Saturday, October 29, 2016

Plendil 2.5mg, Plendil 5mg and Plendil 10mg






Plendil



2.5 mg, 5 mg and 10 mg tablets


felodipine



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


1. What Plendil is and what it is used for

2. Before you take Plendil

3. How to take Plendil

4. Possible side effects

5. How to store Plendil

6. Further information





What Plendil is and what it is used for


Plendil contains a medicine called felodipine. This belongs to a group of medicines called "calcium channel blockers". Plendil is used to treat high blood pressure (hypertension) or to prevent a painful heart condition called angina.


It works by making your blood vessels relax and widen. This helps to lower your blood pressure and to prevent chest pain (angina).




Before you take Plendil



Do not take Plendil if:


  • You are allergic (hypersensitive) to felodipine or any of the other ingredients in Plendil tablets (see Section 6: Further information).

  • You are allergic to dihydropyridine medicines (such as nifedipine or amlodipine).

  • You have something called unstable angina (angina that is not well controlled by medical treatment).

  • You have severe heart problems.

  • You have had a heart attack in the last month.

  • You have something called cardiogenic shock (a serious condition where the heart is unable to supply enough blood to the body).

  • You are pregnant or trying to get pregnant (see "Pregnancy and breast-feeding" below).

Do not take Plendil if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Plendil.




Take special care with Plendil


Before you take Plendil, tell your doctor if you have liver problems.




Taking other medicines


Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes herbal medicines and medicines that you buy without a prescription.


In particular, tell your doctor or pharmacist if you are taking any of the following medicines:


  • Cimetidine (for ulcers).

  • Erythromycin (for bacterial infections).

  • Itraconazole or ketoconazole (for fungal infections).

  • Phenytoin, carbamazepine or phenobarbital (for epilepsy).

  • Tacrolimus (used after kidney or liver transplant).



Taking Plendil with food and drink



Do not drink grapefruit juice while you are taking Plendil tablets. It can affect the way the medicine works.




Pregnancy and breast-feeding


  • Do not take Plendil if you are pregnant or trying to get pregnant. This is because Plendil can harm your unborn baby.

  • If you are breast-feeding, talk to your doctor before taking Plendil.



Driving and using machines


If you feel dizzy after taking this medicine, do not drive or use any tools or machines.





How to take Plendil


Always take Plendil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


  • Swallow your tablet(s) whole with a drink of water. Do not crush or chew the tablets.

  • Your tablets are in a pack with the days of the week shown. This will help you to remember when to take them.


Adults with high blood pressure (hypertension)


  • The usual dose is one 5 mg tablet in the morning.

  • However, your doctor may start you on one 2.5 mg tablet.

  • Your doctor may increase the dose to 10 mg.


Adults with angina


  • The usual dose is one 5 mg tablet in the morning.

  • Your doctor may increase the dose up to 10 mg.


If you take more Plendil than you should


If you have taken more Plendil than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Plendil medicine with you.




If you forget to take Plendil


  • If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

  • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.


If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible side effects


Like all medicines, Plendil can cause side effects, although not everybody gets them.



If any of the following happen to you, stop taking Plendil and tell a doctor straight away:


  • Chest pain and dizziness at the same time.

  • An allergic reaction. The signs may include raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.

Other possible side effects include:



  • Heart and circulation: faster heartbeat, swollen ankles, fainting.


  • Nervous system: pins and needles feeling in your toes or fingers.


  • Liver: liver problems shown on a blood test.


  • Digestive system: stomach pain, feeling sick or being sick, swollen gums. (If you already have swollen gums they may get worse. You can prevent this by careful dental hygiene.)


  • Urinary: passing water (urine) more often.


  • Joints and muscles: pain in joints and muscles.


  • Skin: skin inflammation, rash, itching, being sensitive to sunlight.


  • Sexual: being unable to get an erection (impotence).


  • Other: high temperature (fever).

You may get any of the following side effects at the beginning of treatment or if your dose has been increased:


  • Flushing, headaches, faster or pounding heartbeat, feeling dizzy or tired.

Do not be alarmed by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How to store Plendil


  • Keep out of the reach and sight of children.

  • Do not use this medicine after the expiry date shown on the label. The expiry date refers to the last day of that month.

  • Do not store this medicine above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Plendil contains


  • The active ingredient is felodipine. Plendil tablets contain 2.5 milligrams (mg), 5 mg or 10 mg of felodipine.

  • The other ingredients are polyoxyl 40 hydrogenated castor oil, hydroxypropyl cellulose, propyl gallate, hydroxypropyl methylcellulose, sodium aluminium silicate, microcrystalline cellulose, lactose anhydrous, sodium stearyl fumarate, macrogol, colours E171 and E172 and carnauba wax.



What Plendil looks like and contents of the pack


Plendil 2.5 mg tablets are yellow marked with A/FL on one side and 2.5 on the other side.


Plendil 5 mg tablets are pink marked with A/FM on one side and 5 on the other side.


Plendil 10 mg tablets are red-brown marked with A/FE on one side and 10 on the other side.


Plendil tablets come in blister strips containing 7 tablets which have the days of the week shown. A single pack contains 28 tablets as multiples of the 7 tablet blister strip.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation for Plendil is held by



AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UK


Plendil is manufactured by



AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK



To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:


0800 198 5000 (UK only)


Please be ready to give the following information:



Product name Reference number


Plendil 2.5 mg tablets 17901/0156


Plendil 5 mg tablets 17901/0157


Plendil 10 mg tablets 17901/0155


This is a service provided by the Royal National Institute of the Blind.



Leaflet prepared: March 2010.


