Granisol

Generic Name: granisetron (oral) (gra NIS e tron)

Brand Names: Granisol, Kytril

What is granisetron?

Granisetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Granisetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy or radiation).

Granisetron may be used for other purposes not listed in this medication guide.

What is the most important information I should know about granisetron?

You should not use this medication if you are allergic to granisetron or to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

Before taking granisetron, tell your doctor if you have liver disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.

Granisetron is usually started up to 1 hour before chemotherapy. Tell your doctor if you forget to take the medication within the specified amount of time before your procedure.

What should I discuss with my health care provider before taking granisetron?

You should not use this medication if you are allergic to granisetron, to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

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

• liver disease;


• 
  

  a heart rhythm disorder;

  
  


• 
  

  an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

  
  


• 
  

  a personal or family history of Long QT syndrome.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take granisetron?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Granisetron is usually started up to 1 hour before chemotherapy. Follow your doctor's instructions.

Measure the liquid form of granisetron with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store granisetron at room temperature away from moisture and heat.

What happens if I miss a dose?

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include headache.

What should I avoid while taking granisetron?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Granisetron side effects

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

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  fever, body aches, flu symptoms; or

  
  


• 
  

  easy bruising or bleeding; unusual weakness.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  stomach pain or upset, loss of appetite;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  dizziness; or

  
  


• 
  

  sleep problems (insomnia);

  
  

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

What other drugs will affect granisetron?

There may be other drugs that can interact with granisetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Granisol resources

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

• Granisol Advanced Consumer (Micromedex) - Includes Dosage Information


• Granisol Prescribing Information (FDA)


• Granisetron MedFacts Consumer Leaflet (Wolters Kluwer)


• Granisetron Prescribing Information (FDA)


• Granisetron Hydrochloride Monograph (AHFS DI)


• Kytril Prescribing Information (FDA)


• Kytril Consumer Overview


• Sancuso Prescribing Information (FDA)


• Sancuso Advanced Consumer (Micromedex) - Includes Dosage Information


• Sancuso Consumer Overview


• Sancuso MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Granisol with other medications

• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced

Where can I get more information?

• Your pharmacist can provide more information about granisetron.

See also: Granisol side effects (in more detail)

Coal Tar Foam

Pronunciation: kole tar
Generic Name: Coal Tar
Brand Name: Scytera

Coal Tar Foam is used for:

Relieving itching, irritation, redness, dryness, scaling, and flaking of the skin caused by psoriasis. It may also be used for other conditions as determined by your doctor.

Coal Tar Foam is a keratolytic. It works by slowing bacterial growth and loosening and softening scales and crust.

Do NOT use Coal Tar Foam if:

• you are allergic to any ingredient in Coal Tar Foam


• you have a condition that makes you sensitive to sunlight (eg, lupus, allergy to sunlight)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Coal Tar Foam:

Some medical conditions may interact with Coal Tar Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are using any other treatment for psoriasis, including ultraviolet radiation or a prescription medicine


• if you are using Coal Tar Foam for psoriasis or seborrhea and you also have eczema

Some MEDICINES MAY INTERACT with Coal Tar Foam. However, no specific interactions with Coal Tar Foam are known at this time.

Ask your health care provider if Coal Tar Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Coal Tar Foam:

Use Coal Tar Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before using Coal Tar Foam.


• Shake well before each use.


• Hold the canister upside down to dispense the medicine. Apply the smallest amount necessary to cover the entire area with a thin layer as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• Wash your hands after using Coal Tar Foam, unless your hands are part of the treated area.


• If you miss a dose of Coal Tar Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Coal Tar Foam.

Important safety information:

• Avoid getting Coal Tar Foam in your eyes, nose, or mouth. If you get Coal Tar Foam in your eyes, immediately wash them out with cool tap water.


• Coal Tar Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Coal Tar Foam may stain hair, skin, contact lenses, and clothing.


• Do not use any other medicine or special cleanser on your skin unless directed by your doctor.


• Do not use Coal Tar Foam on open, raw, inflamed, or infected skin.


• Do not use Coal Tar Foam in or around the genital area, groin, or rectum unless you doctor tells you otherwise.


• Do not use Coal Tar Foam over a large area of your body without first talking to your doctor.


• Do not use Coal Tar Foam for a prolonged period of time without consulting your doctor.


• Coal Tar Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Coal Tar Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Different brands of Coal Tar Foam may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of how to use Coal Tar Foam on a child, check with your doctor or pharmacist.


