Wednesday, September 28, 2016

Alurin




Alurin may be available in the countries listed below.


Ingredient matches for Alurin



Allopurinol

Allopurinol is reported as an ingredient of Alurin in the following countries:


  • Guatemala

International Drug Name Search

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mecasermin Subcutaneous


me-ka-SER-min


Commonly used brand name(s)

In the U.S.


  • Increlex

  • Iplex

Available Dosage Forms:


  • Solution

Therapeutic Class: Endocrine-Metabolic Agent


Uses For mecasermin


Mecasermin injection is a man-made version of insulin-like growth factor-1 (IGF-1) hormone. IGF-1 is produced in the liver and plays an important role in childhood growth. Mecasermin is used to replace IGF-1 in children who are severely lacking it in their bodies.


mecasermin is available only with your doctor's prescription.


Before Using mecasermin


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 mecasermin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to mecasermin 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


Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in children younger than 2 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in the geriatric population. Safety and efficacy have not been established.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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 mecasermin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Closed epiphyses (e.g., growth centers in the bones show no more growth potential) or

  • Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)—Should not be used in patients with these conditions.

  • Diabetes or

  • Enlarged tonsils or

  • Head injury or

  • Scoliosis (abnormally curved spine), or history of—Use with caution. May make these conditions worse.

  • Hypothyroidism (underactive thyroid) or

  • Nutrition deficiencies—These problems should be corrected first before starting treatment with mecasermin.

Proper Use of mecasermin


Your doctor will prescribe your child's exact dose and tell you how often it should be given. mecasermin is given as a shot under your child's skin. mecasermin must not be injected into a vein or muscle.


Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using mecasermin at home, your doctor will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.


It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.


mecasermin must be taken 20 minutes before or 20 minutes after a snack or meal. Never let your child skip a meal once your child received mecasermin.


Use a new needle and syringe each time you inject the medicine to your child.


It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites (e.g., upper arms, thighs, buttocks, or abdomen) on your body. This will help to prevent skin problems.


Do not use the medicine if it looks cloudy or has particles in it.


Dosing


The dose of mecasermin 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 mecasermin. 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.


  • For injection dosage form:
    • For treatment of growth failure caused by IGF-1 deficiency:
      • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.04 to 0.08 milligram (mg) per kg (0.018 to 0.036 mg per lb) of body weight injected under the skin two times a day. Your doctor may then increase the dose, if needed.

      • Children younger than 2 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of mecasermin, 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


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.


Store in the refrigerator. Do not freeze.


You may keep the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze the solution and protect it from direct heat and light.


Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.


Precautions While Using mecasermin


Your doctor will need to check your child's progress at regular visits while your child is using mecasermin. Be sure to keep all appointments.


Talk with your doctor if you notice or the child feels that mecasermin is causing too much growth.


mecasermin may cause hypoglycemia (low blood sugar) with the following symptoms that you should be aware of: anxiety; blurred vision; chills; cold sweats; coma; confusion; cool, pale skin; depression; dizziness; fast heartbeat; headache; increased hunger; nausea; nervousness; nightmares; seizures; shakiness; slurred speech; or unusual tiredness or weakness. It is important to have a source of sugar such as orange juice, candy, soda, glucose gel, or milk, if these symptoms occur.


Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if the child has low blood sugar.


You should avoid participating in high risk activities, such as driving, within 2 to 3 hours after receiving the medicine, especially at the beginning of mecasermin treatment.


mecasermin may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after your child receive the medicine.


mecasermin may enlarge your child's tonsils. Call your doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. Your doctor may want to check your child's tonsils regularly while using mecasermin.


mecasermin may cause a dislocation in the hip bone. Check with your doctor right away if your child has a limp or pain in the hip or knee.


mecasermin contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.


Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


mecasermin 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.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Anxiety

  • bluish skin color of the fingertips

  • blurred vision

  • breathlessness

  • chest pain

  • chills

  • cold sweats

  • coma

  • confusion

  • cool, pale skin

  • depression

  • dizziness

  • fast heartbeat

  • headache

  • increased hunger

  • loss of hearing

  • nausea

  • nervousness

  • nightmares

  • rapid growth of normal cells of the thymus (no symptoms)

  • seizures

  • shakiness

  • slurred speech

  • thickening of the skin

  • unusual tiredness or weakness

Incidence not known
  • Change in the ability to see colors, especially blue or yellow

  • cough

  • difficult or labored breathing

  • difficulty with swallowing

  • hives or welts

  • itching

  • itching or hives at the injection site

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

  • limp

  • pain in the hip or knee

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • redness of the skin

  • shortness of breath

  • skin rash

  • tightness in the chest

  • vomiting

  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Anxiety

  • arm or leg pain

  • backache

  • changes in vision

  • excessive sweating

  • extreme weakness

  • frequent urination

  • increase in hands and feet size

  • increased thirst

  • increased volume of pale, diluted urine

  • joint pain

  • stop in menstruation

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
  • Abnormal response of the tympanic membrane to air pressure

  • difficulty with moving

  • difficulty with swallowing

  • ear pain

  • earache

  • large, flat, blue or purplish patches in the skin

  • muffled hearing

  • muscle pain or stiffness

  • redness or swelling in the ear

  • sense of fullness in the ear

  • snoring

  • sore throat

  • voice changing

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.



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.


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More mecasermin Subcutaneous resources


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


Compare mecasermin Subcutaneous with other medications


  • Primary IGF-1 Deficiency

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Celudex




Celudex may be available in the countries listed below.


Ingredient matches for Celudex



Dexamethasone

Dexamethasone phosphate (a derivative of Dexamethasone) is reported as an ingredient of Celudex in the following countries:


  • Bangladesh

International Drug Name Search

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Lactocal-F


Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN


What are Lactocal-F (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.


Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.


Prenatal vitamins may also be used for purposes not listed in this medication guide.


What is the most important information I should know about prenatal vitamins?


There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?


Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.


You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.


The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.


Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


What should I avoid while taking prenatal vitamins?


Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:



  • upset stomach;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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.


What other drugs will affect prenatal vitamins?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:



  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with prenatal vitamins. 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 Lactocal-F resources


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


  • Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

  • CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal Assure Prescribing Information (FDA)

  • CitraNatal Harmony Prescribing Information (FDA)

  • Concept DHA Prescribing Information (FDA)

  • Docosavit Prescribing Information (FDA)

  • Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folcal DHA Prescribing Information (FDA)

  • Folcaps Care One Prescribing Information (FDA)

  • Gesticare DHA Prescribing Information (FDA)

  • Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • Inatal Advance Prescribing Information (FDA)

  • Inatal Ultra Prescribing Information (FDA)

  • Multi-Nate DHA Prescribing Information (FDA)

  • Multi-Nate DHA Extra Prescribing Information (FDA)

  • MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Natelle One Prescribing Information (FDA)

  • Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Paire OB Plus DHA Prescribing Information (FDA)

  • PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

  • PreNexa Prescribing Information (FDA)

  • PreferaOB Prescribing Information (FDA)

  • Prenatal Plus Prescribing Information (FDA)

  • Prenatal Plus Iron Prescribing Information (FDA)

  • Prenate Elite Prescribing Information (FDA)

  • Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prenate Elite tablets

  • Prenate Essential Prescribing Information (FDA)

  • PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

  • PrimaCare ONE capsules

  • PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Renate DHA Prescribing Information (FDA)

  • Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Se-Natal 19 Prescribing Information (FDA)

  • Tandem DHA Prescribing Information (FDA)

  • Tandem OB Prescribing Information (FDA)

  • TriAdvance Prescribing Information (FDA)

  • Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Triveen-PRx RNF Prescribing Information (FDA)

  • UltimateCare ONE NF Prescribing Information (FDA)

  • Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vinate AZ Prescribing Information (FDA)

  • Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zatean-CH Prescribing Information (FDA)



Compare Lactocal-F with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation


Where can I get more information?


  • Your pharmacist can provide more information about prenatal vitamins.


