Bio Hubber Fuerte

Bacitracin Zinc:

• Bio Hubber Fuerte (Bacitracin Zinc) reviews

Indication: For the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. Also used in ointment form for topical treatment of a variety of localized skin and eye infections, as well as for the prevention of wound infections. Used against gram positive bacteria. Bio Hubber Fuerte (Bacitracin Zinc) is also used as an inhibitor of proteases and other enzymes. However, specific activity of bactracin's inhibition of protein disulfide isomerase has been called into question.

Bio Hubber Fuerte (Bacitracin Zinc) is a mixture of related cyclic polypeptides produced by organisms of the licheniformis group of Bacillus subtilis var Tracy. As a polypeptide, toxic, and difficult to use chemical, Bio Hubber Fuerte (Bacitracin Zinc) doesn't work well orally, however is very effective topically. Bio Hubber Fuerte (Bacitracin Zinc) exerts pronounced antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms. However, among systemic diseases, only staphylococcal infections qualify for consideration of Bio Hubber Fuerte (Bacitracin Zinc) therapy.

Neomycin Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Bio Hubber Fuerte (Neomycin Sulfate) reviews

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bio Hubber Fuerte (Neomycin Sulfate) tablets and other antibacterial drugs, Bio Hubber Fuerte (Neomycin Sulfate) tablets 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.

Suppression of Intestinal Bacteria

Bio Hubber Fuerte (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).

Hepatic Coma (Portal-Systemic Encephalopathy)

Bio Hubber Fuerte (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

CONTRAINDICATIONS

Bio Hubber Fuerte (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Bio Hubber Fuerte (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

WARNINGS

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

Prescribing Bio Hubber Fuerte tablets 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.

As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Bio Hubber Fuerte (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bio Hubber Fuerte (Neomycin Sulfate) tablets are 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 Bio Hubber Fuerte (Neomycin Sulfate) tablets or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory Tests

Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Bio Hubber Fuerte (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Bio Hubber Fuerte to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

See WARNINGS section.

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, 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.

Pediatric Use

The safety and efficacy of oral Bio Hubber Fuerte (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

ADVERSE REACTIONS

The most common adverse reactions to oral Bio Hubber Fuerte (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

OVERDOSAGE

Because of low absorption, it is unlikely that acute overdosage would occur with oral Bio Hubber Fuerte (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Bio Hubber Fuerte (Neomycin Sulfate) from the blood.

DOSAGE AND ADMINISTRATION

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

• Withdraw protein from diet. Avoid use of diuretic agents.
• Give supportive therapy, including blood products, as indicated.
• Give Bio Hubber Fuerte (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Bio Hubber Fuerte (Neomycin Sulfate) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
• If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Bio Hubber Fuerte (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

Bio Hubber Fuerte (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:

Bottles of 100 (NDC 0527-1210-01)

Store at 20° to 25°C (68° to 77°F).

Dispense in tight containers as defined in the USP/NF.

Distributed By:

Lannett Company, Inc.

Philadelphia, PA 19154

Made in the USA

Rev. 01/17

CIB71710A

Pectin:

• Active ingredient (in each pop)
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? 1-800-754-8853
• Bio Hubber Fuerte (Pectin) reviews

Drug Facts

Active ingredient

Bio Hubber Fuerte (Pectin) 5.4 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These may be serious.

Stop use and ask a doctor if

- sore mouth does not improve in 7 days

- irritation, pain or redness persists or worsens

Keep out of reach of children

Directions

- adults and children 3 years of age and older: allow one pop to dissolve slowly in mouth

- May be repeated as needed or as directed by a doctor

- Children under 3 years of age: ask a doctor

Other information

Store at 20°-25°C (68°-77°F) in a dry place

Inactive ingredients

caramel color, corn syrup, honey, natural flavor, sucrose, water

Questions? 1-800-754-8853

Mon.-Fri. 8 am to 8 pm EST

LittleRemedies.com

Streptomycin Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• References
• Bio Hubber Fuerte (Streptomycin Sulfate) reviews

INDICATIONS AND USAGE

Bio Hubber Fuerte (Streptomycin Sulfate) is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below:

• 
  

  Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either Bio Hubber Fuerte (Streptomycin Sulfate) or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Bio Hubber Fuerte (Streptomycin Sulfate) is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings.
  