• Coal Tar Foam is flammable. Do not store or use near an open flame or while smoking.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Coal Tar Foam while you are pregnant. It is not known if Coal Tar Foam is found in breast milk. If you are or will be breast-feeding while you are using Coal Tar Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Coal Tar Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Itching, burning, tenderness, or redness; sensitivity to sunlight.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Coal Tar side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Coal Tar Foam:

Store Coal Tar Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not expose to heat or store at temperatures above 120 degrees F (49 degrees C). Do not store in the bathroom. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Coal Tar Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Coal Tar Foam, please talk with your doctor, pharmacist, or other health care provider.


• Coal Tar Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Coal Tar Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Coal Tar resources

• Coal Tar Side Effects (in more detail)
• Coal Tar Use in Pregnancy & Breastfeeding
• Coal Tar Support Group
• 4 Reviews for Coal Tar - Add your own review/rating

Compare Coal Tar with other medications

• Dermatitis
• Psoriasis
• Seborrheic Dermatitis

Octreotide Mayne

Octreotide Mayne 50 micrograms/1ml solution for injection

Octreotide Mayne 100 micrograms/1ml solution for injection

Octreotide Mayne 200 micrograms/ml solution for injection

Octreotide Mayne 500 micrograms/1 ml solution for injection

Octreotide acetate

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

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


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


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


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

In this leaflet

• 1. What Octreotide Mayne is and what it is used for


• 2. Before you use Octreotide Mayne


• 3. How to use Octreotide Mayne


• 4. Possible side effects


• 5. How to store Octreotide Mayne


• 6. Further information

What Octreotide Mayne is and what it is used for

Octreotide Mayne is a synthetic version of a hormone that occurs naturally in the body, called somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones and secretions.

Octreotide Mayne is used:

• To treat the symptoms that occurs with hormone producing gastrointestinal tumours. These symptoms are associated with the over-production of some of the body's natural substances which may result in an imbalance of your natural hormone levels. This imbalance may cause a variety of symptoms in the stomach, pancreas or intestines (gut).


• To reduce the levels of growth hormone and Insulin-like growth factor number 1 (IGF-1) if you have acromegaly and to improve symptoms that you may have due to over-production of these hormones.


• Prior to having an operation on the pancreas, to prevent further complications.

Before you use Octreotide Mayne

Octreotide Mayne should not be used if you are:

• allergic to octreotide or any of the ingredients in Octreotide Mayne (see Section 6).

Special care will be taken:

• as Octreotide may affect your blood sugar levels. You or your doctor should closely monitor your blood sugar levels.


• if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor should closely monitor your blood sugar levels.


• if you have any thyroid problems


• if you have gallstones


• if you have liver disease


• if you are pregnant or planning to become pregnant. If you do become pregnant, tell your doctor immediately.


• if you are breast-feeding

Taking other medicines:

Please tell your doctor if you are taking any of the following medicines;

• ciclosporin (a drug used after a transplant)


• cimetidine (a drug used to reduce stomach acid)


• bromocriptine (a drug used in Parkinson's disease or in acromegaly or to suppress breast milk)


• terfenadine (to relieve allergic symptoms)


• carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy)


• digoxin (medicine for certain heart problems)


• warfarin (a drug used to thin the blood)

Other medicines that are metabolised by the liver can also be affected, so tell your doctor or pharmacist about all the medicines you are taking.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not use Octreotide if you are pregnant, unless you have been told by your doctor that it is absolutely necessary for you to do so.

You should not breastfeed your infant whilst receiving treatment with Octreotide, unless you have been told to do so.

How to use Octreotide Mayne injection

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure of anything.

A doctor or nurse will usually give you this medicine.

The medicine will be given to your either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein).

The usual dosages are given below; however your doctor will decide what dosage to give to you, as this depends on the nature of your treatment, your age and your medical condition:

• To treat the symptoms that occur with hormone producing gastrointestinal tumours: 50 micrograms each 24 hours or each 12 hours, depending on your response, the dose may be increased to 100 to 200 micrograms every 8 hours. The usual recommended maximum daily dosage is 600 micrograms.


• If you have acromegaly: initial doses of 50 to 100 micrograms, every 8 hours. For most patients the dosage is 200 to 300 micrograms per day and the maximum daily dosage is 1500 micrograms.


• Prior to having an operation on the pancreas: 100 micrograms every 8 hours for 7 days, starting on the day of the operation.

Your injection should be given between meals or at bedtime in order to reduce stomach and intestinal (gut) side effects.

To reduce discomfort, Octreotide Mayne solution for injection should reach room temperature before administration. Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

If you use more Octreotide Mayne than advised: if you think you have had too much Octreotide, tell your doctor or nurse immediately.

Octreotide Mayne Side Effects

As other medicinal products, Octreotide Mayne injection can cause side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).


• pancreatitis - this may give you sudden severe pains in your abdomen. It may occur in the first few hours or days of treatment.


• intestinal obstruction - you may feel constipation and pains.

