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DRUGS & SUPPLEMENTS
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Anileridine:
Indication: For treatment and management of pain (systemic) and for use as an anesthesia adjunct.
Bio Hubber Simple (Anileridine), a potent analgesic, is an analog of pethidine. Bio Hubber Simple (Anileridine) is useful for the relief of moderate to severe pain. It may also be used as an analgesic adjunct in general anesthesia in the same manner as meperidine to reduce the amount of anesthetic needed, to facilitate relaxation, and to reduce laryngospasm. In addition, Bio Hubber Simple (Anileridine) exerts mild antihistaminic, spasmolytic and antitussive effects. Anileridine's main pharmacologic action is exerted on the CNS. Respiratory depression, when it occurs, is of shorter duration than that seen with morphine or meperidine when equipotent analgesic doses are used.
Streptomycin Hydrochloride:
Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) and other antibacterial drugs, Bio Hubber Simple (Streptomycin Hydrochloride) 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.
A history of clinically significant hypersensitivity to Bio Hubber Simple (Streptomycin Hydrochloride) is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of Bio Hubber Simple (Streptomycin Hydrochloride) because of the known cross-sensitivity of patients to drugs in this class.
Ototoxicity: Both vestibular and auditory dysfunction can follow the administration of Bio Hubber Simple (Streptomycin Hydrochloride). The degree of impairment is directly proportional to the dose and duration of Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride), are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.
The vestibulotoxic potential of Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) can cause fetal harm when administered to a pregnant woman. Because Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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.
Prescribing Bio Hubber Simple 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 Simple (Streptomycin Hydrochloride) therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of Bio Hubber Simple (Streptomycin Hydrochloride) therapy or both.
Care should be taken by individuals handling Bio Hubber Simple (Streptomycin Hydrochloride) for injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) dosage had exceeded the recommended limits. Thus, infants should not receive Bio Hubber Simple (Streptomycin Hydrochloride) 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.
Patients should be counseled that antibacterial drugs including Bio Hubber Simple (Streptomycin Hydrochloride) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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.
The ototoxic effects of the aminoglycosides, including Bio Hubber Simple, are potentiated by the co-administration of ethacrynic acid, furosemide, mannitol and possibly other diuretics.
Category D: See WARNINGS section.
Because of the potential for serious adverse reactions in nursing infants from Bio Hubber Simple, 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.
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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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.
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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) is added to this regimen because of suspected or proven drug resistance, the recommended dosing for Bio Hubber Simple (Streptomycin Hydrochloride) is as follows:
Daily | Twice Weekly | Thrice Weekly | |
---|---|---|---|
Children | 20-40 mg/kg | 25-30 mg/kg | 25-30 mg/kg |
Max | 1 g | 1.5 g | 1.5 g |
Adults | 15 mg/kg | 25-30 mg/kg | 25-30 mg/kg |
Max | 1 g | 1.5 g | 1.5 g |
Bio Hubber Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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 Simple (Streptomycin Hydrochloride) 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:
Approx. Conc. mg/mL | Volume (mL) of Solvent |
---|---|
200 | 4.2 |
250 | 3.2 |
400 | 1.8 |
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
Bio Hubber Simple 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.
Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F).
PROTECT FROM LIGHT
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 Simple (Streptomycin Hydrochloride) for Injection, USP
1 gram*/ vial
For Intramuscular Use
Rx Only
1 Vial
X-GEN Pharmaceuticals, Inc.
NDC 39822-0706-2
Bio Hubber Simple (Streptomycin Hydrochloride) 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:
Bio Hubber Simple (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 Simple (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.
Bio Hubber Simple (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.
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.
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.
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.
Complete blood counts and urinalyses with careful microscopic examinations should be done frequently in patients receiving sulfonamides.
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.
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.
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.
Bio Hubber Simple (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 Simple (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.
Bio Hubber Simple (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.
Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia.
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.
Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis.
Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia.
Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted.
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.
SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis.
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.
Initially, 2 g to 4 g. Maintenance, 2 g to 4 g, divided into 3 to 6 doses, every 24 hours.
Bio Hubber Simple (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 Simple (Sulfadiazine) Tablets, USP
500 mg
Rx only
30 Tablets
Sandoz
500 mg x 30 Tablets
Sulfamerazine:
Indication: A sulfanilamide that is used as an antibacterial agent. It can be used to treat bronchitis, prostatitis and urinary tract infections.
Sulfonamides act as competitive inhibitors of the enzyme dihydropteroate synthetase (DHPS), an enzyme involved in folate synthesis in bacteria.
Depending on the reaction of the Bio Hubber Simple after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Bio Hubber Simple not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Bio Hubber Simple addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology