Dolgic LQ Oral

Generic Name: butalbital, acetaminophen, and caffeine (Oral route)

bue-TAL-bi-tal, a-seet-a-MIN-oh-fen, KAF-een

Oral route(Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more the one acetaminophen-containing product

Commonly used brand name(s)

In the U.S.

• Anolor 300


• Dolgic LQ


• Esgic


• Esgic-Plus


• Ezol


• Fioricet


• Geone


• Margesic


• Medigesic


• Nonbac


• Pacaps


• Repan

Available Dosage Forms:

• Capsule


• Tablet


• Solution

Therapeutic Class: Butalbital/Acetaminophen Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Uses For Dolgic LQ

Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

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

Before Using Dolgic LQ

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 butalbital, acetaminophen, and caffeine combination in children younger than 12 years of age. 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 butalbital, acetaminophen, and caffeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butalbital, acetaminophen, and caffeine combination.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines is 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.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Anisindione


• Aprobarbital


• Bromazepam


• Brotizolam


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Diazepam


• Dicumarol


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nitrazepam


• Nordazepam


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenindione


• Phenobarbital


• Phenprocoumon


• Prazepam


• Primidone


• Propoxyphene


• Quazepam


• Quetiapine


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Temazepam


• Thiopental


• Triazolam

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

• Acenocoumarol


• Cannabis


• Carbamazepine


• Imipramine


• Isoniazid


• Phenytoin


• Prednisone


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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

• Cabbage


• Ethanol

Other Medical Problems

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

• Alcohol abuse, history of or


• Drug dependence, or history of or


• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Kidney disease or


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

• Porphyria (an enzyme problem)—Should not be used in patients with this condition.

• Stomach problems—Use with caution. May make these conditions worse.

Proper Use of butalbital, acetaminophen, and caffeine

This section provides information on the proper use of a number of products that contain butalbital, acetaminophen, and caffeine. It may not be specific to Dolgic LQ. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

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

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

• For oral dosage form (tablets):
  
  • For tension headaches:
    
    • Adults, teenagers, and children 12 years of age—One or two tablets every 4 hours as needed. However, the dose is usually not more than 6 tablets per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol (R)) per day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Dolgic LQ

It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

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

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may make you dizzy or drowsy. 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 dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

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

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

Dolgic LQ Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Lightheadedness


• shortness of breath

Incidence not known

• Abdominal or stomach pain


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• change in the frequency of urination or amount of urine


• chills


• cough


• diarrhea


• difficulty with breathing


• difficulty with swallowing


• dizziness


• drowsiness


• dry mouth


• fainting


• fast heartbeat


• fast, pounding, or irregular heartbeat or pulse


• flushed or dry skin


• fruit-like breath odor


• hives


• increased hunger


• increased thirst


• increased urination


• itching


• joint or muscle pain


• loss of appetite


• nausea or vomiting


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• seizure


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


• shortness of breath


• skin rash


• sore throat


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


• sweating


• swelling of the feet or lower legs


• tightness in the chest


• trembling or shaking of the hands or feet


• troubled breathing


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• weakness


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion as to time, place, or person


• dark urine


• difficult or painful urination


• difficult or troubled breathing


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


• fever


• general feeling of discomfort or illness


• hallucinations


• headache


• holding false beliefs that cannot be changed by fact


• increased sweating


• irregular, fast or slow, or shallow breathing


• light-colored stools


• loss of appetite


• pale or blue lips, fingernails, or skin


• restlessness


• sleeplessness


• sudden decrease in the amount of urine


• sweating


• trouble sleeping


• unable to sleep


• unpleasant breath odor


• unusual excitement, nervousness, or restlessness


• vomiting of blood


• yellow eyes or skin

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

More common

• Relaxed and calm


• sleepiness

Incidence not known

• Anxiety


• bloated


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• depression


• earache


• excess air or gas in the stomach or intestines


• false or unusual sense of well-being


• full feeling


• hearing loss


• heartburn


• heavy eyelids


• high energy


• hot spells


• hyperventilation


• irritability


• numbness


• pain in the leg


• passing gas


• sluggishness


• stuffy nose


• tingling sensation

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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Loranka

Loranka may be available in the countries listed below.

