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Loxitane C

30/06/10

Generic Name: loxapine (LOX a peen)
Brand Names: Loxitane, Loxitane C

What is Loxitane C (loxapine)?

Loxapine is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxapine is used to treat schizophrenia.

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

What is the most important information I should know about Loxitane C (loxapine)?

Loxapine is not for use in psychotic conditions related to dementia. Loxapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to loxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Call your doctor at once if you have restless muscle movements in your eyes, tongue, jaw, or neck. Loxapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Loxitane C (loxapine)?

Loxapine is not for use in psychotic conditions related to dementia. Loxapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to loxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

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

epilepsy or other seizure disorder;
a history of low white blood cell (WBC) counts;
glaucoma;
urination problems;
heart disease; or
a history of breast cancer;

It is not known whether loxapine is harmful to an unborn baby. Before taking loxapine, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loxapine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Loxitane C (loxapine)?

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

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

Loxapine is usually taken 2 to 4 times daily. Follow your doctor’s instructions.

Take loxapine with a full glass of water. You may not start feeling better right away when you start taking loxapine. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment. Store loxapine at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, weak pulse, slow heart rate, weak or shallow breathing, fainting, or seizure (convulsions).

What should I avoid while taking Loxitane C (loxapine)?

Loxapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

Loxitane C (loxapine) side effects

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

very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
trouble swallowing;
seizure (convulsions);
easy bruising or bleeding, unusual weakness;
fever, chills, body aches, flu symptoms;
vision changes;
severe constipation; or
urinating less than usual or not at all.

Less serious side effects may include:

dizziness or drowsiness;
blurred vision;
puffiness in your face;
feeling restless or agitated;
sleep problems (insomnia);
breast swelling or discharge;
changes in your menstrual periods;
nausea, vomiting, constipation;
changes in weight;
dry mouth, stuffy nose; or
mild skin rash, itching, or flaking.

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

What other drugs will affect Loxitane C (loxapine)?

Before using loxapine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). You should not take loxapine if you have drowsiness caused by other medications.

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

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
glycopyrrolate (Robinul);
mepenzolate (Cantil);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with loxapine. 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.

Where can I get more information?

Your pharmacist can provide more information about loxapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

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Lozi-Flur

30/06/10

Generic Name: fluoride (FLOR ide)
Brand Names: Altaflor, Ethedent Chewable, Fluor-A-Day, Fluoritab, Flura-Drops, Flura-Loz, Flura-Tab, Karidium, Lozi-Flur, Luride, Nafrinse, Pharmaflur, Pharmaflur 1.1

What is Lozi-Flur (fluoride)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Fluoride is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Fluoride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

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

What is the most important information I should know about Lozi-Flur (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

What should I discuss with my healthcare provider before taking Lozi-Flur (fluoride)?

You should not use fluoride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride, or you may need special tests while you are using it.

Talk to your doctor and dentist before taking fluoride if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking fluoride if you are breast-feeding. The American Dental Association’s Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Lozi-Flur (fluoride)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medicine with a full glass of water. Do not take fluoride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the fluoride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.

The chewable forms of fluoride can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.

The fluoride drops can be taken by mouth undiluted, or mixed with fluid or food.

If you mix fluoride with food or water, drink or eat this mixture right away. Do not save it for later use.

It is important to take fluoride regularly to get the most benefit.

Store fluoride at room temperature away from moisture and heat.

What happens if I miss a dose?

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

What should I avoid while taking Lozi-Flur (fluoride)?

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

Lozi-Flur (fluoride) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

discolored teeth;
weakened tooth enamel; or
any changes in the appearance of your teeth.

Less serious side effects may include:

stomach upset;
headache; or
weakness.

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

What other drugs will affect Lozi-Flur (fluoride)?

There may be other drugs that can interact with fluoride. 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.

Where can I get more information?

Your pharmacist can provide more information about fluoride.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

Comments (0)

loxapine (Oral route)

30/06/10

LOX-a-peen

Commonly used brand name(s):

In the U.S.

Loxitane

Available Dosage Forms:

Tablet
Capsule
Solution

Therapeutic Class: Antipsychotic

Chemical Class: Dibenzoxazepine

Uses For loxapine

Loxapine is used to treat a mental condition called schizophrenia.

loxapine is available only with your doctor’s prescription.

