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Tonsillopharyngitis - Acute (1 of 10)

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Tonsillopharyngitis - Acute (1 of 10) 1 Patient presents w/ sore throat 2 EVALUATION Yes EXPERT Are there signs of REFERRAL complication? No 3 4 EVALUATION Is Group A Beta-hemolytic Yes DIAGNOSIS Streptococcus (GABHS) • Rapid antigen detection test infection suspected? (RADT) • roat culture No TREATMENT EVALUATION No A Supportive management Is GABHS confi rmed? B Pharmacological therapy (Non-GABHS) Yes 5 TREATMENT A EVALUATE RESPONSEMIMS Supportive management TO THERAPY C Pharmacological therapy • Antibiotics Poor/No Good D Surgery, if recurrent or complicated response response REASSESS PATIENT COMPLETE THERAPY & REVIEW THE DIAGNOSIS© Not all products are available or approved for above use in all countries. Specifi c prescribing information may be found in the latest MIMS. B269 © MIMS Pediatrics 2020 Tonsillopharyngitis - Acute (2 of 10) 1 ACUTE TONSILLOPHARYNGITIS • Infl ammation of the tonsils & pharynx • Etiologies include bacterial (group A β-hemolytic streptococcus, Haemophilus infl uenzae, Fusobacterium sp, etc) & viral (infl uenza, adenovirus, coronavirus, rhinovirus, etc) pathogens • Sore throat is the most common presenting symptom in older children TONSILLOPHARYNGITIS 2 EVALUATION FOR COMPLICATIONS • Patients w/ sore throat may have deep neck infections including epiglottitis, peritonsillar or retropharyngeal abscess • Examine for signs of upper airway obstruction Signs & Symptoms of Sore roat w/ Complications • Trismus • Inability to swallow liquids • Increased salivation or drooling • Peritonsillar edema • Deviation of uvula • Asymmetry & forward displacement of the soft palate Signs of Upper Airway Obstruction • Stridor • Air hunger • Respiratory distress • Toxic appearance • Cyanosis Management of Complications • All abscesses should be drained • Tonsillectomy if patient has a history of recurrent tonsillitis • Acute tonsillectomy without prior incision 3 EVALUATION FOR GABHS INFECTION • Identify & treat GABHS infection as soon as possible after diagnosis to decrease risk of complications like acute rheumatic fever (ARF), glomerulonephritis, pediatric autoimmune neuropsychiatric disorders associated w/ streptococcal infection (PANDAS) syndrome, & decrease period of contagiousness • GABHS is the most common bacterial pathogen of ATP & warrants antibiotic treatment • GABHS infection should be suspected on clinical & epidemiological grounds & supported by laboratory tests • Viral pathogens are more frequent than bacteria, accounting for about 70-90% of cases in children, & almost 100% in children <3 years of age Signs & Symptoms Suggestive of GABHS Infection • Sore throat/tonsillar swelling/exudates • Swollen anterior cervical nodes • Fever >38ºC (low-grade fever <38ºC in children <3 years old) • Lack of cough, conjunctivitis, rhinorrhea,MIMS hoarseness • Symptoms in a patient aged 5-15 years Signs & Symptoms Suggestive of a Viral Etiology • Rhinorrhea • Cough • Hoarseness • Conjunctivitis • Diarrhea • Oropharyngeal ulceration • Muscle &© joint pain B270 © MIMS Pediatrics 2020 Tonsillopharyngitis - Acute (3 of 10) 4 DIAGNOSIS • Tests not needed for patients whose features do not suggest GABHS infection • For patients 3-15 years of age, perform diagnostic tests when GABHS cannot be excluded Rapid Antigen Detection Test (RADT) • Advantage of speed (within minutes versus 48 hours for culture) & specifi city (≥95%) for GABHS • Children w/ throat pain w/ ≥2 of the following are recommended to undergo RADT: - Absence of cough TONSILLOPHARYNGITIS - Presence of tonsillar exudates/swelling - History of fever - Age >15 years - Positive for swelling & tenderness of the anterior cervical lymph nodes • Confi rmation w/ culture is not necessary after a negative RADT result roat Swab Culture • Highly sensitive (90-95% sensitivity) but not done routinely because of delay in results (18-24 hours) - Recommended for those w/ history of contact w/ symptomatic persons w/ GABHS pharyngitis, recurrent GABHS infection & symptomatic patients at high risk for rheumatic fever • roat swabs from both tonsils & posterior pharyngeal wall • Optimal time for collection is at onset of symptoms & before antibiotics are started Centor Criteria • Used to assess the susceptibility of patients to