18, Jones Street, Ebute-Metta (West),Lagos, Nigeria
Tel: 01 - 8419240, 2348027357195
Saokim Pharmaceutical JSC., Quang Minh Indistry Zone-me Linh-Ha Noi-Vietnam.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet(NRN: A4-4518): Spiramycin 3.000.000 IU Excipients: Dibasic calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talcum, silicone dioxide, hydroxypropytmethyl cellulose,polyethylene glycol, titan dioxide q.s 1 tablet
Pack size: Box of 2 blisters x 5 tablets.
Spiracin (Spiramycin) is an antibiotic belonging to macrolide group with medium-spectrum including Gram-positive bacteria and micoplasma.
Spiramycin is well absorbed from the gastrointestinal tract and widely distributed into many body tissues and fluids, therefore it is widely recommended for treatment of infections caused by susceptible strains of bacteria.
It is lightly bound to plasma protein (around 10%). It is less metabolized than other macrolides. Spiramycin is excreted primarily through the bile.
Spiracin indicated for treatment of:
- Respiratory tract infections: Pharyngitis, acute sinusitis, bronchitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia (not due to pneumococci), tonsillitis.
- Uncomplicated skin infections.
- Infections of muscle and bone.
- Dental diseases: oral infections, pyorrhoea, gingivitis, pulpitis.
- Urinary or genital tract infections.
- Prevention of meningitis due to meningococcus. Especially Spiracin is an effective therapy for N. meningititis resistant to rifampicin in naso-pharynx.
- Infection of Toxoplasma in pregnant women.
- Prevention of recrudescence of acute rheumatism in patients known to show hypersensitivity to penicillin.
- Prevention of acute rheumatic heart disease in patients known to be hypersensitive to penicillins.
Hypersensitivity to Spiramycin, Erythromycin or any drug components.
Patients with severe hepatic disease.
Spiracin can be used during pregnancy. This medicine has not been found to cause birth defects or other problems in humans.
Spiramycin passes into breast milk. Do not breast-feed during treatment course with spiramycin.
Effects on ability to drive and use machines: None.
The concomitant use of Spiramycin and oral contraceptives renders oral contraceptives ineffective.
Spiracin is generally well-tolerated. The side effects are reported in gastrointestinal tract such as nausea, vomiting, diarrhea.
The other side effects are rarely reported including weakness, epistaxis, and sweat, acute colitis, rash, skin eruption, urticaria, anaphylactic shock, supra- infection from prolonged use of spiramycin.
Report any side effects to your physician or pharmacist during period of treatment.
Dosage & Administration
Spiracin 3,000,000 IU/tablet should not be used for children.
Adults: 1,500,000 - 3,000,000 IU/dose, 3 times a day.
Children: 150,000 - 300,000 IU/kg/day, divided into two or three doses.
For severe infections, the adult dose is 6,000,000 - 7,500,000 IU/dose, two times a day.
Prevention of meningitis caused by Meningococcus:
Adults: 3,000,000 IU/12 hours for 5 days.
Children: 75.000 IU/12 hours for 5 days.
Prevention of Toxoplasma infection in pregnancy:
3,000,000 IU every 8 hours for 3 weeks. This therapy is repeated after 2-week period. The concomitant administration of Spiracin and Pyrimethamine/Sulfonamide therapy can achieve good results.
Spiracin is administrated by oral route. Food can reduce bioavaibility of spiramycin. You should receive Spiracin at least 2 hours before meal or 3 hours after meal.
Store in a cool dry place below 28oC, protected from light.
Keep out of reach of children.