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Maxipime



cefepime hydrochloride

Dosage Form: injection, powder, for solution
Maxipime®

(Cefepime Hydrochloride, USP) for Injection

For Intravenous or Intramuscular Use


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxipime® and other antibacterial drugs, Maxipime should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.



Maxipime Description


Maxipime (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:



Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water.


Maxipime for Injection is supplied for intramuscular or intravenous administration in strengths equivalent to 500 mg, 1 g, and 2 g of cefepime. (See DOSAGE AND ADMINISTRATION.) Maxipime is a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the constituted solution at 4.0–6.0. Freshly constituted solutions of Maxipime will range in color from colorless to amber.



Maxipime - Clinical Pharmacology


Cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with in vitro antibacterial activity against facultative Gram-positive and Gram-negative bacteria.



Pharmacokinetics


The average plasma concentrations of cefepime observed in healthy adult male volunteers (n=9) at various times following single 30-minute infusions (IV) of cefepime 500 mg, 1 g, and 2 g are summarized in Table 1. Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2.0 (±0.3) hours and total body clearance of 120.0 (±8.0) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days.



Absorption


The average plasma concentrations of cefepime and its derived pharmacokinetic parameters after intravenous (IV) administration are portrayed in Table 1.














































Table 1: Average Plasma Concentrations in mcg/mL of Cefepime and Derived Pharmacokinetic Parameters (±SD), Intravenous Administration
Maxipime
Parameter500 mg IV1 g IV2 g IV
0.5 h38.278.7163.1
1 h21.644.585.8
2 h11.624.344.8
4 h5.010.519.2
8 h1.42.43.9
12 h0.20.61.1
Cmax, mcg/mL39.1 (3.5)81.7 (5.1)163.9 (25.3)
AUC, h•mcg/mL70.8 (6.7)148.5 (15.1)284.8 (30.6)
Number of subjects

(male)		999

Following intramuscular (IM) administration, cefepime is completely absorbed. The average plasma concentrations of cefepime at various times following a single intramuscular injection are summarized in Table 2. The pharmacokinetics of cefepime are linear over the range of 500 mg to 2 g intramuscularly and do not vary with respect to treatment duration.


















































Table 2: Average Plasma Concentrations in mcg/mL of Cefepime and Derived Pharmacokinetic Parameters (±SD), Intramuscular Administration
Maxipime
Parameter500 mg IM1 g IM2 g IM
0.5 h8.214.836.1
1 h12.525.949.9
2 h12.026.351.3
4 h6.916.031.5
8 h1.94.58.7
12 h0.71.42.3
Cmax, mcg/mL13.9 (3.4)29.6 (4.4)57.5 (9.5)
Tmax, h1.4 (0.9)1.6 (0.4)1.5 (0.4)
AUC, h•mcg/mL60 (8)137 (11)262 (23)
Number of subjects

(male)		6612

Distribution


The average steady-state volume of distribution of cefepime is 18.0 (±2.0) L. The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.


Cefepime is excreted in human milk. A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day. (See PRECAUTIONS: Nursing Mothers.)


Concentrations of cefepime achieved in specific tissues and body fluids are listed in Table 3.
































































Table 3: Average Concentrations of Cefepime in Specific Body Fluids (mcg/mL) or Tissues (mcg/g)
Tissue or FluidDose/Route# of PatientsAverage Time of

Sample Post-Dose (h)		Average

Concentration
Blister Fluid2 g IV61.581.4 mcg/mL
Bronchial Mucosa2 g IV204.824.1 mcg/g
Sputum2 g IV54.07.4 mcg/mL
Urine500 mg IV80–4292 mcg/mL
 1 g IV120–4926 mcg/mL
 2 g IV120–43120 mcg/mL
Bile2 g IV269.417.8 mcg/mL
Peritoneal Fluid2 g IV194.418.3 mcg/mL
Appendix2 g IV315.75.2 mcg/g
Gallbladder2 g IV388.911.9 mcg/g
Prostate2 g IV51.031.5 mcg/g

Data suggest that cefepime does cross the inflamed blood-brain barrier. The clinical relevance of these data is uncertain at this time.



