Uro Hubber

Erythromycin Estolate:

• Pharmacological action
• Pharmacokinetics
• Why is Uro Hubber prescribed?
• Dosage and administration
• Uro Hubber (Erythromycin Estolate) side effects, adverse reactions
• Uro Hubber contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Precautionary measures
• Uro Hubber drug interactions
• Uro Hubber in case of emergency / overdose
• Uro Hubber (Erythromycin Estolate) reviews

Pharmacological action

Uro Hubber is a macrolide antibiotic. Has bacteriostatic action. However at higher doses against susceptible organisms has a bactericidal effect. erythromycin is reversibly bound to the ribosome of bacteria, thereby inhibiting protein synthesis. Uro Hubber (Erythromycin Estolate) is active against gram-positive bacteria: Staphylococcus spp. (strains producing and not producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae); gram-negative bacteria: Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., Bacillus anthracis, Corynebacterium diphtheriae; anaerobic bacteria: Clostridium spp. erythromycin is also active against Mycoplasma spp., Chlamydia spp., Spirochaetaceae, Rickettsia spp. To erythromycin resistant gram-negative bacilli, including Escherichia coli, Pseudomonas aeruginosa, Shigella spp., Salmonella spp.

Pharmacokinetics

Uro Hubber (Erythromycin Estolate) bioavailability is 30-65%. Distributed in most tissues and body fluids. Plasma protein binding is 70-90%. Metabolised in the liver, partly with the formation of inactive metabolites. T1/2 is 1.4-2 hours. It is derived from bile and urine.

Why is Uro Hubber prescribed?

Infectious-inflammatory diseases caused by microorganisms sensitive to erythromycin, including diphtheria, pertussis, trachoma, brucellosis, a disease Legionnaires, sore throat, scarlet fever, otitis media, sinusitis, cholecystitis, pneumonia, gonorrhea, syphilis. Also Uro Hubber (Erythromycin Estolate) used for the treatment of infectious-inflammatory diseases caused by pathogens (eg staphylococci) are resistant to penicillin, tetracycline, chloramphenicol, streptomycin.

For external use: acne vulgaris.

For local use: the infectious-inflammatory diseases of eyes.

Dosage and administration

Uro Hubber prescribed individually depending on the location and severity of infection, the sensitivity of the parasite. In adults use a daily dose of 1-4 g. Children under the age of 3 months - 20-40 mg / kg / day, aged from 4 months to 18 years - 30-50 mg / kg / day. Multiplicity is 4 times / day. The treatment course - 5-14 days after the disappearance of symptoms treatment should be continued for a further 2 days. Accepts up to 1 hour before eating or 2-3 hours after eating.

Solution for external applications lubricate the affected skin.

The ointment is applied to the affected area and in diseases of the eye lay behind the lower eyelid. The dose, frequency and duration of application is determined individually.

Uro Hubber (Erythromycin Estolate) side effects, adverse reactions

Digestive system: nausea, vomiting, epigastric pain, cholestatic jaundice, tenesmus, diarrhea, dysbacteriosis; rarely - pseudomembranous enterocolitis, abnormal liver function, increase in liver transaminases, pancreatitis.

Allergic reactions: skin rash, urticaria, eosinophilia, rarely - anaphylactic shock.

Effects due to the influence of chemotherapy: oral candidiasis, vaginal candidiasis.

From the senses: the reversible ototoxicity - hearing loss and / or tinnitus (in the application of high doses - more than 4 g / day).

Since the cardiovascular system: rarely - tachycardia, prolongation of the QT interval on ECG, flickering and / or atrial flutter (patients with long QT interval on the ECG).

Local reactions: phlebitis at the site of / in the introduction.

Uro Hubber contraindications

Jaundice in history, marked disturbances of liver function, hypersensitivity to macrolides.

Using during pregnancy and breastfeeding

Erythromycin crosses the placental barrier, excreted in breast milk.

In the application of erythromycin in pregnancy should assess the intended benefits to the mother and the potential risk to the fetus. If necessary, use during lactation should decide on the termination of breastfeeding.

Special instructions

With careful use Uro Hubber when disorders of liver function and / or kidneys. Medications that increase the acidity of gastric juice and acidic drinks inactivate erythromycin. erythromycin can not drink milk and dairy products.