Ingredient matches for Loranka

Lormetazepam

Lormetazepam is reported as an ingredient of Loranka in the following countries:

• Belgium


• Luxembourg

International Drug Name Search

Ortho-Cept

Pronunciation: des-oh-JES-trel/ETH-in-il ess-trah-DYE-ole
Generic Name: Desogestrel/Ethinyl Estradiol
Brand Name: Examples include Desogen and Ortho-Cept

Cigarette smoking while taking Ortho-Cept increases the risk of serious heart problems. The risk increases with age (over 35 years of age) and with heavy smoking (15 or more cigarettes per day). Patients who use Ortho-Cept are strongly advised not to smoke.

Ortho-Cept is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Ortho-Cept is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use Ortho-Cept if:

• you are allergic to any ingredient in Ortho-Cept


• you are pregnant or think you may be pregnant


• you have blood clots in the legs, lungs, or eyes; or a history of heart attack, chest pain, or stroke


• you have known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina, or have had vaginal bleeding of unknown causes


• you have a liver tumor or active liver disease, or a history of yellowing of the eyes or skin during pregnancy or previous birth control use


• you have headaches with neurological symptoms or will be on bed rest for a long period following surgery

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

Before using Ortho-Cept:

Some medical conditions may interact with Ortho-Cept. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have high blood pressure; high cholesterol, triglycerides, or calcium levels; have pancreatitis or gallbladder problems; or are obese


• if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial carcinomas, uterine fibroids, or irregular or scanty menstrual periods


• if you have diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression


• if you are having surgery


• if you are a heavy smoker (15 or more cigarettes per day), especially if you are older than 35 years of age

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

• Azole antifungals (eg, itraconazole), aprepitant, bosentan, barbiturates (eg, phenobarbital), carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, and troglitazone because they may decrease the effectiveness of Ortho-Cept. Alternative forms of birth control are strongly recommended when taking any of these medicines along with this birth control medicine.


• Beta-blockers (eg, atenolol), selegiline, theophyllines (eg, aminophylline), and troleandomycin because the risk of their side effects may be increased by Ortho-Cept


• Lamotrigine because its effectiveness may be decreased by Ortho-Cept

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

Use Ortho-Cept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ortho-Cept by mouth with or without food.


• To achieve maximum effectiveness of Ortho-Cept, it must be taken every day (every 24 hours) and at the same time each day.


• Remember to take all of the pills in the pack. Do not skip any doses.


• Be sure to have an extra full pack of this medication available at all times.


• If you miss 1 dose of Ortho-Cept, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 active dose of Ortho-Cept, read the extra patient information leaflet that comes with Ortho-Cept or contact you doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of Ortho-Cept. If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Ortho-Cept.

Important safety information:

• Ortho-Cept may cause dizziness or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ortho-Cept with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.


• Ortho-Cept may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.


• Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.


• Ortho-Cept may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Ortho-Cept.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks beforehand. Special precautions may need to be taken in these circumstances while you are taking Ortho-Cept.


• Bleeding or spotting may occur while taking Ortho-Cept. Do not stop taking Ortho-Cept if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.


• Ortho-Cept may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.


• Taking certain antibiotics or anticonvulsants while you are using Ortho-Cept, or vomiting or diarrhea may decrease the effectiveness of Ortho-Cept. To prevent pregnancy, use an additional form of birth control (such as condoms, spermicide, diaphragm) until your next period. If you have any questions, contact your doctor, nurse, or pharmacist.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• Use of Ortho-Cept will not prevent the spread of sexually transmitted diseases (STDs).


• Lab tests, may be performed while you use Ortho-Cept. These tests may be used to monitor your condition or check for side effects. You will need to have follow-up exams at least once per year. Be sure to keep all doctor and lab appointments.


• Ortho-Cept should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Ortho-Cept if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Continue to use another method of birth control (such as condoms). Ortho-Cept is found in breast milk. Do not breast-feed while you are taking Ortho-Cept. Do not take Ortho-Cept soon after delivery of a baby even if you are not breast-feeding. You should wait 4 weeks after delivery if you are not breast-feeding or 4 weeks after a second trimester abortion.

Possible side effects of Ortho-Cept:

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:

Breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; loss of scalp hair; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding; vomiting.

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 lumps; calf/leg pain or swelling; changes in vision; chest pain or heaviness in the chest; coughing up blood; difficulty wearing contact lenses; dark urine or light-colored bowel movements; dizziness or fainting; fever; loss of appetite; missed menstrual period; mood/mental changes; numbness of an arm or leg; persistent or recurrent abnormal vaginal bleeding; severe pain or tenderness in the stomach area; shortness of breath; sleeplessness; slurred speech; sudden severe headache (migraine); sudden shortness of breath; swelling of fingers or ankles; vaginal infection; vomiting; weakness or fatigue; weakness or numbness in the arm or leg; 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: Ortho-Cept 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 of overdose may include nausea or vomiting; vaginal bleeding.

