PrandiMet

Generic Name: repaglinide and metformin (Oral route)

re-PAG-li-nide, met-FOR-min hye-droe-KLOR-ide

Oral route(Tablet)

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, discontinue metformin hydrochloride/repaglinide and hospitalize the patient immediately .

Commonly used brand name(s)

In the U.S.

• PrandiMet

Available Dosage Forms:

• Tablet

Chemical Class: Meglitinide

Uses For PrandiMet

Repaglinide and metformin combination is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future .

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Repaglinide causes your pancreas to release more insulin into the blood stream. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better .

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

Before Using PrandiMet

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of repaglinide and metformin combination in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of repaglinide and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dosage in patients receiving repaglinide and metformin combination .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid


• Diatrizoate


• Ethiodized Oil


• Gemfibrozil


• Iobenzamic Acid


• Iobitridol


• Iocarmic Acid


• Iocetamic Acid


• Iodamide


• Iodipamide


• Iodixanol


• Iodohippuric Acid


• Iodopyracet


• Iodoxamic Acid


• Ioglicic Acid


• Ioglycamic Acid


• Iohexol


• Iomeprol


• Iopamidol


• Iopanoic Acid


• Iopentol


• Iophendylate


• Iopromide


• Iopronic Acid


• Ioseric Acid


• Iosimide


• Iotasul


• Iothalamate


• Iotrolan


• Iotroxic Acid


• Ioversol


• Ioxaglate


• Ioxitalamic Acid


• Ipodate


• Metrizamide


• Metrizoic Acid


• Tyropanoate Sodium

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

• Acetazolamide


• Alatrofloxacin


• Balofloxacin


• Cimetidine


• Ciprofloxacin


• Clinafloxacin


• Dichlorphenamide


• Dofetilide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Itraconazole


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Topiramate


• Tosufloxacin


• Trovafloxacin Mesylate


• Zonisamide

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

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Cephalexin


• Clarithromycin


• Clorgyline


• Cyclosporine


• Deferasirox


• Dilevalol


• Eltrombopag


• Enalaprilat


• Enalapril Maleate


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Ketoconazole


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Rifampin


• Rifapentine


• Selegiline


• Sotalol


• Talinolol


• Telithromycin


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine


• Trimethoprim


• Trospium

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.

Other Medical Problems

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

• Alcohol intoxication or


• Underactive adrenal glands, not properly controlled or


• Underactive pituitary gland, not properly controlled or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking repaglinide and metformin combination .

• Congestive heart failure or


• Dehydration (not enough water in your body) or


• Heart attack or


• Hypoxemia (low oxygen in the blood) or


• Sepsis (serious illness due to a bacterial infection) or


• Shock—Lactic acidosis can occur in these conditions, and chances of it occurring are even greater with use of this medicine. If these conditions occur, you should stop taking this medicine as soon as possible .

• Diabetic ketoacidosis (ketones in the blood) or


• Kidney disorder or


• Metabolic acidosis (extra acids in the blood) or


• Type I diabetes—Should not be used in patients with these conditions .

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin .

• Liver disorder—Higher blood levels of this medicine may occur, which may cause serious problems. Patients with impaired liver function generally should not use this medicine .

Proper Use of PrandiMet

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed .

This medicine is usually taken within 15 minutes before a meal but may be taken up to 30 minutes before a meal. If you skip a meal, you should skip your dose for that meal .

Dosing

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

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

• For oral dosage form (tablets):
  
  • For Type 2 diabetes:
    
    • For patients on repaglinide therapy:
      
      • Adults—At first, 500 milligrams (mg) metformin two times a day. Your doctor may gradually increase your dose until your blood sugar is controlled.
      
      
      • Children—Use and dose must be determined by your doctor .
      
      
    
    
    • For patients on metformin therapy:
      
      • Adults—At first, 1 milligram (mg) repaglinide and 500 milligrams (mg) metformin combination two times a day. Your doctor may gradually increase your dose until your blood sugar is controlled.
      
      
      • Children—Use and dose must be determined by your doctor .
      
      
    
    
    • For patients not on repaglinide and metformin therapy:
      
      • Adults—At first, either the 1 milligram (mg) repaglinide and 500 milligrams (mg) metformin combination two or three times a day or 2 mg repaglinide and 500 mg metformin combination two or three times a day, as directed by your doctor. Your doctor may increase your dose as needed to control your blood sugar up to a maximum of 10 mg repaglinide and 2500 mg metformin combination per day, divided into two or three doses.
      