Before Using loxapine

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 loxapine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to loxapine 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 loxapine in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of loxapine in geriatric patients. However, elderly patients (especially females) are more likely to have tardive dyskinesia (a movement disorder), which may require caution in patients receiving loxapine.

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

Using loxapine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Metoclopramide

Using loxapine 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.

Hydromorphone
Lithium
Tramadol
Zotepine

Using loxapine 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.

Betel Nut
Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of loxapine

Take loxapine 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. To do so may increase the chance of side effects.

Dosing

The dose of loxapine 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 loxapine. 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 schizophrenia:
- For oral dosage form (capsules):
  - Adults—At first, 20 to 50 milligrams (mg) per day, divided and given in two to four doses per day. Your doctor may increase your dose if needed. However, the dose is usually not more than 250 mg per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of loxapine, 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 loxapine

It is very important that your doctor check your progress at regular visits, especially during the first few months of treatment with loxapine. This will allow changes in your dose and to check for unwanted effects.

Do not stop taking loxapine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This will allow your body time to adjust and to keep your condition from becoming worse.

loxapine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or allergies; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking loxapine.

loxapine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking loxapine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop taking loxapine and check with your doctor right away if you have any of the following symptoms while using loxapine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

loxapine may cause some people to become drowsy or less alert than they are normally, especially when the amount of medicine is increased. Even if you take loxapine at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to loxapine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Although it is not a problem for most patients, dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. However, if the problem continues or gets worse, check with your doctor.

Loxapine may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

loxapine 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

Difficulty with speaking or swallowing
lip smacking or puckering
loss of balance control
mask-like face
puffing of the cheeks
rapid or fine, worm-like movements of the tongue
restlessness or desire to keep moving
shuffling walk
slowed movements
stiffness of the arms and legs
trembling and shaking of the fingers and hands
uncontrolled chewing movements
uncontrolled movements of the arms or legs

Less common

Constipation (severe)
difficult urination
inability to move the eyes
muscle spasms, especially of the neck and back
skin rash
twisting movements of the body

Rare

Convulsions (seizures)
difficult or fast breathing
fast heartbeat or irregular pulse
fever (high)
high or low blood pressure
increased blinking or spasms of the eyelid
increased sweating
loss of bladder control
muscle stiffness (severe)
sore throat and fever
uncontrolled twisting movements of neck, trunk, arms, or legs
unusual bleeding or bruising
unusual facial expressions or body positions
unusual tiredness or weakness
unusually pale skin
yellow eyes or skin

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

Symptoms of overdose

Dizziness (severe)
drowsiness (severe)
muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
troubled breathing (severe)
unusual tiredness or weakness (severe)

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

Blurred vision
confusion
dizziness, lightheadedness, or fainting
drowsiness
dryness of the mouth

Less common

Constipation (mild)
decreased sexual ability
enlargement of breasts (males and females)
headache
increased sensitivity of the skin to sun
missing menstrual periods
nausea or vomiting
trouble with sleeping
unusual secretion of milk
weight gain

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

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

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

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

Advanced,L

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Loxitane

30/06/10

Generic Name: loxapine (LOX a peen)
Brand Names: Loxitane, Loxitane C

What is Loxitane (loxapine)?

Loxapine is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxapine is used to treat schizophrenia.

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

What is the most important information I should know about Loxitane (loxapine)?

Loxapine is not for use in psychotic conditions related to dementia. Loxapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to loxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Loxitane (loxapine)?

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

epilepsy or other seizure disorder;
a history of low white blood cell (WBC) counts;
glaucoma;
urination problems;
heart disease; or
a history of breast cancer;

How should I take Loxitane (loxapine)?

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

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

Loxapine is usually taken 2 to 4 times daily. Follow your doctor’s instructions.

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while taking Loxitane (loxapine)?

Loxapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

Loxitane (loxapine) side effects

very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
trouble swallowing;
seizure (convulsions);
easy bruising or bleeding, unusual weakness;
fever, chills, body aches, flu symptoms;
vision changes;
severe constipation; or
urinating less than usual or not at all.

Less serious side effects may include:

dizziness or drowsiness;
blurred vision;
puffiness in your face;
feeling restless or agitated;
sleep problems (insomnia);
breast swelling or discharge;
changes in your menstrual periods;
nausea, vomiting, constipation;
changes in weight;
dry mouth, stuffy nose; or
mild skin rash, itching, or flaking.

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

What other drugs will affect Loxitane (loxapine)?

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

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
glycopyrrolate (Robinul);
mepenzolate (Cantil);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

Where can I get more information?

Your pharmacist can provide more information about loxapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

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Low-Ogestrel

30/06/10

Generic Name: ethinyl estradiol and norgestrel (ETH in il ess tra DYE ol and nor JESS trel)
Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28

What is Low-Ogestrel (ethinyl estradiol and norgestrel)?

Ethinyl estradiol and norgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.

Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Low-Ogestrel (ethinyl estradiol and norgestrel)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe high blood pressure, severe migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.

What should I discuss with my healthcare provider before taking Low-Ogestrel (ethinyl estradiol and norgestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke or blood clot;
circulation problems (especially if caused by diabetes);
a hormone-related cancer such as breast or uterine cancer;
unusual vaginal bleeding;
liver disease or liver cancer;
severe high blood pressure;
severe migraine headaches;
a heart valve disorder; or
a history of jaundice caused by birth control pills.

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

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. You should not breast-feed while you are taking birth control pills.

How should I take Low-Ogestrel (ethinyl estradiol and norgestrel)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor’s instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

The 28-day birth control pack contains seven “reminder” pills to keep you on your regular cycle. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one “active” pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two “active” pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two “active” pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three “active” pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Low-Ogestrel (ethinyl estradiol and norgestrel)?

Do not smoke while taking birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Low-Ogestrel (ethinyl estradiol and norgestrel) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
nervousness, dizziness, tired feeling.

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

What other drugs will affect Low-Ogestrel (ethinyl estradiol and norgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);
modafinil (Provigil);
dexamethasone (Decadron, Hexadrol);
an antibiotic;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
a barbiturate such as phenobarbital (Solfoton) and others; or
HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norgestrel.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

Comments (0)

Low-Ogestrel-28

30/06/10

Generic Name: ethinyl estradiol and norgestrel (ETH in il ess tra DYE ol and nor JESS trel)
Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28

What is Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.

Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.

What should I discuss with my healthcare provider before taking Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

a history of a stroke or blood clot;
circulation problems (especially if caused by diabetes);
a hormone-related cancer such as breast or uterine cancer;
unusual vaginal bleeding;
liver disease or liver cancer;
severe high blood pressure;
severe migraine headaches;
a heart valve disorder; or
a history of jaundice caused by birth control pills.

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

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

How should I take Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

The 28-day birth control pack contains seven “reminder” pills to keep you on your regular cycle. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one “active” pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

Do not smoke while taking birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Low-Ogestrel-28 (ethinyl estradiol and norgestrel) side effects

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
nervousness, dizziness, tired feeling.

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

What other drugs will affect Low-Ogestrel-28 (ethinyl estradiol and norgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);
modafinil (Provigil);
dexamethasone (Decadron, Hexadrol);
an antibiotic;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;
a barbiturate such as phenobarbital (Solfoton) and others; or
HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and norgestrel.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

Comments (0)

loxapine

30/06/10

Generic Name: loxapine (LOX a peen)
Brand names: Loxitane, Loxitane C, Loxitane IM

What is loxapine?

Loxapine is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxapine is used to treat schizophrenia.

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

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

Loxapine is not for use in psychotic conditions related to dementia. Loxapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to loxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

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

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

epilepsy or other seizure disorder;
a history of low white blood cell (WBC) counts;
glaucoma;
urination problems;
heart disease; or
a history of breast cancer;

How should I take loxapine?

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

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

Loxapine is usually taken 2 to 4 times daily. Follow your doctor’s instructions.

See also: Loxapine dosage in more detail

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while taking loxapine?

Loxapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxapine can decrease perspiration and you may be more prone to heat stroke.

Loxapine side effects

very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
trouble swallowing;
seizure (convulsions);
easy bruising or bleeding, unusual weakness;
fever, chills, body aches, flu symptoms;
vision changes;
severe constipation; or
urinating less than usual or not at all.

Less serious side effects may include:

dizziness or drowsiness;
blurred vision;
puffiness in your face;
feeling restless or agitated;
sleep problems (insomnia);
breast swelling or discharge;
changes in your menstrual periods;
nausea, vomiting, constipation;
changes in weight;
dry mouth, stuffy nose; or
mild skin rash, itching, or flaking.

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

Loxapine Dosing Information

Usual Adult Dose for Schizophrenia:

Initial Dose: 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizophrenia.

Maintenance Dose: 60 mg to 100 mg daily. However, some patients respond to lower dosage and others may require higher dosage for optimal benefit.

Maximum dose: 250 mg/day.

What other drugs will affect loxapine?

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

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
glycopyrrolate (Robinul);
mepenzolate (Cantil);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

Where can I get more information?

Your pharmacist can provide more information about loxapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

Comments (0)

Lovenox

30/06/10

Generic Name: enoxaparin (Subcutaneous route, Injection route)

ee-nox-a-PAR-in

Injection routeSolution

Spinal/Epidural Hematomas
- Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
- Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
- Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

Epidural or spinal hematomas, which may result in long-term or permanent paralysis, may occur in patients who are anticoagulated with low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. Factors that can increase the risk of developing these hematomas include: use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors, or other anticoagulants, or history of traumatic or repeated epidural or spinal puncture, spinal deformity, or spinal surgery. Monitor patients frequently for neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider risks/benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

Commonly used brand name(s):

In the U.S.

Lovenox

Available Dosage Forms:

Solution
Injectable

Therapeutic Class: Anticoagulant

Pharmacologic Class: Low Molecular Weight Heparin

Uses For Lovenox

Enoxaparin is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip or knee replacement surgery, and in some cases following abdominal surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Enoxaparin is also used if you are unable to get out of bed because of a serious illness. In addition, enoxaparin is used to prevent blood clots from forming in the arteries of the heart during certain types of chest pain and heart attacks.

Enoxaparin is used together with warfarin to treat acute deep vein thrombosis with or without pulmonary embolism. It is also used to treat certain types of acute heart attacks.

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

Before Using Lovenox

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 enoxaparin 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 enoxaparin in the elderly. However, elderly patients are more likely to have bleeding problems and age-related kidney disease, which may require an adjustment in the dose for patients receiving enoxaparin, especially those who weigh less than 45 kilograms (99 lbs).

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

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.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Alclofenac
Alteplase, Recombinant
Ancrod
Anisindione
Anistreplase
Antithrombin, Recombinant
Antithrombin III Human
Apazone
Ardeparin
Argatroban
Benoxaprofen
Bivalirudin
Bromfenac
Bufexamac
Carprofen
Certoparin
Cilostazol
Citalopram
Clometacin
Clonixin
Clopidogrel
Dalteparin
Danaparoid
Defibrotide
Dermatan Sulfate
Desirudin
Dexketoprofen
Diclofenac
Dicumarol
Diflunisal
Dipyridamole
Dipyrone
Drotrecogin Alfa
Droxicam
Duloxetine
Enoxaparin
Eptifibatide
Escitalopram
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Heparin
Ibuprofen
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Lamifiban
Lepirudin
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Nabumetone
Nadroparin
Naproxen
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Parnaparin
Paroxetine
Pentosan Polysulfate Sodium
Phenindione
Phenprocoumon
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Protein C, Human
Reteplase, Recombinant
Reviparin
Sertraline
Sibrafiban
Streptokinase
Sulindac
Suprofen
Tenecteplase
Tenidap
Tenoxicam
Tiaprofenic Acid
Ticlopidine
Tinzaparin
Tirofiban
Tolmetin
Urokinase
Warfarin
Xemilofiban
Zomepirac

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.

Aspirin
Benorilate
Choline Salicylate
Magnesium Salicylate
Mesalamine
Olsalazine
Salicylamide
Salicylic Acid
Salsalate
Sodium Salicylate
Sodium Thiosalicylate
Trolamine Salicylate

Interactions with Food/Tobacco/Alcohol

Proper Use of Lovenox

A nurse or other trained health professional will usually give you this medicine in the hospital. This medicine is given as a shot under your skin or into a vein.

If you are using enoxaparin at home, your doctor will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your doctor if you have any problems using the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

If the medicine in the prefilled syringe has changed color, or if you see particles in it, do not use it.

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.

For injection dosage form:
- For prevention of blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
  - Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight injected under the skin every twelve hours for 2 to 8 days. Aspirin 100 to 325 mg orally once a day may also be given. However, the dose is 1 mg per kg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (abdominal surgery):
  - Adults—40 milligrams (mg) injected under the skin once a day for 7 to 10 days. The first dose should be given 2 hours before the surgery. However, the dose is 30 mg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (hip or knee replacement surgery):
  - Adults—30 milligrams (mg) injected under the skin every twelve hours for 7 to 10 days. Alternatively, for hip replacement surgery, the dose may be 40 mg injected under the skin once a day for three weeks. The dose is 30 mg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis (in patients with a serious illness who cannot get out of bed):
  - Adults—40 milligrams (mg) injected under the skin once a day for 6 to 11 days. The dose is 30 mg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For treatment of acute deep vein thrombosis with or without pulmonary embolism:
  - Adults—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 1 milligram (mg) per kilogram (kg) of body weight every 12 hours injected under the skin for 7 days. The dose is 1 mg per kg once a day if you have a poorly performing kidney.
  - Children—Use and dose must be determined by your doctor.
- For treatment of certain type of acute heart attack
  - Adults—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 30 milligrams (mg) injected into your vein and 1 milligram (mg) per kilogram (kg) of body weight injected under the skin followed by 1 mg per kg every 12 hours injected under the skin for 8 days. Aspirin 75 to 325 mg orally once a day may also be given.
  - Older adults—Dose is based on body weight and must be determined by your doctor. However, the starting dose is 0.75 milligram (mg) per kilogram (kg) of body weight injected under the skin every 12 hours for 8 days. Aspirin 75 to 325 mg orally once a day may also be given.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

If you were given a bottle of medicine to use with your syringes, you must use the medicine within 28 days after the first shot. Throw away the unused medicine in the bottle after 28 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Lovenox

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

You may bleed or bruise more easily while you are using this medicine. Stay away from rough sports or other situations where you could be bruised, cut , or injured. Be careful when using sharp objects, including razors and fingernail clippers. Avoid nose picking and forceful nose blowing.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Enoxaparin may cause bleeding problems. This risk is higher if you have a catheter in your back for pain medicine or anesthesia (sometimes called an “epidural”), or if you have kidney problems. The risk of bleeding increases if your kidney problems get worse. Check with your doctor right away if you have any unusual bleeding or bruising; black, tarry stools; bleeding gums; blood in the urine or stools; tingling, numbness, or weakness of the lower legs; or pinpoint red spots on your skin.

This medicine may increase your chance of bleeding or bruising. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Make sure your doctor knows if you have received enoxaparin or heparin before and had a reaction called thrombocytopenia (low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.

Tell your doctor if you have recently given birth, fallen or suffered a blow to the body or head, or had medical or dental surgery. These events may increase the risk of serious bleeding while you are taking enoxaparin.

Lovenox® multiple-dose vials contain benzyl alcohol as a preservative. Tell your doctor right away if you are pregnant or have had an allergic reaction to benzyl alcohol.

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.

Lovenox 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

Bleeding gums
coughing up blood
difficulty with breathing or swallowing
dizziness
headache
increased menstrual flow or vaginal bleeding
nosebleeds
paralysis
prolonged bleeding from cuts
red or black, tarry stools
red or dark brown urine
shortness of breath

Less common

Bruising
chest discomfort
collection of blood under the skin
confusion
continuing bleeding or oozing from the nose and/or mouth, or surgical wound
convulsions (seizures)
fever
irritability
lightheadedness
lower back pain
pain or burning while urinating
swelling of the hands or feet
tightness in the chest
uncontrolled bleeding at the site of injection
vomiting of blood or material that looks like coffee grounds
wheezing

