Enpril

Enpril may be available in the countries listed below.

Ingredient matches for Enpril

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enpril in the following countries:

• Bulgaria

International Drug Name Search

Odoxil

Odoxil may be available in the countries listed below.

Ingredient matches for Odoxil

Cefadroxil

Cefadroxil is reported as an ingredient of Odoxil in the following countries:

• India

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

• India

International Drug Name Search

Restoril

Generic Name: temazepam (Oral route)

tem-AZ-e-pam

Commonly used brand name(s)

In the U.S.

• Restoril

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Hypnotic

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Restoril

Temazepam is used to treat insomnia (trouble with sleeping). This medicine is for short-term (usually 7 to 10 days) use only. Temazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

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

Before Using Restoril

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 temazepam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of temazepam. Elderly patients may require a lower dose to help reduce unwanted effects.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

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.

• Rifapentine


• St John's Wort


• Theophylline

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 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.

• 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 or drug abuse or addiction, history of or


• Breathing problems or lung disease or


• Mental depression, history of or


• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease or


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

Proper Use of Restoril

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.

Take temazepam just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 (capsules):
  
  • For insomnia (trouble sleeping):
    
    • Adults—15 milligrams (mg) at bedtime. Your doctor may adjust your dose if needed.
    
    
    • Older adults—At first, 7.5 mg at bedtime. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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 Restoril

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

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

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though temazepam is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to temazepam before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking temazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop taking this medicine without checking with your doctor first.. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of temazepam or taking alcohol or other CNS depressants with temazepam may lead to breathing problems and unconsciousness.

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

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

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.

Restoril 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:

Less common

• False or unusual sense of well-being


• fear or nervousness


• mood or mental changes

Rare

• Difficult or labored breathing


• fast, irregular, pounding, or racing heartbeat or pulse


• loss of appetite


• loss of memory


• nightmares


• problems with memory


• seeing, hearing, or feeling things that are not there


• shakiness and unsteady walk


• shortness of breath


• tightness in the chest


• trouble sleeping


• uncontrolled eye movements


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


• unusual excitement, nervousness, restlessness, or irritability


• weight loss


• wheezing

Incidence not known

• Muscle cramps


• seizures


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


• stomach cramps


• sweating


• trembling or shaking of the hands or feet


• vomiting

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

Symptoms of overdose

• Blurred vision


• change in consciousness


• confusion


• decreased or absent reflexes


• difficult or troubled breathing


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


• irregular, fast, slow, or shallow breathing


• loss of consciousness


• pale or blue lips, fingernails, or skin


• shortness of breath


• sleepiness or unusual drowsiness


• unusual tiredness or weakness

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

Less common

• Diarrhea


• dry mouth


• feeling of constant movement of self or surroundings


• headache


• nausea


• sensation of spinning


• unusual dullness or feeling of sluggishness

Rare

• Backache


• burning eyes

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

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

See also: Restoril side effects (in more detail)

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

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

More Restoril resources

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

• Restoril Prescribing Information (FDA)


• Restoril Consumer Overview


• Restoril Monograph (AHFS DI)


• Restoril MedFacts Consumer Leaflet (Wolters Kluwer)


• Temazepam Prescribing Information (FDA)


• Temazepam Professional Patient Advice (Wolters Kluwer)

Compare Restoril with other medications

• Insomnia

Mucorama

Mucorama may be available in the countries listed below.

Ingredient matches for Mucorama

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Mucorama in the following countries:

• Venezuela

International Drug Name Search

Ortho Tri-Cyclen Lo

See also: Generic Ortho Tri-Cyclen

Ortho Tri-Cyclen Lo is a brand name of ethinyl estradiol/norgestimate, approved by the FDA in the following formulation(s):

ORTHO TRI-CYCLEN LO (ethinyl estradiol; norgestimate - tablet; oral-28)

• 
  Manufacturer: JANSSEN PHARMS
  
  Approval date: August 22, 2002
  
  Strength(s): 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG ^[RLD][AB]

Has a generic version of Ortho Tri-Cyclen Lo been approved?

