Roximstad: Uses, Dosage & Side Effects
A macrolide antibiotic containing roxithromycin, used to treat respiratory tract, skin, and urinary tract infections
Roximstad is a prescription antibiotic containing the active substance roxithromycin, a semi-synthetic macrolide. It is primarily used to treat bacterial infections of the respiratory tract, skin, soft tissues, and urinary tract. Roxithromycin works by inhibiting bacterial protein synthesis, effectively stopping the growth and reproduction of susceptible bacteria. As a macrolide antibiotic, it serves as an important alternative for patients who are allergic to penicillin or other beta-lactam antibiotics. Roximstad is manufactured by STADA Arzneimittel AG and is available as film-coated tablets in 150 mg and 300 mg strengths.
Quick Facts: Roximstad
Key Takeaways
- Roximstad contains roxithromycin, a macrolide antibiotic that inhibits bacterial protein synthesis; it is effective against a wide range of Gram-positive and some Gram-negative bacteria and is commonly used for respiratory tract, skin, and urinary tract infections.
- Do not take Roximstad if you are allergic to roxithromycin or any other macrolide antibiotic, or if you are taking ergot alkaloids, cisapride, pimozide, astemizole, or terfenadine; these combinations can cause life-threatening cardiac arrhythmias.
- Roximstad must be taken at least 15 minutes before meals for optimal absorption; the standard dose is 150 mg twice daily, and you should always complete the full course of treatment even if symptoms improve early.
- Patients with a history of QT prolongation (either congenital or acquired) or who take medications that prolong the QT interval must not use Roximstad due to the risk of serious cardiac rhythm disturbances.
- Common side effects include nausea, abdominal pain, headache, dizziness, and diarrhea; serious but rare side effects include severe allergic reactions, Stevens-Johnson syndrome, and pseudomembranous colitis requiring immediate medical attention.
What Is Roximstad and What Is It Used For?
Roximstad contains the active substance roxithromycin, a semi-synthetic macrolide antibiotic that was developed in the 1980s as a structural derivative of erythromycin. Macrolide antibiotics are among the most widely prescribed classes of antibiotics worldwide, valued for their broad spectrum of activity, good tissue penetration, and relatively favorable side effect profile. Roxithromycin was specifically designed to improve upon the pharmacokinetic limitations of erythromycin, offering better acid stability, longer half-life (approximately 12 hours compared to 1.5 hours for erythromycin), and improved oral bioavailability.
The mechanism of action of roxithromycin involves binding reversibly to the 50S ribosomal subunit of susceptible bacteria. Bacterial ribosomes, which are structurally different from human ribosomes, are responsible for translating messenger RNA into proteins essential for bacterial survival and reproduction. When roxithromycin binds to the 50S subunit, it inhibits the translocation step of protein synthesis by blocking the peptidyl transferase activity. This prevents the elongation of the peptide chain during translation, effectively halting bacterial protein production. At therapeutic concentrations, roxithromycin is primarily bacteriostatic (inhibiting bacterial growth) but can be bactericidal (killing bacteria) at higher concentrations or against highly susceptible organisms.
Roxithromycin demonstrates good activity against a broad range of clinically important pathogens. It is effective against many Gram-positive bacteria including Streptococcus pneumoniae, Streptococcus pyogenes (Group A streptococcus), Staphylococcus aureus (methicillin-susceptible strains), and Corynebacterium diphtheriae. It also has activity against certain Gram-negative organisms including Moraxella catarrhalis, Bordetella pertussis, Legionella pneumophila, and Haemophilus influenzae. Additionally, roxithromycin is active against atypical pathogens such as Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Ureaplasma urealyticum, making it particularly useful for the empirical treatment of community-acquired respiratory infections where atypical organisms may be responsible.
Roximstad is indicated for the treatment of the following bacterial infections:
- Community-acquired pneumonia: Certain types of pneumonia acquired outside of hospital settings, particularly those caused by atypical pathogens such as Mycoplasma pneumoniae and Chlamydophila pneumoniae. Roxithromycin offers good penetration into lung tissue and bronchial secretions.
- Urinary tract infections: Infections caused by susceptible bacteria, particularly Ureaplasma urealyticum, which do not respond to conventional beta-lactam antibiotics.
- Tonsillitis and pharyngitis: Infection and inflammation of the tonsils and throat caused by Streptococcus pyogenes, particularly in patients who are allergic to or intolerant of beta-lactam antibiotics such as penicillin.
