Roxid M Tablet (10 Tab)

ROXID M TABLET (10 TAB) by ALEMBIC PHARMACEUTICALS LIMITED

Name

Brand Name: ROXID M TABLET

Composition

ROXID M TABLET is a combination medicine containing two active ingredients:

• Roxithromycin (150 mg): A macrolide antibiotic that works by inhibiting bacterial protein synthesis, thereby stopping bacterial growth.
• Ambroxol (60 mg): A mucolytic agent that helps thin and loosen thick mucus (phlegm), making it easier to cough out. Ambroxol also enhances the antibacterial effect of Roxithromycin.

Uses

ROXID M TABLET is primarily prescribed to treat various bacterial respiratory tract infections (both upper and lower airways) associated with excessive mucus production. These conditions include:

• Bronchitis
• Pneumonia
• Sinusitis
• Otitis (ear inflammation)
• Pharyngitis (sore throat)
• Tonsillitis It also provides relief from cough and associated symptoms by clearing mucus from the chest.

Dosage and Administration

• Adults: A typical dosage is usually one tablet twice daily, ideally taken 12 hours apart.
• ROXID M TABLET can be taken with or without food. However, it is generally recommended to take it on an empty stomach (at least 15 minutes before food or three hours after food) for optimal absorption, or after food to minimize potential gastrointestinal side effects.
• Swallow the tablet whole with a glass of water; do not crush or chew it.
• Complete the full course of treatment as prescribed by your doctor, even if symptoms improve, to prevent antibiotic resistance and ensure complete eradication of the infection.
• Do not alter the dosage or discontinue the medication without consulting your physician.

Side Effects

Common side effects may include:

• Nausea or vomiting
• Diarrhea
• Abdominal pain or stomach pain
• Loss of appetite
• Changes in sense of taste
• Mouth sores
• Vaginal thrush
• Skin rash
• Headache

Serious side effects such as severe allergic reactions (rashes, itching, swelling of face/mouth, difficulty breathing) are rare but require immediate medical attention.

Precautions

• Allergies: Do not take ROXID M TABLET if you are allergic to Roxithromycin, Ambroxol, other macrolide antibiotics, or any of its ingredients.
• Liver/Kidney/Heart Conditions: Use with caution in patients with pre-existing liver, kidney, or heart problems. It is generally not recommended for individuals with severe hepatic impairment.
• Pregnancy and Breastfeeding: ROXID M TABLET is generally not recommended for use during pregnancy or breastfeeding unless specifically advised by a doctor after careful consideration of benefits and risks.
• Alcohol Consumption: Avoid consuming alcohol while taking this medication, as it may worsen side effects.
• Driving: This medicine may cause dizziness, so avoid driving or operating heavy machinery if you experience these symptoms.
• Drug Interactions: Inform your doctor about all other medications you are currently taking, especially theophylline, ergotamine, dihydroergotamine, disopyramide, terfenadine, astemizole, warfarin, digoxin, and midazolam, as interactions can occur.
• Other Conditions: Inform your doctor if you have myasthenia gravis, bronchial motor activity syndrome with a large production of secretion (risk of a mucous plug), or peptic ulcers.

Storage

Store ROXID M TABLET in a cool, dry place below 30°C. Protect it from moisture and direct sunlight. Keep it out of the sight and reach of children and pets.

Here are the most frequently asked questions about ROXID M TABLET, which contains Roxithromycin and Ambroxol:

What is ROXID M TABLET used for?

ROXID M TABLET is a combination medicine primarily used to treat various bacterial infections, especially those affecting the respiratory tract, such as bronchitis, pneumonia, sinusitis, pharyngitis, and tonsillitis. It is also effective against certain skin and soft tissue infections, as well as urinary tract and dental infections. The Ambroxol component also helps to thin and loosen thick mucus, making it easier to cough out.

How does ROXID M TABLET work?

