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Lipitor

Generic Name: atorvastatin (Oral route)

a-tor-va-STAT-in

Commonly used brand name(s)

In the U.S.

Lipitor

Available Dosage Forms:

Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

Uses For Lipitor

Atorvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems (e.g., chest pain, heart attack, or stroke) caused by such substances clogging the blood vessels. This medicine may also be used to prevent certain types of heart problems in adults with risk factors for heart problems .

Atorvastatin 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.

Atorvastatin is available only with your doctor's prescription.

Importance of Diet

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, 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.

Also, Lipitor is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

Before Using This Medicine

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:

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects.

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

This medicine is safe to use in boys and some girls 10 to 17 years of age for treating certain types of high cholesterol.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different problems in older people than it does in younger adults. However, blood levels of atorvastatin tend to be higher in older people than they do 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

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

Interactions with Medicines

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

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

Telaprevir

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.

Atazanavir

Bezafibrate

Ciprofibrate

Clarithromycin

Clofibrate

Conivaptan

Dalfopristin

Danazol

Daptomycin

Diltiazem

Erythromycin

Fenofibrate

Fluconazole

Fusidic Acid

Gemfibrozil

Itraconazole

Ketoconazole

Mibefradil

Nefazodone

Niacin

Posaconazole

Quinupristin

Telithromycin

Tipranavir

Troleandomycin

Verapamil

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.

Amprenavir

Azithromycin

Bexarotene

Black Cohosh

Bosentan

Colchicine

Cyclosporine

Darunavir

Digoxin

Efavirenz

Eltrombopag

Etravirine

Fosamprenavir

Fosphenytoin

Indinavir

Lopinavir

Nelfinavir

Oat Bran

Pectin

Phenytoin

Pioglitazone

Quinine

Rifampin

Saquinavir

St John's Wort

Voriconazole

Interactions with Food/Tobacco/Alcohol

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

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

Grapefruit Juice

Proper Use of Lipitor

Use this medicine 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, this medicine 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 this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

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

Atorvastatin should not be taken with large amounts of grapefruit juice or other grapefruit products because these may increase the concentrations of atorvastatin in the body.

This medicine may be taken with or without food .

Dosing

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

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

For high cholesterol:
- For oral dosage form (tablets):
  - Adults—At first, 10 or 20 milligrams (mg) once daily. Your doctor may increase your dose up to a maximum of 80 mg per day if needed.
  - Children (10 to 17 years of age)—At first, 10 milligrams (mg) once daily. Your doctor may increase your dose up to a maximum of 20 mg per day if needed.
  - Children (less than 10 years of age)—Use and dose must be determined by your doctor .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Lipitor

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 levels and to decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. HMG-CoA reductase inhibitors 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 this medicine.

Do not take over-the-counter (OTC) niacin preparations without consulting your doctor. Niacin may increase atorvastatin's adverse effects on muscle, which can lead to serious kidney problems.

Do not use excessive amounts of alcohol while taking atorvastatin because it can worsen the adverse effects of this medicine on the liver.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine's adverse effects on muscle can lead to serious kidney problems.

Lipitor Side Effects

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

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

Less common or rare

Cough

difficulty swallowing

dizziness

fast heartbeat

hives

itching

muscle cramps, pain, stiffness, swelling, or weakness, especially if accompanied by unusual tiredness or fever

persistent elevation of liver function tests

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

shortness of breath

skin rash

tightness in chest

unusual tiredness or weakness

wheezing

Frequency not determined

Blistering, peeling, loosening of skin

chills

dark-colored urine

diarrhea

fever

itching

joint pain

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

red skin lesions, often with a purple center sore

red, irritated eyes

redness, tenderness, itching, burning, or peeling of skin

sore throat

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

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

Headache

hoarseness

lower back or side pain

pain or tenderness around eyes and cheekbones

painful or difficult urination

stuffy or runny nose

Less common

Abdominal pain

accidental injury

back pain

belching or excessive gas

constipation

general feeling of discomfort or illness

heartburn, indigestion, or stomach discomfort

lack or loss of strength

loss of appetite

nausea

shivering

sweating

trouble sleeping

vomiting

Frequency not determined

Appetite increased

black, tarry stools

blindness

bloody nose

bloody or cloudy urine

bluish color changes in skin

blurred vision

bruising, large, flat, blue patches on the skin

chapped, red, or swollen lips

continuing ringing or buzzing or other unexplained noise in ears

depersonalization

difficult, burning, or painful urination

difficulty seeing at night

dysphoria

euphoria

excessive muscle tone or tension

frequent urge to urinate or defecate

fruit-like breath odor

groin or scrotum pain

inability to have or keep an erection

increased body movements

increased sensitivity of eyes to light

increased sensitivity to touch or pain

increased thirst

increased urination

loss of bladder control

loss of sexual ability, drive, or desire

lumps in breasts

mental depression

nervousness

nightmares

normal menstrual bleeding occurring earlier or lasting longer

pale skin

paranoia

pinpoint red spots on skin

slurred speech

swollen or tender lymph glands in neck, armpit, or groin

transient, mild, pleasant aromatic odor

unable to move or feel face

unusual bleeding or bruising

weight loss

yellow skin or eyes

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

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

See also: Lipitor side effects (in more detail)

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

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More Lipitor resources

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

Lipitor Prescribing Information (FDA)

Lipitor Consumer Overview

Lipitor Monograph (AHFS DI)

Lipitor MedFacts Consumer Leaflet (Wolters Kluwer)

Atorvastatin Prescribing Information (FDA)

Compare Lipitor with other medications

High Cholesterol
High Cholesterol, Familial Heterozygous
High Cholesterol, Familial Homozygous
Hyperlipoproteinemia
Hyperlipoproteinemia Type IIa, Elevated LDL
Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL
Hyperlipoproteinemia Type IV, Elevated VLDL
Prevention of Cardiovascular Disease

Lanoxin Elixir

Pronunciation: di-JOX-in
Generic Name: Digoxin
Brand Name: Lanoxin

Lanoxin Elixir is used for:

Treating heart failure or slowing the heart rate in patients with chronic atrial fibrillation, a type of abnormal heart rhythm. It may also be used for other conditions as determined by your doctor.