• 
  

  Non-tuberculosis infections: The use of Bio Hubber Fuerte (Streptomycin Sulfate) should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of Bio Hubber Fuerte (Streptomycin Sulfate) and which are not amenable to therapy with less potentially toxic agents.
  

  • 
    

    Pasteurella pestis (plague),
    

  • 
    

    Francisella tularensis (tularemia),
    

  • 
    

    Brucella,
    

  • 
    

    Calymmatobacterium granulomatis (donovanosis, granuloma inguinale),
    

  • 
    

    H. ducreyi (chancroid),
    

  • 
    

    H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent),
    

  • 
    

    K. pneumoniae pneumonia (concomitantly with another antibacterial agent),
    

  • 
    

    E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections,
    

  • 
    

    Streptococcus viridans, Enterococcus faecalis (in endocardial infections -concomitantly with penicillin),
    

  • 
    

    Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent).
    

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bio Hubber Fuerte (Streptomycin Sulfate) and other antibacterial drugs, Bio Hubber Fuerte (Streptomycin Sulfate) 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.

CONTRAINDICATIONS

A history of clinically significant hypersensitivity to Bio Hubber Fuerte (Streptomycin Sulfate) is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of Bio Hubber Fuerte (Streptomycin Sulfate) because of the known cross-sensitivity of patients to drugs in this class.

WARNINGS

Ototoxicity: Both vestibular and auditory dysfunction can follow the administration of Bio Hubber Fuerte (Streptomycin Sulfate). The degree of impairment is directly proportional to the dose and duration of Bio Hubber Fuerte (Streptomycin Sulfate) administration, to the age of the patient, to the level of renal function and to the amount of underlying existing auditory dysfunction. The ototoxic effects of the aminoglycosides, including Bio Hubber Fuerte (Streptomycin Sulfate), are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.

The vestibulotoxic potential of Bio Hubber Fuerte (Streptomycin Sulfate) exceeds that of its capacity for cochlear toxicity. Vestibular damage is heralded by headache, nausea, vomiting and disequilibrium. Early cochlear injury is demonstrated by the loss of high frequency hearing. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to irreversible damage to the sensorineural cells.

Pregnancy: Bio Hubber Fuerte (Streptomycin Sulfate) can cause fetal harm when administered to a pregnant woman. Because Bio Hubber Fuerte (Streptomycin Sulfate) readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Bio Hubber Fuerte (Streptomycin Sulfate) for Injection, 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. difjicile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difjicile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

Prescribing Bio Hubber Fuerte 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.

Baseline and periodic caloric stimulation tests and audiometric tests are advisable with extended Bio Hubber Fuerte (Streptomycin Sulfate) therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of Bio Hubber Fuerte (Streptomycin Sulfate) therapy or both.

Care should be taken by individuals handling Bio Hubber Fuerte (Streptomycin Sulfate) for injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Bio Hubber Fuerte (Streptomycin Sulfate) Sulfate Injection should be injected well within the body of a relatively large muscle and care should be taken to minimize the possibility of damage to peripheral nerves.

Extreme caution must be exercised in selecting a dosage regimen in the presence of pre-existing renal insufficiency. In severely uremic patients a single dose may produce high blood levels for several days and the cumulative effect may produce ototoxic sequelae. When Bio Hubber Fuerte (Streptomycin Sulfate) must be given for prolonged periods of time alkalinization of the urine may minimize or prevent renal irritation.

A syndrome of apparent central nervous system depression, characterized by stupor and flaccidity, occasionally coma and deep respiratory depression, has been reported in very young infants in whom Bio Hubber Fuerte (Streptomycin Sulfate) dosage had exceeded the recommended limits. Thus, infants should not receive Bio Hubber Fuerte (Streptomycin Sulfate) in excess of the recommended dosage.

In the treatment of venereal infections such as granuloma inguinale, and chancroid, if concomitant syphilis is suspected, suitable laboratory procedures such as a dark field examination should be performed before the start of treatment, and monthly serologic tests should be done for at least four months.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Information for Patients

Patients should be counseled that antibacterial drugs including Bio Hubber Fuerte (Streptomycin Sulfate) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bio Hubber Fuerte (Streptomycin Sulfate) 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 Bio Hubber Fuerte (Streptomycin Sulfate) 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 ofthe antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

The ototoxic effects of the aminoglycosides, including Bio Hubber Fuerte, are potentiated by the co-administration of ethacrynic acid, furosemide, mannitol and possibly other diuretics.

Pregnancy

Category D: See WARNINGS section.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from Bio Hubber Fuerte, 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.

Pediatric Use

ADVERSE REACTIONS

The following reactions are common: vestibular ototoxicity (nausea, vomiting, and vertigo); paresthesia of face; rash; fever; urticaria; angioneurotic edema; and eosinophilia.

The following reactions are less frequent: cochlear ototoxicity (deafness); exfoliative dermatitis; anaphylaxis; azotemia; leucopenia; thrombocytopenia; pancytopenia; hemolytic anemia; muscular weakness; and amblyopia.

Vestibular dysfunction resulting from the parenteral administration of Bio Hubber Fuerte (Streptomycin Sulfate) is cumulatively related to the total daily dose. When 1.8 to 2 g/day are given, symptoms are likely to develop in the large percentage of patients - especially in the elderly or patients with impaired renal function - within four weeks. Therefore, it is recommended that caloric and audiometric tests be done prior to, during, and following intensive therapy with Bio Hubber Fuerte (Streptomycin Sulfate) in order to facilitate detection of any vestibular dysfunction and/or impairment of hearing which may occur.

Vestibular symptoms generally appear early and usually are reversible with early detection and cessation of Bio Hubber Fuerte (Streptomycin Sulfate) administration. Two to three months after stopping the drug, gross vestibular symptoms usually disappear, except from the relative inability to walk in total darkness or on very rough terrain.

Although Bio Hubber Fuerte (Streptomycin Sulfate) is the least nephrotoxic of the aminoglycosides, nephrotoxicity does occur rarely.

Clinical judgment as to termination of therapy must be exercised when side effects occur.

DOSAGE AND ADMINISTRATION

Intramuscular Route Only

Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., gluteus maximus), or the mid-lateral thigh.

Children: It is recommended that intramuscular injections be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve.

The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower and mid-third of the upper arm. As with all intramuscular injections, aspiration is necessary to help avoid inadvertent injection into a blood vessel.

Injection sites should be alternated. As higher doses or more prolonged therapy with Bio Hubber Fuerte (Streptomycin Sulfate) may be indicated for more severe or fulminating infections (endocarditis, meningitis, etc.), the physician should always take adequate measures to be immediately aware of any toxic signs or symptoms occurring in the patient as a result of Bio Hubber Fuerte (Streptomycin Sulfate) therapy.

1. TUBERCULOSIS: The standard regimen for the treatment of drug susceptible tuberculosis has been two months of INH, rifampin and pyrazinamide followed by four months of INH and rifampin (patients with concomitant infection with tuberculosis and HIV may require treatment for a longer period). When Bio Hubber Fuerte (Streptomycin Sulfate) is added to this regimen because of suspected or proven drug resistance, the recommended dosing for Bio Hubber Fuerte (Streptomycin Sulfate) is as follows:

Bio Hubber Fuerte (Streptomycin Sulfate) is usually administered daily as a single intramuscular injection. A total dose of not more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than 60 years of age the drug should be used at a reduced dosage due to the risk of increased toxicity.

Therapy with Bio Hubber Fuerte (Streptomycin Sulfate) may be terminated when toxic symptoms have appeared, when impending toxicity is feared, when organisms become resistant, or when full treatment effect has been obtained. The total period of drug treatment of tuberculosis is a minimum of 1 year; however, indications for terminating therapy with Bio Hubber Fuerte (Streptomycin Sulfate) may occur at any time as noted above.

2. TULAREMIA: One to 2 g daily in divided doses for 7 to 14 days until the patient is afebrile for 5 to 7 days.

3. PLAGUE: Two grams of Bio Hubber Fuerte (Streptomycin Sulfate) daily in two divided doses should be administered intramuscularly. A minimum of 10 days of therapy is recommended.