A generic version of Ortho Tri-Cyclen Lo has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Ortho Tri-Cyclen Lo and have been approved by the FDA:

NORGESTIMATE AND ETHINYL ESTRADIOL (ethinyl estradiol; norgestimate tablet; oral-28)

• 
  Manufacturer: WATSON LABS
  
  Approval date: March 9, 2011
  
  Strength(s): 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG ^[AB]

TRI LO SPRINTEC (ethinyl estradiol; norgestimate tablet; oral-28)

• 
  Manufacturer: BARR
  
  Approval date: June 29, 2009
  
  Strength(s): 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ortho Tri-Cyclen Lo. 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

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Triphasic oral contraceptive
  Patent 6,214,815
  Issued: April 10, 2001
  Inventor(s): Shangold; Gary & Rubin; Arkady & Upmalis; David
  Assignee(s): Ortho-McNeil Pharmaceuticals, Inc.
  A method of contraception in which an estrogen and a progestogen are administered daily in a three phase sequence for 21 days is disclosed. In the first phase a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 23-28 .mu.g of 17.alpha.-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone is administered for 5-8 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.25-1.0 mg of norethindrone for 7-11 days; followed by the administering of the same dosage of estrogen and a progestogen corresponding in progestogenic activity to 0.35-2.0 mg of norethindrone for 3-7 days; followed by 4-8 days without administering either an estrogen or a progestogen.
  
  Patent expiration dates:
  
  
  • June 9, 2019
    
    ✓ 
    Patent use: CONTRACEPTION
  
  
  
  • December 9, 2019
    
    ✓ 
    Pediatric exclusivity
  
  

See also...

• Ortho Tri-Cyclen Lo Consumer Information (Cerner Multum)
• Norgestimate and Ethinyl Estradiol Consumer Information (Wolters Kluwer)
• Ortho-Tri-Cyclen Consumer Information (Wolters Kluwer)
• Ethinyl estradiol and norgestimate Consumer Information (Cerner Multum)

Cobalamin H

Cobalamin H may be available in the countries listed below.

Ingredient matches for Cobalamin H

Hydroxocobalamin

Hydroxocobalamin acetate (a derivative of Hydroxocobalamin) is reported as an ingredient of Cobalamin H in the following countries:

• Japan

International Drug Name Search

Fyrantel

Fyrantel may be available in the countries listed below.

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

Ingredient matches for Fyrantel

Pyrantel

Pyrantel embonate (a derivative of Pyrantel) is reported as an ingredient of Fyrantel in the following countries:

• Sweden

International Drug Name Search

Dilcontin

Dilcontin may be available in the countries listed below.

Ingredient matches for Dilcontin

Diltiazem

Diltiazem is reported as an ingredient of Dilcontin in the following countries:

• India


• Sri Lanka

Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Dilcontin in the following countries:

• Bangladesh

International Drug Name Search

Profilax

Profilax may be available in the countries listed below.

Ingredient matches for Profilax

Montelukast

Montelukast sodium salt (a derivative of Montelukast) is reported as an ingredient of Profilax in the following countries:

• Colombia

International Drug Name Search

Tacirel

Tacirel may be available in the countries listed below.

Ingredient matches for Tacirel

Trimetazidine

Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Tacirel in the following countries:

• Portugal

International Drug Name Search

Simplicef

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

Ingredient matches for Simplicef

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Simplicef in the following countries:

• United States

International Drug Name Search

Metostad

Metostad may be available in the countries listed below.

Ingredient matches for Metostad

Metoprolol

Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metostad in the following countries:

• Philippines

International Drug Name Search

Novalcina

Novalcina may be available in the countries listed below.

Ingredient matches for Novalcina

Metamizole

Metamizole sodium monohydrate (a derivative of Metamizole) is reported as an ingredient of Novalcina in the following countries:

• Venezuela

International Drug Name Search

Terbinafina Germed

Terbinafina Germed may be available in the countries listed below.