      
      • Children—Use and dose must be determined by your doctor .
      
      
    
    
    • For patients previously treated separately with repaglinide and metformin:
      
      • Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
      
      
      • Children—Use and dose must be determined by your doctor .
      
      
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using PrandiMet

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine .

Make sure your doctor knows if you are using gemfibrozil (Lopid®) and itraconazole (Sporanox®) before you start taking this medicine. Using both of them together with this medicine may increase your risk of having serious side effects. Also tell your doctor if you are using insulin to treat your diabetes .

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines .

Under certain conditions, too much metformin and repaglinide can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Call your doctor right away if you have abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; nausea; or unusual sleepiness, tiredness, or weakness .

Radiologic procedures (e.g., x-rays, CT scans, and MRIs) that use intravenous contrast media can cause kidney problems and lactic acidosis in people who take metformin. Use of this medicine should be discontinued before you have one of these procedures. The medicine should not be started again during the 48 hours after the procedure. You may begin taking your medicine again after the doctor checks your kidneys for normal function

Use of this medicine should be stopped during surgical procedures (except for minor surgical procedures). You can take your medicine again after your doctor makes sure your kidneys are normal

Repaglinide and metformin combination can cause low blood sugar. However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take repaglinide and metformin combination with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly .

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness .

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it .

PrandiMet 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


• blurred vision


• body aches or pain


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• cough


• depression


• difficulty in breathing


• dizziness


• ear congestion


• fast heartbeat


• fever


• headache


• increased hunger


• loss of voice


• nasal congestion


• nausea


• nervousness


• nightmares


• runny nose


• seizures


• shakiness


• slurred speech


• sneezing


• sore throat


• unusual tiredness or weakness

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

• Diarrhea


• vomiting

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

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

See also: PrandiMet side effects (in more detail)

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More PrandiMet resources

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

• PrandiMet Prescribing Information (FDA)


• PrandiMet MedFacts Consumer Leaflet (Wolters Kluwer)


• PrandiMet Consumer Overview

Compare PrandiMet with other medications

• Diabetes, Type 2

Eviplera 200 mg / 25 mg / 245 mg film coated tablets

1. Name Of The Medicinal Product

Eviplera 200 mg/25 mg/245 mg film-coated tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).

Excipients with known effect:

Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110).

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed on one side with “GSI” and plain on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Eviplera is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load

The demonstration of the benefit of the combination emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate in antiretroviral therapy is based on week 48 safety and efficacy analyses from two randomised, double-blind, controlled Phase III studies in treatment-naïve patients (see section 5.1).

As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Eviplera (see sections 4.4 and 5.1).

4.2 Posology And Method Of Administration

Therapy should be initiated by a physician experienced in the management of HIV infection.

Posology

Adults: The recommended dose of Eviplera is one tablet, taken orally, once daily. Eviplera must be taken with a meal (see section 5.2).

Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate are available. Please refer to the Summary of Product Characteristics for these medicinal products.

If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with a meal as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with a meal. If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose.

Special populations

Elderly: Eviplera has not been studied in patients over the age of 65 years. Eviplera should be administered with caution to elderly patients (see sections 4.4 and 5.2).

Renal impairment: Treatment with Eviplera resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).

Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance 50-80 ml/min). However, long-term safety data for the emtricitabine and tenofovir disoproxil fumarate components of Eviplera have not been evaluated in patients with mild renal impairment. Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks (see sections 4.4 and 5.2).

Eviplera is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min). Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).

Hepatic impairment: There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B). No dose adjustment of Eviplera is required in patients with mild or moderate hepatic impairment. Eviplera should be used with caution in patients with moderate hepatic impairment. Eviplera has not been studied in patients with severe hepatic impairment (CPT Score C). Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).

If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).

Paediatric population: The safety and efficacy of Eviplera in children under the age of 18 years have not been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.

Method of administration

Eviplera must be taken orally, once daily with a meal (see section 5.2). It is recommended that Eviplera be swallowed whole with water. The film-coated tablet should not be chewed or crushed as it may impact the absorption of Eviplera.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Eviplera should not be co-administered with the following medicinal products as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Eviplera:

• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin

• the antimycobacterials rifabutin, rifampicin, rifapentine

• proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole

• the systemic glucocorticoid dexamethasone, except as a single dose treatment

• St John's wort (Hypericum perforatum).

