Search PLR Articles Directory Cook Islands: June 2012

Saturday 30 June 2012

Esgic-Plus Oral

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

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

Oral route(Tablet)

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

Commonly used brand name(s)

In the U.S.

Anolor 300

Dolgic LQ

Esgic

Esgic-Plus

Ezol

Fioricet

Geone

Margesic

Medigesic

Nonbac

Pacaps

Repan

Available Dosage Forms:

Capsule

Tablet

Solution

Therapeutic Class: Butalbital/Acetaminophen Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

Uses For Esgic-Plus

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

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

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

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

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

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

Before Using Esgic-Plus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, and caffeine combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, and caffeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butalbital, acetaminophen, and caffeine combination.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Anisindione

Aprobarbital

Bromazepam

Brotizolam

Butabarbital

Butalbital

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Diazepam

Dicumarol

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nitrazepam

Nordazepam

Oxazepam

Oxycodone

Oxymorphone

Pentobarbital

Phenindione

Phenobarbital

Phenprocoumon

Prazepam

Primidone

Propoxyphene

Quazepam

Quetiapine

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Temazepam

Thiopental

Triazolam

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

Acenocoumarol

Cannabis

Carbamazepine

Imipramine

Isoniazid

Phenytoin

Prednisone

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

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

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

Ethanol

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

Cabbage

Ethanol

Proper Use of butalbital, acetaminophen, and caffeine

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

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

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

Dosing

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

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

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

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Esgic-Plus

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

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

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

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

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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

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

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

Esgic-Plus Side Effects

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

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

More common

Lightheadedness

shortness of breath

Incidence not known

Abdominal or stomach pain

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

blurred vision

change in the frequency of urination or amount of urine

chills

cough

diarrhea

difficulty with breathing

difficulty with swallowing

dizziness

drowsiness

dry mouth

fainting

fast heartbeat

fast, pounding, or irregular heartbeat or pulse

flushed or dry skin

fruit-like breath odor

hives

increased hunger

increased thirst

increased urination

itching

joint or muscle pain

loss of appetite

nausea or vomiting

pinpoint red spots on the skin

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

red skin lesions, often with a purple center

red, irritated eyes

seizure

shakiness in the legs, arms, hands, or feet

shortness of breath

skin rash

sore throat

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

sweating

swelling of the feet or lower legs

tightness in the chest

trembling or shaking of the hands or feet

troubled breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

weakness

wheezing

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

Symptoms of overdose

Confusion as to time, place, or person

dark urine

difficult or painful urination

difficult or troubled breathing

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

fever

general feeling of discomfort or illness

hallucinations

headache

holding false beliefs that cannot be changed by fact

increased sweating

irregular, fast or slow, or shallow breathing

light-colored stools

loss of appetite

pale or blue lips, fingernails, or skin

restlessness

sleeplessness

sudden decrease in the amount of urine

sweating

trouble sleeping

unable to sleep

unpleasant breath odor

unusual excitement, nervousness, or restlessness

vomiting of blood

yellow eyes or skin

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

More common

Relaxed and calm

sleepiness

Incidence not known

Anxiety

bloated

constipation

continuing ringing or buzzing or other unexplained noise in the ears

depression

earache

excess air or gas in the stomach or intestines

false or unusual sense of well-being

full feeling

hearing loss

heartburn

heavy eyelids

high energy

hot spells

hyperventilation

irritability

numbness

pain in the leg

passing gas

sluggishness

stuffy nose

tingling sensation

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

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

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

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.

Monday 25 June 2012

Actisite

Generic Name: tetracycline (Mucous membrane, oral route)

tet-ra-SYE-kleen

Commonly used brand name(s)

In the U.S.