© AstraZeneca 2010


Plendil is a trade mark of the AstraZeneca group of companies.


CV 10 0022



P027715






Friday, October 28, 2016

AmBisome





1. Name Of The Medicinal Product



AmBisome 50 mg Powder for solution for infusion


2. Qualitative And Quantitative Composition



Each vial contains 50 mg of amphotericin (50,000 units) encapsulated in liposomes. After reconstitution, the concentrate contains 4 mg/mL amphotericin B.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



AmBisome is a sterile, Powder for solution for infusion. AmBisome is a yellow lyophilised cake or powder. After reconstitution, the product is an injectable intended to be administered by intravenous infusion.



4. Clinical Particulars



4.1 Therapeutic Indications



AmBisome is indicated in:



• the treatment of severe systemic and/or deep mycoses where toxicity (particularly nephrotoxicity) precludes the use of conventional systemic amphotericin B in effective dosages.



• the treatment of visceral leishmaniasis in immunocompetent patients including both adults and children.



• the empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause.



Infections successfully treated with AmBisome include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis.



This drug should not be used to treat the common clinically inapparent forms of fungal disease which show only positive skin or serologic tests.



4.2 Posology And Method Of Administration



AmBisome should be administered by intravenous infusion over a 30 - 60 minute period. For doses greater than 5mg/kg/day, intravenous infusion over a 2 hour period is recommended (see section 4.4). The recommended concentration for intravenous infusion is 0.20 mg/ml to 2.00 mg/ml amphotericin B as AmBisome.



Adult Patients



Treatment of mycoses:



Therapy is usually instituted at a daily dose of 1.0 mg/kg of body weight, and increased stepwise to 3.0 mg/kg, as required. Data are presently insufficient to define total dosage requirements and duration of treatment necessary for resolution of mycoses. However, a cumulative dose of 1.0 - 3.0 g of amphotericin B as AmBisome over 3 - 4 weeks has been typical. Dosage of amphotericin B as AmBisome must be adjusted to the specific requirements of each patient.



Treatment of visceral leishmaniasis:



A total dose of 21.0 - 30.0 mg/kg of body weight given over 10-21 days may be used in the treatment of visceral leishmaniasis. Particulars as to the optimal dosage and the eventual development of resistance are as yet incomplete. The product should be administered under strict medical supervision.



Empirical treatment of febrile neutropenia:



The recommended daily dose is 3 mg/kg body weight per day. Treatment should be continued until the recorded temperature is normalised for 3 consecutive days. In any event, treatment should be discontinued after a maximum of 42 days.



Paediatric Patients: Both systemic fungal infections in children and presumed fungal infections in children with febrile neutropenia have been successfully treated with AmBisome, without reports of unusual adverse events. Paediatric patients have received AmBisome at doses comparable to those used in adults on a per kilogram body weight basis.



AmBisome is not recommended for use in children below 1 month old due to a lack of data on safety and efficacy.



Elderly Patients: No alteration in dose or frequency of dosing is required.



Renal Impairment: AmBisome has been administered to a large number of patients with pre-existing renal impairment at starting doses ranging from 1-3 mg/kg/day in clinical trials and no adjustment in dose or frequency of administration was required (See section 4.4).



Hepatic Impairment: No data are available on which to make a dose recommendation for patients with hepatic impairment (See section 4.4).



For instructions on reconstitution and dilution of the product before administration, see section 6.6.



4.3 Contraindications



AmBisome is contraindicated in those patients who have shown hypersensitivity to the active substance or to any of the excipients unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to AmBisome therapy.



4.4 Special Warnings And Precautions For Use



Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome (see section 4.8). Therefore, administration of a test dose is still advisable before a new course of treatment. For this purpose a small amount of an AmBisome infusion (e.g. 1 mg) can be administered for about 10 minutes, the infusion stopped and the patient observed carefully for the next 30 minutes. If there have been no severe allergic or anaphylactic/anaphylactoid reactions the infusion of AmBisome dose can be continued. If a severe allergic or anaphylactic/anaphylactoid reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusion of AmBisome.



Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome (see section 4.8). Although infusion-related reactions are not usually serious, consideration of precautionary measures for the prevention or treatment of these reactions should be given to patients who receive AmBisome therapy. Slower infusion rates (over 2 hours) or routine doses of diphenhydramine, paracetamol, pethidine and/or hydrocortisone have been reported as successful in their prevention or treatment.



AmBisome has been shown to be substantially less toxic than conventional amphotericin B, particularly with respect to nephrotoxicity; however, adverse reactions including renal adverse reactions, may still occur.



In studies comparing AmBisome 3 mg/kg daily with higher doses (5, 6 or 10 mg/kg daily, it was found that the incidence rates of increased serum creatinine, hypokalaemia and hypomagnesaemia were notably higher in the high dose groups.



In particular, caution should be exercised when prolonged therapy is required. Regular laboratory evaluation of serum electrolytes, particularly potassium and magnesium as well as renal, hepatic and haematopoietic function should be performed, at least once weekly. This is particularly important in patients receiving concomitant nephrotoxic medications (see section 4.5). Renal function should be closely monitored in these patients. Due to the risk of hypokalaemia, appropriate potassium supplementation may be required during the course of AmBisome administration. If clinically significant reduction in renal function or worsening of other parameters occurs, consideration should be given to dose reduction, treatment interruption or discontinuation.



Acute pulmonary toxicity has been reported in patients given amphotericin B (as sodium deoxycholate complex) during or shortly after leukocyte transfusions. It is recommended that these infusions are separated by as long a period as possible and pulmonary function should be monitored.