Precautionary measures

The use of erythromycin containing benzene for IV injection sometimes accompanied by the development of a fatal syndrome Gaspinga in children, as well as acute hepatitis drug in adults and children.

Uro Hubber drug interactions

With simultaneous use of Uro Hubber (Erythromycin Estolate) with theophylline, aminophylline, caffeine, there is an increase in their concentration in blood plasma and thus increases the risk of toxic effects.

Erythromycin increases the concentrations of cyclosporine in the blood plasma and may increase the risk of nephrotoxicity.

Drugs that block tubular secretion prolongs T1/2 of erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

Uro Hubber (Erythromycin Estolate) reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

With simultaneous use of erythromycin increases the concentration of theophylline.

At the same time receiving chemotherapy, which is carried metabolism in the liver (carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, dizopiramid, lovastatin, bromocriptine), may increase the concentration of these drugs in plasma (an inhibitor of microsomal liver enzymes).

IV injection of erythromycin increases the effects of ethanol (accelerating gastric emptying and decrease the duration of alcohol dehydrogenase in the gastric mucosa).

Erythromycin reduces the clearance of triazolam and midazolam and therefore may increase the pharmacological effects of benzodiazepines.

At the same time taking with terfenadine or astemizole may develop arrhythmias (fibrillation and ventricular flutter, ventricular tachycardia, until death); with dihydroergotamine or non hydrated ergot alkaloids may vasoconstriction to spasm, dysesthesia.

With simultaneous application Uro Hubber (Erythromycin Estolate) slows elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of cumarine series.

In a joint appointment with lovastatin increased rhabdomyolysis.

Erythromycin increases the bioavailability of digoxin.

Erythromycin reduces the effectiveness of hormonal contraceptives.

Uro Hubber in case of emergency / overdose

Symptoms: disruption of the liver until the acute liver failure, and hearing loss.

Treatment: gastric lavage, forced diuresis, hemo-and peritoneal dialysis. Produced a constant monitoring of vital functions (ECG, electrolyte composition of blood).

Nitrofurantoin:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Storage
• References
• Uro Hubber (Nitrofurantoin) reviews

INDICATIONS AND USAGE

Uro Hubber (Nitrofurantoin) macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Uro Hubber (Nitrofurantoin) is not indicated for the treatment of pyelonephritis or perinephric abscesses.

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

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Uro Hubber (Nitrofurantoin) macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Uro Hubber (Nitrofurantoin) macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Uro Hubber (Nitrofurantoin) macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

CONTRAINDICATIONS

Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug.

Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks’ gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age.

Uro Hubber (Nitrofurantoin) macrocrystals is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Uro Hubber (Nitrofurantoin).

Uro Hubber (Nitrofurantoin) macrocrystals is also contraindicated in those patients with known hypersensitivity to Uro Hubber (Nitrofurantoin).

WARNINGS

Pulmonary Reactions

ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH Uro Hubber. IF THESE REACTIONS OCCUR, Uro Hubber (Nitrofurantoin) MACROCRYSTALS SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH.

CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS.

Hepatotoxicity

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken.

Neuropathy

Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment, anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy. Patients receiving long-term therapy should be monitored periodically for changes in renal function.

Optic neuritis has been reported rarely in postmarketing experience with Uro Hubber (Nitrofurantoin) formulations.

Hemolytic Anemia

Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by Uro Hubber (Nitrofurantoin). Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin. Hemolysis is an indication for discontinuing Uro Hubber (Nitrofurantoin) macrocrystals; hemolysis ceases when the drug is withdrawn.

Clostridium difficile-associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Uro Hubber (Nitrofurantoin), 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

Information for Patients

Patients should be advised to take Uro Hubber macrocrystals with food to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course of therapy; however, they should be advised to contact their physician if any unusual symptoms occur during therapy.

Many patients who cannot tolerate microcrystalline Uro Hubber (Nitrofurantoin) are able to take Uro Hubber (Nitrofurantoin) macrocrystals without nausea.

Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking Uro Hubber (Nitrofurantoin) macrocrystals.