- Acute otitis media: Middle ear infection, again primarily used as an alternative in patients who cannot tolerate beta-lactam antibiotics.
- Skin and soft tissue infections: Bacterial infections of the skin and surrounding tissue, including furunculosis (boils), pyoderma, impetigo, and erysipelas. These are commonly caused by Staphylococcus aureus and Streptococcus pyogenes.
One of the notable pharmacokinetic advantages of roxithromycin is its long elimination half-life of approximately 12 hours, which allows for convenient twice-daily dosing. The drug achieves high concentrations in various tissues including respiratory tract tissues, tonsils, prostate, and skin, often exceeding plasma concentrations by several-fold. This excellent tissue penetration contributes to its clinical efficacy in treating infections at these sites. Roxithromycin is approximately 96% protein-bound in plasma and is primarily metabolized by the liver, with approximately 65% of the dose excreted in the feces and the remainder in urine.
Roxithromycin, like all antibiotics, only works against bacterial infections. It is ineffective against viral infections such as the common cold, influenza, or most cases of sore throat and bronchitis. Inappropriate use of antibiotics contributes to antimicrobial resistance, which the WHO recognizes as one of the greatest global health threats. Only take Roximstad when prescribed by a healthcare professional for a confirmed or strongly suspected bacterial infection, and always complete the full prescribed course.
What Should You Know Before Taking Roximstad?
Contraindications
There are specific situations where Roximstad must never be used. Understanding these absolute contraindications is essential for preventing serious and potentially life-threatening adverse events.
- Macrolide allergy: Do not take Roximstad if you are allergic to roxithromycin, any other macrolide antibiotic (such as erythromycin, azithromycin, or clarithromycin), or any of the inactive ingredients in the formulation (listed in the Ingredients section).
- Ergot alkaloid use: Concurrent use with ergot alkaloids such as ergotamine or dihydroergotamine (used for migraine treatment) is strictly contraindicated. The combination can cause severe ergotism, characterized by intense vasospasm leading to peripheral ischemia, gangrene, and potentially fatal outcomes.
- Cisapride: Co-administration with cisapride (a gastrointestinal motility agent) is contraindicated due to the risk of QT prolongation and ventricular arrhythmias, including potentially fatal torsades de pointes.
- Pimozide: Concurrent use with pimozide (an antipsychotic) is contraindicated because macrolides can inhibit the metabolism of pimozide, leading to elevated plasma levels and an increased risk of QT prolongation, cardiac arrhythmias, and sudden cardiac death.
- Astemizole and terfenadine: These antihistamines must not be taken with Roximstad due to the risk of serious cardiac arrhythmias including QT prolongation and torsades de pointes.
- QT prolongation: Roximstad is contraindicated in patients with congenital QT prolongation (long QT syndrome), a family history of QT prolongation, or documented acquired QT prolongation. Your doctor may perform an ECG to check for this condition before prescribing Roximstad.
Warnings and Precautions
Roximstad can cause QT prolongation, a condition that affects the electrical activity of the heart. This can lead to serious and potentially fatal cardiac arrhythmias including torsades de pointes. If you experience symptoms of irregular or rapid heartbeat during treatment, stop taking Roximstad and contact your doctor immediately. Your doctor will perform an ECG to check your heart rhythm.
You should inform your doctor before taking Roximstad if any of the following conditions apply to you:
- Coronary artery disease: If your heart muscle does not receive adequate blood supply (ischemic heart disease), you may be at increased risk of cardiac events when taking medications that can affect the QT interval.
- History of ventricular arrhythmia: Previous episodes of irregular heartbeat originating from the ventricles increase the risk of recurrence when taking medications that prolong the QT interval.
- Electrolyte imbalance: Low levels of potassium (hypokalemia) or magnesium (hypomagnesemia) in the blood significantly increase the risk of QT prolongation and cardiac arrhythmias. These imbalances should be corrected before starting Roximstad.
- Bradycardia: A heart rate below 50 beats per minute increases the risk of QT-related cardiac events.
- QT-prolonging medications: If you are taking other medications known to prolong the QT interval, including certain antiarrhythmics (quinidine, procainamide, disopyramide, dofetilide, amiodarone), antidepressants (citalopram, tricyclic antidepressants), methadone, antipsychotic agents (phenothiazines), fluoroquinolone antibiotics (moxifloxacin), protease inhibitors (telaprevir), or antifungal agents (ketoconazole, fluconazole, pentamidine).
