic assay for aztreonam. streptomycin - erythromycin ointment. 436.362 Thin-layer chromatographic test for 436.511
Load more

Recommended publications
  • "Macrolides"? Classify Each Drug in This Chapter As a Macrolide Or Azalide, and As an Antibiotic Or Semi-Synthetic Derivative
    STUDY GUIDE THE MACROLIDE/AZALIDE ANTIMICROBIAL AGENTS 1. Why are these antibiotics derivatives called "macrolides"? Classify each drug in this chapter as a macrolide or azalide, and as an antibiotic or semi-synthetic derivative. 2. What are the key structural differences between erythromycin, clarithromycin, azithromycin and dirithromycin? 3. Generally how does spiramycin and josamycin differ in structure from the commercial macrolides/azalides (2 reasons)? 4. What are the “ketolides and how do they differ in structure from the commercial macrolides? 5. What is the biosynthetic source of erythromycin? What is the lactone moiety of erythromycin called? What sugar moieties are present and what are their properties? 6. What hydrolysis product forms from erythromycin in aqueous acid or base? What is the significance of this reaction? Can it occur with other macrolides? 7. When does the “intramolecular cyclization” reaction occur with erythromycin? What is it's significance (two reasons) and how does it occur? Which functional groups are important for this reaction? 8. What salt forms of erythromycin are available? Which are water soluble? Which are water-insoluble? How is each salt form formulated and used (oral or parenteral)? 9. What ester and ester salt derivatives of erythromycin are available? What is the estolate? How is each salt form formulated and used (oral or parenteral)? What are the advantages of these esters dosage forms? 10. How does clarithromycin differ in structure from erythromycin? Why was this macrolide developed (the role of the 6-methoxy)? 11. How does azithromycin differ in structure from erythromycin? Why was this macrolide developed? 12. How does dirithromycin differ in structure from erythromycin? Why was this macrolide developed? What is the active form of this prodrug? 13.
    [Show full text]
  • 35 Cyproterone Acetate and Ethinyl Estradiol Tablets 2 Mg/0
    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrCYESTRA®-35 cyproterone acetate and ethinyl estradiol tablets 2 mg/0.035 mg THERAPEUTIC CLASSIFICATION Acne Therapy Paladin Labs Inc. Date of Preparation: 100 Alexis Nihon Blvd, Suite 600 January 17, 2019 St-Laurent, Quebec H4M 2P2 Version: 6.0 Control # 223341 _____________________________________________________________________________________________ CYESTRA-35 Product Monograph Page 1 of 48 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................. 3 INDICATION AND CLINICAL USE ..................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ....................................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................................ 20 OVERDOSAGE ....................................................................................................................................
    [Show full text]
  • Erythromycin Versus Tetracycline for Treatment of Mediterranean Spotted Fever
    Arch Dis Child: first published as 10.1136/adc.61.10.1027 on 1 October 1986. Downloaded from Archives of Disease in Childhood, 1986, 61, 1027-1029 Erythromycin versus tetracycline for treatment of Mediterranean spotted fever T MUNOZ-ESPIN, P LOPEZ-PARtS, E ESPEJO-ARENAS, B FONT-CREUS, I MARTINEZ- VILA, J TRAVERIA-CASANOVA, F SEGURA-PORTA, AND F BELLA-CUETO Hospital de Sant Llatzer, Terrassa, Clinica Infantil del Nen Jesus, Sabadell, and Hospital Mare de Deu de la Salut, Sabadell, Barcelona, Spain SUMMARY Eighty one children aged between 1 and 13 years participated in a randomised comparative trial of tetracycline hydrochloride and erythromycin stearate for treatment of Mediterranean spotted fever. Both therapeutic regimens proved effective, but in patients treated with tetracycline both clinical symptoms and fever disappeared significantly more quickly. Likewise, when those patients who began treatment within the first 72 hours of illness are considered the febrile period had a significantly shorter duration in the group treated with tetracycline. One patient was switched to tetracycline because there was no improvement of clinical manifestations, with persistence of fever, myalgias, and prostration, after receiving eight days of treatment with erythromycin. These results suggest that tetracyclines are superior to erythromycin in the treatment of Mediterranean spotted fever. copyright. Mediterranean spotted fever is an acute infectious were not included in the trial; neither were those disease caused by Rickettsia conorii. During the