In the Treatment of Diabetic Patients: It should be noted that AmBisome contains approximately 900 mg of sucrose in each vial.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No specific interaction studies have been performed with AmBisome. However, the following drugs are known to interact with amphotericin B and may interact with AmBisome:



Nephrotoxic medications: Concurrent administration of AmBisome with other nephrotoxic agents (for example ciclosporin, aminoglycosides, polymixins, tacrolimus and pentamidine) may enhance the potential for drug-induced renal toxicity in some patients. However, in patients receiving concomitant ciclosporin and/or aminoglycosides, AmBisome was associated with significantly less nephrotoxicity compared to amphotericin B. Regular monitoring of renal function is recommended in patients receiving AmBisome with any nephrotoxic medications.



Corticosteroids, corticotropin (ACTH) and diuretics: Concurrent use of corticosteroids, ACTH and diuretics (loop and thiazide) may potentiate hypokalemia.



Digitalis glycosides: AmBisome-induced hypokalemia may potentiate digitalis toxicity.



Skeletal muscle relaxants: AmBisome-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine).



Antifungals: No evidence of benefit from the use of flucytosine with AmBisome has been observed. Whilst synergy between amphotericin and flucytosine has been reported, concurrent use may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion.



Antineoplastic agents: Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm and hypotension. Antineoplastic agents should be given concomitantly with caution.



Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients given amphotericin B (as sodium deoxycholate complex) during or shortly after leukocyte transfusions. It is recommended these infusions are separated by as long a period as possible and pulmonary function should be monitored.



4.6 Pregnancy And Lactation



Pregnancy



Teratogenicity studies in both rats and rabbits have concluded that AmBisome had no teratogenic potential in these species (See also section 5.3).



The safety of AmBisome in pregnant women has not been established. AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks to the mother and foetus.



Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the foetus, but the number of cases reported is insufficient to draw any conclusions on the safety of AmBisome in pregnancy.



Lactation



It is unknown whether AmBisome is excreted in human breast milk. A decision on whether to breastfeed while receiving AmBisome should take into account the potential risk to the child as well as the benefit of breast feeding for the child and the benefit of AmBisome therapy for the mother.



4.7 Effects On Ability To Drive And Use Machines



No studies on the effects on the ability to drive and use machines have been performed. Some of the undesirable effects of AmBisome presented below may impact the ability to drive and use machines.



4.8 Undesirable Effects



Fever and chills/rigors are the most frequent infusion-related reactions expected to occur during AmBisome administration. Less frequent infusion-related reactions may consist of one or more of the following symptoms: back pain, chest tightness or pain, dyspnoea, bronchospasm, flushing, tachycardia, and hypotension. These resolve rapidly on stopping the infusion and may not occur with every subsequent dose or when slower infusion rates (over 2 hours) are used. In addition, infusion-related reactions may also be prevented by the use of premedication. However, severe infusion-related reactions may necessitate the permanent discontinuation of AmBisome (see section 4.4).



In two double-blind, comparative studies, AmBisome treated patients experienced a significantly lower incidence of infusion-related reactions, as compared to patients treated with conventional amphotericin B or amphotericin B lipid complex.



In pooled study data from randomised, controlled clinical trials comparing AmBisome with conventional amphotericin B therapy in greater than 1,000 patients, reported adverse reactions were considerably less severe and less frequent in AmBisome treated patients as compared with conventional amphotericin B treated patients.



Nephrotoxicity occurs to some degree with conventional amphotericin B in most patients receiving the drug intravenously. In a double-blind study involving 687 patients, the incidence of nephrotoxicity with AmBisome (as measured by serum creatinine increase greater than 2.0 times baseline measurement), was approximately half that for conventional amphotericin B. In another double-blind study involving 244 patients, the incidence of nephrotoxicity with AmBisome (as measured by serum creatinine increase greater than 2.0 times baseline measurement) is approximately half that for Amphotericin B lipid complex.



The following adverse reactions have been attributed to AmBisome based on clinical trial data and post-marketing experience. The frequency is based on analysis from pooled clinical trials of 688 AmBisome treated patients; the frequency of adverse reactions identified from post-marketing experience is not known. Adverse reactions are listed below by body system organ class using MedDRA and are sorted by frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.



Frequencies are defined as:












Very common




(




Common




(




Uncommon




(




Very rare




(<1/10,000), not known (cannot be estimated from the available data)



BLOOD AND LYMPHATIC SYSTEM DISORDERS



Uncommon: thrombocytopenia



Not known: anemia



IMMUNE SYSTEM DISORDERS



Uncommon: anaphylactoid reaction



Not known: anaphylactic reactions, hypersensitivity



METABOLISM AND NUTRITION DISORDERS



Very common: hypokalemia



Common: hyponatremia, hypocalcemia, hypomagnesaemia hyperglycemia,



NERVOUS SYSTEM DISORDERS



Common: headache



Uncommon: convulsion



CARDIAC DISORDERS



Common: tachycardia



Not known: cardiac arrest, arrhythmia



VASCULAR DISORDERS



Common: hypotension, vasodilatation, flushing,



RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS



Common: dyspnoea



Uncommon: bronchospasm



GASTROINTESTINAL DISORDERS



Very common: nausea, vomiting



Common: diarrhoea, abdominal pain



HEPATOBILIARY DISORDERS



Common: liver function tests abnormal, hyperbilirubinaemia, alkaline phosphatase increased



SKIN AND SUBCUTANEOUS DISORDERS



Common: rash



Not known: angioneurotic oedema



MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS



Common: back pain



Not Known: rhabdomyolysis (associated with hypokalemia)



RENAL AND URINARY DISORDERS



Common: increased creatinine, blood urea increased



Not known: renal failure, renal insufficiency



GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS



Very Common: rigors, pyrexia,



Common: chest pain



Interference with Phosphorus Chemistry Assay:



False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.



