WebSite Guatemala: September 2016

Friday, September 30, 2016

Ultracet

Generic Name: tramadol and acetaminophen (Oral route)

TRAM-a-dol hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen

Oral route(Tablet)

Ultracet(R) contains tramadol hydrochloride and acetaminophen; acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death and most cases of liver injury associated with doses exceeding 4000 mg/day and often involve more than one acetaminophen-containing product

Commonly used brand name(s)

In the U.S.

Ultracet

In Canada

Tramacet

Available Dosage Forms:

Tablet

Therapeutic Class: Analgesic Combination

Chemical Class: Tramadol

Uses For Ultracet

Tramadol and acetaminophen combination is used to relieve pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for the short-term relief of pain, physical dependence will probably not occur.

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

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

Before Using Ultracet

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 tramadol and acetaminophen combination 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 tramadol and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving tramadol and acetaminophen combination.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

Rasagiline

Selegiline

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.

Acetophenazine

Amitriptyline

Amoxapine

Bromperidol

Carbamazepine

Chlorpromazine

Chlorprothixene

Citalopram

Clobazam

Clomipramine

Clorgyline

Clovoxamine

Clozapine

Cyclobenzaprine

Desipramine

Desvenlafaxine

Dothiepin

Doxepin

Duloxetine

Escitalopram

Ethopropazine

Femoxetine

Fluoxetine

Flupenthixol

Fluphenazine

Fluvoxamine

Haloperidol

Imipramine

Isocarboxazid

Ketamine

Linezolid

Lofepramine

Loxapine

Melperone

Mesoridazine

Methotrimeprazine

Milnacipran

Mirtazapine

Moclobemide

Molindone

Nortriptyline

Olanzapine

Paroxetine

Penfluridol

Perphenazine

Phenelzine

Pimozide

Pipotiazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Protriptyline

Remoxipride

Risperidone

Sertraline

Sulpiride

Tapentadol

Thiethylperazine

Thioridazine

Thiothixene

Tranylcypromine

Trifluoperazine

Triflupromazine

Trimeprazine

Trimipramine

Venlafaxine

Vilazodone

Zuclopenthixol

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

Acenocoumarol

Carbamazepine

Digoxin

Isoniazid

Phenytoin

Quinidine

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

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

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

Ethanol

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

Cabbage

Proper Use of tramadol and acetaminophen

This section provides information on the proper use of a number of products that contain tramadol and acetaminophen. It may not be specific to Ultracet. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

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

Dosing

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

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

For oral dosage form (tablets):
- For pain:
  - Adults—2 tablets every 4 to 6 hours as needed for up to 5 days.
  - 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.

Precautions While Using Ultracet

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

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

This medicine 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; medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; opioids; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

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

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet.

Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures (convulsions) and may cause a serious condition called serotonin syndrome.

This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

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

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

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing; irregular, fast or slow, or shallow breathing; nausea or vomiting; pain in the upper stomach; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, shortness of breath, or yellow eyes or skin.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

Ultracet 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:

Rare

Burning, itching, and redness of the skin

chest pain

cough

difficulty with swallowing

dizziness

fast heartbeat

hives

itching

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

seizures (convulsions)

shortness of breath

skin rash

tightness in the chest

unusual tiredness or weakness

vomiting

wheezing

Incidence not known

Blistering, peeling, or loosening of the skin

chills

diarrhea

difficulty with breathing

joint or muscle pain

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

noisy breathing

red skin lesions, often with a purple center

red, irritated eyes

sore throat

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

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

Symptoms of overdose

Abdominal or stomach pain

black, tarry stools

chest pain or discomfort

dark urine

difficulty with sleeping

disorientation

drowsiness to profound coma

fever

headache

irregular, fast or slow, or shallow breathing

lethargy

light-colored stools

lightheadedness

loss of appetite

mood or other mental changes

nausea

pale or blue lips, fingernails, or skin

seeing, hearing, or feeling things that are not there

unpleasant breath odor

vomiting of blood

yellow eyes or skin

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

Less common

Acid or sour stomach

anxiety

belching

bloated or full feeling

constipation

dry mouth

excess air or gas in the stomach or intestines

false or unusual sense of well-being

feeling of warmth

heartburn

increase in bowel movements

increased sweating

indigestion

loose stools

loss of strength or energy

muscle pain or weakness

nervousness

numbness or tingling of the hands, legs, and feet

painful or difficult urination

redness of the face, neck, arms, and occasionally the upper chest

sleepiness or unusual drowsiness

sleeplessness

soft stools

stomach discomfort

trouble with sleeping

unable to sleep

weight loss

Rare

Abnormal thinking

blurred vision

change in vision

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

cold sweats

continuing ringing, buzzing, or unexplained noise in the ears

crying

decrease in the frequency or amount of urination

decreased awareness or responsiveness

decreased interest in sexual intercourse

depression

difficulty in passing urine (dribbling)