- Liver disease: Patients with mild to moderate liver impairment should be carefully assessed before treatment. Patients with severe liver disease (such as cirrhosis with hepatitis or ascites) should generally not take Roximstad. If treatment is deemed essential, the dose must be reduced to half (150 mg once daily). Liver function should be monitored regularly during treatment, and Roximstad must be discontinued if liver function worsens.
- Myasthenia gravis: Macrolide antibiotics, including roxithromycin, may exacerbate symptoms of myasthenia gravis, a condition causing muscle weakness. This can affect the respiratory muscles, potentially causing life-threatening breathing difficulties. If symptoms worsen during treatment, stop Roximstad immediately and seek medical attention.
Serious allergic reactions, including anaphylaxis, have been reported with roxithromycin. Symptoms may include swelling of the face, tongue, or throat, difficulty breathing, and widespread hives. If you experience any signs of a severe allergic reaction, stop taking Roximstad immediately and seek emergency medical care.
Rare but life-threatening skin reactions have been reported with roxithromycin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). If you develop a widespread rash with blistering, skin peeling, fever, or flu-like symptoms, stop taking Roximstad and seek immediate medical attention.
Antibiotic-associated colitis, caused by Clostridioides difficile, can occur during or after treatment with roxithromycin. Symptoms include severe, persistent, or watery diarrhea that may contain blood. If you develop these symptoms, stop taking Roximstad immediately, contact your doctor, and do not take anti-diarrheal medications. Your doctor will prescribe appropriate treatment.
Pregnancy and Breastfeeding
Animal reproductive studies with roxithromycin have not demonstrated harmful effects on the developing fetus. However, no adequate and well-controlled studies have been conducted in pregnant women. As a precautionary measure, Roximstad should only be used during pregnancy if the expected benefit to the mother clearly outweighs the potential risk to the fetus. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medication.
Roxithromycin is excreted in breast milk in small amounts. The effects on the nursing infant have not been adequately studied. Breastfeeding women should only take Roximstad if their doctor determines that the benefit outweighs the potential risk to the infant. If you are breastfeeding and your infant develops diarrhea, rash, or signs of an allergic reaction, contact your pediatrician immediately.
Driving and Operating Machinery
Roximstad may occasionally cause dizziness, blurred vision, or visual disturbances. If you experience any of these symptoms, you should not drive, operate machinery, or engage in activities that require alertness and clear vision. These effects are usually temporary and resolve when treatment is completed. You are responsible for assessing whether you are fit to drive or perform tasks requiring concentration. Discuss any concerns with your doctor or pharmacist.
Important Information About Ingredients
Roximstad film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. Each tablet also contains less than 1 mmol (23 mg) sodium, meaning it is essentially sodium-free.
How Does Roximstad Interact with Other Drugs?
Drug interactions with roxithromycin can range from clinically insignificant to life-threatening. Macrolide antibiotics, as a class, are known to interact with numerous medications, primarily through their effects on hepatic cytochrome P450 enzymes (particularly CYP3A4) and their potential to prolong the cardiac QT interval. While roxithromycin is considered to have a lower potential for CYP3A4 inhibition compared to erythromycin and clarithromycin, clinically relevant interactions still occur and must be carefully considered.