Patients should be counseled that antibacterial drugs including Uro Hubber (Nitrofurantoin) macrocrystals should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Uro Hubber (Nitrofurantoin) macrocrystals is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Uro Hubber (Nitrofurantoin) macrocrystals or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

General

Prescribing Uro Hubber (Nitrofurantoin) macrocrystals in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions

Antacids containing magnesium trisilicate, when administered concomitantly with Uro Hubber, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of Uro Hubber (Nitrofurantoin) onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of Uro Hubber (Nitrofurantoin). The resulting increase in Uro Hubber (Nitrofurantoin) serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Drug/Laboratory Test Interactions

As a result of the presence of Uro Hubber (Nitrofurantoin), a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions but not with the glucose enzymatic test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Uro Hubber was not carcinogenic when fed to female Holtzman rats for 44.5 weeks or to female Sprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing male and female Sprague-Dawley rats and two chronic bioassays in Swiss mice and in BDF₁ mice revealed no evidence of carcinogenicity.

Uro Hubber (Nitrofurantoin) presented evidence of carcinogenic activity in female B6C3F₁ mice as shown by increased incidences of tubular adenomas, benign mixed tumors, and granulosa cell tumors of the ovary. In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms, osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one study involving subcutaneous administration of 75 mg/kg Uro Hubber (Nitrofurantoin) to pregnant female mice, lung papillary adenomas of unknown significance were observed in the F1 generation.

Uro Hubber (Nitrofurantoin) has been shown to induce point mutations in certain strains of Salmonella typhimurium and forward mutations in L5178Y mouse lymphoma cells. Uro Hubber (Nitrofurantoin) induced increased numbers of sister chromatid exchanges and chromosomal aberrations in Chinese hamster ovary cells but not in human cells in culture. Results of the sex-linked recessive lethal assay in Drosophila were negative after administration of Uro Hubber (Nitrofurantoin) by feeding or by injection. Uro Hubber (Nitrofurantoin) did not induce heritable mutation in the rodent models examined.

The significance of the carcinogenicity and mutagenicity findings relative to the therapeutic use of Uro Hubber (Nitrofurantoin) in humans is unknown.

The administration of high doses of Uro Hubber (Nitrofurantoin) to rats causes temporary spermatogenic arrest; this is reversible on discontinuing the drug. Doses of 10 mg/kg/day or greater in healthy human males may, in certain unpredictable instances, produce a slight to moderate spermatogenic arrest with a decrease in sperm count.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Several reproduction studies have been performed in rabbits and rats at doses up to six times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Uro Hubber. In a single published study conducted in mice at 68 times the human dose (based on mg/kg administered to the dam), growth retardation and a low incidence of minor and common malformations were observed. However, at 25 times the human dose, fetal malformations were not observed; the relevance of these findings to humans is uncertain. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-Teratogenic Effects

Uro Hubber (Nitrofurantoin) has been shown in one published transplacental carcinogenicity study to induce lung papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The relationship of this finding to potential human carcinogenesis is presently unknown. Because of the uncertainty regarding the human implications of these animal data, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

See CONTRAINDICATIONS.

Nursing Mothers

Uro Hubber has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Uro Hubber (Nitrofurantoin) in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see CONTRAINDICATIONS).

Pediatric Use

Uro Hubber (Nitrofurantoin) macrocrystals is contraindicated in infants below the age of one month (see CONTRAINDICATIONS).

Geriatric Use

Clinical studies of Uro Hubber (Nitrofurantoin) macrocrystals did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Spontaneous reports suggest a higher proportion of pulmonary reactions, including fatalities, in elderly patients; these differences appear to be related to the higher proportion of elderly patients receiving long-term Uro Hubber (Nitrofurantoin) therapy. As in younger patients, chronic pulmonary reactions generally are observed in patients receiving therapy for six months or longer (see WARNINGS). Spontaneous reports also suggest an increased proportion of severe hepatic reactions, including fatalities, in elderly patients (see WARNINGS).

In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy should be considered when prescribing Uro Hubber (Nitrofurantoin) macrocrystals. 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. Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications (see C ONTRAINDICATIONS). 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.

ADVERSE REACTIONS

Respiratory

CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR.

CHRONIC PULMONARY REACTIONS OCCUR GENERALLY IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE, DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY REACTION. FEVER IS RARELY PROMINENT.

THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY, EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY.

In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and Uro Hubber therapy is not stopped, the symptoms may become more severe.

Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea, pulmonary infiltration with consolidation or pleural effusion on x-ray, and eosinophilia. Acute reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution often is dramatic (see WARNINGS).

Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in association with pulmonary reactions.

Cyanosis has been reported rarely.

Hepatic

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely (see WARNINGS).

Neurologic

Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been reported. Conditions such as renal impairment, anemia, diabetes mellitus, electrolyte imbalance, Vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy (see WARNINGS).

Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness also have been reported with the use of Uro Hubber (Nitrofurantoin).

Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.

Dermatologic

Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been reported rarely. Transient alopecia also has been reported.

Allergic

A lupus-like syndrome associated with pulmonary reactions to Uro Hubber has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; and chills have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with Uro Hubber (Nitrofurantoin) formulations.

Gastrointestinal

Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. There have been sporadic reports of pseudomembranous colitis with the use of Uro Hubber (Nitrofurantoin). The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment (see WARNINGS).

Hematologic

Cyanosis secondary to methemoglobinemia has been reported rarely.

Miscellaneous

As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas species or Candida species, can occur.

Laboratory Adverse Events

The following laboratory adverse events have been reported with the use of Uro Hubber (Nitrofurantoin): increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see WARNINGS), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely.

OVERDOSAGE

Occasional incidents of acute overdosage of Uro Hubber (Nitrofurantoin) macrocrystals have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. It is dialyzable.

DOSAGE AND ADMINISTRATION

Uro Hubber macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.

Adults

50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients

5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

HOW SUPPLIED

Uro Hubber (Nitrofurantoin) Macrocrystals Capsules USP are available as pink opaque/white opaque capsules, imprinted with

, “Zenith 50 mg” on the cap and “2130”, underlined with a double bar, on the body, in black ink, containing 50 mg Uro Hubber (Nitrofurantoin) macrocrystals, packaged in bottles of 100 and 1000 capsules and unit-dose boxes of 100 capsules.

Uro Hubber (Nitrofurantoin) Macrocrystals Capsules USP are available as pink opaque capsules, imprinted with

, “Zenith 100 mg” on the cap and “2131”, underlined with a triple bar, on the body, in black ink, containing 100 mg Uro Hubber (Nitrofurantoin) macrocrystals, packaged in bottles of 100 and 1000 capsules and unit-dose boxes of 100 capsules.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

STORAGE

Store at 20° to 25°C (68° to 77°F).

REFERENCES

1.) Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Eighth Edition. CLSI document M07-A8 [ISBN 1-56238-689-1]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.

2.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Tenth Edition. CLSI document M02-A 10 [ISBN 1-56238-688-3]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.

3.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement. CLSI document M100-S19 [ISBN 1-56238-716-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010.

To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at tel: 1-888-838-2872, x6351 or drug.safetyUro Hubber (Nitrofurantoin)tevausa.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. E 6/2011

Uro Hubber (Nitrofurantoin) Macro. 50mg Cap

Uro Hubber (Nitrofurantoin) Structural Formula Imprinted logo Imprinted logo

Tetracycline Hydrochloride:

• Activer ingredient (in each gram)
• Purpose
• Use
• Warnings
• Directions
• Other information
• Inactive ingredients
• Package label: 71491-100-00 viabeclicne 5 ml package label: 71491-100-01 viabecline 15ml
• Uro Hubber (Tetracycline Hydrochloride) reviews

Activer Ingredient

Uro Hubber (Tetracycline Hydrochloride) 30 mg

Purpose

First Aid Antibiotic

Use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert: Do not use if allergic to any ingredient listed on this label.

Do not use

• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor

Ask doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if the condition persists or gets worse.

Keep out of reach of children. ​If swallowed, get medical help or contact a poison Control Center right away.

Directions

• Clean the affected area
• Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
• May be covered with a sterile bandage.

Other information

• Keep product refrigerated to preserve its effectiveness and color
• Stop use if the product is misused: If the bottle is left open and or not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
• This product is an OTC antibiotic for human use.
• Contains no alcohol, no animal ingredients.
• Blended for typical skin color.
• May stain cloth.
• No claims regarding stem cell healing are implied for this product.

Inactive Ingredients

ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYL-CELLULOSE, MAGNESIUM STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

Package Label: 71491-100-00 VIABECLICNE 5 ML

Package Label: 71491-100-01 Uro Hubber 15ML

1 2 3 7 5