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

dysphoria

euphoria

fainting

fast, pounding, or irregular heartbeat or pulse

feeling of constant movement of self or surroundings

feeling unusually cold

headache, severe or continuing

high or low blood pressure

increased muscle tone

involuntary muscle contractions

loss of memory

loss of sense of reality

loss of sexual ability, desire, drive, or performance

migraine headache

morbid dreaming

paranoia

pounding in the ears

problems with memory

quick to react or overreact emotionally

rapidly changing moods

sensation of spinning

severe stomach pain

shakiness and unsteady walk

shivering

swelling of the tongue

vomiting of blood or material that looks like coffee grounds

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: Ultracet side effects (in more detail)

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

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

More Ultracet resources

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

Ultracet Prescribing Information (FDA)

Ultracet MedFacts Consumer Leaflet (Wolters Kluwer)

Ultracet Consumer Overview

Compare Ultracet with other medications

Pain
Rheumatoid Arthritis

Up and Up All Day Allergy Relief

Dosage Form: tablet
Target Corp. All Day Allergy Relief Tablets Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

do not use if blister unit is broken or torn (Blister Only)

do not use if printed foil under cap is broken or missing (Larger Stretch Card Configurations Only)

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions?

Call 1-800-910-6874

Principal Display Panel

All Day Allergy Relief

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

Compare to active ingredient in Zyrtec®

Original Prescription Strength

Indoor and Outdoor Allergies

24-Hour Relief of: Sneezing/Runny Nose/Itchy, Watery Eyes/Itchy Throat or Nose

Actual Size

24 Hour Relief

# Tablets {Replace "#" with the number of Tablets in the package}

All Day Allergy Relief Tablets Stretch Pack

Up and Up All Day Allergy Relief
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	11673-458
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11673-458-66	1 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		14 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (11673-458-66)
2	11673-458-39	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
2		30 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (11673-458-39)
3	11673-458-95	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
3		45 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (11673-458-95)
4	11673-458-76	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
4		120 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (11673-458-76)
5	11673-458-03	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
5		350 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (11673-458-03)
6	11673-458-48	1 BOTTLE In 1 PACKAGE	contains a BOTTLE
6		180 TABLET In 1 BOTTLE	This package is contained within the PACKAGE (11673-458-48)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	05/27/2009

Labeler - Target Corporation (006961700)

Revised: 05/2009Target Corporation

More Up and Up All Day Allergy Relief resources

Up and Up All Day Allergy Relief Side Effects (in more detail)
Up and Up All Day Allergy Relief Use in Pregnancy & Breastfeeding
Drug Images
Up and Up All Day Allergy Relief Drug Interactions
Up and Up All Day Allergy Relief Support Group
73 Reviews for Up and Up All Day Allergy Relief - Add your own review/rating

Compare Up and Up All Day Allergy Relief with other medications

Hay Fever
Urticaria

UAD Caine

Generic Name: lidocaine injection (LYE doe kane)

Brand Names: Anestacaine, UAD Caine, Xylocaine HCl, Xylocaine-MPF

What is UAD Caine (lidocaine injection)?

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine injection is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.

Lidocaine injection is also given in an epidural (spinal block) to reduce the discomfort of contractions during labor.

Lidocaine injection is sometimes used to treat irregular heart rhythms that may signal a possible heart attack.

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

What is the most important information I should know about UAD Caine (lidocaine injection)?

You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

Before you receive lidocaine injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.

To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.

Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use lidocaine injection at home. Never use the LidoPen auto-injector without first calling your doctor.

With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

What should I discuss with my healthcare provider before receiving UAD Caine (lidocaine injection)?

You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

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

liver disease;

kidney disease;

heart disease;

coronary artery disease, circulation problems; or

a history of malignant hyperthermia.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lidocaine injection 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 is lidocaine injection given?

