Spiramycin

• Mild and moderate infections
• Severe infections
• Gonorrhea
• Toxoplasmosis

• Mild and moderate infections
• Severe infections
• Gonorrhea
• Toxoplasmosis

For mild to moderate infections, the recommended dosage of Spiramycin is as follows: Oral administration should consist of 6,000,000 to 9,000,000 units (equivalent to 4 to 6 capsules of Spiramycin "500") per day, divided into two doses.

In the case of severe infections, the recommended dosage of Spiramycin is: Oral administration should consist of 12,000,000 to 15,000,000 units (equivalent to 8 to 10 capsules of Spiramycin "500") per day, divided into two doses.

For the treatment of gonorrhea, the recommended oral dosage of Spiramycin is: 12,000,000 to 13,500,000 units (equivalent to 8 to 9 capsules of Spiramycin "500") as a single dose. It is important to note that spiramycin is not a recommended therapy for gonorrhea according to clinical practice guidelines from CDC .

In cases of toxoplasmosis with the goal of preventing vertical transmission in pregnant patients (off-label use), the recommended oral dosage of Spiramycin is: 1 g (equivalent to 3,000,000 units or 2 capsules of Spiramycin "500") every 8 hours. This treatment regimen should be continued until term if there is no evidence of fetal transmission. However, it is important to note that if fetal infection is suspected or confirmed, alternative agents are recommended .

Capsules: 250 mg, 500 mg.

Capsules

• Dosage Adjustments in Pediatric Patients:

No specific dietary restrictions associated with the use of Spiramycin have been found.

• Hypersensitivity to Macrolides: Spiramycin should not be used in individuals with a known hypersensitivity or allergic reaction to macrolide antibiotics, including erythromycin.
• Severe Impaired Hepatic Function: Spiramycin is contraindicated in patients with severely impaired liver function. 
• Concurrent Therapy with Vasoconstrictive Ergot Alkaloids: The simultaneous use of Spiramycin with vasoconstrictive ergot alkaloids is contraindicated. 

Superinfection by Resistant Organisms: Prolonged or repeated use of antibiotics, including Spiramycin, may lead to superinfection by bacteria that are resistant to the drug. If superinfection occurs, Spiramycin should be discontinued, and appropriate therapy should be initiated.

Antibiotic-Associated Pseudomembranous Colitis: The use of antibiotics has been associated with a condition called pseudomembranous colitis, caused by a toxin produced by Clostridium difficile. This condition can range from mild to life-threatening. Patients experiencing diarrhea or colitis while on antibiotic therapy, or even several weeks after discontinuation, should be evaluated for pseudomembranous colitis. Mild cases may resolve with discontinuation of the drug alone, while moderate to severe cases may require treatment with an oral antibacterial agent effective against Clostridium difficile, along with fluid and electrolyte replacement therapy.

Drugs that Delay Peristalsis : Medications that slow down intestinal movements, such as opiates and diphenoxylate with atropine, should not be used as they can worsen the condition associated with pseudomembranous colitis.

Aggravation of Myasthenia Gravis: Spiramycin, like other macrolide antibiotics, has the potential to worsen symptoms of myasthenia gravis, a neuromuscular disorder. Caution should be exercised when prescribing Spiramycin to patients with this condition.

Bullous Skin Reactions: Severe skin reactions, such as Stevens-Johnson Syndrome or Toxic Epidermal Necrosis, have been reported with the use of Spiramycin. If symptoms such as progressive skin rash with blisters or mucosal lesions occur, treatment with Spiramycin should be discontinued.

Ergot Alkaloids: Combining Spiramycin with vasoconstrictive ergot alkaloids can lead to severe vasoconstriction and potential tissue necrosis. Prior to prescribing Spiramycin, the absence of treatment with these alkaloids should always be confirmed.

Interaction with Coumarin Anticoagulants: Concomitant use of Spiramycin and coumarin anticoagulants can increase the International Normalized Ratio (INR) levels in patients. Close monitoring is recommended for patients taking both medications.

Prolongation of QT Interval: Macrolide antibiotics, including Spiramycin, have been associated with prolongation of the QT interval, which can lead to serious ventricular arrhythmias. Prescribers should consider the risk of QT prolongation in patients with pre-existing QT interval prolongation, those taking other medications known to prolong QT interval, patients with electrolyte disturbances, and those with cardiac conditions.

Impaired Hepatic and Renal Function: Patients with impaired hepatic or renal function may require dosage adjustments or careful monitoring when using Spiramycin. In severe hepatic insufficiency, the dose should be reduced, and in renal failure or elderly patients, dosage reduction is generally not required for the usual short course of treatment.

There is no specific warning against the consumption of alcohol while taking Spiramycin. However, it is generally advisable to avoid or limit alcohol consumption during antibiotic treatment. Alcohol can interfere with the effectiveness of antibiotics and may also increase the risk of certain side effects.

It is recommended to take Spiramycin with or without food. No specific dietary restrictions or precautions associated with the use of Spiramycin have been found.