Lanoxin Elixir is a digitalis glycoside. It works by increasing the force of contraction of the heart and slowing heart rate.

Do NOT use Lanoxin Elixir if:

you are allergic to any ingredient in Lanoxin Elixir

you are taking sucralfate

you have certain types of heart rhythm problems, such as ventricular fibrillation

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

Before using Lanoxin Elixir:

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

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

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

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

if you have severe heart failure or other heart problems (eg, inflammation, heart block, cor pulmonale, cardiomyopathy, amyloid heart disease ), extra heart beats (premature ventricular contractions [PVCs]), other types of abnormal heart rhythm, heart problems due to low thiamine (eg, beriberi heart disease), Wolff-Parkinson-White syndrome, heart blood vessel problems, or fainting due to a heart problem

if you have severe kidney, liver, or lung problems, or thyroid problems

if you have low blood levels of calcium, magnesium, or potassium, or high blood levels of potassium or calcium

if you have had a recent heart attack

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

Alprazolam, amiodarone, amphotericin B, anticholinergics (eg, propantheline), beta-blockers (eg, propranolol, carvedilol), bupivacaine, calcium, cyclosporine, diltiazem, diphenoxylate, diuretics (eg, furosemide, hydrochlorothiazide), indomethacin, itraconazole, macrolides (eg, erythromycin), propafenone, quinidine, quinine, spironolactone, stimulants (eg, amphetamine), succinylcholine, sympathomimetics (eg, albuterol, pseudoephedrine), tetracyclines (eg, doxycycline), thioamines (eg, methimazole), or verapamil because they may increase the risk of Lanoxin Elixir's side effects, especially on the heart

Acarbose, certain anticancer medicines, cholestyramine, colestipol, kaolin-pectin, metoclopramide, penicillamine, rifampin, sulfasalazine, or thyroid hormones (eg, levothyroxine) because they may decrease Lanoxin Elixir's effectiveness

Oral aminoglycosides (eg, neomycin) because the actions and side effects of Lanoxin Elixir may be increased or decreased

Spironolactone because it may interfere with certain lab tests for digoxin blood levels and give incorrect readings

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lanoxin Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lanoxin Elixir:

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

Take Lanoxin Elixir by mouth. Do not take it within 1 hour of food high in fiber.

Do not take antacids containing aluminum or magnesium, cholestyramine, or colestipol within 2 to 4 hours of taking Lanoxin Elixir.

Use the dropper that comes with Lanoxin Elixir to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

If you miss a dose of Lanoxin Elixir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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

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

Lanoxin Elixir may interfere with certain lab tests, including an electrocardiogram (ECG). Be sure your doctor and lab personnel know you are using Lanoxin Elixir.

Lab tests, including ECG, electrolytes, kidney function, and blood digoxin levels, may be performed while you use Lanoxin Elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

Use Lanoxin Elixir with extreme caution in NEWBORN INFANTS, especially those who are premature or immature; they may be more sensitive to its effects.

Poisoning may occur in children who accidently swallow Lanoxin Elixir or receive too much medicine. In case of an overdose, call a doctor or poison control center right away.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lanoxin Elixir while you are pregnant. Lanoxin Elixir is found in breast milk. If you are or will be breast-feeding while you are taking Lanoxin Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lanoxin Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, yellow vision, or other vision changes; confusion; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); severe or persistent nausea, vomiting, or stomach pain; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lanoxin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include very fast, very slow, or irregular heartbeat.

Proper storage of Lanoxin Elixir:

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

General information:

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

Lanoxin Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lanoxin Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Lanoxin resources

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

Compare Lanoxin with other medications

Atrial Fibrillation
Heart Failure

Lioresal Double Strength

Generic Name: baclofen (Oral route)

BAK-loe-fen

Commonly used brand name(s)

In Canada

Lioresal

Lioresal Double Strength

Available Dosage Forms:

Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Chemical Class: Gamma Aminobutyric Acid (class)

Uses For Lioresal Double Strength

Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects. Baclofen may also be used to relieve other conditions as determined by your doctor.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, baclofen is used in certain patients with trigeminal neuralgia (severe burning or stabbing pain along the nerves in the face); also called ''tic douloureux.''

Before Using Lioresal Double Strength

Allergies

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of baclofen in children with use in other age groups.

Geriatric

Side effects such as hallucinations, confusion or mental depression, other mood or mental changes, and severe drowsiness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of baclofen.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of baclofen

This section provides information on the proper use of a number of products that contain baclofen. It may not be specific to Lioresal Double Strength. Please read with care.

Dosing

For oral dosage form (tablets):
- For muscle relaxation:
  - Adults and teenagers—At first, the dose is 5 milligrams (mg) three times a day. Then, each dose may be increased by 5 mg every three days until the desired response is reached. No more than 80 mg should be taken within a twenty-four-hour period.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Precautions While Using Lioresal Double Strength

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using baclofen.

