Urochinasi may be available in the countries listed below.
Urochinasi (DCIT) is known as Urokinase in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
Medical conditions associated with miscellaneous antidepressants:
Generic Name: acetaminophen and phenyltoloxamine (a seet a MIN oh fen and FEN il toe LOX a meen)
Brand Names: Aceta-Gesic, Acuflex, Alpain, Apagesic, BeFlex, BP Poly-650, Dologesic, Flextra-650, Flextra-DS, Genasec, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Percogesic, Phenagesic, Phenylgesic, Q Flex, Q-Gesic, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Vistra, Vitoxapap
Acetaminophen is a pain reliever and a fever reducer.
Phenyltoloxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.
Acetaminophen and phenyltoloxamine may also be used for other purposes not listed in this medication guide.
Ask a doctor or pharmacist about taking acetaminophen and phenyltoloxamine if you have:
diabetes;
glaucoma;
urination problems;
an enlarged prostate;
heart disease or high blood pressure;
a stomach ulcer; or
an overactive thyroid.
Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.
Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking acetaminophen and phenyltoloxamine.
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include dizziness, drowsiness, diarrhea, loss of appetite, and seizure (convulsions), or coma.
fast, pounding, or uneven heartbeat;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.
Less serious side effects may include:
dry eyes, nose, and mouth;
drowsiness or dizziness;
blurred vision;
urinating less than usual; or
feeling restless or excited (especially in children).
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.
There may be other drugs that can interact with acetaminophen and phenyltoloxamine. 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.
See also: Q-Gesic side effects (in more detail)
Generic Name: progestin contraceptives (Oral route, Parenteral route)
In the U.S.
Available Dosage Forms:
Progestins are hormones.
The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.
Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.
No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.
Progestin contraceptives are available only with your doctor's prescription.
Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.
Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.
Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Camila. Please read with care.
To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.
Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.
Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.
When using levonorgestrel tablet dosage form for emergency contraception:
When using medroxyprogesterone injection dosage form for contraception:
When using an oral progestin dosage form:
Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.
The dose medicines in this class 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 these medicines. 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.
Call your doctor or pharmacist for instructions.
For oral dosage form (tablets):
For injection dosage form:
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.
Progestins may cause dizziness 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.
It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:
Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.
If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.
The following medicines might reduce the effectiveness of progestins for contraception:
Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.
If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.
If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.
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:
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:
Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Brimonidin dura may be available in the countries listed below.
Brimonidine tartrate (a derivative of Brimonidine) is reported as an ingredient of Brimonidin dura in the following countries:
International Drug Name Search
Etilefrin may be available in the countries listed below.
Etilefrine hydrochloride (a derivative of Etilefrine) is reported as an ingredient of Etilefrin in the following countries:
International Drug Name Search
Generic Name: clindamycin topical (klin da MYE sin)
Brand Names: Cleocin T, Clindagel, ClindaMax, ClindaReach Pledget, Evoclin
Clindamycin is an antibiotic. Clindamycin topical prevents bacteria from growing on the skin.
Clindamycin topical (for the skin) is used to treat severe acne.
Clindamycin topical may also be used for other purposes not listed in this medication guide.
Use clindamycin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.
It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve.
Although this medicine is applied to the skin, your body may absorb enough clindamycin to cause serious side effects. You may not be able to use this medication if you have inflammation of your intestines (also called enteritis), ulcerative colitis, or if you have ever had severe diarrhea caused by antibiotic medicine.
inflammation of your intestines (also called enteritis);
ulcerative colitis; or
if you have ever had severe diarrhea caused by antibiotic medicine.
Use clindamycin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Wash your face with a mild soap or cleanser and pat the skin dry with a clean towel.
It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve.
Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms include bloody or watery diarrhea, which may result if you absorb this medicine through your skin by applying too much.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.
severe redness, itching, or dryness of treat skin areas; or
diarrhea that is watery or bloody.
Less serious side effects may include:
mild burning or itching;
mild dryness of treated skin; or
redness or other irritation.
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.
Before using clindamycin topical, tell your doctor if you are using any of the following drugs:
erythromycin topical (Akne-Mycin, Emcin Clear, Eryderm, Erygel, Erythra-Derm, Ery-Sol, and others); or
erythromycin taken by mouth (E.E.S., E-Mycin, Ery-Tab, E-Mycin, Robimycin, and others).
This list is not complete and there may be other drugs that can interact with clindamycin topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Cleocin T side effects (in more detail)
Generic Name: acetaminophen/chlorpheniramine/phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/fen ill proe pa NOLE a meen)
Brand Names: Chlor-Trimeton Sinus, Coricidin D, Pyrroxate, Sinulin, Triaminicin
Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions such as: headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.
Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.
Acetaminophen/chlorpheniramine/phenylpropanolamine is used to treat nasal congestion; itchy, watery eyes; itchy throat; sneezing; headache; fever; and other symptoms associated with allergies, hay fever, and the common cold.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Acetaminophen/chlorpheniramine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Before taking this medication, tell your doctor if you have
diabetes,
glaucoma,
any type of heart disease or high blood pressure,
thyroid disease,
emphysema or chronic bronchitis, or
difficulty urinating or an enlarged prostate.
You may not be able to take acetaminophen/chlorpheniramine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take acetaminophen/chlorpheniramine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
To ensure that you get a correct dose, measure the liquid form of acetaminophen/chlorpheniramine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Do not take acetaminophen/chlorpheniramine/phenylpropanolamine for longer than 7 to 10 days in a row. If your symptoms do not improve, if they get worse or if you have a fever, see your doctor.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
Symptoms of an acetaminophen/chlorpheniramine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, vomiting, abdominal pain, diarrhea, seizures, confusion, sweating, and an irregular heartbeat.
Acetaminophen/chlorpheniramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/phenylpropanolamine is taken with any of these medications.
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);
blood problems (easy or unusual bleeding or bruising); or
low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).
Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/chlorpheniramine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience
dryness of the eyes, nose, and mouth;
drowsiness or dizziness;
blurred vision;
difficulty urinating; or
excitation in children.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Urine glucose tests for diabetics may produce false results while you are taking acetaminophen. Talk to your doctor if you have diabetes and you notice changes in blood glucose levels during treatment with acetaminophen/chlorpheniramine/phenylpropanolamine.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking acetaminophen/chlorpheniramine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.
Acetaminophen/chlorpheniramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/phenylpropanolamine is taken with any of these medications.
Drugs other than those listed here may also interact with acetaminophen/chlorpheniramine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
There are many formulations of acetaminophen/chlorpheniramine/ phenylpropanolamine available over the counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Clindobion may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Clindobion in the following countries:
International Drug Name Search
Treating irritation and itching associated with skin conditions such as insect bites, minor cuts or irritation, or poison ivy, oak, or sumac. It may also be used for other conditions as determined by your doctor.
Clear Calamine is a protectant and anesthetic combination. It works by temporarily relieving itching and pain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Clear Calamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Clear Calamine. Because little, if any, of Clear Calamine is absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Clear Calamine 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.
Use Clear Calamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Clear Calamine.
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:
Dryness; itching.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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: Clear Calamine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Clear Calamine at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Clear Calamine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Clear Calamine. 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.
Catalin may be available in the countries listed below.
Pirenoxine is reported as an ingredient of Catalin in the following countries:
Pirenoxine sodium salt (a derivative of Pirenoxine) is reported as an ingredient of Catalin in the following countries:
International Drug Name Search
WARNING
Fluoroquinolones, including Ciprofloxacin Injection, USP, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. (See WARNINGS).
Fluoroquinolones, including Ciprofloxacin Injection, USP, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Ciprofloxacin Injection, USP in patients with known history of myasthenia gravis(See WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection, USP and other antibacterial drugs, Ciprofloxacin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Ciprofloxacin Injection USP (ciprofloxacin) is a synthetic broad-spectrum antimicrobial agent for intravenous (I.V.) administration. Ciprofloxacin, a fluoroquinolone, is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its chemical structure is:
Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin Injection, USP solutions are available as sterile 1.0% aqueous concentrates, which are intended for dilution prior to administration, and as 0.2% ready-for-use infusion solutions in 5% Dextrose Injection. All formulas contain lactic acid as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 1.0% aqueous concentrates in vials is 3.3 to 3.9. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6.
The plastic container is fabricated from a specially formulated polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di(2-ethylhexyl) phthalate (DEHP), up to 5 parts per million. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.