4.9 Overdose



The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease administration immediately. Carefully monitor clinical status including renal and hepatic function, serum electrolytes and haematological status. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics; ATC code: J02AA01.



Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. Liposomes are closed, spherical vesicles formed from a variety of amphiphilic substances such as phospholipids. Phospholipids arrange themselves into membrane bilayers when exposed to aqueous solutions. The lipophilic moiety of amphotericin allows the drug to be integrated into the lipid bilayer of the liposomes.



Amphotericin B is fungistatic or fungicidal depending on the concentration attained in body fluids and the susceptibility of the fungus. The drug is thought to act by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules. Mammalian cell membranes also contain sterols, and it has been suggested that the damage to human cells and fungal cells caused by amphotericin B may share common mechanisms.



Microbiology



Amphotericin B, the antifungal component of AmBisome, shows a high order of in vitro activity against many species of fungi. Most strains of Histoplasma capsulatum, Coccidioides immitis, Candida spp., Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenkii, Mucor mucedo and Aspergillus fumigatus, are inhibited by concentrations of amphotericin B ranging from 0.03 to 1.0 mcg/ml in vitro. Amphotericin has minimal or no effect on bacteria and viruses.



5.2 Pharmacokinetic Properties



The pharmacokinetic profile of AmBisome, based upon total plasma concentrations of amphotericin B, was determined in cancer patients with febrile neutropenia and bone marrow transplant patients who received 1 hour infusions of 1.0 to 7.5mg/kg/day AmBisome for 3 to 20 days. AmBisome has a significantly different pharmacokinetic profile from that reported in the literature for conventional presentations of amphotericin B, with higher amphotericin B plasma concentrations (Cmax) and increased exposure (AUC0-24) following administration of AmBisome as compared to conventional amphotericin B. After the first dose and last dose, the pharmacokinetic parameters of AmBisome (mean ± standard deviation) ranged from:














C max




7.3 μg/ml (± 3.8) to 83.7 μg/ml (± 43.0)




T 1/2




6.3 hr (± 2.0) to 10.7 hr (± 6.4)




AUC 0-24




27 μg.hr/ml (±14) to 555 μg.hr/ml (± 311)




Clearance (CI)




11 ml/hr/kg (± 6) to 51 ml/hr/kg (± 44)




Volume of distribution (Vss)




0.10 L/kg (± 0.07) to 0.44 L/kg (±0.27)



Minimum and maximum pharmacokinetic values do not necessarily come from the lowest and highest doses, respectively. Following administration of AmBisome steady state was reached quickly (generally within 4 days of dosing). AmBisome pharmacokinetics following the first dose appear non-linear such that serum AmBisome concentrations are greater than proportional with increasing dose. This non-proportional dose response is believed to be due to saturation of reticuloendothelial AmBisome clearance. There was no significant drug accumulation in the plasma following repeated administration of 1 to 7.5mg/kg/day. Volume of distribution on day 1 and at steady state suggests that there is extensive tissue distribution of AmBisome. After repeated administration of AmBisome, the terminal elimination half-life (t½β) for AmBisome was approximately 7 hours. The excretion of AmBisome has not been studied. The metabolic pathways of amphotericin B and AmBisome are not known. Due to the size of the liposomes, there is no glomerular filtration and renal elimination of AmBisome, thus avoiding interaction of amphotericin B with the cells of the distal tubuli and reducing the potential for nephrotoxicity seen with conventional amphotericin B presentations.



Renal Impairment



The effect of renal impairment on the pharmacokinetics of AmBisome has not been formally studied. Data suggest that no dose adjustment is required in patients undergoing haemodialysis or filtration procedures, however, AmBisome administration should be avoided during the procedure.



5.3 Preclinical Safety Data



In subchronic toxicity studies in dogs (1 month), rabbits (1 month) and rats (3 months) at doses equal to or, in some species, less than the clinical therapeutic doses of 1 to 3 mg/kg/day, the target organs for AmBisome toxicity were the liver and kidneys with thrombocytopenia also observed. All are known targets for amphotericin B toxicity.



AmBisome was found to be non-mutagenic in bacterial and mammalian systems.



Carcinogenicity studies have not been conducted with AmBisome.



No adverse effects on male or female reproductive function were noted in rats.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Hydrogenated soy phosphatidylcholine



Cholesterol



Distearoylphosphatidylglycerol



Alpha tocopherol



Sucrose



Disodium succinate hexahydrate



Sodium hydroxide (for pH adjustment)



Hydrochloric acid (for pH adjustment)



6.2 Incompatibilities



AmBisome is incompatible with saline solutions and may not be mixed with other drugs or electrolytes.



This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.



6.3 Shelf Life



3 years



Shelf –life of AmBisome after first opening



As AmBisome does not contain any bacteriostatic agent, from a microbiological point of view, the reconstituted or diluted product should be used immediately.



In-use storage times and conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.



However, the following chemical and physical in-use stability data for AmBisome has been demonstrated:



Shelf-life after reconstitution:



Glass vials for 24 hours at 25±2°C exposed to ambient light



Glass vials and polypropylene syringes up to 7 days at 2-8°C



Do not freeze



DO NOT STORE partially used vials for future patient use.



Shelf-life after dilution with Dextrose:



PVC or Polyolefin infusion bags: 25±2°C exposed to ambient light or at 2-8°C. Do not freeze. See table below for recommendations.


