This medicine may cause drowsiness, dizziness, vision problems, or clumsiness or unsteadiness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

For diabetic patients:

This medicine may cause your blood sugar levels to rise. If you notice a change in the results of your blood or urine sugar test or if you have any questions about this, check with your doctor.

Lioresal Double Strength 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 as soon as possible if any of the following side effects occur:

Less common or rare

Bloody or dark urine

chest pain

fainting

hallucinations (seeing or hearing things that are not there)

mental depression or other mood changes

ringing or buzzing in the ears

skin rash or itching

Symptoms of overdose

Blurred or double vision

convulsions (seizures)

muscle weakness (severe)

shortness of breath or unusually slow or troubled breathing

vomiting

More common

Confusion

dizziness or lightheadedness

drowsiness

nausea

unusual weakness, especially muscle weakness

Less common or rare

Abdominal or stomach pain or discomfort

clumsiness, unsteadiness, trembling, or other problems with muscle control

constipation

diarrhea

difficult or painful urination or decrease in amount of urine

false sense of well-being

frequent urge to urinate or uncontrolled urination

headache

loss of appetite

low blood pressure

muscle or joint pain

numbness or tingling in hands or feet

pounding heartbeat

sexual problems in males

slurred speech or other speech problems

stuffy nose

swelling of ankles

trouble in sleeping

unexplained muscle stiffness

unusual excitement

unusual tiredness

weight gain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Convulsions (seizures)

hallucinations (seeing or hearing things that are not there)

increase in muscle spasm, cramping, or tightness

mood or mental changes

unusual nervousness or restlessness

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

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

See also: Lioresal Double Strength side effects (in more detail)

More Lioresal Double Strength resources

Lioresal Double Strength Side Effects (in more detail)
Lioresal Double Strength Dosage
Lioresal Double Strength Use in Pregnancy & Breastfeeding
Drug Images
Lioresal Double Strength Drug Interactions
Lioresal Double Strength Support Group
5 Reviews for Lioresal Double Strength - Add your own review/rating

Compare Lioresal Double Strength with other medications

Alcohol Withdrawal
Cerebral Spasticity
Cervical Dystonia
Dystonia
Hiccups
Huntington's Disease
Migraine Prevention
Muscle Spasm
Muscle Twitching
Neuralgia
Periodic Limb Movement Disorder
Spasticity
Trigeminal Neuralgia

Lioresal

baclofen

Dosage Form: Tablets

C98-22 (Rev. 4/98)

667794

Lioresal®

baclofen USP

Tablets

10 mg

20 mg

Muscle Relaxant, Antispastic

Rx only

Prescribing Information

Lioresal Description

Lioresal, baclofen USP, is a muscle relaxant and antispastic, available as 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.

Inactive Ingredients. Cellulose compounds, magnesium stearate, povidone, and starch.

ACTIONS

The precise mechanism of action of Lioresal is not fully known. Lioresal is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although Lioresal is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, Lioresal has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Lioresal is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Lioresal is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

INDICATIONS

Lioresal is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that Lioresal treatment will aid in restoring residual function.

Lioresal may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Lioresal is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of Lioresal in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

Contraindications

Hypersensitivity to baclofen.

Warnings

a. Abrupt Drug Withdrawal:

Hallucinations and seizures have occurred on abrupt withdrawal of Lioresal. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

b. Impaired Renal Function:

Because Lioresal is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

c. Stroke:

Lioresal has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

d. Pregnancy:

Lioresal has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Lioresal should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of Lioresal may be additive to those of alcohol and other CNS depressants.

Lioresal should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking Lioresal.

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with Lioresal.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with Lioresal for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The most common is transient drowsiness (10%-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving Lioresal compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5%-15%), weakness (5%-15%) and fatigue (2%-4%). Others reported:

Neuropsychiatric:

Confusion (1%-11%), headache (4%-8%), insomnia (2%-7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.

Cardiovascular:

Hypotension (0%-9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal:

Nausea (4%-12%), constipation (2%-6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary:

Urinary frequency (2%-6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other:

Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy.

The following laboratory tests have been found to be abnormal in a few patients receiving Lioresal: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Overdosage

Signs and Symptoms:

Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures.

Treatment:

In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Lioresal Dosage and Administration

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days

10 mg t.i.d. for 3 days

15 mg t.i.d. for 3 days

20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

How is Lioresal Supplied

Tablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side)

Bottles of 100………………………………………………….NDC 0028-0023-01

Unit Dose (blister pack)

Box of 100 (strips of 10)………………………………………NDC 0028-0023-61

Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side)

Bottles of 100………………………………………………….NDC 0028-0033-01

Unit Dose (blister pack)

Box of 100 (strips of 10)………………………………………NDC 0028-0033-61

Do not store above 30ºC (86ºF). Dispense in tight container (USP).

