Rodogyl (Spiramycin, Metronidazole)

Active Ingredient: Spiramycin, Metronidazole
Dosage: 750.000 UI/125 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 20 tablets per pack
Availability: Out of stock

Why is Rodogyl not used in the USA?

Rodogyl is not available in the USA primarily due to lack of FDA approval, which requires rigorous testing and validation to ensure drug safety and efficacy. The combination of Spiramycin and Metronidazole has not been approved by the FDA for use in treating infections in the United States.

Rodogyl Equivalents Sold in the USA

Below are drugs available in the USA similar to Rodogyl, grouped by their primary treatment focus:

Antibiotics for Anaerobic Infections:

Antibiotics for Aerobic and Mixed Infections:

Broad-Spectrum Antibiotics:

What is Rodogyl?

Rodogyl is a broad-spectrum antibiotic that is used to treat bacterial infections of the vagina, stomach or intestines, liver, skin, joints, brain, heart, and respiratory tract. It works by stopping the growth of certain bacteria and parasites. Rodogyl may also be used with other drugs to treat stomach/intestinal ulcers caused by bacteria.

Indications

Acute, chronic or relapsing stomatological infections:

• Dental abscesses, phlegmon, premaxillary cellulitis, pericoronitis;
• Stomatitis;
• Periodontitis;
• Preventive treatment of postoperative local infectious complications in odontostomatologic surgery.

Popularity of Rodogyl in Various Countries

Rodogyl is popular in several countries outside the USA, particularly in parts of Europe, Africa, and some Asian countries. The reasons for its popularity in these regions can vary, but generally include:

1. Effectiveness Against Local Strains: Rodogyl is effective against a range of bacterial pathogens common in these regions, including those causing dental and oral infections, which are prevalent due to various socio-economic and health factors.
2. Versatility: The combination of Spiramycin and Metronidazole allows it to treat infections caused by both aerobic and anaerobic organisms, making it a versatile option for treating infections in various body parts, such as the respiratory tract, gastrointestinal system, and skin.
3. Accessibility and Cost: In many of these countries, the medication may be more accessible and cost-effective compared to other antibiotics, especially for treating complex infections that require broad-spectrum coverage.
4. Medical Practice Patterns: Local medical practice patterns and guidelines may favor the use of certain traditional or well-established medications like Rodogyl, especially in areas with limited access to newer antibiotics.
5. Regulatory Approvals: In countries where Rodogyl is approved, it has likely undergone the necessary regulatory review that confirms its safety and efficacy, aiding its adoption in clinical settings.

Dosage and administration

The drug is taken orally. The tablets should be swallowed with a full glass of water during the meal.

• Adults: 4-6 tablets per day in 2 or 3 doses. In severe cases, the dosage may be increased to 8 tablets per day;
• Children: From 6 to 10 years: 2 tablets per day; 10 to 15 years: 3 tablets per day.

The specific dosages of Rodogyl depend on the infection’s location, severity, and the patient’s overall health condition. It is typically prescribed in tablet form, with dosages ranging from two to three tablets per day, taken according to medical advice.

Contraindications

• Hypersensitivity to spiramycin;
• Hypersensitivity to metronidazole;
• Hypersensitivity to imidazole;
• Children under 6 years;
• G6PD deficiency;
• Breastfeeding;
• Alcohol consumption;
• Cockayne syndrome.

Side effects

• Digestive disorders: Gastralgias, nausea, vomiting, diarrhea, and very rare cases of pseudomembranous colitis;
• Skin and allergic manifestations: rashes, hives, pruritus; rarely, Quincke’s edema, anaphylactic shock;
• Central and peripheral nervous system: Occasional and transient paresthesias;
• Hepatic manifestations: Very rare cases of liver function abnormalities;
• Immune system disorders: angioedema, anaphylactic shock;
• Psychiatric disorders: psychotic disorders, including confusion, hallucinations, depressive mood;
• Eye disorders: transient visual disorders such as diplopia and myopia, blurred vision, decreased visual acuity, changes in color vision, optic neuropathy/neuritis;
• Disorders in the lymphatic system and blood: cases of agranulocytosis, neutropenia and thrombocytopenia have been reported;
  Hepatobiliary disorders: cholestasis or mixed hepatitis and hepatocellular damage, sometimes with jaundice, liver failure;
• Skin and subcutaneous tissue disorders: erythema, pruritus, blushing, hives, pustular eruptions;
• General disorders: fever;
• Blood system: acute hemolysis.

Overdose

In case of an overdose, call your local emergency services or go to your nearest emergency room.

Interaction

Rodogyl may interact with the following drugs:

• Anticoagulant;
• Phenytoin;
• Lithium;
• Disulfiram;
• Ciclosporin.

The list is incomplete. Consult your doctor.