No information provided.
A history of clinically significant hypersensitivity to Estreptomicina Labesfal is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of Estreptomicina Labesfal because of the known cross-sensitivity of patients to drugs in this class.
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 Estreptomicina Labesfal 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 Estreptomicina Labesfal 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 Estreptomicina Labesfal 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 Estreptomicina Labesfal 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.
Estreptomicina Labesfal is indicated for the treatment of individuals with moderate to severe infections caused by susceptible strains of microorganisms in the specific conditions listed below:
1. Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either Estreptomicina Labesfal 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.
Estreptomicina Labesfal 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.
2. Non-tuberculosis infections: The use of Estreptomicina Labesfal should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of Estreptomicina Labesfal and which are not amenable to therapy with less potentially toxic agents.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Estreptomicina Labesfal and other antibacterial drugs, Estreptomicina Labesfal 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.
Ototoxicity: Both vestibular and auditory dysfunction can follow the administration of Estreptomicina Labesfal. The degree of impairment is directly proportional to the dose and duration of Estreptomicina Labesfal 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 Estreptomicina Labesfal, are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.
The vestibulotoxic potential of Estreptomicina Labesfal 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: Estreptomicina Labesfal can cause fetal harm when administered to a pregnant woman. Because Estreptomicina Labesfal 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.
PRECAUTIONSGeneral: Prescribing Estreptomicina Labesfal 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 Estreptomicina Labesfal therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of Estreptomicina Labesfal therapy or both.
Care should be taken by individuals handling Estreptomicina Labesfal for Injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Estreptomicina Labesfal for 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. (See DOSAGE AND ADMINISTRATION.)
Extreme caution must be exercised in selecting a dosage regimen in the presence of preexisting 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 Estreptomicina Labesfal 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 Estreptomicina Labesfal dosage had exceeded the recommended limits. Thus, infants should not receive Estreptomicina Labesfal 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.
Pregnancy: Category D: See WARNINGS section.
Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from Estreptomicina Labesfal, 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: (See DOSAGE AND ADMINISTRATION.)
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 Estreptomicina Labesfal 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 Estreptomicina Labesfal 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 Estreptomicina Labesfal is added to this regimen because of suspected or proven drug resistance (see INDICATIONS AND USAGE section), the recommended dosing for Estreptomicina Labesfal is as follows:
| Daily | Twice Weekly | Twice Weekly | |
| Chil dren | 20-40mg /kg | 25-30 mg/kg | 25-30 mg/kg |
| Max 1 g | Max 1.5 g | Max 1.5 g | |
| Adults | 15 mg/kg | 25-30 mg/kg | 25-30 mg/kg |
| Max 1 g | Max 1.5 g | Max 1.5 g |
Estreptomicina Labesfal 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. (See BOXED WARNING.)
Therapy with Estreptomicina Labesfal 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 Estreptomicina Labesfal 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 Estreptomicina Labesfal daily in two divided doses should be administered intramuscularly. A minimum of 10 days of therapy is recommended.
4. BACTERIAL ENDOCARDITIS:
5. CONCOMITANT USE WITH OTHER AGENTS: For concomitant use with other agents to which the infecting organism is also sensitive: Estreptomicina Labesfal is considered a second-line agent for the treatment of gram-negative bacillary bacteremia, 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.