Following 60-minute intravenous infusions of 200 mg and 400 mg ciprofloxacin to normal volunteers, the mean maximum serum concentrations achieved were 2.1 and 4.6 µg/mL, respectively; the concentrations at 12 hours were 0.1 and 0.2 µg/mL, respectively.
| Steady-state Ciprofloxacin Serum Concentrations (µg/mL) After 60-minute I.V. Infusions q12 h. | ||||||
| Time after starting the infusion | ||||||
| Dose | 30 min. | 1 hr | 3 hr | 6 hr | 8 hr | 12 hr |
| 200 mg | 1.7 | 2.1 | 0.6 | 0.3 | 0.2 | 0.1 |
| 400 mg | 3.7 | 4.6 | 1.3 | 0.7 | 0.5 | 0.2 |
The pharmacokinetics of ciprofloxacin are linear over the dose range of 200 to 400 mg administered intravenously. Comparison of the pharmacokinetic parameters following the 1st and 5th I.V. dose on a q 12 h regimen indicates no evidence of drug accumulation. The absolute bioavailability of oral ciprofloxacin is within a range of 70-80% with no substantial loss by first pass metabolism. An intravenous infusion of 400-mg ciprofloxacin given over 60 minutes every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by a 500-mg oral dose given every 12 hours. An intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 8 hours has been shown to produce an AUC at steady-state equivalent to that produced by a 750-mg oral dose given every 12 hours. A 400-mg I.V. dose results in a Cmax similar to that observed with a 750-mg oral dose. An infusion of 200 mg ciprofloxacin given every 12 hours produces an AUC equivalent to that produced by a 250-mg oral dose given every 12 hours.
| ||||
| Steady-state Pharmacokinetic Parameter Following Multiple Oral and I.V. Doses | ||||
| Parameters | 500 mg q12h, P.O. | 400 mg q12h, I.V. | 750 mg q12h, P.O. | 400 mg q8h, I.V. |
| AUC (µg•hr/mL) | 13.7* | 12.7* | 31.6† | 32.9‡ |
| Cmax (µg/mL) | 2.97 | 4.56 | 3.59 | 4.07 |
After intravenous administration, ciprofloxacin is present in saliva, nasal and bronchial secretions, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. It has also been detected in the lung, skin, fat, muscle, cartilage, and bone. Although the drug diffuses into cerebrospinal fluid (CSF), CSF concentrations are generally less than 10% of peak serum concentrations. Levels of the drug in the aqueous and vitreous chambers of the eye are lower than in serum.
After I.V. administration, three metabolites of ciprofloxacin have been identified in human urine which together account for approximately 10% of the intravenous dose. The binding of ciprofloxacin to serum proteins is 20 to 40%. Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Coadministration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug (see CONTRAINDICATIONS; WARNINGS; PRECAUTIONS: Drug Interactions.)
The serum elimination half-life is approximately 5-6 hours and the total clearance is around 35 L/hr. After intravenous administration, approximately 50% to 70% of the dose is excreted in the urine as unchanged drug. Following a 200-mg I.V. dose, concentrations in the urine usually exceed 200 µg/mL 0-2 hours after dosing and are generally greater than 15 µg/mL 8-12 hours after dosing. Following a 400-mg I.V. dose, urine concentrations generally exceed 400 µg/mL 0-2 hours after dosing and are usually greater than 30 µg/mL 8-12 hours after dosing. The renal clearance is approximately 22 L/hr. The urinary excretion of ciprofloxacin is virtually complete by 24 hours after dosing.
Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after intravenous dosing, only a small amount of the administered dose (< 1%) is recovered from the bile as unchanged drug. Approximately 15% of an I.V. dose is recovered from the feces within 5 days after dosing.
Pharmacokinetic studies of the oral (single dose) and intravenous (single and multiple dose) forms of ciprofloxacin indicate that plasma concentrations of ciprofloxacin are higher in elderly subjects (> 65 years) as compared to young adults. Although the Cmax is increased 16-40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant. (See PRECAUTIONS: Geriatric Use.)