Major Interactions (Contraindicated)
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Ergot alkaloids (ergotamine, dihydroergotamine) | Macrolides can inhibit the metabolism of ergot alkaloids, leading to severe vasospasm, peripheral ischemia, and potentially gangrene (ergotism) | Absolutely contraindicated. Do not combine under any circumstances. If you take ergot-based migraine medication, inform your doctor before starting Roximstad. |
| Cisapride | Increased plasma levels of cisapride leading to QT prolongation and risk of ventricular arrhythmias including torsades de pointes | Absolutely contraindicated. Do not take these medications together. |
| Pimozide | Inhibition of pimozide metabolism leading to elevated plasma levels, QT prolongation, and risk of sudden cardiac death | Absolutely contraindicated. Inform your doctor if you are taking pimozide for any psychiatric condition. |
| Astemizole and terfenadine | Increased plasma levels of these antihistamines leading to QT prolongation and potentially fatal cardiac arrhythmias | Absolutely contraindicated. These antihistamines have been withdrawn from many markets precisely because of this interaction risk. |
Clinically Significant Interactions (Use With Caution)
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Cyclosporine | Roxithromycin may increase plasma concentrations of cyclosporine, potentially increasing the risk of nephrotoxicity and other cyclosporine-related adverse effects | Monitor cyclosporine blood levels closely during concurrent use. Dose adjustment may be necessary. This is particularly important for organ transplant recipients. |
| Warfarin and other anticoagulants | Roxithromycin may enhance the anticoagulant effect of warfarin by altering vitamin K-producing gut flora and potentially inhibiting warfarin metabolism, increasing INR and bleeding risk | Monitor INR more frequently during and after roxithromycin treatment. Warfarin dose adjustment may be required. Report any unusual bleeding or bruising immediately. |
| Digoxin (cardiac glycosides) | Macrolides can increase the absorption of digoxin by reducing the gut bacteria that normally inactivate digoxin, leading to elevated digoxin levels and potential toxicity | Monitor digoxin levels and watch for symptoms of toxicity (nausea, visual disturbances, bradycardia). Dose reduction may be needed. |
| Midazolam | Roxithromycin may increase plasma levels of midazolam, enhancing and prolonging its sedative effects | Use with caution. Monitor for excessive sedation. Dose adjustment of midazolam may be necessary. |
| Theophylline | Roxithromycin may cause modest increases in theophylline levels, although the interaction is generally less significant than with erythromycin | Monitor theophylline levels, especially at the start and end of roxithromycin treatment. Watch for signs of theophylline toxicity (nausea, tremor, tachycardia). |
| Disopyramide | Additive QT-prolonging effect and potential for increased disopyramide levels, increasing the risk of ventricular arrhythmias | Avoid concurrent use if possible. If combination is unavoidable, ECG monitoring and disopyramide level monitoring are essential. |
| Bromocriptine | Roxithromycin may increase plasma levels of bromocriptine, potentially increasing dopaminergic side effects | Monitor for increased bromocriptine effects (nausea, hypotension, hallucinations). Dose adjustment may be needed. |
| Simvastatin and other statins | Macrolides can inhibit the metabolism of certain statins, increasing the risk of myopathy and rhabdomyolysis (muscle breakdown) | Consider temporarily discontinuing statin therapy during the course of roxithromycin. Report any unexplained muscle pain, tenderness, or weakness immediately. |
| Oral contraceptives | The effectiveness of hormonal contraceptives may be reduced during roxithromycin treatment, potentially through disruption of enterohepatic recirculation of ethinylestradiol | Use additional barrier contraception (e.g., condoms) during treatment and for 7 days after completing the course. This is especially important if vomiting or diarrhea occurs. |
| Rifabutin | Rifabutin may reduce roxithromycin levels through enzyme induction, while roxithromycin may increase rifabutin levels | Monitor for both reduced antibiotic efficacy and increased rifabutin-related side effects (uveitis, neutropenia). Dose adjustments may be necessary. |
Roximstad should be taken at least 15 minutes before a meal with a glass of water. Food can reduce the absorption of roxithromycin by approximately 50%, which may compromise the effectiveness of the antibiotic. Consistent timing in relation to meals helps maintain stable blood levels throughout the treatment course.
What Is the Correct Dosage of Roximstad?
Roximstad dosing is based on established international guidelines for macrolide antibiotics. Always follow your doctor's specific instructions, as doses may be adjusted based on your individual clinical situation, the type and severity of infection, and your liver and kidney function.
Adults, Elderly, and Children Over 40 kg
Standard Oral Dosing
Standard dose: 150 mg twice daily (every 12 hours)
Pneumonia: Your doctor may prescribe 300 mg once daily
Administration: Take at least 15 minutes before a meal with a glass of water
| Infection | Dose | Duration |
|---|---|---|
| Community-acquired pneumonia | 300 mg once daily or 150 mg BD | 7–14 days |
| Tonsillitis / Pharyngitis | 150 mg BD | At least 10 days |
| Acute otitis media | 150 mg BD | 5–10 days |
| Urinary tract infection | 150 mg BD | 7–14 days |
| Skin and soft tissue infections | 150 mg BD | 7–14 days |
BD = twice daily (every 12 hours)
It is important to continue treatment for 3 to 4 days after symptoms have improved. For certain infections, particularly streptococcal pharyngitis (strep throat), treatment should last at least 10 days to prevent complications such as rheumatic fever. Your doctor will determine the appropriate duration based on the type and severity of your infection.