Lidocaine is given as an injection through a needle placed into a vein or directly into the body area to be numbed. Your doctor, nurse, or other healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving lidocaine injection in a hospital setting.

To treat irregular heart rhythms, you may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

The LidoPen auto-injector is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times. Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use the injection.

Never use the LidoPen auto-injector without first calling your doctor.

Do not use the auto-injector in or near a vein or into your buttocks. Inject the medication only in your upper thigh or upper arm.

With the LidoPen auto-injector you will also receive a CardioBeeper. This device is used to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper so you will be able to quickly use it in an emergency.

Store the LidoPen auto-injector at room temperature away from moisture and extreme hot or cold.

What happens if I miss a dose?

Since lidocaine injection is used only when needed, you are not likely to be on a dosing schedule.

Never use the LidoPen auto-injector without first calling your doctor.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, confusion, nervousness, ringing in your ears, blurred vision, feeling hot or cold, numbness, muscle twitches, uneven heartbeats, seizure (convulsions), slowed breathing, or respiratory failure (breathing stops).

What should I avoid while receiving UAD Caine (lidocaine injection)?

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.

UAD Caine (lidocaine injection) side effects

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

feeling anxious, shaky, dizzy, restless, or depressed;

drowsiness, vomiting, ringing in your ears, blurred vision;

confusion, twitching, seizure (convulsions);

fast heart rate, rapid breathing, feeling hot or cold;

weak or shallow breathing, slow heart rate, weak pulse; or

feeling like you might pass out.

Less serious side effects include:

mild bruising, redness, itching, or swelling where the medication was injected;

mild dizziness;

nausea;

numbness in places where the medicine is accidentally applied.

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 UAD Caine (lidocaine injection)?

There may be other drugs that can interact with lidocaine injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More UAD Caine resources

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

Lidocaine Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)

lidocaine Intradermal Advanced Consumer (Micromedex) - Includes Dosage Information

Lidocaine Prescribing Information (FDA)

Lidocaine Hydrochloride Monograph (AHFS DI)

Lidocaine Hydrochloride (Local Anesthetic) Monograph (AHFS DI)

Compare UAD Caine with other medications

Anesthesia
Arrhythmia
Ventricular Fibrillation
Ventricular Tachycardia

Where can I get more information?

Your doctor or pharmacist can provide more information about lidocaine injection.

See also: UAD Caine side effects (in more detail)

Ultrabrom

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is Ultrabrom (brompheniramine and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ultrabrom (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine 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 drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Ultrabrom (brompheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

kidney disease;

diabetes;

glaucoma;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

an enlarged prostate; or

problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Ultrabrom (brompheniramine and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. 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 feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Ultrabrom (brompheniramine and pseudoephedrine)?

This medication 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 drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Ultrabrom (brompheniramine and pseudoephedrine) 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:

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

confusion, hallucinations, unusual thoughts or behavior;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

urinating less than usual or not at all.

Less serious side effects may include:

blurred vision;

dry mouth;

nausea, stomach pain, constipation;

mild loss of appetite, stomach upset;

warmth, tingling, or redness under your skin;

sleep problems (insomnia);

restless or excitability (especially in children);

skin rash or itching;

dizziness, drowsiness;

problems with memory or concentration; or

ringing in your ears.

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 Ultrabrom (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

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

medicines to treat high blood pressure;

a diuretic (water pill);

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

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

More Ultrabrom resources

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

Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

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Where can I get more information?

Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: Ultrabrom side effects (in more detail)

Ultravate Cream

Pronunciation: HAL-oh-BAY-ta-sol
Generic Name: Halobetasol
Brand Name: Ultravate

Ultravate Cream is used for:

Treating inflammation and itching caused by certain skin conditions. It may also be used for other conditions as determined by your doctor.

Ultravate Cream is a topical corticosteroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation).

Do NOT use Ultravate Cream if:

you are allergic to any ingredient in Ultravate Cream

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

Before using Ultravate Cream:

Some medical conditions may interact with Ultravate Cream. 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 rosacea, any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin

if you have had a recent vaccination; you have measles, tuberculosis (TB), chickenpox, or shingles; or you have had a positive TB test

if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Ultravate Cream. However, no specific interactions with Ultravate Cream are known at this time.