Ingredient matches for Terbinafina Germed

Terbinafine

Terbinafine is reported as an ingredient of Terbinafina Germed in the following countries:

• Portugal

International Drug Name Search

Ibuprofen Yung Shin

Ibuprofen Yung Shin may be available in the countries listed below.

Ingredient matches for Ibuprofen Yung Shin

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofen Yung Shin in the following countries:

• Singapore

International Drug Name Search

Clomipramina

Clomipramina may be available in the countries listed below.

Ingredient matches for Clomipramina

Clomipramine

Clomipramina (DCIT) is known as Clomipramine in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

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

Ribasphere Capsules

Pronunciation: RYE-ba-VIR-in
Generic Name: Ribavirin
Brand Name: Examples include Rebetol and Ribasphere

Ribasphere Capsules may cause serious birth defects and/or fetal death when used during pregnancy. It should not be used by women who are pregnant or by men whose female partners are pregnant. Women of childbearing potential who either take Ribasphere Capsules or are sexual partners of men who take Ribasphere Capsules must:

• have a negative pregnancy test immediately before therapy with Ribasphere Capsules is started.


• avoid becoming pregnant during therapy with Ribasphere Capsules or within the first 6 months after Ribasphere Capsules is stopped.

At least 2 reliable forms of effective birth control must be used during treatment with Ribasphere Capsules and for 6 months after treatment with Ribasphere Capsules is stopped.

Use of Ribasphere Capsules alone is not effective for treating chronic hepatitis C infection. Ribasphere Capsules must be used with another medicine (interferon) in order to treat hepatitis C infection.

Ribasphere Capsules may cause serious blood problems (hemolytic anemia), which can cause serious and sometimes fatal heart attacks in patients who have heart disease. Do not take Ribasphere Capsules if you have a history of serious or uncontrolled heart problems.

Ribasphere Capsules is used for:

Treating chronic hepatitis C infection in certain patients when used in combination with interferon. It may also be used for other conditions as determined by your doctor.

Ribasphere Capsules is an antiviral medicine. Exactly how it works to treat hepatitis C is not known.

Do NOT use Ribasphere Capsules if:

• you are allergic to any ingredient in Ribasphere Capsules or have had a severe allergic reaction (eg, red, swollen, blistered, or peeling skin) to ribavirin or any other ingredient in Ribasphere Capsules


• you are pregnant or planning to become pregnant while you take Ribasphere Capsules or within 6 months after you stop taking it


• you are a man with a female sexual partner who is pregnant or planning to become pregnant while you take Ribasphere Capsules or within 6 months after you stop taking it


• you have certain blood disorders (eg, hemolytic anemia, sickle-cell anemia, thalassemia major), a history of serious or uncontrolled heart problems, severe kidney problems, or inflammation of the pancreas (acute pancreatitis)


• you have autoimmune hepatitis (liver problems caused by your body instead of a virus)


• you are taking didanosine

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

Before using Ribasphere Capsules:

Some medical conditions may interact with Ribasphere Capsules. 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 have a female sexual partner who is of childbearing age


• 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 a history of cancer, heart problems or a heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia, spherocytosis), stomach or bowel bleeding, thyroid problems, HIV infection or other immune system problems, or eye or vision problems


• if you have liver problems other than hepatitis C infection (eg, hepatitis B infection), cirrhosis of the liver, or decreased liver function


• if you have a history of anxiety or other mood or mental disorders (eg, depression), thoughts of suicide, or suicidal behavior


• if you have used interferon before to treat hepatitis C and it did not work


• if you had an organ transplant


• if you have a history of drug or alcohol abuse

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

• Didanosine or other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), other antiretroviral medicines for HIV infection, or thiopurines (eg, azathioprine) because serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, bone marrow suppression, lactic acidosis, and severe or fatal liver failure, may be increased by Ribasphere Capsules


• Anticoagulants (eg, warfarin) or certain NRTIs (eg, lamivudine, stavudine, zidovudine) because their effectiveness may be decreased by Ribasphere Capsules

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

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

• Ribasphere Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ribasphere Capsules refilled.


• Take Ribasphere Capsules by mouth with food.


• Swallow Ribasphere Capsules whole. Do not break, crush, or chew before swallowing.