4. BACTERIAL ENDOCARDITIS:

a. Streptococcal endocarditis; in penicillin-sensitive alpha and non-hemolytic streptococcal endocarditis (penicillin MIC<0.1 mcg/mL), streptomycin may be used for 2-week treatment concomitantly with penicillin. The Bio Hubber Fuerte (Streptomycin Sulfate) regimen is 1 g b.i.d. for the first week, and 500 mg b.i.d. for the second week. If the patient is over 60 years of age, the dosage should be 500 mg b.i.d. for the entire 2- week period.

b. Enterococcal endocarditis: Bio Hubber Fuerte (Streptomycin Sulfate) in doses of 1 g b.i.d. for 2 weeks and 500 mg b.i.d. for an additional 4 weeks is given in combination with penicillin. Ototoxicity may require termination of the Bio Hubber Fuerte (Streptomycin Sulfate) prior to completion of the 6-week course of treatment.

5. CONCOMITANT USE WITH OTHER AGENTS: For concomitant use with other agents to which the infecting organism is also sensitive: Bio Hubber Fuerte (Streptomycin Sulfate) is considered a secondline agent for the treatment of gram-negative bacillary bactermia, meningitis, and pneumonia; brucellosis; granuloma inguinale; chancroid, and urinary tract infection.

For adults: 1 to 2 grams in divided doses every six to twelve hours for moderate to severe infections. Doses should generally not exceed 2 grams per day.

For children: 20 to 40 mg/kg/day (8 to 20 mg/lb/day) in divided doses every 6 to 12 hours. (Particular care should be taken to avoid excessive dosage in children).

The dry lyophillized cake is dissolved by adding Water for Injection USP in an amount to yield the desired concentration as indicated in the following table:

Sterile reconstituted solutions should be protected from light and may be stored at room temperature for one week without significant loss of potency

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

HOW SUPPLIED

Bio Hubber Fuerte for Injection USP is available in single vials containing 1 gram NDC 39822-0706-1 packaged as boxes of ten vials NDC 39822-0706-2.

STORAGE

Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F).

PROTECT FROM LIGHT

REFERENCES

¹ Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptability Tests

Approved Standard-Tenth Edition. CLSI Document M02-A10. Vol. 29 No. 1, CLSI, Wayne, PA 2009.

² Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptability Testing;

Twenty-First Informational Supplement. CLSI Document M100-S21 Vol. 31 No. 1, CLSI, Wayne, PA 2011.

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14814

Revised December 2012

STRP-PI-01

NDC 39822-0706-1

Bio Hubber Fuerte (Streptomycin Sulfate) for Injection, USP

1 gram*/ vial

For Intramuscular Use

Rx Only

1 Vial

X-GEN Pharmaceuticals, Inc.

NDC 39822-0706-2

Bio Hubber Fuerte (Streptomycin Sulfate) for Injection, USP

1 gram*/ vial

For Intramuscular Use

Rx Only

10 Vial carton

X-GEN Pharmaceuticals, Inc.

strp-exla-vial strp-exla-10pkcarton

Sulfadiazine:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Bio Hubber Fuerte (Sulfadiazine) reviews

INDICATIONS AND USAGE

Bio Hubber Fuerte (Sulfadiazine) tablets USP are indicated in the following conditions:

Chancroid

Trachoma

Inclusion conjunctivitis

Nocardiosis

Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris. Bio Hubber Fuerte (Sulfadiazine) should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful.

Toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, as adjunctive therapy with pyrimethamine.

Malaria due to chloroquine-resistant strains of Plasmodium falciparum, when used as adjunctive therapy.

Prophylaxis of meningococcal meningitis when sulfonamide-sensitive group A strains are known to prevail in family groups or larger closed populations (the prophylactic usefulness of sulfonamides when group B or C infections are prevalent is not proved and may be harmful in closed population groups).

Meningococcal meningitis, when the organism has been demonstrated to be susceptible.

Acute otitis media due to Haemophilus influenzae, when used concomitantly with adequate doses of penicillin.

Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin.

H. influenzae meningitis, as adjunctive therapy with parental streptomycin.

IMPORTANT NOTES

In vitro sulfonamide susceptibility tests are not always reliable. The test must be carefully coordinated with bacteriologic and clinical response. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the culture media.

