Roxid 300

ROXID 300

Name

• Common Name: Roxithromycin
• Brand Name: ROXID 300 (by ALEMBIC PHARMACEUTICALS LTD)

Composition

ROXID 300 contains Roxithromycin 300 mg as its active ingredient. Roxithromycin is a semi-synthetic macrolide antibiotic.

Uses

ROXID 300 is prescribed for the treatment of various bacterial infections. It works by inhibiting the growth of bacteria. It is effective against a broad spectrum of pathogens and is used for:

• Respiratory Tract Infections: Including tonsillitis, pharyngitis, sinusitis, acute bronchitis, exacerbations of chronic bronchitis, and community-acquired pneumonia.
• Skin and Soft Tissue Infections: Such as impetigo, cellulitis, and erysipelas.
• Urinary Tract Infections (UTIs): Including infections of the kidneys, bladder, ureters, and urethra.
• Sexually Transmitted Infections (STIs): Such as Chlamydia and non-gonococcal urethritis.

It is important to note that ROXID 300 is an antibiotic and is not effective against viral infections like the common cold or flu.

Dosage and Administration

• Adults: The typical recommended dosage for adults is 300 mg once daily, or 150 mg twice daily.
• Children: For children weighing 40 kg and over, the recommended dosage is one 150 mg tablet twice daily. The dosage for children is generally dependent on their weight (5 to 8 mg/kg/day divided into two doses), and 300 mg tablets are typically not used for children due to their fixed strength.
• Administration: ROXID 300 tablets should be swallowed whole with a glass of water. For optimal absorption, it is best taken on an empty stomach, at least 15 minutes before food or more than three hours after a meal.
• Duration: The usual treatment duration is five to ten days, but it may vary depending on the type and severity of the infection. For streptococcal throat infections, a minimum of ten days of therapy is required. It is crucial to complete the full course of treatment as prescribed by your doctor, even if symptoms improve, to prevent the infection from returning or developing antibiotic resistance.

Side Effects

While ROXID 300 is generally well-tolerated, some individuals may experience side effects.

• Common Side Effects: Nausea, vomiting, abdominal pain/cramps, diarrhoea, decreased appetite, skin rash, headache, and dizziness. Vaginal thrush or oral thrush may also occur.
• Serious Side Effects (seek immediate medical attention if experienced): Severe or persistent diarrhoea (especially with blood in stools), signs of an allergic reaction (difficulty breathing, swelling of the face, lips, tongue or throat, or severe skin rash), liver problems (yellowing of the skin or eyes, dark urine, pain in the stomach area), fainting, or a fast heartbeat.

Precautions

• Allergies: Do not take ROXID 300 if you are allergic to roxithromycin or any other macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin).
• Drug Interactions:
  • Antacids: Antacids containing aluminium or magnesium can reduce the absorption of roxithromycin. It is advisable to take ROXID 300 at least 2 hours before or after taking antacids.
  • Warfarin: Roxithromycin may enhance the effect of warfarin, increasing the risk of bleeding.
  • Other Medications: Inform your doctor about all medications you are taking, including over-the-counter drugs, as roxithromycin can interact with digoxin, theophylline, ergot alkaloids, cisapride, and cyclosporine, potentially increasing their levels and side effects.
• Medical Conditions: Use with caution in patients with liver impairment, abnormal heart rhythm, low potassium levels (hypokalaemia), or a history of severe diarrhoea. Liver function should be monitored regularly during treatment.
• Pregnancy and Breastfeeding: Consult your doctor before using ROXID 300 if you are pregnant, planning to become pregnant, or breastfeeding.
• Alcohol Consumption: Avoid consuming alcohol while taking ROXID 300, as it may increase the risk of side effects.
• Driving and Operating Machinery: As ROXID 300 may cause dizziness, exercise caution when driving or operating heavy machinery.

Storage

Store ROXID 300 tablets in their original packaging at room temperature, ideally below 25°C or 30°C. Protect from direct sunlight, heat, and moisture. Do not freeze. Keep this medicine out of the sight and reach of children.

ROXID 300 is an antibiotic medication manufactured by Alembic Pharmaceuticals Ltd., with Roxithromycin as its active ingredient. It belongs to the macrolide class of antibiotics, used to treat various bacterial infections.

Here are some frequently asked questions about ROXID 300:

What is ROXID 300 used for?

