Tamsulosin

Generic Name: tamsulosin (tam soo LOE sin)

Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

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

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

You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use.

What should I discuss with my healthcare provider before taking tamsulosin?

You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children.

How should I take tamsulosin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

See also: Tamsulosin dosage (in more detail)

What happens if I miss a dose?

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

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose?

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

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking tamsulosin?

Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin.

Tamsulosin 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.

Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:

• 
  

  feeling like you might pass out;

  
  


• 
  

  chest pain;

  
  


• 
  

  fever, chills, body aches, or flu symptoms; or

  
  


• 
  

  penis erection that is painful or lasts 4 hours or longer.

  
  

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  weakness, drowsiness;

  
  


• 
  

  headache;

  
  


• 
  

  nausea, diarrhea;

  
  


• 
  

  back pain;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dental problems;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  abnormal ejaculation, decreased sex drive; or

  
  


• 
  

  runny nose, sore throat, cough.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

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

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  methimazole (Tapazole);

  
  


• 
  

  pioglitazone (Actos);

  
  


• 
  

  ropinirole (Requip);

  
  


• 
  

  ticlopidine (Ticlid);

  
  


• 
  

  warfarin (Coumadin);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

  
  


• 
  

  an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

  
  


• 
  

  antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

  
  


• 
  

  anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

  
  


• 
  

  erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

  
  


• 
  

  medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

  
  

This list is not complete and there are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More tamsulosin resources

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

• tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information


• Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer)


• Tamsulosin Prescribing Information (FDA)


• Flomax Prescribing Information (FDA)


• Flomax Monograph (AHFS DI)


• Flomax Consumer Overview

Compare tamsulosin with other medications

• Benign Prostatic Hyperplasia
• Overactive Bladder
• Urinary Tract Stones

Where can I get more information?

• Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)

NuLYTELY

peg-3350, sodium chloride, sodium bicarbonate and potassium chloride

Dosage Form: powder, for solution
NuLYTELY® with Flavor Packs

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution

Rx only

DESCRIPTION:

A white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride and one 2.0 g flavor pack (optional). When dissolved in water to a volume of 4 liters, NuLYTELY (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution having a pleasant mineral water taste. NuLYTELY is administered orally or via nasogastric tube as a gastrointestinal lavage. NuLYTELY Flavor Packs are available in Cherry, Lemon -Lime, Orange and Pineapple. This preparation can be used without the addition of a NuLYTELY Flavor Pack.

CLINICAL PHARMACOLOGY:

NuLYTELY induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

INDICATIONS AND USAGE:

NuLYTELY is indicated for bowel cleansing prior to colonoscopy.

CONTRAINDICATIONS:

NuLYTELY is contraindicated in patients known to be hypersensitive to any of the components. NuLYTELY is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

WARNINGS:

NuLYTELY Flavor Packs are for use only in combination with the contents of the accompanying 4 liter container. No additional ingredients, e.g. flavorings, should be added to the solution. NuLYTELY should be used with caution in patients with severe ulcerative colitis. Use of NuLYTELY in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

PRECAUTIONS:

General: Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of NuLYTELY, especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of NuLYTELY.

Information for patients: NuLYTELY produces a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking NuLYTELY.

Adults drink 240 mL (8 oz.) every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Continue drinking until the watery stool is clear and free of solid matter. Any unused portion should be discarded. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of NuLYTELY administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

Use of NuLYTELY in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

Drug Interactions: Oral medication administered within one hour of the start of administration of NuLYTELY may be flushed from the gastrointestinal tract and not absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenic and reproductive studies with animals have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with NuLYTELY. It is also not known whether NuLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. NuLYTELY should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and effectiveness of NuLYTELY in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of NuLYTELY in adults with additional safety and efficacy data from published studies of similar formulations.

ADVERSE REACTIONS:

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of NuLYTELY. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Published literature contains isolated reports of serious adverse reaction following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest X-ray after vomiting and aspirating PEG.

DOSAGE AND ADMINISTRATION:

NuLYTELY is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to NuLYTELY administration, but in no case should solid food be given for at least two hours before the solution is given.

Oral administration: Adults: At a rate of 240 mL(8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric tube administration: Adults: At a rate of 20-30 mL per minute (1.2-1.8 liters per hour). Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear.

The first bowel movement should occur approximately one hour after the start of NuLYTELY administration. Ingestion of 4 liters of NuLYTELY solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients.

Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer NuLYTELY on the evening before the examination.

Preparation of the solution: NuLYTELY solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to insure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.

HOW SUPPLIED:

NuLYTELY, Cherry Flavor NuLYTELY, Lemon-Lime Flavor NuLYTELY, Orange Flavor NuLYTELY are available in a disposable jug, in powdered form, for oral administration as a solution following reconstitution.

