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Pentrexyl INJECTION 250mg 2ml, Ampicillin

Pentrexyl INJECTION 250mg 2ml, Ampicillin
Model:750104194104
Current Reviews:0
Price:$14.00

Pentrexyl INJECTION 250mg 2ml, Ampicillin

THIS IS A BRAND MEDICATION

INDICATIONS: PENTREXYL * is indicated for the treatment of the following infections due to susceptible strains of Gram-positive and Gram-negative bacteria:

- Respiratory tract infections.

- Bacterial Meningitis (the addition of an aminoglycoside may enhance the effectiveness of ampicillin against gram-negative bacteria in particular).

- Septicemia and endocarditis (the addition of an aminoglycoside may enhance the effectiveness of ampicillin in the case of enterococcal endocarditis).

- Urinary tract infections.

- Gastrointestinal infections.

Bacteriological studies should be conducted to determine the etiologic agent and its sensitivity to ampicillin.

The treatment can be instituted before obtaining the results of the sensitivity tests.

Reservations recommended parenteral form of this drug for moderately severe and severe infections, for patients who can not take oral forms. In the presence of shock absorption from the intramuscular site is reduced, therefore, it is recommended in severe patients intravenously. As soon as may be deemed appropriate PENTREXYL * switch to oral.

Pharmacokinetics in humans:

Pharmacology: PENTREXYL * is stable in the presence of gastric acid and is well absorbed in the gastrointestinal tract. Diffuses rapidly in most tissues and fluids. However, penetrates the cerebrospinal fluid and brain only when the meninges are inflamed. Ampicillin is excreted in large quantities in the urine unchanged and that removal can be delayed by concurrent administration of probenecid. The active form is found in bile in higher concentrations in the serum. In all penicillins, which is fixed at least whey is ampicillin, averaging nearly 20% compared with 60-90% approximately of the others. PENTREXYL * is well tolerated by most patients and has been administered a dose of 2 g daily, for several weeks without adverse reactions.

Microbiology has been shown in in vitro studies, that most of the following bacteria are susceptible to PENTREXYL *:

Gram positive: Streptococcus haemolyticus haemolyticus and S. pneumoniae, lactamase producing Staphylococcus not, Clostridium sp, B. anthracis, L. monocytogenes and most strains of enterococci.

-Negative: H. influenzae, N. gonorrhoeae, N. meningitidis, P. mirabilis and various strains of Salmonella, Shigella and E. coli.

PENTREXYL * not resists destruction of penicillinase. Use a sensitivity test disk 10 mcg of ampicillin to estimate the sensitivity of the bacteria in vitro to PENTREXYL *.

Contraindications are contraindicated history of prior hiperserisibilidad reaction to penicillin or any component of the formula.

PRECAUTIONS: Official Journal of 4 May 2000.

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: In laboratory animal studies were conducted by administering higher doses of reproduction in humans and have revealed no evidence of adverse effects due to ampicillin. However, pregnant women are not well-controlled studies. Given that animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if it is truly indicated.

Breastfeeding: Ampicillin is excreted in small amounts in human milk. Therefore caution should be exercised when class antibiotics are administered ampicillin to a nursing woman.

The oral penicillins are absorbed to a much lesser extent in infants than in adults (see DOSAGE AND FOR ADMINISTRATION).

ADVERSE REACTIONS: As with any penicillin, reactions may occur mainly hypersensitivity phenomena.

It is more likely to occur in individuals who have previously been shown to be hypersensitive to penicillins and in those with a history of allergy, asthma, hay fever or urticaria.

They have reported the following adverse reactions with the use of ampicillin:

Gastrointestinal: Glossitis, stomatitis, glosotriquia, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea (these reactions are usually associated with the oral form).

Hypersensitivity Reactions: Often have reported skin rashes and hives, as well as some cases of exfoliative dermatitis and erythema multiforme. Anaphylaxis is the most severe reaction experienced and is often associated with parenteral dosage forms.

Note: urticaria, other skin rashes, and the like reactions of serum sickness can be controlled with antihistamines and, if necessary, with systemic corticosteroids. If you submit any of these reactions, ampicillin should be discontinued unless, in the opinion of the physician, the infection being treated threatens the patient's life and can only be treated with ampicillin. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids.