Ask your health care provider if Ultravate Cream 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 Ultravate Cream:

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

Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed.

Wash your hands after you apply Ultravate Cream, unless your hands are part of the treated area.

Do not bandage or cover the treated skin area unless directed by your doctor.

If you miss a dose of Ultravate Cream, apply 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 apply 2 doses at once.

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

Important safety information:

Ultravate Cream is for external use only. Do not get Ultravate Cream in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.

Do not use Ultravate Cream on the face, in the groin area, or under the armpits.

Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with you doctor.

If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.

Check with your doctor before you receive any vaccine while you are using Ultravate Cream.

Do not use Ultravate Cream for other skin conditions at a later time.

Do not use other medicines or products on your skin without first checking with your doctor.

Overuse of topical products may worsen your condition.

Ultravate Cream is a corticosteroid. Before you start any new prescription or nonprescription medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

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

Serious side effects may occur if too much of Ultravate Cream is absorbed through the skin. This may be more likely to occur if you use Ultravate Cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Ultravate Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.

Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Ultravate Cream.

Ultravate Cream should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ultravate Cream while you are pregnant. It is not known if Ultravate Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Ultravate Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ultravate Cream:

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

Dryness; mild stinging, burning, or itching.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Ultravate Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; symptoms of high blood sugar (eg, flushing, confusion, drowsiness, increased thirst, increased urination); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Ultravate 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Ultravate Cream:

Store Ultravate Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Ultravate Cream out of the reach of children and away from pets.

General information:

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

Ultravate Cream 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 Ultravate Cream. 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 Ultravate resources

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

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Univasc

Generic Name: Moexipril Hydrochloride
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: (3S-(2(R*(R*)),3R*))-2-(2-((1 - (Ethoxycarbonyl) - 3 - phenylpropyl)amino) - 1 - oxopropyl) - 1,2,3,4 - tetrahydro - 6,7 - dimethoxy - 3 - isoquinolinecarboxylic acid monohydrochloride
Molecular Formula: C₂₇H₃₄N₂O₇•ClH
CAS Number: 82586-52-5

May cause fetal and neonatal morbidity and mortality if used during pregnancy.¹ ¹¹⁰ ¹¹¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

If pregnancy is detected, discontinue as soon as possible.¹ ¹¹¹

Introduction

Nonsulfhydryl ACE inhibitor.¹

Uses for Univasc

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).¹

One of several preferred initial therapies in hypertensive patients with heart failure, post-MI, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.⁹⁵

Can be used as monotherapy for initial management of uncomplicated hypertension;¹ however, thiazide diuretics are preferred by JNC 7.⁹⁵

CHF

Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.¹⁰ ¹¹ ¹² ¹⁴ ⁹⁴ ⁹⁶

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with diabetes mellitus.¹⁰⁰ ¹⁰¹ ¹⁰²

Univasc Dosage and Administration

General

Moexipril/hydrochlorothiazide fixed combination should not be used for initial treatment of hypertension.⁸³

Administration

Oral Administration

Administer orally once or twice daily 1 hour before meals.¹ ³ ¹⁸ ⁸³

Dosage

Available as moexipril hydrochloride; dosage expressed in terms of the salt.¹ ⁸³

Adults

Hypertension

Oral

Initially, 7.5 mg once daily as monotherapy.¹ ³ ⁵ ¹⁸ ⁹⁵

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating moexipril.¹ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ³⁷ ⁴⁶ May cautiously resume diuretic therapy if BP not controlled adequately with moexipril alone.¹ ²⁸ ²⁹ ³⁰ ³⁹ If diuretic cannot be discontinued, increase sodium intake and give lower initial moexipril dose (3.75 mg) under close medical supervision.¹ ⁸ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ⁸³ ⁸⁴

Usual dosage: 7.5–30 mg daily, given in 1 dose or 2 divided doses.¹ ⁸³ ⁹⁵

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.¹

Moexipril/Hydrochlorothiazide Combination Therapy

Oral

If BP is not adequately controlled by monotherapy with moexipril, can switch to the fixed-combination preparation containing moexipril hydrochloride 7.5 mg and hydrochlorothiazide 12.5 mg, moexipril hydrochloride 15 mg and hydrochlorothiazide 12.5 mg, or moexipril hydrochloride 15 mg and hydrochlorothiazide 25 mg.⁸³ Adjust dosage of either or both drugs according to patient’s response.⁸³