    [Show full text]
  • Portia®(Levonorgestrel and Ethinyl Estradiol Tablets USP)
    PORTIA- levonorgestrel and ethinyl estradiol Teva Pharmaceuticals USA, Inc. ---------- Portia® (levonorgestrel and ethinyl estradiol tablets USP) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Portia® (levonorgestrel and ethinyl estradiol tablets USP) consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel, USP, (18, 19-Dinorpregn-4-en-20-yn- 3-one, 13-ethyl-17-hydroxy-, (17α)-(−)-), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 white inert tablets. The inactive ingredients in the pink active tablets include anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The ingredients in the film-coating include FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. Each white inert tablet contains anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formulas are as follows: Levonorgestrel, USP C21H28O2 M.W. 312.45 Ethinyl Estradiol, USP C20H24O2 M.W. 296.40 CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective.
    [Show full text]
  • FDA Approved Medications Part 3: Review of Individual Medications Part 4: Additional Board-Pertinent Information
    Dr. Jack’s MedQuik Guide A Psychotropic Medication Guide for Board Exam Preparation Free Additional Board Exam Preparation Resources www.BeatTheBoards.com • 877-225-8384 Dr. Jack’s MedQuik Guide Table of Contents Part 1: Medications FDA Approved In 2009-2010 Part 2: List of Psychiatric Disorders With Their FDA Approved Medications Part 3: Review of Individual Medications Part 4: Additional Board-Pertinent Information Copyright Notice Copyright © 2007-2010 American Physician Institute for Advanced Professional Studies, LLC. All rights reserved. This manuscript may not be transmitted, copied, reprinted, in whole or in part, without the express written permission of the copyright holder. Requests for permission or further information should be addressed to Jack Krasuski at: [email protected] or American Physician Institute for Advanced Professional Studies, LLC, 125 Windsor Dr., Suite 111, Oak Brook, IL 60523 Disclaimer Notice This publication is designed to provide general educational advice. It is provided to the reader with the understanding that Jack Krasuski and American Physician Institute for Advanced Professional Studies LLC are not rendering medical services. This guide is designed to aid physicians in exam preparation and is not to be considered medical advice for guiding medical care of patients. If medical or other expert assistance is required, the services of a medical or other consultant should be obtained. The author and publisher disclaim any liability arising directly or indirectly from the use of this book.
    [Show full text]
  • Use of Antibiotics to Prevent Calf Diarrhea and Septiceinia
    PEER REVIEWED Use of Antibiotics to Prevent Calf Diarrhea and Septiceinia Peter D. Constable, BVSc, PhD, DACVIM Department of Veterinary Clinical Medicine, University of Illinois at Urbana-Champaign, Urbana, IL 61802 Abstract l'oxytetracycline (0.15 to 6.0 mg/lb [0.32 to 13.2 mg/kg] au 24 h, per os) sont efficaces dans le traitement de la This article reviews studies related to the use of diarrhee chez les veaux et permettent un accroissement antimicrobial agents to prevent calf diarrhea and septi­ du taux de croissance des veaux nourris au lait. De cemia, and discusses whether prophylactic administra­ plus, la chlortetracycline permet la diminution du taux tion of antibiotics in neonatal calves is effective and de mortalite lorsque administree chez les veaux indicated. Orally administered chlortetracycline, oxytet­ nouveau-nes pour prevenir la diarrhee. 11 n'y a pas racycline, tetracycline and neomycin have label claims d'antibiotiques qui promettent de prevenir la in the US for the "control" or "aid in the control" of calf septicemie chez les veaux. Paree qu'il ne semble pas diarrhea caused by bacteria susceptible to the antibi­ exister d'etudes sur l'efficacite de la tetracycline et de otic. Chlortetracycline and oxytetracycline (0.15 to 6.0 la neomycine et parce que !'utilisation hors homologa­ mg/lb [0.32 to 13.2 mg/kg], q 24 h, PO) are efficacious tion des medicaments. n'est pas permise pour la for preventing calf diarrhea and increasing growth rate prevention routiniere des maladies ou !'augmentation in milk-fed calves, and chlortetracycline (3 mg/lb [7 mg/ du taux de croissance et du taux de conversion kg], q 12 h, PO) is efficacious for decreasing mortality alimentaire, selon le code de l'AMDUCA de 1994, seule when administered to prevent diarrhea in neonatal !'administration orale de chlortetracycline et calves.