Clinical studies have shown that the once-daily 300 mg dose is associated with more gastrointestinal side effects than the twice-daily 150 mg regimen. When possible, the twice-daily regimen is preferred for better tolerability. However, once-daily dosing may be selected for pneumonia or when patient adherence with twice-daily dosing is a concern.
Children
Pediatric Dosing
Children over 6 years and over 40 kg: Same as adult dose (150 mg twice daily)
Children under 6 years or under 40 kg: Roximstad film-coated tablets are not suitable. Other roxithromycin formulations (such as oral suspension) are available for younger children and should be used instead.
Note: Always consult a pediatrician before giving roxithromycin to children. Weight-based dosing using an appropriate liquid formulation is recommended for younger children.
Elderly Patients
No specific dose adjustment is routinely required for elderly patients based on age alone. However, elderly patients are more likely to have reduced liver and kidney function, and may be taking multiple medications that could interact with roxithromycin. Your doctor will assess your overall health, kidney and liver function, and current medications before prescribing Roximstad. Elderly patients may also be more susceptible to QT prolongation and should be monitored accordingly.
Renal and Hepatic Impairment
Dose Adjustments for Organ Impairment
Kidney impairment: No dose adjustment is required for patients with reduced kidney function, as roxithromycin is primarily metabolized by the liver.
Mild to moderate liver impairment: Your doctor will carefully assess the benefit versus risk before prescribing Roximstad.
Severe liver impairment: Roximstad should generally not be used. If treatment is deemed essential, the dose should be reduced to 150 mg once daily (half the standard daily dose). Liver function should be monitored regularly throughout treatment.
Missed Dose
If you forget to take a dose of Roximstad, simply continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Consistency is important for maintaining effective antibiotic levels in your blood, so try to take your doses at approximately the same times each day. If you miss multiple doses, contact your doctor, as your treatment may need to be extended to ensure the infection is fully treated.
Overdose
If you suspect a roxithromycin overdose, or if a child has accidentally ingested this medication, contact your local emergency services or poison control center immediately.
Symptoms of Roximstad overdose may include nausea, vomiting, diarrhea, headache, and dizziness. Treatment is primarily supportive, focusing on managing symptoms and maintaining hydration. There is no specific antidote for roxithromycin overdose. In severe cases, gastric lavage (stomach washing) may be considered if the patient presents within a short time after ingestion. Activated charcoal may also be administered to reduce further absorption of the drug.
What Are the Side Effects of Roximstad?
Like all antibiotics, Roximstad can cause side effects, although not everyone experiences them. Clinical data indicate that the once-daily 300 mg dose is associated with more side effects than the twice-daily 150 mg regimen. The following section classifies potential side effects by frequency, based on clinical trials, regulatory submissions, and post-marketing surveillance data.
Common
- Nausea: Feeling sick to the stomach; may be reduced by taking the medication with a small amount of water and on a more consistent schedule
- Epigastric pain: Pain in the upper middle area of the abdomen
- Headache: Usually mild and transient
- Dizziness: A sensation of lightheadedness or unsteadiness
- Dyspepsia: Indigestion or an uncomfortable feeling of fullness after eating
- Diarrhea: Loose or watery stools, usually mild and self-limiting
- Itching (pruritus): Generalized or localized skin itching
Uncommon
- Vomiting: Active expulsion of stomach contents
- Severe constipation (obstipation): Significant difficulty passing stools
- Flatulence: Excessive intestinal gas and bloating
- Elevated liver enzymes: Detected through blood tests; may indicate liver stress
- Skin redness (erythema): Flushing or reddening of the skin
- Urticaria (hives): Raised, itchy welts on the skin
- Eosinophilia: Increased eosinophil white blood cells in the blood
- Erythema multiforme: A skin condition causing spots, red or purple patches, or blisters
Rare
- Angioedema: Swelling of the face, lips, tongue, or throat; difficulty swallowing; hives and difficulty breathing – a potentially life-threatening reaction requiring emergency treatment
- Changed blood values: Alterations in blood cell counts or chemistry values detected through laboratory testing