• Drinking extra fluids while you are taking Ribasphere Capsules is recommended. Check with your doctor for instructions.


• Taking Ribasphere Capsules at the same time each day will help you remember to take it.


• Take Ribasphere Capsules on a regular schedule to get the most benefit from it.


• Continue to use Ribasphere Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Ribasphere Capsules, 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 Ribasphere Capsules.

Important safety information:

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


• Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.


• At least 2 reliable forms of effective birth control must be used during treatment by men and women who take Ribasphere Capsules and for 6 months after Ribasphere Capsules is stopped. Men who take Ribasphere Capsules should use a condom with spermicide as 1 of the 2 forms of birth control.


• Women of childbearing potential who either take Ribasphere Capsules or are sexual partners of men who take Ribasphere Capsules must have a pregnancy test before therapy with Ribasphere Capsules is started, monthly during therapy, and monthly for 6 months after Ribasphere Capsules is stopped.


• Children and teenagers who take Ribasphere Capsules may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Ribasphere Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, aggression, anger, anxiety, nervousness, irritable behavior, or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Ribasphere Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Ribasphere Capsules may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking Ribasphere Capsules. Brush and floss your teeth carefully at least twice a day and visit the dentist regularly.


• If vomiting occurs while you are taking Ribasphere Capsules, be sure to rinse your mouth and clean your teeth afterwards.


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


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


• Lab tests, including pregnancy; complete blood cell counts; hemoglobin or hematocrit levels; heart, liver, kidney, thyroid, and lung function; and eye exams, may be performed while you use Ribasphere Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ribasphere Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia.


• Ribasphere Capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Ribasphere Capsules.


• Use Ribasphere Capsules with extreme caution in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Ribasphere Capsules:

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:

Constipation; cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; sinus problems; tiredness; upset stomach; weakness or fatigue.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in hearing, taste, or vision; chest pain; dark, tarry, or bloody stools; dark urine; decrease in the amount of urine; fainting; fever, chills, or sore throat; hair loss; joint pain; menstrual problems; mood or mental problems (eg, agitation, aggression, anger, anxiety, decreased concentration, depression, irritability, nervousness); muscle pain or weakness; numbness of an arm or leg; pale stools; prolonged nausea and vomiting; rapid breathing; red, swollen, blistered, or peeling skin; severe headache; severe or persistent diarrhea; severe stomach or back pain; shortness of breath; suicidal thoughts or actions; trouble sleeping; unusual bruising or bleeding; unusual or severe tiredness, weakness, or fatigue; weight loss; yellowing of the eyes or skin.

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: Ribasphere side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Ribasphere Capsules:

Store Ribasphere Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ribasphere Capsules out of the reach of children and away from pets.

General information:

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


• Ribasphere Capsules 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 Ribasphere Capsules. 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 Ribasphere resources

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

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• Hepatitis C

Regro

Regro may be available in the countries listed below.

Ingredient matches for Regro

Minoxidil

Minoxidil is reported as an ingredient of Regro in the following countries:

• Singapore

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Fentanyl beta

Fentanyl beta may be available in the countries listed below.

Ingredient matches for Fentanyl beta

Fentanyl

Fentanyl is reported as an ingredient of Fentanyl beta in the following countries:

• Germany

International Drug Name Search

Biogenerics Rifampicin

Biogenerics Rifampicin may be available in the countries listed below.

Ingredient matches for Biogenerics Rifampicin

Rifampicin

Rifampicin is reported as an ingredient of Biogenerics Rifampicin in the following countries:

• Philippines

International Drug Name Search

Clindamycin Phosphate

Ingredient matches for Clindamycin Phosphate

Clindamycin

Clindamycin Phosphate (BANM, USAN) is known as Clindamycin in the US.

International Drug Name Search

Glossary

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

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

Fensaide

Fensaide may be available in the countries listed below.

Ingredient matches for Fensaide

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Fensaide in the following countries:

• India

International Drug Name Search

Blotex

Blotex may be available in the countries listed below.

