Introduction About ROZECLAV 625 TABLET

ROZECLAV 625 TABLET is a combination of Amoxicillin and Clavulanic Acid, which belongs to the group of medicines called Antibiotics. It is used to manage bacterial infections including middle ear & sinus infections, respiratory tract infections, genital tract infections, urinary tract infections, skin & soft tissue infections such as dental infections, bone & joint infections, septic abortion and abdominal infections. The symptoms of bacterial infection include fever, difficulty in breathing, pus formation, and pain.

ROZECLAV 625 TABLET is not recommended for use if you have liver problems or jaundice upon taking an antibiotic or amoxicillin-clavulanate. Before taking this medicine, inform your doctor if you are suffering from hepatic impairment, liver disease, renal impairment, kidney disease, glandular fever, or are unable to pass water properly.

ROZECLAV 625 TABLET should be used with caution in pregnant and breastfeeding women only if it is considered necessary. It should be used with caution in children (aged below 12 years) and elderly patients (above 50 years). Consult your doctor before taking ROZECLAV 625 TABLET.

The common side effects associated with the use of ROZECLAV 625 TABLET are diarrhoea, thrush (fungal infection in the vagina, skin folds, or mouth), nausea, and vomiting. Contact your doctor immediately if any of the symptoms worsen.

Uses Of ROZECLAV 625 TABLET

• Manage bacterial infection

How ROZECLAV 625 TABLET Works

ROZECLAV 625 TABLET helps in managing bacterial infection where amoxicillin is a penicillin that works by inhibiting the enzymes that help in the synthesis of the integral structural component of the bacterial cell wall whereas clavulanic acid is a beta-lactam (structurally related to penicillin) that works by inactivating an enzyme, namely beta-lactamase, thereby managing the inactivation of amoxicillin.

How to use ROZECLAV 625 TABLET

Film-coated tablets:

Take ROZECLAV 625 TABLET as advised by your physician. Swallow the tablet with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Dispersible tablets:

Take ROZECLAV 625 TABLET as advised by your physician. Place the tablet in the mouth, let it dissolve, and then swallow. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Powder for oral suspension (in sachets):

Take ROZECLAV 625 TABLET as advised by your physician. Open the sachet, mix the contents thoroughly in a glass of water, and swallow the mixture immediately. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Side Effects Of ROZECLAV 625 TABLET

How To Manage Side Effects

Diarrhea

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to manage diarrhoea and consult your doctor if the symptom gets worse.

Nausea And Vomiting

Try to take ROZECLAV 625 TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Warning & Precautions

Pregnancy

Use with Caution

ROZECLAV 625 TABLET should be used with caution in pregnant women only if it is considered necessary. Consult your doctor before taking ROZECLAV 625 TABLET.

Breastfeeding

Use with Caution

ROZECLAV 625 TABLET should be used with caution in breastfeeding women. Consult your doctor before taking ROZECLAV 625 TABLET.

Driving and Using Machines

Monitoring required

Do not drive or operate machines while taking if you feel unwell.

Kidney

Use with Caution

ROZECLAV 625 TABLET should be used with caution in patients with renal impairment or kidney problems. Consult your doctor before taking ROZECLAV 625 TABLET.

Liver

Contraindicated

ROZECLAV 625 TABLET is not recommended for use if you have ever had liver problems or jaundice upon taking an antibiotic or amoxicillin-clavulanate. It should be used with caution in patients with hepatic impairment or liver problems. Consult your doctor before taking ROZECLAV 625 TABLET.

Allergy

Monitoring required

Do not take ROZECLAV 625 TABLET if you are allergic to amoxicillin, clavulanic acid, penicillin, any antibiotic, or any other ingredients of this medicine. Consult your doctor before taking ROZECLAV 625 TABLET.

Interactions

A. Drug-Drug Interactions

Before taking ROZECLAV 625 TABLET, inform your doctor, if you are taking any of the following medicine:

• allopurinol, probenecid (a medicine used to manage gout)
• warfarin (a medicine used to delay blood clotting)
• methotrexate (a medicine used to manage rheumatic diseases or certain cancers)
• mycophenolate mofetil (a medicine used to manage organ rejection after an organ transplant)
• contraceptives (medicines used to manage conception)

Overdosage:

If you or anyone else accidentally takes too much of ROZECLAV 625 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are gastrointestinal symptoms (including heartburn, indigestion, bloating, and constipation).

Synopsis

More Information

• Keep the medicine out of reach from children
• Store ROZECLAV 625 TABLET at a temperature not exceeding 30°C

FAQs About ROZECLAV 625 TABLET

Q: What ROZECLAV 625 TABLET is used for?