These are very serious side effects. You may need urgent medical attention. These side effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Tell your doctor as soon as possible if you notice any of the following side effects:

Common (occurs in less than 1 in 10 patients but more than 1 in 100):

• changes in blood sugar levels (both high or low levels may occur)


• diarrhoea


• vomiting


• steatorrhea (fatty material in the faeces)


• flatulence - excessive gas in your stomach or bowels


• feeling sick


• stomach pain


• gallstones that could gives gallbladder pain


• pain where the injection has been given

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):

• severe loss of appetite (anorexia)


• being sick


• epigastric pain (pain in upper part of stomach)

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):

• ileus-like conditions (your gut may not work properly)


• loss of hair


• rashes


• heart beating slower than normal

Your doctor will take blood tests to check for changes in liver function, which is a side effect of treatment with Octreotide.

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

How to store Octreotide Mayne

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect the product from light.

The multidose vials of Octreotide 200 micrograms/ml solution for injection for daily use may be stored for two weeks below 25°C.

Octreotide Mayne, diluted in 0.9% sodium chloride would not normally be stored for longer than 24 hours in a refrigerator.

Keep out of the reach and sight of children.

Do not use Octreotide after the expiry date stated on the carton and label.

The injection should only be used if it is clear and free of particles.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

Other information

Octreotide Mayne is available as vials containing a clear, colourless solution for injection. It contains octreotide as the active ingredient.

The vials also contain Glacial Acetic Acid, Sodium Acetate Trihydrate, Sodium Chloride and Water for Injections. The multi-dose vials additionally contain Phenol (a preservative).

This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially sodium free) per ml of solution.

Octreotide Mayne is available in the following pack sizes:

• Octreotida Mayne solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials)


• Octreotida Mayne solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)

The vials may be overwrapped with a protective plastic to minimise the risk of spillage if the vials break; these vials are referred to as ONCO-TAIN.

Marketing authorisation holder and manufacturer:

Mayne Pharma Plc

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

This leaflet was last approved in June 2007

Invanz

Generic Name: Ertapenem Sodium
Class: Carbapenems
VA Class: AM130
Chemical Name: [4R - [3(3S*,5S*),4α,5β,6βS*)]] - (3 - [[5 - [[(3 - Carboxyphenyl)amino]carbonyl] - 3 - pyrrolidinyl]thio] - 6 - (1 - hydroxyethyl) - 4 - methyl - 7 - oxo - 1 - azabicyclo[3.2.0]hept - 2 - ene - 2 - carboxylic acid
Molecular Formula: C₂₂H₂₄N₃NaO₇S
CAS Number: 153832-38-3

Introduction

Antibacterial; carbapenem β-lactam antibiotic.^{1 2 3 4}

Uses for Invanz

Gynecologic Infections

Treatment of moderate to severe acute pelvic infections (including postpartum endomyometritis, septic abortion, postsurgical infections) caused by susceptible Streptococcus agalactiae (group B streptococci), Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus, or Prevotella bivia.¹

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections caused by susceptible E. coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus, B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, or B. uniformis.¹

Respiratory Tract Infections

Treatment of moderate to severe community-acquired pneumonia (CAP) caused by susceptible Streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia.¹

Treatment of moderate to severe CAP caused by susceptible Haemophilus influenzae (non-β-lactamase-producing strains only) or Moraxella catarrhalis.¹

Skin and Skin Structure Infections

Treatment of complicated skin and skin structure infections, including diabetic foot infections without concurrent osteomyelitis, caused by susceptible Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only), Streptococcus agalactiae, S. pyogenes (group A β-hemolytic streptococci), E. coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia.^{1 c}

Urinary Tract Infections (UTIs)

Treatment of complicated UTIs (including pyelonephritis) caused by susceptible E. coli (including cases with concurrent bacteremia) or Klebsiella pneumoniae.¹

Invanz Dosage and Administration

Administration

Administer by IV infusion or IM injection.¹

Administered once daily in adolescents ≥13 years of age and adults.^c Administered twice daily in children 3 months to 12 years of age.^c

IM route may be used as an alternative to the IV route in treatment of those infections for which IM therapy is appropriate.¹ Duration of IM therapy should be ≤7 days.¹ Solutions reconstituted for IM administration should not be given IV.¹

IV Infusion

Reconstitution and Dilution

Reconstitute 1-g vial with 10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection.¹ Shake well to ensure complete dissolution of the drug.¹ The appropriate dose should be withdrawn from the vial and diluted in 0.9% sodium chloride to provide a solution containing ≤20 mg/mL.^c For a 1-g dose, dilute in 50 mL of 0.9% sodium choride.¹

