INTRODUCTION

ACUCLAV is a combination of Amoxicillin and Clavulanic acid which belongs to the group of medicine called Antibiotics. It is indicated for the treatment of various infections like respiratory tract infections (Ex. adequately diagnosed community acquired pneumonia, chronic bronchitis), middle ear and sinus infections (Ex. acute otitis media, acute bacterial sinusitis), urinary tract infections (Ex. pyelonephritis or cystitis), skin and soft tissue infections (Ex. cellulitis, animal bites, dental infection) or bone and joint infections (Ex. osteomyelitis) caused by suspected drug- resistant bacterial strains in both adults and in children (weighing not less than 45 kg). Bacterial infections can be defined as a proliferation of various harmful strains of bacteria in the body. They can affect any part(s) of the body including the respiratory tract, urinary tract, eyes, ears, skin, soft tissue, or bones.

Amoxicillin is a penicillin-like antibiotic that acts by inhibiting the biosynthesis of a protective layer called peptidoglycan in the bacterial cell wall and clavulanic acid is a beta-lactamase inhibitor that acts by the reducing resistance for amoxicillin by inhibiting the activity of an enzyme called beta-lactamase in the bacterial cell. Collectively they interrupt the construction of the bacterial cell wall and ultimately lead to the destruction, or lysis, of the bacteria.

Try to take this medicine with or just after a meal or a snack to avoid feeling sick (nausea). Your doctor will decide the correct dose for you depending upon your age, body weight, health condition and type of infection. During the therapy your doctor might recommend you have several tests to monitor your kidney and liver function to rule the risk of unwanted side effects. Before taking this medicine, inform your doctor if you have any liver or kidney problems. ACUCLAV should be used with caution in pregnant or breastfeeding women. Consult your doctor before taking. The most common side effects of taking this medicine are diarrhea, nausea, vomiting, and stomach upset. Consult your doctor if any of the symptoms worsen.

USES OF ACUCLAV

It is used to treat the following bacterial infections in both adults and in children (weighing not less than 40kg):

• middle ear and sinus infections (Ex. acute otitis media, acute bacterial sinusitis)
• respiratory tract infections (Ex. adequately diagnosed community acquired pneumonia, chronic bronchitis)
• urinary tract infections (Ex. pyelonephritis or cystitis)
• skin and soft tissue infections (Ex. cellulitis, animal bites, dental infection)
• bone and joint infections (Ex. osteomyelitis)

HOW ACUCLAV WORKS

ACUCLAV kills the growth of harmful bacteria, where amoxicillin acts by inhibiting the biosynthesis of the peptidoglycan layer (a layer which is responsible for the survival of the bacteria) of the bacterial cell wall and clavulanic acid acts by restoring the antimicrobial effects of amoxicillin by deactivating an enzyme called beta-lactamase (which is responsible for causing resistance to various standard beta-lactam antimicrobials) in the bacterial cell. Collectively they interrupt the construction of the cell wall and ultimately lead to the destruction, or lysis, of the bacteria.

DIRECTIONS FOR USE

Take this medicine with meals or as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose for you depending upon your age, body weight and type of infection. Continue to take this medicine, if your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF ACUCLAV

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take this medicine with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food.

Diarrhea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink lot of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Inform your physician, if you are taking,

• allopurinol or probenecid (used to treat gout)
• medicines used to stop blood clots (such as warfarin)
• methotrexate (a medicine used to treat rheumatic diseases or cancer)
• mycophenolate mofetil (a medicine used to prevent graft rejection)

Overdosage:

If you or anyone else accidentally take too much of this medicine, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage might include upset stomach, nausea, vomiting, diarrhea, or convulsions.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store at room temperature

FAQs ABOUT ACUCLAV

Can ACUCLAV treat cold?

No. This medicine is used to treat bacterial infections of respiratory tract such as sore throat. It has no impact on the harmful virus causing cold and cough.

Can ACUCLAV be taken together with azithromycin?

Yes. There were no interactions found between this medicine with other antibiotics such as azithromycin. However, consult your doctor before taking this medicine.

Can ACUCLAV treat typhoid?

Although ciprofloxacin and intravenous ampicillin were the first-line medicines prescribed to treat typhoid fever, this medicine was also found to be effective against typhoid causing bacteria. However, consult your doctor before taking.

Can ACUCLAV treat hemorrhoids?

This medicine can treat hemorrhoids caused by susceptible bacteria. However, consult your doctor before taking this medicine if you have hemorrhoids. Your doctor will decide the suitable medicine, dose, and duration of therapy for you depending upon your age, body weight and type of infection.

Can ACUCLAV be mixed with milk?

This medicine can be mixed with milk, baby formula, fruit juice or other cold beverages to encourage consumption by the children. Although, milk has some influence on the bioavailability of this medicine there were no notable interactions between this medicine and milk and therefore it can be considered safe when mixed with milk before consumption. Consult your doctor before taking as a precaution.

REFERENCES

1. KD. Tripathi. Beta-Lactam Antibiotics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 723 & 724.

2. Gerald G. Briggs and Roger K. Freeman. A & C. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 206 & 848.

3. S J Pedler and A J Bint. Comparative study of amoxicillin-clavulanic acid and cephalexin in the treatment of bacteriuria during pregnancy. NCBI; PMC US National Library of Medicine, National Institute of Health. April 1985. [Accessed 2nd November 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC180085/

4. A Iravani and G A Richard. Treatment of urinary tract infections with a combination of amoxicillin and clavulanic acid. NCBI; PMC US National Library of Medicine, National Institute of Health. October 1982. [Accessed 2nd November 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC183812/

5. Hanie Ahmadi,  Alireza Ebrahimi and Fatemeh Ahmadi. Antibiotic Therapy in Dentistry. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2021. [Accessed 3rd November 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861949/

6. KLEIN, JEROME. Amoxicillin/clavulanate for infections in infants and children: past, present, and future. The pediatric infectious disease journal. [Accessed 2nd November 2021] https://journals.lww.com/pidj/fulltext/2003/08001/amoxicillin_clavulanate_for_infections_in_infants.5.aspx

7. Brown & Burk UK Ltd. Electronic Medicines Compendium (EMC). [Revised in December 2018] [Accessed 2nd November 2021] https://www.medicines.org.uk/emc/files/pil.10900.pdf

8. PenCef Pharma GmbH. Electronic Medicines Compendium (EMC). [Revised in April 2018] [Accessed 2nd November 2021] https://www.medicines.org.uk/emc/files/pil.9127.pdf

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count
• Peripheral Smear Examination