Drug secnol 2g what is it for

Piperacillin Actavis 2g

Pharmacological groupBeta-lactam antibiotics, penicillins

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author

Actavis Group PTC ehf

What is it and what is it used for?

What Piperacillin Actavis 1g / 2g / 4g is and what it is used for
Piperacillin-Actavis 1g / 2g / 4g is an antibiotic, a parenterally applicable penicillin with a very broad spectrum and Pseudomonas activity.
For the treatment of acute and chronic bacterial infections of various locations and intensities caused by pathogens sensitive to piperacillin, such as

  • Respiratory infections, e.g. B. empyema, lung abscess, and pneumonia. Clinical improvement can be achieved in patients with chronic respiratory infections or cystic fibrosis.
  • Ear, nose and throat infections
  • severe systemic infections, including septicemia
  • intra-abdominal infections, such as B. Infections of the biliary tract, peritonitis and intra-abdominal abscesses (often caused by gram-negative and / or anaerobic organisms of the normal intestinal flora)
  • Genitourinary infections, including pyelonephritis, cystitis, and urethritis. In addition, Piperacillin Actavis 1g / 2g / 4g is effective for acute, uncomplicated infections caused by Neisseria gonorrhoeae, including prostatitis
  • bacterial endocarditis
  • gynecological infections such as B. Endometritis, abscesses and inflammation of the pelvis, salpingitis
  • Skin and soft tissue infections, including post-accident, surgical, and burn infections
  • Bone and joint infections, including osteomyelitis