667794 C98 - 22 (Rev. 4/98)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

Lioresal
baclofen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0028-0023
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
baclofen (baclofen)	Active	10 MILLIGRAM In 1 TABLET
Cellulose compounds	Inactive
magnesium stearate	Inactive
povidone	Inactive
starch	Inactive

Product Characteristics
Color	WHITE (white)	Score	2 pieces
Shape	OVAL (Oval)	Size	11mm
Flavor		Imprint Code	Lioresal;10;10
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1		100 TABLET In 1 BLISTER PACK	None
2	0028-0023-01	100 TABLET In 1 BOTTLE	None

Lioresal
baclofen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0028-0033
Route of Administration	ORAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
baclofen (baclofen)	Active	20 MILLIGRAM In 1 TABLET
Cellulose compounds	Inactive
magnesium stearate	Inactive
povidone	Inactive
starch	Inactive

Product Characteristics
Color	WHITE (white)	Score	2 pieces
Shape	OVAL (Capsule shaped)	Size	16mm
Flavor		Imprint Code	Lioresal;20;20
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1		100 TABLET In 1 BLISTER PACK	None
2	0028-0033-01	100 TABLET In 1 BOTTLE	None

Revised: 04/2006Novartis Pharmaceuticals Corporation

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Hiccups
Huntington's Disease
Migraine Prevention
Muscle Spasm
Muscle Twitching
Neuralgia
Periodic Limb Movement Disorder
Spasticity
Trigeminal Neuralgia

Liotrix

Class: Thyroid Agents
ATC Class: H03AA02
VA Class: HS851
CAS Number: 8065-29-0
Brands: Thyrolar

Introduction

Synthetic thyroid agent; combination preparation containing tetraiodothyronine (levothyroxine, T₄) sodium and triiodothyronine (liothyronine, T₃) sodium.^a ^b ^c ^d ^j

Uses for Liotrix

Hypothyroidism

Replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.^a ^b Specific indications include primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism.^a ^b

Not considered drug of choice for replacement therapy because offers no therapeutic advantage over levothyroxine sodium and may result in excessive serum T₃ concentrations.^a Levothyroxine is considered drug of choice for replacement therapy.^c

For treatment of congenital hypothyroidism (cretinism), levothyroxine is considered drug of choice.^a

Pituitary TSH Suppression

Treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s thyroiditis), multinodular goiter, and in the management of thyroid cancer.^a ^b

Diagnosis of Thyroid Disorders

Used diagnostically in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.^a ^b Use with caution in patients in whom there is a strong suspicion of thyroid gland autonomy because exogenous hormone effects will be additive to endogenous source.^b

Thyrotoxicosis

Has been used in combination with antithyroid agents for the treatment of thyrotoxicosis to prevent goitrogenesis and hypothyroidism.^a

Liotrix Dosage and Administration

General

Initially, monitor response to therapy about every 6–8 weeks.^e ^k Once normalization of thyroid function and serum TSH concentrations has been achieved, patients may be evaluated less frequently (i.e., every 6–12 months).^e ^k However, if dosage is changed, measure serum TSH concentrations after 8–12 weeks.^k

Natural and synthetic thyroid agent preparations are not necessarily directly comparable; however, the following equivalencies have been suggested based on clinical response:^j

Equivalencies of Thyroid Preparations Based on Clinical Responsej
Thyroid Agent	Approximate Equivalent Dosage
Levothyroxine sodium	100 mcg or less
Liothyronine sodium	25 mcg
Liotrix (levothyroxine sodium/liothyronine sodium)	50 mcg/12.5 mcg (Thyrolar)
Thyroglobulin	65 mg
Thyroid	60–65 mg (1 grain)

Administration

Oral Administration

Administer orally, usually as a single daily dose before breakfast.^a ^b

Dosage

Available as fixed-combination preparation containing levothyroxine sodium and liothyronine sodium; dosage expressed in terms of the salts of both drugs.^a ^b

Current USP standards define liotrix as containing levothyroxine sodium and liothyronine sodium in a ratio of 4:1 by weight.^a Thus, Thyrolar-1 contains 50 mcg of levothyroxine sodium and 12.5 mcg of liothyronine sodium, which is approximately equivalent to 60 mg of thyroid.^a (See General under Dosage and Administration.)

Adjust dosage carefully according to clinical and laboratory response to treatment.^a ^j Avoid undertreatment or overtreatment.^j (See Therapy Monitoring under Cautions.)

Initiate at a lower dosage level in geriatric patients, in patients with functional or ECG evidence of cardiovascular disease, and in patients with severe, long-standing hypothyroidism or other endocrinopathies.^a ^j

Pediatric Patients

Hypothyroidism

Oral

Initiate therapy at full replacement dosages as soon as possible after diagnosis of congenital hypothyroidism to prevent deleterious effects on intellectual and physical growth and development.^b ^h The following dosages have been recommended:^a

Dosage for Management of Hypothyroidism in Pediatric Patientsab
Age	Daily T₃/T₄ Dosage
0–6 months	3.1/12.5–6.25/25 mcg
6–12 months	6.25/25–9.35/37.5 mcg
1–5 years	9.35/37.5–12.5/50 mcg
6–12 years	12.5/50–18.75/75 mcg
>12 years	>18.75/75 mcg

When transient hypothyroidism is suspected, therapy may be temporarily discontinued when the child is >3 years of age to reassess the condition.^b ^j ^m (See Pediatric Use under Cautions.)

Adults

Hypothyroidism

Oral

Usual initial dosage is one tablet of Thyrolar-1/2 daily.^a ^b Increase by one tablet of Thyrolar-1/4 at intervals of 2–3 weeks.^a ^b

For management of long-standing myxedema, particularly when cardiovascular impairment is suspected, usual initial dosage is one tablet of Thyrolar-1/4 daily.^b

Usual maintenance dosage is one tablet of Thyrolar-1 to one tablet of Thyrolar-2 daily.^a ^b Serum TSH and T₄ concentrations usually return to normal after 2–3 weeks of therapy.^a ^b Failure to respond adequately to one Thyrolar-3 tablet daily suggests presence of malabsorption or patient noncompliance.^a ^b

Pituitary TSH Suppression

Thyroid Cancer

Oral

Administration of dosages higher than those used for replacement therapy usually is required to suppress TSH to low or undetectable concentrations.^b Medullary carcinoma of the thyroid usually unresponsive to this therapy.^b