Ingredient matches for Blotex

Atenolol

Atenolol is reported as an ingredient of Blotex in the following countries:

• Mexico

International Drug Name Search

Criten

Criten may be available in the countries listed below.

Ingredient matches for Criten

Bromocriptine

Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Criten in the following countries:

• Chile

International Drug Name Search

Still

Still may be available in the countries listed below.

Ingredient matches for Still

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Still in the following countries:

• Brazil

International Drug Name Search

Domycotin

Domycotin may be available in the countries listed below.

Ingredient matches for Domycotin

Fluprednidene

Fluprednidene 21-acetate (a derivative of Fluprednidene) is reported as an ingredient of Domycotin in the following countries:

• Greece

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Domycotin in the following countries:

• Greece

International Drug Name Search

Fluoxetina Genfar

Fluoxetina Genfar may be available in the countries listed below.

Ingredient matches for Fluoxetina Genfar

Fluoxetine

Fluoxetine is reported as an ingredient of Fluoxetina Genfar in the following countries:

• Colombia


• Ecuador

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetina Genfar in the following countries:

• Peru

International Drug Name Search

Relieva

Relieva may be available in the countries listed below.

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Frovatriptan

Frovatriptan succinate monohydrate (a derivative of Frovatriptan) is reported as an ingredient of Relieva in the following countries:

• Bulgaria

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Flupamid

Flupamid may be available in the countries listed below.

Ingredient matches for Flupamid

Indapamide

Indapamide is reported as an ingredient of Flupamid in the following countries:

• Georgia


• Turkey

International Drug Name Search

Ledclair

Ledclair may be available in the countries listed below.

Ingredient matches for Ledclair

Edetic Acid

Edetic Acid calcium disodium salt (a derivative of Edetic Acid) is reported as an ingredient of Ledclair in the following countries:

• Ireland


• United Kingdom

International Drug Name Search

Reodon

Reodon may be available in the countries listed below.

Ingredient matches for Reodon

Repaglinide

Repaglinide is reported as an ingredient of Reodon in the following countries:

• Croatia (Hrvatska)

International Drug Name Search

Diclofenac-Akri

Diclofenac-Akri may be available in the countries listed below.

Ingredient matches for Diclofenac-Akri

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenac-Akri in the following countries:

• Russian Federation

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Olsalazine

Pronunciation: ol-SAL-a-zeen
Generic Name: Olsalazine
Brand Name: Dipentum

Olsalazine is used for:

Controlling symptoms of ulcerative colitis in patients who cannot take sulfasalazine.

Olsalazine is a salicylate. It works by reducing inflammation of the colon by possibly preventing the production of substances that cause this inflammation.

Do NOT use Olsalazine if:

• you are allergic to any ingredient in Olsalazine


• you are allergic to aspirin or medications similar to aspirin (eg, salicylates)


• you have received the varicella (chickenpox) vaccine within the past 6 weeks

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

Before using Olsalazine:

Some medical conditions may interact with Olsalazine. 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 kidney or liver problems, asthma, or severe allergies


• if you have or recently had a viral infection (eg, flu, chickenpox)

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

• Thiopurines (eg, azathioprine, mercaptopurine, thioguanine) because the risk of bone marrow toxicity may be increased


• Anticoagulants (eg, warfarin) or heparin because the risk of their side effects may be increased by Olsalazine

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

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

• Take Olsalazine by mouth with food.


• Take Olsalazine in evenly divided doses.


• Continue taking Olsalazine for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Olsalazine, 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. If more than one dose is missed, contact your doctor or pharmacist.

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

Important safety information:

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


• If diarrhea occurs while taking Olsalazine, contact your health care provider.


• If your symptoms do not improve or if they worsen after you start using Olsalazine, check with your doctor.


• Salicylates have been linked to a serious illness called Reye syndrome. Check with your doctor before you give Olsalazine to a child or teenager who has the flu, chickenpox, or a viral infection, or has recently had such an illness. Contact your doctor with any questions or concerns.


• Olsalazine should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Olsalazine while you are pregnant. Olsalazine is found in breast milk. Do not breast-feed while taking Olsalazine.