4.4 Special Warnings And Precautions For Use

Patients should be advised that current antiretroviral therapy does not cure HIV, and there is still a risk of passing HIV to others through sexual contact or contamination with blood when taking Eviplera. Appropriate precautions to prevent the transmission of HIV should continue to be employed.

Virologic failure and development of resistance

Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy. Eviplera should be avoided in patients with HIV-1 harbouring the K65R mutation. The list of rilpivirine-associated mutations presented in section 5.1 should only guide the use of Eviplera in the treatment-naïve population.

In the pooled analysis from the two Phase III clinical studies (C209 and C215), patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (15.3% with rilpivirine versus 5.9% with efavirenz) compared to patients with a baseline viral load

As with other antiretroviral medicinal products, resistance testing should guide the use of Eviplera (see section 5.1).

Cardiovascular

At supra-therapeutic doses (75 mg and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5, 4.8, and 5.2). Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Eviplera should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.

Co-administration of other medicinal products

Eviplera should not be administered concomitantly with other medicinal products containing emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate or other cytidine analogues, such as lamivudine (see section 4.5). Eviplera should not be administered concomitantly with adefovir dipivoxil.

Co-administration of Eviplera and didanosine: is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil fumarate that may increase the risk of didanosine-related adverse reactions (see section 4.5). Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported.

Renal impairment

Eviplera is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min). Patients with moderate or severe renal impairment require a dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.2 and 5.2). Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5). If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly (see section 4.5).

Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice (see section 4.8).

It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Eviplera and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and then every three months. In patients at risk for renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil, consideration should be given to more frequent monitoring of renal function.

If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any patient receiving Eviplera, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy). Since Eviplera is a combination product and the dosing interval of the individual components cannot be altered, treatment with Eviplera must be interrupted in patients with confirmed creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l). Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate are available.

Bone effects

A dual energy x-ray absorptiometry (DEXA) substudy for both the Phase III studies (C209 and C215) investigated the effect of rilpivirine as compared with control, overall and by background regimen on changes in whole body bone mineral density (BMD) and bone mineral content (BMC) at week 48 and week 96. DEXA substudies showed that small but statistically significant decreases from baseline in whole body BMD and BMC were similar for rilpivirine and control at week 48 and week 96. There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil fumarate.

In a 144-week controlled clinical study that compared tenofovir disoproxil fumarate with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups. Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil fumarate treatment group at 144 weeks. Decreases in BMD of hip were significantly greater in this group until 96 weeks. However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.

Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8). If bone abnormalities are suspected then appropriate consultation should be obtained.

Patients with HIV and hepatitis B or C virus co-infection

Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.

Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.

In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.

The safety and efficacy of Eviplera have not been established for the treatment of chronic HBV infection. Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).

Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. Patients co-infected with HIV and HBV who discontinue Eviplera should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of hepatitis B therapy may be warranted. In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.

Liver disease

The safety and efficacy of Eviplera have not been established in patients with significant underlying liver disorders. The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment. Emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited. No dose adjustment is required for rilpivirine hydrochloride in patients with mild or moderate hepatic impairment (CPT Score A or B). Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C). The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required in these patients.

It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment (see sections 4.2 and 5.2). Eviplera should be used with caution in patients with moderate hepatic impairment (CPT Score B) and is not recommended in patients with severe hepatic impairment (CPT Score C).

Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Lactic acidosis Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues. Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness). Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure. Lactic acidosis generally occurred after a few or several months of treatment. Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels. Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol). Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk. Patients at increased risk should be followed closely.

Lipodystrophy

Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to the measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8).

Mitochondrial dysfunction

Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues. The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia). These events are often transitory. Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour). Whether the neurological disorders are transient or permanent is currently unknown. Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms. These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.

Immune Reactivation Syndrome

In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.

Osteonecrosis

Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

Elderly

Eviplera has not been studied in patients over the age of 65 years. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see sections 4.2 and 5.2).

Excipients

Eviplera contains lactose monohydrate. Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Eviplera contains a colourant called sunset yellow aluminium lake (E110), this may cause allergic reactions in some people.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interaction studies have been conducted using Eviplera. As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate, any interactions that have been identified with these agents individually may occur with Eviplera. Interaction studies with these agents have only been performed in adults.

Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A. Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).

Concomitant use contraindicated

Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).

Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).

