Sumamecin Dosage

How do you administer this medicine?
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Dosage of Sumamecin in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Packet,

Oral:

Zithromax: 1 g (3 ea, 10 ea) [cherry-banana flavor]

Generic: 1 g (3 ea, 10 ea)

Solution Reconstituted,

Intravenous [preservative free]:

Zithromax: 500 mg (1 ea)

Generic: 500 mg (1 ea)

Suspension Reconstituted,

Oral:

Zithromax: 100 mg/5 mL (15 mL) [cherry-vanilla-banana flavor]

Zithromax: 200 mg/5 mL (15 mL, 22.5 mL, 30 mL) [cherry flavor]

Zmax: 2 g (1 ea [DSC]) [cherry-banana flavor]

Generic: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL, 30 mL)

Tablet,

Oral:

Zithromax: 250 mg, 500 mg, 600 mg [DSC]

Zithromax Tri-Pak: 500 mg

Zithromax Z-Pak: 250 mg

Generic: 250 mg, 500 mg, 600 mg

Dosing: Adult

Coronavirus disease 2019 (COVID-19): Sumamecin, in combination with hydroxychloroquine, was described in 1 small, open-label, nonrandomized study in hospitalized patients with COVID-19 and appeared to have additive benefit in reducing viral carriage (Gautret 2020). Due to the limitations of this trial and the small number of patients who received Sumamecin (n=6), the role of Sumamecin in the management of COVID-19 has not been established. Sumamecin continues to be under investigation for use in the treatment of COVID-19. Whenever possible, treatment should be given as part of a clinical trial. If evidence demonstrating safety and efficacy becomes available, dosing recommendations may be provided.

Note: Zmax suspension has been discontinued in the United States for more than 1 year.

Note: ER suspension (Zmax) is not interchangeable with IR formulations. Use should be limited to approved indications. All doses are expressed as IR Sumamecin unless otherwise specified.

Acne vulgaris, inflammatory (moderate to severe) (off-label use):

Note: Use as an adjunct to topical acne therapy (AAD [Zaenglein 2016]).

Oral:

Dosing regimens used in clinical trials have varied greatly. All trials used pulse-dosing regimens; regimens included: 500 mg once daily for 4 consecutive days per month for 3 consecutive months (Babaeinejad 2011; Parsad 2001) or 500 mg once daily for 3 days in the first week, followed by 500 mg once weekly until week 10 (Maleszka 2011) or 500 mg once daily for 3 consecutive days each week in month 1, followed by 500 mg once daily for 2 consecutive days each week in month 2, then 500 mg once daily for 1 day each week in month 3 (Kus 2005). The shortest possible duration should be used to minimize development of bacterial resistance; reevaluate at 3 to 4 months (AAD [Zaenglein 2016]).

Babesiosis (off-label use):

Mild to moderate disease:

Oral:

500 mg on day 1, followed by 250 mg once daily in combination with atovaquone for 7 to 10 days in immunocompetent patients (IDSA [Wormser 2006]; Krause 2000; Vannier 2012); higher doses of Sumamecin may be used in immunocompromised patients (600 mg to 1 g daily) (IDSA [Wormser 2006]; Weiss 2001; Wormser 2010).

Severe disease: IV: 500 mg daily in combination with atovaquone for 7 to 10 days (Kletsova 2017; Sanchez 2016); a longer duration is needed for those at high risk for relapse (Krause 2008; Sanchez 2016; Vannier 2012). Note: May switch to oral Sumamecin (at the same dose) following improvement on IV therapy (Sanchez 2016); when switching to oral treatment in immunocompromised patients, a higher dose (600 mg to 1 g daily) has been used (IDSA [Wormser 2006]; Sanchez 2016; Weiss 2001).

Bronchiectasis (noncystic fibrosis), prevention of pulmonary exacerbations (off-label use):

Oral:

500 mg 3 times weekly (Wong 2012) or 250 mg once daily (Altenburg 2013). Note: Recommended for patients with ≥2 (Barker 2020) or ≥3 (ERS [Polverino 2017]) exacerbations per year; for those who do not have Pseudomonas aeruginosa infection, have P. aeruginosa but cannot take an inhaled antibiotic, or continue to have exacerbations despite an inhaled antibiotic. Patients should be screened for nontuberculous mycobacterial infection prior to treatment, and Sumamecin should not be given if present (ERS [Polverino 2017]).