NuLYTELY with Flavor Packs is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached package containing 4 flavor packs; one each 2.0 g: Cherry, Lemon-Lime, Orange and Pineapple flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing.

Each jug contains:

NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Cherry Flavor NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Lemon-Lime Flavor NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Orange Flavor NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

NuLYTELY with Flavor Packs: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

NDC 52268-400-01

Distributed by Braintree Laboratories, Inc., Braintree, MA 02185

S 12/08

PAKAGE LABEL – PRINCIPAL DISPLAY PANEL

NDC 52268-400-01

NuLYTELY®

(PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution)

With Flavor Packs

Rx Only

Visit www.braintreelabs.com for more information.

NuLYTELY  peg-3350, sodium chloride, sodium bicarbonate and potassium chloride  powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52268-400 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 210 g  in 2 L SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 2.86 g  in 2 L SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 5.6 g  in 2 L POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 0.74 g  in 2 L

Inactive Ingredients Ingredient Name Strength CHERRY   ORANGE   PINEAPPLE   LEMON   LIME

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52268-400-01 4 L In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019797	04/17/2007

Labeler - Braintree Laboratories, Inc. (107904591)

Registrant - Braintree Laboratories, Inc. (107904591)

Establishment
Name	Address	ID/FEI	Operations
Braintree Laboratories, Inc.		107904591	ANALYSIS, MANUFACTURE

Revised: 10/2009Braintree Laboratories, Inc.

More NuLYTELY resources

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

• NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Colyte Advanced Consumer (Micromedex) - Includes Dosage Information


• Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)


• MoviPrep Advanced Consumer (Micromedex) - Includes Dosage Information


• MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)


• MoviPrep Consumer Overview

Compare NuLYTELY with other medications

• Bowel Preparation
• Constipation, Chronic
• Gastrointestinal Decontamination

Testosterone Enanthate

Pronunciation: tes-TOS-ter-one
Generic Name: Testosterone Enanthate
Brand Name: Delatestryl

Testosterone Enanthate is used for:

Treating symptoms of low testosterone in men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for other conditions as determined by your doctor. It is also used to treat certain types of breast cancer in women.

Testosterone Enanthate is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body. It also counteracts the effects of estrogen in certain types of breast cancer, which helps to decrease cancer growth.

Do NOT use Testosterone Enanthate if:

• you are allergic to any ingredient in Testosterone Enanthate


• you are pregnant, may become pregnant, or are breast-feeding


• you have breast cancer and are male; known or suspected prostate cancer; or serious heart, liver, or kidney problems

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

Before using Testosterone Enanthate:

Some medical conditions may interact with Testosterone Enanthate. 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 (especially sesame oil)


• if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)


• if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity

Some MEDICINES MAY INTERACT with Testosterone Enanthate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by Testosterone Enanthate


• Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because their side effects, including risk of bleeding, may be increased by Testosterone Enanthate


• Propranolol because its effectiveness may be decreased by Testosterone Enanthate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Testosterone Enanthate 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 Testosterone Enanthate:

Use Testosterone Enanthate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Testosterone Enanthate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Testosterone Enanthate at home, a health care provider will teach you how to use it. Be sure you understand how to use Testosterone Enanthate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Testosterone Enanthate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Testosterone Enanthate, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Testosterone Enanthate.

Important safety information:

• Tell your doctor or dentist that you take Testosterone Enanthate before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Testosterone Enanthate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Testosterone Enanthate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Testosterone Enanthate.


• Lab tests, including liver function, blood cell counts, blood cholesterol, prostatic specific antigen, bone growth, and blood testosterone, may be performed while you use Testosterone Enanthate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Testosterone Enanthate with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.


• Testosterone Enanthate should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Testosterone Enanthate if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Testosterone Enanthate is found in breast milk. Do not breast-feed while using Testosterone Enanthate.

Possible side effects of Testosterone Enanthate:

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:

Acne; bitter or strange taste in mouth; change in sex drive; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache.

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); breast growth or pain; change in the size or shape of the testicles; changes in menstrual periods; coughing fit; dark urine or light-colored bowel movements; depression or mood changes; dizziness; facial hair growth; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; shortness of breath; stomach pain; swelling of the ankles or legs; urination problems; voice changes or hoarseness; weight gain; yellowing of the skin or eyes.

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: Testosterone Enanthate 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. Symptoms may include confusion; one-sided weakness; vision problems.

Proper storage of Testosterone Enanthate:

Store Testosterone Enanthate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Testosterone Enanthate out of the reach of children and away from pets.