Actisite

Available Dosage Forms:

Powder for Suspension

Implant

Therapeutic Class: Antibacterial

Chemical Class: Tetracycline (class)

Uses For Actisite

Tetracycline periodontal fibers are used to help treat periodontal disease (a disease of your gums). Periodontal disease is caused by bacteria growing beneath the gum line. Tetracycline works by keeping the number of bacteria from growing. Lowering the amount of bacteria helps to reduce inflammation and swelling in your mouth, and the amount of bleeding around the teeth. Tetracycline fibers are placed in the inflamed mouth areas by your dentist after he or she has thoroughly cleaned your teeth.

Before Using Actisite

Allergies

Pediatric

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

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

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 Actisite

When tetracycline periodontal fibers are in place in your mouth, try to avoid any actions that may knock the fibers loose. For example:

Do not chew hard, crusty, or sticky foods, or chewing gum.

Do not brush or floss near any treated areas, but continue to clean the other teeth.

Do not use a dental spray device (e.g., Water-Pik).

Do not probe or pick at the fibers with your tongue, toothpicks, or fingers.

Dosing

The amount of tetracycline periodontal fibers that will be put in your gums will be determined by your dentist. The number of teeth that need treatment and the depth of the pockets in your gums will determine the amount of fiber that is used.

Precautions While Using Actisite

Check with your dentist right away if the fibers become loose or fall out before your next dental visit.

Check with your dentist right away if you have pain or swelling or other problems in the treated areas.

It is very important that your dentist check your progress and remove the tetracycline periodontal fibers after ten days. Do not miss any dental appointments.

Actisite 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

Gum redness, swelling, and pain in the areas of treatment

tongue pain and redness

More common

Discomfort in the area where the fibers have been placed

redness in the area where the fibers were removed

Rare

Sore throat

staining of the tongue

white patches on tongue or in mouth

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: Actisite side effects (in more detail)

More Actisite resources

Actisite Side Effects (in more detail)
Actisite Use in Pregnancy & Breastfeeding
Actisite Drug Interactions
Actisite Support Group
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Thursday 21 June 2012

Boots Pharmacy Cold and Flu 24 Hour Capsules

Boots Pharmacy Cold & Flu 24 Hour Capsules

Please read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice

What this medicine is for

The Day capsules and Night capsules both contain paracetamol, an analgesic, which relieves pain and reduces fever, a decongestant to relieve a blocked up nose and a cough suppressant to relieve coughing. The Night capsules also contain an antihistamine, which causes drowsiness and helps you to get a restful night's sleep.

It can be used to relieve even the worst symptoms of colds and flu during the day and night, and to help you get a restful night's sleep.

Before you take this medicine

This medicine can be taken by adults and children over the age of 12. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

If you are pregnant or breastfeeding

If you are allergic to any of the ingredients

If you have heart disease or have high blood pressure (including that due to a tumour near your kidneys)

If you suffer from hyperexcitability, diabetes, an overactive thyroid, enlarged prostate, or high pressure in the eye (glaucoma)

If you suffer from severe liver or kidney problems, chronic bronchitis or bronchiectasis

If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days

Talk to your pharmacist or doctor:

If you have asthma

Other important information

Driving and using machinery: The Night Capsules may cause drowsiness or dizziness. You should not drive or operate machinery until you are sure you are not affected.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients in this medicine: The colours allura red (E129) in the Day capsules, and ponceau 4R (E124) in the Night capsules, may cause allergic reactions.

Taking other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Barbiturates, sleeping tablets, strong painkillers, sedatives or tranquillisers (because the Night capsules may make you feel more sleepy for a longer time)

Tricyclic antidepressants and atropine like medicines such as antihistamines or other medicines which may cause a dry mouth (you may have more risk of having some of the side effects)

Medicines for high blood pressure (your blood pressure may increase whilst you are taking this medicine)

Digoxin for heart problems (this may make your heart beat too fast)

Domperidone or metoclopramide, for nausea and vomiting (may increase the effect of the painkiller in this medicine)

Cholestyramine, for lowering blood lipid levels (may reduce the effect of the painkiller in this medicine)

Warfarin or other coumarins (for thinning the blood) - If you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself including herbal and homeopathic remedies.