Rate of Administration

Administer by IV infusion over 30 minutes.¹

IM Administration

Inject IM deeply into a large muscle mass, such as the gluteus or lateral part of the thigh.¹ Use caution to avoid inadvertent injection into a blood vessel.¹

Reconstitution

Reconstitute 1-g vial with 3.2 mL of 1% lidocaine injection (without epinephrine) and shake thoroughly to ensure dissolution.¹ Administer within 1 hour of reconstitution.^c

Dosage

Available as ertapenem sodium; dosage expressed in terms of ertapenem.¹

Duration of therapy depends on the type and severity of infection.¹ IV route may be continued for ≤14 days; IM route may be continued for ≤7 days.¹

Pediatric Patients

Gynecologic Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 3–10 days.^c

Adolescents ≥13 years of age: 1 g once daily for 3–10 days.^c

Intra-abdominal Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 5–14 days.^c

Adolescents ≥13 years of age: 1 g once daily for 5–14 days.^c

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adolescents ≥13 years of age: 1 g once daily.^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Skin and Skin Structure Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 7–14 days.^c

Adolescents ≥13 years of age: 1 g once daily for 7–14 days.^c

Urinary Tract Infections (UTIs)

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adolescents ≥13 years of age: 1 g once daily.^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adults

Gynecologic Infections

IV or IM

1 g once daily for 3–10 days.¹

Intra-abdominal Infections

IV or IM

1 g once daily for 5–14 days.¹

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

1 g once daily.¹ Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.¹

Skin and Skin Structure Infections

IV or IM

1 g once daily for 7–14 days.¹ In adults with diabetic foot infections, anti-infective therapy (parenteral or parenteral followed by oral) has been given for up to 28 days.^c

Urinary Tract Infections (UTIs)

IV or IM

1 g once daily.¹ Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.¹

Special Populations

Hepatic Impairment

Dosage recommendations not available; pharmacokinetics have not been studied.¹

Renal Impairment

Dosage adjustments recommended in patients with Cl_cr ≤30 mL/minute.¹

Adults with Cl_cr ≤30 mL/minute, including those with end-stage renal disease (Cl_cr ≤10 mL/minute) and those undergoing hemodialysis, should receive 500 mg once daily.¹ If the dose is given within 6 hours prior to hemodialysis, a supplementary dose of 150 mg should be given after the hemodialysis session; supplemental dose not necessary if daily dose is given ≥6 hours prior to hemodialysis.¹ Data not available in pediatric patients undergoing dialysis.^c

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Invanz

Contraindications

• 
  

  Known hypersensitivity to ertapenem, other carbapenems, or any ingredient in the formulation.¹

  
  


• 
  

  History of anaphylactic reaction to β-lactams.¹

  
  


• 
  

  IM injections are prepared using lidocaine hydrochloride and are contraindicated in patients with known hypersensitivity to local anesthetics of the amide type.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible organisms.¹ Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives may permit overgrowth of clostridia.¹ Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.¹

CNS Effects

Seizures and other CNS effects reported, especially in those with CNS disorders (e.g., brain lesions, history of seizures) and/or renal impairment.¹

Do not exceed recommended dosage, especially in those with known factors that predispose to seizures.¹ Anticonvulsant therapy should be continued in those with known seizure disorders.¹

If focal tremors, myoclonus, or seizures occur, evaluate the patient neurologically, initiate anticonvulsant therapy if necessary, and determine whether ertapenem dosage should be decreased or the drug discontinued.¹

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) reported with β-lactams.¹

If hypersensitivity occurs, discontinue ertapenem and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and other β-lactams.¹

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to ertapenem, cephalosporins, penicillins, or other drugs.¹

General Precautions

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.¹

Sodium Content

Contains approximately 6 mEq (137 mg) of sodium per g of ertapenem.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy established in children 3 months to 17 years of age for the treatment of acute pelvic infections, complicated intra-abdominal infections, CAP, complicated skin and skin structure infections, and complicated UTIs.^c Not recommended for the treatment of meningitis; therapeutic concentrations not achieved in CNS.^c Not recommended in infants <3 months of age; data on use in this age group not available.^c

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.¹ Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.¹

No dosage adjustments except those related to renal function.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not established.¹

Renal Impairment

Increased AUC.¹ Dosage adjustments recommended in adults with Cl_cr ≤30 mL/minute, including those with end-stage renal disease and those undergoing hemodialysis.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea, nausea, vomiting); local reactions (infused vein complication, phlebitis/thrombophlebitis); headache; vaginitis.¹

Interactions for Invanz

Drugs Metabolized by Hepatic Microsomal Enzymes

Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4; pharmacokinetic interactions unlikely with drugs metabolized by these enzymes.¹

Drugs with p-Glycoprotein-mediated Clearance

Does not inhibit and is not a substrate for p-glycoprotein-mediated transport.¹ Pharmacokinetic interaction unlikely with drugs that undergo p-glycoprotein-mediated clearance (e.g., digoxin, vinblastine).¹