General information:

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


• Testosterone Enanthate 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 Testosterone Enanthate. 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 Testosterone Enanthate resources

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

• Testosterone Enanthate Monograph (AHFS DI)


• Testosterone Enanthate Prescribing Information (FDA)


• Testosterone Professional Patient Advice (Wolters Kluwer)


• Testosterone Prescribing Information (FDA)


• AndroGel Prescribing Information (FDA)


• Androderm Prescribing Information (FDA)


• Androderm Advanced Consumer (Micromedex) - Includes Dosage Information


• Androgel Consumer Overview


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Solarcaine First Aid Lidocaine Spray Topical

Generic Name: lidocaine and prilocaine (Gingival route)

LYE-doe-kane, PRIL-oh-kane

Commonly used brand name(s)

In the U.S.

• Oraqix

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Anesthetic, Amino Amide Combination

Chemical Class: Amino Amide

Uses For Solarcaine First Aid Lidocaine Spray

Lidocaine and prilocaine periodontal (gingival) gel is used on the gums to cause numbness or loss of feeling during dental procedures. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the gum.

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

Before Using Solarcaine First Aid Lidocaine Spray

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 lidocaine and prilocaine periodontal gel 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 lidocaine and prilocaine periodontal gel in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine periodontal gel.

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, history of or


• Heart disease or


• Heart rhythm problems—May cause side effects to become worse.

• Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition.

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

Proper Use of lidocaine

This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to Solarcaine First Aid Lidocaine Spray. Please read with care.

A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.

Precautions While Using Solarcaine First Aid Lidocaine Spray

It is very important that your dentist check you closely for any problems or unwanted effects that may be caused by this medicine.

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

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.

During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

Solarcaine First Aid Lidocaine Spray 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:

More common

• Gum numbness that continues


• gum swelling or irritation


• nausea

Rare

• Itching


• hoarseness or trouble with swallowing


• rash


• shortness of breath


• swelling of the eyelids, face, lips, or tongue


• tightness in the chest


• trouble with breathing


• wheezing

Incidence not known

• Blue or blue-purple color of lips, fingernails, mouth, or skin


• blurred or double vision


• convulsions


• dark urine


• dizziness or drowsiness


• fainting


• feeling hot, cold, or numb


• headache


• irregular or fast heartbeat


• muscle twitching or trembling


• nausea or vomiting


• ringing or buzzing in the ears


• shortness of breath or troubled breathing


• unusual excitement, nervousness, or restlessness


• 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

• Bad or bitter taste


• headache


• mouth pain or soreness


• mouth ulcers


• tiredness

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: Solarcaine First Aid Lidocaine Topical 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.

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• Anesthesia

Tequin

Generic Name: Gatifloxacin
Class: Quinolones
VA Class: AM900
Chemical Name: (±-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline- carboxylic acid sesquihydrate
Molecular Formula: C₁₉H₂₂FN₃O₄
CAS Number: 112811-59-3

Introduction

Antibacterial; 8-methoxy fluoroquinolone.^{1 2}

Uses for Tequin

Respiratory Tract Infections

Acute bacterial sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae.^{1 8 12}

Acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae, H. parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains).^{1 8 11 b}

Community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains), H. influenzae, H. parainfluenzae, M. catarrhalis, S. aureus, Mycoplasma pneumoniae, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Legionella pneumophila.^{1 8 13 14 15 b}

Skin and Skin Structure Infections

Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, cellulitis) caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains) or S. pyogenes (group A β-hemolytic streptococci).^{1 b}

Urinary Tract Infections (UTIs)

Uncomplicated UTIs caused by susceptible Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.¹

Complicated UTIs caused by susceptible E. coli, K. pneumoniae, or P. mirabilis.¹

Pyelonephritis caused by susceptible E. coli.^{1 8}

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).^c AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,^c but a fluoroquinolone (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used.^c Consultation with an infectious disease specialist is recommended.^c

Gonorrhea

Uncomplicated urethritis and cervicitis caused by susceptible Neisseria gonorrhoeae.¹

Acute, uncomplicated rectal infections caused by susceptible N. gonorrhoeae in women.¹

Should not be used for treatment of gonococcal infections acquired in Asia or Pacific islands (including Hawaii); use may be inadvisable in other areas where N. gonorrhoeae with quinolone resistance has been reported (including California).^{18 20}

Anthrax

Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax)† when oral ciprofloxacin and oral doxycycline are unavailable.²¹

Alternative for treatment of inhalational anthrax† when a parenteral regimen is unavailable (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).²¹

Mycobacterial Infections

Alternative for use in multiple-drug regimens for treatment of active tuberculosis† in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.²⁸

Tequin Dosage and Administration

Administration

Administer orally or by slow IV infusion; not for IM, rapid IV, intrathecal, intraperitoneal, or sub-Q use.¹

No dosage adjustment needed when switching from IV to oral administration, or vice versa.¹

Administer once daily every 24 hours.¹

Oral Administration

Administer tablets without regard to meals, including milk or dietary supplements containing calcium.¹ (See Interactions: Specific Drugs.)