Liver: There has been a moderate increase in serum glutamic oxaloacetic transaminase (SGOT), particularly in infants, but the significance of this sign is still unknown. Also been observed transient elevations of SGOT slightly in individuals receiving repeated intramuscular injections more than usual (2-4 times).

Evidence indicates that the TGO is released at the site of intramuscular injection of sodium ampicillin and the presence of high concentrations of this enzyme in the blood does not necessarily indicate a liver disease.

Hemic and Lymphatic: anemia have been reported thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis during treatment with penicillin. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Warnings: serious reactions have been reported and occasionally fatal anaphylactic in patients receiving therapy with ampicillin. Although anaphylaxis is more frequent following parenteral therapy, has also occurred with oral penicillin. It is more likely that these reactions occur in patients with a history of penicillin hypersensitivity and / or other allergens.

There are well-documented reports of patients with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions to cephalosporins.

Before initiating therapy with a penicillin, the physician should inquire about previous hypersensitivity reactions to penicillins, cephalosporins, and / or other allergens.

DRUG INTERACTIONS AND OTHER GENDER: Simultaneous administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known if the rash exacerbation by ampicillin is due to allopurinol or hyperuricemia present in these patients.

CHANGES IN RESULTS OF LABORATORY TESTS: In the presence of high concentrations of ampicillin in urine may occur false-positive glycosuria when copper reduction methods are used. Therefore, we recommend the use of glucose tests based on enzymatic reactions of glucose oxidase.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals prolonged observation with this medicine.

Other Precautions: It should be borne in mind the possibility of superinfections caused by resistant pathogenic fungi or bacteria during treatment. In these cases, it is recommended to discontinue the drug and institute appropriate treatment. A high percentage (over 90%) of patients with infectious mononucleosis or lymphatic leukemia who receive ampicillin develop a rash. Typically appears 7 to 10 days after starting administration of ampicillin and remains for several days to a week after the drug has been discontinued. In most cases, the rash is maculopapular, pruritic, and generalized. Therefore, administration of ampicillin is not recommended in patients with mononucleosis. It is not known whether these patients are truly allergic to ampicillin.

As with any potent medication should be monitored periodically review the functioning of some organs such as kidney and liver and hematopoietic system during prolonged treatment.

Dosage adjustment is recommended in patients with impaired renal function (creatinine clearance? 50 ml / min).

DOSAGE AND ADMINISTRATION:

Respiratory tract infections and soft tissue:

Oral:

Patients weighing 20 kg or more: 250 mg every 6 hours.

Patients weighing less than 20 kg: 50 mg / kg / day in equally divided doses every 6 to 8 hours.

Instructions for parenteral administration route: Managing product intravenously or intramuscularly in the space of one hour after the solution prepared under that after this period, the power of the product may decrease significantly.

Parenteral:

Patients weighing less than 40 kg: 25-50 mg /
kg / day in equally divided doses at intervals of 6 to 8 hours.

Patients weighing more than 40 kg: 250 to 500 mg every 6 hours.

Infections of the gastrointestinal and genitourinary tracts:

Oral:

Patients weighing 20 kg or more: 500 mg every 6 hours.

Patients weighing less than 20 kg: 100 mg / kg / day in equally divided doses every 6 to 8 hours.

Parenteral: (including genitourinary infections caused by N. gonorrhoeae in females).

Patients weighing 40 kg or more: 500 mg every 6 hours.

Patients weighing less than 40 kg: 50 mg / kg / day in equally divided doses every 6 to 8 hours.

In the treatment of chronic intestinal and urinary tract is required frequently clinical and bacteriological controls.

Should not be used less than the recommended dose. Higher doses may be used in severe or resistant infections. In resistant infections, the treatment may be required for several weeks. Occasionally, it may be necessary clinical and / or bacteriological for several months after treatment ends.

Urethritis in men and women due to N. gonorrhoeae:

Oral: 3.5 g to 1.0 g of probenecid given simultaneously.

Urethritis in males due to N. gonorrhoeae:

Parenteral:

Adults: 2 doses of 500 mg each at intervals of 8-12 hours. Treatment may be repeated if necessary or extended if required.