Special Populations

Patients with Cardiovascular Disease

Hypothyroidism

Initiate therapy at lower dosages than those recommended for patients without cardiovascular disease.^b ^j ^k

Usual initial dosage is one Thyrolar-1/4 tablet or one Thyrolar -1/2 tablet daily.^b If angina appears or if cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.^b ^j

Geriatric Patients

Hypothyroidism

Initiate therapy at lower dosages than those recommended for younger patients.^b ^j ^k

Usual initial dosage is one Thyrolar-1/4 tablet or one Thyrolar -1/2 tablet daily.^b If cardiovascular disease is aggravated, reduce dosage or temporarily withhold therapy and then cautiously restart therapy at a lower dosage.^b ^j

Cautions for Liotrix

Contraindications

Untreated thyrotoxicosis.^b ^j

AMI uncomplicated by hypothyroidism.^j

Uncorrected adrenal insufficiency.^b ^j

Known hypersensitivity to any ingredient in the formulation.^b ^j (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Unlabeled Uses

Should not be used for the treatment of obesity or for weight loss either alone or with other therapeutic agents.^b ^j ^k ^r In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.^b ^j ^r Larger doses may produce serious or life-threatening toxicity, particularly when given in conjunction with sympathomimetic amines (e.g., anorectic agents).^b ^j ^r

Should not be used in the treatment of male or female infertility unless this condition is associated with hypothyroidism.^b ^j ^k ^r

Sensitivity Reactions

Hypersensitivity to thyroid hormone is not known to occur.^b However, hypersensitivity reactions to inactive ingredients of thyroid hormone products have been reported and include urticaria, pruritus, rash, flushing, angioedema, abdominal pain, nausea, vomiting, diarrhea, fever, arthralgia, serum sickness, and wheezing.^j

Major Toxicities

Effects on Bone Mineral Density

Increased markers of bone turnover.^d

General Precautions

Therapy Monitoring

Thyroid agents have a narrow therapeutic index.^j Avoid undertreatment or overtreatment, which may result in adverse effects on growth and development in pediatric patients, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, GI function, and glucose and lipid metabolism.^j

Periodically perform appropriate laboratory tests (e.g., serum TSH, total or free T₄, total T₃) and clinical evaluations to monitor adequacy of therapy.^a ^b ^c ^j

Preexisting Cardiovascular Disease

Use with extreme caution.^b ^j (See Patients with Cardiovascular Disease under Dosage and Administration.) Patients with CHD should be monitored closely during surgical procedures due to increased risk of arrhythmias.^j

Associated Endocrine Disorders

Hypopituitarism, adrenal insufficiency, and other endocrine disorders such as diabetes mellitus and diabetes insipidus are characterized by signs and symptoms which may be diminished in severity or obscured by hypothyroidism.^j Thyroid agents may aggravate the intensity of previously obscured symptoms in patients with endocrine disorders, and appropriate adjustment of therapy for these concomitant disorders may be required.^b ^j

In patients with secondary or tertiary hypothyroidism, consider possibility of additional hypothalamic/pituitary hormone deficiencies and treat if diagnosed.^q

Chronic autoimmune thyroiditis may occur in association with other autoimmune disorders (e.g., adrenal insufficiency, pernicious anemia, type 1 diabetes mellitus.)^e ^f

Patients with concomitant adrenal insufficiency should be treated with replacement corticosteroids prior to initiation of thyroid agents.^j Failure to do so may precipitate an acute adrenal crisis due to increased metabolic clearance of corticosteroids when the thyroid agent is initiated.^j

Patients with diabetes mellitus may require increased dosages of antidiabetic agents when treated with thyroid agents.^b ^j

Specific Populations

Pregnancy

Category A.^b

During pregnancy, serum free T₄ levels may decrease and serum TSH levels increase to values outside the normal range.^d ^q Elevations in serum TSH may occur at 4 weeks’ gestation;^q monitor TSH levels during each trimester (or every 6 weeks) and adjust liotrix dosage accordingly.^d ^e ^k Reduce dosage to pre-pregnancy level immediately after delivery, since postpartum TSH concentrations are similar to preconception levels; measure serum TSH concentrations 6–8 weeks postpartum.^q

Lactation

Although thyroid hormones are distributed minimally into human milk, exercise caution when administering to a nursing woman.^b However, adequate replacement dosages generally are needed to maintain normal lactation.^o ^q

Pediatric Use

The goal of treatment in pediatric patients with hypothyroidism is to achieve and maintain normal intellectual and physical growth and development.^b ^j Initiate therapy immediately upon diagnosis.^b ^j Maintain therapy for life, unless transient hypothyroidism is suspected.^b ^j

Neonates with suspected hypothyroidism should receive thyroid agent therapy pending results of confirmative tests.^j If a positive diagnosis cannot be made on the basis of laboratory findings but there is a strong clinical suspicion of congenital hypothyroidism, initiate replacement therapy to achieve euthyroidism until the child is 1–2 years of age.^j During the first 2 weeks of therapy, closely monitor infants for cardiac overload, arrhythmias, and aspiration resulting from avid suckling.^j Evaluate infant’s clinical response to therapy about 6 weeks after initiation of thyroid agent therapy and at least at 6 and 12 months of age and yearly thereafter.^j

When transient hypothyroidism is suspected, temporarily discontinue therapy for 2–8 weeks to reassess the condition when the child is >3 years of age.^b ^j ^m If the diagnosis of permanent hypothyroidism is confirmed, reinstitute full replacement therapy.^j However, if serum concentrations of free T₄ and TSH are normal, discontinue thyroid agent therapy and monitor carefully;^b ^j repeat thyroid function tests if manifestations of hypothyroidism develop.^j