Bronchiolitis obliterans syndrome in lung transplant recipients, treatment (off-label use):

Oral:

250 mg daily for 5 days, followed by 250 mg 3 times weekly for at least a 3-month trial (ISHLT/ATS/ERS [Meyer 2014]); some experts continue indefinitely, regardless of response to therapy (Pilewski 2019). Note: When studied to prevent bronchiolitis obliterans syndrome in patients with hematologic malignancy who underwent allogeneic hematopoietic cell transplantation, rates of cancer relapse and mortality were increased among patients receiving long-term Sumamecin, leading to early trial termination (Bergeron 2017; FDA Drug Safety Communication 2018).

Cat scratch disease (lymphadenitis) (off-label use):

Oral:

500 mg as a single dose, then 250 mg once daily for 4 additional days (Bass 1998; IDSA [Stevens 2014]; Psarros 2012).

Cesarean delivery (intrapartum or after rupture of membranes), preoperative prophylaxis (off-label use): IV: 500 mg as a single dose 1 hour prior to surgical incision; use in combination with standard preoperative antibiotics (ACOG 199 2018; Tita 2016).

Chronic obstructive pulmonary disease, acute exacerbation:

Acute exacerbation, treatment:

Oral:

500 mg in a single loading dose on day 1, followed by 250 mg once daily on days 2 to 5 (Castaldo 2003) or 500 mg once daily for 3 days (Swanson 2005). Note: Some experts reserve for patients without risk factors for Pseudomonas infection or poor outcomes (eg, age <65 years without major comorbidities, FEV >50% predicted, infrequent exacerbations) (Sethi 2020).

Prevention of exacerbations (off-label use):

Oral:

250 to 500 mg 3 times weekly (Berkhof 2013; GOLD 2019; Uzun 2014) or 250 mg once daily (Albert 2011; GOLD 2019).

Cystic fibrosis, anti-inflammatory (off-label use):

Oral:

250 mg (<40 kg) or 500 mg (≥40 kg) 3 times weekly (Saiman 2003) or 250 mg once daily (Wolter 2002). Note: Patients should be screened for nontuberculous mycobacterial infection prior to treatment and Sumamecin should not be given if present (Mogayzel 2013; Saiman 2003).

Diarrhea, infectious (off-label use):

Campylobacter infection:

Oral:

1 g as a single dose or 500 mg once daily for 3 days (ACG [Riddle 2016]; Tribble 2007). If symptoms have not resolved after 24 hours following single-dose therapy, continue with 500 mg once daily for 2 more days (ACG [Riddle 2016]). For HIV-infected patients, 500 mg once daily for 5 days is recommended (HHS [OI adult] 2019). Note: Increased nausea may occur with the 1 g single-dose regimen (Tribble 2007), which may be reduced by administering Sumamecin as 2 divided doses on the same day (CDC 2018; Riddle 2017).

Cholera (alternative agent):

Oral:

1 g as a single dose (Saha 2006)

Shigella infection: Note: Confirm susceptibility if possible (Agha 2019; HHS [OI adult] 2019; WHO 2005).

Oral:

500 mg once daily for 3 days (ACG [Riddle 2016]); 5 days of therapy should be given for Shigella dysenteriae type 1 infection or for patients with HIV coinfection (Agha 2019; HHS [OI adult] 2019).

Travelers' diarrhea, empiric treatment:

Oral:

1 g as a single dose or 500 mg once daily for 3 days (ACG [Riddle 2016]; CDC 2018; Riddle 2017; Tribble 2007). If symptoms have not resolved after 24 hours following single-dose therapy, continue with 500 mg once daily for 2 more days. A 3-day course of 500 mg once daily is the preferred regimen for dysentery or febrile diarrhea (ACG [Riddle 2016]). Note: Most cases are self-limited and may not warrant antimicrobial therapy. Increased nausea may occur with the 1 g single-dose regimen (Tribble 2007), which may be reduced by administering Sumamecin as 2 divided doses on the same day (CDC 2018; Riddle 2017).

Endocarditis prophylaxis, dental or invasive respiratory tract procedure (alternative agent for penicillin-allergic patients) (off-label use):

Oral:

500 mg 30 to 60 minutes prior to procedure. Note: Only recommended for patients with cardiac conditions associated with the highest risk of an adverse outcome from endocarditis and who are undergoing a procedure likely to result in bacteremia with an organism that has the potential to cause endocarditis. (AHA [Wilson 2007]).