Diluent




Dilution




Concentration of Amphotericin B mg/mL




Maximum duration of storage at 2-8˚C




Maximum duration of storage at 25±2˚C




5% Dextrose




1:2




2.0




7 days




48 hours




1:8




0.5




7 days




48 hours


 


1:20




0.2




4 days




24 hours


 


10% Dextrose




1:2




2.0




48 hours




72 hours




20% Dextrose




1:2




2.0




48 hours




72 hours



6.4 Special Precautions For Storage



AmBisome: Unopened vials; Do not store above 25°C. Do not freeze. Keep container in the outer carton.



For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.



6.5 Nature And Contents Of Container



AmBisome is presented in 15 ml or 30ml sterile, Type I glass vials. The closure consists of a grey butyl rubber stopper and aluminium ring seal fitted with a removable plastic cap. Single-dose vials are packed ten per carton with 10 filters. Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



READ THIS ENTIRE SECTION AND SECTION 4.4 CAREFULLY BEFORE BEGINNING RECONSTITUTION



AmBisome is not interchangeable with other amphotericin products.



AmBisome must be reconstituted using Sterile Water for Injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%,10% or 20%) for infusion only.



The use of any solution other than those recommended, or the presence of a bacteriostatic agent (e.g. benzyl alcohol) in the solution, may cause precipitation of AmBisome.



AmBisome is NOT compatible with saline and must not be reconstituted or diluted with saline or administered through an intravenous line that has previously been used for saline unless first flushed with dextrose solution (5%,10% or 20%) for infusion. If this is not feasible, AmBisome should be administered through a separate line.



Do NOT mix AmBisome with other drugs or electrolytes.



Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present in AmBisome, or in the materials specified for reconstitution and dilution.



AmBisome Must Be Reconstituted By Suitably Trained Staff.



Vials of AmBisome Containing 50 mg of Amphotericin are Prepared as Follows:














1.




Add 12 ml of Sterile Water for Injection to each AmBisome vial, to yield a preparation containing 4 mg/ml amphotericin.




2.




IMMEDIATELY after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the AmBisome. After reconstitution the concentrate is a translucent, yellow dispersion. Visually inspect the vial for particulate matter and continue shaking until complete dispersion is obtained. Do not use if there is any evidence of precipitation of foreign matter.




3.




Calculate the amount of reconstituted (4 mg/ml) AmBisome to be further diluted (see table below).




4.




The infusion solution is obtained by dilution of the reconstituted AmBisome with between one (1) and nineteen (19) parts dextrose solution (5%, 10% or 20%) for infusion by volume, to give a final concentration in the recommended range of 2.00 mg/ml to 0.20 mg/ml amphotericin as AmBisome (see table below).




5.




Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. Using the 5 micron filter provided, instill the AmBisome preparation into a sterile container with the correct amount of dextrose solution (5%, 10% or 20%) for infusion.



An in-line membrane filter may be used for intravenous infusion of AmBisome. However, the mean pore diameter of the filter should not be less than 1.0 micron.



Example of the preparation of AmBisome solution for infusion at a dose of 3mg/kg/day in dextrose 5% solution for infusion.




































































Weight (kg)




Number of vials




Amount AmBisome (mg) to be withdrawn for further dilution




Volume of reconstituted AmBisome (ml)*




To make up a 0.2mg/ml concentration



(1:19 dilution)




To make up a 2.0mg/ml concentration



(1:2 dilution)


  

 

 

 

 


Volume of 5% dextrose needed (ml)




Total volume (ml; AmBisome plus 5% dextrose)




Volume of 5% dextrose needed (ml)




Total volume (ml; AmBisome plus 5% dextrose)




10




1




30




7.5




142.5




150




7.5




15




25




2




75




18.75




356.25




375




18.75




37.5




40




3




120




30




570




600




30




60




55




4




165




41.25




783.75




825




41.25




82.5




70




5




210




52.5




997.5




1050




52.5




105




85




6




255




63.75




1211.25




1275




63.75




127.5



* Each vial of AmBisome (50mg) is reconstituted with 12ml Water for Injection to provide a concentration of 4mg/ml Amphotercin B.



Any unused product or waste material should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



Gilead Sciences International Limited,



Granta Park,



Abington,



Cambridge,



CB21 6GT.



8. Marketing Authorisation Number(S)



PL: 16807/0001



9. Date Of First Authorisation/Renewal Of The Authorisation



11 September 1998/24 September 2004.



10. Date Of Revision Of The Text



22/07/2010





Human Albumin Biotest 5%





1. Name Of The Medicinal Product



Human Albumin Biotest 5%, solution for infusion


2. Qualitative And Quantitative Composition



Human albumin



Human Albumin Biotest 5% is a solution containing 50 g/l of total protein of which at least 95% is human albumin.



The product has a mildly hypooncotic effect.



For excipients, see 6.1.



3. Pharmaceutical Form



Solution for infusion.



A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.



4. Clinical Particulars



4.1 Therapeutic Indications



Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.



The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.



4.2 Posology And Method Of Administration



The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements.



Posology



The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.



If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:



− arterial blood pressure and pulse rate



− central venous pressure



− pulmonary artery wedge pressure



− urine output



− electrolyte



− haemaotcrit / haemoglobin



Method of administration



Human albumin can be directly administered by the intravenous route.



The infusion rate should be adjusted according to the individual circumstances and the indication.



In plasma exchange the infusion-rate should be adjusted to the rate of removal.



4.3 Contraindications



Hypersensitivity to albumin preparations or to any of the excipients.