Possible side effects of Olsalazine:

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:

Diarrhea; joint pain; nausea; stomach pain or cramps.

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); change in the amount of urine; chest pain; dark urine; fast or irregular heartbeat; pale stools; severe stomach pain; trouble urinating; unusual bruising or bleeding; yellowing of the eyes or skin.

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: Olsalazine 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 nausea, vomiting, or diarrhea.

Proper storage of Olsalazine:

Store Olsalazine in a tightly closed container 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 Olsalazine out of the reach of children and away from pets.

General information:

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


• Olsalazine 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 Olsalazine. 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 Olsalazine resources

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

• olsalazine Concise Consumer Information (Cerner Multum)


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• Dipentum Prescribing Information (FDA)


• Dipentum Monograph (AHFS DI)

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Renate DHA

prenatal multivitamin and minerals

Dosage Form: tablet
Renate DHA Prenatal Multivitamin and Minerals

Renate DHA Description

Renate DHA Extra 430 mg is a high-potency, multivitamin,

multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).


Other Ingredients (Renate DHA Extra

430 mg caplet): Mono and Diglycerides,

Croscarmellose Sodium, Maltodextrin, Microcrystalline

Cellulose, Crospovidone, Stearic Acid, Hydroxypropyl

Methylcellulose, Titanium Dioxide, Magnesium Stearate,

Silicon Dioxide, Acacia, Sucrose, Starch, Gelatin, Dicalcium

Phosphate, Triacetin, Ascorbyl Palmitate, dl-Alpha

Tocopherol, Sodium Ascorbate, Carmine Powder

CFR73.100/E120, Caramel Color CFR73.85/E150,

Polysorbate. May contain Polyethylene Glycol.

Contains Soy.


Other Ingredients (Renate DHA

Extra 430 mg Enteric-Coated

softgel): Gelatin, Water, Glycerin, Polysorbate 80,

Ethylcellulose, Sodium Alginate, Polyethylene Glycol,

Oleic Acid, Fractionated Coconut Oil, Purified Stearic

Acid, Ammonium Hydroxide.

Also contains Eicosapentaenoic Acid (EPA) and other

omega-3 fatty acids (from tuna oil).

Contains Soy and Fish Oil (from tuna oil).


Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based

by-products.


WARNING: Accidental overdose of iron-containing products is a leading cause of

fatal poisoning in children under 6. Keep this and all drugs out of reach of children. In

case of accidental overdose, call a doctor or poison control center immediately.

Renate DHA Extra 430 mg supplies important prenatal vitamins, minerals and nutrients

to supplement the nutritional needs of women, before, during and after pregnancy.

Deficiencies of these nutrients are common during pregnancy and lactation, and should

be prescribed by a physician prior to conception.


Renate DHA Extra 430 mg caplet is manufactured in a drug-certified cGMP (current

good manufacturing practices) facility and meets or exceeds USP standards for potency,

purity and dissolution. Renate DHA Extra 430 mg Enteric-Coated softgel complies with

the most stringent worldwide standards for fish oil and is manufactured in a NSF

Certified cGMP Facility.

Indications and Usage for Renate DHA

Renate DHA Extra 430 mg is a prescription regimen

of prenatal multivitamin, multi-mineral and omega-3 fatty acid supplements indicated

for use in improving the nutritional status of women throughout pregnancy and in the

post-natal period for both lactating and non-lactating mothers. Renate DHA Extra

430 mg is also useful in improving the nutritional status prior to conception.

Renate DHA Dosage and Administration

Before, during and after pregnancy, adult

women (over 12 years of age), take one (1) caplet and one (1) softgel by mouth daily,

between meals or as prescribed by a physician. Caplet and softgel may be taken

separately. Do not exceed the recommended dosage. Do not administer to children

under 12 years of age or persons age 65 or older. Do not exceed one gram (1,000 mg)

of DHA per day.

Contraindications

Renate DHA Extra 430 mg is contraindicated in patients

with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is

contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic

anemias. This product is contraindicated for persons with pernicious anemia, as folic

acid may obscure its signs and symptoms.

