Cetirizinhydrochlorid Stada may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizinhydrochlorid Stada in the following countries:
International Drug Name Search
Artexal may be available in the countries listed below.
Tertatolol hydrochloride (a derivative of Tertatolol) is reported as an ingredient of Artexal in the following countries:
International Drug Name Search
Class: Quinolones
VA Class: AM900
Chemical Name: (±-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline- carboxylic acid sesquihydrate
Molecular Formula: C19H22FN3O4
CAS Number: 112811-59-3
Brands: Tequin
Antibacterial; 8-methoxy fluoroquinolone.1 2
Acute bacterial sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae.1 8 12
Acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae, H. parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains).1 8 11 b
Community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains), H. influenzae, H. parainfluenzae, M. catarrhalis, S. aureus, Mycoplasma pneumoniae, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Legionella pneumophila.1 8 13 14 15 b
Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, cellulitis) caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains) or S. pyogenes (group A β-hemolytic streptococci).1 b
Uncomplicated UTIs caused by susceptible Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.1
Complicated UTIs caused by susceptible E. coli, K. pneumoniae, or P. mirabilis.1
Pyelonephritis caused by susceptible E. coli.1 8
Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).c AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,c but a fluoroquinolone (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used.c Consultation with an infectious disease specialist is recommended.c
Uncomplicated urethritis and cervicitis caused by susceptible Neisseria gonorrhoeae.1
Acute, uncomplicated rectal infections caused by susceptible N. gonorrhoeae in women.1
Should not be used for treatment of gonococcal infections acquired in Asia or Pacific islands (including Hawaii); use may be inadvisable in other areas where N. gonorrhoeae with quinolone resistance has been reported (including California).18 20
Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax)† when oral ciprofloxacin and oral doxycycline are unavailable.21
Alternative for treatment of inhalational anthrax† when a parenteral regimen is unavailable (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).21
Alternative for use in multiple-drug regimens for treatment of active tuberculosis† in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.28
Administer orally or by slow IV infusion; not for IM, rapid IV, intrathecal, intraperitoneal, or sub-Q use.1
No dosage adjustment needed when switching from IV to oral administration, or vice versa.1
Administer once daily every 24 hours.1
Administer tablets without regard to meals, including milk or dietary supplements containing calcium.1 (See Interactions: Specific Drugs.)
Gatifloxacin injection concentrate must be diluted prior to administration.1 (See Solution Compatibility under Stability.)
No further dilution necessary for gatifloxacin premixed injection.1
Manufacturer states that additives or other drugs should not be added to gatifloxacin solutions or infused simultaneously through the same IV line1 .
Dilute gatifloxacin injection concentrate to concentration of 2 mg/mL with a compatible IV solution before administration (see Solution Compatibility under Stability).1 Do not use water for injection as a diluent;1 a hypotonic solution results.1
Use strict aseptic technique since drug product contains no preservative.1
Administer by IV infusion over 1 hour.1
400 mg once daily.1 Usual duration is 5 days for acute bacterial exacerbation of chronic bronchitis, 10 days for acute sinusitis, and 7–14 days for CAP.1
400 mg once daily for 7–10 days.1
400 mg as a single dose or 200 mg once daily for 3 days in patients with uncomplicated UTIs; 400 mg once daily for 7–10 days in those with complicated UTIs or pyelonephritis.1
400 mg as a single dose in men with uncomplicated urethral gonorrhea or in women with endocervical or rectal gonorrhea.1
400 mg once daily for ≥60 days for postexposure prophylaxis or treatment of inhalational anthrax.21 22 23
400 mg once daily.28 Must be used in conjunction with other antituberculosis agents.28
Multiple-drug regimen usually given for 12–18 months when rifampin-resistant M. tuberculosis are involved; for 18–24 months when isoniazid- and rifampin-resistant strains are involved; or for 24 months when the strain is resistant to isoniazid, rifampin, ethambutol, and/or pyrazinamide.28
Dosage adjustment not necessary in patients with moderate (Child-Pugh class B) cirrhosis.1
Not studied to date in patients with severe (Child-Pugh class C) impairment;1 manufacturer makes no recommendations regarding dosage in such patients.16
Adjust dosage in patients with Clcr <40 mL/minute, including those who require hemodialysis or CAPD: initial dose of 400 mg, followed by 200 mg daily beginning on day 2 of therapy.1 Administer dose in hemodialysis patients after dialysis session.1
Dosage adjustment not required for single-dose regimen (for uncomplicated UTIs or gonorrhea) or 3-day regimen (for uncomplicated UTIs).1
Renal impairment increases risk of dysglycemia.b (See Hypoglycemia and Hyperglycemia under Cautions.)
Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.b (See Renal Impairment under Dosage and Administration.)
Known hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.1
Diabetes mellitus.b
Symptomatic hypoglycemia or hyperglycemia reported.1 Usually have occurred in patients with diabetes, but blood glucose disturbances (especially hyperglycemia) have occurred in patients without a history of diabetes.1
Serious (sometimes fatal) disturbances of glucose homeostasis (e.g., hyperosmolar nonketotic hyperglycemic coma, diabetic ketoacidosis, hypoglycemic coma, seizures, loss of consciousness) reported rarely during postmarketing surveillance.b
In addition to diabetes, risk factors for dysglycemia during gatifloxacin therapy include advanced age, renal insufficiency, and concurrent use of glucose-altering medication (especially oral hypoglycemic agents).b
Closely monitor blood glucose concentrations in patients with risk factors for developing dysglycemia.1 If signs and symptoms of hypoglycemia or hyperglycemia occur, discontinue gatifloxacin and immediately initiate appropriate therapy.1
Arthropathy and chondrodysplasia in weight-bearing joints of in immature animals reported with fluoroquinolones, including gatifloxacin.1 b Permanent lesions in cartilage reported in immature dogs; clinical relevance to humans unknown.1 Safety and efficacy not established in children and adolescents <18 years of age or in pregnant or lactating women.1
Rupture of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability reported in patients receiving fluoroquinolones, including gatifloxacin.b Tendon rupture can occur during or after treatment; tendinitis or tendon rupture may occur more frequently in those receiving corticosteroids, especially geriatric patients.b
Discontinue gatifloxacin if pain, inflammation, or tendon rupture occurs.b Patient should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture excluded.b
Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including gatifloxacin.1
QT interval prolongation is dose related; do not exceed recommended dosage or infusion rate.b
Increased torsades de pointes risk with advanced age (>60 years of age), female gender, underlying cardiac disease, and/or concurrent use of multiple medications.b
Avoid use in patients with prolonged QTc interval or uncorrected hypokalemia. Also avoid use in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.b Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride,17 erythromycin, antipsychotic agents, tricyclic antidepressants) and in patients with ongoing proarrhythmic conditions, such as clinically important bradycardia or acute myocardial ischemia.1
Seizures, increased intracranial pressure, and psychoses reported with fluoroquinolones, including gatifloxacin.1 CNS stimulation leading to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, nervousness, agitation, or anxiety also reported.1
Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors predisposing to seizures.1
If CNS effects occur, discontinue gatifloxacin and institute appropriate measures.1
Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones.b
Discontinue gatifloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.b
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1
Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones.1 These reactions may occur with first dose.1
Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions.1
In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses.1 These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.1
Discontinue gatifloxacin at first appearance of rash or any other sign of hypersensitivity.1 Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1
Phototoxicity reported with some other quinolones.1 Potential for photosensitivity reaction may be lower with gatifloxacin than with some other fluoroquinolones (e.g., ciprofloxacin, levofloxacin).1
Avoid excessive sunlight or artificial UV light (e.g., tanning beds).1
To reduce development of drug-resistant bacteria and maintain effectiveness of gatifloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.b
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.b In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.b
Category C.1
Distributed into milk in rats.1 Use with caution.1 16
Safety and efficacy not established in children <18 years of age.1
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1
Patients ≥65 years of age with unrecognized diabetes, age-related decreases in renal function, underlying medical problems, or receiving concomitant therapy associated with alterations of blood glucose concentration may be at particular risk for serious dysglycemia.a (See Hypoglycemia and Hyperglycemia under Cautions.)