GABHS infection based on the patient’s age & symptoms - Results may assist in the decision to start antibiotic treatment • Uses a points system utilizing the following signs/symptoms: - Fever (>38oC) (1) - Absence of cough (1) - Tender anterior cervical node (1) - Tonsillar exudate/swelling (1) - Age 3-14 years (1) - Age 15-44 years (0) - Age >44 years (-1) • Modifi ed total risk based on total ATP score: Total score Risk of GABHS ≥4 51-53% 3 28-35% 2 11-17% 1 5-10% ≤0 1-2.5% FeverPAIN Score • May be used to assess the need to start antibiotic treatment as well as the severity of throat pain • High results may indicate streptococcal infection; results should be correlated w/ Centor criteria score 5 RESPONSE TO THERAPY • Clinical response is usually evident withinMIMS 24-48 hours • Persistence beyond 48 hours may indicate alternative causes or development of suppurative complications which warrants reassessment A SUPPORTIVE MANAGEMENT General Measures • Adequate fl uid intake • Warm saline gargle (¼ teaspoon of salt per 8 oz glass of water) • Elimination of close contact w/ family members or visitors if patient has been confi rmed to have GABHS • Remain at© home until 24 hours of antibiotic therapy has been received Alternative erapy • ere are not enough studies to support use of acupunture & herbal treatments for tonsillopharyngitis Not all products are available or approved for above use in all countries. Specifi c prescribing information may be found in the latest MIMS. B271 © MIMS Pediatrics 2020 Tonsillopharyngitis - Acute (4 of 10) B PHARMACOLOGICAL THERAPY - NON-GABHS INFECTION Symptomatic Treatment • Symptomatic treatment is important in the management of children w/ sore throat Simple Analgesics/Antipyretics • Paracetamol is the drug of choice for analgesia in sore throat • Aspirin is not recommended due to the risk of Reye’s syndrome Nonsteroidal Anti-infl ammatory Drugs (NSAIDs) TONSILLOPHARYNGITIS • Ibuprofen is a safe & eff ective alternative for analgesia & antipyrexia • Diclofenac may also be used for against pain caused by ATP • As NSAIDs are associated w/ signifi cant risk of GI bleeding, their routine use is not recommended roat Lozenges/Gargle/Spray • May be helpful especially in those w/ signifi cant throat pain or discomfort C PHARMACOLOGICAL THERAPY - GABHS INFECTION Symptomatic Treatment • Important in the management of children w/ sore throat • Same as for non-GABHS infection Antimicrobial erapy • Treatment started only for documented GABHS infection • Due to practical constraints, antibiotics may be started empirically if: - GABHS is clinically suspected - Patient is toxic-looking - Follow-up is not possible • Empiric treatment of GABHS is discouraged due to poor diagnostic accuracy even w/ elaborate clinical scoring systems • A RADT or throat swab should be taken before starting empiric antibiotics • If antibiotics are started empirically, & culture results are negative, the antibiotic should be discontinued • Appropriate antibiotics prevent ARF, prevent suppurative complications, decrease infectivity & shorten clinical course Penicillin • Drug of choice • Proven effi cacy, narrow spectrum, safety & low cost • Full 10-day course of treatment for oral medications • IM penicillin may be advisable if poor compliance is a concern Amoxicillin • Better tolerated than Penicillin • 2nd line to Penicillin in pediatric patients due to taste preference Macrolides • Eg Azithromycin, Clarithromycin, Erythromycin, Roxithromycin • May be used for patients w/ Penicillin allergy • Local resistance patterns vary geographically & should be included in the consideration for an alternative antibiotic in Penicillin-allergic patients MIMS • Azithromycin or Cephalexin may be used for Erythromycin-intolerant patients Cephalosporins • Eg Cefaclor, Cefadroxil, Cefdinir, Cefi xime, Cefpodoxime, Cephalexin • Alternative to Amoxicillin for the eradication of streptococcal infection especially in recurrent cases • Studies show that a 5-day treatment w/ a cephalosporin is superior to a 10-day course w/ Penicillin Clindamycin • May be used for those who are both Penicillin-allergic & Erythromycin-intolerant • Reported resistance of GABHS isolates to Clindamycin are generally low & thus may still be considered a reasonable© alternative to macrolides & Penicillin Not all products are available or approved for above use