Concomitant use not recommended

As a fixed combination, Eviplera should not be administered concomitantly with other medicinal products containing any of the components emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil fumarate.

Due to similarities with emtricitabine, Eviplera should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.4). Eviplera should not be administered concomitantly with adefovir dipivoxil.

Didanosine: The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).

Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Eviplera with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.

Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product. Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin).

Other NNRTIs: It is not recommended to co-administer Eviplera with other NNRTIs.

Concomitant use where caution is recommended

Cytochrome P450 enzyme inhibitors: Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.

QT prolonging medicinal products: Eviplera should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes. There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).

P-glycoprotein substrates: Eviplera should be administered with caution when co-administered with medicinal products that are substrates for P-glycoprotein (e.g. digoxin and dabigatran). Rilpivirine inhibits P-glycoprotein in vitro. The clinical relevance of this inhibition is unknown. Rilpivirine may inhibit intestinal P-glycoprotein and affect medicinal products that are transported by P-glycoprotein in the intestine, such as dabigatran. This may lead to increased plasma concentrations of such medicinal products.

Rilpivirine inhibits the active renal tubular secretion of creatinine. Via the same mechanism exposure to metformin may be increased. Patients should be carefully monitored when initiating or stopping the concomitant administration of rilpivirine and metformin.

Other interactions

Interactions between the components of Eviplera and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “

Table 1: Interactions between the individual components of Eviplera and other medicinal products