    [Show full text]
  • Divestra Leaflet
    • Known or suspected estrogen-dependent neoplasia Drugs which may decrease the therapeutic effect of Cyproterone acetate+Ethinyl Pregnancy and Breastfeeding • Undiagnosed abnormal vaginal bleeding Combination of Cyproterone acetate and Ethinyl estradiol is contraindicated during estradiol and increase the incidence of breakthrough bleeding • Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete pregnancy and breastfeeding. loss of vision or defect in visual fields Effects on ability to drive and use machines • Concomitant use with other Estrogen+Progestogen combinations or estrogens or Unknown progestogens alone • When pregnancy is suspected or diagnosed Adverse Reactions • Severe diabetes with vascular changes Common adverse reactions includes headaches, nausea, abdominal pain, weight gain, • A history of otosclerosis with deterioration during pregnancy depressed or altered mood and breast pain or tenderness. • Hypersensitivity to this drug or to any ingredient in the formulation or component of the Uncommon adverse reactions include vomiting, diarrhea, fluid retention and migraine. container. Overdose (Cyproterone acetate + Warnings and Precautions There is no antidote and treatment should be symptomatic. Ethinyl estradiol) Discontinue Cyproterone acetate+Ethinyl estradiol tablets at the earliest manifestation of the following: PHARMACOLOGICAL PROPERTIES • Thromboembolic and Cardiovascular Disorders such as thrombophlebitis, pulmonary Pharmacotherapeutic group: Sex hormones and modulators of the genital system, QUALITATIVE AND QUANTITATIVE COMPOSITION embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, and anti-androgens and estrogens. ATC code: G03HB01 Each film-coated tablet contains: retinal thrombosis. Cyproterone acetate (Ph.Eur.)………...2 mg • Conditions that predispose to Venous Stasis and to Vascular Thrombosis (eg. Mechanism of action Ethinyl estradiol (USP)……………...0.035 mg immobilization after accidents or confinement to bed during long-term illness).