In the treatment of gonococcal urethritis complications such as prostatitis and epididymitis, prolonged treatment is recommended and intense. Analysis should be made in cases of gonorrhea with a suspected primary lesion of syphilis before instituting therapy. In all other cases where a suspected concomitant syphilis, serological tests should be done every month for a minimum of four months. Parenteral doses preceding infection can occur either intramuscularly or I.V. Where appropriate you can switch to the oral form of ampicillin PENTREXYL *.

Bacterial Meningitis:

Only injectors:

Adults and children: 150 to 200 mg / kg / day. Start with the administration I.V. for at least three days and continue intramuscularly every 3 to 4 hours.

Septicemia:

Only injectors: Adults and children 150-200 mg / kg / day divided in equal doses every 3 to 4 hours. Start with intravenous administration for at least three days and continue with intravenous or intramuscular.

Dose adjustment for patients with impaired kidney function.

We recommend an adjustment in the dose range for ampicillin when used parenterally in those patients with a creatinine clearance? 50 ml / min.

Patients with creatinine clearance 10-50 ml / min should receive therapy in infections which is normally at intervals of six hours per vial, a vial every 6-12 hours. In patients with creatinine clearance <10 ml / min interval should be 12-24 hours per vial.

For more severe infections such as sepsis or bacterial meningitis may be more frequent doses required.

The treatment of all infections should be continued for a minimum of 48 to 72 hours after the patient is asymptomatic or have evidence shows that the infection has been eradicated. We recommend a minimum of 10 days for the treatment of beta-hemolytic streptococcal infections in order to prevent recurrence of acute rheumatic fever and acute glomerulonephritis.

The following dosage schedule may be useful as a guide to treatment pediatric drops:

Pediatric drops dosage-scheme
 
Weight (kg)
 Infections

respiratory
 Infections

gastrointestinal

and genitourinary
 
Up to 4
 50 mg C / 6 h

(½ dropper w / 6 h)
 100 mg C / 6 h

(1 dropper w / 6 h)
 
4.1 to 6
 75 mg C / 6 h

(¾ dropper w / 6 h)
 150 mg C / 6 h

(1 ½ dropper w / 6 h)
 
6.1 to 8
 100 mg C / 6 h

(1 dropper w / 6 h)
 200 mg C / 6 h

(2 droppers c / 6 h)
 
8.1 to 12
 150 mg C / 6 h

(1 ½ dropper w / 6 h)
 300 mg C / 6 h

(3 droppers c / 6 h)
 

Note: For ease of administration, the dropper is calibrated to 50 mg (½ dropper) to 75 mg (¾ dropper) and 100 mg (1 dropper). Children over 10 kg are usually dosed PENTREXYL * Oral suspension.

Preparing for oral suspension and pediatric drops: these forms must be prepared to manage time, to facilitate the preparation add water to the bottle in two portions and mix well after each addition. Add the total amount of water as indicated on the label. The reconstituted formulation is stable for 14 days refrigerated.

Parenteral: Injections I.V. or I.M. be administered before one hour after its preparation, as can significantly decrease its power after this period.

For intramuscular Dissolve the contents of a vial with the amount of sterile water for injection listed in the table.

PENTREXYL *-reconstitution volumes
 
Presentation
 Amount

recommended

diluent
 Volume
 Concentration

(Mg / ml)
 
125 mg
 1.2 ml
 1 ml
 125 mg
 
250 mg
 1.0 ml
 1 ml
 250 mg
 
500 mg
 1.8 ml
 2 ml
 250 mg
 
1 g
 3.5 ml
 4 ml
 250 mg
 

PENTREXYL * in 1 g is recommended for intravenous use, however, can be used intramuscularly presentations when 250 or 500 mg are not available. In such case the content is recommended dissolve in sterile water for injection in 3.5 or 6.8 ml.

PENTREXYL * 125 mg is primarily for pediatric use. Also can be used when small amounts are required parenteral antibiotic.