Specific Drugs

Drug	Interaction	Comments
Probenecid	Decreased renal tubular secretion of ertapenem; increased ertapenem concentrations and AUC and prolonged half-life1	Concomitant use not recommended1

Invanz Pharmacokinetics

Absorption

Bioavailability

Following IM injection, mean bioavailability is approximately 90%;¹ peak plasma concentrations attained in approximately 2.3 hours.¹

Exhibits nonlinear pharmacokinetics because of concentration-dependent plasma protein binding.¹

Distribution

Extent

Distributed into blister fluid.¹

Therapeutic concentrations not achieved in CNS.^c

Crosses the placenta in rats; not known whether crosses the placenta in humans.¹ Distributed into milk.¹

Plasma Protein Binding

Highly bound to plasma protein, principally albumin.¹ 95% bound at plasma concentration <100 mcg/mL and 85% bound at 300 mcg/mL.¹

Elimination

Metabolism

Does not appear to undergo hepatic metabolism.¹ The major metabolite is an inactive ring-opened derivative formed by hydrolysis of the β-lactam ring.¹

Elimination Route

Eliminated principally in urine.¹

Approximately 80% of an IV dose eliminated in urine (38% as unchanged drug and 37% as the ring-opened metabolite) and 10% eliminated in feces.¹

Half-life

Healthy young adults: 4 hours.¹

Pediatric patients 13–17 years of age: 4 hours.^c

Pediatric patients 3 months to 12 years of age: 2.5 hours.^c

Special Populations

Pharmacokinetics in patients with hepatic impairment not established.¹

In patients with severe renal impairment (Cl_cr 5–30 mL/minute per 1.73 m²) or end-stage renal disease, the extent of exposure to unbound drug is increased 4.4- or 7.6-fold, respectively.¹

Stability

Storage

Parenteral

Powder for IM Injection or IV Infusion

≤25°C.¹

Reconstituted and diluted IV solutions may be stored at room temperature, but the infusion should be completed within 6 hours.¹ These solutions may be refrigerated at 5°C for up to 24 hours, but the infusion should be completed within 4 hours after removal from refrigeration.¹ Do not freeze.¹

IM solutions should be used within 1 hour of reconstitution.^c

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Reconstitute with sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection, then dilute in 0.9% sodium chloride.¹

Do not reconstitute or dilute with dextrose-containing solutions or admix with other medications.¹

Actions and SpectrumActions

• 
  

  Synthetic carbapenem β-lactam antibiotic; structurally and pharmacologically related to imipenem and meropenem.^{1 2 3 4 5 6}

  
  


• 
  

  Usually bactericidal in action.¹

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹

  
  


• 
  

  Spectrum of activity includes many gram-positive and -negative aerobic bacteria and some gram-positive and -negative anaerobic bacteria.¹ Stable in the presence of a variety of β-lactamases (including penicillinases, cephalosporinases, and extended-spectrum β-lactamases).¹

  
  


• 
  

  Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus, Streptococcus agalactiae (group B streptococci), S. pneumoniae (penicillin-susceptible strains only), and S. pyogenes (group A β-hemolytic streptococci).^{1 3} Also active in vitro against S. pneumoniae (penicillin-intermediate strains)^{1 3} and S. epidermidis (oxacillin- susceptible strains only).^c Oxacillin-resistant (methicillin-resistant) staphylococci and Enterococcus are resistant.¹

  
  


• 
  

  Gram-negative aerobes: Active in vitro and in clinical infections against Escherichia coli, Haemophilus influenzae (β-lactamase-negative strains only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.^{1 c} Also active in vitro against Citrobacter, Enterobacter, H. influenzae (β-lactamase-producing strains), H. parainfluenzae, K. oxytoca, Morganella morganii, P. vulgaris, Providencia rettgeri, P. stuartii, and Serratia marcescens.^{1 c}

  
  


• 
  

  Anaerobes: Active in vitro and in clinical infections against Bacteroides fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. uniformis, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus, Porphyromonas asaccharolytica, and Prevotella bivia.^{1 2} Also active in vitro against B. vulgaris, C. perfringens, and Fusobacterium.^{1 c}

  
  

Advice to Patients

• 
  

  Importance of informing clinicians of other medical conditions, including history of seizures.¹

  
  


• 
  

  Importance of discontinuing therapy and informing clinician if an allergic or hypersensitivity reaction occurs.¹

  
  


• 
  

  Importance of reporting persistent or worsening symptoms of infection.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ertapenem Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	1 g (of ertapenem)	Invanz	Merck

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Merck & Co, Inc. Invanz (ertapenem) for injection prescribing information. Whitehouse Station, NJ; 2001 Nov.