Metabolism and Excretion


Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a significant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment. (See DOSAGE AND ADMINISTRATION.)



Specific Populations


Renal impairment: Cefepime pharmacokinetics have been investigated in patients with various degrees of renal impairment (n=30). The average half-life in patients requiring hemodialysis was 13.5 (±2.7) hours and in patients requiring continuous peritoneal dialysis was 19.0 (±2.0) hours. Cefepime total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function, which serves as the basis for dosage adjustment recommendations in this group of patients. (See DOSAGE AND ADMINISTRATION.)


Hepatic impairment: The pharmacokinetics of cefepime were unaltered in patients with hepatic impairment who received a single 1 g dose (n=11).


Geriatric patients: Cefepime pharmacokinetics have been investigated in elderly (65 years of age and older) men (n=12) and women (n=12) whose mean (SD) creatinine clearance was 74.0 (±15.0) mL/min. There appeared to be a decrease in cefepime total body clearance as a function of creatinine clearance. Therefore, dosage administration of cefepime in the elderly should be adjusted as appropriate if the patient's creatinine clearance is 60 mL/min or less. (See DOSAGE AND ADMINISTRATION.)


Pediatric patients: Cefepime pharmacokinetics have been evaluated in pediatric patients from 2 months to 11 years of age following single and multiple doses on every 8 hours (n=29) and every 12 hours (n=13) schedules. Following a single intravenous dose, total body clearance and the steady-state volume of distribution averaged 3.3 (±1.0) mL/min/kg and 0.3 (±0.1) L/kg, respectively. The urinary recovery of unchanged cefepime was 60.4 (±30.4)% of the administered dose, and the average renal clearance was 2.0 (±1.1) mL/min/kg. There were no significant effects of age or gender (25 male vs 17 female) on total body clearance or volume of distribution, corrected for body weight. No accumulation was seen when cefepime was given at 50 mg per kg every 12 hours (n=13), while Cmax, AUC, and t½ were increased about 15% at steady state after 50 mg per kg every 8 hours. The exposure to cefepime following a 50 mg per kg intravenous dose in a pediatric patient is comparable to that in an adult treated with a 2 g intravenous dose. The absolute bioavailability of cefepime after an intramuscular dose of 50 mg per kg was 82.3 (±15)% in eight patients.



Microbiology


Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefepime has a broad spectrum of in vitro activity that encompasses a wide range of Gram-positive and Gram-negative bacteria. Cefepime has a low affinity for chromosomally-encoded beta-lactamases. Cefepime is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into Gram-negative bacterial cells. Within bacterial cells, the molecular targets of cefepime are the penicillin binding proteins (PBP).


Cefepime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.


Aerobic Gram-Negative Microorganisms:


 

Enterobacter

 

Escherichia coli

 

Klebsiella pneumoniae

 

Proteus mirabilis

 

Pseudomonas aeruginosa

Aerobic Gram-Positive Microorganisms:


 

Staphylococcus aureus (methicillin-susceptible isolates only)

 

Streptococcus pneumoniae

 

Streptococcus pyogenes (Lancefield’s Group A streptococci)

 

Viridans group streptococci

The following in vitro data are available, but their clinical significance is unknown. Cefepime has been shown to have in vitro activity against most isolates of the following microorganisms; however, the safety and effectiveness of cefepime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.


Aerobic Gram-Positive Microorganisms:


 

Staphylococcus epidermidis (methicillin-susceptible isolates only)

 

Staphylococcus saprophyticus

 

Streptococcus agalactiae (Lancefield’s Group B streptococci)

NOTE: Most isolates of enterococci, eg, Enterococcus faecalis, and methicillin-resistant staphylococci are resistant to cefepime.


Aerobic Gram-Negative Microorganisms:


 

Acinetobacter calcoaceticus subsp. lwoffii

 

Citrobacter diversus

 

Citrobacter freundii

 

Enterobacter agglomerans

 

Haemophilus influenzae (including beta-lactamase producing isolates)

 

Hafnia alvei

 

Klebsiella oxytoca

 

Moraxella catarrhalis (including beta-lactamase producing isolates)

 

Morganella morganii

 

Proteus vulgaris

 

Providencia rettgeri

 

Providencia stuartii

 

Serratia marcescens

NOTE: Cefepime is inactive against many isolates of Stenotrophomonas (formerly Xanthomonas maltophilia and Pseudomonas maltophilia).