Age-related decline in renal function may increase risk of adverse reactions.1
Effects of severe hepatic impairment on gatifloxacin pharmacokinetics not determined.1 Use with caution.1
Decreased clearance.1 Dosage adjustment recommended.1 (See Renal Impairment under Dosage and Administration.)
Renal impairment increases risk of dysglycemia.b (See Hypoglycemia and Hyperglycemia under Cautions.)
Nausea, vaginitis, redness at injection site, diarrhea, headache, dizziness.1
Does not inhibit CYP isoenzymes 3A4, 2D6, 2C9, 2C19, or 1A2 in vitro and is not an enzyme inducer.1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.1
Potential pharmacologic interaction (possible additive hypoglycemic or hyperglycemic effect); monitor blood glucose.a (See Hypoglycemia and Hyperglycemia under Cautions.)
Potential pharmacologic interaction (additive effect on QT interval prolongation).1 (See Prolongation of QT Interval under Cautions.)
Drug | Interaction | Comments |
|---|---|---|
Antacids (aluminum- or magnesium-containing) | Decreased absorption of gatifloxacin1 | Administer gatifloxacin at least 4 hours before such antacids1 |
Antacids (calcium-containing); calcium supplements, milk | No clinically important pharmacokinetic interactions 1 | |
Antidiabetic agents (e.g., glyburide) | Hypoglycemia and hyperglycemia reportedb Glyburide: Pharmacokinetic interaction unlikely1 | Closely monitor blood glucose; discontinue gatifloxacin and initiate appropriate therapy if hypoglycemia or hyperglycemia occurs1 |
Didanosine | Decreased absorption of gatifloxacin with buffered didanosine preparations1 16 | Administer gatifloxacin at least 4 hours before buffered didanosine preparations1 16 |
Digoxin | Potential increase in serum digoxin concentration and toxicity1 | Monitor for digoxin toxicity; determine serum digoxin concentrations and adjust digoxin dosage as appropriate1 |
Iron preparations | Decreased absorption of gatifloxacin1 | Administer gatifloxacin at least 4 hours before ferrous sulfate and dietary supplements containing iron1 |
Multivitamins and mineral supplements | Decreased absorption of gatifloxacin1 | Administer gatifloxacin at least 4 hours before supplements containing zinc, magnesium, or iron1 |
NSAIAs | Possible increased risk of CNS stimulation, seizures1 | |
Omeprazole | Pharmacokinetic interaction unlikelyb | |
Probenecid | Increased systemic exposure to gatifloxacin1 | |
Sucralfate | Potential pharmacokinetic interaction16 | |
Warfarin | Potential for enhanced warfarin effect1 16 | Careful monitoring recommended1 |
Well absorbed from the GI tract following oral administration.1 40 Absolute bioavailability is 96%.1 37 41 When administered orally in fasting individuals, peak plasma concentrations usually occur 1–2 hours following a dose.1 b
Pharmacokinetics are similar after oral or IV (1-hour infusion) administration.1 41
Administration with food does not affect peak plasma concentration or extent or rate of absorption.39
Rapidly and widely distributed into most body tissues and fluids.1 37 38 41
Distributed into milk in rats; not known whether distributed into milk in humans.1
Approximately 20%.1 41
Undergoes limited biotransformation.1
Excreted principally in urine as unchanged drug;1 37 38 41 <1% of a dose is excreted in urine as metabolites,1 and 5% is recovered in feces as unchanged drug.1 40
7–14 hours.1 37 40
In patients with moderate to severe renal insufficiency, clearance is decreased and systemic exposure is increased.1
Tightly sealed containers at 25°C (may be exposed to 15–30°C).1
25°C (may be exposed to 15–30°C).1
Following dilution to concentration of 2 mg/mL with compatible IV fluid, solution is stable for 14 days at room temperature (20–25°C) or under refrigeration (2–8°C).1
Following dilution to concentration of 2 mg/mL with compatible IV fluid (except 5% sodium bicarbonate injection), solution may be stored for up to 6 months at -25 to -10°C.1 Thaw at controlled room temperature;1 stable for 14 days at room temperature or under refrigeration after thawing.1 Do not refreeze.1
25°C (may be exposed to 15–30°C);1 do not freeze.1
For information on systemic interactions resulting from concomitant use, see Interactions.