How to take this medicine

Check that the foil is not broken before use.

If it is discard the capsule.

The pack contains two types of capsules.

The Day capsules are for you to take during the day.

The Night capsules are for you to take at bedtime only.

Adults and children 12 years and over

Take two Day capsules every four hours, if you need to, up to a maximum of 6 capsules in 24 hours and Take 2 Night capsules at bedtime only, at least four hours after the last day capsule

Don't take more than 8 capsules in 24 hours

Swallow each capsule whole with water.

Do not give to children under 12 years.

Do not take more than the dose recommended above.

Do not take this medicine for more than 7 days unless your doctor agrees.

If symptoms persist consult your doctor.

If you take too many capsules: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once.

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

Drowsiness, tiredness, dizziness, muscular weakness

Feeling sick, being sick, diarrhoea, constipation, stomach pain

Headache, blurred vision, ringing in the ears, loss of appetite

Irritability, nightmares

Hallucinations, particularly in children

Difficulty in passing urine, dry mouth, fast heart rate, tremors, skin rashes

Unusual bruising, or infections such as sore throats - that may be a sign of very rare changes in the blood

If any side effect becomes severe, or if you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Do not use this medicine after the "Use by" date on the carton.

Do not store above 25°C.

Store it in the original package.

What is in this medicine

Each Day capsule contains Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride 30 mg, which are the active ingredients.

As well as the active ingredients, the Day capsules also contain sodium lauryl sulphate, sodium starch glycolate, magnesium stearate. The capsule shell contains gelatin and colours, which are; quinoline yellow (E104), allura red (E129), titanium dioxide (E171), and Opacode black (printing ink containing shellac, iron oxide (E172), soya lecithin, Antifoam DC 1510).

Each Night capsule contains Diphenhydramine Hydrochloride 12.5 mg, Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride 30 mg which are the active ingredients.

As well as the active ingredients, the Night capsules also contain sodium lauryl sulphate, sodium starch glycolate, magnesium stearate. The capsule shell contains gelatin and colours, which are; brilliant blue (E133), black iron oxide (E172), titanium dioxide (E171), ponceau 4R (E124) and Opacode white (printing ink containing titanium dioxide (E171), shellac, soya lecithin, Antifoam DC 1510).

This pack contains 18 Day capsules and 6 Night capsules.

The Day capsules are yellow and orange with 0580 and BOOTS printed in black.

The Night capsules are blue and purple with 0581 and BOOTS printed in white.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

Boots Pharmacy

Nottingham

NG2 3AA

Hamol Limited

Nottingham

NG90 2DB

PL00014/0582

Leaflet prepared October 2007

If you would like any further information about this product, please contact The Boots Company PLC Nottingham NG2 3AA.

BTC22868 vs C 16/01/08

Sunday 17 June 2012

Vazotab

Generic Name: brompheniramine and phenylephrine (BROM fen IR a meen and FEN il EFF rin)

Brand Names: Alacol, Alenaze-D, Alenaze-D NR, B-Vex D, BPM PE, Brom Tann PE, Bromfed, Bromfed-PD Capsules, BroveX ADT, BroveX PEB, Brovex-D, Children's Cold & Allergy, Dimaphen Elixir, Dimetapp Cold & Allergy, Entre-B, J-Tan D, J-Tan D SR, Phenyl 15/12mg, Phenyl 7.5/6mg, RespaHist II, Rhinabid, Rhinabid PD, Seradex-LA, Tanabid SR, V-Hist, VazoBid, VaZol-D, Vazotab, Zotex-PE

What is Vazotab (brompheniramine and phenylephrine)?

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.

Phenylephrine 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 phenylephrine is used to treat nasal congestion, sneezing, itching, watery eyes, and runny nose caused by allergies, hay fever, and the common cold.