In patients with reduced renal function, the half-life of ciprofloxacin is slightly prolonged and dosage adjustments may be required. (See DOSAGE AND ADMINISTRATION.) In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. However, the kinetics of ciprofloxacin in patients with acute hepatic insufficiency have not been fully elucidated. Following a single oral dose of 10 mg/kg ciprofloxacin suspension to 16 children ranging in age from 4 months to 7 years, the mean Cmax was 2.4 µg/mL (range: 1.5 to 3.4 µg/mL) and the mean AUC was 9.2 µg•h/mL (range: 5.8 to 14.9 µg•h/mL). There was no apparent age-dependence, and no notable increase in Cmax or AUC upon multiple dosing (10 mg/kg TID). In children with severe sepsis who were given intravenous ciprofloxacin (10 mg/kg as a 1-hour infusion), the mean Cmax was 6.1 µg/mL (range: 4.6 to 8.3 µg/mL) in 10 children less than 1 year of age; and 7.2 µg/mL (range: 4.7 to 11.8 µg/mL) in 10 children between 1 and 5 years of age. The AUC values were 17.4 µg•h/mL (range: 11.8 to 32 µg•h/mL) and 16.5 µg•h/mL (range: 11 to 23.8 µg•h/mL) in the respective age groups. These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of pediatric patients with various infections, the predicted mean half-life in children is approximately 4 - 5 hours, and the bioavailability of the oral suspension is approximately 60%.
Drug-drug Interactions: Concomitant administration with tizanidine is contraindicated. (See CONTRAINDICATIONS). The potential for pharmacokinetic drug interactions between ciprofloxacin and theophylline, caffeine, cyclosporins, phenytoin, sulfonylurea glyburide, metronidazole, warfarin, probenecid, and piperacillin sodium has been evaluated. (See WARNINGS; PRECAUTIONS: Drug Interactions.)
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin and other quinolones. There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations.
Ciprofloxacin is slightly less active when tested at acidic pH. The inoculum size has little effect when tested in vitro. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2.
Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for Ciprofloxacin Injection, USP (ciprofloxacin for intravenous infusion).
Aerobic gram-positive microorganisms
Enterococcus faecalis (Many strains are only moderately susceptible.)
Staphylococcus aureus (methicillin-susceptible strains only)
Staphylococcus epidermidis (methicillin-susceptible strains only)
Staphylococcus saprophyticus
Streptococcus pneumoniae (penicillin-susceptible strains)
Streptococcus pyogenes
Aerobic gram-negative microorganisms
Citrobacter diversus Morganella morganii
Citrobacter freundii Proteus mirabilis
Enterobacter cloacae Proteus vulgaris
Escherichia coli Providencia rettgeri
Haemophilus influenzae Providencia stuartii
Haemophilus parainfluenzae Pseudomonas aeruginosa
Klebsiella pneumoniae Serratia marcescens
Moraxella catarrhalis
Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker. (See INDICATIONS AND USAGE and INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION). The following in vitro data are available, but their clinical significance is unknown.
Ciprofloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1 µg/mL or less against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of ciprofloxacin intravenous formulations in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Aerobic gram-positive microorganisms
Staphylococcus haemolyticus
Staphylococcus hominis
Streptococcus pneumoniae (penicillin-resistant strains)
Aerobic gram-negative microorganisms
Acinetobacter iwoffi Salmonella typhi
Aeromonas hydrophila Shigella boydii
Campylobacter jejuni Shigella dysenteriae
Edwardsiella tarda Shigella flexneri
Enterobacter aerogenes Shigella sonnei
Klebsiella oxytoca Vibrio cholerae
Legionella pneumophila Vibrio parahaemolyticus
Neisseria gonorrhoeae Vibrio vulnificus
Pasteurella multocida Yersinia enterocolitica
Salmonella enteritidis
Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.
Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method 1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of ciprofloxacin powder. The MIC values should be interpreted according to the following criteria:
| |
| MIC (µg/mL) | Interpretation |
| ≤ 1 | Susceptible (S) |
| 2 | Intermediate (I) |
| ≥ 4 | Resistant (R) |
| |
| MIC (µg/mL) | Interpretation |
| ≤ 1 | Susceptible (S) |
The current absence of data on resistant strains precludes defining any results other than “Susceptible”. Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard ciprofloxacin powder should provide the following MIC values:
| ||
| Organism | MIC (µg/mL) | |
| E. faecalis | ATCC 29212 | 0.25 -2.0 |
| E. coli | ATCC 25922 | 0.004 -0.015 |
| H. influenzae* | ATCC 49247 | 0.004 -0.03 |
| P. aeruginosa | ATCC 27853 | 0.25 -1.0 |
| S. aureus | ATCC 29213 | 0.12 -0.5 |
Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5-µg ciprofloxacin to test the susceptibility of microorganisms to ciprofloxacin.
Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5-µg ciprofloxacin disk should be interpreted according to the following criteria:
| |
| Zone Diameter (mm) | Interpretation |
| ≥ 21 | Susceptible (S) |
| 16 - 20 | Intermediate (I) |
| ≤ 15 | Resistant (R) |
| |
| Zone Diameter (mm) | Interpretation |
| ≥ 21 | Susceptible (S) |
The current absence of data on resistant strains precludes defining any results other than “Susceptible”. Strains yielding zone diameter results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for ciprofloxacin.
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 5-µg ciprofloxacin disk should provide the following zone diameters in these laboratory test quality control strains:
| ||
| Organism | Zone Diameter (mm) | |
| E. coli | ATCC 25922 | 30 - 40 |
| H. influenzae* | ATCC 49247 | 34 - 42 |
| P. aeruginosa | ATCC 27853 | 25 - 33 |
| S. aureus | ATCC 25923 | 22 - 30 |
Ciprofloxacin Injection, USP is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia), Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
Nosocomial Pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.
Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillinsusceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Complicated Intra-Abdominal Infections (used in conjunction with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.
Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.
Empirical Therapy for Febrile Neutropenic Patients in combination with piperacillin sodium. (See CLINICAL STUDIES.)
Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. (See WARNINGS, PRECAUTIONS: Pediatric Use, ADVERSE REACTIONS and CLINICAL STUDIES.) Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals. (See ANIMAL PHARMACOLOGY.)
Inhalational Anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for this indication.4 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.(See also, INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION).
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with Ciprofloxacin Injection, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
As with other drugs, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection, USP and other antibacterial drugs, Ciprofloxacin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.
Concomitant administration with tizanidine is contraindicated. (See PRECAUTIONS: Drug Interactions.)
Tendinopathy and Tendon Rupture:Fluoroquinolones, including Ciprofloxacin injection, USP are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Injection, USP should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.
Exacerbation of Myasthenia Gravis: Fluoroquinolones, including Ciprofloxacin Injection, USP, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ciprofloxacin Injection, USP in patients with known history of myasthenia gravis. (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS: Post-Marketing Adverse Event Reports.)
Pregnant Women: THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS: Pregnancy, and Nursing Mothers subsections.)
Pediatrics: Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.(See ADVERSE REACTIONS.)
In pre-clinical studies, oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. (See ANIMAL PHARMACOLOGY.)
Cytochrome P450 (CYP450): Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (e.g. theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug.
Central Nervous System Disorders: Convulsions, increased intracranial pressure and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction). (See PRECAUTIONS: General, Information for Patients, Drug Interaction and ADVERSE REACTIONS.)
Theophylline: SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF INTRAVENOUS CIPROFLOXACIN AND THEOPHYLLINE. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar serious adverse events have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: General, Information for Patients and ADVERSE REACTIONS).
Pseudomembranous Colitis: Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Peripheral Neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.
IINTRAVENOUS CIPROFLOXACIN SHOULD BE ADMINISTERED BY SLOW INFUSION OVER A PERIOD OF 60 MINUTES. Local I.V. site reactions have been reported with the intravenous administration of ciprofloxacin. These reactions are more frequent if infusion time is 30 minutes or less or if small veins of the hand are used. (See ADVERSE REACTIONS.)
Quinolones, including ciprofloxacin, may also cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia. (See WARNINGS, Information for Patients, and Drug Interaction.)
Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline. (See ANIMAL PHARMACOLOGY.) Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving ciprofloxacin. Patients should be well hydrated to prevent the formation of highly concentrated urine.
Alteration of the dosage regimen is necessary for patients with impairment of renal function. (See DOSAGE AND ADMINISTRATION.)
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (See and ADVERSE REACTIONS/ Post-Marketing Adverse Events).
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
Prescribing Ciprofloxacin Injection, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Patients should be advised:
