INTRODUCTION

REOPIN SB 1.5GM INJECTION is a combination of Ampicillin and Sulbactum which belongs to the group of medicines called Antibiotics. It is used in the treatment of upper and lower respiratory tract infections including sinusitis, otitis media and epiglottitis, pneumonias, urinary tract infections, pyelonephritis, peritonitis, cholecystitis, endometritis and pelvic cellulitis, bacterial septicaemia, skin or skin structure infections, bone and joint infections, gonococcal infections.

It is also used to treat peri-operatively to reduce the incidence of post-operative wound infections after abdominal or pelvic surgery, in termination of pregnancy or caesarean section and may be used prophylactically to reduce post-operative sepsis.

REOPIN SB 1.5GM INJECTION is not recommended for use in patients with history of jaundice or hepatic dysfunction associated with use of this medicine.

Before receiving this medicine, tell your doctor if you have any lung disease such as asthma, liver or kidney disease. REOPIN SB 1.5GM INJECTION should be used with caution in pregnant women. Contact your doctor before receiving.

REOPIN SB 1.5GM INJECTION should be used with caution in breast-feeding women. Contact your doctor before receiving. REOPIN SB 1.5GM INJECTION should be used with caution in children. Contact our doctor before receiving.

REOPIN SB 1.5GM INJECTION should be used with caution in elderly patients aged above 65 years. Contact your doctor before receiving.

The most common side effects of this medicine are nausea, vomiting, diarrhea, abdominal pain, rash and allergic reaction. Contact your doctor if any of the side effects worsen.

USES OF REOPIN SB 1.5GM INJECTION

It is used to treat bacterial infections such as:

• upper and lower respiratory tract infections (Ex. sinusitis, otitis media and epiglottitis, pneumonias)
• urinary tract infections
• pyelonephritis
• intra-abdominal infections (Ex. peritonitis, cholecystitis, endometritis and pelvic cellulitis)
• bacterial septicaemia
• skin, soft tissue, bone and joint infections
• gonococcal infections
• post-operative wound infections after abdominal or pelvic surgery

HOW REOPIN SB 1.5GM INJECTION WORKS

REOPIN SB 1.5GM INJECTION helps to treat bacterial infections, where Ampicillin works by preventing the formation of formation of bacterial cell wall and Sulbactum works by binding and inhibiting beta-lactamase (an enzyme that destroys antibiotic activity) produced by bacterial cells and thereby prevents the reduction in antibacterial activity.

DIRECTIONS FOR USE

REOPIN SB 1.5GM INJECTION will be administered to you only by a doctor or a nurse into a vein or muscle. Your doctor will administer the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF REOPIN SB 1.5GM INJECTION

HOW TO MANAGE SIDE EFFECTS

Nausea or Vomiting:

Take this medicine with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own for treating diarrhea. Contact your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the symptom did not improve.

Stomach pain:

Try to rest and relax. Eat small meals but take frequently. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

Skin rash:

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

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Inform your physician, if you are taking any of the following medicine:

• allopurinol, probenecid (medicines used to treat gout)
• medicines used to treat bacterial infections (Ex. amikacin, chloramphenicol, erythromycin, sulfonamides, tetracyclines)
• medicines used to treat blood clots (oral anticoagulants like dabigatran, rivaroxaban)
• methotrexate (medicines acting on the immune system)
• medicines used to prevent pregnancy (Ex. oral contraceptives)

Overdosage:

REOPIN SB 1.5GM INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms such as convulsions.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store below 30°C

FAQs ABOUT REOPIN SB 1.5GM INJECTION

Does REOPIN SB 1.5GM INJECTION cause liver damage?

Yes. REOPIN SB 1.5GM INJECTION may cause jaundice or hepatitis. Contact your doctor if you experience any unusual symptoms like yellowish discoloration of skin and white of eyes, fever, abdominal pain and change in urine or stool colour.

How REOPIN SB 1.5GM INJECTION works?

REOPIN SB 1.5GM INJECTION helps to treat bacterial infections, where Ampicillin works by preventing the formation of formation of bacterial cell wall and Sulbactum works by binding and inhibiting beta-lactamase (an enzyme that destroys antibiotic activity) produced by bacterial cells and thereby prevents the reduction in antibacterial activity.

What are the side effects of REOPIN SB 1.5GM INJECTION?

The most common side effects of this medicine are nausea, vomiting, diarrhea, abdominal pain, rash and allergic reaction. Contact your doctor if any of the side effects worsen.

What does REOPIN SB 1.5GM INJECTION treat?

REOPIN SB 1.5GM INJECTION is used in the treatment of sinusitis, otitis media and epiglottitis, pneumonias, urinary tract infections and pyelonephritis, peritonitis, cholecystitis, endometritis and pelvic cellulitis, bacterial septicaemia, skin, soft tissue, bone and joint infections and gonococcal infections, post-operative wound infections after abdominal or pelvic surgery, termination of pregnancy or caesarean section and may be used prophylactically to reduce post-operative sepsis.

Can I use REOPIN SB 1.5GM INJECTION for viral infections?

No. REOPIN SB 1.5GM INJECTION does not treat viral infections like cold, flu or other viral infections. Contact your doctor before receiving.

REFERENCES

1. KD. Tripathi. Beta lactam Antibiotics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 722-723,725.

2. Robert J. Kizor, Keith J. Hodgson. Ampicillin sulbactum. Saunders nursing drug handbook. 29th edition. 2021. Page – 68 to 70.

3. Linda skidmore-roth. Ampicillin sulbactum.  Mosby 2021 nursing drug reference. 34th edition. 2021. Page -81 to 83.

4. Peechakara BV, Gupta M. Mechanism of Ampicillin/Sulbactam. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised on September 2021] [Accessed on 17th May 2022]  https://www.ncbi.nlm.nih.gov/books/NBK526117/

5. A. Rodriguez-Guardado, A. Blanco and J.A. Carton.  Uses of ampicillin and sulbactum. Clinical Medicine Reviews in Therapeutics. January 2010. [Accessed on 17th May 2022] https://www.researchgate.net/publication/269659432_AmpicillinSulbactam_in_Combination_A_Review_of_its_Use_in_the_Treatment_of_Severe_Bacterial_Infections/link/5543a9760cf24107d396336c/download

6. Pfizer. U.S. Food & Drug Administration. [Revised on April 2007] [Accessed on 17th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050608s029lbl.pdf

7. Haupt Pharma Latina S.r.l. Ampicillin and sulbactum. [Revised on October 2016] [Accessed on 17th May 2022] https://www.pfizerpro.com.my/sites/default/files/lpd_ampicillin_sodium_sulbactam_sodium_-_unasyn_-_mys_-_english.pdf

8. Pfizer Inc. Ampicillin and sulbactum. [Revised on October 2020] [Revised on 17th May 2022] https://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=653

9. Ampicillin + sulbactum. Mims.com. [Accessed on 17th May 2022] https://www.mims.com/india/drug/info/ampicillin%20+%20sulbactam?type=full&mtype=generic#dosage

USEFUL DIAGNOSTIC TESTS

• Complete blood count
• Peripheral smear examination