2. Hoellman DB, Kelly LM, Credito K et al. In vitro antianaerobic activity of ertapenem (MK-0826) compared to seven other compounds. Antimicrob Agents Chemother. 2002; 46:220-4. [PubMed 11751138]

3. Pankuch GA, Davies TA, Jacobs MR et al. Antipneumococcal activity of ertapenem (MK-0826) compared to those of other agents. Antimicrob Agents Chemother. 2002; 46:42-6. [PubMed 11751109]

4. Odenholt I. Ertapenem: a new carbapenem. Expert Opin Investig Drugs. 2001; 10:1157-66. [PubMed 11772242]

5. Wiseman LR, Wagstaff AJ, Brogden RN et al. Meropenem: a review of its antibacterial activity, pharmacokinetic properties and clinical efficacy. Drugs. 1995; 50:73-101. [PubMed 7588092]

6. Pryka RD, Haig GM. Meropenem: a new carbapenem antimicrobial. Ann Pharmacother. 1994; 28:1045-54. [IDIS 335809] [PubMed 7803882]

7. Fukasawa M, Sumita Y, Harabe ET et al. Stability of meropenem and effect of 1beta- methyl substitution on its stability in the presence of renal dehydropeptidase I. Antimicrob Agents Chemother. 1992; 36:1577-9. [PubMed 1510457]

8. Briceland LL, Tobin EH. Focus on meropenem: a broad-spectrum parenteral carbapenem antimicrobial agent. Formulary. 1996; 31:759-74.

a. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]

b. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:161-2,182-3,196-8,364-5,411-2.

c. Merck & Co, Inc. Invanz (ertapenem) for injection prescribing information. Whitehouse Station, NJ; 2005 Dec.

More Invanz resources

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

• Invanz Prescribing Information (FDA)


• Invanz MedFacts Consumer Leaflet (Wolters Kluwer)


• Invanz Concise Consumer Information (Cerner Multum)


• Invanz Advanced Consumer (Micromedex) - Includes Dosage Information


• Ertapenem Professional Patient Advice (Wolters Kluwer)

Compare Invanz with other medications

• Infection Prophylaxis
• Intraabdominal Infection
• Kidney Infections
• Pelvic Infections
• Pneumonia
• Skin Infection
• Urinary Tract Infection

sodium benzoate and sodium phenylacetate

SOE-dee-um BEN-zoe-ate, SOE-dee-um fen-il-AS-e-tate

Commonly used brand name(s)

In the U.S.

• Ucephan

Available Dosage Forms:

• Solution

Therapeutic Class: Hyperammonemia Agent

Uses For sodium benzoate and sodium phenylacetate

Sodium benzoate and sodium phenylacetate combination is used to treat a condition caused by too much ammonia in the blood (hyperammonemia). sodium benzoate and sodium phenylacetate works by causing less ammonia to be produced by the body.

Ammonia is formed from the breakdown of protein in the body. If the ammonia cannot be removed by the body, then a buildup may cause serious unwanted effects.

Sodium benzoate and sodium phenylacetate combination is available only with your doctor's prescription.

Before Using sodium benzoate and sodium phenylacetate

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 sodium benzoate and sodium phenylacetate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sodium benzoate and sodium phenylacetate 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

sodium benzoate and sodium phenylacetate has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

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 or if they cause different side effects or problems in older people. There is no specific information comparing the use of sodium benzoate and sodium phenylacetate in the elderly with use in other age groups.

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 sodium benzoate and sodium phenylacetate. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer—Use of sodium benzoate and sodium phenylacetate may increase your chance of side effects

• Edema (swelling) or


• Heart disease—Increased retention of water may make these conditions worse

• Kidney disease or


• Liver disease—May increase the amount of medicine in your body

Proper Use of sodium benzoate and sodium phenylacetate

It is important that you follow any special instructions from your doctor, such as following a low protein diet. If you have any questions about this, check with your doctor.

Dosing

The dose of sodium benzoate and sodium phenylacetate 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 sodium benzoate and sodium phenylacetate. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For injection dosage form (solution):
  
  • Treatment of too much ammonia in the blood:
    
    • Adults and children—The dose is based on body weight and must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of sodium benzoate and sodium phenylacetate, 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 sodium benzoate and sodium phenylacetate

Your doctor should check your progress at regular visits to make sure that sodium benzoate and sodium phenylacetate is working properly.

sodium benzoate and sodium phenylacetate 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.