- Allergic (hypersensitivity) reactions: Including anaphylaxis
- Taste disturbances (dysgeusia): Altered taste perception, including loss of taste (ageusia)
- Smell disturbances (parosmia): Altered smell perception, including loss of smell (anosmia)
- Bronchospasm: Wheezing or difficulty breathing due to narrowing of the airways
- Cholestatic hepatitis: Bile flow obstruction causing liver damage and jaundice
- Acute hepatitis: Sudden liver inflammation
- Pancreatitis: Inflammation of the pancreas causing severe abdominal pain
- Eczema: Skin redness, itching, and scaling
- Weakness and malaise: General feeling of being unwell or fatigued
Not Known (Frequency Cannot Be Estimated)
- Pseudomembranous colitis: Severe bowel inflammation causing persistent, watery, or bloody diarrhea – stop treatment and seek medical care immediately
- Toxic epidermal necrolysis (TEN): Severe skin reaction causing widespread redness and shedding of the outer skin layer – potentially fatal
- Stevens-Johnson syndrome (SJS): Severe skin and mucous membrane reaction with blistering and peeling
- Acute generalized exanthematous pustulosis (AGEP): Red, scaly rash with bumps and blisters under the skin
- Hemorrhagic pancreatitis: Potentially fatal inflammation of the pancreas with bleeding
- Anaphylactic shock: Severe, life-threatening allergic reaction requiring immediate emergency treatment
- Agranulocytosis: Severe reduction in white blood cells, greatly increasing infection risk
- Superinfection: Secondary infection by resistant bacteria or fungi during prolonged treatment
- Thrombocytopenia: Reduced blood platelet count causing easy bruising and bleeding
- Confusion and hallucinations: Seeing or hearing things that are not there
- Psychosis: Loss of contact with reality
- Paresthesia: Abnormal tingling or pins-and-needles sensations
- Visual disturbances: Blurred vision or impaired sight
- QT prolongation: Abnormal heart rhythm visible on ECG
- Ventricular tachycardia: Rapid heart rate originating from the ventricles
- Torsades de pointes: A specific type of dangerous ventricular arrhythmia
- Anorexia: Loss of appetite
- Jaundice: Yellowing of the skin and whites of the eyes due to liver dysfunction
- Myasthenia gravis exacerbation: Worsening of muscle weakness in patients with this condition
- Neutropenia: Low white blood cell count
- Purpura: Purple or red spots on the skin caused by small bleeds under the skin
- Hearing disturbances: Transient deafness, hearing loss, vertigo (spinning sensation), and tinnitus (ringing in the ears)
Stop taking Roximstad and contact emergency services immediately if you experience: swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe skin rash with blistering or peeling; severe or bloody diarrhea; rapid or irregular heartbeat; yellowing of the skin or eyes; severe abdominal pain with nausea, vomiting, and fever; or unexplained muscle weakness affecting breathing.
If you experience any side effects while taking Roximstad, even if they are not listed here, you can report them to your national pharmacovigilance authority (e.g., the MHRA Yellow Card scheme in the UK, the FDA MedWatch program in the US, or the EMA EudraVigilance system in the EU). Reporting suspected adverse reactions helps regulatory authorities continuously monitor the benefit-risk balance of medications.
How Should You Store Roximstad?
Proper storage of Roximstad is important to ensure the medication remains effective and safe throughout its intended shelf life. Follow these storage guidelines:
- Temperature: Store at or below 30°C (86°F). Do not refrigerate or freeze. Avoid storing in excessively hot or humid environments, such as bathrooms or cars during summer.
- Packaging: Keep the tablets in their original blister packaging until you are ready to take them. The aluminum and PVC blister pack provides protection from moisture and light.
- Child safety: Keep all medicines securely out of the sight and reach of children. Store in a locked cabinet or a high shelf that children cannot access.
- Expiry date: Do not use Roximstad after the expiry date stated on the packaging after "EXP." The expiry date refers to the last day of the stated month. If the tablets appear discolored, crumbled, or damaged, do not use them and consult your pharmacist.
- Disposal: Do not dispose of medications via household waste or down drains, as this can harm the environment. Return unused or expired Roximstad to your local pharmacy for safe disposal in accordance with local regulations.
What Does Roximstad Contain?
Each Roximstad film-coated tablet contains roxithromycin as the active pharmaceutical ingredient. The inactive ingredients (excipients) serve various pharmaceutical functions including binding, filling, disintegrating, lubricating, and coating the tablet.