IV Administration

Gatifloxacin injection concentrate must be diluted prior to administration.¹ (See Solution Compatibility under Stability.)

No further dilution necessary for gatifloxacin premixed injection.¹

Manufacturer states that additives or other drugs should not be added to gatifloxacin solutions or infused simultaneously through the same IV line¹ .

Dilution

Dilute gatifloxacin injection concentrate to concentration of 2 mg/mL with a compatible IV solution before administration (see Solution Compatibility under Stability).¹ Do not use water for injection as a diluent;¹ a hypotonic solution results.¹

Use strict aseptic technique since drug product contains no preservative.¹

Rate of Administration

Administer by IV infusion over 1 hour.¹

Dosage

Adults

Respiratory Tract Infections

Oral or IV

400 mg once daily.¹ Usual duration is 5 days for acute bacterial exacerbation of chronic bronchitis, 10 days for acute sinusitis, and 7–14 days for CAP.¹

Skin and Skin Structure Infections

Oral or IV

400 mg once daily for 7–10 days.¹

UTIs

Oral or IV

400 mg as a single dose or 200 mg once daily for 3 days in patients with uncomplicated UTIs; 400 mg once daily for 7–10 days in those with complicated UTIs or pyelonephritis.¹

Gonorrhea

Oral or IV

400 mg as a single dose in men with uncomplicated urethral gonorrhea or in women with endocervical or rectal gonorrhea.¹

Anthrax†

Oral

400 mg once daily for ≥60 days for postexposure prophylaxis or treatment of inhalational anthrax.^{21 22 23}

Mycobacterial Infections†

Active Tuberculosis

Oral

400 mg once daily.²⁸ Must be used in conjunction with other antituberculosis agents.²⁸

Multiple-drug regimen usually given for 12–18 months when rifampin-resistant M. tuberculosis are involved; for 18–24 months when isoniazid- and rifampin-resistant strains are involved; or for 24 months when the strain is resistant to isoniazid, rifampin, ethambutol, and/or pyrazinamide.²⁸

Special Populations

Hepatic Impairment

Dosage adjustment not necessary in patients with moderate (Child-Pugh class B) cirrhosis.¹

Not studied to date in patients with severe (Child-Pugh class C) impairment;¹ manufacturer makes no recommendations regarding dosage in such patients.¹⁶

Renal Impairment

Adjust dosage in patients with Cl_cr <40 mL/minute, including those who require hemodialysis or CAPD: initial dose of 400 mg, followed by 200 mg daily beginning on day 2 of therapy.¹ Administer dose in hemodialysis patients after dialysis session.¹

Dosage adjustment not required for single-dose regimen (for uncomplicated UTIs or gonorrhea) or 3-day regimen (for uncomplicated UTIs).¹

Renal impairment increases risk of dysglycemia.^b (See Hypoglycemia and Hyperglycemia under Cautions.)

Geriatric Patients

Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.^b (See Renal Impairment under Dosage and Administration.)

Cautions for Tequin

Contraindications

• 
  

  Known hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.¹

  
  


• 
  

  Diabetes mellitus.^b

  
  

Warnings/Precautions

Warnings

Hypoglycemia and Hyperglycemia

Symptomatic hypoglycemia or hyperglycemia reported.¹ Usually have occurred in patients with diabetes, but blood glucose disturbances (especially hyperglycemia) have occurred in patients without a history of diabetes.¹

Serious (sometimes fatal) disturbances of glucose homeostasis (e.g., hyperosmolar nonketotic hyperglycemic coma, diabetic ketoacidosis, hypoglycemic coma, seizures, loss of consciousness) reported rarely during postmarketing surveillance.^b

In addition to diabetes, risk factors for dysglycemia during gatifloxacin therapy include advanced age, renal insufficiency, and concurrent use of glucose-altering medication (especially oral hypoglycemic agents).^b

Closely monitor blood glucose concentrations in patients with risk factors for developing dysglycemia.¹ If signs and symptoms of hypoglycemia or hyperglycemia occur, discontinue gatifloxacin and immediately initiate appropriate therapy.¹

Musculoskeletal Effects

Arthropathy and chondrodysplasia in weight-bearing joints of in immature animals reported with fluoroquinolones, including gatifloxacin.^{1 b} Permanent lesions in cartilage reported in immature dogs; clinical relevance to humans unknown.¹ Safety and efficacy not established in children and adolescents <18 years of age or in pregnant or lactating women.¹