Rare

Back pain
burning, pricking, tickling, or tingling sensation
chest pain
chills
cough
decreased urine output
dilated neck veins
dizziness or lightheadedness when getting up suddenly from a lying or sitting position
extreme fatigue
fainting
fast or irregular heartbeat
general feeling of discomfort or illness
irregular breathing
leg weakness
problems with bowel or bladder function
skin rash or hives
sneezing
sore throat
sudden fainting
swelling of the face, fingers, feet, genitals, mouth, or tongue
thickening of the bronchial secretions
troubled breathing
weight gain

Incidence not known

Abdominal or stomach pain
deep, dark purple bruise
hives or welts
irregular heartbeat
itching, pain, redness, or swelling
large, flat, blue, or purplish patches in the skin
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the skin
skin rash
unusual tiredness or weakness
weakness or heaviness of the legs

Less common

Diarrhea
irritation, pain, or redness at the place of injection

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.

Advanced,L

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lovastatin and niacin

30/06/10

Generic Name: lovastatin and niacin (LOE va sta tin and NYE a sin)
Brand Names: Advicor

What is lovastatin and niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Lovastatin is in a group of drugs called HMG CoA reductase inhibitors, or “statins.” Lovastatin reduces levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL).

The combination of lovastatin and niacin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Lovastatin and niacin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about lovastatin and niacin?

You should not take this medication if you are allergic to niacin (Niaspan, Niacor, and others) or lovastatin (Altoprev, Mevacor), if you are pregnant or breast-feeding, or if you have liver disease, severe bleeding, or a stomach ulcer. Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking lovastatin and niacin, tell your doctor if you have ever had liver or kidney disease, heart disease, diabetes, gout, or a thyroid disorder, if you have recently had a heart attack, or if you drink more than 2 alcoholic beverages daily.

In rare cases, lovastatin and niacin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

There are many other drugs that can increase your risk of serious medical problems if you take them together with lovastatin and niacin. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I discuss with my healthcare provider before taking lovastatin and niacin?

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

history of liver disease;
history of kidney disease;
diabetes;
gout;
a thyroid disorder;
heart disease, or if you have recently had a heart attack;
if you drink more than 2 alcoholic beverages daily; or
if you are switched to this medication from regular niacin, nicotinic acid, or nicotinamide (or vitamin supplements that contain niacin).

In rare cases, lovastatin and niacin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

danazol (Danocrine);
nefazodone (an antidepressant);
gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);
antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);
HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;
other medicines that contain niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others); or
drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take lovastatin and niacin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking lovastatin and niacin. Lovastatin and niacin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking lovastatin and niacin.

How should I take lovastatin and niacin?

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

Lovastatin and niacin is usually taken at bedtime with a low-fat snack. Follow your doctor’s instructions. Do not take lovastatin and niacin on an empty stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Niacin can cause dizziness, sweating, chills, redness or tingly feeling, fast or pounding heartbeats, shortness of breath, or feeling like you might pass out. These side effects can be made worse if you drink alcohol or hot beverages shortly after you take lovastatin and niacin. These effects should disappear over time as you keep taking the medicine.

Your doctor may recommend you take aspirin 30 minutes before you take lovastatin and niacin to prevent certain side effects. Do not take aspirin without your doctor’s advice about how much aspirin to take.

You may need to stop using lovastatin and niacin for a short time if you have surgery or a medical emergency. If you stop taking the medicine for longer than 7 days in a row, talk with your doctor before restarting the medication. You may need a lower dose.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Niacin can raise your blood sugar, and may cause unusual results with certain medical tests. Tell any doctor who treats you that you are using lovastatin and niacin.

Lovastatin and niacin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take lovastatin and niacin on a long-term basis for the treatment of high cholesterol. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe dizziness, severe redness or tingling, vomiting, or fainting.

What should I avoid while taking lovastatin and niacin?

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 4 to 6 hours before or after you take lovastatin and niacin.

Avoid eating foods that are high in fat or cholesterol. Lovastatin and niacin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with lovastatin and niacin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Lovastatin and niacin side effects

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

unexplained muscle pain, tenderness, or weakness;
fever, unusual tiredness, and dark colored urine;
chest pain, extreme dizziness, feeling like you might pass out;
swelling, weight gain, urinating less than usual or not at all; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

headache, mild dizziness;
diarrhea, mild nausea, stomach pain or indigestion;
mild skin rash;
back pain;
flushing (warmth, redness, or tingly feeling); or
cold symptoms such as stuffy nose, sneezing, sore throat.

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

Lovastatin and niacin Dosing Information

Usual Adult Dose for Hyperlipoproteinemia:

Initial: 20 mg-500 mg orally once a day.

Maintenance: 20 mg-500 mg to 40 mg-1000 mg orally once a day.

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL):

Initial: 20 mg-500 mg orally once a day.

Maintenance: 20 mg-500 mg to 40 mg-1000 mg orally once a day.

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL):

Initial: 20 mg-500 mg orally once a day.

Maintenance: 20 mg-500 mg to 40 mg-1000 mg orally once a day.

What other drugs will affect lovastatin and niacin?

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

cimetidine (Tagamet);
a blood thinner such as warfarin (Coumadin);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
nitroglycerin (Nitro-Dur, Nitrolingual, Nitrostat, Transderm-Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), or isosorbide mononitrate (Imdur, ISMO, Monoket); or
any other “statin” medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin).

This list is not complete and other drugs may interact with lovastatin and niacin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about lovastatin and niacin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,L

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lovastatin and niacin (Oral route)

30/06/10

NYE-a-sin, loe-va-STAT-in

Commonly used brand name(s):

In the U.S.

Advicor

Available Dosage Forms:

Tablet
Tablet, Extended Release

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Vitamin B

Chemical Class: Nicotinic Acid (class)

Uses For lovastatin and niacin

Niacin extended-release and Lovastatin combination medicine is used to help lower high cholesterol and fat levels in the blood. This may help prevent medical problems caused by cholesterol and fat clogging the blood vessels.

Niacin extended-release and lovastatin combination medicine combines two drugs that work together to treat cholesterol and lipid (fat) disorders. Niacin is a B-complex vitamin that reduces the amount of cholesterol in the blood. Lovastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood

lovastatin and niacin is available only with your doctor’s prescription.

Before Using lovastatin and niacin

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 lovastatin and niacin, the following should be considered:

This combination medicine should not be used until after your body has adjusted to each of the individual medicines. Be sure to check with your doctor about this.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lovastatin and niacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on lovastatin and niacin have been done only in adult patients, and there is no specific information comparing use of niacin extended-release and lovastatin combination in children with use in other age groups.

Geriatric

lovastatin and niacin has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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

Interactions with Medicines

Using lovastatin and niacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Atazanavir
Darunavir
Fosamprenavir
Itraconazole
Lopinavir
Mibefradil
Ritonavir
Saquinavir
Tipranavir

Using lovastatin and niacin 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.

Amiodarone
Amprenavir
Atorvastatin
Bezafibrate
Cerivastatin
Ciprofibrate
Clarithromycin
Clofibrate
Colchicine
Cyclosporine
Dalfopristin
Danazol
Delavirdine
Erythromycin
Ezetimibe
Fenofibrate
Fluconazole
Gemfibrozil
Indinavir
Ketoconazole
Lovastatin
Nefazodone
Nelfinavir
Niacin
Pitavastatin
Quinupristin
Rosuvastatin
Simvastatin
Telithromycin
Verapamil

Using lovastatin and niacin 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.

Azithromycin
Bosentan
Diltiazem
Oat Bran
Pectin
St John’s Wort
Voriconazole

Interactions with Food/Tobacco/Alcohol

Using lovastatin and niacin 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 lovastatin and niacin, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice

Proper Use of lovastatin and niacin

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, particularly saturated fat, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor’s orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Use lovastatin and niacin only as directed by your doctor. Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered. Also, lovastatin and niacin works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Remember that lovastatin and niacin will not cure your condition but it does help control it. Therefore, you must continue to take it as directed to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you.This is an important part of controlling your condition, and is necessary if the medicine is to work properly.

Do not drink any grapefruit juice around the time you take lovastatin and niacin. It may be best to drink any grapefruit juice approximately 12 hours before or after you take your medicine. In addition, do not drink grapefruit juice in large quantities (more than one quart per day) while you are being treated with niacin extended-release and lovastatin combination. To do so may increase the risk of developing muscle problems. Check with your doctor if you have any questions.