Stop taking sodium benzoate and sodium phenylacetate and get emergency help immediately if any of the following effects occur:

More common

• Confusion


• convulsions


• decreased urine


• dry mouth


• headache


• increase in frequency of seizures


• increased thirst


• irregular heartbeat


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea


• numbness or tingling in hands, feet, or lips


• problems with movement, walking or speech


• shortness of breath


• swelling of face


• unusual tiredness or weakness


• vomiting


• yellow eyes or skin

Less common

• Blood in stools


• blood in urine


• bruising


• change in consciousness


• coughing or vomiting blood


• difficulty in breathing


• drowsiness


• loss of consciousness


• mental changes


• muscle cramps in hands, arms, feet, legs, or face


• muscle tremors


• persistent bleeding or oozing from puncture sites, mouth, or nose


• rapid, deep breathing


• rash


• restlessness


• shortness of breath


• stomach cramps


• tightness in chest


• tremor


• troubled breathing


• wheezing

Frequency unknown

• Abnormally slow deep breathing


• blue lips, fingernails, or skin


• blurred vision


• bulging soft spot on head of an infant


• change in ability to see colors, especially blue or yellow


• chest pain or discomfort


• dizziness or fainting


• injection site hemorrhage


• insomnia


• irregular, fast or slow, or shallow breathing


• lightheadedness


• severe headache


• shakiness


• sleepiness


• slow heartbeat


• slow to respond


• slurred speech


• unconsciousness

Symptoms of overdose

• Agitation


• back pain


• blue lips, fingernails, or skin


• blurred vision


• bulging soft spot on head of an infant


• change in ability to see colors, especially blue or yellow


• chest pain or discomfort


• chills


• cold, clammy, pale skin


• coma


• confusion


• continuing nausea or vomiting


• cough


• deep or fast breathing with dizziness


• difficult or troubled breathing


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


• drowsiness


• fainting


• fast heartbeat


• fever


• general feeling of discomfort or illness


• hallucinations


• headache


• high blood pressure


• insomnia


• irregular, fast or slow, or shallow breathing


• irregular heartbeats


• irritability


• lightheadedness


• loss of appetite


• mood or mental changes


• muscle twitching


• no blood pressure


• not alert


• numbness to feet, hands and around mouth


• rapid, shallow breathing


• restlessness


• seizures


• slow heart rate


• stiff neck


• sweating


• swelling of face


• swelling of feet or lower legs


• thickening of bronchial secretions


• trouble with coordination


• unusual tiredness or weakness


• vomiting


• weakness


• yellow eyes or skin

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

More common

• Changes in skin color


• cold hands and feet


• confusion or excitement


• cough or hoarseness;


• dry mouth;


• fever or chills


• flushed, dry skin;


• fruit-like breath odor


• increased hunger


• increased thirst


• increased urination


• lower back or side pain


• mental depression or anxiety


• nightmares or unusually vivid dreams


• painful or difficult urination


• pain, redness, or swelling in arm or leg


• skin disorders


• sweating


• unexplained weight loss

Less common

• Bladder pain


• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection; inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site


• decrease in urine-concentrating ability


• diarrhea


• difficult, burning, or painful urination


• frequent urge to urinate


• hyperventilation


• nervousness


• pale skin


• shaking


• troubled breathing with exertion


• trouble sleeping


• unusual bleeding or bruising

Frequency unknown

• Blister


• full or bloated feeling or pressure in the stomach


• itching skin


• rash with flat lesions or small raised lesions on the skin


• swelling of abdominal or stomach area


• uncontrolled jerking movement

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 sodium benzoate and sodium phenylacetate resources

• Sodium benzoate and sodium phenylacetate Use in Pregnancy & Breastfeeding
• Sodium benzoate and sodium phenylacetate Drug Interactions
• Sodium benzoate and sodium phenylacetate Support Group
• 0 Reviews for Sodium benzoate and sodium phenylacetate - Add your own review/rating

Compare sodium benzoate and sodium phenylacetate with other medications

• Hyperammonemia

Topcare Nicotine Lozenge

Dosage Form: lozenge
Topco Nicotine Polacrilex Lozenge 4 mg (nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg (nicotine)

Purpose

Stop smoking aid

Uses

• reduces withdrawal symptoms, including nicotine craving associated with quitting smoking

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• a sodium-restricted diet


• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• stomach ulcer or diabetes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

• mouth problems occur


• persistent indigestion or severe sore throat occurs


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s Guide for complete directions and other important information


• stop smoking completely when you begin using the lozenge


• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge


• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6	Weeks 7 to 9	Weeks 10 to 12
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

• nicotine lozenge is a medicine and must be used a certain way to get the best results


• place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.


• you may feel a warm or tingling sensation


• occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)


• do not eat or drink 15 minutes before using or while the lozenge is in your mouth


• to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks


• do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects


• do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.


• stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Other information

• each lozenge contains: sodium 15 mg


• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge


• sugar alcohol content: 1 g mannitol per lozenge


• store at 20-25°C (68-77°F)


• keep vial closed and protect from light

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel

4 mg nicotine lozenge

Nicotine Polacrilex Lozenge 4 mg (nicotine)

Stop Smoking Aid

Includes User’s Guide

For those who smoke their first cigarette within 30 minutes of waking up.

If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Lozenge, 2 mg

Actual Size

Mint Flavor

QuitTube

(# QuitTube™ containers of #)

Compare to Commit® active ingredient

Nicotine Polacrilex Lozenge 4 mg (nicotine) Carton

TOPCARE NICOTINE  nicotine polacrilex  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-873 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code L873 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-873-05 3 VIAL In 1 CARTON contains a VIAL 1 24 LOZENGE In 1 VIAL This package is contained within the CARTON (36800-873-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077007	09/03/2009

Labeler - Topco Associates LLC (006935977)

Revised: 06/2009Topco Associates LLC

More Topcare Nicotine Lozenge resources

• Topcare Nicotine Lozenge Side Effects (in more detail)
• Topcare Nicotine Lozenge Use in Pregnancy & Breastfeeding
• Topcare Nicotine Lozenge Drug Interactions
• Topcare Nicotine Lozenge Support Group
• 42 Reviews for Topcare Nicotine - Add your own review/rating

Compare Topcare Nicotine Lozenge with other medications

• Smoking Cessation

Lioresal Double Strength

Generic Name: baclofen (Oral route)

BAK-loe-fen

Commonly used brand name(s)

In Canada

• Lioresal


• Lioresal Double Strength

Available Dosage Forms:

• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Chemical Class: Gamma Aminobutyric Acid (class)

Uses For Lioresal Double Strength

Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects. Baclofen may also be used to relieve other conditions as determined by your doctor.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, baclofen is used in certain patients with trigeminal neuralgia (severe burning or stabbing pain along the nerves in the face); also called ''tic douloureux.''

Before Using Lioresal Double Strength

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of baclofen in children with use in other age groups.

Geriatric

Side effects such as hallucinations, confusion or mental depression, other mood or mental changes, and severe drowsiness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of baclofen.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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:

• Type 2 diabetes mellitus—Baclofen may raise blood sugar levels

• Epilepsy or


• Kidney disease or


• Mental or emotional problems or


• Stroke or other brain disease—The chance of side effects may be increased

Proper Use of baclofen

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

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 muscle relaxation:
    
    • Adults and teenagers—At first, the dose is 5 milligrams (mg) three times a day. Then, each dose may be increased by 5 mg every three days until the desired response is reached. No more than 80 mg should be taken within a twenty-four-hour period.
    
    
    • 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.

Precautions While Using Lioresal Double Strength

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using baclofen.

This medicine may cause drowsiness, dizziness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

For diabetic patients:

• This medicine may cause your blood sugar levels to rise. If you notice a change in the results of your blood or urine sugar test or if you have any questions about this, check with your doctor.

Lioresal Double Strength 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:

Less common or rare

• Bloody or dark urine


• chest pain


• fainting


• hallucinations (seeing or hearing things that are not there)


• mental depression or other mood changes


• ringing or buzzing in the ears


• skin rash or itching

Symptoms of overdose

• Blurred or double vision


• convulsions (seizures)


• muscle weakness (severe)


• shortness of breath or unusually slow or troubled breathing


• vomiting

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

• Confusion


• dizziness or lightheadedness


• drowsiness


• nausea


• unusual weakness, especially muscle weakness

Less common or rare

• Abdominal or stomach pain or discomfort


• clumsiness, unsteadiness, trembling, or other problems with muscle control


• constipation


• diarrhea


• difficult or painful urination or decrease in amount of urine


• false sense of well-being


• frequent urge to urinate or uncontrolled urination


• headache


• loss of appetite


• low blood pressure


• muscle or joint pain


• numbness or tingling in hands or feet


• pounding heartbeat


• sexual problems in males


• slurred speech or other speech problems


• stuffy nose


• swelling of ankles


• trouble in sleeping


• unexplained muscle stiffness


• unusual excitement


• unusual tiredness


• weight gain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Convulsions (seizures)


• hallucinations (seeing or hearing things that are not there)


• increase in muscle spasm, cramping, or tightness


• mood or mental changes


• unusual nervousness or restlessness

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: Lioresal Double Strength 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.

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More Lioresal Double Strength resources

• Lioresal Double Strength Side Effects (in more detail)
• Lioresal Double Strength Dosage
• Lioresal Double Strength Use in Pregnancy & Breastfeeding
• Drug Images
• Lioresal Double Strength Drug Interactions
• Lioresal Double Strength Support Group
• 5 Reviews for Lioresal Double Strength - Add your own review/rating

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