Prescribing Limits

Adults

Hypertension

Oral

Usually, maximum 30 mg daily.¹ Dosages >60 mg daily have not been extensively evaluated in hypertensive patients.¹ ⁵

Special Populations

Renal Impairment

Hypertension

Oral

Initially, 3.75 mg once daily in patients with severe renal impairment (Cl_cr ≤40 mL/minute); titrate until BP is controlled or to maximum of 15 mg daily.¹

Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.⁸³

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.¹

Cautions for Univasc

Contraindications

Known hypersensitivity (e.g., history of angioedema) to moexipril or another ACE inhibitor.¹ ⁸³

Warnings/Precautions

Warnings

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those with restricted salt intake, treated with diuretics, undergoing dialysis, with nausea or vomiting, or with CHF).¹ Risk of marked hypotension, sometimes associated with oliguria and azotemia, and rarely acute renal failure and death in patients with CHF with or without associated renal insufficiency.¹

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.¹

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.¹ May minimize potential for hypotension by withholding diuretic therapy and/or increasing sodium intake for 2–3 days prior to initiation of moexipril.¹

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).¹

Initiate therapy in patients with CHF (with or without associated renal insufficiency) under close medical supervision; monitor closely for first 2 weeks following initiation of moexipril or any increase in moexipril or diuretic dosage.¹

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with moexipril is unknown.¹ ⁸³

Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.¹ ⁸³

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.¹ ¹¹¹ (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.¹¹¹

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.¹¹⁰ ¹¹¹

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.¹ ¹¹⁰ ¹¹¹ Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.⁷⁵

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.¹

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.¹

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal.¹ ⁸³ Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.¹ ⁸³ Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.¹ ⁸³

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption¹ ⁵¹ ⁵² ⁸³ or following initiation of hemodialysis that utilized high-flux membrane.¹ ⁴⁷ ⁴⁸ ⁴⁹ ⁸³

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.¹ ⁸³

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.¹ ⁸³

General Precautions

Renal Effects

Transient increases in BUN and S_cr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.¹ ⁸³ Possible increases in BUN and S_cr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitors and/or diuretic.¹ ⁸³

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.¹ ⁸³

Closely monitor renal function following initiation of therapy in such patients.¹ ⁸³ Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.¹ ⁸³

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).¹ (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.¹

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.¹

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.⁸³

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Not known whether moexipril is distributed into milk.¹ Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Renal Impairment

Systemic exposure to moexipril and moexiprilat may be increased.¹ Initial dosage adjustment recommended in patients with severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.⁸³

Blacks

BP reduction may be smaller in black patients compared with nonblack patients; however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.²⁵ ⁸³ ⁹² ⁹³ ⁹⁵ ¹⁰⁸ ¹⁰⁹ Use in combination with a diuretic.²⁵ ⁸³ ⁸⁶ ⁹⁵

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.¹

Common Adverse Effects

Cough, dizziness, diarrhea, flu syndrome, fatigue, pharyngitis, flushing, rash, myalgia.¹

Interactions for Univasc

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral	Clinically important interaction not observed¹
Cimetidine	Clinically important interaction not observed¹
Digoxin	Clinically important interaction not observed¹
Diuretics	Increased hypotensive effect¹	If possible, discontinue diuretic before initiating moexipril¹ (see Dosage under Dosage and Administration)
Diuretic, potassium-sparing (amiloride, spironolactone, triamterene)	Enhanced hyperkalemic effect¹	Use with caution; monitor serum potassium concentrations frequently¹
Lithium	Increased serum lithium concentrations; possible toxicity¹	Use with caution; monitor serum lithium concentration frequently¹
Potassium supplements or potassium-containing salt substitutes.	Enhanced hyperkalemic effect¹	Use with caution; monitor serum potassium concentrations frequently¹

Univasc Pharmacokinetics

Absorption

Bioavailability

About 13% of oral dose is absorbed.¹ Peak plasma concentration of moexiprilat is achieved within about 1.5 hours.¹

Onset

Following a single oral dose, antihypertensive effects are observed within about 1 hour with peak BP reduction at 3–6 hours.¹

During chronic therapy, maximum antihypertensive effect with any dose is achieved after 4 weeks.¹

Duration

Antihypertensive effect of a single dose persists for about 24 hours.¹

Food

Food reduces peak plasma concentration of moexipril; administer 1 hour before meals.¹