Medicinal product by therapeutic areas	Effects on drug levels Mean percent change in AUC, Cmax, Cmin	Recommendation concerning co-administration with Eviplera
ANTI-INFECTIVES
Antiretrovirals
Nucleoside or Nucleotide Reverse Transcriptase Inhibitors (NRTIs/N[t]RTIs)
Didanosine/Emtricitabine	Interaction not studied.	Co-administration of Eviplera and didanosine is not recommended (see section 4.4).
Didanosine (400 mg once daily) /Rilpivirine1	Didanosine: AUC: ↑ 12% Cmin: NA Cmax: ↔ Rilpivirine: AUC: ↔ Cmin: ↔ Cmax: ↔
Didanosine/Tenofovir disoproxil fumarate	Co-administration of tenofovir disoproxil fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions. Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported. Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine. A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Protease Inhibitors (PI) - Boosted (with co-administration of low-dose ritonavir)
Atazanavir/Ritonavir/Emtricitabine	Interaction not studied.	Concomitant use of Eviplera with ritonavir boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). No dose adjustment is required.
Atazanavir/Ritonavir/Rilpivirine	Interaction not studied.
Atazanavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil fumarate (300 mg once daily)	Atazanavir: AUC: Cmax: Cmin: Tenofovir: AUC: ↑ 37% Cmax: ↑ 34% Cmin: ↑ 29%
Darunavir/Ritonavir/Emtricitabine	Interaction not studied.
Darunavir (800 mg once daily)/ Ritonavir (100 mg once daily)/ Rilpivirine1	Darunavir: AUC: ↔ Cmin: Cmax: ↔ Rilpivirine: AUC: ↑ 130% Cmin: ↑ 178% Cmax: ↑ 79%
Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil fumarate (300 mg once daily)	Darunavir: AUC: ↔ Cmin: ↔ Tenofovir: AUC: ↑ 22% Cmin: ↑ 37%
Lopinavir/Ritonavir/Emtricitabine	Interaction not studied.
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)	Lopinavir: AUC: ↔ Cmin: Cmax: ↔ Rilpivirine: AUC: ↑ 52% Cmin: ↑ 74% Cmax: ↑ 29%
Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil fumarate(300 mg once daily)	Lopinavir/Ritonavir: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↑ 32% Cmax: ↔ Cmin: ↑ 51%
CCR5 Antagonists
Maraviroc/Emtricitabine	Interaction not studied	No clinically relevant drug-drug interaction is expected. No dose adjustment is required.
Maraviroc/Rilpivirine	Interaction not studied
Maraviroc (300 mg twice daily)/ Tenofovir disoproxil fumarate (300 mg once daily)	AUC: ↔ Cmax: ↔ Tenofovir concentrations not measured, no effect is expected
Integrase Strand Transfer Inhibitors
Raltegravir/ Emtricitabine	Interaction not studied	No clinically relevant drug-drug interaction is expected. No dose adjustment is required.
Raltegravir/ Rilpivirine	Interaction not studied
Raltegravir (400 mg twice daily)/ Tenofovir disoproxil fumarate	Raltegravir: AUC: ↑ 49% C12h: ↑ 3% Cmax: ↑ 64% (mechanism of interaction unknown) Tenofovir: AUC: C12h: Cmax:
Other Antiviral Agents
Ribavirin	Interaction not studied with any components of Eviplera	No clinically relevant drug-drug interaction is expected. No dose adjustment is required.
Antifungals
Ketoconazole/Emtricitabine	Interaction not studied.	Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). At a dose of 25 mg of rilpivirine, no dose adjustment is required.
Ketoconazole (400 mg once daily)/ Rilpivirine1       Fluconazole2 Itraconazole2 Posaconazole2 Voriconazole2	Ketoconazole: AUC: Cmin: Cmax: ↔ Rilpivirine: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
Ketoconazole/Tenofovir disoproxil fumarate	Interaction not studied.
Antimycobacterials
Rifabutin/Emtricitabine	Interaction not studied.	Eviplera must not be used in combination with rifabutin as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). This may result in loss of therapeutic effect of Eviplera.
Rifabutin (300 mg once daily)/ Rilpivirine1	Rifabutin: AUC: ↔ Cmin: ↔ Cmax: ↔ 25-O-desacetyl-rifabutin: AUC: ↔ Cmin: ↔ Cmax: ↔ Rilpivirine: AUC: Cmin: Cmax:
Rifabutin/Tenofovir disoproxil fumarate	Interaction not studied.
Rifampicin/Emtricitabine	Interaction not studied.	Eviplera must not be used in combination with rifampicin as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). This may result in loss of therapeutic effect of Eviplera.
Rifampicin (600 mg once daily)/ Rilpivirine1                         Rifapentine2	Rifampicin: AUC: ↔ Cmin: NA Cmax: ↔ 25-desacetyl-rifampicin: AUC: Cmin: NA Cmax: ↔ Rilpivirine: AUC: Cmin: Cmax:
Rifampicin (600 mg once daily)/ Tenofovir disoproxil fumarate (300 mg once daily)	Rifampicin: AUC: ↔ Cmax: ↔ Tenofovir: AUC: ↔ Cmax: ↔
Macrolide antibiotics
Clarithromycin Erythromycin Troleandomycin	Interaction not studied with any components of Eviplera	The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). Where possible, alternatives such as azithromycin should be considered.
ANTICONVULSANTS
Carbamazepine Oxcarbazepine Phenobarbital Phenytoin	Interaction not studied with any components of Eviplera	Eviplera must not be used in combination with these anticonvulsants as co-administration may cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). This may result in loss of therapeutic effect of Eviplera.
GLUCOCORTICOIDS
Dexamethasone (systemic, except for single dose use)	Interaction not studied with any components of Eviplera.	Eviplera should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may cause significant dose dependent decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes). This may result in loss of therapeutic effect of Eviplera. Alternatives should be considered, particularly for long-term use.
PROTON PUMP INHIBITORS
Omeprazole/Emtricitabine	Interaction not studied.	Eviplera must not be used in combination with proton pump inhibitors as co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH). This may result in loss of therapeutic effect of Eviplera.
Omeprazole (20 mg once daily)/ Rilpivirine1       Lansoprazole2 Rabeprazole2 Pantoprazole2 Esomeprazole2	Omeprazole: AUC: Cmin: NA Cmax: Rilpivirine: AUC: Cmin: Cmax:
Omeprazole/Tenofovir disoproxil fumarate	Interaction not studied.
H2-RECEPTOR ANTAGONISTS
Famotidine/Emtricitabine	Interaction not studied.	The combination of Eviplera and H2-receptor antagonists should be used with particular caution as co-administration may cause signi

Azo-Septic

Generic Name: phenazopyridine (Oral route)

fen-ay-zoe-PIR-i-deen

Commonly used brand name(s)

In the U.S.

• Azo-Gesic


• Azo-Septic


• Azo-Standard


• Baridium


• Phenazo 95


• Prodium


• Pyridiate


• Pyridium


• RE-Azo


• Urinary Pain Relief


• Uristat


• UTI Relief

Available Dosage Forms:

• Tablet


• Kit

Therapeutic Class: Analgesic

Uses For Azo-Septic

Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract. It is not an antibiotic and will not cure the infection itself.

In the U.S., phenazopyridine is available only with your doctor's prescription.