Lyme disease (erythema migrans or borrelial lymphocytoma) (alternative agent) (off-label use):

Oral:

500 mg once daily for 7 to 10 days. Note: Use with caution and only when recommended agents cannot be used (due to decreased efficacy compared to other agents) (IDSA [Wormser 2006]).

Mycobacterial (nontuberculous) infection:

Mycobacterium avium complex (MAC) infection:

Disseminated disease in HIV-infected patients:

Treatment:

Oral:

500 to 600 mg daily as part of a combination therapy regimen (HHS [OI adult] 2019).

Primary prophylaxis (patients with CD4 count <50 cells/mm in response to ART (HHS [OI adult] 2019).

Pulmonary disease (nodular/bronchiectatic disease) (off-label use):

Oral:

500 to 600 mg 3 times weekly as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year (ATS/IDSA [Griffith 2007]); some experts prefer 500 mg 3 times weekly due to improved tolerability (BTS [Haworth 2017]).

Pulmonary disease (severe nodular/bronchiectatic or cavitary disease) (off-label use):

Oral:

250 to 500 mg once daily as part of an appropriate combination regimen (ATS/IDSA [Griffith 2007]; BTS [Haworth 2017]; Deshpande 2016; van Ingen 2012); continue treatment until patient is culture negative on therapy for ≥1 year (ATS/IDSA [Griffith 2007]; BTS [Haworth 2017]). Preliminary data suggest a relationship between peak concentration and clinical outcome among patients receiving daily therapy for pulmonary MAC (Jeong 2016); as such, some experts recommend checking levels and/or using higher doses of Sumamecin (Kasperbauer 2019).

Pulmonary disease in patients with cystic fibrosis (off-label use):

Oral:

250 to 500 mg once daily as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year. Note: Intermittent dosing (3 times weekly) is not recommended for patients with cystic fibrosis (CFF/ECFS [Floto 2016]).

Mycobacterium abscessus infection (off-label use):

Note: Presence of inducible erm gene can result in decreased susceptibility even with a “susceptible” MIC result; perform susceptibility testing before and after ≥14 days of clarithromycin incubation to evaluate for the presence of an active erm gene, which may preclude use of Sumamecin (CFF/ECFS [Floto 2016]; Griffith 2019).

Pulmonary, skin, soft tissue, or bone infection:

Oral:

250 to 500 mg once daily as part of an appropriate combination regimen and continued for ≥6 to 12 months for pulmonary and bone infections, and ≥4 months for skin/soft tissue infections (ATS/IDSA [Griffith 2007]; CFF/ECFS [Floto 2016]; Griffith 2019). Note: Patients should be under the care of a clinician with expertise in managing mycobacterial infection.

Pertussis (off-label use):

Oral:

500 mg on day 1, followed by 250 mg once daily on days 2 to 5 (CDC [Tiwari 2005]).

Pneumonia, community acquired:

Outpatient:

Oral:

500 mg on day 1, followed by 250 mg once daily for 4 days or 500 mg once daily for 3 days (Amsden 1999; ATS/IDSA [Metlay 2019]; Schönwald 1991). Note: May use as monotherapy (alternative agent) for outpatients without comorbidities or risk factors for antibiotic-resistant pathogens only if local pneumococcal resistance is <25%. Must be used as part of an appropriate combination regimen in outpatients with comorbidities (ATS/IDSA [Metlay 2019]); some experts prefer to use as part of an appropriate combination regimen in all outpatients, regardless of comorbidities (File 2020).

Inpatient:

Oral, IV:

500 mg once daily for a minimum of 3 days, as part of an appropriate combination regimen (ATS/IDSA [Metlay 2019]; File 2020).

Sexually transmitted infections:

Cervicitis, empiric therapy:

Oral:

1 g as a single dose, preferably under direct observation; give in combination with ceftriaxone if the patient is at high risk for gonorrhea, if follow-up is a concern, or if the local prevalence of gonorrhea is high (eg, >5%) (CDC [Workowski 2015]; Hsu 2019).

Chancroid (due to Haemophilus ducreyi):

Oral:

1 g as a single dose. Note: Data are limited concerning efficacy in HIV infected patients (CDC [Workowski 2015]).