in all countries. Specifi c prescribing information may be found in the latest MIMS. B272 © MIMS Pediatrics 2020 Tonsillopharyngitis - Acute (5 of 10) D SURGERY Treatment Goal • For recurrent tonsillopharyngitis, surgery aims for reduction in occurrence of sore throat & improved general health w/ tonsillectomy Indications for Tonsillectomy Recurrent Tonsillitis • Sore throat due to infl ammation of tonsils TONSILLOPHARYNGITIS • ≥7 episodes of tonsillitis over a 12-month period or ≥5 episodes/year in the past 2 years or ≥3 episodes/year in the past 3 years w/ documentation for each episode of sore throat & ≥1 of the following: - Temperature >38.3°C (101°F) - Cervical adenopathy - Tonsillar exudate - Positive test for GABHS infection • Symptoms interfere w/ patient’s normal daily function Peritonsillar Abscess or Quinsy • All abscesses should be drained • Tonsillectomy if without response to appropriate antibiotics &/or incision & drainage Contraindications to
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    510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091024 B. Purpose for Submission: Premarket notification C. Measurand: Methicillin Resistant Staphylococcus aureus (MRSA) D. Type of Test: Detection of MRSA using a selective and differential chromogenic media E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: chromID™ MRSA Agar G. Regulatory Information: 1. Regulation section: 21 CFR 866.1700 2. Classification: Class II 3. Product code: JSO Culture media, Antimicrobial susceptibility test, excluding Mueller Hinton Agar 1 4. Panel: Microbiology H. Intended Use: 1. Intended use(s): chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of nasal colonization of methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromID™ MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. 2. Indication(s) for use: The chromID™ MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. 3. Special conditions for use statement(s): Prescription use 4. Special instrument requirements: Not applicable I. Device Description: The chromID™ MRSA agar is translucent and a light tan color. After the plates are inoculated and incubated, colonies growing on the plates will have either a green appearance, which indicates a positive MRSA status or a colorless appearance which indicates a negative MRSA status. The green color is more vivid if the colonies are observed through the agar from the bottom of the plate.
  • Adverse Effects and Precautions

    Adverse Effects and Precautions

    1736 Disinfectants and Preservatives i Amylmetacresoi (BAN, riNN) ..................Preparat ons........ Adverse Effects and Precautions ProprietaryPreparations (details are given in Volume B) The alkyl gallates may cause contact sensitivity and skin Aml!metacreso!; A[ililrnetakrezol: Amylrnet.acreso[; Amylrne.­ AM<InM<;· Multi-ingredient Preparations. Singapore: Esemdent. reactions. ta�resolurn; Amylmetakresol: Amyylirnetakresoli; TaKpe30J1. Effects on the blood. Methaemoglobinaemia associated 6-Pentyl-rn,cresol; S;Methyl.-2-pentylpheooi. Alkyl Gallates with the antoxidants (butylated hydroxyanisole, butylated C1 J1,80= 178.3 hydroxytoluene, and propyl gallate) used to preserve the CAS 1300,94-3. .de Gaiatos alquilo; AnKwnrannalJ:>t. oil in a soybean infant feed fom1ula has been reported.1 UN!! -'-· 05W904P57F: Propyl gallate was suspected of being the most likely cause Dodecyl Gallate because its chemical structure is similar to pyrogallol Pharmacopoeias. In Bur. (see p. vii). (p. 1718.2), a methaemoglobinaemia inducer. Ph. Eur. 8: (Amylmetacresol). A clear or almost clear liquid Dodecilo galatas; Dociecyle,. gallate Dodecylgallat; . de; ..•. I. Nitzan M, et al. Infantile methemoglobinemia caused by food additives. or a solid crystalline mass, colourless or slightly yellow Dodecyi-9Jilat; D(0ec%lis (iallas:. Dodekyyligallaattl; E312; Clin Toxicol 1979; 15: 273-80. when freshly prepared; it darkens or discolours to dark m Galata • de dodecflo; Laury! Gailate; Laurylum Gafikw ; yellow, brownish-yellow, or pink on keeping. F.p. about 22 }logel\vfn rarinar. Preparations degrees. Practically insoluble in water; very soluble in Dodecyi 3,4,5-trihyc;lroxybenzoate. ...................... alcohol and in acetone. Store in non�metallic airtight (details are given in Volume B) C;ul;lje0$=338.4 ProprietaryPreparations containers. Protect from light.