ampicillin trihydrate
Pharmaranks rates Ampicillin Trihydrate 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ampicillin Trihydrate (Ampicillin/Ampicillin Trihydrate) is a medication supplied as a capsule.
Ampicillin/Ampicillin Trihydrate · by Aurobindo Pharma Ltd
Generic of Penbritin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ampicillin/Ampicillin Trihydrate
- Form
- Capsule
- Strength
- AMPICILLIN/AMPICILLIN Trihydrate EQ 250MG Base · AMPICILLIN/AMPICILLIN Trihydrate EQ 500MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Aurobindo Pharma Ltd
- FDA application
- ANDA216554
What is Ampicillin Trihydrate?
From the FDA label:To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and other antibacterial drugs, ampicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5 R , 6 R )-6-[( R )-2-Amino-2-phenylacetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid. Its structural formula is: Molecular formula: C 16 H 19 N 3 O 4 S · 3 H 2 O Molecular weight: 403.5 Ampicillin capsules, USP for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin USP. Inactive ingredients: ammonium hydroxide, black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide. Meets USP dissolution test 2. str
How to use
Adults and pediatric patients weighing over 20 kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses. For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended. Physicians are cautioned to use no less than the above recommended dosage for the treatment of gonorrhea. Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy. In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections , the usual dose is 250 mg qid in equally spaced doses. Pediatric patients weighing 20 kg or less: For genitourinary or gastrointestinal tract infections , the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses. For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily. Doses for children should not exceed doses recommended for adults. All Patients, Irrespective of Age and Weight : Larger doses may be required for severe or…
Side effects
As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillin and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin: Infections and Infestations: Clostridioides difficile - associated diarrhea (see WARNINGS section). Gastrointestinal : glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs. Hypersensitivity Reactions : Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, and acute generalized exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics (see WARNINGS ). An erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days. Other hypersensitivity reactions that have been reported are: skin rash,…
Warnings
Important safety information
Severe Cutaneous Adverse Reactions Ampicillin may cause severe cutaneous adverse reactions (SCARs), such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), exfoliative dermatitis, erythema multiforme, and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and ampicillin discontinued if lesions progress. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. Clostridioides difficile -Associated Diarrhea Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ampicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Who should not take Ampicillin Trihydrate
The use of ampicillin is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin or to other beta-lactam antibacterial drugs. Ampicillin is also contraindicated in infections caused by penicillinase-producing organisms. Ampicillin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with ampicillin.
Overdose — what happens if you take too much
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
When administered concurrently, the following drugs may interact with ampicillin. Allopurinol : Substantially increased incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Bacteriostatic Antibiotics : Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented. Oral Contraceptives : May be less effective and increased breakthrough bleeding may occur. Probenecid : May decrease renal tubular secretion of ampicillin resulting in increased blood levels and/or ampicillin toxicity.
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How is Ampicillin Trihydrate rated?
- pharmaranks gives Ampicillin Trihydrate a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ampicillin Trihydrate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ampicillin Trihydrate. To pay less, Ampicillin Trihydrate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ampicillin Trihydrate?
- Ampicillin Trihydrate is marketed by Aurobindo Pharma Ltd. You can see Aurobindo Pharma Ltd's full profile, rating, and other products on pharmaranks.
- Is Ampicillin Trihydrate a brand-name or generic drug?
- Ampicillin Trihydrate is a generic medication; its active ingredient is Ampicillin/Ampicillin Trihydrate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ampicillin Trihydrate available over the counter?
- No. Ampicillin Trihydrate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ampicillin Trihydrate come in?
- Ampicillin Trihydrate is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Ampicillin Trihydrate FDA-registered?
- Ampicillin Trihydrate is on record with the U.S. FDA under application number ANDA216554. You can verify this on its official FDA label.
- Has Ampicillin Trihydrate been recalled by the FDA?
- Ampicillin Trihydrate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ampicillin Trihydrate safe?
- There's no single safe-or-not verdict. pharmaranks gives Ampicillin Trihydrate a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ampicillin Trihydrate?
- Ampicillin Trihydrate's side effects are taken directly from its FDA label. From the label: As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillin and in those with a history of allergy, asthma, hay fever,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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ampicillin trihydrate
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