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Spiramycin (United States: Available via FDA or other investigational drug [IND] protocol only): Drug information

Spiramycin (United States: Available via FDA or other investigational drug [IND] protocol only): Drug information
(For additional information see "Spiramycin (United States: Available via FDA or other investigational drug [IND] protocol only): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Rovamycine 250;
  • Rovamycine 500
Pharmacologic Category
  • Antibiotic, Macrolide
Dosing: Adult
Mild to moderate infections

Mild to moderate infections: Oral: 6,000,000 to 9,000,000 units (4 to 6 capsules of Rovamycine “500” per day) in 2 divided doses.

Severe infections

Severe infections: Oral: 12,000,000 to 15,000,000 units (8 to 10 capsules of Rovamycine “500” per day) in 2 divided doses.

Gonorrhea

Gonorrhea: Oral: 12,000,000 to 13,500,000 units (8 to 9 capsules of Rovamycine “500”) as a single dose. Note: Spiramycin is not a recommended therapy for gonorrhea in clinical practice guidelines (CDC [Workowski 2021]; PHAC 2021).

Toxoplasmosis, vertical transmission prophylaxis, in patients who are pregnant

Toxoplasmosis, vertical transmission prophylaxis, in patients who are pregnant (off-label use): Oral: 1 g (3,000,000 units [2 capsules of Rovamycine “500”]) every 8 hours to prevent transmission to fetus. If there is no evidence of transmission to the fetus, spiramycin can be continued until term. Note: If fetal infection has occurred or is suspected, agents other than spiramycin are recommended (HHS [OI adult 2022]; Maldonado 2017; SOGC [Paquet 2018]).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Susceptible infections

Susceptible infections: Oral: Dosage by body weight; usual dosage 150,000 units/kg; expressed as the number of 750,000 unit (Rovamycine “250”) capsules per day. Daily dose should be administered in 2 to 3 divided doses.

15 kg = 3 capsules per day

20 kg = 4 capsules per day

30 kg = 6 capsules per day

Note: In severe infections, dosage may be increased by 50%.

Dosing: Kidney Impairment: Pediatric

No dosage adjustment required.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Vasculitis

Dermatologic: Pruritus, skin rash, urticaria

Gastrointestinal: Clostridioides difficile colitis, diarrhea, nausea, vomiting

Hematologic & oncologic: Henoch-Schönlein purpura

Hepatic: Abnormal hepatic function tests

Hypersensitivity: Anaphylactic shock, angioedema

Nervous system: Paresthesia (transient)

Postmarketing:

Hematologic & oncologic: Hemolysis (acute)

Hepatic: Hepatotoxicity (idiosyncratic) (Chalasani 2021)

Contraindications

Hypersensitivity to spiramycin or any component of the formulation; treatment of meningitis.

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Macrolides have been associated with rare QTc prolongation and ventricular arrhythmias, including torsade de pointes; use with caution in patients at risk of prolonged cardiac repolarization.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with pre-existing liver disease; hepatic impairment, including hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been observed. Discontinue if symptoms of malaise, nausea, vomiting, abdominal colic, and fever.

Product Availability

Not available in the US

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Rovamycine 250: 750,000 units [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]

Rovamycine 500: 1,500,000 units

Prescribing and Access Restrictions

Spiramycin is not commercially available in the US; it is available for treatment of toxoplasmosis in pregnant women through the US Food and Drug Administration (301-796-1400).

Administration: Adult

Oral: Administer without regard to meals; however, administration during a meal may improve GI tolerance (Peyron 2019).

Administration: Pediatric

Oral: Administer without regard to meals.

Use: Labeled Indications

Note: Not approved in the United States.

Treatment of infections of the respiratory tract, buccal cavity, skin, and soft tissues due to susceptible organisms; as an alternative agent for gonorrhea in patients allergic to the penicillins. Note: Spiramycin is not a recommended therapy for gonorrhea in clinical practice guidelines (CDC [Workowski 2021]; PHAC 2021).

Use: Off-Label: Adult

Toxoplasmosis, vertical transmission prophylaxis, in patients who are pregnant

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Carbidopa: Spiramycin may decrease the serum concentration of Carbidopa. And thus may decrease the effectiveness of levodopa. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mizolastine: Macrolide Antibiotics may increase the serum concentration of Mizolastine. Risk X: Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Macrolide Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Spiramycin concentrates in the placenta; fetal exposure is limited (Couvreur 1993; Gratzl 2002; Montoya 2008).

Spiramycin is not considered to be teratogenic (HHS [OI adult] 2022; Maldonado 2017).

