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CEFTIN
Overview
What is CEFTIN?
CEFTIN tablets and CEFTIN for oral suspension contain cefuroxime as cefuroxime axetil. CEFTIN is a semisynthetic, cephalosporin antibacterial drug for oral administration.
The chemical name of cefuroxime axetil (1‑(acetyloxy) ethyl ester of cefuroxime) is ()-1-hydroxyethyl (6,7)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 7-()-(-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is CHNOS, and it has a molecular weight of 510.48.
Cefuroxime axetil is in the amorphous form and has the following structural formula:
Tablets are film‑coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate, sodium lauryl sulfate, and titanium dioxide.
Oral suspension, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. Oral suspension contains the inactive ingredients acesulfame potassium, aspartame, povidone K30, stearic acid, sucrose, tutti‑frutti flavoring, and xanthan gum.
What does CEFTIN look like?
What are the available doses of CEFTIN?
CEFTIN tablets are white, capsule‑shaped, film‑coated tablets available in the following strengths:
CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL.
What should I talk to my health care provider before I take CEFTIN?
How should I use CEFTIN?
CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of .
CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of .
Limitations of Use
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What interacts with CEFTIN?
Sorry No Records found
What are the warnings of CEFTIN?
Sorry No Records found
What are the precautions of CEFTIN?
Sorry No Records found
What are the side effects of CEFTIN?
Sorry No records found
What should I look out for while using CEFTIN?
CEFTIN is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to CEFTIN or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
What might happen if I take too much CEFTIN?
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
How should I store and handle CEFTIN?
StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX ES7" on one side and blank on the other side as follows:CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule‑shaped, film‑coated tablets engraved with "GX EG2" on one side and blank on the other side as follows:Store the tablets between 15° and 30°C (59° and 86°F). Replace cap securely after each opening.CEFTIN for oral suspension is provided as dry, white to off‑white, tutti‑frutti–flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:125 mg/5 mL:250 mg/5 mL:Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CEFTIN is an antibacterial drug
Non-Clinical Toxicology
CEFTIN is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to CEFTIN or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).As with all drugs, the potential exists for interaction with other drugs by a variety of mechanisms.
CNS-Active Drugs
Ethanol: Zaleplon 10 mg potentiated the CNS-impairing effects of ethanol 0.75 g/kg on balance testing and reaction time for 1 hour after ethanol administration and on the digit symbol substitution test (DSST), symbol copying test, and the variability component of the divided attention test for 2.5 hours after ethanol administration. The potentiation resulted from a CNS pharmacodynamic interaction; zaleplon did not affect the pharmacokinetics of ethanol.
Imipramine: Coadministration of single doses of zaleplon 20 mg and imipramine 75 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Paroxetine: Coadministration of a single dose of zaleplon 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. Additionally, paroxetine did not alter the pharmacokinetics of zaleplon, reflecting the absence of a role of CYP2D6 in zaleplon 's metabolism.
Thioridazine: Coadministration of single doses of zaleplon 20 mg and thioridazine 50 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Venlafaxine: Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of either zaleplon or venlafaxine. In addition, there was no pharmacodynamic interaction as a result of coadministration of zaleplon and venlafaxine ER.
Promethazine: Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. However, the pharmacodynamics of coadministration of zaleplon and promethazine have not been evaluated. Caution should be exercised when these 2 agents are coadministered.
Drugs That Induce CYP3A4
Rifampin: CYP3A4 is ordinarily a minor metabolizing enzyme of zaleplon. Multiple-dose administration of the potent CYP3A4 inducer rifampin (600 mg every 24 hours, q24h, for 14 days), however, reduced zaleplon C and AUC by approximately 80%. The coadministration of a potent CYP3A4 enzyme inducer, although not posing a safety concern, thus could lead to ineffectiveness of zaleplon. An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital.
Drugs That Inhibit CYP3A4
CYP3A4 is a minor metabolic pathway for the elimination of zaleplon because the sum of desethylzaleplon (formed via CYP3A4 in vitro) and its metabolites, 5-oxo-desethylzaleplon and 5-oxo-desethylzaleplon glucuronide, account for only 9% of the urinary recovery of a zaleplon dose. Coadministration of single, oral doses of zaleplon with erythromycin (10 mg and 800 mg respectively), a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's maximal plasma concentrations and a 20% increase in the area under the plasma concentration-time curve. The magnitude of interaction with multiple doses of erythromycin is unknown. Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon. A routine dosage adjustment of zaleplon is not considered necessary.
Drugs That Inhibit Aldehyde Oxidase
The aldehyde oxidase enzyme system is less well studied than the cytochrome P450 enzyme system.
Diphenhydramine: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug. However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4
Cimetidine: Cimetidine inhibits both aldehyde oxidase (in vitro) and CYP3A4 (in vitro and in vivo), the primary and secondary enzymes, respectively, responsible for zaleplon metabolism. Concomitant administration of zaleplon (10 mg) and cimetidine (800 mg) produced an 85% increase in the mean C and AUC of zaleplon. An initial dose of 5 mg should be given to patients who are concomitantly being treated with cimetidine (see ).
Drugs Highly Bound to Plasma Protein
Zaleplon is not highly bound to plasma proteins (fraction bound 60% 15%); therefore, the disposition of zaleplon is not expected to be sensitive to alterations in protein binding. In addition, administration of zaleplon to a patient taking another drug that is highly protein bound should not cause transient increase in free concentrations of the other drug.
Drugs with a Narrow Therapeutic Index
Digoxin: Zaleplon (10 mg) did not affect the pharmacokinetic or pharmacodynamic profile of digoxin (0.375 mg q24h for 8 days).
Warfarin: Multiple oral doses of zaleplon (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25-mg oral dose of warfarin.
Drugs That Alter Renal Excretion
Ibuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. There was no apparent pharmacokinetic interaction between zaleplon and ibuprofen following single dose administration (10 mg and 600 mg, respectively) of each drug. This was expected because zaleplon is primarily metabolized and renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on β-lactam antibacterials. These reactions are more likely to occur in individuals with a history of β-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. CEFTIN is contraindicated in patients with a known hypersensitivity to CEFTIN or other β-lactam antibacterial drugs . Before initiating therapy with CEFTIN, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue CEFTIN and institute appropriate therapy.
The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label:
Anaphylactic Reactions
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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