Rovamycine 500
Rovamycine 500 Uses, Dosage, Side Effects, Food Interaction and all others data.
Rovamycine 500 is a macrolide antibacterial that inhibits protein synthesis by irreversibly binding to the 50S subunit of the ribosomal subunit thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting in stunted cell growth.
The absolute bioavailability of oral spiramycin is generally within the range of 30 to 40%. After a 1 g oral dose, the maximum serum drug concentration was found to be within the range 0.4 to 1.4 mg/L.
| Trade Name | Rovamycine 500 |
| Generic | Spiramycin |
| Spiramycin Other Names | Demycarosylturimycin H, Foromacidin A, Foromacidine A, Spiramycin 1, Spiramycin A, Spiramycin I |
| Type | |
| Formula | C43H74N2O14 |
| Weight | Average: 843.065 Monoisotopic: 842.514005071 |
| Protein binding | Low level of protein binding (10-25%). |
| Groups | Approved |
| Therapeutic Class | Macrolides |
| Manufacturer | |
| Available Country | Portugal |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Acne vulgaris, Cryptosporidiosis, Protozoal infections, Susceptible infections, Toxoplasmosis
Rovamycine 500 is also used to associated treatment for these conditions: Bacterial Infections
How Rovamycine 500 works
The mechanism of action of macrolides has been a matter of controversy for some time. Rovamycine 500, a 16-membered macrolide, inhibits translocation by binding to bacterial 50S ribosomal subunits with an apparent 1 : 1 stoichiometry. This antibiotic is a potent inhibitor of the binding to the ribosome of both donor and acceptor substrates. The primary mechanism of action is done by stimulation of dissociation of peptidyl-tRNA from ribosomes during translocation.I
Dosage
Rovamycine 500 dosage
Intravenous-
Toxoplasmosis, Cryptosporidiosis, Protozoal infections, Susceptible infections:
- Adult: 1.5 million units by slow infusion every 8 hr, may double the dose in severe infections.
Oral-Cryptosporidiosis, Protozoal infections, Susceptible infections, Toxoplasmosis:
- Adult: 6-9 million units/day in 2-3 divided doses, increased to 15 million units/day, given in divided doses for severe infections.
- Child and neonates: Chemoprophylaxis of congenital toxoplasmosis: 50 mg/kg bid.
May be taken with or without food.
Side Effects
Nausea, vomiting, abdominal pain, diarrhoea; urticaria, pruritus, macular rashes. Transient paraesthesia may occur.
Toxicity
Cardiac toxicity, specifically QT prolongation (irregular heartbeat; recurrent fainting).
Cholestatic hepatitis (abdominal pain; nausea; vomiting; yellow eyes or skin).
Gastrointestinal toxicity, specifically acute colitis (abdominal pain and tenderness; bloody stools; fever).
Intestinal injury (abdominal pain and tenderness).
Ulcerated esophagitis (chest pain; heartburn).
Precaution
Hepatic impairment; pregnancy and lactation. Monitor liver function. History of arrhythmias or predisposition to QT interval prolongation.
Interaction
Decreases carbidopa absorption and levodopa concentrations. Increased risk of ventricular arrhythmias when used with astemizole, cisapride and terfenadine. Risk of acute dystonia when used with fluphenazine
Food Interaction
- No food interactions are expected.
Volume of Distribution
The tissue distribution of spiramycin is extensive. The volume of distribution is in excess of 300 L, and concentrations achieved in bone, muscle, respiratory tract and saliva exceed those found in serum. Rovamycine 500 showed high concentrations in tissues such as: lungs, bronchi, tonsils, and sinuses.
Elimination Route
The extent of absorption of Rovamycine 500 was shown to be incomplete. Oral bioavailability ranges from 30-39%. Rovamycine 500 has slower rate of absorption than Erythromycin. It has a high pKa (7.9) which could be a result of high degree of ionization in acidic medium of the stomach.
Half Life
Intravenous: Young persons (18 to 32 years of age): Approximately 4.5 to 6.2 hours. Elderly persons (73 to 85 years of age): Approximately 9.8 to 13.5 hours.
Oral: 5.5-8 hours, Rectal in children: 8 hours
Clearance
80% of the administered dose excreted in the bile, which makes the fecal-biliary route is the most important route of elimination. Enterohepatic recycling could also occur. Only 4 to 14% of an administered dose is eliminated through renal-urinary excretion route.
Elimination Route
Fecal-biliary route is the primary route of elimination. The secondary route is renal-urinary route.
Pregnancy & Breastfeeding use
Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Contraindication
Hypersensitivity.
Innovators Monograph
You find simplified version here Rovamycine 500
Rovamycine 500 contains Spiramycin see full prescribing information from innovator Rovamycine 500 Monograph, Rovamycine 500 MSDS, Rovamycine 500 FDA label
FAQ
What is Rovamycine 500 used for?
Rovamycine 500 is used to treat a wide variety of bacterial infections. This medication is known as a macrolide antibiotic.Rovamycine 500 works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
How safe is Rovamycine 500?
Rovamycine 500 1.5 mg tablet is safe for kidney disease patients to use. No dosage change is recommended for the Rovamycine 500 1.5mg Tablet. Liver - Consult the physician Limited information on the use of the Rovamycine 500 1.5mg tablet in patients with liver disease is available.
What are the common side effects of Rovamycine 500?
Indigestion, nausea, vomiting, diarrhea or stomach ache may occur. If any of these effects continue or become bothersome, inform your doctor. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately.
Is Rovamycine 500 safe during pregnancy?
Yes, Rovamycine 500 is safe to use in pregnancy. Rovamycine 500 is considered safe to use during pregnancy. Animal studies have shown little to no adverse effects on the developing baby; human studies, however, are minimal.
Is Rovamycine 500 safe during pregnancy?
Rovamycine 500 has less side effects and is recommended during breastfeeding period.
Is Rovamycine 500 a penicillin?
Rovamycine 500 proved to be equivalent to penicillin in the treatment of acute bacterial tonsillitis in adults.
Can I drive after taking Rovamycine 500?
Rovamycine 500 normally does not affect your driving performance.
Does Rovamycine 500 cross placenta?
Rovamycine 500 is a macrolide antibiotic, which aims at the prevention of fetal infection. It does not cross the blood-placental barrier and, therefore, has no teratogenic effects to the fetus, or toxicity to the mother.
When is the best time to take Rovamycine 500?
Rovamycine 500 is best taken on an empty stomach. To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days.
How to take Rovamycine 500?
Tell your doctor if you have ever had any unusual or allergic reaction to Rovamycine 500 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Is there any food or drink I need to avoid when taking Rovamycine 500?
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
How to proper use of Rovamycine 500?
Rovamycine 500 is best taken on an empty stomach.To help clear up your infection completely, keep taking Rovamycine 500 for the full time of treatment, even if you begin to feel better after a few days. If you stop taking Rovamycine 500 too soon, your symptoms may return.
What happens if I miss a dose of Rovamycine 500?
If you miss a dose of Rovamycine 500, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
What happen if I overdose of Rovamycine 500?
Symptoms of overdose may include nausea, vomiting, and diarrhea.
Is Rovamycine 500 an antibiotic?
Rovamycine 500 is a macrolide antibiotic, first isolated from Streptomyces ambofaciens.
Is spiramycin broad spectrum?
Rovamycine 500 is a broad-spectrum macrolide antibiotic effective against gram-negative and gram-positive bacteria as well as some Toxoplasma parasites. Rovamycine 500 is a mixture of Rovamycine 500 I, II, and III and has been used to study sepsis in mice.