For dilution of gatifloxacin injection concentrate:
Compatible1 g |
|---|
Dextrose 5% in Ringer’s injection, lactated |
Dextrose 5% in sodium chloride 0.45% with potassium chloride 20 mEq/L |
Dextrose 5% in sodium chloride 0.9% |
Dextrose 5% in water |
Plasma-Lyte 56 and dextrose 5% |
Sodium bicarbonate 5% |
Lactated Ringer’s and dextrose 5% |
Sodium bicarbonate 5% |
Sodium chloride 0.9% |
Sodium lactate (1/6)M |
Compatible |
|---|
Acyclovir sodium |
Alfentanil HCl |
Amikacin sulfate |
Aminophylline |
Ampicillin sodium |
Ampicillin sodium-sulbactam sodium |
Aztreonam |
Bretylium tosylate |
Buprenorphine HCl |
Butorphanol tartrate |
Calcium chloride |
Calcium gluconate |
Carboplatin |
Cefazolin sodium |
Cefotetan disodium |
Ceftazidime |
Ceftizoxime sodium |
Ceftriaxone sodium |
Chlorpromazine HCl |
Cimetidine HCl |
Cisplatin |
Clindamycin phosphate |
Co-trimoxazole |
Cyclophosphamide |
Cyclosporine |
Cytarabine |
Dexamethasone sodium phosphate |
Dexmedetomidine HCl |
Digoxin |
Diphenhydramine HCl |
Dobutamine HCl |
Dopamine HCl |
Doxorubicin HCl |
Droperidol |
Enalaprilat |
Esmolol HCl |
Etoposide phosphate |
Famotidine |
Fenoldopam mesylate |
Fentanyl citrate |
Fluconazole |
Fluorouracil |
Ganciclovir sodium |
Gemcitabine HCl |
Gentamicin sulfate |
Granisetron HCl |
Haloperidol lactate |
Hydrocortisone sodium succinate |
Hydromorphone HCl |
Hydroxyzine HCl |
Ifosfamide |
Imipenem-cilastatin sodium |
Labetalol HCl |
Leucovorin calcium |
Lidocaine HCl |
Lorazepam |
Magnesium sulfate |
Mannitol |
Meperidine HCl |
Mesna |
Methotrexate sodium |
Methylprednisolone sodium succinate |
Metoclopramide HCl |
Metronidazole |
Midazolam HCl |
Mitoxantrone HCl |
Morphine sulfate |
Nalbuphine HCl |
Naloxone HCl |
Nicardipine HCl |
Nitroglycerin |
Ondansetron HCl |
Paclitaxel |
Pentamidine isethionate |
Pentobarbital sodium |
Phenobarbital sodium |
Potassium chloride |
Prochlorperazine edisylate |
Promethazine HCl |
Propranolol HCl |
Ranitidine HCl |
Remifentanil HCl |
Sodium bicarbonate |
Sodium phosphates |
Sufentanil citrate |
Theophylline |
Ticarcillin disodium |
Ticarcillin disodium-clavulanate potassium |
Tobramycin sulfate |
Trimethoprim-sulfamethoxazole |
Vecuronium bromide |
Verapamil HCl |
Vinblastine sulfate |
Vincristine sulfate |
Vinorelbine tartrate |
Zidovudine |
Incompatible |
Amphotericin B |
Amphotericin B cholesteryl sulfate complex |
Cefoperazone sodium |
Cefoxitin sodium |
Diazepam |
Furosemide |
Heparin sodium |
Phenytoin sodium |
Piperacillin sodium-tazobactam sodium |
Potassium phosphates |
Vancomycin HCl |
Like other fluoroquinolone antibacterials, gatifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1 2 29
Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative bacteria, a few anaerobic bacteria, and some other organisms (e.g., Mycobacterium, Chlamydia, Mycoplasma).1
More active in vitro than ciprofloxacin or levofloxacin against Streptococcus pneumoniae (including penicillin-resistant strains) and anaerobic bacteria (i.e., Clostridium and Bacteroides),3 6 7 while retaining in vitro activity of ciprofloxacin and levofloxacin against gram-negative organisms3 6 and etiologic agents of atypical pneumonia (e.g., C. pneumoniae, M. pneumoniae, Legionella).3
Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only),1 b S. pneumoniae (including multidrug-resistant strains),1 b and S. pyogenes (group A β-hemolytic streptococci).1 Also active in vitro against some other staphylococci (e.g., S. epidermidis, S. saprophyticus) and some other streptococci (e.g., S. agalactiae [group B streptococci], S. pneumoniae [penicillin-resistant strains], viridans streptococci).1
