Ampicillin-Sulbactam 15gm Inj, 1vl

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

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 Clostridioides difficile-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 occurred rarely with this medication, and in some cases, 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

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur with this medication. These reactions can affect other 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

Most people do not experience significant side effects, but some may occur. 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 given intramuscularly)

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 you experienced, including any symptoms that occurred.
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 previously experienced liver problems or jaundice (turned yellow) while taking this medication, as this may indicate a sensitivity to the drug.

This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or change the dose 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 your healthcare providers and lab 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, discuss the potential benefits and risks of this medication with your doctor to ensure the best decision for you and your baby.

• Allopurinol (increased incidence of skin rash with ampicillin)
• Probenecid (decreases renal tubular secretion of ampicillin and sulbactam, leading to increased and prolonged plasma concentrations)
• Methotrexate (decreased clearance of methotrexate, potentially leading to increased toxicity)

• Oral Contraceptives (may reduce efficacy of oral contraceptives; advise backup contraception)
• Anticoagulants (e.g., Warfarin; may enhance anticoagulant effect by altering gut flora and reducing vitamin K synthesis)
• Bacteriostatic antibiotics (e.g., tetracyclines, chloramphenicol; may interfere with the bactericidal effect of ampicillin)

• Skin rash (maculopapular rash, urticaria)
• Diarrhea (especially severe or persistent, suggestive of C. difficile-associated diarrhea)
• Nausea/vomiting
• Headache
• Fatigue
• Signs of allergic reaction (hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
• Signs of C. difficile infection (severe watery diarrhea, abdominal cramps, fever)

Ampicillin-sulbactam is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed.

Ampicillin and sulbactam are excreted in small amounts into breast milk. The amount is generally considered too low to cause harm to a nursing infant. It is generally considered compatible with breastfeeding.

Dosing must be carefully calculated based on weight and age, especially in neonates and infants. Renal function should be monitored, as elimination is primarily renal. Safety and efficacy in neonates less than 1 week old have not been established.

Elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Monitor renal function closely. They may also be more susceptible to adverse effects such as C. difficile-associated diarrhea.

• Ampicillin-sulbactam (Unasyn) is a broad-spectrum antibiotic effective against many Gram-positive, Gram-negative, and anaerobic bacteria, particularly those that produce beta-lactamase.
• It is a common choice for polymicrobial infections, such as those found in intra-abdominal or gynecological infections, and for skin and soft tissue infections, including diabetic foot infections.
• Crucial to adjust dosage in patients with renal impairment to prevent accumulation and potential toxicity (e.g., seizures).
• The 15gm vial is a bulk package, typically requiring reconstitution and dilution for multiple doses. Ensure proper aseptic technique for preparation and administration.
• While generally well-tolerated, watch for common side effects like diarrhea and rash. Severe diarrhea should prompt investigation for C. difficile infection.
• Not effective against atypical pathogens (e.g., Mycoplasma, Chlamydia) or MRSA.

• Carbapenems (e.g., Imipenem-cilastatin, Meropenem, Ertapenem) for broader spectrum or more severe infections.
• Cephalosporins (e.g., Cefoxitin, Cefotetan, Ceftriaxone with Metronidazole) depending on the specific pathogen and infection site.
• Fluoroquinolones (e.g., Moxifloxacin, Ciprofloxacin with Metronidazole) for certain intra-abdominal or skin infections.
• Metronidazole (for anaerobic coverage) in combination with other antibiotics.

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. Unless instructed otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper 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 quantity, and the time of ingestion.