Chlamydia trachomatis infection of the cervix, urethra, or pharynx (off-label use [pharynx]):

Oral:

1 g as a single dose, preferably under direct observation (CDC [Workowski 2015]).

Chlamydia trachomatis infection, expedited partner therapy (off-label use):

Oral:

1 g as a single dose, preferably under direct observation. Note: Clinical evaluation and presumptive treatment is preferred for sexual partners of patients with chlamydia. Alternatively, expedited partner therapy for chlamydia can be used for heterosexual partners if the provider is concerned that the partner will otherwise not be promptly evaluated and treated; state laws regarding expedited partner therapy vary (CDC [Workowski 2015]).

Empiric treatment following sexual assault (off-label use):

Oral:

1 g as a single dose in combination with ceftriaxone (plus metronidazole or tinidazole) (CDC [Workowski 2015]).

Gonococcal infection, disseminated (arthritis, arthritis-dermatitis) (off-label use):

Oral:

1 g as a single dose in combination with ceftriaxone, preferably under direct observation (CDC [Workowski 2015]).

Gonococcal infection, expedited partner therapy (off-label use):

Oral:

1 g as a single dose in combination with cefixime. Note: Clinical evaluation and presumptive treatment is preferred for sexual partners of patients with gonorrhea. Alternatively, expedited partner therapy for gonorrhea can be used for heterosexual partners if the provider is concerned that the partner will otherwise not be promptly evaluated and treated; state laws regarding expedited partner therapy vary (CDC [Workowski 2015]).

Gonococcal infection, uncomplicated (infection of the cervix, urethra, rectum, or pharynx; conjunctivitis):

Oral:

Dual-therapy regimen (off-label): 1 g as a single dose in combination with ceftriaxone (CDC [Workowski 2015]).

Patients with severe cephalosporin allergy (off-label): 2 g as a single dose in combination with gemifloxacin (not available in the US) or gentamicin IM (CDC [Workowski 2015]). Note: Patients with pharyngeal infection treated with an alternative regimen should have a test-of-cure performed. Consult an infectious diseases specialist when treatment failure is suspected and report failures to the CDC through state and local health departments within 24 hours of diagnosis (CDC [Workowski 2015]).

Granuloma inguinale (donovanosis) (off-label use):

Oral:

1 g once weekly or 500 mg once daily for ≥3 weeks and until lesions have healed. Note: If symptoms do not improve within the first few days of therapy, the addition of gentamicin may be considered (CDC [Workowski 2015]).

Mycoplasma genitalium (off-label use):

Oral:

Note: Sumamecin resistance is rapidly emerging; consider alternative therapy. Sumamecin is not recommended for persistent infection when included in the initial regimen (CDC [Workowski 2015]; Martin 2019).

Initial treatment: 500 mg on day 1, followed by 250 mg once daily on days 2 through 5 (CDC [Workowski 2015]; Falk 2015); some experts favor high dose (1 g on day 1 followed by 500 mg once daily on days 2 through 4 with a test of cure 3 to 4 weeks after initiation) (Durukan 2019; Martin 2019; Read 2019).

Syphilis, primary and secondary (alternative agent for penicillin-allergic patients) (off-label use):

Oral:

2 g as a single dose. Note: Limited data support the use of alternatives to penicillin; close serologic and clinical follow-up is warranted. Use only if no other options are available due to the potential for rapid emergence of macrolide resistance in Treponema pallidum and treatment failure; do not use to treat syphilis in patients with HIV, pregnant women, or the men who have sex with men (MSM) population (CDC [Workowski 2015]).

Urethritis, empiric therapy:

Oral:

1 g as a single dose, preferably under direct observation; give in combination with ceftriaxone if there is microscopic evidence of gonococcal urethritis or if there is high clinical suspicion for gonococcal infection (Bachmann 2020; CDC [Workowski 2015]).

Streptococcal pharyngitis (group A) (alternative agent for severely penicillin-allergic patients):

Oral:

500 mg on day 1, followed by 250 mg once daily on days 2 through 5 (IDSA [Shulman 2012]) or 500 mg once daily for 3 days (Casey 2005).