Spiramycin is used off label for the management of acute toxoplasmosis and reactivated latent toxoplasmosis in pregnant patients to prevent fetal infection. Maternal infection may be asymptomatic; however, congenital transmission may occur. Fetal Toxoplasma gondii infection can lead to adverse outcomes such as chorioretinitis, visual impairment, hearing loss, and/or developmental delay in the newborn. The risk of fetal infection increases with gestational age; however, congenital disease severity increases the earlier in gestation the fetal infection occurs (ACOG 2015; HHS [OI adult] 2022; SOGC [Paquet 2018]).

Maternal treatment with spiramycin is recommended to prevent congenital transmission when maternal infection is diagnosed prior to fetal infection. Spiramycin does not cross the placenta in concentrations to treat the fetus; if fetal infection has occurred, agents other than spiramycin are recommended. Amniotic fluid testing, when needed for fetal diagnosis, should be avoided prior to 18 weeks’ gestation to minimize the possibility of false-negative results. Monthly fetal monitoring is recommended during spiramycin therapy (ACOG 2015; HHS [OI adult] 2022; SOGC [Paquet 2018]).

Dietary Considerations

Food may improve gastrointestinal tolerance.

Mechanism of Action

Inhibits growth of susceptible organisms; mechanism not established.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BD) Bangladesh: Rovamycin;
  • (BR) Brazil: Rovamicina;
  • (CN) China: Acetylspiramycin | Yi nuo xin;
  • (DE) Germany: Selectomycin;
  • (DO) Dominican Republic: Dicorvin;
  • (ES) Spain: Dicorvin;
  • (ID) Indonesia: Acetyl Spiramycin | Hypermycin;
  • (QA) Qatar: Rovamycine
  1. American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 151: Cytomegalovirus, parvovirus B19, varicella zoster, and toxoplasmosis in pregnancy. Obstet Gynecol. 2015;125(6):1510-1525. doi:10.1097/01.AOG.0000466430.19823.53 [PubMed 26000539]
  2. Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2014;109(7):950-966. doi:10.1038/ajg.2014.131 [PubMed 24935270]
  3. Chalasani NP, Maddur H, Russo MW, Wong RJ, Reddy KR; Practice parameters Committee of the American College of Gastroenterology. ACG clinical guideline: diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol. 2021;116(5):878-898. doi:10.14309/ajg.0000000000001259 [PubMed 33929376]
  4. Couvreur J, Thulliez P, Daffos F, et al. In utero treatment of toxoplasmic fetopathy with the combination pyrimethamine-sulfadiazine. Fetal Diagn Ther. 1993;8(1):45-50. doi:10.1159/000263746 [PubMed 8452648]
  5. Daffos F, Forestier F, Capella-Pavlovsky M, et al. Prenatal management of 746 pregnancies at risk for congenital toxoplasmosis. N Engl J Med. 1988;318(5):271-275. doi:10.1056/NEJM198802043180502 [PubMed 3336419]
  6. Gratzl R, Sodeck G, Platzer P, et al. Treatment of toxoplasmosis in pregnancy: concentrations of spiramycin and neospiramycin in maternal serum and amniotic fluid. Eur J Clin Microbiol Infect Dis. 2002;21(1):12-16. doi:10.1007/s10096-001-0644-6 [PubMed 11913495]
  7. Hohlfeld P, Daffos F, Thulliez P, et al. Fetal toxoplasmosis: outcome of pregnancy and infant follow-up after in utero treatment. J Pediatr. 1989;115(5, pt 1):765-769. doi:10.1016/s0022-3476(89)80660-2 [PubMed 2681638]
  8. Maldonado YA, Read JS; Committee on Infectious Diseases. Diagnosis, treatment, and prevention of congenital toxoplasmosis in the United States. Pediatrics. 2017;139(2):e20163860. doi:10.1542/peds.2016-3860 [PubMed 28138010]
  9. Montoya JG, Remington JS. Management of Toxoplasma gondii infection during pregnancy. Clin Infect Dis. 2008;47(4):554-566. doi:10.1086/590149 [PubMed 18624630]
  10. Paquet C, Yudin MH. No. 285-Toxoplasmosis in pregnancy: prevention, screening, and treatment. J Obstet Gynaecol Can. 2018;40(8):e687-e693. doi:10.1016/j.jogc.2018.05.036 [PubMed 30103893]
  11. Peyron F, L'ollivier C, Mandelbrot L, et al. Maternal and congenital toxoplasmosis: diagnosis and treatment recommendations of a French multidisciplinary working group. Pathogens. 2019;8(1):24. doi:10.3390/pathogens8010024 [PubMed 30781652]
  12. Public Health Agency of Canada. Gonorrhea guide: key information and resources. https://www.canada.ca/en/public-health/services/infectious-diseases/sexual-health-sexually-transmitted-infections/canadian-guidelines/gonorrhea.html. Updated November 9, 2021. Accessed January 19, 2022.
  13. Rovamycine (spiramycin) [product monograph]. Quebec, Canada: Aventis Pharma Inc; April 2018.
  14. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/whats-new. Accessed February 16, 2022.
  15. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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