Proper storage of Ortho-Cept:

Store Ortho-Cept at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ortho-Cept out of the reach of children and away from pets.

General information:

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


• Ortho-Cept 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 Ortho-Cept. 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 Ortho-Cept resources

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

• Ortho-Cept Prescribing Information (FDA)


• Apri Prescribing Information (FDA)


• Caziant Prescribing Information (FDA)


• Cesia Prescribing Information (FDA)


• Cyclessa Prescribing Information (FDA)


• Cyclessa Advanced Consumer (Micromedex) - Includes Dosage Information


• Desogen Consumer Overview


• Desogen Prescribing Information (FDA)


• Emoquette Prescribing Information (FDA)


• Kariva Prescribing Information (FDA)


• Mircette Consumer Overview


• Mircette Prescribing Information (FDA)


• Reclipsen Prescribing Information (FDA)


• Solia Prescribing Information (FDA)


• Velivet Prescribing Information (FDA)

Compare Ortho-Cept with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Polycystic Ovary Syndrome

Airmax

Airmax may be available in the countries listed below.

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Salbutamol is reported as an ingredient of Airmax in the following countries:

• Colombia

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Ciclopirox Qualimed

Ciclopirox Qualimed may be available in the countries listed below.

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Ciclopirox

Ciclopirox is reported as an ingredient of Ciclopirox Qualimed in the following countries:

• France

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Alfadil BPH

Alfadil BPH may be available in the countries listed below.

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Doxazosin

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• Sweden

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VibraVet

VibraVet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Doxycycline

Doxycycline is reported as an ingredient of VibraVet in the following countries:

• South Africa

Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of VibraVet in the following countries:

• Australia


• Italy


• New Zealand

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Folinacid

Folinacid may be available in the countries listed below.

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• Greece

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Formoterol Aldo Union

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Formoterol

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Brontex

Pronunciation: gwye-FEN-e-sin/KOE-deen
Generic Name: Guaifenesin/Codeine
Brand Name: Examples include Brontex and Pro-Clear

Brontex is used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Brontex is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant works by loosening mucus and lung secretions in the chest and making coughs more productive.

Do NOT use Brontex if:

• you are allergic to any ingredient in Brontex or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are taking sodium oxybate (GHB)

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

Before using Brontex:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)


• if you have a history of an enlarged prostate gland or other prostate problems, heart problems, kidney or liver problems, a blockage of your bowel or bladder, adrenal gland problems (eg, Addison disease), or an underactive thyroid


• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

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

• HIV protease inhibitors (eg, ritonavir) because the risk of side effects from Brontex may be increased


• Cimetidine, digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone or quinidine because the effectiveness of Brontex may be decreased

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

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

• Take Brontex by mouth with or without food.


• Drink plenty of water while taking Brontex.


• If you miss a dose of Brontex, 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 Brontex.

Important safety information:

• Brontex may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Brontex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Brontex may interfere with certain lab test results. Make sure that your doctor and lab personnel know that you are taking Brontex.


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


• Use Brontex with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Brontex in CHILDREN; they may be more sensitive to its effects.


• Brontex should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Brontex while you are pregnant. It is not known if Brontex is found in breast milk. Do not breast-feed while taking Brontex.

Possible side effects of Brontex:

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:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

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: Brontex 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Brontex:

Store Brontex at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Brontex out of the reach of children and away from pets.

General information:

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


• Brontex 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 Brontex. 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 Brontex resources

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

• Brontex Concise Consumer Information (Cerner Multum)


• ExeClear-C Prescribing Information (FDA)


• Guaifenesin AC Liquid Concise Consumer Information (Cerner Multum)

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Foscarnet Sodium

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J05AD01

CAS registry number (Chemical Abstracts Service)

0063585-09-1

Chemical Formula

C-Na3-O5-P

Molecular Weight

191

Therapeutic Category

Antiviral agent

Chemical Name

Phosphinecarboxylic acid, dihydroxy-, oxide, trisodium salt

Foreign Names

• Foscarnetum Natricum (Latin)
• Foscarnet natrium (German)
• Foscarnet sodique (French)
• Foscarnet sodico (Spanish)