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

What is the most important information I should know about Vazotab (brompheniramine and phenylephrine)?

Do not give this medication to a child younger than 4 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. You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist about taking brompheniramine and phenylephrine if you have heart disease or high blood pressure, diabetes, a thyroid disorder, glaucoma, kidney disease, an enlarged prostate, or problems with urination.

What should I discuss with my healthcare provider before taking Vazotab (brompheniramine and phenylephrine)?

You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

glaucoma;

kidney disease;

an enlarged prostate; or

problems with urination.

FDA pregnancy category C. It is not known whether brompheniramine and phenylephrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Brompheniramine and phenylephrine 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.

How should I take Vazotab (brompheniramine and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or 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 4 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 the medicine with a full glass of water. Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before you swallow it.

Measure liquid 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.

Shake the oral suspension (liquid) well just before you measure a dose. Do not take brompheniramine and phenylephrine for longer than 7 days in a row. 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. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include 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 Vazotab (brompheniramine and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Drinking alcohol can increase certain side effects of brompheniramine and phenylephrine. Ask a doctor or pharmacist before using any other cold, cough, allergy, or pain medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Vazotab (brompheniramine and phenylephrine) 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 a serious side effect such as:

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, restless feeling, or nervousness;

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

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

drowsiness or dizziness;

blurred vision;

dry mouth, nose, or throat;

mild stomach pain, constipation;

problems with memory or concentration;

feeling restless or excited (especially in children);

sleep problems (insomnia); or

warmth, redness, or tingly feeling under your skin.

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 Vazotab (brompheniramine and phenylephrine)?

Before using brompheniramine and phenylephrine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine and phenylephrine.

Tell your doctor about all other medications you are using, especially:

medicines to treat high blood pressure;

a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

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

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

More Vazotab resources

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

Vazotab Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Alenaze-D Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Bromfed MedFacts Consumer Leaflet (Wolters Kluwer)

BroveX-D Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Entre-B Prescribing Information (FDA)

Rhinabid Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vazotab with other medications

Hay Fever
Nasal Congestion
Rhinitis

Where can I get more information?

Your pharmacist can provide more information about brompheniramine and phenylephrine.

See also: Vazotab side effects (in more detail)

Pindolol

Pronunciation: PIN-doe-lol
Generic Name: Pindolol
Brand Name: Generic only. No brands available.

Do not suddenly stop taking Pindolol. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Pindolol. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Pindolol for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Pindolol again.

Pindolol is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Pindolol is a beta-adrenergic blocking agent. It works by slowing down the heart and decreasing the amount of blood it pumps out. This helps to decrease blood pressure, helps the heart pump more efficiently, and reduces the workload on the heart.

Do NOT use Pindolol if:

you are allergic to any ingredient in Pindolol

you have a very slow heartbeat, heart block, uncontrolled heart failure, or shock caused by serious heart problems

you have asthma

you are taking mibefradil

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

Before using Pindolol:

Some medical conditions may interact with Pindolol. 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 a history of an adrenal gland tumor (eg, pheochromocytoma); chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other lung or breathing disease; heart problems (eg, congestive heart failure, slow or irregular heartbeat); blood vessel problems, narrowing of blood vessels of the legs, arms, stomach, or kidneys; an unusually slow heartbeat; diabetes; kidney or liver problems; low blood sugar; or an overactive thyroid

if you have a history of severe allergic reactions

if you are scheduled to have surgery or receive anesthesia

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

Clonidine because stopping it or Pindolol suddenly can lead to a rapid increase in blood pressure

Catecholamine-depleting medicines (eg, reserpine), cimetidine, digoxin, diltiazem, disopyramide, flecainide, ketanserin, mefloquine, mibefradil, phenothiazines (eg, thioridazine), or verapamil because serious side effects, such as very slow heart rate, very low blood pressure, fainting, severe dizziness, or light-headedness when standing, may occur

Indomethacin because it may decrease Pindolol's effectiveness

Fingolimod, insulin, meglitinide antidiabetics (eg, nateglinide), or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Pindolol

Sympathomimetics (eg, albuterol) or theophylline because their effectiveness may be decreased by Pindolol

Epinephrine because the effectiveness may be decreased by Pindolol. The risk of side effects, such as high blood pressure and slow heartbeat, may be increased

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

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

Pindolol may be taken with or without food.