For direct intravenous use: Add 5 ml of sterile water to the vial of 125, 250 and 500 mg and manage them slowly over a period of 3 to 5 minutes. * Of 1.0 g PENTREXYL also be administered intravenously directly. Dissolve it in 7.4 ml of sterile water and at least manage them slowly over a period of 15 minutes. Each gram of ampicillin containing 2.9 mEq of sodium.

Warnings: The administration can produce faster seizures.

For administration by drip IV: Reconstitute, as mentioned before diluting with the intravenous solution. Stability studies of ampicillin sodium at various concentrations in various intravenous solutions indicate that the drug will lose less than 10% activity at room temperature for the periods indicated in the following table:

* I.V. stability PENTREXYL
 
Room temperature (25 ° C)
 
Diluent
 Concentrations
 Periods

this-

ity
 
Sterile water for injection
 Up to 30 mg / ml
 8 hours
 
Isotonic sodium chloride
 Up to 30 mg / ml
 8 hours
 
Sodium lactate solution M / 6
 Up to 30 mg / ml
 8 hours
 
5% dextrose in water
 10 to 20 mg / ml
 2 hours
 
5% dextrose in water
 Up to 2 mg / ml
 4 hours
 
5% dextrose in 0.45% NaCl
 Up to 2 mg / ml
 4 hours
 
Invert sugar 10% in water
 Up to 2 mg / ml
 4 hours
 
Lactated Ringer
 Up to 30 mg / ml
 8 hours
 
Refrigerated (4 ° C)
 
Diluent
 Concentrations
 Periods

this-

ity
 
Sterile water for injection
 30 mg / ml
 48 hours
 
Sterile water for injection
 Up to 20 mg / ml
 72 hours
 
* I.V. stability PENTREXYL
 
Refrigerated (4 ° C)
 
Diluent
 Concentrations
 Periods

this-

ity
 
Isotonic sodium chloride
 30 mg / ml
 48 hours
 
Isotonic sodium chloride
 Up to 20 mg / ml
 72 hours
 
Lactated Ringer
 Up to 30 mg / ml
 24 hours
 
M sodium lactate / 6
 Up to 30 mg / ml
 8 hours
 
5% dextrose in water
 Up to 20 mg / ml
 4 hours
 
5% dextrose in 0.45% NaCl
 Up to 10 mg / ml
 4 hours
 
Invert sugar 10% in water
 Up to 20 mg / ml
 3 hours
 

Only solutions mentioned above are used for intravenous infusion PENTREXYL *. The concentrations should fall within the specified range. The concentration of drug and the rate and volume of infusion should be adjusted to the total dose administered ampicillin before the drug loses its stability in the solution used.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: In case of overdose, discontinue medication, treat symptomatically and institute patient support measures required. In patients with impaired renal function, antibiotic ampicillin class can be removed by hemodialysis but not by peritoneal dialysis.

PRESENTATIONS:

Capsules: Box with 20 capsules of 250 and 500 mg.

Drops: Bottle with 20 ml of 100 mg / 1 ml.

Solution for injection:

Box 3 vials with powder 125 mg / 2 ml, 250 mg / 2 ml, 500 mg / 2 ml and 1 g / 3 ml.

With vial of 250 mg / 2 ml, 500 mg / 2 ml, 1 g / 3 ml. All with diluent.

Suspension: Bottle with 90 ml of 125 mg / 5 ml, 250 mg / 5 ml and 500 mg / 5 ml.

Tablets: Box with 10 tablets of 1 g.

RECOMMENDED STORAGE: Store at room temperature not exceeding 30 ° C and dry (capsules and tablets).

Keep the bottle tightly closed at room temperature to no more than 30 ° C (drops and suspension).

Of mixing the product is stored 7 days at room temperature not exceeding 30 ° C or 14 days under refrigeration at 2-8 ° C (suspension and beads).

Of mixing, administer immediately and discard the excess (solution for injection).

Store at room temperature to not more than 30 ° C (solution injection).
Drug Name: PENTREXYL
Comparable patent medicine: PENTREXYL
Active substance: ampicillin
Presentation: injection solution
Concentration: 250 mg / 2 ml
Prolonged release tablets: No
Laboratory Corden Pharma Latina
Box of 3 vials with powder and 3 vials with 2ML
Made in: Italy


   
   
   
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