Rupture of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability reported in patients receiving fluoroquinolones, including gatifloxacin.^b Tendon rupture can occur during or after treatment; tendinitis or tendon rupture may occur more frequently in those receiving corticosteroids, especially geriatric patients.^b

Discontinue gatifloxacin if pain, inflammation, or tendon rupture occurs.^b Patient should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture excluded.^b

Prolongation of QT Interval

Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including gatifloxacin.¹

QT interval prolongation is dose related; do not exceed recommended dosage or infusion rate.^b

Increased torsades de pointes risk with advanced age (>60 years of age), female gender, underlying cardiac disease, and/or concurrent use of multiple medications.^b

Avoid use in patients with prolonged QT_c interval or uncorrected hypokalemia. Also avoid use in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.^b Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride,¹⁷ erythromycin, antipsychotic agents, tricyclic antidepressants) and in patients with ongoing proarrhythmic conditions, such as clinically important bradycardia or acute myocardial ischemia.¹

CNS Effects

Seizures, increased intracranial pressure, and psychoses reported with fluoroquinolones, including gatifloxacin.¹ CNS stimulation leading to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, nervousness, agitation, or anxiety also reported.¹

Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors predisposing to seizures.¹

If CNS effects occur, discontinue gatifloxacin and institute appropriate measures.¹

Peripheral Neuropathy

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones.^b

Discontinue gatifloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.^b

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹

Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones.¹ These reactions may occur with first dose.¹

Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions.¹

In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses.¹ These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.¹

Discontinue gatifloxacin at first appearance of rash or any other sign of hypersensitivity.¹ Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Photosensitivity Reactions

Phototoxicity reported with some other quinolones.¹ Potential for photosensitivity reaction may be lower with gatifloxacin than with some other fluoroquinolones (e.g., ciprofloxacin, levofloxacin).¹

Avoid excessive sunlight or artificial UV light (e.g., tanning beds).¹

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of gatifloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^b

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^b In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^b

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats.¹ Use with caution.^{1 16}

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

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

Patients ≥65 years of age with unrecognized diabetes, age-related decreases in renal function, underlying medical problems, or receiving concomitant therapy associated with alterations of blood glucose concentration may be at particular risk for serious dysglycemia.^a (See Hypoglycemia and Hyperglycemia under Cautions.)

Age-related decline in renal function may increase risk of adverse reactions.¹

Hepatic Impairment

Effects of severe hepatic impairment on gatifloxacin pharmacokinetics not determined.¹ Use with caution.¹

Renal Impairment

Decreased clearance.¹ Dosage adjustment recommended.¹ (See Renal Impairment under Dosage and Administration.)

Renal impairment increases risk of dysglycemia.^b (See Hypoglycemia and Hyperglycemia under Cautions.)

Common Adverse Effects

Nausea, vaginitis, redness at injection site, diarrhea, headache, dizziness.¹

Interactions for Tequin

Does not inhibit CYP isoenzymes 3A4, 2D6, 2C9, 2C19, or 1A2 in vitro and is not an enzyme inducer.¹ Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.¹

Drugs Affecting Glucose Metabolism

Potential pharmacologic interaction (possible additive hypoglycemic or hyperglycemic effect); monitor blood glucose.^a (See Hypoglycemia and Hyperglycemia under Cautions.)

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).¹ (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Antacids (aluminum- or magnesium-containing)	Decreased absorption of gatifloxacin1	Administer gatifloxacin at least 4 hours before such antacids1
Antacids (calcium-containing); calcium supplements, milk	No clinically important pharmacokinetic interactions 1
Antidiabetic agents (e.g., glyburide)	Hypoglycemia and hyperglycemia reportedb Glyburide: Pharmacokinetic interaction unlikely1	Closely monitor blood glucose; discontinue gatifloxacin and initiate appropriate therapy if hypoglycemia or hyperglycemia occurs1
Didanosine	Decreased absorption of gatifloxacin with buffered didanosine preparations1 16	Administer gatifloxacin at least 4 hours before buffered didanosine preparations1 16
Digoxin	Potential increase in serum digoxin concentration and toxicity1	Monitor for digoxin toxicity; determine serum digoxin concentrations and adjust digoxin dosage as appropriate1
Iron preparations	Decreased absorption of gatifloxacin1	Administer gatifloxacin at least 4 hours before ferrous sulfate and dietary supplements containing iron1
Multivitamins and mineral supplements	Decreased absorption of gatifloxacin1	Administer gatifloxacin at least 4 hours before supplements containing zinc, magnesium, or iron1
NSAIAs	Possible increased risk of CNS stimulation, seizures1
Omeprazole	Pharmacokinetic interaction unlikelyb
Probenecid	Increased systemic exposure to gatifloxacin1
Sucralfate	Potential pharmacokinetic interaction16
Warfarin	Potential for enhanced warfarin effect1 16	Careful monitoring recommended1