In pediatric patients with transient severe hypothyroidism, reduce replacement dose by half for 30 days to reassess condition.^m If, after 30 days, serum TSH >20 mU/L, consider the hypothyroidism permanent and reinstitute full replacement therapy.^m However, if serum TSH has not increased, temporarily discontinue thyroid agent therapy for another 30 days, then repeat serum free T₄ and TSH measurements.^m Reinstitute or discontinue replacement therapy based on laboratory findings.^m

Monitor patients closely to avoid undertreatment or overtreatment.^j Undertreatment may result in poor school performance (due to impaired concentration and slowed mentation) and reduced adult height.^j Overtreatment may result in craniosynostosis in infants and accelerate aging of bones, resulting in premature epiphyseal closure and compromised adult stature.^j ^m

Treated children may manifest a period of catch-up growth, which may be adequate in some cases to achieve normal adult height.^j In children with severe or long-standing hypothyroidism, catch-up growth may not be adequate to achieve normal adult height.^j

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving thyroid agents.^j

Geriatric Use

Because of the increased risk of cardiovascular disease among geriatric patients, liotrix therapy should not be initiated at the full replacement dose.^b ^j ^k (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Adverse reactions result from overdosage and resemble manifestations of hyperthyroidism,^a ^b ^j including fatigue,^b ^j weight loss,^j increased appetite,^j heat intolerance,^j fever,^j excessive sweating,^b ^j headache,^b ^j hyperactivity,^j nervousness,^j anxiety,^b ^j irritability,^j emotional lability,^j insomnia,^b ^j tremor,^b ^j muscle weakness,^j palpitations,^b ^j tachycardia,^j arrhythmias,^b ^j increased heart rate and BP,^b ^j heart failure,^j angina,^j AMI,^j cardiac arrest,^j diarrhea,^j vomiting,^j abdominal cramps,^j elevations in liver function test results,^j hair loss,^b ^j flushing,^j decreased bone mineral density,^j menstrual irregularities,^j and impaired fertility.^j

Interactions for Liotrix

Drugs Affecting Hepatic Microsomal Enzymes

Potential increased metabolism of thyroid agent with drugs that induce hepatic microsomal enzymes resulting in increased thyroid agent dosage requirements.^j

Drugs That May Decrease T₄ 5’-Deiodinase Activity

Inhibitors of T₄ 5’ mono-deiodinase decrease peripheral conversion of T₄ to T₃, resulting in decreased T₃ concentrations.^j ^p However, serum T₄ concentrations usually remain within normal range but may occasionally be slightly increased.^j ^q

Specific Drugs and Foods

Drug	Interaction	Comments
Amiodarone	Decreased metabolism of T₄ to T₃^d ^j
Anticoagulants, oral (e.g., coumarins)	Potentiation of anticoagulant activity^b ^j	Carefully monitor PT and adjust anticoagulant dosage accordingly when thyroid agent therapy is initiated^b ^j
Antidepressants (tricyclics, tetracyclics, SSRIs)	Increased risk of cardiac arrhythmias and CNS stimulation when levothyroxine is used with tricyclics or tetracyclics^j Faster onset of action of tricyclics following concomitant use with levothyroxine^j Sertraline may increase levothyroxine requirements^j
Antidiabetic agents (biguanides, meglitinides, sulfonylureas, thiazolidinediones, insulin)	Thyroid agent may cause increased antidiabetic agent or insulin requirements^b ^d ^j	Carefully monitor diabetic control, especially when thyroid therapy is initiated, changed, or discontinued^b ^d ^j
β-Adrenergic blocking agents (e.g., propranolol hydrochloride dosages >160 mg daily)	Decreased metabolism of T₄ to T₃^j Impaired antihypertensive effects when hypothyroid patient is converted to euthyroid state^j
Bile acid sequestrants (e.g., cholestyramine, colestipol)	Impaired thyroid agent absorption^b ^d ^j	Administer liotrix ≥4 hours apart from these agents^b ^j
Carbamazepine	Potential increased metabolism of thyroid agent^d ^j Reduced levothyroxine serum protein binding^j	May require thyroid agent dosage increase^j ^q
Cardiac glycosides	Decreased serum digitalis glycoside concentrations in patients with hyperthyroidism or in patients with hypothyroidism in whom a euthyroid state has been achieved; potential for reduced therapeutic effects of digitalis glycosides with thyroid agent use^j	May need to increase dosage of digitalis glycoside when hypothyroidism has been corrected^d ^q
Corticosteroids (e.g., dexamethasone at dosages ≥4 mg daily)	Decreased metabolism of T₄ to T₃^j Short-term administration of large doses of corticosteroids may decrease serum T₃ concentrations by 30% with minimal change in serum T₄ concentrations^j
Estrogen or estrogen-containing oral contraceptives	Possible decreased free T₄ concentrations^b ^d ^j	Patients without a functioning thyroid gland may require liotrix dosage increase^b ^j
Ferrous sulfate	Delayed or impaired thyroid absorption^d ^j	Administer liotrix ≥4 hours apart from this agent^d ^j
Food with large amounts of fiber (e.g., cotton seed meal, infant soybean formula, soybean flour, walnuts)	Decreased levothyroxine absorption^b ^q
Furosemide (at IV dosages >80 mg)	Concomitant use with levothyroxine produces transient increases in serum free T₄ concentrations; continued administration results in a decrease in serum T₄ and normal free T₄ and TSH concentrations, and therefore, patients are clinically euthyroid^j
GI drugs (e.g., antacids [aluminum hydroxide, magnesium hydroxide, calcium carbonate], simethicone, sucralfate)	Delayed or impaired thyroid agent absorption^d ^j	Administer liotrix ≥4 hours apart from these agents^d
Growth hormones (e.g., somatropin)	Excessive use of thyroid agents with growth hormones may accelerate epiphyseal closure; however, untreated hypothyroidism may interfere with growth response to growth hormone^j
Heparin	Concomitant use with levothyroxine produces transient increases in serum free T₄ concentrations; continued administration results in a decrease in serum T₄ and normal free T₄ and TSH concentrations, and therefore, patients are clinically euthyroid^j
Hydantoins (e.g., phenytoin)	Potential increased metabolism of thyroid agent^d ^j Reduced levothyroxine serum protein binding^d ^j Concomitant use with levothyroxine produces transient increases in serum free T₄ concentrations; continued administration results in a decrease in serum T₄ and normal free T₄ and TSH concentrations, and therefore, patients are clinically euthyroid^j	May require thyroid agent dosage increase^j
Ketamine	Risk of marked hypertension and tachycardia^j	Use with caution^j
NSAIAs (e.g., fenamates, phenylbutazone)	Concomitant use with levothyroxine produces transient increases in serum free T₄ concentrations; continued administration results in a decrease in serum T₄ and normal free T₄and TSH concentrations, and therefore, patients are clinically euthyroid^j
Phenobarbital	Potential increased metabolism of thyroid agent^d ^j	May require thyroid agent dosage increase^j
Radiographic agents (iodine-containing)	Reduced uptake of ¹²³I, ¹³¹I, and ^99mTc^j
Rifampin	Potential increased metabolism of thyroid agent^j	May require thyroid agent dosage increase^j
Salicylates (dosages >2 g daily)	Concomitant use with levothyroxine produces transient increases in serum free T₄ concentrations; continued administration results in a decrease in serum T₄ and normal free T₄and TSH concentrations, and therefore, patients are clinically euthyroid^j
Sodium polystyrene sulfonate	Delayed or impaired thyroid absorption^d ^j	Administer liotrix ≥4 hours apart from this agent^j
Sympathomimetic agents	Potentiation of sympathomimetic effects; increased risk of coronary insufficiency in patients with CAD^j	Observe patient carefully when sympathomimetic agent is administered^j
Xanthine derivatives (e.g., theophylline)	Clearance of xanthine derivatives may be decreased in hypothyroid patients but returns to normal when the euthyroid state is achieved^d ^j