Piperacillin-Actavis 1g / 2g / 4g can also be used for perioperative short-term prophylaxis when the patient is at increased risk from infections.
In terms of calculated chemotherapy, intravenous treatment with Piperacillin-Actavis 1g / 2g / 4g can, if necessary, be initiated in severe, highly acute infections before an antibiogram is available, provided that the pathogens involved are known to be resistant only in exceptional cases. If there is a threat of severe bacterial infections with unknown or less sensitive pathogens, as well as mixed infections with one or more unknown or less sensitive pathogens, a combination treatment with other bactericidal substances is indicated.
Above all, combination partners, whose effectiveness comes into consideration
ß-lactamase formation, the most common cause of piperacillin resistance, is not reduced.
In vitro studies on the susceptibility of bacteria to piperacillin:
The following types of bacteria are generally sensitive (more than 90% of the strains):
Gram positive aerobes
Enterococcus faecalis
Streptococci
Gram-negative aerobes
Proteus vulgaris
Anaerobes
Clostridium perfringens
Fusobacterium spp.
Peptostreptococci
In the following types of bacteria, resistance to piperacillin occurs in 10% to 50% of cases. In the case of empirical treatment without information about the sensitivity of the strain involved, treatment failure must therefore be expected:
Gram positive aerobes
Corynebacterium spp.
Enterococcus faecium
Gram-negative aerobes
Citrobacter freundii
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella spp.
Serratia marcescens
Anaerobes
Bacteroides spp.
The following types of bacteria are predominantly (more than 50% of the strains) resistant to piperacillin:
Gram positive aerobes
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus spp. (Coagulase negative)
Gram-negative aerobes
Xanthomonas maltophilia
What should be considered in infants, children and the elderly?
Separate dosage guidelines apply to children (see section 3. How to use Piperacillin Actavis 1g / 2g / 4g). There are no special precautions for elderly patients unless renal impairment is present.
In patients with allergic reactions (e.g. hay fever, bronchial asthma, urticaria), the risk of more severe hypersensitivity reactions is increased during injection or infusion treatment, which is why Piperacillin-Actavis 1g / 2g / 4g should be used with particular caution in such cases.
With simultaneous use of Piperacillin Actavis 1g / 2g / 4g and muscle relaxants of the non-depolarizing type, e.g. B. in infection prophylaxis during an operation, the neuromuscular blockade can be deepened and prolonged. These interactions can cause unexpected and potentially life-threatening incidents.
Long-term applications or high doses:
In general, caution is advised in patients with an increased tendency to bleed (e.g. as a result of hemorrhagic diathesis, anticoagulant or fibrinolytic treatment) or with simultaneous treatment with acetylsalicylic acid preparations and high-dose piperacillin treatment. Attention should be paid to possible sources of bleeding, such as ulcers of the gastrointestinal tract (duodenal ulcer, gastric ulcer, intestinal malignancy, etc.).
If apparent bleeding occurs and no other cause of bleeding is apparent, Piperacillin Actavis 1g / 2g / 4g should be discontinued and appropriate therapeutic measures taken. In the case of high-dose treatment with Piperacillin-Actavis 1g / 2g / 4g for longer than 10 days, a reduction in the number of white blood cells (leukocyte depressions up to agranulocytosis) must be expected, which regress quickly and completely after discontinuation.
Regular blood tests are therefore recommended for longer periods of treatment. Coagulation parameters should be monitored more frequently and regularly in patients concomitantly receiving high-dose heparin, oral anticoagulants, acetylsalicylic acid, and other agents that affect the blood coagulation system and / or platelet function.
Long-term and repeated use of Piperacillin-Actavis 1g / 2g / 4g can lead to superinfections with resistant bacteria or fungi.
When using Piperacillin Actavis 1g / 2g / 4g with others
Medicines:
Please tell your doctor or pharmacist if you are taking any other medicines
are taking or have recently taken, even if it is not
prescription drugs.
Piperacillin / probenecid or analgesics / antipyretics and others.
The simultaneous administration of probenecid leads to higher and longer-lasting piperacillin concentrations in the serum and in the bile as a consequence of an inhibition of the renal excretion. Indomethacin, phenylbutazone, salicylates and sulfinpyrazone also lead to higher and longer-lasting serum concentrations.
Piperacillin / muscle relaxants
If Piperacillin-Actavis 1g / 2g / 4g is administered during or immediately after surgery, the neuromuscular blockade can be deepened and prolonged if muscle relaxants of the non-depolarizing type are used at the same time. (See also section? Take special care with Piperacillin-Actavis 1g / 2g / 4g?)
Piperacillin / heparin, oral anticoagulants, platelet aggregation inhibitors and others:
If high-dose heparin, oral anticoagulants, and other agents that affect the blood coagulation system or platelet function are administered at the same time, coagulation parameters should be monitored more frequently and regularly.
Piperacillin / other antibiotics
Combination therapy with suitable antibiotics (e.g. aminoglycosides, staphylococcal penicillins) can lead to an intensified (synergistic) effect.
Bacteriostatic antibiotics such as tetracyclines, sulfonamides and chloramphenicol can, under certain circumstances, reduce the antibacterial effectiveness of the bactericidal piperacillin.
By competitive inhibition of tubular secretion, high doses of piperacillin can prolong the half-life of other ß-lactam antibiotics.
When Piperacillin-Actavis 1g / 2g / 4g and tobramycin are administered together, the area under the blood level / time curve with regard to tobramycin is reduced by about 10% and the renal clearance and excretion in the urine by about a third. The changed pharmacokinetics of tobramycin when used together with piperacillin could be due to in-vivo and in-vitro inactivation of tobramycin in the presence of piperacillin.
Influence on laboratory diagnostic examinations:
Non-enzymatic methods for determining urine sugar can produce a false positive
Result.
Urobilinogen detection and the ninhydrin sample can also be disturbed.
Various chemical methods for determining protein in urine can give false positive results. The protein determination with test strips remains unaffected.

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What do you need to consider before use?