    [Show full text]
  • Drugs Interfering with the Metabolism of Tacrolimus (FK506)
    BLOOD SCIENCES DEPARTMENT OF CLINICAL BIOCHEMISTRY Title of Document: Drugs Interfering with the metabolism of tacrolimus (FK506) Q Pulse Reference No: BS/CB/DCB/TOX/4 Version NO: 6 Authoriser: P Beresford Page 1 of 3 Drugs Interfering with the Metabolism of Tacrolimus (FK506) Introduction Tacrolimus (FK506) is an immunosuppressant drug. The purpose of this protocol is to highlight drug interactions in the metabolism of tacrolimus (FK506) Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels. It is therefore recommended to monitor tacrolimus blood levels whenever substances which have the potential to alter CYP3A metabolism are used concomitantly and to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure Inhibitors of metabolism Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole and voriconazole, the macrolide antibiotic erythromycin or HIV protease inhibitors (e.g. ritonavir). Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients. Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone. In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen, troleandomycin. Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
    [Show full text]
  • Long-Term Use of Spironolactone for Acne in Women: a Case Series of 403 Patients
    Long-term use of spironolactone for acne in women: A case series of 403 patients Vaibhav Garg, BS,a JulianaK.Choi,MD,PhD,b William D. James, MD,b and John S. Barbieri, MD, MBAb Philadelphia, Pennsylvania Background: There are limited data regarding the long-term outcomes of spironolactone use for women with acne and its effect on truncal acne. Objective: To comprehensively describe outcomes of patients treated with spironolactone in routine clinical practice, including long-term outcomes. Methods: We performed a retrospective case series of 403 adult women treated for acne with spironolactone at an academic medical center between 2008 and 2019. Rates of objective, as assessed by Comprehensive Acne Severity Scale scores, and subjective acne clearance were evaluated, as well as rates of treatment discontinuation, dosage changes, and drug survival. Logistic regression was used to assess for association between incidence of menstrual adverse effects and combined oral contraceptive use. Results: As evaluated by Comprehensive Acne Severity Scale scores, at the first follow-up, 75.5%, 84.0%, and 80.2% of patients with available data had reduction or complete clearance of acne on the face, chest, and back, respectively. The mean drug survival was 470.7 days. Menstrual adverse effects were less common among those using combined oral contraception (odds ratio, 0.23; 95% confidence interval, 0.11-0.50). Limitations: This study was conducted at a single academic medical center. Conclusions: Spironolactone improves clinical outcomes and is well tolerated for many adult women with acne using it for an extended duration. ( J Am Acad Dermatol 2021;84:1348-55.) Key words: acne; acne vulgaris; birth control pill; combined oral contraceptive; comprehensive acne severity scale; oral antibiotics; outcomes; spironolactone.
    [Show full text]
  • Prednisolone / Neomycin / Tetracycline For- Mulation
    SAFETY DATA SHEET Prednisolone / Neomycin / Tetracycline For- mulation Version Revision Date: SDS Number: Date of last issue: 25.08.2020 3.6 09.04.2021 407521-00015 Date of first issue: 07.01.2016 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name : Prednisolone / Neomycin / Tetracycline Formulation 1.2 Relevant identified uses of the substance or mixture and uses advised against Use of the Sub- : Veterinary product stance/Mixture 1.3 Details of the supplier of the safety data sheet Company : MSD 20 Spartan Road 1619 Spartan, South Africa Telephone : +27119239300 E-mail address of person : [email protected] responsible for the SDS 1.4 Emergency telephone number +1-908-423-6000 SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification (REGULATION (EC) No 1272/2008) Skin sensitisation, Category 1 H317: May cause an allergic skin reaction. Reproductive toxicity, Category 1A H360D: May damage the unborn child. Effects on or via lactation H362: May cause harm to breast-fed children. Short-term (acute) aquatic hazard, Cate- H400: Very toxic to aquatic life. gory 1 Long-term (chronic) aquatic hazard, Cat- H410: Very toxic to aquatic life with long lasting egory 1 effects. 2.2 Label elements Labelling (REGULATION (EC) No 1272/2008) Hazard pictograms : Signal word : Danger Hazard statements : H317 May cause an allergic skin reaction. H360D May damage the unborn child. H362 May cause harm to breast-fed children. H410 Very toxic to aquatic life with long lasting effects. 1 / 23 SAFETY DATA SHEET Prednisolone / Neomycin / Tetracycline For- mulation Version Revision Date: SDS Number: Date of last issue: 25.08.2020 3.6 09.04.2021 407521-00015 Date of first issue: 07.01.2016 Precautionary statements : Prevention: P201 Obtain special instructions before use.