Before Using Azo-Septic

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

Allergies

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

Pediatric

Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or


• Hepatitis or


• Kidney disease—The chance of side effects may be increased.

Proper Use of phenazopyridine

This section provides information on the proper use of a number of products that contain phenazopyridine. It may not be specific to Azo-Septic. Please read with care.

This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.

Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.

Dosing

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

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

• For oral dosage form (tablets):
  
  • For relieving pain, burning, and discomfort in the urinary tract:
    
    • Adults and teenagers—200 milligrams (mg) three times a day.
    
    
    • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Azo-Septic

Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .

Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.

For patients who wear soft contact lenses:

• It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.

For diabetic patients:

• This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Azo-Septic 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 as soon as possible if any of the following side effects occur:

Rare

• Blue or blue-purple color of skin


• fever and confusion


• shortness of breath, tightness in chest, wheezing, or troubled breathing


• skin rash


• sudden decrease in the amount of urine


• swelling of face, fingers, feet, and/or lower legs


• unusual tiredness or weakness


• weight gain


• yellow eyes or skin

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

Less common or rare

• Dizziness


• headache


• indigestion


• itching of the skin


• stomach cramps or pain

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

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

See also: Azo-Septic side effects (in more detail)

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

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

More Azo-Septic resources

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

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• Dysuria
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Amikin

Generic Name: amikacin (Injection route)

a-mi-KAY-sin

Injection route(Solution)

Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside-induced ototoxicity is usually irreversible. Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Neuromuscular blockade and respiratory paralysis have also been reported following administration. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided .

Commonly used brand name(s)

In the U.S.

• Amikin


• Amikin Pediatric

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Amikin

Amikacin injection is used to treat serious bacterial infections in many different parts of the body. This medicine is for short-term use only (7 to 10 days).

Amikacin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

Amikacin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of this medicine as well as the risks.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Amikin

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amikacin injection in children. However, this medicine should be used with caution in premature and newborn infants.

Geriatric

No information is available on the relationship of age to the effects of amikacin injection in geriatric patients. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving amikacin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Lysine


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Succinylcholine


• Tacrolimus


• Tubocurarine


• Vancomycin


• Vecuronium

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

• Ibuprofen

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Asthma or


• Sulfite allergy, history of—This medicine contains sodium metabisulfite which may cause an allergic reaction in patients with these conditions.

• Kidney disease, severe or


• Muscle problems or


• Myasthenia gravis (severe muscle weakness) or


• Nerve problems or


• Parkinson's disease—Use with caution. May make these condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of this medicine from the body.

Proper Use of amikacin

This section provides information on the proper use of a number of products that contain amikacin. It may not be specific to Amikin. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle or into a vein.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.

To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you or your child are receiving this medicine.

Precautions While Using Amikin

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of a damage to your hearing or sense of balance.

Tell your doctor right away if you have trouble using your muscles or trouble breathing while receiving this medicine.

Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.

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 or vitamin supplements.

Amikin 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 or nurse immediately if any of the following side effects occur:

Incidence not known

• Agitation


• black, tarry stools


• bloody or cloudy urine


• bluish lips or skin


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• coma


• confusion


• cough


• decrease in the amount of urine


• decreased urine output


• depression


• difficulty with breathing


• difficulty with moving


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• dry mouth


• feeling of fullness in the ears


• fever


• headache


• hearing loss


• irritability


• lethargy


• loss of balance


• loss or change in hearing


• muscle pain or stiffness


• muscle twitching


• nausea


• not breathing


• pain in the joints


• pain in the lower back or side


• painful or difficult urination


• pale skin


• rapid weight gain


• ringing or buzzing in the ears


• seizures


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• sweating


• swelling of the face, ankles, or hands


• swollen glands


• thirst


• trembling or shaking of the hands or feet


• trouble with hearing


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

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:

Incidence not known

• Skin rash


• vomiting

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

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

See also: Amikin side effects (in more detail)

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More Amikin resources

• Amikin Side Effects (in more detail)
• Amikin Use in Pregnancy & Breastfeeding
• Amikin Drug Interactions
• Amikin Support Group
• 1 Review for Amikin - Add your own review/rating

• Amikin Prescribing Information (FDA)


• Amikin MedFacts Consumer Leaflet (Wolters Kluwer)


• Amikin Concise Consumer Information (Cerner Multum)


• Amikacin Prescribing Information (FDA)


• Amikacin Sulfate Monograph (AHFS DI)

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