4.4 Special Warnings And Precautions For Use



Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.



Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:



− Decompensated cardiac insufficiency



− Hypertension



− Oesophageal varices



− Pulmonary oedema



− Haemorrhagic diathesis



− Severe anaemia



− Renal and post-renal anuria



Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.



If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).



Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. At the fist clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.



Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.



There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.



It is strongly recommended that every time that Human Albumin Biotest 5% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No specific interactions of human albumin with other products are known.



4.6 Pregnancy And Lactation



The safety of Human Albumin Biotest 5% for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.



Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or fetus, the course of gestation and peri- and postnatal development.



However, human albumin is a normal constituent of human blood.



4.7 Effects On Ability To Drive And Use Machines



No effects on ability to drive and use machines have been observed.



4.8 Undesirable Effects



Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions as far as shock may occur. In these cases, the infusion should be stopped and an appropriate treatment should be initiated.



For safety with respect to transmissible agents, see 4.4.



4.9 Overdose



Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code: B05AA01.



Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.



Physiochemical data: Human albumin 40 to 50 g/l is mildly hypooncotic to normal plasma.



The most important physiological functions of albumin results from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.



5.2 Pharmacokinetic Properties

Under normal situations the total exchangeable albumin pool is 4-5 g/kg body weight, of which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.


Under normal conditions the half-life of albumin is on average about 19 days. The balance between synthesis and breakdown is normally achieved by feed-back regulation. Elimination is predominantly intracellular and due to lysosome proteases.



In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.



5.3 Preclinical Safety Data



Human albumin is a normal constituent of the human plasma and acts like the physiological albumin.



In animals, single-dose toxicity testing is of little relevance and does not permit the evaluation of toxic or lethal doses or of a dose-effect relationship. Repeated-dose toxicity testing is impracticable due to the development of antibodies to heterologous protein in animal models.



To date, human albumin has not been reported to be associated with embryo-fetal toxicity, oncogenic or mutagenic potential.



No signs of acute toxicity have been described in animal models.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Caprylate (4 mmol/l), N-acetyl-DL-tryptophanate (4 mmol/l), sodium ions (145 mmol/l), water for injections ad 1000 ml.



6.2 Incompatibilities



Human albumin must not be mixed with other medicinal products (except the recommended diluent), whole blood and packed red blood cells.



6.3 Shelf Life



3 years



6.4 Special Precautions For Storage



Do not store above 25°C. Do not freeze.



Keep the container in the outer carton in order to protect from light.



6.5 Nature And Contents Of Container



250 ml of a solution in a vial (Type II glass) with a grey rubber stopper (bromobutyl) and a cap (aluminium) – pack size of one vial.



6.6 Special Precautions For Disposal And Other Handling



The solution can be directly administered by the intravenous route.



Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.



If large volumes are administered, the product should be warmed to room or body temperature before use.



The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated.



Once the container has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



Biotest Pharma GmbH



Landsteinerstraße 5



63303 Dreieich



Germany



8. Marketing Authorisation Number(S)



PL 04500/0011



9. Date Of First Authorisation/Renewal Of The Authorisation



24/02/2009



10. Date Of Revision Of The Text



24/02/2009





Zetia



Generic Name: ezetimibe (Oral route)

ez-ET-i-mide

Commonly used brand name(s)

In the U.S.


  • Zetia

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antihyperlipidemic


Pharmacologic Class: Cholesterol Absorption Inhibitor


Uses For Zetia


Ezetimibe is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.


This medicine is available only with your doctor's prescription.


Before Using Zetia


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. This medicine should only be used in children 10 years of age or older.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ezetimibe in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Clofibrate

  • Gemfibrozil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Cholestyramine

  • Colestipol

  • Cyclosporine

  • Fenofibrate

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Liver disease (or history of) or

  • Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

Proper Use of Zetia


Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.


Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.


  • For tablet dosage form:
    • For high cholesterol:
      • Adults: 10 milligrams (mg) once daily. May take with or without food.

      • Children up to 10 years of age—Use is not recommended.

      • Children 10 years of age and older—10 milligrams (mg) once daily. May take with or without food.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Zetia


It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.


Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.


Tell your doctor if you experience any unexplained muscle pain, tenderness, or weakness.


Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.


Zetia Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Frequency not determined
  • Abdominal fullness

  • black tarry stools

  • bleeding gums

  • bloating

  • blood in urine or stools

  • chills

  • constipation

  • darkened urine

  • fast heartbeat

  • fever

  • gaseous abdominal pain

  • general tiredness or weakness

  • indigestion

  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

  • loss of appetite

  • light-colored stools

  • muscle cramps or spasms

  • muscular tenderness, wasting or weakness

  • nausea

  • pains in stomach, side or abdomen, possibly radiating to the back

  • pinpoint red spots on skin

  • recurrent fever

  • severe nausea

  • skin rash

  • unusual bleeding or bruising

  • upper right abdominal pain

  • vomiting

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Fever

  • headache

  • muscle pain

  • runny nose

  • sore throat

Less common
  • Back pain

  • body aches or pain

  • chest pain

  • chills

  • cold or flu-like symptoms

  • congestion

  • coughing

  • diarrhea

  • difficulty in moving

  • dizziness

  • dryness or soreness of throat

  • hoarseness

  • muscle pain or stiffness

  • pain in joints

  • pain or tenderness around eyes and cheekbones

  • shortness of breath or troubled breathing

  • stomach pain

  • stuffy nose

  • tender, swollen glands in neck

  • tightness of chest or wheezing

  • trouble in swallowing

  • unusual tiredness or weakness

  • voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zetia side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Zetia resources


