Vicalvit D

Vicalvit D may be available in the countries listed below.

Ingredient matches for Vicalvit D

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Vicalvit D in the following countries:

• Poland

Colecalciferol

Colecalciferol is reported as an ingredient of Vicalvit D in the following countries:

• Poland

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Soldesanil

Soldesanil may be available in the countries listed below.

Ingredient matches for Soldesanil

Dexamethasone

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

• Greece

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Diralon

Diralon may be available in the countries listed below.

Ingredient matches for Diralon

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diralon in the following countries:

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estradiol valerate and dienogest

es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate, dye-EN-oh-jest, es-tra-DYE-ol VAL-er-ate, es-tra-DYE-ol VAL-er-ate

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use; this risk increases in women who are over 35 years of age and with number of cigarettes smoked. COCs should not be used by women who are over 35 years of age and smoke .

Commonly used brand name(s)

In the U.S.

• Natazia

Uses For estradiol valerate and dienogest

Estradiol valerate and dienogest combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your doctor your options for birth control.

Estradiol valerate and dienogest combination does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

estradiol valerate and dienogest is available only with your doctor's prescription.

Before Using estradiol valerate and dienogest

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 estradiol valerate and dienogest, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to estradiol valerate and dienogest 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 on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. estradiol valerate and dienogest may be used for birth control in teenage females but is not indicated before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the geriatric population. estradiol valerate and dienogest is not indicated for use in elderly women.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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 estradiol valerate and dienogest, 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 estradiol valerate and dienogest 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.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

Using estradiol valerate and dienogest 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.

• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Clarithromycin


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Ginseng


• Griseofulvin


• Itraconazole


• Ketoconazole


• Lamotrigine


• Levothyroxine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Tacrine


• Telaprevir


• Tetracycline


• Tipranavir


• Topiramate


• Troglitazone


• Troleandomycin


• Voriconazole


• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using estradiol valerate and dienogest with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use estradiol valerate and dienogest, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of estradiol valerate and dienogest. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or


• Bleeding problems, or history of or


• Breast cancer, known or suspected, or a history of or


• Cancer of the uterus or cervix or


• Diabetes with kidney, eye, or blood vessel damage or


• Heart attack, history of or


• Heart or blood vessel disease or


• Heart rhythm problems or


• Hypertension (high blood pressure), uncontrolled or


• Jaundice (yellow eyes or skin) during pregnancy or from using hormonal therapy in the past or


• Liver disease, including tumors or cancer or


• Migraine headache, new or worse or a new kind of headache or


• Problems with circulation or blood clots, now or in the past or


• Problems with heart valves or


• Stroke, history of—Should not be used in patients with these conditions.

• Angioedema (swelling of the face, tongue, or throat), inherited or


• Depression, history of or


• Diabetes or


• Dyslipidemia (high cholesterol or fats in the blood) or


• Gallbladder disease or


• Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper Use of estradiol valerate and dienogest

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

estradiol valerate and dienogest comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

estradiol valerate and dienogest is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using estradiol valerate and dienogest, your body will require at least 9 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 9 days of your first cycle of pills.

Take estradiol valerate and dienogest at the same time each day, such as after the evening meal or at bedtime. Do not skip or delay taking your pill by more than 12 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills, or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take estradiol valerate and dienogest. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking estradiol valerate and dienogest, follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Natazia®, take the first dark yellow pill on the first day of your period. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take estradiol valerate and dienogest.

If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Natazia®, take the first dark yellow pill on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take estradiol valerate and dienogest.

Do not eat grapefruit or drink grapefruit juice while you are using estradiol valerate and dienogest.

Dosing

The dose of estradiol valerate and dienogest 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 estradiol valerate and dienogest. 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.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it.

• For oral dosage form (tablets):
  
  • For contraception (to prevent pregnancy):
    
    • Adults and teenagers—One tablet taken at the same time each day for 28 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

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 estradiol valerate and dienogest

It is very important that your doctor check your progress at regular visits to make sure estradiol valerate and dienogest is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Although you are using estradiol valerate and dienogest to prevent pregnancy, you should know that using estradiol valerate and dienogest while you are pregnant could harm the unborn baby. If you suspect that you may be pregnant, stop using estradiol valerate and dienogest immediately and check with your doctor.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

• If this should occur, continue with your regular dosing schedule.


• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.


• If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

Do not use estradiol valerate and dienogest if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Stop using estradiol valerate and dienogest and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using estradiol valerate and dienogest.

Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Stop using estradiol valerate and dienogest and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

estradiol valerate and dienogest may not work as well in women who are overweight. If you gain a lot of weight after you start taking estradiol valerate and dienogest, ask your doctor if you should change to another type of birth control pill.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using estradiol valerate and dienogest. You may need to stop using estradiol valerate and dienogest several days before having surgery or certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

estradiol valerate and dienogest 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

• Breast pain, discomfort, or tenderness


• headache, severe and throbbing


• irregular menstrual periods


• nausea


• normal menstrual bleeding occurring earlier, possibly lasting longer than expected


• vomiting

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• difficulty with breathing


• dizziness


• fever


• headache


• itching


• loss of appetite


• pain in the chest, groin, or legs, especially the calves


• rash


• slurred speech


• sudden loss of coordination


• sudden, severe weakness or numbness in the arm or leg


• sudden, unexplained shortness of breath


• unpleasant breath odor


• unusual tiredness or weakness


• vision changes


• vomiting of blood


• yellow eyes or skin

Incidence not known

• Abdominal or stomach bloating


• blood in the stool


• chest pain or discomfort


• pain or discomfort in the arms, jaw, back, or neck


• pain, redness, or swelling in the arm or leg


• pelvic pain


• shortness of breath


• stomach or pelvic discomfort, aching, or heaviness


• sweating

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:

Less common

• Blemishes on the skin


• increased weight


• pimples

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.

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 estradiol valerate and dienogest resources

• Estradiol valerate and dienogest Use in Pregnancy & Breastfeeding
• Estradiol valerate and dienogest Drug Interactions
• Estradiol valerate and dienogest Support Group
• 9 Reviews for Estradiol valerate and dienogest - Add your own review/rating

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Depo Eligard

Depo Eligard may be available in the countries listed below.

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Leuprorelin

Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Depo Eligard in the following countries:

• Belgium


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Amoxicillin Tablets for Suspension

Dosage Form: tablet, for suspension
Amoxicillin Tablets for Oral Suspension, USP


To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets for oral suspension and other antimicrobial drugs, amoxicillin tablets for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Amoxicillin Tablets for Suspension Description

Amoxicillin tablets for oral suspension contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid trihydrate. The structural formula is:

The amoxicillin molecular formula is C16H19N3O5S • 3H2O, and the molecular weight is 419.45.


Amoxicillin tablets for oral suspension are intended for oral administration.

 

Each amoxicillin tablet for oral suspension contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 200 mg or 400 mg.  Inactive ingredients:  aspartame•, colloidal silicon dioxide, croscarmellose sodium, FD&C Red no. 40 aluminium lake, magnesium stearate, microcrystalline cellulose and strawberry guarana flavor.

 

• See PRECAUTIONS

Amoxicillin Tablets for Suspension - Clinical Pharmacology

Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from conventional amoxicillin tablets and conventional amoxicillin suspension has been partially investigated. The 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of amoxicillin is 61.3 minutes. Most of the amoxicillin is excreted unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid. In blood serum, amoxicillin is approximately 20% protein-bound.


Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.

 

Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg conventional tablets of amoxicillin with 875 mg conventional tablets of amoxicillin/clavulanate potassium showed that the 875 mg conventional tablet of amoxicillin produces an AUC0-∞ of 35.4 ± 8.1 mcg.hr./mL and a Cmax of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.


Conventional amoxicillin chewable tablets, 125 mg and 250 mg, produced blood levels similar to those achieved with corresponding doses of conventional amoxicillin oral suspensions. Orally administered doses of conventional amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.

 

Oral administration of single doses of 400 mg conventional amoxicillin chewable tablets and 400 mg/5 mL conventional suspension to 24 adult volunteers yielded comparable pharmacokinetic data:

†  Administered at the start of a light meal. ‡ Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
Dose†	AUC0-∞ (mcg.hr./mL)	Cmax (mcg/mL)‡
amoxicillin	amoxicillin (±SD)	amoxicillin (±SD)
400 mg (5 mL of suspension)	17.1 (3.1)	5.92 (1.62)
400 mg (1 chewable tablet)	17.9 (2.4)	5.18 (1.64)

Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Following a 1 gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Approximately 60% of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours.