Gram-negative aerobes: Active in vitro and in clinical infections against E. coli,1 H. influenzae,1 H. parainfluenzae,1 K. pneumoniae,1 M. catarrhalis,1 N. gonorrhoeae,1 and P. mirabilis.1 Also active in vitro against some strains of Acinetobacter, Citrobacter, Enterobacter, K. oxytoca, Morganella, and P. vulgaris.1
Other organisms: Active in vitro and in clinical infections against Chlamydophila pneumonia (formerly Chlamydia pneumoniae),1 L. pneumophila,1 M. pneumoniae,1 and M. tuberculosis.30 32
Advise patients that antibacterials (including gatifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).b
Importance of completing full course of therapy, even if feeling better after a few days.b
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with gatifloxacin or other antibacterials in the future.b
Importance of taking gatifloxacin at least 4 hours before multivitamins containing iron, magnesium, or zinc; aluminum- or magnesium-containing antacids; or didanosine chewable/dispersible buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution prepared as an admixture with antacid.1 16
Importance of notifying clinician of persistent or worsening symptoms of infection.1
Potential for gatifloxacin to impair mental alertness or physical coordination; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.1 16
Potential for gatifloxacin to cause other CNS effects, including confusion, tremor, hallucinations, and depression.b
Importance of informing clinician if medical history includes palpitations, convulsions, or fainting spells or if any of these events occur during therapy.1
Importance of discontinuing therapy and of informing clinician if an allergic or hypersensitivity reaction occurs.1
Potential for hypoglycemia or hyperglycemia, usually in patients with diabetes or in patients at risk for dysglycemia, but also in those without diabetes.b Importance of monitoring blood sugar concentrations.b Importance of initiating appropriate therapy immediately, discontinuing gatifloxacin, and contacting clinician if symptoms of high or low blood sugar occur.b (See Hypoglyecemia and Hyperglycemia under Cautions.)
Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia).1 b
Importance of discontinuing therapy and consulting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) develop.b
Advise patients of risk of adverse musculoskeletal effects and importance of discontinuing gatifloxacin, resting, refraining from exercise, and consulting clinician if pain, inflammation, or rupture of a tendon occurs.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially drugs that may affect the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants), antiarrhythmic agents (e.g., amiodarone, quinidine, procainamide, sotalol), diuretics (e.g., furosemide, hydrochlorothiazide), or drugs that may affect blood sugar concentrations.1 b
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 200 mg | Tequin | Bristol-Myers Squibb |
400 mg | Tequin | Bristol-Myers Squibb | ||
Parenteral | For injection concentrate, for IV infusion | 10 mg/mL (400 mg) | Tequin Injection | Bristol-Myers Squibb |
Injection, for IV infusion | 2 mg/mL (200 and 400 mg) in 5% dextrose | Tequin Injection Premixed (in flexible containers) | Bristol-Myers Squibb |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2010, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Bristol-Myers Squibb Company. Tequin (gatifloxacin) tablets and injection prescribing information. Princeton, NJ; 2002 Dec.
2. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]
3. Blondeau JM. Expanded activity and utility of the new fluoroquinolones: a review. Clin Ther. 1999; 21:3-40. [IDIS 424194] [PubMed 10090423]
4. Nakashima M, Uematsu T, Kosuge K et al. Single- and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob Agents Chemother. 1995; 39:2635-40. [IDIS 358702] [PubMed 8592993]
5. Lober S, Ziege S, Rau M et al. Pharmacokinetics of gatifloxacin and interaction with an antacid containing aluminum and magnesium. Antimicrob Agents Chemother. 1999; 43:1067-71. [IDIS 426804] [PubMed 10223915]
6. Bauernfeind A. Comparison of the antibacterial activities of the quinolones Bay 12-8039, gatifloxacin (AM-1155), trovafloxacin, clinafloxacin, levofloxacin and ciprofloxacin. J Antimicrob Chemother. 1997; 40:639-51. [IDIS 398240] [PubMed 9421311]
7. Blondeau JM. A review of the comparative in-vitro activities of 12 antimicrobial agents, with a focus on five new ’respiratory quinolones’. J Antimicrob Chemother. 1999; 43(Suppl):1B-11B.
8. Perry CM, Barman Balfour JA, Lamb HM. Gatifloxacin. Drugs. 1999; 58:683-96. [PubMed 10551438]
9. Bayer Corporation. Avelox (moxifloxacin) tablets and I.V. prescribing information. West Haven, CT; 2003 Mar.
10. Andriole VT. The future of the quinolones. Drugs. 1999; 58(Suppl 2): 1-5. [PubMed 10553697]
11. DeAbate CA, McIvor RA, Di Bartolo C et al. Gatifloxacin vs. cefuroxime axetil in patients with acute exacerbations of chronic bronchitis. J Respir Dis. 1999; 20(Suppl 11A):23-9.
12. Fogarty C, McAdoo M, Paster RZ et al. Gatifloxacin vs. clarithromycin in the management of acute sinusitis. J Respir Dis. 1999; 20(Suppl 11A):17-22.
13. Fogarty C, Powell ME, Ellison T et al. Treating community-acquired pneumonia in hospitalized patients: gatifloxacin vs. ceftriaxone/clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):60-9.
14. Ramirez J, Nguyen TH, Tellier G et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. twice-daily clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):40-8.
15. Sullivan JG, McElroy AD, Hunsinger RW et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. once-daily levofloxacin. J Respir Dis. 1999; 20(Suppl 11A):49-59.
16. Manufacturer’s comments (personal observations).
17. US Food and Drug Administration. Janssen Pharmaceutica stops marketing cisapride in the U.S. FDA Talk Paper. Rockville, MD; 2000 March 23.
18. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.
19. Centers for Disease Control and Prevention. Decreased susceptibility of Neisseria gonorrhoeae to fluoroquinolones—Ohio and Hawaii, 1992–1994. MMWR Morb Mortal Wkly Rep. 1994; 43:325-7. [IDIS 329259] [PubMed 8164636]
20. Centers for Disease Control and Prevention. Fluoroquinolone-resistance in Neisseria gonorrhoeae, Hawaii, 1999, and decreased susceptibility to azithromycin in N. gonorrhoeae, Missouri, 1999. MMWR Morb Mortal Wkly Rep. 2000; 49:833-7. [IDIS 453336] [PubMed 11012233]
21. Inglesby TV, O’Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002; 287:2236-52. [IDIS 480001] [PubMed 11980524]
22. Centers for Disease Control and Prevention. Update: investigation of anthrax associated with intentional exposure and interim public health guidelines, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:889-93. [IDIS 471389] [PubMed 11686472]
23. Centers for Disease Control and Prevention. Update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:909-19. [IDIS 471910] [PubMed 11699843]
24. Bartlett JG, Dowell SF, Mandell LA et al. Practice guidelines for the management of community-acquired pneumonia in adult. Clin Infect Dis. 2000; 31:347-82. [IDIS 454042] [PubMed 10987697]
25. Heffelfinger JD, Dowell SF, Jorgensen JH et al. Management of community-acquired pneumonia in the era of pneumococcal resistance: a report from the drug-resistance streptococcus pneumoniae therapeutic working group. Arch Intern Med. 2000; 160:1399-1408. [IDIS 448719] [PubMed 10826451]
26. American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Resp Crit Care Med. 2001; 163:1730-54. [IDI
Domperin may be available in the countries listed below.
