Availability & Expiry
INTRODUCTION
NOVACLAV is a combination of Amoxicillin and Clavulanic Acid which belongs to the group of medicines called Antibiotics. It is used to treat 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.
NOVACLAV 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 a hepatic impairment, liver disease, renal impairment, kidney disease, glandular fever, or are unable to pass water properly.
NOVACLAV 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 NOVACLAV.
The common side effects associated with the use of NOVACLAV 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 NOVACLAV
- Treats bacterial infection
HOW NOVACLAV WORKS
NOVACLAV helps in treating 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 preventing the inactivation of amoxicillin.
DIRECTIONS FOR USE
Film-coated tablets:
Take NOVACLAV 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 NOVACLAV 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 NOVACLAV 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 NOVACLAV
COMMON
- diarrhoea
- thrush (fungal infection in the vagina, skin folds, or mouth)
- nausea
- vomiting
UNCOMMON
- skin rash
- itching
- raised itchy rash (hives)
- indigestion
- dizziness
- headache
RARE
- erythema multiforme (a skin rash that looks like small targets)
- reversible leucopoenia including neutropenia (deficiency of white blood cells)
- reversible thrombocytopenia (deficiency of blood platelets)
Stop taking NOVACLAV and contact your doctor if you experience any of the following side effects:
- signs of allergic reactions on the skin such as skin rash
- signs of vasculitis (inflammation of blood vessels) such as raised red or purple spots on the skin
- signs of allergic reactions such as fever, joint pain, swollen glands in the neck, armpit or groin
- signs of angioedema such as swelling on the face or mouth resulting in difficulty in breathing, or collapse
- inflammation of the liver (hepatitis)
- jaundice
- inflammation of kidney tubes
- prolongation of blood clotting time
- convulsions
- black tongue with hairy look
- staining of teeth
HOW TO MANAGE SIDE EFFECTS
Diarrhoea:
Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.
Nausea and vomiting:
Try to take NOVACLAV 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
NOVACLAV should be used with caution in pregnant women only if it is considered clearly necessary. Consult your doctor before taking NOVACLAV.
BREASTFEEDING
NOVACLAV should be used with caution in breastfeeding women. Consult your doctor before taking NOVACLAV.
DRIVING AND USING MACHINES
Do not drive or operate machines while taking if you feel unwell.
KIDNEY
NOVACLAV should be used with caution in patients with renal impairment or kidney problems. Consult your doctor before taking NOVACLAV.
LIVER
NOVACLAV is not recommended for use if you have if you 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 NOVACLAV.
ALLERGY
Do not take NOVACLAV if you are allergic to amoxicillin, clavulanic acid, penicillin, any antibiotic, or any other ingredients of this medicine. Consult your doctor before taking NOVACLAV.
OTHERS
Before taking NOVACLAV, inform your doctor if you:
- have glandular fever
- are unable to pass water properly
Use in Paediatrics:
NOVACLAV should be used with caution in children (below 12 years). Consult your doctor before taking NOVACLAV.
Use in Geriatrics:
NOVACLAV should be used with caution in elderly patients (above 50 years). Consult your doctor before taking NOVACLAV.
INTERACTIONS
A. Drug-Drug Interactions
Before taking NOVACLAV, inform your doctor, if you are taking any of the following medicine:
- allopurinol, probenecid (medicine used to treat gout)
- warfarin (medicine used to delay blood clotting)
- methotrexate (medicine used to treat rheumatic diseases or certain cancers)
- mycophenolate mofetil (a medicine used to prevent the organ rejection after organ transplant)
- contraceptives (medicines used to prevent conception)
Overdosage:
If you or anyone else accidentally takes too much of NOVACLAV, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are gastrointestinal symptoms (including heartburn, indigestion, bloating, and constipation).
SYNOPSIS
| Drug | : | Amoxicillin, Clavulanic Acid |
| Pharmacological Category | : | Antibiotics |
| Therapeutic Indication | : | Bacterial infections |
| Dosage Forms | : | Tablet, Dispersible Tablet, Capsule, Sachet |
MORE INFORMATION
- Keep the medicine out of reach of children
- Store NOVACLAV at a temperature not exceeding 30°C
FAQs ABOUT NOVACLAV
What NOVACLAV is used for?
NOVACLAV is used for treating 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.
What happens if you take more NOVACLAV than your required dose?
If you or anyone else accidentally takes too much of NOVACLAV, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are gastrointestinal symptoms (including heartburn, indigestion, bloating, and constipation).
What side effects are seen with NOVACLAV?
The common side effects associated with the use of NOVACLAV 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.
Who should avoid taking NOVACLAV?
Do not take NOVACLAV 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.
Is NOVACLAV safe to use in children?
NOVACLAV should be used with caution in children (below 12 years). Children (aged 6 years or below) should be treated with oral suspension or sachets containing amoxicillin and clavulanic acid. Consult your doctor before taking NOVACLAV.
How does NOVACLAV work?
NOVACLAV helps in treating 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 preventing the inactivation of amoxicillin.
What is the method of taking NOVACLAV?
Film-coated tablets:
Take NOVACLAV 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 NOVACLAV 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 NOVACLAV 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.
What if I forget to take NOVACLAV dose?
If you forgot to take NOVACLAV 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 NOVACLAV.
When to stop taking NOVACLAV?
Do not stop taking NOVACLAV without thoroughly discussing it with your doctor until the treatment 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.
Is NOVACLAV safe to use in liver patients?
NOVACLAV 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 NOVACLAV.
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. [Assessed 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] [Assessed 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] [Assessed 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. [Assessed on 26th October 2022] https://www.macleodspharma.com/products/
6. Micro Labs Ltd. Erox CV Dispersible Tablets. [Assessed on 26th October 2022] http://www.microlabsltd.com/elibrary/node/2192
USEFUL DIAGNOSTIC TESTS
- blood tests
- urine tests
- liver function test
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