Surgical prophylaxis, uterine evacuation (induced abortion or pregnancy loss) (alternative agent) (off-label use):

Oral:

500 mg as a single dose 1 hour before the procedure (may be administered up to 12 hours before the procedure) (Shih 2019).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Coronavirus disease 2019 (COVID-19): Sumamecin, in combination with hydroxychloroquine, was described in 1 small, open-label, nonrandomized study in hospitalized adult patients (mean age of treated patients: 51.2 ± 18.7 years) with COVID-19 and appeared to have additive benefit in reducing viral carriage (Gautret 2020). Due to the limitations of this trial and the small number of patients who received Sumamecin (n=6) the role of Sumamecin in the management of COVID-19 has not been established. Sumamecin continues to be under investigation for use in the treatment of COVID-19. Whenever possible, treatment should be given as part of a clinical trial. No studies in pediatric patients have been reported. If evidence demonstrating safety and efficacy becomes available, dosing recommendations may be provided.

Note: Zmax 2 g extended-release oral suspension has been discontinued in the US for more than 1 year.

Note: Extended-release suspension (Zmax) is not interchangeable with immediate-release formulations. All doses are expressed as immediate-release Sumamecin unless otherwise specified.

General dosing, susceptible infection (Red Book [AAP] 2012): Infants, Children, and Adolescents:

Mild to moderate infection:

Oral: 5 to 12 mg/kg/dose; typically administered as 10 to 12 mg/kg/dose on day 1 followed by 5 to 6 mg/kg once daily for remainder of treatment duration; usual maximum dose for the total course: 1,500 to 2,000 mg

Serious infection: IV: 10 mg/kg once daily; maximum dose: 500 mg/dose

Babesiosis: Infants, Children, and Adolescents:

Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), then 5 mg/kg once daily on days 2 to 10 (maximum dose: 250 mg/dose) in combination with atovaquone; longer duration of therapy may be necessary in some cases; in immunocompromised patients, higher doses (eg, adults: 600 to 1,000 mg daily) may be required (Red Book [AAP] 2012; IDSA [Wormser 2006])

Bartonellosis:

Oral:

Cat scratch disease (B. henselae) with extensive lymphadenopathy (IDSA [Stevens] 2014): Non-HIV-exposed/-positive:

Infants, Children, and Adolescents ≤45 kg: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose)

Children and Adolescents >45 kg: 500 mg as a single dose on day 1, then 250 mg once daily for 4 additional days

Cutaneous bacillary angiomatosis (B. henselae or B. quintana): HIV- exposed/-positive: Infants, Children, and Adolescents: 5 to 12 mg/kg once daily; maximum dose: 600 mg/dose; usual treatment duration: 3 months (CDC 2009)

Chancroid (CDC 2010; Red Book [AAP] 2012):

Oral:

<45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose

≥45 kg: 1,000 mg as a single dose

Chlamydial infections:

Cervicitis, urethritis (C. trachomatis): Children and Adolescents ≥45 kg:

Oral: 1,000 mg as a single dose (CDC 2010;

Red Book [AAP] 2012)

Conjunctivitis: Infants:

Oral, IV: 20 mg/kg once daily for 3 days (

Red Book [AAP] 2012)

Pneumonia, community-acquired (Bradley 2011): Infants >3 months, Children, and Adolescents:

Mild infection or step-down therapy:

Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose) followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose)

Severe infection: IV: 10 mg/ kg once daily for at least 2 days, then transition to oral route with a single daily dose of 5 mg/kg to complete course of therapy; maximum dose: 500 mg/dose

Cystic fibrosis; improve lung function, reduce exacerbation frequency: Limited data available; dosing regimen variable (Mogayzel 2013; Saiman 2003; Saiman 2010): Children ≥6 years and Adolescents:

Oral:

18 to 35.9 kg: 250 mg three times weekly (Monday, Wednesday, Friday)

≥36 kg: 500 mg three times weekly (Monday, Wednesday, Friday)

Diarrhea, infectious:

Campylobacter: Infants, Children, and Adolescents:

Oral: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose (Red Book [AAP] 2012)

Shigellosis: Infants, Children, and Adolescents:

Oral:

AAP Recommendation: 12 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 6 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose) (Red Book [AAP] 2012)

Alternate dosing: 10 mg/kg once daily for 3 days (Dupont 2009; Mackell 2005); WHO Guidelines recommend up to 20 mg/kg/dose and in some cases, a wider range of duration of therapy (eg, 1 to 5 days) (WHO 2005)

