Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
Brand Name :
Rovamycine 500, Rovamycine 250
Synonyms :
spiramycin
Class :
Antibiotic, Macrolide
Dosage forms and strengths Â
Capsule (Oral)Â
Rovamycine 500 (1,500,000 units)Â
Rovamycine 250 (750,000 units)Â
Indicated for mild to moderate infections
4-6 capsules (6,000,000-9,000,000 units) of Rovamycine 500 orally daily (in two divided doses)
Indicated for severe Infections
8-10 capsules (12,000,000-15,000,000 units) of Rovamycine 500 orally daily (in two divided doses)
8-9 capsules (12,000,000-13,500,000 units) of Rovamycine 500 orally administered as one dose
Note: spiramycin is not advised as a suitable treatment for gonorrhea according to clinical practice guidelines
Dosage forms and strengthsÂ
Capsule (Oral)Â
Rovamycine 500 (1,500,000 units)Â
Rovamycine 250 (750,000 units)Â
Based on the body weight-(150,000 units/kg) stated as 750,000 units of Rovamycine 250 orally every day
The daily intake is divided into 2-3 doses
For 30 kg of body weight: Take six capsules every day
For 20 kg of body weight: Take four capsules every day
For 15 kg of body weight: Take Three capsules every day
Note: For severe infections, the recommended dosage can be raised by 50%
Refer adult dosingÂ
Actions and Spectrum:Â
Action: spiramycin exerts its antimicrobial effect by inhibiting bacterial protein synthesis. It does so by binding to the 50S ribosomal subunit of the bacterial ribosome, which prevents the proper assembly of new proteins necessary for bacterial growth and replication. This action reduces bacterial cell division and multiplication, ultimately helping to control and eliminate the infection.Â
Spectrum: spiramycin has a relatively narrow spectrum of activity compared to some other antibiotics. It is primarily effective against certain Gram-positive bacteria and some Gram-negative bacteria. Its spectrum of activity includes:Â
Gram-positive bacteria:Â
Streptococci (including Streptococcus pyogenes, Streptococcus pneumoniae)Â
Staphylococci (limited activity against some strains)Â
CorynebacteriaÂ
Mycoplasma spp. (atypical bacteria)Â
Gram-negative bacteria:Â
Limited activity against some Gram-negative bacteria, mainly Neisseria spp. (such as Neisseria gonorrhoeae), Brucella spp., and Legionella spp.Â
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Frequency not defined Â
Gastrointestinal: vomiting, nausea, DiarrheaÂ
Dermatologic: urticaria, skin rash, PruritusÂ
Central nervous system: Paresthesia (transient)Â
Black Box Warning:Â Â
None
Contraindication/Caution:Â Â
Hypersensitivity: Individuals with a known hypersensitivity or allergy to spiramycin, other macrolide antibiotics, or any of the excipients in the medication should not take spiramycin.Â
Myasthenia Gravis: spiramycin may exacerbate the symptoms of myasthenia gravis.Â
Prolonged QT Interval: spiramycin may cause prolongation of the QT interval on an electrocardiogram (ECG), which could potentially lead to a dangerous arrhythmia. It should be used with caution in individuals with a history of QT interval prolongation, arrhythmias, or certain heart conditions.Â
Liver Dysfunction: spiramycin is metabolized in the liver, and individuals with severe liver impairment may have difficulties metabolizing the drug properly. Dosing adjustments may be necessary in these cases.Â
Kidney Dysfunction: While spiramycin is mainly eliminated through the liver, individuals with severe kidney dysfunction should be monitored closely when taking this medication.Â
Pregnancy and Breastfeeding: spiramycin should be used with caution during pregnancy and breastfeeding, and its use should be carefully considered in these situations. It has been used to treat certain infections during pregnancy, but its safety profile in these circumstances should be assessed by a healthcare professional.Â
Use in Neonates: Safety and efficacy data for spiramycin’s use in neonates are limited, and One should exercise caution when contemplating its utilization within this group.Â
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excreted into human milk is unknownÂ
Pregnancy Categories:        Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.Â
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology:Â Â
spiramycin is an antibiotic medication that belongs to the macrolide class. Its primary use to treat infections caused by susceptible microorganisms.Â
Pharmacodynamics:Â Â
spiramycin binds to the 50S ribosomal subunit of bacterial ribosomes, interfering with the translocation step of protein synthesis. This results in the inhibition of peptide bond formation between amino acids and the disruption of bacterial protein synthesis.Â
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Pharmacokinetics:Â
AbsorptionÂ
spiramycin is an antibiotic drug that is typically administered orally. It is absorbed in the gastrointestinal tract after oral ingestion. Â
DistributionÂ
spiramycin is distributed throughout the body via the bloodstream. It has been found to accumulate in various tissues, including the liver and lungs. Distribution may be influenced by factors such as tissue perfusion, protein binding, and lipid solubility.Â
MetabolismÂ
spiramycin undergoes limited metabolism in the liver. The primary metabolic pathways involve hydrolysis of the sugar moiety and cleavage of the macrolide ring. The metabolites formed are generally less active than the parent compound. The metabolism of spiramycin is relatively minor compared to some other drugs.Â
Excretion and EliminationÂ
The primary route of excretion for spiramycin and its metabolites is through the bile into the feces. Renal excretion is a minor elimination pathway. spiramycin and its metabolites are eliminated from the body over time, with a half-life ranging from several hours to around 12 hours.Â
Administration: Â
The administration is by oral route.Â
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Patient information leafletÂ
Generic Name: spiramycinÂ
Why do we use spiramycin? Â
Respiratory Tract Infections: spiramycin may be recommended for addressing a range of respiratory tract infections, including pneumonia, bronchitis, and sinusitis, that are attributed to bacteria susceptible to its effects.Â
Urogenital Infections: It may be used to treat urogenital infections like urinary tract infections (UTIs) and sexually transmitted infections (STIs) caused by susceptible bacteria.Â
Gastrointestinal Infections: spiramycin can be effective in treating certain gastrointestinal infections, including those caused by bacteria like Campylobacter and Helicobacter pylori.Â
Dental Infections: It might be used to manage dental infections, including periodontal infections and other oral bacterial infections.Â
Toxoplasmosis: spiramycin can be used in the treatment of toxoplasmosis, which is a parasitic infection caused by the protozoan Toxoplasma gondii. It is often used to protect the fetus from infection during pregnancy.Â
Prevention of Streptococcal Infections: spiramycin can be used as a preventive measure against Group B Streptococcus (GBS) infections in pregnant women, especially during labor and delivery.Â
Other Bacterial Infections: It may also be used to treat various other bacterial infections, including skin and soft tissue infections.Â
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