ROXID 300 is used to treat a variety of bacterial infections. These commonly include infections of the respiratory tract (such as acute pharyngitis, tonsillitis, sinusitis, acute bronchitis, acute exacerbations of chronic bronchitis, and community-acquired pneumonia), skin and soft tissue infections, and non-gonococcal urethritis. It may also be used for certain dental infections and urinary tract infections.

How does ROXID 300 work?

ROXID 300 works by interfering with the protein synthesis of bacteria, which is essential for their growth and survival. It binds to the 50S subunit of bacterial ribosomes, preventing the bacteria from producing the necessary proteins. This action inhibits bacterial growth and helps to eliminate the infection. At lower concentrations, it is bacteriostatic (inhibits growth), while at higher concentrations, it can be bactericidal (kills bacteria).

What is the usual dosage for ROXID 300?

For adults, the recommended dosage is typically 300 mg once daily, or 150 mg twice daily. The tablets should be swallowed whole with a drink. It is usually best taken on an empty stomach, at least 15 minutes before food or more than three hours after a meal, as food intake can delay absorption. The usual duration of treatment ranges from five to ten days, but it may be longer (up to 20 days) for specific infections like non-gonococcal genital infections or streptococcal throat infections. For children, the dosage is usually adjusted based on body weight, typically 5 to 8 mg/kg/day given in two divided doses, and treatment should not exceed ten days.

What are the possible side effects of ROXID 300?

Common side effects may include gastrointestinal issues such as nausea, vomiting, abdominal pain, diarrhea (which may rarely contain blood), decreased appetite, and flatulence. Other common side effects can include headache, dizziness, vaginal thrush, and skin rash. Less common but serious side effects can include severe bullous skin reactions (like Stevens Johnson Syndrome or Toxic Epidermal Necrosis), Clostridium difficile-associated diarrhea (pseudomembranous colitis), and, rarely, abnormal liver function values or alterations in the senses of smell and taste.

Is ROXID 300 safe during pregnancy or breastfeeding?

Pregnancy: ROXID 300 (Roxithromycin) should be used with caution during pregnancy and is generally not recommended unless specifically prescribed by a doctor when the potential benefits outweigh the risks. Animal studies did not show developmental abnormalities at certain doses, but safety for the human fetus has not been established.

Breastfeeding: Small amounts of Roxithromycin are excreted in breast milk. While generally considered to pose a low risk for adverse effects in breastfed infants, it is advisable to monitor the infant for potential effects on gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash). Consult your doctor if you are breastfeeding or planning to breastfeed.

Can ROXID 300 be taken with other medications?

ROXID 300 can interact with certain medications. It is contraindicated with vasoconstrictive ergot alkaloids (used for migraines) due to the risk of severe vasoconstriction. Caution is advised when taken with drugs that prolong the QT interval (e.g., some antiarrhythmic agents, astemizole, cisapride, pimozide). Roxithromycin may increase the plasma concentrations of digoxin, theophylline, warfarin (increasing bleeding risk), cyclosporine, and disopyramide. It is recommended to maintain a gap of at least 2 hours between taking ROXID 300 and antacids containing aluminium or magnesium, as they can reduce its absorption. It does not appear to interact with oral contraceptives, prednisolone, carbamazepine, or ranitidine. Always inform your doctor about all medications, vitamins, and herbal supplements you are currently taking.

What precautions should be taken while using ROXID 300?

Do not use ROXID 300 if you have a known hypersensitivity to roxithromycin or any other macrolide antibiotics, or if you have severe hepatic impairment. Use with caution if you have liver or kidney problems, a history of cardiac arrhythmia, or conditions that prolong the QT interval (e.g., low potassium or magnesium levels). Prolonged use of antibiotics like ROXID 300 can lead to superinfection by resistant organisms or antibiotic-associated pseudomembranous colitis. It's important to complete the full course of treatment as prescribed, even if symptoms improve, to prevent the infection from returning or developing antibiotic resistance. Avoid alcohol consumption as it may worsen side effects like dizziness or stomach upset. Since the medicine may cause dizziness, exercise caution when driving or operating machinery until you know how it affects you.

What happens if a dose of ROXID 300 is missed?

If you miss a dose of ROXID 300, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should ROXID 300 be stored?

ROXID 300 tablets should be stored in their original packaging in a cool, dry place. The recommended storage temperature is below 25°C (or below 30°C in some regions), away from direct sunlight, heat, and moisture. Do not freeze the medicine. Keep it out of the reach of children and pets.