    [Show full text]
  • Process to Increase the Production of Clavam
    Europäisches Patentamt *EP000832247B1* (19) European Patent Office Office européen des brevets (11) EP 0 832 247 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: C12N 15/54, C12P 17/18, of the grant of the patent: C12N 1/20 24.11.2004 Bulletin 2004/48 // (C12N1/20, C12R1:465) (21) Application number: 96921954.2 (86) International application number: PCT/EP1996/002497 (22) Date of filing: 06.06.1996 (87) International publication number: WO 1996/041886 (27.12.1996 Gazette 1996/56) (54) PROCESS TO INCREASE THE PRODUCTION OF CLAVAM ANTIBIOTICS VERFAHREN ZUR ERHÖHUNG DER PRODUKTION VON CLAVAM-ANTIBIOTIKA PROCEDE POUR AUGMENTER LA PRODUCTION D’ANTIBIOTIQUES CLAVAM (84) Designated Contracting States: (56) References cited: AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC EP-A- 0 349 121 WO-A-94/18326 NL PT SE Designated Extension States: • FEMS MICROBIOLOGY LETTERS, vol. 110, 1993, SI pages 239-242, XP000601357 J.M.WARD AND J.E.HODGSON: "The biosynthetic genes for (30) Priority: 09.06.1995 GB 9511679 clavulanic acid and cephamycin production occur as a ’super-cluster’ in three (43) Date of publication of application: Streptomyces" cited in the application 01.04.1998 Bulletin 1998/14 • MICROBIOLOGY, vol. 140, no. 12, December 1994, pages 3367-3377, XP000601913 H.YU ET (73) Proprietors: AL.: "Possible involvement of the lat gene in the • SmithKline Beecham plc expression of the genes encoding ACV Brentford, Middlesex TW8 9GS (GB) synthetase (pcbAB) and isopenicillin N synthase • THE GOVERNORS OF THE UNIVERSITY OF (pcbC) in Streptomyces clavuligerus" cited in ALBERTA the application Edmonton, Alberta T6G 2E1 (CA) • MALMBERG ET AL: ’Precursor flux control through targeted chromosomal insertion of the (72) Inventors: lysine epsilon-aminotransferase (LAT) gene in • HOLMS, William, Henry Bioflux Limited Cephamycin C biosynthesis.’ JOURNAL OF 54 Dumbarton Road Glasgow G11 6AQ (GB) BACTERIOLOGY vol.
    [Show full text]
  • Staining and Hypoplasia of Enamel Caused by Tetracycline: Case Report P
    PEDIATRIC DENTISTRY/Copyright © 1987 by The American Academy of Pediatric Dentistry Volume 9 Number 3 Staining and hypoplasia of enamel caused by tetracycline: case report P. Fleming, BDentSc, FDS C.J. Witkop, Jr., DDS, MS W.H. Kuhlmann, DDS, MSD Abstract Case Report Staining of developing teeth due to tetracycline therapy A 23-year-old white male requested restoration of has been publicized widely. However, the ability of tetracy- his stained and hypoplastic anterior teeth (Fig 1). A clines to cause hypoplasia of enamel has not been accepted history revealed that between 2 and 3 years of age he had universally. This is a case report of enamel hypoplasia and received extensive tetracycline therapy for tonsillitis. staining presumably caused byahigh dosage of'tetracy'dines in There was no history of a prolonged fever at the time of childhood. Restoration of the teeth with bonded composite the illness. resins produced an esthetic result. -UK Schwachman and Schuster (1956) were the first to report unsightly staining of teeth due to tetracycline administered during the period of tooth formation in children with cystic fibrosis. This observation was con- y firmed by Zegarelli et al. (1961) who noted staining of the teeth in 38 of 52 cystic fibrosis patients who had been ijgj treated with large doses of antibiotics, frequently tetracy- .^••W^^ clines. With reports by Davies et al. (1962) and articles by Wallman and Hilton (1962) and Witkop and Wolf (1963) this complication of tetracycline therapy became widely recognized. FIG 1. Tetracycline staining and hypoplasia of the permanent Hypoplasia of enamel of the primary dentition asso- anterior teeth.
    [Show full text]