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia

in that hematological remission can occur while neurological manifestations remain

progressive.

Warning

Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA],

eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more

than 3 grams per day may present antithrombotic effects, including increased bleeding

time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with

inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products

should consult with their physician prior to ingesting omega-3 fatty acids.

Precautions

Folic acid in dosages above 400 mcg daily may obscure

megaloblastic (pernicious) anemia in that hematological remission can occur while

neurological manifestations (Addisonian anemia) remain progressive.

Adverse Reactions

Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur

but are usually mild and can subside with continuation of therapy. Although the

absorption of iron is best when taken between meals, Renate DHA Extra 430 mg, when

taken after meals, may control occasional G.I. disturbances. Renate DHA Extra 430 mg

is best absorbed when taken at bedtime.


Folic Acid: Allergic sensitizations have been reported following both oral and

parenteral administration of folic acid.


Call your doctor for medical advice about side effects. You may

report suspected side effects to the FDA at: 1-800-FDA-1088.

USE IN SPECIFIC POPULATIONS

Renate DHA Extra 430 mg is not advocated

for pediatric or geriatric use.

OVERDOSE

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may

cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular

collapse and death. Other symptoms include pallor and cyanosis, melena, shock,

drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body

weight. When overdoses are ingested by children, severe reactions, including fatalities

have resulted. Renate DHA Extra 430 mg should be stored beyond the reach of children

to prevent against accidental iron poisoning. Keep this and all other drugs out of reach

of children. Treatment: For specific therapy, exchange transfusion and chelating agents

should be used. For general management, perform gastric lavage with sodium

bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use

oxygen.

How is Renate DHA Supplied

Renate DHA Extra 430 mg is a 30-day regimen supplied as one

bottle containing 30 dark red Renate DHA Extra 430 mg Prenatal capsule-shaped

caplets imprinted “RE 340” and one bottle containing 30 light yellow DHA,

Enteric-Coated softgels. NDC: 68032-373-60. Dispense in tight, light-resistant

containers as defined in the USP/NF with child resistant closures. Store at controlled

room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.


CAUTION: Rx Only


RESERVED FOR PROFESSIONAL RECOMMENDATION: Made in the

USA exclusively for River’s Edge Pharmaceuticals, LLC, Suwanee, GA, 30024. All rights

reserved. Copyright © by River’s Edge Pharmaceuticals.

PACKAGING

Sample Packaging:

RENATE  Renate DHA prenatal multivitamin and minerals with dha  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-373 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 3 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg IRON (IRON) IRON 29 mg MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg ZINC OXIDE (ZINC) ZINC OXIDE 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 430 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 295 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color red Score no score Shape CAPSULE Size 20mm Flavor Imprint Code RE;340 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-373-60 60 TABLET In 1 KIT None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/02/2009	12/31/2010

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2009River's Edge Pharmaceuticals, LLC

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• Renate DHA Side Effects (in more detail)
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digoxin immune FAB

Generic Name: digoxin immune FAB (di JOX in im MYOON FAB)

Brand Names: Digibind, DigiFab

What is digoxin immune FAB?

Digoxin immune FAB is used as an antidote to treat a life-threatening overdose of digoxin or digitoxin.

Digoxin immune FAB is not for treating a mild digitalis overdose.

Digoxin immune FAB may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about digoxin immune FAB?

If possible, before you receive digoxin immune FAB, tell your doctor if you have heart disease or kidney disease, or if you are allergic to antibiotics or papaya extracts such as papain or chymopapain.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you received this medication.

After treatment with digoxin immune FAB, you will be watched to make sure the medication has been effective and you no longer have any effects of the digitalis overdose.

What should I discuss with my health care provider before receiving digoxin immune FAB?

If possible, before you receive digoxin immune FAB, tell your doctor if you have:

• 
  

  heart disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  if you are allergic to antibiotics; or

  
  


• 
  

  if you are allergic to papaya extracts such as papain or chymopapain (Chymodiactin).