Active Ingredient
- Roximstad 150 mg: Each film-coated tablet contains 150 mg roxithromycin
- Roximstad 300 mg: Each film-coated tablet contains 300 mg roxithromycin
Inactive Ingredients (Excipients)
Tablet core: Microcrystalline cellulose (filler and binder), colloidal anhydrous silica (anti-caking agent), croscarmellose sodium (disintegrant to aid tablet breakdown), poloxamer 188 (surfactant to improve drug dissolution), povidone (binder), talc (lubricant), and magnesium stearate (lubricant).
Film coating: Lactose monohydrate (filler), hypromellose (coating polymer), macrogol 400 (plasticizer), and titanium dioxide E171 (colorant providing the white appearance).
Tablet Appearance
Roximstad 150 mg: A round, white, film-coated tablet.
Roximstad 300 mg: An oblong, white, capsule-shaped film-coated tablet with an off-white core and a score line on one side. The score line is intended to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.
Roximstad is supplied in PVC and aluminum blister packs. Available pack sizes for 150 mg include 5, 10, 12, 14, 16, 20, 28, 30, 50, 60, 90, 100, 250, and 500 tablets. Not all pack sizes may be marketed in all countries.
Roximstad contains lactose monohydrate in its film coating. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The sodium content is less than 1 mmol (23 mg) per tablet, which is essentially sodium-free.
Frequently Asked Questions About Roximstad
Roximstad contains roxithromycin, a macrolide antibiotic used to treat bacterial infections. Its primary indications include community-acquired pneumonia, tonsillitis (sore throat), pharyngitis, acute otitis media (middle ear infection), urinary tract infections caused by susceptible bacteria, and skin and soft tissue infections such as boils, impetigo, and erysipelas. It is particularly valuable as an alternative antibiotic for patients who cannot take penicillin or other beta-lactam antibiotics due to allergy or intolerance. Roximstad does not treat viral infections such as the common cold or flu.
Take Roximstad at least 15 minutes before a meal with a glass of water. This ensures optimal absorption of the medication. The standard dose for adults and children over 40 kg is 150 mg twice daily (every 12 hours). For pneumonia, your doctor may prescribe 300 mg once daily. Always complete the full course of treatment as prescribed, even if your symptoms improve. You should continue taking the tablets for 3 to 4 days after your symptoms have resolved. Stopping treatment early can lead to treatment failure and contribute to antibiotic resistance.
The most common side effects (affecting up to 1 in 10 people) include nausea, upper abdominal pain, headache, dizziness, indigestion, diarrhea, and itching. These side effects are generally mild and resolve after treatment is completed. The twice-daily 150 mg regimen tends to produce fewer gastrointestinal side effects than a single daily dose of 300 mg. Serious but rare side effects include severe allergic reactions, severe skin reactions, liver problems, and heart rhythm disturbances. If you experience any severe or unusual symptoms, stop taking the medication and consult your doctor immediately.
Animal studies have not demonstrated harmful effects of roxithromycin on pregnancy, but the use of Roximstad in pregnant women has not been adequately studied in clinical trials. Therefore, Roximstad should only be used during pregnancy if your doctor determines that the benefit clearly outweighs the potential risk. Roxithromycin is excreted in breast milk, so breastfeeding mothers should only use it if absolutely necessary, as determined by their healthcare provider. If you are pregnant, planning to become pregnant, or breastfeeding, always inform your doctor before starting any new medication.
Roximstad must not be taken with ergot alkaloids (ergotamine, dihydroergotamine), cisapride, pimozide, astemizole, or terfenadine, as these combinations can cause life-threatening cardiac arrhythmias or severe vasospasm. You should also exercise caution with drugs that prolong the QT interval, including certain heart medications (quinidine, amiodarone, disopyramide), some antidepressants (citalopram, tricyclics), methadone, antipsychotics, and fluoroquinolone antibiotics. Additionally, Roximstad may interact with cyclosporine, warfarin, digoxin, theophylline, midazolam, statins, and oral contraceptives. Always provide your doctor and pharmacist with a complete list of all medications you are currently taking.
Roximstad film-coated tablets are not suitable for children under 6 years of age or patients weighing less than 40 kg, as the tablets cannot be divided into appropriate doses for smaller children. For children in these age and weight categories, other formulations of roxithromycin (such as oral suspension) are available and should be used instead, as they allow for accurate weight-based dosing. Children over 6 years of age who weigh more than 40 kg can take the standard adult dose of 150 mg twice daily, but this should always be determined and supervised by a pediatrician or physician.
References
This article is based on current international medical guidelines, regulatory documents, and peer-reviewed research. All sources meet evidence level 1A standards.
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