ROXID M TABLET contains two active ingredients: Roxithromycin and Ambroxol. Roxithromycin is a macrolide antibiotic that works by stopping the growth of bacteria by inhibiting their protein synthesis, which is essential for their multiplication and survival. Ambroxol is a mucolytic agent that thins and loosens mucus (phlegm), making it easier to clear from the airways. This combination helps to combat the infection and alleviate associated symptoms like excessive mucus.

What is the usual dosage for ROXID M TABLET?

For adults, the recommended dosage is typically 300 mg per day, which can be taken as one 300 mg tablet once daily or one 150 mg tablet twice daily. The usual duration of treatment ranges from five to ten days, depending on the type and severity of the infection and clinical response. It should generally be taken on an empty stomach, about 15 minutes before food or at least three hours after a meal, to ensure optimal absorption. For children (6-40 kg), the dosage is usually 5-8 mg/kg daily given in two divided doses, and treatment should not exceed 10 days. Always follow your doctor's specific instructions.

What are the possible side effects of ROXID M TABLET?

Common side effects include nausea, vomiting, diarrhea, abdominal pain, loss of appetite, headache, dizziness, and altered taste. Less common side effects can include rashes, abnormal liver function values, and changes in the senses of smell and taste. More serious, though rare, side effects that require immediate medical attention include severe or persistent diarrhea (which may be bloody), signs of an allergic reaction (such as swelling of the face, lips, tongue, or throat, severe skin rash, or difficulty breathing), and problems with liver function (like yellowing of the skin or eyes, dark urine, or abdominal pain).

Is ROXID M TABLET safe during pregnancy or breastfeeding?

If you are pregnant or planning a pregnancy, you should consult your doctor before taking ROXID M TABLET. For breastfeeding mothers, Roxithromycin passes into breast milk in very low levels and is generally not expected to cause adverse effects in breastfed infants. However, it's advisable to monitor the infant for potential effects on gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash). Some evidence suggests that maternal use of macrolide antibiotics, especially during the first month of breastfeeding, might be linked to an increased risk of infantile hypertrophic pyloric stenosis, so it may be prudent to avoid it during this period.

Can ROXID M TABLET be taken with other medications?

ROXID M TABLET can interact with several medications. It may increase the plasma concentrations of drugs like theophylline (used for asthma), disopyramide (for irregular heart rhythms), ciclosporin, and midazolam. Concomitant use with warfarin (a blood thinner) requires close monitoring of INR due to an increased risk of bleeding. Co-administration with vasoconstrictive ergot alkaloids (e.g., ergotamine) is not recommended as it may lead to severe vasoconstriction. Antacids containing aluminum or magnesium can reduce the absorption of Roxithromycin, so it's advisable to take Roxithromycin at least 2 hours before or after taking antacids. Caution is advised with drugs known to prolong the QT interval, such as certain antiarrhythmics, astemizole, cisapride, and pimozide, due to an increased risk of irregular heart rhythms. Always inform your doctor about all other medications you are taking.

What precautions should be taken while taking ROXID M TABLET?

Inform your doctor if you have a known allergy to Roxithromycin or any other macrolide antibiotic. Exercise caution if you have liver problems, as the dose may need adjustment, or if you have severe hepatic impairment, this medicine is generally not recommended. Patients with pre-existing heart conditions, such as clinically relevant bradycardia, cardiac arrhythmia, or other cardiac insufficiencies, or those at risk for QT prolongation, should use this medicine with caution. Complete the full course of treatment as prescribed, even if you start feeling better, to prevent antibiotic resistance and ensure the complete eradication of the infection. If you experience dizziness, avoid alcohol as it can worsen this side effect.

What happens if a dose of ROXID M TABLET is missed?

If you miss a dose, 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, as this can increase the risk of side effects.

How should ROXID M TABLET be stored?

ROXID M TABLET should be stored in a cool, dry place, ideally below 25°C. Keep the tablets in their original blister pack and protect them from light and moisture. Always keep this and all medicines out of the reach of children.