Domperidone is reported as an ingredient of Domperin in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
0074176-31-1
C24-H38-O5
406
Prostaglandin analogue
5-Heptenoic acid, 7-[2-(5-cyclohexyl-3-hydroxy-1-pentynyl)-3,5-dihydroxycyclopentyl]-, methyl ester, [1R-[1α(Z),2ß(S*),3α,5α]]-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Relieving pressure, bloating, and gas in the digestive tract. It may also be used for other conditions as determined by your doctor.
Gas-X Chewable Tablets are an antiflatulent. It works by breaking up gas bubbles, which makes gas easier to eliminate.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Gas-X Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Gas-X Chewable Tablets. However, no specific interactions with Gas-X Chewable Tablets are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gas-X Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Gas-X Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Gas-X Chewable Tablets.
All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Gas-X side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Gas-X Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Avoid temperatures above 104 degrees F (40 degrees C). Keep Gas-X Chewable Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Gas-X Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Anksen may be available in the countries listed below.
Dipotassium Clorazepate is reported as an ingredient of Anksen in the following countries:
International Drug Name Search
Treating mastocytosis, including improvement of symptoms such as diarrhea, flushing, headaches, vomiting, hives, stomach pain, nausea, and itching in some patients. It may also be used for other conditions as determined by your doctor.
Gastrocrom Concentrate is a mast cell stabilizer. It works by preventing the mast cells of the body from releasing substances that cause symptoms of mastocytosis.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Gastrocrom Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Gastrocrom Concentrate. However, no specific interactions with Gastrocrom Concentrate are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gastrocrom Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Gastrocrom Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Gastrocrom Concentrate.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; nausea.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; hoarseness; mental or mood changes; seizures.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Gastrocrom side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Gastrocrom Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store ampules in pouch until ready to use. Keep Gastrocrom Concentrate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Gastrocrom Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Penicillin-V-Wolff may be available in the countries listed below.
Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penicillin-V-Wolff in the following countries:
International Drug Name Search
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.
Gentamicin Sulfate Ophthalmic Ointment USP is a sterile ointment for topical ophthalmic use. Each gram contains gentamicin sulfate (equivalent to 3 mg gentamicin) in a base of white petrolatum and mineral oil.
Gentamicin is obtained from cultures of Micromonospora purpurea. Gentamicin sulfate is a mixture of the sulfate salts of gentamicin C1, C2 and C1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:
Microbiology: Gentamicin sulfate is active in vitro against many strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis,
Streptococcus pyogenes, Streptococcus pneumoniae,
Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae,
Klebsiella pneumoniae, Neisseria gonorrhoeae,
Pseudomonas aeruginosa, and Serratia marcescens.
GARAMYCIN Ophthalmic Ointment is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
GARAMYCIN Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of the components.
NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Ointment is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Prolonged use of topical antibiotics may give rise to overgrowth of non-susceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.
If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation, and appropriate therapy should be instituted.
Ophthalmic ointments may retard corneal healing.
To avoid contamination, do not touch tip of container to the eye, eyelid, or any surface.
There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
Teratogenic effects - Pregnancy Category C. Gentamicin has been shown to depress body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness in neonates have not been established.
Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.
The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects, and conjunctival hyperemia.
Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura, and hallucinations.
To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday - Friday 9am-5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Apply a small amount (about 1/2 inch) to the affected eye(s) two to three times a day.
GARAMYCIN Ophthalmic Ointment (equivalent to 3 mg gentamicin) is supplied as follows:
NDC 48102-009-35 3.5 gram tubes
Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF)
[see USP Controlled Room Temperature].
