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Amoxicillin (Amoxil) Drug Side Effects, User Reviews, Drug


Udocheals.orgAmoxicillin
10.17.2017 | Logan Miers
Amoxicillin
Amoxicillin (Amoxil) Drug Side Effects, User Reviews, Drug

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Bristol, TN 37620. Reddy's Laboratories Tennessee,LLC. By: Dr. Manufactured. Revised: Sep 2015.

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus amoxicillin should not be administered to patients with mononucleosis.

home drugs a-z list side effects drug center amoxil (amoxicillin) drug.

AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. influenzae. (α-and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H.

High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis. Renal impairment appears to be reversible with cessation of drug administration.

Tap bottle until all powder flows freely. Add approximay 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. difficile may need to be discontinued.

There are, however, no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). Pregnancy Category B. There was no evidence of harm to the fetus due to amoxicillin. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The 875-mg tablet is scored on the reverse side.

Store at or below 20° C (68° F) -250 mg and 500 mg Capsules and 125 mg and 250 mg unreconstituted powder.

Store at or below 25° C (77° F) -500 mg and 875 mg Tablets and 200 mg and 400 mg unreconstituted powder.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500. Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate.

The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.45.

NDC 50-mL bottle NDC 75-mL bottle NDC 100-mL bottle.

NDC Bottles of 100 NDC Bottles of 20.

These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AMOXIL. In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Please refer to clarithromycin and lansoprazole full prescribing information. The recommended adult oral dose is 1 gram AMOXIL and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

AMOXIL (amoxicillin) Capsules, Tablets, or Powder for Oral Suspension.

Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. Penicillins have been shown to be excreted in human milk.

Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Refrigeration is preferable, but not required.

AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Due to incompley developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided every 12 hours. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. There are currently no dosing recommendations for pediatric patients with impaired renal function. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented.

Capsules : Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. 40, gelatin, magnesium stearate, and titanium dioxide. 28, FD&C Blue No. Inactive ingredients: D&C Red No. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500-mg capsule are imprinted with AMOXIL and 500. 1, FD&C Red No.

NDC Bottles of 100 NDC Bottles of 500.

Call your doctor at once if you have a serious side effect such as:

It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone.

NDC 50-mL bottle NDC 75-mL bottle NDC 100-mL bottle.

Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.

Before initiating therapy with AMOXIL, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.

Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. 500 mg, 875 mg. The 875-mg tablet is scored on the reverse side. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively.

Prescribing AMOXIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Dispense in a tight container.

Long-term studies in animals have not been performed to evaluate carcinogenic potential. AUGMENTIN was negative in the mouse micronucleus test and in the dominant lethal assay in mice. AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximay 2 times the 3 g human dose based on body surface area ). AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN).

These preparations should then be taken immediay. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing.

Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: FD&C Red No. Powder for Oral Suspension : Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium.

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms.

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin1.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Tablets : Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. The 875-mg tablet is scored on the reverse side.

An analysis of clinical studies of AMOXIL was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.

Chemically, it is (2S,5,R,6,R)-6--3,3-dimethyl-7-oxo-4-thia-1-azabicycloheptane-2-carboxylic acid trihydrate. Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. It may be represented structurally as:.

Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX) be used. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST, Benedict' s Solution, or Fehling's Solution.

See Dosing in Renal Impairment for specific recommendations in patients with renal impairment. Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR < 30 mL/min).

In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients.

Included as part of the PRECAUTIONS section.

The oral suspensions of Amoxil do not contain phenylalanine and can be used by phenylketonurics. Amoxil chewable tablets contain aspartame which contains phenylalanine. Each 200 mg chewable tablet contains 1.82 mg phenylalanine; each 400 mg chewable tablet contains 3.64 mg phenylalanine.

Dual therapy : The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.

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Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. 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 use. Hypertoxin-producing strains of C. difficile produces toxins A and B which contribute to the development of CDAD. C.

Powder for Oral Suspension: Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

) Eradication of H. AMOXIL, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. (See the clarithromycin package insert, Microbiology. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

NDC 80-mL bottle NDC 100-mL bottle NDC 150-mL bottle.

NDC 80-mL bottle NDC 100-mL bottle NDC 150-mL bottle.

In some infections, therapy may be required for several weeks. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500. 250 mg, 500 mg. Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial drugs, AMOXIL should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Abnormal prolongation of prothrombin time (increased international normalized ratio ) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

Because of incompley developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger ( ≤ 3 months).

(α-and β-hemolytic isolates only), Staphylococcus spp., or E. coli. AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp.

The most common adverse reactions (> 1%) observed in clinical trials of AMOXIL capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea.

Table 2: Amount of Water for Mixing Oral Suspension Strength Bottle Size Amount of Water Reauired for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AMOXIL, 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gumflavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. pylori. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. AMOXIL, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H.

Triple therapy : The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

The recommended adult oral dose is 1 gram AMOXIL, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

NDC Bottles of 100 NDC Bottles of 500.

AMOXIL may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/ progesterone contraceptives.

The following are discussed in more detail in other sections of the labeling:

NDC Bottles of 100 NDC Bottles of 500.

Amoxicillin