Drugs Affecting Thyroid Function or Thyroid Function Tests

Various drugs or concomitant medical conditions (e.g., pregnancy, infectious hepatitis) may adversely affect thyroid function (e.g., alter endogenous thyroid hormone secretion, reduce TSH secretion) resulting in hypothyroidism or hyperthyroidism or interfere with laboratory tests used to assess thyroid function.^b ^j Consult specialized references for information.

Some drugs may affect transport of thyroid hormones (T₃, T₄) by affecting serum thyroxine-binding globulin (TBG) concentrations.^j ^q However, free T₄ concentrations may remain normal and the patient may remain euthyroid.^j ^q Monitor therapy and adjust liotrix dosage as necessary.^j

Drugs Affecting Thyroxine Binding Globulin Concentrations^b ^j

Drugs That May Increase Serum TBG Concentration

Estrogens, oral (including estrogen-containing oral contraceptives)^b ^j

Fluorouracil^j

Methadone^j

Mitotane^j

Tamoxifen^j

Drugs That May Decrease Serum TBG Concentration

Androgens^b ^j

Asparaginase^j

Corticosteroids^b ^j

Niacin (extended-release)^j

Liotrix Pharmacokinetics

Absorption

Bioavailability

Levothyroxine (T₄): Variably absorbed from the GI tract (range: 40–80%).^b ^j Extent of absorption is increased in the fasting state and decreased in malabsorption states.^b ^j

Liothyronine (T₃): Almost completely absorbed from the GI tract (about 95%).^b ^h ^j

Onset

Liothyronine has a more rapid onset of action than levothyroxine (24–72 hours versus 1–3 weeks).^h ⁱ ^j

Distribution

Extent

T₄ is distributed throughout most body tissues and fluids; highest concentrations found in liver and kidneys.^j

Thyroid hormones do not readily cross the placenta;^b ^j ^q however, some transfer does occur, as evidenced by levels in cord blood of athyrotic fetuses being approximately one-third maternal levels.^q

Thyroid hormones are minimally distributed into breast milk.^b ^j ^q

Plasma Protein Binding

Circulating thyroid hormones are >99% bound to serum proteins, including TBG, thyroxine-binding prealbumin (TBPA), and albumin.^b ^j ^q T₄ is more extensively and firmly bound to TBG and TBPA than T₃.^b ^j ^q Only unbound hormone is metabolically active.^b ^q

Elimination

Metabolism

T₄ and T₃ are metabolized principally in the liver through sequential deiodination.^b ^j ^q Approximately 80% of the daily dose of T₄ is deiodinated to yield equal amounts of T₃ and reverse T₃ (rT₃).^j ^q T₃ and rT₃ are further deiodinated to diiodothyronine.^j ^q Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.^b ^j ^q

Elimination Route

Thyroid hormones are primarily eliminated by the kidneys.^q A portion of the conjugated hormone reaches the colon unchanged and is eliminated in the feces.^q Approximately 20% of T₄ is eliminated in stool.^q Urinary excretion of T₄ decreases with age.^q