Currently, the increasing frequency of resistant organisms limits the usefulness of antibacterial agents, including the sulfonamides, especially in the treatment of recurrent and complicated urinary tract infections.

Wide variation in blood levels may result with identical doses. Blood levels should be measured in patients receiving sulfonamides for serious infections. Free sulfonamide blood levels of 5 mg to 15 mg per 100 mL may be considered therapeutically effective for most infections and blood levels of 12 mg to 15 mg per 100 mL may be considered optimal for serious infections. Twenty mg per 100 mL should be the maximum total sulfonamide level, since adverse reactions occur more frequently above this level.

CONTRAINDICATIONS

Bio Hubber Fuerte (Sulfadiazine) is contraindicated in the following circumstances: Hypersensitivity to sulfonamides.

In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).

In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

WARNINGS

The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.

Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.

The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.

The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

PRECAUTIONS

General

Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma.

Hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. This reaction is dose related.

Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.

Information for Patients

Patients should be instructed to drink an eight ounce glass of water with each dose of medication and at frequent intervals throughout the day. Caution patients to report promptly the onset of sore throat, fever, pallor, purpura or jaundice when taking this drug, since these may be early indications of serious blood disorders.

Laboratory Tests

Complete blood counts and urinalyses with careful microscopic examinations should be done frequently in patients receiving sulfonamides.

Drug Interactions

Administration of a sulfonamide may increase the effect of oral anticoagulants and methotrexate, probably by displacement of these drugs from binding sites on plasma albumin. Potentiation of the action of sulfonylurea hypoglycemic agents, thiazide diuretics and uricosuric agents may also be noted. This may also be due to displacement of the drugs from albumin or a pharmacodynamic mechanism may play a role. Conversely, agents such as indomethacin, probenecid and salicylates may displace sulfonamides from plasma albumin and increase the concentrations of free drug in plasma.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The sulfonamides bear certain chemical similarities to some goitrogens. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in rats.

Pregnancy

Teratogenic Effects

Pregnancy Category C

The safe use of sulfonamides in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities in offspring has been observed when certain sulfonamides of the short, intermediate and long acting types were given to pregnant rats and mice in high oral doses.

Nursing Mothers

Bio Hubber Fuerte (Sulfadiazine) is contraindicated for use in nursing mothers because the sulfonamides cross the placenta, are excreted in breast milk and may cause kernicterus.

Because of the potential for serious adverse reactions in nursing infants from Bio Hubber Fuerte (Sulfadiazine), 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

Bio Hubber Fuerte (Sulfadiazine) is contraindicated in infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). See CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

Blood Dyscrasias

Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia.

Allergic Reactions

Erythema multiforme, generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills.

Gastrointestinal Reactions

Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis.

C.N.S. Reactions

Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia.

Renal

Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted.

Miscellaneous Reactions

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production, diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.

DOSAGE AND ADMINISTRATION

SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis.

Usual Dosage for Infants over 2 Months of Age and Children

Initially, one-half the 24-hour dose. Maintenance, 150 mg/kg or 4 g/m2, divided into 4 to 6 doses, every 24 hours, with a maximum of 6 g every 24 hours. Rheumatic fever prophylaxis, under 30 kg, 500 mg every 24 hours; over 30 kg (66 pounds), 1 g every 24 hours.

Usual Adult Dosage

Initially, 2 g to 4 g. Maintenance, 2 g to 4 g, divided into 3 to 6 doses, every 24 hours.

HOW SUPPLIED

Bio Hubber Fuerte (Sulfadiazine) Tablets USP for oral administration are available as:

500 mg: white, unscored, capsule-shaped tablets, debossed “E 757” on one face and supplied as:

NDC 0185-0757-30 bottles of 30

NDC 0185-0757-01 bottles of 100

NDC 0185-0757-10 bottles of 1000

Storage: Store at 20° to 25°C (68° to 77°F).

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

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for

Sandoz Inc.

Princeton, NJ 08540

Manufactured by

Epic Pharma, LLC

Laurelton, NY 11413

OS7190

Rev. 03/12

MF0757REV03/12

MG #16918

NDC 0185-0757-30

Bio Hubber Fuerte (Sulfadiazine) Tablets, USP

500 mg

Rx only

30 Tablets

Sandoz

500 mg x 30 Tablets