Take lovastatin and niacin at bedtime after eating a low fat snack. Swallow the tablet whole. Do not crush, break, or chew the tablet before you swallow it.

lovastatin and niacin may cause you to have skin flushing which makes your face, neck, arms and occasionally, your upper chest to feel warm and look red. Flushing usually starts about two to four hours after you take your medicine, and may last up to several hours. Flushing can also cause itching and/or a tingling sensation. A more intense episode of flushing may include dizziness or faintness. If you take your medicine at bedtime, you may sleep through any flushing that occurs. If awakened by flushing, rise slowly to minimize the potential for dizziness or fainting. Avoiding alcohol or hot drinks may reduce the flushing. This effect should lessen after several weeks as your body gets used to the medicine. However, if the problem continues or gets worse, check with your doctor.

Dosing

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

For oral dosage form (tablets):
- - Adults—The starting dose is usually, 500 milligrams (mg) of niacin extended-release and 20 mg of lovastatin (combined in one tablet) one time a day, at bedtime with a low fat snack. Then your doctor may increase your dose a little at a time every 4 weeks, as your body gets used to the medicine, until your cholesterol is controlled.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lovastatin and niacin, 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.

If you have not taken lovastatin and niacin for more than 7 days, check with your doctor. You may need to have your dose reduced before you can start taking lovastatin and niacin again.

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 lovastatin and niacin

Check with your doctor immediately if you have dark-colored urine, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak.Niacin extended-release and lovastatin combination may cause a serious, but rare, problem called rhabdomyolysis. It is important to call your doctor right away if you have any of these symptoms.

It is very important that your doctor check your progress at regular visits.This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and that it does not cause unwanted side effects. At regular intervals, your doctor will want to do routine blood tests.

For diabetic patients: lovastatin and niacin may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not stop taking niacin extended-release and lovastatin combination without first checking with your doctor. When you stop taking lovastatin and niacin, your blood cholesterol levels may increase again.

Check with your doctor immediately if you think that you may be pregnant. Niacin extended-release and lovastatin combination may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking lovastatin and niacin.

lovastatin and niacin 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

Asthenia, such as, lack or loss of strength
infection, such as, cough or hoarseness, fever or chills, lower back or side pain, painful or difficult urination
pain

Less common

Abdominal pain, such as, stomach pain
hyperglycemia, such as, abdominal pain, blurred vision, dry mouth, fatigue, dry skin, fruit-like breath odor, increased hunger, increased thirst, increased urination, nausea, unexplained weight loss, vomiting
myalgia, such as, difficulty in moving, joint pain, muscle aching, cramping pain or stiffness, swollen joints
myopathy, such as, muscle aches, weakness, tenderness, or pain
stomach pain

Rare

Rhabdomyolysis, such as, dark-colored urine, fever, muscle cramps, pain, spasm, or stiffness, unusual tiredness or weakness

Symptoms of Overdose

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

Cardiac arrhythmia, such as, chest pain or discomfort, dizziness, fainting, fast, slow or irregular heartbeat, lightheadedness, pounding or rapid pulse
diarrhea
dizziness
flushing, severe, such as, feeling of warmth, redness, itching, and/or tingling of the face, neck, arms, and occasionally, upper chest, dizziness, fainting
hypotension, such as, blurred vision, confusion, dizziness, faintness, lightheadedness when getting up from a lying or sitting position, sudden sweating, unusual tiredness or weakness
nausea and vomiting
syncope, such as, fainting

More Common

Chills
diarrhea
flu syndrome, such as, chills, diarrhea, fever, general feeling of discomfort or illness, headache, joint pain, loss of appetite, muscle aches and pains, nausea, runny nose, shivering, sore throat, sweating, trouble sleeping, unusual tiredness or weakness, vomiting
flushing, such as, feeling of warmth, redness, itching, and/or tingling of the face, neck, arms, and occasionally, upper chest
edema, such as, swelling
headache
nausea
pruritus, such as, itching skin
rash
shortness of breath
sweating
syncope, such as, feeling faint or fainting
tachycardia, such as, fast, pounding, or irregular heartbeat or pulse

Less common

dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort, upset or pain

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.

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