Generic Names

• Foscarnet sodico (OS: DCIT)
• Foscarnet sodique (OS: DCF)
• Foscarnet Sodium (OS: USAN, BAN)
• A 29622 (IS)
• EHB 776 (IS)
• PFA (IS)
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• Foscarnet Sodium Hexahydrate (PH: Ph. Eur. 6)
• Foscarnet-Natrium-Hexahydrat (PH: Ph. Eur. 6)
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Brand Names

• Foscarnet Dosa
  Dosa, Argentina



• Foscarnet Sodium Injection
  Hospira, United States; PharmaForce, United States



• Foscavir
  AstraZeneca, Spain; AstraZeneca, Italy; IFET, Greece



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• Triapten
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Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

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Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Klorpo

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Sulindac

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Propranolol

Propranolol is reported as an ingredient of SPMC Propranolol in the following countries:

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Propofol

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Lactulose EG

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Lactulose

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Paclitaxel

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Lithobid is a brand name of lithium, approved by the FDA in the following formulation(s):

LITHOBID (lithium carbonate - tablet, extended release; oral)

• 
  Manufacturer: NOVEN THERAP
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 300MG ^[RLD][AB]

Has a generic version of Lithobid been approved?

Yes. The following products are equivalent to Lithobid:

lithium carbonate tablet, extended release; oral

• 
  Manufacturer: GLENMARK GENERICS
  
  Approval date: December 27, 2010
  
  Strength(s): 300MG ^[AB]


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  Approval date: October 28, 2004
  
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Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lithobid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Lithobid.

See also...

• Lithobid Controlled-Release and Extended-Release Tablets Consumer Information (Wolters Kluwer)
• Lithobid Consumer Information (Cerner Multum)
• Lithobid Advanced Consumer Information (Micromedex)
• Lithium Consumer Information (Drugs.com)
• Lithium Consumer Information (Wolters Kluwer)
• Lithium Controlled-Release and Extended-Release Tablets Consumer Information (Wolters Kluwer)
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• Lithium Consumer Information (Cerner Multum)
• Lithium Advanced Consumer Information (Micromedex)
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Ofloxacin Ophthalmic Solution

Dosage Form: ophthalmic solution
Ofloxacin Ophthalmic Solution USP

Ofloxacin Ophthalmic Solution Description

Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.

Chemical Name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyridol[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.

C18H20FN3O4Molecular Weight 361.37

Active: ofloxacin 0.3% (3 mg/mL).

Preservative: benzalkonium chloride (0.005%).

Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Ofloxacin Ophthalmic Solution is unbuffered and formulated with a pH of 6.4 (range – 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.

Ofloxacin Ophthalmic Solution - Clinical Pharmacology

Pharmacokinetics

Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with Ofloxacin Ophthalmic Solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10½ days. Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin.

Tear ofloxacin concentrations ranged from 5.7 mcg/g to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of Ofloxacin Ophthalmic Solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified.

Microbiology

Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria. Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides.

Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the INDICATIONS AND USAGE section.

Aerobes, Gram-Positive:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Anaerobic Species:

Propionibacterium acnes

Aerobes, Gram-Negative:

Enterobacter cloacae

Haemophilus influenzae

Proteus mirabilis

Pseudomonas aeruginosa

Serratia marcescens*

*Efficacy for this organism was studied in fewer than 10 infections

The safety and effectiveness of Ofloxacin Ophthalmic Solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials. Ofloxacin Ophthalmic Solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown.

Aerobes, Gram-Positive:

Enterococcus faecalis

Listeria monocytogenes

Staphylococcus capitis

Staphylococcus hominus

Staphylococcus simulans

Streptococcus pyogenes

Aerobes, Gram-Negative:

Acinetobacter calcoaceticus var. anitratus

Acinetobacter calcoaceticus var. lwoffii

Citrobacter diversus

Citrobacter freundii

Enterobacter aerogenes

Enterobacter agglomerans

Escherichia coli

Haemophilus parainfluenzae

Klebsiella oxytoca

Klebsiella pneumoniae

Moraxella (Branhamella) catarrhalis

Moraxella lacunata

Morganella morganii

Neisseria gonorrhoeae

Pseudomonas acidovorans

Pseudomonas fluorescens

Shigella sonnei

Other:

Chlamydia trachomatis

Clinical Studies

Conjunctivitis: In a randomized, double-masked, multi-center clinical trial, Ofloxacin Ophthalmic Solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

Corneal Ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, Ofloxacin Ophthalmic Solution treated subjects had an overall clinical success rate (complete re-epithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% cefazolin solutions. The median time to clinical success was 11 days for the ofloxacin treated group and 10 days for the fortified treatment group.