  • Zetia Side Effects (in more detail)
  • Zetia Use in Pregnancy & Breastfeeding
  • Drug Images
  • Zetia Drug Interactions
  • Zetia Support Group
  • 10 Reviews for Zetia - Add your own review/rating


  • Zetia Prescribing Information (FDA)

  • Zetia Consumer Overview

  • Zetia Monograph (AHFS DI)

  • Zetia MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ezetimibe Professional Patient Advice (Wolters Kluwer)



Compare Zetia with other medications


  • High Cholesterol
  • High Cholesterol, Familial Heterozygous
  • Sitosterolemia


Imipenem and cilastatin


Generic Name: imipenem and cilastatin (IM i PEN em and SYE la STAT in)

Brand names: Primaxin IM, Primaxin IV, Primaxin IV ADD-Vantage


What is imipenem and cilastatin?

Imipenem is an antibiotic that fights serious infections caused by bacteria.


Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.


Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.


Imipenem and cilastatin may also be used for other purposes not listed here.


What is the most important information I should know about imipenem and cilastatin?


Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

Before using imipenem and cilastatin, tell your doctor if you have kidney disease (or if you are on dialysis), or a seizure disorder.


Also tell your doctor if you are either allergic to or are currently taking a penicillin or cephalosporin antibiotic such as Amoxil, Augmentin, Bactocill, Beepen-VK, Ceclor, Ceftin, Duricef, Dycill, Dynapen, Keflex, Ledercillin VK, Omnipen, Pen-V, Pfizerpen, Principen, Veetids, and others.

Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.


Call your doctor at once if you have serious side effects such as pounding heartbeats, confusion, hallucinations, seizure (convulsions), feeling light-headed, fainting, flu symptoms, nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


What should I discuss with my healthcare provider before use imipenem and cilastatin?


Do not use imipenem and cilastatin if you are allergic to it, if you have heart block, or if you are allergic to lidocaine or other local anesthetics (numbing medicine).

If you have any of these other conditions, you may need a dose adjustment or special tests:


  • kidney disease (or if you are on dialysis);


  • epilepsy or other seizure disorder;




  • a history of allergy to penicillin antibiotics such as Amoxil, Augmentin, Omnipen, Principen, Dycill, Dynapen, Bactocill, Beepen-VK, Ledercillin VK, Pen-V, Pfizerpen, Veetids, and others; or




  • a history of allergy to cephalosporin antibiotics such as Ceclor, Ceftin, Duricef, Keflex, and others.




FDA pregnancy category C. It is not known whether imipenem and cilastatin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether imipenem and cilastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use imipenem and cilastatin?


Imipenem and cilastatin is injected into a vein (IV) or into a muscle (IM).


Imipenem and cilastatin is usually given in a clinic or hospital setting. The IV medicine must be given as a slow infusion and can take up to an hour to complete. Tell your caregiver if you feel nauseated during the infusion. You may need to receive the medicine at a slower rate.


The IM form of imipenem and cilastatin is given as a rapid injection into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Primaxin IM (for the muscle) and Primaxin IV (for the vein) are different forms of this medicine and should be used only for their specific type of injection. Do not inject Primaxin IM into a vein and do not inject Primaxin IV into a muscle.


Imipenem and cilastatin is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.


Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Imipenem and cilastatin will not treat a viral infection such as the common cold or flu.


Do not give this medication to another person, even if they have the same symptoms you do.


Imipenem and cilastatin is a powder that must be mixed with a liquid (diluent). Primaxin IM and Primaxin IV are each mixed with different types of diluent.


Prepare your dose in a syringe only when you are ready to give yourself an injection.


After mixing Primaxin IV, you may keep it in a refrigerator and use it within 24 hours. You may also store the mixed IV medicine at room temperature if you use it within 4 hours. Store unmixed imipenem and cilastatin powder at room temperature away from moisture and heat.

What happens if I miss a dose?


If imipenem and cilastatin is given in a hospital setting, it is not likely that you will miss a dose. If you are using the medication at home and you miss a dose, give the injection as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weakness, drooping eyelid, tremors, trouble breathing, or seizure (black-out or convulsions).


What should I avoid while using imipenem and cilastatin?


Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


Imipenem and cilastatin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;




  • diarrhea that is watery or bloody;




  • confusion, tremors, hallucinations, seizure (convulsions);




  • feeling light-headed, fainting;




  • fever, chills, body aches, flu symptoms;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.



Less serious side effects may include:



  • pain, swelling, or redness where the medicine was injected;




  • mild nausea, vomiting, heartburn, or stomach pain;




  • sore throat;




  • vaginal itching or discharge;




  • mild skin rash or itching;




  • dizziness or tired feeling;




  • numbness or tingling; or




  • ringing in your ears.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Imipenem and cilastatin Dosing Information


Usual Adult Dose for Aspiration Pneumonia:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: Parenteral therapy should be continued until the patient's clinical condition stabilizes and fever subsides. Oral antibiotic therapy may then be initiated according to microbiologic sensitivity data. Therapy of documented anaerobic pleuropulmonary infections should be continued until the infiltrate is cleared or a residual scar forms, sometimes requiring 2 to 4 months.