Special Populations

In patients with cirrhosis, peak plasma concentration and AUC of moexipril following a single oral dose were increased, while peak plasma concentration of moexiprilat was decreased and AUC of moexiprilat was increased.¹

In patients with renal impairment, increased moexipril and moexiprilat concentrations.¹

Distribution

Extent

Not known whether distributed into milk.¹

Plasma Protein Binding

Moexiprilat: 50%.¹

Elimination

Metabolism

Metabolized in the liver, principally to an active metabolite, moexiprilat.¹

Elimination Route

Following oral administration, eliminated in feces (53%), principally as moexiprilat, and to a lesser extent in urine (13%).¹

Following IV administration, eliminated principally in urine, as moexiprilat (40%) and moexipril (26%), and to lesser extent in feces (about 20%, mainly as moexiprilat).¹

Half-life

Moexiprilat: 12 hours.¹

Special Populations

In patients with renal impairment (Cl_cr 10–40 mL/minute), threefold to fourfold increase in moexiprilat half-life.¹

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.¹

ActionsActions

Prodrug; not pharmacologically active until hydrolyzed in the liver to moexiprilat.¹

Suppresses the renin-angiotensin-aldosterone system.¹

Advice to Patients

Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.¹ Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.¹

Importance of reporting signs of infection (e.g., sore throat, fever).¹

Risk of hypotension.¹ Importance of informing clinicians promptly if lightheadedness or fainting occurs.¹

Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.¹

Risks of use during pregnancy.¹ ¹¹⁰ ¹¹¹ (See Boxed Warning.)

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).¹

Importance of taking moexipril 1 hour before meals.¹

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

Importance of advising patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Moexipril Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	7.5 mg*	Moexipril Hydrochloride Tablets	Teva
			Univasc (scored)	Schwarz
		15 mg*	Moexipril Hydrochloride Tablets	Teva
			Univasc (scored)	Schwarz

Moexipril Hydrochloride Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	7.5 mg with Hydrochlorothiazide 12.5 mg	Uniretic (scored)	Schwarz
		15 mg with Hydrochlorothiazide 12.5 mg	Uniretic (scored)	Schwarz
		15 mg with Hydrochlorothiazide 25 mg	Uniretic (scored)	Schwarz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Moexipril HCl 15MG Tablets (WATSON LABS): 30/$41.99 or 90/$109.98

Moexipril HCl 7.5MG Tablets (WATSON LABS): 30/$40.99 or 90/$100.97

Moexipril-Hydrochlorothiazide 15-12.5MG Tablets (WATSON LABS): 100/$109.98 or 300/$315.96

Moexipril-Hydrochlorothiazide 15-25MG Tablets (WATSON LABS): 30/$36.99 or 90/$89.97

Moexipril-Hydrochlorothiazide 7.5-12.5MG Tablets (TEVA PHARMACEUTICALS USA): 30/$37.99 or 90/$95.97

Uniretic 15-12.5MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$228.98

Uniretic 15-25MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$228.98

Uniretic 7.5-12.5MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$231.97

Univasc 15MG Tablets (SCHWARZ PHARMA): 30/$91.99 or 90/$244.97

Univasc 7.5MG Tablets (SCHWARZ PHARMA): 30/$61.99 or 90/$164.97

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.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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39. Hodsman GP, Brown JJ, Cumming AMM et al. Enalapril in treatment of hypertension with renal artery stenosis: changes in blood pressure, renin, angiotensin I and II, renal function, and body composition. Am J Med. 1984; 77:52-60.

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49. Tielemans C, Madhoun P, Lenaers M et al. Anaphylactoid reactions during hemodialysis on AN69 membranes in patients receiving ACE inhibitors. Kidney Int. 1990; 38:982-4. [PubMed 2266684]

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54. Merck & Co. Vasotec I.V. Enalaprilat (enalapril) prescribing information. West Point, PA; 1994 Apr.

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59. Bünning P. Inhibition of angiotensin converting enzyme by 2-[N-[(S)-1-carboxy-3-phenylpropyl]-l -alanyl]- (1S,3S,5S)-2-azabicyclo[3.3.0]octane-3-carboxylic acid (Hoe 498 Diacid). Arzneimittelforschung. 1984; 34:1406-10. [PubMed 6097266]

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Friday, September 30, 2016

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