Piperacillin Actavis 1g / 2g / 4g must not be used
Because of the risk of anaphylactic shock, Piperacillin Actavis 1g / 2g / 4g must not be used in patients with proven penicillin hypersensitivity. There may be a cross-allergy with other ß-lactam antibiotics.
Take special care when using Piperacillin Actavis 1g / 2g / 4g

The following describes when to take Piperacillin Actavis 1g / 2g / 4g only
under certain conditions and only with special caution. Please ask your doctor about this. This also applies if this information applied to you in the past.
Patients with impaired kidney or liver function:
Separate dosage guidelines apply for patients with impaired kidney function (see section 3, How to use Piperacillin Actavis 1g / 2g / 4g? And section? If you use more Piperacillin Actavis 1g / 2g / 4g than you should?) .
With impaired liver function, the excretion of the drug from the body (total clearance) is reduced by up to 20% and the half-life can be increased by up to 50%. However, if there are no concomitant renal impairment, no dose adjustments are required.
What must be considered during pregnancy and breastfeeding?
As there is no experience with its use in humans during pregnancy and breastfeeding, Piperacillin Actavis 1g / 2g / 4g should not be used during pregnancy and breastfeeding.
pregnancy and breast feeding period
Ask your doctor or pharmacist before using any medicine
Advice.
As there is no experience of its use in humans during pregnancy and breastfeeding, Piperacillin Actavis 1g / 2g / 4g should not be used during pregnancy and breastfeeding.
Driving and using machines:
According to previous experience, piperacillin 1g / 2g / 4g has no influence on the ability to concentrate and react. In individual cases, side effects (see there) have been observed that make it impossible to carry out the activities mentioned (e.g. seizures, anaphylactic shock).
Important information about some of the ingredients of Piperacillin Actavis 1g / 2g / 4g
No

How is it used?

How to use Piperacillin Actavis 1g / 2g / 4g?
Use this medicine according to the dosage recommendation below.
a) Adults:
Clinical experience shows that Piperacillin Actavis 1g / 2g / 4g should be given intravenously in severe and complicated infections.
Intravenous use (injection or infusion):
The recommended daily dose is usually between 100 and 200 mg piperacillin per kg body weight, divided into 2 - 4 single doses. The usual clinical dosage is 6-12 g piperacillin per day.
In severe cases, between 200 and 300 mg piperacillin per kg body weight should be given daily. The application should take place in 3 - 4 single doses. The maximum recommended daily dose is 24 g, although higher doses were tolerated without complications.
Piperacillin Actavis 2g: Intramuscular use
In uncomplicated infections or for maintenance therapy, Piperacillin Actavis 2g can also be administered intramuscularly.
Intravenous treatment can be continued with intramuscular treatment if necessary. The single dose per injection and application site should not be more than 2 g of piperacillin.
b) Infants and children (1 month to 12 years):
For infants and children, only intravenous administration of piperacillin is recommended.
Intravenous use (injection or infusion):
The recommended daily dose is usually between 100 and 200 mg piperacillin per kg body weight, divided into 2 - 4 single doses.
In severe cases (such as septicemia), between 200 and 300 mg piperacillin per kg body weight should be given daily, divided into 2 - 4 single doses.
c) newborns (<1 month)
For newborns, only intravenous administration of piperacillin is recommended.
150 mg / kg body weight per day, i.v., divided into three single doses for newborns younger than 7 days or older than 7 days but weighing <2,000 g.
300 mg / kg body weight per day, i.v., divided into 3 or 4 single doses for newborns older than 7 days and with a body weight> 2,000 g.
Renal failure:
In patients with renal insufficiency, intravenous administration should be adapted to the respective degree of impairment of renal function.
Recommended dosage for adults:
The following recommendations are upper dose limits and apply to an average adult weight of 70 kg:

Kidney functionCreatinine Clearance(Serum Creatinine *) (mg%)daily
Maximum dose
Dosing interval
(ml / min)
Slight restriction40 - 80(1,5 - 3)*16 g4 g every 6 hours
Moderate restriction20 - 40(3 - 5)*12 g4 g every 8 hours
Severe restriction< 20(more than 5) *8 g4 g every 12 hours
Hemodialysis patients **6 g2 g every 8 hours
* The serum creatinine values ​​are guide values ​​and do not indicate exactly the same degree of impairment for all patients with impaired renal function; If only the serum creatinine is known at the beginning of the therapy, the creatinine clearance can be approximated using the following formula.
Men: Creatinine Clearance (ml / min) = Weight (kg) x (140 - Age)
72 x serum creatinine (mg / dl)
or.
Men: Creatinine Clearance (ml / min) = Weight (kg) x (140 - Age)
0.814 x serum creatinine (mol / l)
Women: 0.85 x the value applicable to men
** Hemodialysis removes 30-50% piperacillin in 4 hours. Therefore, an additional 1 g of piperacillin should be administered after each dialysis period.
Dosage recommendation for children (older than 1 month to 12 years):
Creatinine Clearance
(ml / min) *
uncomplicated urinary tract infectioncomplicated urinary tract infectionSevere general infection
> 40no dose adjustment required
20 - 40no dose adjustment
required
150 mg / kg body weight / day200 mg / kg body weight / day
< 2075 mg / kg body weight / day100 mg / kg body weight / day133 mg / kg body weight / day
* based on a body surface of 1.73 m2
In acute infections, the duration of use of Piperacillin-Actavis 1g / 2g / 4g should exceed 2 to 4 days after the main clinical symptoms or the increased temperature have subsided. However, the duration of treatment should be determined according to the course of the disease.
If you use more Piperacillin Actavis 1g / 2g / 4g
than you should
See also section 4. What side effects are possible?
In very high doses, penicillins can lead to cerebral (epileptic) cramps, central nervous excitement and myoclonus - generally only in the case of simultaneous renal insufficiency.
A specific antidote is not known.
In an emergency, all necessary intensive care measures are indicated.
Hemodialysis can reduce high serum levels.
Anticonvulsants (such as diazepam or barbiturates) may be indicated in the event of motor excitement or convulsions.
If you forget to use Piperacillin Actavis 1g / 2g / 4g
Do not use a double dose to make up for a forgotten dose.
If you stop using Piperacillin Actavis 1g / 2g / 4g
Not specified
If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

What are the possible side effects?

When using Piperacillin-Actavis 1g / 2g / 4g together
with food and drink
Not specified
What side effects are possible?
Like all medicines, Piperacillin Actavis 1g / 2g / 4g can cause side effects, although not everybody gets them.
When evaluating side effects, the following frequencies are used as a basis:

very common: more than 1 in 10 people
common: less than 1 in 10, but more than 1 in 100 patients
uncommon: less than 1 in 100, but more than 1 in 1000 patients
rare: less than 1 in 1000 but more than 1 in 10,000 patients
very rare: less than 1 in 10,000 patients, or unknown
Significant side effects or signs to look out for, and
Actions to take if you are concerned:
Effects on the gastrointestinal tract
Gastrointestinal disorders with symptoms such as nausea, vomiting, gastric pressure, flatulence and diarrhea occur during treatment with Piperacillin Actavis 1g / 2g / 4g.
If severe, persistent diarrhea occurs during or in the first few weeks after treatment, pseudomembranous colitis should be considered (in most cases caused by Clostridium difficile). This intestinal disease caused by antibiotic treatment can be life-threatening (see also section? What countermeasures should be taken in the event of side effects ??).
Skin and skin appendages (see also hypersensitivity symptoms)
Often skin rashes (exanthemas) and inflammation of the mucous membranes, purpura or mucosal bleeding can occur, especially with high-dose piperacillin therapy.
Hypersensitivity symptoms
Often allergic reactions are to be expected, mostly in the form of skin reactions (e.g. exanthema, erythema, itching).
An immediate reaction in the form of a hives usually indicates a real penicillin allergy and forces treatment to be discontinued. Occasionally, serious allergic reactions as a result of sensitization to the 6-amino-penicillanic acid group, e.g. B. in the form of drug fever, joint pain, an increase in certain blood cells (eosinophilia), painful swelling of the skin and mucous membrane (angioneurotic edema), internal swelling of the larynx with narrowing of the airways and shortness of breath (laryngeal edema), serum sickness, anemia (hemolytic anemia), allergic vascular disease or kidney disease (vasculitis or nephritis) is observed.
Skin conditions such as erythema exudativum multiforme and Stevens-Johnson syndrome (life-threatening diseases with extensive blistering of the skin) have been reported rarely.
An antigen community can exist between skin fungi and penicillin, so that reactions such as after a second contact cannot be ruled out in the case of mycosis sufferers, even when penicillin is administered for the first time.
Hypersensitivity reactions of all degrees of severity - up to anaphylactic shock - have also been observed after administration of piperacillin (see also section? What countermeasures should be taken in the event of side effects?). Severe anaphylactoid reactions require immediate appropriate emergency response.
Kidneys, urinary tract and genital organs
Frequently, there can be an increase in the concentrations of substances normally excreted in the urine (creatinine, uric acid and urea) in the blood and rarely an acute kidney inflammation (interstitial nephritis).
Nervous system
Often headache.
High concentrations of piperacillin in the blood, which can also be due to impaired kidney function, can lead to states of central nervous excitement, muscle twitching (myoclonus), tonic / clonic spasms, tremors and dizziness.
What countermeasures should be taken in the event of side effects?
The following very rare side effects (for a more detailed explanation of these side effects see above) can under certain circumstances be acutely life-threatening. A doctor should therefore be informed immediately if such an event occurs suddenly or develops unexpectedly.
Pseudomembranous colitis:
The doctor must consider discontinuing treatment with Piperacillin Actavis 1g / 2g / 4g depending on the indication and, if necessary, initiate appropriate treatment immediately (e.g. oral vancomycin, 250 mg 4 times daily for adults).
Medicines that inhibit bowel movement (peristalsis) must not be taken.
Severe acute hypersensitivity reactions (e.g. anaphylaxis):
In this case, treatment with piperacillin 1g / 2g / 4g must be stopped immediately and the usual appropriate emergency measures (e.g. antihistamines, corticosteroids, sympathomimetics and, if necessary, ventilation) initiated.
Occurrence of (epilepsy-like) seizures:
The usual, appropriate emergency measures are indicated (e.g. keep airways free, anticonvulsants such as diazepam or barbiturates).
Other possible side effects
Changes in blood count
Very rarely a decrease in the number of white blood cells and platelets (leukopenia to agranulocytosis, thrombocytopenia), an increase in certain white blood cells caused by allergies (eosinophilia) and a decrease in
Concentration of potassium in the blood. Uncommon decrease in the amount of pigment in the blood (hemoglobin and hematocrit), increase in platelet count.
With high-dose piperacillin treatment, functional disorders of the blood platelets have occasionally been observed, which manifest themselves as a prolongation of the bleeding time and as small-spotted bleeding in the skin or mucous membrane (purpura). This occurs especially in patients with severely impaired kidney function. Bleeding may occur with prolonged treatment (see section? Take special care with Piperacillin-Actavis 1g / 2g / 4g?).
Liver and biliary tract
Temporary increase in liver enzymes (transaminases, alkaline phosphatase) and serum bilirubin levels.
Local reactions
Pain at the injection site and phlebitis up to thrombophlebitis are possible.

How should it be stored?

How to store Piperacillin Actavis 1g / 2g / 4g
Store drug out of reach of children.
You may use the medicine according to the? Use by? On the label and the carton. Do not use the stated expiry date. The expiry date refers to the last day of the month.
Storage conditions:
This medicinal product does not require special storage conditions.
Information on the shelf life after opening or preparation
The shelf life of the finished medicinal product in the undamaged container is 2 years.
The chemical and physical stability of the ready-to-use preparation with