Usual Adult Dose for Bacteremia:

500 mg IV every 6 hours or 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Septicemia:

500 mg IV every 6 hours or 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Bronchitis:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Pelvic Infections:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Endometritis:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Deep Neck Infection:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 3 to 4 weeks, depending on the nature and severity of the infection

Usual Adult Dose for Endocarditis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Febrile Neutropenia:

500 mg IV every 6 hours if suspected causative organism is fully susceptible, 1 g IV every 8 hours if other suspected causative organisms are moderately susceptible, or 1 g IV every 6 hours if Pseudomonas aeruginosa is suspected causative organism (based on imipenem content)
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: Once the patient is stable and afebrile for at least 24 hours, and the absolute neutrophil count is at least 500 cells/mm3, oral antimicrobial therapy, based on susceptibility patterns, may be initiated. Then duration of therapy is dependent on the clinical situation.

Usual Adult Dose for Intraabdominal Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 14 days, depending on the nature and severity of the infection

IM:
Mild to moderate infections: 750 mg IM every 12 hours
Maximum dose: 1500 mg/day

Usual Adult Dose for Joint Infection:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 3 to 4 weeks, depending on the nature and severity of the infection
Longer therapy, 6 weeks or more, may be required for prosthetic joint infections.

Usual Adult Dose for Meningitis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection
Treatment of meningitis due to Listeria species should be continued for 3 to 6 weeks.

Usual Adult Dose for Nosocomial Pneumonia:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Initial empiric treatment with broad-spectrum coverage according to the hospital's and/or ICU's antibiogram is recommended if multidrug-resistant organisms are suspected.

Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: If the causative organism is not Pseudomonas aeruginosa, the duration of treatment should be as short as clinically possible (e.g., as little as 7 days) to reduce the risk of superinfections with resistant organisms.

Usual Adult Dose for Osteomyelitis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 4 to 6 weeks, depending on the nature and severity of the infection
Chronic osteomyelitis may require additional oral antimicrobial therapy, possibly for up to 6 months. Surgical debridement of devitalized bone is also critical.

Usual Adult Dose for Peritonitis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 10 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Pneumonia:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 days if pneumococcal pneumonia is suspected and up to 21 days for other infecting organisms, depending on the nature and severity of the infection

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Pyelonephritis:

250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Skin or Soft Tissue Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 10 days, or for 3 days after acute inflammation resolves, depending on the nature and severity of the infection
For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Skin and Structure Infection:

IV: 250 mg IV every 6 hours or 500 mg to 1 g IV every 6 to 8 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 7 to 10 days, or for 3 days after acute inflammation resolves, depending on the nature and severity of the infection
For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

IM:
Mild to moderate infections: 500 to 750 mg IM every 12 hours (based on imipenem content), depending on the nature and severity of the infection
Maximum dose: 1500 mg/day

Usual Adult Dose for Urinary Tract Infection:

Uncomplicated: 250 mg IV every 6 hours (based on imipenem content)
Complicated: 500 mg IV every 6 hours (based on imipenem content)

Maximum dose: 50 mg/kg/day or 4 g/day, whichever is less
Duration: 3 to 7 days, depending on the nature and severity of the infection

Usual Pediatric Dose for Bacteremia:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Endocarditis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Intraabdominal Infection:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Joint Infection:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Osteomyelitis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Peritonitis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Pneumonia:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Pyelonephritis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Septicemia:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Bacterial Infection:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Urinary Tract Infection:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Skin and Structure Infection:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Bronchitis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Pelvic Infections:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Endometritis:

IV:
Non-CNS infections: (based on imipenem content)
Less than 7 days, less than 1500 g: 20 to 25 mg/kg IV every 12 hours
Less than 7 days, 1500 g or more: 25 mg/kg IV every 12 hours
1 to 4 weeks, less than 1200 g: 25 mg/kg IV every 12 hours
1 to 4 weeks, 1200 g or more: 25 mg/kg IV every 8 hours
4 weeks to 3 months: 25 mg/kg IV every 6 hours
3 months or older: 15 to 25 mg/kg IV every 6 hours

Maximum dose: 2 g/day for fully susceptible organisms and 4 g/day for moderately susceptible organisms

IM: Safety and efficacy of IM imipenem-cilastatin have not been established in pediatric patients below the age of 12 years.

Usual Pediatric Dose for Pneumonia with Cystic Fibrosis:

Greater than 12 years with normal renal function: Up to 90 mg/kg/day IV in divided doses (based on imipenem content)
Maximum dose: 4 g/day


What other drugs will affect imipenem and cilastatin?


Tell your doctor about all other medications you use, especially:



  • valproic acid (Depakene, Stavzor);




  • ganciclovir (Cytovene);




  • probenecid (Benemid);




  • a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others); or




  • a cephalosporin antibiotic such as cefaclor (Ceclor), cefuroxime (Ceftin), cefadroxil (Duricef), cephalexin (Keflex), and others.



This list is not complete and other drugs may interact with imipenem and cilastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More imipenem and cilastatin resources


  • Imipenem and cilastatin Use in Pregnancy & Breastfeeding
  • Imipenem and cilastatin Drug Interactions
  • Imipenem and cilastatin Support Group
  • 0 Reviews for Imipenem and cilastatin - Add your own review/rating


Compare imipenem and cilastatin with other medications


  • Aspiration Pneumonia
  • Bacteremia
  • Bacterial Infection
  • Bone infection
  • Bronchitis
  • Deep Neck Infection
  • Endocarditis
  • Endometritis
  • Febrile Neutropenia
  • Intraabdominal Infection
  • Joint Infection
  • Kidney Infections
  • Meningitis
  • Nosocomial Pneumonia
  • Pelvic Infections
  • Peritonitis
  • Pneumonia
  • Pneumonia with Cystic Fibrosis
  • Septicemia
  • Skin and Structure Infection
  • Skin Infection
  • Urinary Tract Infection


Where can I get more information?


  • Your doctor or pharmacist can provide more information about imipenem and cilastatin.