 

The following pharmacokinetic data is from Ranbaxy’s study of DisperMox™ tablets and conventional amoxicillin oral suspension, 400 mg/5 mL.

 

The dispersed mixture of DisperMox™ tablets, 400 mg, produced blood levels similar to those achieved with the corresponding doses of conventional amoxicillin oral suspensions. Orally administered doses of conventional amoxicillin suspension, 400 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 3.3 mcg/mL to 11.5 mcg/mL. Orally administered doses of 400 mg DisperMox™ tablets result in average peak blood levels 1 to 2 hours after administration in the range of 3.2 mcg/mL to 11.5 mcg/mL.

 

Oral administration of single doses of 400 mg DisperMox™ tablets and 400 mg/5 mL conventional suspension to 24 adult volunteers yielded comparable pharmacokinetic data:

¶   Dosing was following an overnight fast. †† Mean values of 24 normal volunteers.  Peak concentrations occurred approximately 1 hour after the dose.
Dose¶	AUC0-∞ (mcg.hr./mL)	Cmax (mcg/mL)††
amoxicillin	amoxicillin	amoxicillin
400 mg (5 mL of suspension)	18.5	8.4
400 mg (one tablet for oral suspension)	17.9	7.5

Microbiology

Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Amoxicillin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Aerobic gram-positive microorganisms

Enterococcus faecalis

Staphylococcus spp.† (β-lactamase-negative strains only)

Streptococcus pneumoniae

Streptococcus spp. (α- and β-hemolytic strains only)

†  Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin     

  should be considered as resistant to amoxicillin.

Aerobic gram-negative microorganisms:

Escherichia coli (β-lactamase-negative strains only)

Haemophilus influenzae (β-lactamase-negative strains only)

Neisseria gonorrhoeae (β-lactamase-negative strains only)

Proteus mirabilis (β-lactamase-negative strains only) Helicobacter

Helicobacter pylori 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 ampicillin powder. Ampicillin is sometimes used to predict susceptibility of Streptococcus pneumoniae to amoxicillin; however, some intermediate strains have been shown to be susceptible to amoxicillin. Therefore, Streptococcus pneumoniae susceptibility should be tested using amoxicillin powder. The MIC values should be interpreted according to the following criteria:


For gram-positive aerobes:


Enterococcus

MIC (mcg/mL)	Interpretation
≤ 8	Susceptible (S)
≥ 16	Resistant (R)

Staphylococcusa

MIC (mcg/mL)	Interpretation
≤ 0.25	Susceptible (S)
≥ 0.5	Resistant (R)

Streptococcus (except S. pneumoniae) 

MIC (mcg/mL)	Interpretation
≤ 0.25	Susceptible (S)
0.5 to 4	Intermediate (I)
≥ 8	Resistant (R)

S. pneumoniaeb from non-meningitis sources.

(Amoxicillin powder should be used to determine susceptibility.)

MIC (mcg/mL)	Interpretation
≤ 2	Susceptible (S)
4	Intermediate (I)
≥ 8	Resistant (R)

Note: These interpretive criteria are based on the recommended doses for respiratory tract infections.


For gram-negative aerobes:


Enterobacteriaceae

MIC (mcg/mL)	Interpretation
≤ 8	Susceptible (S)
16	Intermediate (I)
≥ 32	Resistant (R)

H. influenzaec

MIC (mcg/mL)	Interpretation
≤ 1	Susceptible (S)
2	Intermediate (I)
≥ 4	Resistant (R)

a. Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to amoxicillin.

b. These interpretive standards are applicable only to broth microdilution susceptibility tests using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood.

c. These interpretive standards are applicable only to broth microdilution test with Haemophilus influenzae using Haemophilus Test Medium (HTM).1

 

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. Standard ampicillin powder should provide the following MIC values:

Microorganism	MIC (mcg/mL)
E. coli                        ATCC 25922	2 to 8
E. faecalis                 ATCC 29212	0.5 to 2
H. influenzae            ATCC 49247d	2 to 8
S. aureus                   ATCC 29213	0.25 to 1

Using amoxicillin to determine susceptibility:

Microorganism	MIC Range (mcg/mL)
S. pneumoniae         ATCC 49619e	0.03 to 0.12

d. This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using HTM.1

e. This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by the broth microdilution procedure using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood.