  • Water for injections was for 24 hours at room temperature, not above 25 ° C, and for
  • Glucose solution 5%, saline solution 0.9%, lactated Ringer's solution: 8 hours at room temperature, not above 25 ° C,

proven.
Unused solutions must be destroyed after this time.
From a microbiological point of view, the ready-to-use preparation should be used immediately, unless the method of reconstitution excludes the risk of microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

additional Information

What Piperacillin Actavis 1g / 2g / 4g contain
The active ingredient is:
Piperacillin Actavis 1g
1 vial contains:
Piperacillin sodium 1.042 g (equivalent to 1.0 g piperacillin)
Piperacillin Actavis 2g
1 vial contains:
Piperacillin sodium 2.084 g (equivalent to 2.0 g piperacillin)
Piperacillin Actavis 4g
1 vial contains:
Piperacillin sodium 4.168 g (equivalent to 4.0 g piperacillin)
Other ingredients
No
What Piperacillin Actavis 1g / 2g / 4g looks like and contents of the pack
Piperacillin Actavis 1g
Powder vial for solution for injection or infusion
Piperacillin Actavis 2g
Powder vial for solution for injection or infusion
Piperacillin Actavis 4g
Powder vial for solution for injection or infusion
Pharmaceutic entrepreneur
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Co-distribution
Actavis Germany GmbH & Co. KG
Elisabeth-Selbert-Str. 1
40764 Langenfeld
Telephone: 0217674 - 0
Fax: 0217 674 - 240
Manufacturer
Actavis Germany GmbH & Co. KG
Elisabeth-Selbert-Str. 1
40764 Langenfeld
or
Laboratorio Reig Jofr?
C / Jarama, s / n Pol. ind.
45007 Toledo
Spain
This medicine is available in the member states of the European
Economic area (EEA) under the following designations:
Not applicable
This leaflet was last revised in 0008
The following information is for medical or healthcare professionals only
Certainly:
Piperacillin is administered parenterally. Piperacillin-Actavis 1g / 2g / 4g can be administered as a slow intravenous injection (3 to 5 min.) Or as an intravenous infusion (20 to 40 min.). Piperacillin Actavis 2g can also be given as an intramuscular injection.
Intravenous injection:
Piperacillin Actavis 1g
The contents of one vial of Piperacillin Actavis 1g should be dissolved in at least 5 ml of water for injections.
Piperacillin Actavis 2g
The contents of one vial of Piperacillin Actavis 2g should be dissolved in at least 10 ml of water for injections.
Piperacillin Actavis 4g
The contents of one vial of Piperacillin Actavis 4g should be dissolved in at least 20 ml of water for injections.
The solutions should be injected intravenously slowly (3-5 minutes).
Intravenous infusion:
Piperacillin Actavis 1g
The contents of one vial of Piperacillin Actavis 1g should be dissolved in 10 ml of water for injections.
Piperacillin Actavis 2g
The contents of one vial of Piperacillin Actavis 2g should be dissolved in 20 ml - 50 ml water for injections.
Piperacillin Actavis 4g
The contents of one vial of Piperacillin Actavis 4g should be dissolved in 50 ml of water for injections.
A further dilution to larger desired volumes is possible. The duration of the infusion should be 20-40 minutes. A dilution can be made with the following solvents:
Water for injections
Glucose solution 5%
Saline solution 0.9%
Lactated Ringer's solution
When using the solvents mentioned above, piperacillin solutions lose less than 5% of their activity if the following storage times are not exceeded:

  • Water for injections: 24 hours at room temperature, not above 25 ° C
  • Glucose solution 5%, saline solution 0.9%, lactated Ringer's solution: 8 hours at room temperature, not above 25 ° C

Unused solutions must be destroyed after this time.
Intramuscular injection:
Piperacillin Actavis 2g
The contents of one vial of Piperacillin Actavis 2g should be dissolved in at least 4 ml of water for injections.
No more than 2g of piperacillin should be given per injection at the same injection site.
Main incompatibilities:
Unless compatibility with other infusion solutions (see section? Information on shelf life after opening or preparation?) And medicinal products has been proven, piperacillin solution should always be used separately. In particular, piperacillin must not be mixed with solutions containing sodium hydrogen carbonate, aminoglycosides, blood products or protein hydrolysates.

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