Amp-Sulbacta 1-0.5gm Inj, 1 Vial

Ampicillin is an aminopenicillin that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. Sulbactam is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamases, enzymes produced by bacteria that can hydrolyze and inactivate beta-lactam antibiotics. This protects ampicillin from degradation, extending its spectrum of activity to include many 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.

Antibiotic-Associated Diarrhea

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
Before treating diarrhea, consult with your doctor.

Liver Problems

Rarely, this medication can cause liver problems, which can be fatal. Seek medical attention immediately if you notice any of the following symptoms:
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 any of the following symptoms:
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. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Diarrhea
Pain at the injection site (if administered via muscle injection)

Reporting Side Effects

These are not all the possible side effects that may occur. 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 (turned 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 with your existing health conditions and other medications. Never start, stop, or adjust 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 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, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Methotrexate: Increased methotrexate levels and toxicity due to reduced renal clearance.
• Oral Contraceptives: May reduce efficacy of oral contraceptives (though evidence is limited and controversial, advise backup contraception).

• Allopurinol: Increased incidence of skin rash (especially in hyperuricemic patients).
• Probenecid: Decreases renal tubular secretion of ampicillin and sulbactam, resulting in increased and prolonged serum concentrations of both drugs.
• Anticoagulants (e.g., Warfarin): May alter coagulation parameters (e.g., INR) by affecting gut flora and vitamin K production, or by direct interaction (rare).

• Tetracyclines: May antagonize the bactericidal effect of ampicillin (avoid concomitant use).

• Allergic reactions (rash, pruritus, urticaria, dyspnea, angioedema)
• Gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain)
• Signs of Clostridioides difficile-associated diarrhea (CDAD) (severe, persistent diarrhea, abdominal cramps, fever)
• Injection site reactions (pain, tenderness, induration)
• Neurological symptoms (seizures, especially with high doses in renal impairment)

Category B. Studies in animals have not shown evidence of harm to the fetus. Adequate and well-controlled studies in pregnant women are lacking, but human experience with ampicillin and other penicillins has not shown evidence of adverse effects. Use only if clearly needed.

Both ampicillin and sulbactam are excreted in human milk in low concentrations. Generally considered compatible with breastfeeding (L2). Monitor breastfed infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions (rash).

Dosing must be carefully calculated based on weight and age. Neonates and infants may have immature renal function, requiring careful monitoring and dose adjustment. Safety and efficacy in neonates have not been fully established for all indications.

No specific dose adjustment is typically needed based on age alone, but elderly 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 many beta-lactamase producing strains.
• It is commonly used for polymicrobial infections, such as intra-abdominal infections, gynecological infections, and skin and soft tissue infections.
• Administer IV doses slowly over 15-30 minutes to minimize injection site reactions and potential for seizures with rapid infusion.
• Reconstituted solutions should be used promptly; stability varies by diluent and concentration.
• Patients with a history of penicillin allergy should be carefully assessed; cross-reactivity with cephalosporins is possible but low (approx. 1-5%).
• Monitor for C. difficile-associated diarrhea, which can occur during or even weeks after antibiotic therapy.

• Carbapenems (e.g., Imipenem/Cilastatin, Meropenem, Ertapenem) for broader spectrum or resistant infections
• Cephalosporins (e.g., Cefoxitin, Cefotetan, Ceftriaxone + Metronidazole for anaerobes)
• Fluoroquinolones (e.g., Moxifloxacin, Ciprofloxacin + Metronidazole)
• Metronidazole (for anaerobic coverage when combined with other agents)
• Clindamycin (for anaerobic and some Gram-positive coverage)

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 to do so by a healthcare professional, do not flush medications down the toilet or pour them down the 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it happened, as this will aid in receiving appropriate treatment.