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 10 mcg ampicillin to test the susceptibility of microorganisms, except S. pneumoniae, to amoxicillin. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for ampicillin.

 

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 10 mcg ampicillin disk should be interpreted according to the following criteria: 


For gram-positive aerobes:


Enterococcus

Zone Diameter (mm)	Interpretation
≥ 17	Susceptible (S)
≤ 16	Resistant (R)

 

Staphylococcusf

Zone Diameter (mm)	Interpretation
≥ 29	Susceptible (S)
≤ 28	Resistant (R)

β-hemolytic streptococci

Zone Diameter (mm)	Interpretation
≥ 26	Susceptible (S)
19 to 25	Intermediate (I)
≤18	Resistant  (R)

NOTE: For streptococci (other than β-hemolytic streptococci and S. pneumoniae), an ampicillin MIC should be determined.


S. pneumoniae


S. pneumoniae should be tested using a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm.


For gram-negative aerobes:

 

Enterobacteriaceae

Zone Diameter (mm)	Interpretation
≥ 17	Susceptible  (S)
14 to 16	Intermediate (I)
≤ 13	Resistant (R)

H. influenzaeg

Zone Diameter (mm)	Interpretation
≥ 22	Susceptible (S)
19 to 21	Intermediate (I)
≤ 18	Resistant (R)

f.  Staphylococci which are susceptible to amoxicillin but resistant to methicillin/oxacillin should be considered as resistant to amoxicillin.

g. These interpretive standards are applicable only to disk diffusion susceptibility tests with H. influenzae using Haemophilus Test Medium (HTM).2

 

Interpretation should be as stated above for results using dilution techniques.

 

As with standard dilution techniques, disk diffusion susceptibility test procedures require the use of laboratory control microorganisms. The 10 mcg ampicillin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism	Zone Diameter (mm)
E. coli                     ATCC 25922	16 to 22
H. influenzae            ATCC 49247h	13 to 21
S. aureus                   ATCC 25923	27 to 35

Using 1 mcg oxacillin disk:

Microorganism	Zone Diameter (mm)
S. pneumoniae          ATCC 49619i	8 to 12

h. This quality control range is applicable to only H. influenzae ATCC 49247 tested by a disk diffusion procedure using HTM.2

i.  This quality control range is applicable to only S. pneumoniae ATCC 49619 tested by a disk diffusion procedure using Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO2.

Susceptibility testing for Helicobacter pylori

In vitro susceptibility testing methods and diagnostic products currently available for determining minimum inhibitory concentrations (MICs) and zone sizes have not been standardized, validated, or approved for testing H. pylori microorganisms.

 

Culture and susceptibility testing should be obtained in patients who fail triple therapy. If clarithromycin resistance is found, a non-clarithromycin-containing regimen should be used.

Indications and Usage for Amoxicillin Tablets for Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets for oral suspension and other antibacterial drugs, amoxicillin tablets for oral suspension 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.

 

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:

 

Infections of the ear, nose, and throat due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae

 

Infections of the genitourinary tract due to E. coli, P. mirabilis, or E. faecalis

 

Infections of the skin and skin structure due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli

 

Infections of the lower respiratory tract due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae

 

Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females) Therapy may be instituted prior to obtaining results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to amoxicillin.

 

Indicated surgical procedures should be performed.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple therapy: Amoxicillin/clarithromycin/lansoprazole

Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Dual therapy: Amoxicillin/lansoprazole

Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Contraindications

A history of allergic reaction to any of the penicillins is a contraindication.

Warnings

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.


Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.


Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.”


After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

Precautions

General

Prescribing amoxicillin tablets for oral suspension 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.


The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

Information for Patients

Patients should be counseled that antibacterial drugs including amoxicillin tablets for oral suspension should only be used to treat bacterial infections.  They do not treat viral infections (e.g., the common cold).  When amoxicillin tablets for oral suspension are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy the medicine should be taken exactly as directed.  Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin tablets for oral suspension or other antibacterial drugs in the future.


A Patient Information Sheet is provided with the drug product.

Phenylketonurics

Each 200 mg amoxicillin tablet for oral suspension contains 3.1 mg phenylalanine; each 400 mg amoxicillin tablet for oral suspension contains 6.2 mg phenylalanine.

Laboratory Tests

As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.

 

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.


Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Drug/Laboratory Test Interactions

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest®, Benedict’s Solution or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.


Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Mixture of amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Mixture of amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Mixture of amoxicillin and potassium clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micro-nucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).

Pregnancy

Teratogenic Effects

Pregnancy Category B.

 

Reproduction studies have been performed in mice and rats at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.

Pediatric Use

Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months). (See DOSAGE AND ADMINISTRATION - Neonates and infants.)

Geriatric Use

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.  Of the 1,811 subjects treated with capsules of amoxicillin, 85% were <60 years old, 15% were ≥61 years old and 7% were ≥71 years old.  This analysis and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:


Gastrointestinal:  nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.

 

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)


Hypersensitivity Reactions:  Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.


NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.


Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis have been reported.


Renal:  Crystalluria has also been reported (see OVERDOSAGE).


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


Central Nervous System:  Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.

 

Miscellaneous:  Tooth discoloration (brown, yellow, or gray staining) has been rarely reported.  Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Combination therapy with clarithromycin and lansoprazole

In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole.

Triple therapy: amoxicillin/clarithromycin/lansoprazole

The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual therapy: amoxicillin/lansoprazole

The most frequently reported adverse events for patients who received amoxicillin t.i.d.  plus lansoprazole t.i.d. dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin t.i.d. plus lansoprazole t.i.d. dual therapy than with lansoprazole alone.


For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.

Overdosage

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.3


Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.


Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients.  In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

Amoxicillin Tablets for Suspension Dosage and Administration

Amoxicillin may be given without regard to meals.

Direction for Amoxicillin Tablets for Oral Suspension

Mix one tablet in a small amount of water [approximately 2 teaspoonfuls]. Drink the entire mixture.  Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken. Do not chew or swallow the tablets. The tablets will not rapidly dissolve in your mouth.


The tablet is not recommended to be mixed with any liquid other than water, as studies have only been conducted using water.


ALL RECOMMENDED DOSAGES FOR AMOXICILLIN ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSES ONLY. THE 200 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 200 mg DOSE AND THE 400 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 400 mg DOSE.

Neonates and infants aged ≤ 12 weeks (≤ 3 months)

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

Adults and pediatric patients > 3 months

Infection	Severity‡	Usual Adult Dose	Usual Dose for Children >3    Months§
‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections. §The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
Ear/nose/throat	Mild/Moderate	500 mg every 12 hours    or 250 mg every 8 hours	25 mg/kg/day in divided    doses every 12 hours
			or
			20 mg/kg/day in divided    doses every 8 hours
	Severe	875 mg every 12 hours    or 500 mg every 8 hours	45 mg/kg/day in divided    doses every 12 hours
			or
			40 mg/kg/day in divided    doses every 8 hours
Lower respiratory tract	Mild/Moderate or Severe	875 mg every 12 hours    or 500 mg every 8 hours	45 mg/kg/day in divided    doses every 12 hours
			or
			40 mg/kg/day in divided    doses every 8 hours
Skin/skin structure	Mild/Moderate	500 mg every 12 hours    or 250 mg every 8 hours	25 mg/kg/day in divided    doses every 12 hours
			or
			20 mg/kg/day in divided    doses every 8 hours
	Severe	875 mg every 12 hours    or 500 mg every 8 hours	45 mg/kg/day in divided    doses every 12 hours
			or
			40 mg/kg/day in divided    doses every 8 hours
Genitourinary tract	Mild/Moderate	500 mg every 12 hours    or 250 mg every 8 hours	25 mg/kg/day in divided    doses every 12 hours
			or
			20 mg/kg/day in divided    doses every 8 hours
	Severe	875 mg every 12 hours    or 500 mg every 8 hours	45 mg/kg/day in divided    doses every 12 hours
			or
			40 mg/kg/day in divided    doses every 8 hours
Gonorrhea Acute,    uncomplicated    ano-genital and    urethral infections    in males and    females		3 grams as single oral    dose	Prepubertal children:   50    mg/kg amoxicillin,    combined with 25 mg/kg    probenecid as a single dose.    NOTE: SINCE    PROBENECID IS    CONTRAINDICATED    IN CHILDREN UNDER    2 YEARS, DO NOT USE        THIS REGIMEN IN    THESE CASES.

Terby

Terby may be available in the countries listed below.

Ingredient matches for Terby

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terby in the following countries:

• Japan

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