  
  

FDA pregnancy category C. Digoxin immune FAB may be harmful to an unborn baby. Tell your doctor if you are pregnant before receiving this medication. It is not known whether digoxin immune FAB passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In a poisoning situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with digoxin immune FAB. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.

How is digoxin immune FAB given?

Digoxin immune FAB is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting. The medicine must be given slowly through an IV infusion, and each dose can take up to 30 minutes to complete.

To be sure this medication is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. This will help your doctor determine how long to treat you with digoxin immune FAB.

This medication can cause you to have unusual results with certain digitalis tests. Tell any doctor who treats you that you have been treated with digoxin immune FAB.

What happens if I miss a dose?

Since digoxin immune FAB is given in an emergency situation by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

An overdose of this medication is unlikely since it is given by a healthcare provider.

What should I avoid after receiving digoxin immune FAB?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you are treated with digoxin immune FAB.

Digoxin immune FAB side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

• 
  

  fever;

  
  


• 
  

  high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  
  


• 
  

  feeling short of breath, even with mild exertion; or

  
  


• 
  

  swelling, rapid weight gain.

  
  

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.

Digoxin immune FAB Dosing Information

Usual Adult Dose for Digitalis Glycoside Toxicity:

Unknown amount of ingestion: 800 mg IV infusion if acute ingestion, 240 mg IV infusion if chronic ingestion.

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Dosing based on Serum Level:
Digoxin: Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).
Digitoxin: Dose (in # of vials) = (Serum digitoxin level in ng/mL) x (weight in kg) / (1000).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

Usual Pediatric Dose for Digitalis Glycoside Toxicity:

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Children less than or equal to 20 kg: Dilution of reconstituted vial to 1 mg/mL may be desirable for doses of 3 mg or less.
Dose ( in # of mg) = Dose (in # vials) x 38 mg/vial.
Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection. The vial may be reconstituted and administered undiluted using a tuberculin syringe in infants and small children requiring small doses.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

What other drugs will affect digoxin immune FAB?

This list is not complete and there may be other drugs that can interact with digoxin immune FAB. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More digoxin immune FAB resources

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

• Digibind Prescribing Information (FDA)


• Digifab Prescribing Information (FDA)


• Digoxin Immune Fab MedFacts Consumer Leaflet (Wolters Kluwer)

Compare digoxin immune FAB with other medications

• Digitalis Glycoside Toxicity

Where can I get more information?

• Your doctor or pharmacist can provide more information about digoxin immune FAB.

See also: digoxin immune FAB side effects (in more detail)

Claritromicina Pharmagenus

Claritromicina Pharmagenus may be available in the countries listed below.

Ingredient matches for Claritromicina Pharmagenus

Clarithromycin

Clarithromycin is reported as an ingredient of Claritromicina Pharmagenus in the following countries:

• Spain

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Petibelle

Petibelle may be available in the countries listed below.

Ingredient matches for Petibelle

Drospirenone

Drospirenone is reported as an ingredient of Petibelle in the following countries:

• Germany

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Petibelle in the following countries:

• Germany

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Nonalcoholic Fatty Liver Disease Medications

Definition of Nonalcoholic Fatty Liver Disease: Nonalcoholic fatty liver disease (NAFLD) describes a range of conditions that affect people who drink little or no alcohol.

Drugs associated with Nonalcoholic Fatty Liver Disease

The following drugs and medications are in some way related to, or used in the treatment of Nonalcoholic Fatty Liver Disease. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Actigall

Actos

Avandia

Cystadane-Powder

Urso

Urso-Forte

Xenical

Malaban

Malaban may be available in the countries listed below.

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

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Malathion

Malathion is reported as an ingredient of Malaban in the following countries:

• Australia

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Furo-Puren

Furo-Puren may be available in the countries listed below.

Ingredient matches for Furo-Puren

Furosemide

Furosemide is reported as an ingredient of Furo-Puren in the following countries:

• Germany

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Befunololo

Befunololo may be available in the countries listed below.

Ingredient matches for Befunololo

Befunolol

Befunololo (DCIT) is also known as Befunolol (Rec.INN)

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Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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