Tequin Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract following oral administration.^{1 40} Absolute bioavailability is 96%.^{1 37 41} When administered orally in fasting individuals, peak plasma concentrations usually occur 1–2 hours following a dose.^{1 b}

Pharmacokinetics are similar after oral or IV (1-hour infusion) administration.^{1 41}

Food

Administration with food does not affect peak plasma concentration or extent or rate of absorption.³⁹

Distribution

Extent

Rapidly and widely distributed into most body tissues and fluids.^{1 37 38 41}

Distributed into milk in rats; not known whether distributed into milk in humans.¹

Plasma Protein Binding

Approximately 20%.^{1 41}

Elimination

Metabolism

Undergoes limited biotransformation.¹

Elimination Route

Excreted principally in urine as unchanged drug;^{1 37 38 41} <1% of a dose is excreted in urine as metabolites,¹ and 5% is recovered in feces as unchanged drug.^{1 40}

Half-life

7–14 hours.^{1 37 40}

Special Populations

In patients with moderate to severe renal insufficiency, clearance is decreased and systemic exposure is increased.¹

Stability

Storage

Oral

Tablets

Tightly sealed containers at 25°C (may be exposed to 15–30°C).¹

Parenteral

Injection Concentrate for IV infusion

25°C (may be exposed to 15–30°C).¹

Following dilution to concentration of 2 mg/mL with compatible IV fluid, solution is stable for 14 days at room temperature (20–25°C) or under refrigeration (2–8°C).¹

Following dilution to concentration of 2 mg/mL with compatible IV fluid (except 5% sodium bicarbonate injection), solution may be stored for up to 6 months at -25 to -10°C.¹ Thaw at controlled room temperature;¹ stable for 14 days at room temperature or under refrigeration after thawing.¹ Do not refreeze.¹

Premixed Injection for IV infusion

25°C (may be exposed to 15–30°C);¹ do not freeze.¹

Compatibility

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

Parenteral

Solution Compatibility

For dilution of gatifloxacin injection concentrate:

Compatible1 g
Dextrose 5% in Ringer’s injection, lactated
Dextrose 5% in sodium chloride 0.45% with potassium chloride 20 mEq/L
Dextrose 5% in sodium chloride 0.9%
Dextrose 5% in water
Plasma-Lyte 56 and dextrose 5%
Sodium bicarbonate 5%
Lactated Ringer’s and dextrose 5%
Sodium bicarbonate 5%
Sodium chloride 0.9%
Sodium lactate (1/6)M

Drug Compatibility

Y-Site Compatibilityg

Compatible
Acyclovir sodium
Alfentanil HCl
Amikacin sulfate
Aminophylline
Ampicillin sodium
Ampicillin sodium-sulbactam sodium
Aztreonam
Bretylium tosylate
Buprenorphine HCl
Butorphanol tartrate
Calcium chloride
Calcium gluconate
Carboplatin
Cefazolin sodium
Cefotetan disodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Chlorpromazine HCl
Cimetidine HCl
Cisplatin
Clindamycin phosphate
Co-trimoxazole
Cyclophosphamide
Cyclosporine
Cytarabine
Dexamethasone sodium phosphate
Dexmedetomidine HCl
Digoxin
Diphenhydramine HCl
Dobutamine HCl
Dopamine HCl
Doxorubicin HCl
Droperidol
Enalaprilat
Esmolol HCl
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fentanyl citrate
Fluconazole
Fluorouracil
Ganciclovir sodium
Gemcitabine HCl
Gentamicin sulfate
Granisetron HCl
Haloperidol lactate
Hydrocortisone sodium succinate
Hydromorphone HCl
Hydroxyzine HCl
Ifosfamide
Imipenem-cilastatin sodium
Labetalol HCl
Leucovorin calcium
Lidocaine HCl
Lorazepam
Magnesium sulfate
Mannitol
Meperidine HCl
Mesna
Methotrexate sodium
Methylprednisolone sodium succinate
Metoclopramide HCl
Metronidazole
Midazolam HCl
Mitoxantrone HCl
Morphine sulfate
Nalbuphine HCl
Naloxone HCl
Nicardipine HCl
Nitroglycerin
Ondansetron HCl
Paclitaxel
Pentamidine isethionate
Pentobarbital sodium
Phenobarbital sodium
Potassium chloride
Prochlorperazine edisylate
Promethazine HCl
Propranolol HCl
Ranitidine HCl
Remifentanil HCl
Sodium bicarbonate
Sodium phosphates
Sufentanil citrate
Theophylline
Ticarcillin disodium
Ticarcillin disodium-clavulanate potassium
Tobramycin sulfate
Trimethoprim-sulfamethoxazole
Vecuronium bromide
Verapamil HCl
Vinblastine sulfate
Vincristine sulfate
Vinorelbine tartrate
Zidovudine
Incompatible
Amphotericin B
Amphotericin B cholesteryl sulfate complex
Cefoperazone sodium
Cefoxitin sodium
Diazepam
Furosemide
Heparin sodium
Phenytoin sodium
Piperacillin sodium-tazobactam sodium
Potassium phosphates
Vancomycin HCl