Anaerobic Microorganisms:


NOTE: Cefepime is inactive against most isolates of Clostridium difficile.



Susceptibility Tests


Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cefepime powder. The MIC values should be interpreted according to the following criteria:























Table 4
MIC (mcg/mL)
MicroorganismSusceptible (S)Intermediate (I)Resistant (R)
*NOTE: Isolates from these species should be tested for susceptibility using specialized dilution testing methods.1 Also, isolates of Haemophilus spp. with MICs greater than 2 mcg/mL should be considered equivocal and should be further evaluated.
Microorganisms other than

    Haemophilus spp.* and

    Streptococcus pneumoniae*		≤816≥32
Haemophilus spp.*≤2—*—*
S. pneumoniae*≤0.51≥2

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.


Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Laboratory control microorganisms are specific strains of microbiological assay organisms with intrinsic biological properties relating to resistance mechanisms and their genetic expression within bacteria; the specific strains are not clinically significant in their current microbiological status. Standard cefepime powder should provide the following MIC values (Table 5) when tested against the designated quality control strains:






















Table 5
MicroorganismATCCMIC (mcg/mL)
Escherichia coli259220.016–0.12
Staphylococcus aureus292131–4
Pseudomonas aeruginosa278531–4
Haemophilus influenzae492470.5–2
Streptococcus pneumoniae496190.06–0.25
Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of cefepime to test the susceptibility of microorganisms to cefepime. Interpretation is identical to that stated above for results using dilution techniques.


Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-mcg cefepime disk should be interpreted according to the following criteria:



















Table 6
Zone Diameter (mm)
MicroorganismSusceptible (S)Intermediate (I)Resistant (R)
*NOTE: Isolates from these species should be tested for susceptibility using specialized diffusion testing methods.2 Isolates of Haemophilus spp. with zones smaller than 26 mm should be considered equivocal and should be further evaluated. Isolates of S. pneumoniae should be tested against a 1-mcg oxacillin disk; isolates with oxacillin zone sizes larger than or equal to 20 mm may be considered susceptible to cefepime.
Microorganisms other than

    Haemophilus spp.* and

    S. pneumoniae*		≥1815–17≤14
Haemophilus spp.*≥26—*—*

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Laboratory control microorganisms are specific strains of microbiological assay organisms with intrinsic biological properties relating to resistance mechanisms and their genetic expression within bacteria; the specific strains are not clinically significant in their current microbiological status. For the diffusion technique, the 30-mcg cefepime disk should provide the following zone diameters in these laboratory test quality control strains (Table 7):



















Table 7
MicroorganismATCCZone Size Range (mm)
Escherichia coli2592229–35
Staphylococcus aureus2592323–29
Pseudomonas aeruginosa2785324–30
Haemophilus influenzae4924725–31

Indications and Usage for Maxipime


Maxipime is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):


 

Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

 

Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See CLINICAL STUDIES.)

 

Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

 

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.

 

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See CLINICAL STUDIES.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxipime and other antibacterial drugs, Maxipime should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.



Clinical Studies



Febrile Neutropenic Patients


The safety and efficacy of empiric cefepime monotherapy of febrile neutropenic patients have been assessed in two multicenter, randomized trials comparing cefepime monotherapy (at a dose of 2 g intravenously every 8 hours) to ceftazidime monotherapy (at a dose of 2 g intravenously every 8 hours). These studies comprised 317 evaluable patients. Table 8 describes the characteristics of the evaluable patient population.















