A: ROZECLAV 625 TABLET is used for managing bacterial infections including middle ear & sinus infections, respiratory tract infections, genital tract infections, urinary tract infections, skin & soft tissue infections such as dental infections, bone & joint infections, septic abortion (any abortion complicated by uterine infection), and abdominal infections. 

Q: What happens if you take more ROZECLAV 625 TABLET than your required dose?

A: If you or anyone else accidentally takes too much of ROZECLAV 625 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are gastrointestinal symptoms (including heartburn, indigestion, bloating, and constipation).

Q: What side effects are seen with ROZECLAV 625 TABLET?

A: The common side effects associated with the use of ROZECLAV 625 TABLET are diarrhoea, thrush (fungal infection in the vagina, skin folds, or mouth), nausea, and vomiting. Contact your doctor immediately if any of the symptoms worsen.

Q: Who should avoid taking ROZECLAV 625 TABLET?

A: Do not take ROZECLAV 625 TABLET if you are allergic to amoxicillin, clavulanic acid, penicillin, or any antibiotic. It is not recommended for use if you have liver problems or jaundice upon taking an antibiotic or amoxicillin-clavulanate.

Q: Is ROZECLAV 625 TABLET safe to use in children?

A: ROZECLAV 625 TABLET should be used with caution in children (below 12 years). Children (aged 6 years or below) should be managed with oral suspension or sachets containing amoxicillin and clavulanic acid. Consult your doctor before taking ROZECLAV 625 TABLET.

Q: How does ROZECLAV 625 TABLET work?

A: ROZECLAV 625 TABLET helps in managing bacterial infection where amoxicillin is a penicillin that works by inhibiting the enzymes that help in the synthesis of an integral structural component of the bacterial cell wall whereas clavulanic acid is a beta-lactam (structurally related to penicillin) that works by inactivating an enzyme, namely beta-lactamase, thereby managing the inactivation of amoxicillin.

Q: What is the method of taking ROZECLAV 625 TABLET?

A: Film-coated tablets:

Take ROZECLAV 625 TABLET as advised by your physician. Swallow the tablet with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Dispersible tablets:

Take ROZECLAV 625 TABLET as advised by your physician. Place the tablet in the mouth, let it dissolve, and then swallow. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Powder for oral suspension (in sachets):

Take ROZECLAV 625 TABLET as advised by your physician. Open the sachet, mix the contents thoroughly in a glass of water, and swallow the mixture immediately. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Q: What if I forget to take ROZECLAV 625 TABLET dose?

A: If you forgot to take ROZECLAV 625 TABLET dose, take it as early as possible. Avoid taking the next dose too soon. Wait for about 4 hours before taking the scheduled next dose. Consult your doctor before taking ROZECLAV 625 TABLET.

Q: When to stop taking ROZECLAV 625 TABLET?

A: Do not stop taking ROZECLAV 625 TABLET without thoroughly discussing it with your doctor until the management course is completed, even if you start feeling better. This is because if some bacteria survive due to incomplete medication, they may relapse into the infection.

Q: Is ROZECLAV 625 TABLET safe to use in liver patients?

A: ROZECLAV 625 TABLET is not recommended for use if you have liver problems or jaundice upon taking an antibiotic or amoxicillin-clavulanate. It should be used with caution in patients with hepatic impairment or liver problems. Consult your doctor before taking ROZECLAV 625 TABLET.

References

1. KD Tripathi. Beta-Lactam Antibiotics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 723.

2. Justin Evans, Maryam Hannoodee, Micah Wittler. Amoxicillin Clavulanate. NIH National Library of Medicine. National Centre for Biotechnology Information. StatPearls [Internet]. December 2021. [Accessed on 26th October 2022] https://www.ncbi.nlm.nih.gov/books/NBK538164/

3. Lek Pharmaceuticals d.d. Health Products Regulatory Authority (HPRA). [Revised in December 2014] [Accessed on 26th October 2022] https://www.hpra.ie/img/uploaded/swedocuments/pl-clean-2157753-09062015140435-635694554758986250.pdf

4. GSK group of companies. Augmentin. [Revised in December 2017] [Accessed on 26th October 2022] https://gskpro.com/content/dam/global/hcpportal/en_MU/PI/Clavulin-228.5mg5ml-Susp-GDS-24.pdf

5. Macleods Pharmaceuticals Ltd. Polyclav DS Tab. [Accessed on 26th October 2022] https://www.macleodspharma.com/products/

6. Micro Labs Ltd. Erox CV Dispersible Tablets. [Accessed on 26th October 2022] http://www.microlabsltd.com/elibrary/node/2192

Useful Diagnostic Tests

• blood tests
• urine tests
• liver function test