Actions

• 
  

  Like other fluoroquinolone antibacterials, gatifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.^{1 2 29}

  
  


• 
  

  Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative bacteria, a few anaerobic bacteria, and some other organisms (e.g., Mycobacterium, Chlamydia, Mycoplasma).¹

  
  


• 
  

  More active in vitro than ciprofloxacin or levofloxacin against Streptococcus pneumoniae (including penicillin-resistant strains) and anaerobic bacteria (i.e., Clostridium and Bacteroides),^{3 6 7} while retaining in vitro activity of ciprofloxacin and levofloxacin against gram-negative organisms^{3 6} and etiologic agents of atypical pneumonia (e.g., C. pneumoniae, M. pneumoniae, Legionella).³

  
  


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  Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only),^{1 b} S. pneumoniae (including multidrug-resistant strains),^{1 b} and S. pyogenes (group A β-hemolytic streptococci).¹ Also active in vitro against some other staphylococci (e.g., S. epidermidis, S. saprophyticus) and some other streptococci (e.g., S. agalactiae [group B streptococci], S. pneumoniae [penicillin-resistant strains], viridans streptococci).¹

  
  


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  Gram-negative aerobes: Active in vitro and in clinical infections against E. coli,¹ H. influenzae,¹ H. parainfluenzae,¹ K. pneumoniae,¹ M. catarrhalis,¹ N. gonorrhoeae,¹ and P. mirabilis.¹ Also active in vitro against some strains of Acinetobacter, Citrobacter, Enterobacter, K. oxytoca, Morganella, and P. vulgaris.¹

  
  


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  Other organisms: Active in vitro and in clinical infections against Chlamydophila pneumonia (formerly Chlamydia pneumoniae),¹ L. pneumophila,¹ M. pneumoniae,¹ and M. tuberculosis.^{30 32}

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including gatifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).^b

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.^b

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with gatifloxacin or other antibacterials in the future.^b

  
  


• 
  

  Importance of taking gatifloxacin at least 4 hours before multivitamins containing iron, magnesium, or zinc; aluminum- or magnesium-containing antacids; or didanosine chewable/dispersible buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution prepared as an admixture with antacid.^{1 16}

  
  


• 
  

  Importance of notifying clinician of persistent or worsening symptoms of infection.¹

  
  


• 
  

  Potential for gatifloxacin to impair mental alertness or physical coordination; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.^{1 16}

  
  


• 
  

  Potential for gatifloxacin to cause other CNS effects, including confusion, tremor, hallucinations, and depression.^b

  
  


• 
  

  Importance of informing clinician if medical history includes palpitations, convulsions, or fainting spells or if any of these events occur during therapy.¹

  
  


• 
  

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

  
  


• 
  

  Potential for hypoglycemia or hyperglycemia, usually in patients with diabetes or in patients at risk for dysglycemia, but also in those without diabetes.^b Importance of monitoring blood sugar concentrations.^b Importance of initiating appropriate therapy immediately, discontinuing gatifloxacin, and contacting clinician if symptoms of high or low blood sugar occur.^b (See Hypoglyecemia and Hyperglycemia under Cautions.)

  
  


• 
  

  Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia).^{1 b}

  
  


• 
  

  Importance of discontinuing therapy and consulting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) develop.^b

  
  


• 
  

  Advise patients of risk of adverse musculoskeletal effects and importance of discontinuing gatifloxacin, resting, refraining from exercise, and consulting clinician if pain, inflammation, or rupture of a tendon occurs.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially drugs that may affect the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants), antiarrhythmic agents (e.g., amiodarone, quinidine, procainamide, sotalol), diuretics (e.g., furosemide, hydrochlorothiazide), or drugs that may affect blood sugar concentrations.^{1 b}

  
  


• 
  

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

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Gatifloxacin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg	Tequin	Bristol-Myers Squibb
		400 mg	Tequin	Bristol-Myers Squibb
Parenteral	For injection concentrate, for IV infusion	10 mg/mL (400 mg)	Tequin Injection	Bristol-Myers Squibb
	Injection, for IV infusion	2 mg/mL (200 and 400 mg) in 5% dextrose	Tequin Injection Premixed (in flexible containers)	Bristol-Myers Squibb

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, 1959-2010, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Myers Squibb Company. Tequin (gatifloxacin) tablets and injection prescribing information. Princeton, NJ; 2002 Dec.

2. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]

3. Blondeau JM. Expanded activity and utility of the new fluoroquinolones: a review. Clin Ther. 1999; 21:3-40. [IDIS 424194] [PubMed 10090423]

4. Nakashima M, Uematsu T, Kosuge K et al. Single- and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob Agents Chemother. 1995; 39:2635-40. [IDIS 358702] [PubMed 8592993]

5. Lober S, Ziege S, Rau M et al. Pharmacokinetics of gatifloxacin and interaction with an antacid containing aluminum and magnesium. Antimicrob Agents Chemother. 1999; 43:1067-71. [IDIS 426804] [PubMed 10223915]

6. Bauernfeind A. Comparison of the antibacterial activities of the quinolones Bay 12-8039, gatifloxacin (AM-1155), trovafloxacin, clinafloxacin, levofloxacin and ciprofloxacin. J Antimicrob Chemother. 1997; 40:639-51. [IDIS 398240] [PubMed 9421311]

7. Blondeau JM. A review of the comparative in-vitro activities of 12 antimicrobial agents, with a focus on five new ’respiratory quinolones’. J Antimicrob Chemother. 1999; 43(Suppl):1B-11B.

8. Perry CM, Barman Balfour JA, Lamb HM. Gatifloxacin. Drugs. 1999; 58:683-96. [PubMed 10551438]

9. Bayer Corporation. Avelox (moxifloxacin) tablets and I.V. prescribing information. West Haven, CT; 2003 Mar.

10. Andriole VT. The future of the quinolones. Drugs. 1999; 58(Suppl 2): 1-5. [PubMed 10553697]

11. DeAbate CA, McIvor RA, Di Bartolo C et al. Gatifloxacin vs. cefuroxime axetil in patients with acute exacerbations of chronic bronchitis. J Respir Dis. 1999; 20(Suppl 11A):23-9.

12. Fogarty C, McAdoo M, Paster RZ et al. Gatifloxacin vs. clarithromycin in the management of acute sinusitis. J Respir Dis. 1999; 20(Suppl 11A):17-22.

13. Fogarty C, Powell ME, Ellison T et al. Treating community-acquired pneumonia in hospitalized patients: gatifloxacin vs. ceftriaxone/clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):60-9.

14. Ramirez J, Nguyen TH, Tellier G et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. twice-daily clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):40-8.

15. Sullivan JG, McElroy AD, Hunsinger RW et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. once-daily levofloxacin. J Respir Dis. 1999; 20(Suppl 11A):49-59.

16. Manufacturer’s comments (personal observations).

17. US Food and Drug Administration. Janssen Pharmaceutica stops marketing cisapride in the U.S. FDA Talk Paper. Rockville, MD; 2000 March 23.

18. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.

19. Centers for Disease Control and Prevention. Decreased susceptibility of Neisseria gonorrhoeae to fluoroquinolones—Ohio and Hawaii, 1992–1994. MMWR Morb Mortal Wkly Rep. 1994; 43:325-7. [IDIS 329259] [PubMed 8164636]

20. Centers for Disease Control and Prevention. Fluoroquinolone-resistance in Neisseria gonorrhoeae, Hawaii, 1999, and decreased susceptibility to azithromycin in N. gonorrhoeae, Missouri, 1999. MMWR Morb Mortal Wkly Rep. 2000; 49:833-7. [IDIS 453336] [PubMed 11012233]

21. Inglesby TV, O’Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002; 287:2236-52. [IDIS 480001] [PubMed 11980524]

22. Centers for Disease Control and Prevention. Update: investigation of anthrax associated with intentional exposure and interim public health guidelines, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:889-93. [IDIS 471389] [PubMed 11686472]

23. Centers for Disease Control and Prevention. Update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:909-19. [IDIS 471910] [PubMed 11699843]

24. Bartlett JG, Dowell SF, Mandell LA et al. Practice guidelines for the management of community-acquired pneumonia in adult. Clin Infect Dis. 2000; 31:347-82. [IDIS 454042] [PubMed 10987697]

25. Heffelfinger JD, Dowell SF, Jorgensen JH et al. Management of community-acquired pneumonia in the era of pneumococcal resistance: a report from the drug-resistance streptococcus pneumoniae therapeutic working group. Arch Intern Med. 2000; 160:1399-1408. [IDIS 448719] [PubMed 10826451]

26. American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Resp Crit Care Med. 2001; 163:1730-54. [IDIS