GARAMYCIN is a Trademark of Fera Pharmaceuticals, LLC.
Mfd. for:
Fera Pharmaceuticals, LLC
Locust Valley, NY 11560
STERILE Rx only
GaramycinTM
brand of
GENTAMICIN
SULFATE
OPHTHALMIC
OINTMENT, USP
Gentamicin Sulfate,
USP equivalent to 3 mg
NDC 48102-009-35
STERILE Rx only
GaramycinTM
brand of
GENTAMICIN
SULFATE
OPHTHALMIC
OINTMENT, USP
Gentamicin Sulfate,
USP equivalent to 3 mg
gentamicin per gram.
Each gram contains:
Gentamicin sulfate,
USP equivalent to 3 mg
gentamicin base, in a
base of white petrolatum
and mineral oil.
Net Wt. 3.5 g (1/8 Oz)
| GARAMYCIN gentamicin sulfate ointment | ||||||||||||||||||||
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA065024 | 10/08/2010 | |
| Labeler - Fera Pharmaceuticals, LLC (831023713) |
| Registrant - Fera Pharmaceuticals, LLC (831023713) |
ga-ni-REL-ix
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Luteinizing Hormone Releasing Hormone Antagonist
Ganirelixis used as a fertility medicine to prevent premature luteinizing hormone (LH) surges in women undergoing the fertility procedure of controlled ovarian hyperstimulation. LH is involved in ovulation, which is the development of eggs in the ovaries. Ganirelix may help reduce the need for follicle-stimulating hormone (FSH) , which is also involved in ovulation.
Ganirelix is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ganirelix, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to ganirelix or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of ganirelix. Make sure you tell your doctor if you have any other medical problems.
To make using ganirelix as safe and reliable as possible, you should understand how and when to use ganirelix and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of ganirelix. Read this paper carefully and ask your health care professional for any additional information or explanation.
Sometimes ganirelix can be given by injection at home. If you are using ganirelix at home:
The dose of ganirelix will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ganirelix. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.
If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.
If severe abdominal pain occurs with use of ganirelix, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Stop taking ganirelix and get emergency help immediately if any of the following effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: ganirelix Subcutaneous side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Gainpro 10
Type A
Medicated Article
PERMITTED CLAIMS AND LIMITATIONS
Cattle Fed in Bambermycins 10 to 20 Increased rate None
Confinement for mg/hd/day** of weight gain,
Slaughter* improved feed
efficiency
Pasture Bambermycins 10 to 40 Increased rate None
Cattle* mg/hd/day*** of weight gain
*Only a single level of bambermycins (i.e. 2 grams bambermycins/ton) can be
indicated on a feed tag. A different feed tag must be submitted for each level of
bambermycins needed for your complete feeding program.
CATTLE FED IN CONFINEMENT FOR SLAUGHTER:
**THE APPROVED DOSAGE IN CATTLE FED IN CONFINEMENT FOR SLAUGHTER IS 10
TO 20 MG OF BAMBERMYCINS/HD/DAY. The amount of bambermycins will range between
1 and 4 grams per ton of feed depending upon the daily feed consumption of the cattle fed in
confinement for slaughter. The amount of Type A Medicated Article added to the complete
ration (Type C Medicated Feed) must be based on daily feed consumption, the number of
animals in the pen and the level (10-20 mg/hd/day) of bambermycins being fed. From this
information the grams of bambermycins per ton of feed can be calculated in order to fulfill
feed assay requirements. No Type C Medicated Feed should be manufactured with less than
1 g bambermycins/ton. Feed assays for bambermycins with expected levels below 1 g/t may
not be accurate. See the following table for conversions from mg/hd/day to g/t.
Bag Label Image
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA141034 | 06/29/2009 | |
| Labeler - Huvepharma, Inc. (619153559) |
| Registrant - Huvepharma AD (552691651) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Huvepharma, Inc. | 619153559 | manufacture, analysis, label, pack | |