Endocarditis; prophylaxis: Infants, Children, and Adolescents:

Oral: 15 mg/kg/dose 30 to 60 minutes before procedure; maximum dose: 500 mg/dose (Wilson 2007)

Gonococcal infection; uncomplicated (cervicitis, urethritis, anorectal):

Oral:

Children <45 kg: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose (Red Book [AAP] 2012)

Children > 8 years and ≥45 kg and Adolescents: 1,000 mg as a single dose (CDC 2012; Red Book [AAP] 2012)

Group A streptococcal infection; treatment of streptococcal tonsillopharyngitis:

Manufacturer's labeling and AHA recommendations: Infants, Children, and Adolescents:

Oral: 12 mg/kg/dose once daily for 5 days; maximum dose: 500 mg/dose (AHA [Gerber 2009])

Alternate dosing:

IDSA recommendations: Note: Recommended as an alternative agent for group A streptococcal pharyngitis in penicillin-allergic patients. Infants, Children, and Adolescents:

Oral: 12 mg/kg (maximum: 500 mg/dose) on day 1 followed by 6 mg/kg/dose (maximum: 250 mg/dose) once daily on days 2 through 5 (IDSA [Shulman 2012]).

Three-day regimen: Limited data available: Children and Adolescents:

Oral: 20 mg/kg/dose once daily for 3 days; maximum dose: 1,000 mg/dose (Cohen 2004; O'Doherty 1996)

Meningococcal disease, chemoprophylaxis of high-risk contacts: Infants, Children, and Adolescents:

Oral: 10 mg/kg as a single dose; maximum dose: 500 mg/dose; Note: Not routinely recommended; may consider if fluoroquinolone resistance detected (Red Book [AAP] 2012)

Mycobacterium avium complex (MAC) infection (HIV-exposed/-positive):

Infants and Children (DHHS [pediatric] 2013):

Oral:

Treatment: 10 to 12 mg/kg once daily in combination with ethambutol, with or without rifabutin; maximum dose: 500 mg/dose; treatment duration at least 12 months; dependent upon clinical response

Primary prevention of first episode: Preferred: 20 mg/kg once weekly (maximum dose: 1,200 mg/dose) or alternatively, 5 mg/kg once daily (maximum dose: 250 mg/dose)

Secondary prevention of recurring episodes: 5 mg/kg once daily in combination with ethambutol, with or without rifabutin; maximum dose: 250 mg/dose

Adolescents (DHHS [adult] 2013):

Oral:

Treatment: 500 to 600 mg daily in combination with ethambutol

Primary prophylaxis: 1,200 mg once weekly or alternatively, 600 mg twice weekly

Secondary prophylaxis: 500 to 600 mg daily in combination with ethambutol

Otitis media, acute (AOM): Infants ≥6 months, Children, and Adolescents:

Oral:

Note: Due to increased S pneumonia and H. influenzae resistance, Sumamecin is not routinely recommended as a treatment option (AAP [Lieberthal 2013])

Single-dose regimen: 30 mg/kg as a single dose; maximum dose: 1,500 mg/dose; if patient vomits within 30 minutes of dose, repeat dosing has been administered although limited data available on safety

Three-day regimen: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose

Five-day regimen: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg (maximum dose: 250 mg/dose) once daily on days 2 to 5

Peritonitis (peritoneal dialysis), prophylaxis for patients receiving peritoneal dialysis who require dental procedures: Infants, Children, and Adolescents:

Oral: 15 mg/kg administered 30 to 60 minutes before dental procedure; maximum dose: 500 mg/dose (Warady [ISPD 2012])

Pertussis (CDC 2005; Red Book [AAP] 2012):

Oral, IV:

Infants 1 to 5 months: 10 mg/kg/dose once daily for 5 days

Infants ≥6 months, Children, and Adolescents: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose)

Pneumonia, community-acquired (excluding mycobacterial [mycoplasma pneumoniae] and chlamydial infections):

Oral:

Immediate release: Infants >3 months, Children, and Adolescents: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg (maximum dose: 250 mg/dose) once daily on days 2 to 5 (Bradley 2011)

Extended-release oral suspension (Zmax): Infants ≥6 months, Children, and Adolescents: 60 mg/kg as a single dose; maximum dose: 2,000 mg/dose