Indications and Usage for Ofloxacin Ophthalmic Solution

Ofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

Conjunctivitis

Gram-Positive Bacteria:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Pseudomonas aeruginosa

Corneal Ulcers

Gram-Positive Bacteria:

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Gram-Negative Bacteria:

Enterobacter cloacae

Haemophilus influenzae

Proteus mirabilis

Gram-Negative Bacteria:

Pseudomonas aeruginosa

Serratia marcescens*

Anaerobic Species:

Propionibacterium acnes

*Efficacy for this organism was studied in fewer than 10 infection

Contraindications

Ofloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones or to any of the components in this medication.

Warnings

NOT FOR INJECTION.

Ofloxacin Ophthalmic Solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction of ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.

Precautions

General

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent to 110 times the maximum recommended daily adult ophthalmic dose) has been associated with these types of effects.

Information for patients

Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.

Drug interactions

Specific drug interaction studies have not been conducted with Ofloxacin Ophthalmic Solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine and enhance the effects of the oral anticoagulant warfarin and its derivatives and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Carcinogenesis, mutagenesis, impairment of fertility

Long term studies to determine the carcinogenic potential of ofloxacin have not been conducted.

Ofloxacin was not mutagenic in the Ames test, in vitro and in vivo cytogenic assay, sister chromatid exchange assay (Chinese hamster and human cell lines), unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay or mouse micronucleus assay. Ofloxacin was positive in the UDS test using rat hepatocyte and in the mouse lymphoma assay.

In fertility studies in rats, ofloxacin did not affect male or female fertility or morphological or reproductive performance at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended daily ophthalmic dose).

Pregnancy

Teratogenic effects

Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.

Nonteratogenic effects

Additional studies in rats with doses up to 360 mg/kg/day during late gestation showed no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability or growth of the newborn.

There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

In nursing women a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not known whether ofloxacin is excreted in human milk following topical ophthalmic administration. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

Safety and effectiveness in infants below the age of one year have not been established.

Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.

Geriatric use

No overall differences in safety or effectiveness have been observed between elderly and younger patients

Adverse Reactions

Ophthalmic Use

The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness and nausea have been received.

Ofloxacin Ophthalmic Solution Dosage and Administration

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

Days 1 and 2	Instill one to two drops every two to four hours in the affected eye(s).
Days 3 through 7	Instill one to two drops four times daily.

The recommended dosage regimen for the treatment of bacterial cornealulcer is:

Days 1 and 2	Instill one to two drops into the affected eye every 30 minutes, while awake. Awaken at approximately four and six hours after retiring and instill one to two drops.
Days 3 through 7 to 9	Instill one to two drops hourly, while awake.
Days 7 to 9 through treatment completion	Instill one to two drops, four times daily.

How is Ofloxacin Ophthalmic Solution Supplied

Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic dropper bottles of the following sizes: 5 mL and 10 mL.

Storage

Store at 20° to 25°C (68° to 77°F)

Manufactured by

Cipla, Ltd.

Goa, India

for

Sandoz Inc.

Princeton, NJ 08540

OS8877

Issued 11/08

MF7502ISS11/08

0.3% (5 mL Sterile) Carton

NDC 0185-7502-72

Ofloxacin Ophthalmic Solution USP

0.3%

Rx only

5 mL Sterile

Sandoz

0.3% (10 mL Sterile) Carton

NDC 0185-7502-71

Ofloxacin Ophthalmic Solution USP

0.3%

Rx only

10 mL Sterile

Sandoz

OFLOXACIN OPHTHALMIC  ofloxacin ophthalmic  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0185-7502 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OFLOXACIN (OFLOXACIN) OFLOXACIN 0.3 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID   WATER   SODIUM CHLORIDE   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-7502-72 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (0185-7502-72) 2 0185-7502-71 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 2 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (0185-7502-71)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076848	11/25/2008

Labeler - Eon Labs, Inc. (012656273)

Revised: 09/2011Eon Labs, Inc.

More Ofloxacin Ophthalmic Solution resources

• Ofloxacin Ophthalmic Solution Dosage
• Ofloxacin Ophthalmic Solution Use in Pregnancy & Breastfeeding
• Ofloxacin Ophthalmic Solution Support Group
• 0 Reviews for Ofloxacin Ophthalmic - Add your own review/rating

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