Ampicillin-Sulbact 3gm Inj, 1 Vial

Ampicillin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis. Sulbactam is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamases, protecting ampicillin from hydrolysis and extending its spectrum of activity against beta-lactamase-producing strains.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
In rare cases, allergic reactions can be fatal.

Diarrhea and Bowel Problems

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur. This condition can lead to life-threatening bowel problems. If you experience any of the following symptoms, contact your doctor right away:
Stomach pain
Cramps
Very loose, watery, or bloody stools
Do not treat diarrhea without consulting your doctor first.

Liver Problems

Liver problems have been reported in rare cases, and in some instances, they have been fatal. If you notice any of the following symptoms, contact your doctor immediately:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can affect body organs and be life-threatening. Seek medical help right away if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
* Pain at the injection site (if administered via muscle injection)

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin, as this may impact your ability to take this medication safely.
If you have been diagnosed with mononucleosis (mono), as this condition may affect how your body responds to the medication.
If you have experienced liver problems or jaundice (turning yellow) while taking this medication in the past, as this may indicate a sensitivity to the drug.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking it.

If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the results.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best outcome for both you and your baby.

• Allopurinol (increased risk of rash)
• Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
• Probenecid (decreases renal tubular secretion of ampicillin and sulbactam, increasing and prolonging plasma concentrations)
• Oral Contraceptives (may decrease efficacy of oral contraceptives)

• Anticoagulants (e.g., Warfarin - may alter INR due to effects on gut flora and vitamin K synthesis)
• Tetracyclines (may antagonize the bactericidal effect of penicillins)

• Signs of allergic reaction (rash, pruritus, urticaria, dyspnea, angioedema)
• Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
• Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
• Neurological symptoms (e.g., seizures, especially with high doses in renal impairment)
• Unusual bleeding or bruising (rare, related to coagulation effects)

Ampicillin-sulbactam is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Both ampicillin and sulbactam are excreted into breast milk in small amounts. The American Academy of Pediatrics considers ampicillin compatible with breastfeeding. Sulbactam is also considered compatible. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (rash).

Ampicillin-sulbactam is safe and effective for use in pediatric patients for appropriate indications. Dosing is weight-based and adjusted for age. Neonatal dosing requires careful consideration due to immature renal function.

No specific dose adjustment is required based on age alone. However, geriatric patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor for adverse effects and superinfections.

• Ampicillin-sulbactam is a broad-spectrum antibiotic effective against many Gram-positive, Gram-negative, and anaerobic bacteria, including those that produce beta-lactamase.
• Commonly used for skin and soft tissue infections, intra-abdominal infections, gynecological infections, and community-acquired pneumonia.
• It is NOT effective against MRSA (Methicillin-resistant Staphylococcus aureus) or Pseudomonas aeruginosa.
• Risk of Clostridioides difficile-associated diarrhea (CDAD) is a significant concern with broad-spectrum antibiotics like ampicillin-sulbactam.
• Administer IV slowly over 15-30 minutes or IM deeply into a large muscle mass.
• Reconstituted solutions have limited stability; follow manufacturer's guidelines for storage and use.

• Carbapenems (e.g., Imipenem/cilastatin, Meropenem, Ertapenem) for broader spectrum or more severe infections.
• Certain Cephalosporins (e.g., Cefoxitin, Ceftriaxone, Cefotaxime) depending on the specific pathogen and site of infection.
• Fluoroquinolones (e.g., Moxifloxacin, Levofloxacin) for specific indications, but resistance is a growing concern.
• Metronidazole (for anaerobic coverage, often combined with other agents).

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.