Half-life

T₄: Approximately 6–7 days.^h ⁱ ^j

T₃: Approximately 1–2 days.^c ^h ⁱ ^j

These plasma half-lives are decreased in patients with hyperthyroidism and increased in those with hypothyroidism.^h ⁱ ^j

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 2–8°C.^a ^b

ActionsActions

Thyroid hormones (T₄ and T₃) regulate multiple metabolic processes, including augmentation of cellular respiration and thermogenesis, as well as metabolism of proteins, carbohydrates, and lipids.^b ^j ^q

Thyroid hormones also play an essential role in normal growth and development and normal maturation of the CNS and bone.^b ^j The protein anabolic effects of thyroid hormones are essential for normal growth and development.^j ^q

The physiologic actions of thyroid hormones are produced predominantly by T₃, most of which (approximately 80%) is derived from T₄ by deiodination in peripheral tissues.^b ^j

T₃ is approximately 4 times more potent than T₄.^b

Advice to Patients

Importance of understanding the need to continue thyroid agent therapy for life, unless transient hypothyroidism is suspected.^b ^j

Importance of taking thyroid agent exactly as prescribed.^q Do not alter regimen or discontinue therapy unless directed by a clinician.^q

Risk of transient hair loss.^b ^q Importance of immediately informing a clinician if rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event occurs.^b ^q

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease, diabetes mellitus, clotting disorders, adrenal or pituitary gland problems).^b

In patients with diabetes mellitus, importance of monitoring blood and/or urinary glucose levels and immediately reporting any changes to a clinician.^b ^d ^q In patients receiving concomitant anticoagulant therapy, importance of monitoring clotting status frequently.^b

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^b ^f Dosage may need to be increased during pregnancy.^e ^f

Importance of informing physician or dentist of current thyroid hormone therapy prior to any surgery.^j

Importance of informing patients of other important precautionary information.^a ^b (See Cautions.)

Preparations

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

U.S. Pharmacopeia, an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the United States, has mandated new specifications for a component used in the manufacturing of Thyrolar. As a result, all strengths of Thyrolar are currently on long-term back order while Forest makes the modifications necessary to meet these new specifications. Forest is working diligently to complete these modifications. In the meantime, patients should speak with their physician regarding appropriate treatment for their condition, and check for future updates on the availability of Thyrolar through the Forest product availability toll-free hotline at (866) 927-3260.

Liotrix
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	Levothyroxine Sodium 12.5 mcg and Liothyronine Sodium 3.1 mcg	Thyrolar-¼	Forest
		Levothyroxine Sodium 25 mcg and Liothyronine Sodium 6.25 mcg	Thyrolar-½	Forest
		Levothyroxine Sodium 50 mcg and Liothyronine Sodium 12.5 mcg	Thyrolar-1	Forest
		Levothyroxine Sodium 100 mcg and Liothyronine Sodium 25 mcg	Thyrolar-2	Forest
		Levothyroxine Sodium 150 mcg and Liothyronine Sodium 37.5 mcg	Thyrolar-3	Forest

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Thyrolar-1 60 (12.5-50)MG (MCG) Tablets (FOREST): 30/$29.99 or 90/$72.97

Thyrolar-1/2 30 (6.25-25)MG (MCG) Tablets (FOREST): 30/$26.99 or 90/$57.97

Thyrolar-1/4 15 (3.1-12.5)MG (MCG) Tablets (FOREST): 30/$24.99 or 90/$54.97

Thyrolar-2 120 (25-100)MG (MCG) Tablets (FOREST): 30/$32.99 or 90/$82.98

Thyrolar-3 180 (37.5-150)MG (MCG) Tablets (FOREST): 30/$39.99 or 90/$100.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

a. AHFS Drug Information 2008. McEvoy GK, ed. Liotrix. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3307-8.

b. Forest Pharmaceuticals, Inc. Thyrolar (liotrix) tablets prescribing information. St. Louis, MO; 2005 Apr.

c. Dong BJ. Thyroid Disorders. In: Koda-Kimble MA, Young LY, eds. Applied therapeutics: The clinical use of drugs. 8th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:49-1–49-19.

d. Anon. Drugs for hypothyroidism and hyperthyroidism. Treat Guidel Med Lett. 2006; 4:17–24.

e. American Association of Clinical Endocrinologists. Medical guidelines for clinical practice for the evaluation and treatment of hyperthyroidism and hypothyroidism, 2006 amended version. Endocr Pract; 2002:457–69.

f. American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, number 37, August 2002: Thyroid disease in pregnancy. Obstet Gynecol. 2002; 100:387-96. [PubMed 12166417]

h. AHFS Drug Information 2008. McEvoy GK, ed. Liothyronine Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3306-7.

i. AHFS Drug Information 2008. McEvoy GK, ed. Levothyroxine Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3302-6.

j. AHFS Drug Information 2008. McEvoy GK, ed. Thyroid Agents General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3298-302.

k. Singer PA, Cooper DS, Levy EG et al. Treatment guidelines for patients with hyperthyroidism and hypothyroidism. JAMA; 1995; 273:808-12.

m. American Academy of Pediatrics, American Thyroid Association, and Lawson Wilkins Pediatric Endocrine Society. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006; 117:2290-303. [PubMed 16740880]

o. Joshi JV, Bhandarkar SD, Chadha M et al. Menstrual irregularities and lactation failure may precede thyroid dysfunction or goitre. J Postgrad Med. 1993; 39:137-41. [PubMed 8051643]

Friday, September 16, 2016

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