IV: Infants >3 months, Children, and Adolescents: 10 mg/kg once daily for at least 2 days, follow IV therapy by the oral route with a single daily dose of 5 mg/kg to complete a 5-day course of therapy; maximum dose: 500 mg/dose (Bradley 2011)

Pneumonia, community acquired; mycoplasma pneumoniae, or chlamydial infection (Bradley 2011): Infants >3 months, Children, and Adolescents:

Mild infection or step-down therapy:

Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose) followed by 5 mg/kg once daily on days 2 to 5 (maximum dose: 250 mg/dose)

Severe infection: IV: 10 mg/kg once daily for at least 2 days (maximum dose: 500 mg/dose), then transition to oral route with a single daily dose of 5 mg/kg to complete course of therapy (maximum dose: 250 mg/dose)

Rhinosinusitis, bacterial:

Oral: Infants ≥6 months, Children, and Adolescents: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose; Note: Although FDA approved, macrolides are not recommended for empiric therapy due to high rates of resistance (Chow 2012).

Sexual victimization, prophylaxis:

Oral:

Note: Use in combination with cefixime or ceftriaxone and completion of hepatitis B virus immunization; also consider prophylaxis for trichomoniasis and bacterial vaginosis (CDC 2010; Red Book [AAP] 2012).

Children <45 kg: 20 mg/kg as a single dose

Children ≥45 kg and Adolescents: 1,000 mg as a single dose

Toxoplasma gondii, encephalitis (HIV-exposed/-positive); treatment and prevention:

Oral: Adolescents: 900 to 1,200 mg once daily in combination with pyrimethamine/leucovorin; treatment duration: 6 weeks or longer if extensive disease or incomplete response at 6 weeks (DHHS [adult] 2013)

What other drugs will affect Sumamecin?

Many drugs can interact with Sumamecin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Sumamecin, especially:

This list is not complete and many other drugs can interact with Sumamecin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Sumamecin interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Sumamecin, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Antacid: In patients receiving Sumamecin and antacids, Sumamecin should be taken at least 1 hr before or 2 hrs after the antacid.

Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepines or its active metabolite.

Cimetidine: A single dose of cimetidine administered 2 hrs before Sumamecin had no effect on the pharmacokinectics of Sumamecin.

Cyclosporine: In a pharmacokinetic study with healthy volunteers that were administered a 500-mg/day oral dose of Sumamecin for 3 days and were then administered a single 10-mg/kg oral dose of cyclosporine, the resulting cyclosporine Cmax and AUC0-5 were found to be significantly elevated (by 24% and 21%, respectively), however, no significant changes were seen in AUC0-∞. Consequently, caution should be exercised before considering co-administration of these 2 drugs. If co-administration is necessary, cyclosporine levels should be monitored and the dose adjusted accordingly.

Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant Sumamecin and digoxin, the possibility of raised digoxin levels should be borne in mind, and digoxin levels monitored.

Ergot Derivatives: Because of the theoretical possibility of ergotism, Sumamecin and ergot derivatives should not be co-administered.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Sumamecin had no significant effect on the pharmacokinetics of methylprednisolone.

Terfenadine: Because of the occurrence of serious dysrhythmias secondary to prolongation of the QTc interval in patients receiving other anti-infectives in conjunction with terfenadine, pharmacokinetic interaction studies have been performed. These studies have reported no evidence of an interaction between Sumamecin and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred. As with other macrolides, Sumamecin should be administered with caution in combination with terfenadine.

Theophylline: Theophylline levels may be increased in patients taking Sumamecin.

Coumarin-Type

Oral Anticoagulants:

In a pharmacodynamic interaction study, Sumamecin did not alter the anticoagulant effect of a single 15-mg dose of warfarin administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of Sumamecin and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when Sumamecin is used in patients receiving coumarin-type oral anticoagulants.

Zidovudine: Single 1000-mg doses and multiple 1200- or 600-mg doses of Sumamecin did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Sumamecin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.

Didanosine: Co-administration of daily doses of Sumamecin 1200 mg with didanosine in 6 subjects did not appear to affect the pharmacokinetics of didanosine as compared with placebo.

Rifabutin: Co-administration of Sumamecin and rifabutin did not affect the serum concentration of either drug. Neutropenia was observed in subjects receiving concomitant treatment of Sumamecin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Sumamecin has not been established.


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References

  1. DailyMed. "AZITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "J2KLZ20U1M: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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