● Nausea

● Vomiting

● Diarrhea

● Pseudomembranous colitis

● Liver abnormalities

● Rash

● Urticaria

● Pruritus

● Anaphylactic shocks

● Hemolysis

It has been reported that Spiramycin can hinder the absorption of carbidopa and lower levodopa plasma levels. In cases where it is necessary, patients should be carefully monitored, and the dosage of levodopa may need to be adjusted accordingly.

● Nausea

● Vomiting

● Diarrhea

● Inflamed bowels

● Pruritus

● Numbness in the skin

There have been no reported cases of accidental over dosage. However, if oral doses exceeding 4g per day are taken, it may lead to symptoms such as abdominal discomfort, Nausea, or diarrhea. In such cases, management should focus on addressing the symptoms, as no specific treatment has been recommended.

Typically, the oral administration of spiramycin results in an absolute bioavailability of approximately 30 to 40%. Following an oral dose of 1 g, the maximum concentration of the drug in the bloodstream ranged from 0.4 to 1.4 mg/L.

• Absorption

The absorption of Spiramycin is not complete, with an oral bioavailability ranging from 30-39%. Compared to Erythromycin, Spiramycin has a slower rate of absorption. This may be due to its high pKa, leading to a significant degree of ionization in the acidic environment of the stomach.

• Volume of distribution

Spiramycin exhibits extensive tissue distribution, with a volume of distribution exceeding 300 L. Concentrations achieved in bone, muscle, respiratory tract, and saliva are higher than those found in the serum. Spiramycin shows particularly high concentrations in tissues such as the lungs, bronchi, tonsils, and sinuses.

• Protein binding

Spiramycin has a low level of protein binding, ranging from 10-25%.

• Metabolism

Compared to other macrolides, Spiramycin undergoes less metabolism. However, the process of metabolism has not been extensively studied. The liver is primarily responsible for metabolizing Spiramycin into active metabolites.

• Route of elimination

The primary route of elimination for Spiramycin is through the fecal-biliary route. The secondary route is through the renal-urinary route.

1. The American College of Obstetricians and Gynecologists (ACOG) published a practice bulletin titled "Cytomegalovirus, parvovirus B19, varicella zoster, and toxoplasmosis in pregN.A.ncy" in Obstetrics and Gynecology in 2015. The bulletin is identified as ACOG Practice Bulletin No. 151, with the citation doi:10.1097/01.AOG.0000466430.19823.53 [PubMed 26000539].
2. The ACG (American College of Gastroenterology) released a clinical guideline titled "The diagnosis and maN.A.gement of idiosyncratic drug-induced liver injury" in the American JourN.A.l of Gastroenterology in 2014. This guideline is referred to as ACG Clinical Guideline and has the citation doi:10.1038/ajg.2014.131 [PubMed 24935270].
3. A study conducted by Couvreur et al. in 1993 investigated the in utero treatment of toxoplasmic fetopathy using the combiN.A.tion of pyrimethamine-sulfadiazine. The study was published in Fetal Diagnosis and Therapy with the citation doi:10.1159/000263746 [PubMed 8452648].
4. Daffos et al. conducted a study in 1988 that focused on the preN.A.tal maN.A.gement of 746 pregN.A.ncies at risk for congenital toxoplasmosis. The study was published in the New England JourN.A.l of Medicine with the citation doi:10.1056/NEJM198802043180502 [PubMed 3336419].
5. Gratzl et al. conducted a study in 2002 that examined the concentrations of spiramycin and neospiramycin in materN.A.l serum and amniotic fluid for the treatment of toxoplasmosis in pregN.A.ncy. The study was published in the European JourN.A.l of Clinical Microbiology and Infectious Diseases with the citation doi:10.1007/s10096-001-0644-6 [PubMed 11913495].
6. Hohlfeld et al. conducted a study in 1989 to evaluate the outcome of pregN.A.ncy and infant follow-up after in utero treatment for fetal toxoplasmosis. The study was published in the JourN.A.l of Pediatrics with the citation doi:10.1016/s0022-3476(89)80660-2 [PubMed 2681638].
7. MaldoN.A.do YA and Read JS published a paper in Pediatrics in 2017, which provides guidelines on the diagnosis, treatment, and prevention of congenital toxoplasmosis in the United States. The paper has the citation doi:10.1542/peds.2016-3860 [PubMed 28138010].
8. Montoya JG and Remington JS published a paper in Clinical Infectious Diseases in 2008, focusing on the maN.A.gement of Toxoplasma gondii infection during pregN.A.ncy. The paper has the citation doi:10.1086/590149 [PubMed 18624630].
9. Paquet C and Yudin MH published a paper in the JourN.A.l of Obstetrics and GyN.A.ecology CaN.A.da in 2018 titled "Toxoplasmosis in pregN.A.ncy: prevention, screening, and treatment" with the citation doi:10.1016/j.jogc.2018.05.036 [PubMed 30103893].
10. Peyron F et al. published a paper in Pathogens in 2019, providing diagnosis and treatment recommendations for materN.A.l and congenital toxoplasmosis based on a French multidiscipliN.A.ry working group. The paper has the citation doi:10.3390/pathogens8010024 [PubMed 30781652].