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: Oral: 12,000,000 to 15,000,000 units (8 to 10 capsules of Rovamycine “500” per day) in 2 divided doses.
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 (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]).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
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%.
No dosage adjustment required.
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)
Hypersensitivity to spiramycin or any component of the formulation; treatment of meningitis.
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.
Not available in the US
Yes
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
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).
Oral: Administer without regard to meals; however, administration during a meal may improve GI tolerance (Peyron 2019).
Oral: Administer without regard to meals.
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).
Toxoplasmosis, vertical transmission prophylaxis, in patients who are pregnant
None known.
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 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
Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy
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
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]).
Food may improve gastrointestinal tolerance.
Inhibits growth of susceptible organisms; mechanism not established.
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