Table 8: Demographics of Evaluable Patients (First Episodes Only)
CefepimeCeftazidime
Total164153
ANC = absolute neutrophil count; SBP = systolic blood pressure
Median age (yr)56.0 (range, 18–82)55.0 (range, 16–84)
Male86 (52%)85 (56%)
Female78 (48%)68 (44%)
Leukemia65 (40%)52 (34%)
Other hematologic malignancies43 (26%)36 (24%)
Solid tumor54 (33%)56 (37%)
Median ANC nadir (cells/microliter)20 (range, 0–500)20 (range, 0–500)
Median duration of neutropenia (days)6 (range, 0–39)6 (range, 0–32)
Indwelling venous catheter97 (59%)86 (56%)
Prophylactic antibiotics62 (38%)64 (42%)
Bone marrow graft9 (5%)7 (5%)
SBP less than 90 mm Hg at entry7 (4%)2 (1%)

Table 9 describes the clinical response rates observed. For all outcome measures, cefepime was therapeutically equivalent to ceftazidime.
























Table 9: Pooled Response Rates for Empiric Therapy of Febrile Neutropenic Patients
% Response
Outcome MeasuresCefepime

(n=164)		Ceftazidime

(n=153)
Primary episode resolved with no treatment modification, no new febrile episodes or infection, and oral antibiotics allowed for completion of treatment5155
Primary episode resolved with no treatment modification, no new febrile episodes or infection and no post-treatment oral antibiotics3439
Survival, any treatment modification allowed9397
Primary episode resolved with no treatment modification and oral antibiotics allowed for completion of treatment6267
Primary episode resolved with no treatment modification and no post-treatment oral antibiotics4651

Insufficient data exist to support the efficacy of cefepime monotherapy in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia). No data are available in patients with septic shock.



Complicated Intra-Abdominal Infections


Patients hospitalized with complicated intra-abdominal infections participated in a randomized, double-blind, multicenter trial comparing the combination of cefepime (2 g every 12 hours) plus intravenous metronidazole (500 mg every 6 hours) versus imipenem/cilastatin (500 mg every 6 hours) for a maximum duration of 14 days of therapy. The study was designed to demonstrate equivalence of the two therapies. The primary analyses were conducted on the protocol-valid population, which consisted of those with a surgically confirmed complicated infection, at least one pathogen isolated pretreatment, at least 5 days of treatment, and a 4 to 6 week follow-up assessment for cured patients. Subjects in the imipenem/cilastatin arm had higher APACHE II scores at baseline. The treatment groups were otherwise generally comparable with regard to their pretreatment characteristics. The overall clinical cure rate among the protocol-valid patients was 81% (51 cured/63 evaluable patients) in the cefepime plus metronidazole group and 66% (62/94) in the imipenem/cilastatin group. The observed differences in efficacy may have been due to a greater proportion of patients with high APACHE II scores in the imipenem/cilastatin group.



Contraindications


Maxipime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.



Warnings


BEFORE THERAPY WITH Maxipime FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS IMMEDIATE HYPERSENSITIVITY REACTIONS TO CEFEPIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Maxipime OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CORTICOSTEROIDS, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.


In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Maxipime (cefepime hydrochloride) should be adjusted to compensate for the slower rate of renal elimination. Because high and prolonged serum antibiotic concentrations can occur from usual dosages in patients with renal impairment or other conditions that may compromise renal function, the maintenance dosage should be reduced when cefepime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms. (See specific recommendations for dosing adjustment in DOSAGE AND ADMINISTRATION.) During postmarketing surveillance, serious adverse events have been reported including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and non-convulsive status epilepticus (see ADVERSE REACTIONS: Postmarketing Experience). Most cases occurred in patients with renal impairment who received doses of cefepime that exceeded the recommended dosage schedules. However, some cases of encephalopathy occurred in patients receiving a dosage adjustment for their renal function. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis.


Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Maxipime, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.


C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.


If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.



Precautions



General


Prescribing Maxipime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.


As with other antimicrobials, prolonged use of Maxipime may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient’s condition is essential. Should superinfection occur during therapy, appropriate measures should be taken.


Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.


Positive direct Coombs’ tests have been reported during treatment with Maxipime. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug.


Maxipime (cefepime hydrochloride) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.


Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Maxipime. The effect of lower doses is not

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Tuesday, September 27, 2016

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