Continue to use Pindolol even if you feel well. Do not miss any doses.

Do not suddenly stop taking Pindolol. You may have an increased risk of side effects. If you need to stop Pindolol, your doctor will gradually lower your dose.

If you miss a dose of Pindolol, 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 Pindolol.

Important safety information:

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

Pindolol may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

It may take up to 2 to 4 weeks to get the full benefit from Pindolol. Do not stop using Pindolol or change your dose of Pindolol without checking with your doctor.

Pindolol may mask the signs of hyperthyroidism (overactive thyroid). If thyroid patients stop taking these medicines too suddenly, symptoms of hyperthyroidism (eg, a rapid pulse) may occur.

If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Pindolol.

If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.

Pindolol may interfere with the glaucoma screening test.

Diabetes patients - Pindolol may mask signs of low blood sugar such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you hungrier. Pindolol may also affect blood sugar levels. Check blood glucose levels closely. Ask your doctor before you change the dose of your diabetes medicine.

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

Do not suddenly stop taking Pindolol without first consulting with your doctor. Severe chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Pindolol. The risk may be greater if you have certain types of heart disease. If your doctor decides you should no longer take Pindolol, the dosage should be gradually reduced according to your doctor's instructions. If new or worsened chest pain or other heart problems develop, contact your doctor right away. You may need to start taking Pindolol again.

Lab tests, including blood pressure, may be performed while you use Pindolol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Pindolol with extreme caution in CHILDREN; safety and effectiveness 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 Pindolol while you are pregnant. Pindolol is found in breast milk. Do not breast-feed while using Pindolol.

If you suddenly stop taking Pindolol, you may experience WITHDRAWAL symptoms, including worsening chest pain, along with possible heart attack.

Possible side effects of Pindolol:

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

Dizziness; fatigue; joint or muscle pain; muscle cramps; nausea; nervousness; sleeplessness; tiredness; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; cold fingers or toes; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; light-headedness; mental or mood changes; numbness, burning, or tingling; severe or persistent dizziness; short-term memory problems; shortness of breath; sudden, unexplained weight gain; swelling of the arms of legs; unusual bruising or bleeding.

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: Pindolol 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 difficulty breathing; fainting; light-headedness; severe dizziness; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; very slow heart rate; wheezing.

Proper storage of Pindolol:

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

General information:

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

Pindolol 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 Pindolol. 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 Pindolol resources

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

Pindolol Prescribing Information (FDA)

Pindolol Monograph (AHFS DI)

Pindolol Professional Patient Advice (Wolters Kluwer)

pindolol Concise Consumer Information (Cerner Multum)

pindolol Advanced Consumer (Micromedex) - Includes Dosage Information

Visken Prescribing Information (FDA)

Compare Pindolol with other medications

High Blood Pressure

Friday 15 June 2012

Icrom

Icrom may be available in the countries listed below.

Ingredient matches for Icrom

Cromoglicic Acid

Cromoglicic Acid is reported as an ingredient of Icrom in the following countries:

Bangladesh

International Drug Name Search

Foltabs

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Foltabs (prenatal multivitamins)?

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

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

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

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

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

More Foltabs resources

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

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Foltabs with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

See also: Foltabs side effects (in more detail)

Thursday 14 June 2012

Beta-Adalat

1. Name Of The Medicinal Product

Beta-Adalat

2. Qualitative And Quantitative Composition

One capsule contains 20 mg nifedipine and 50 mg atenolol.

For excipients see Section 6.1.

3. Pharmaceutical Form

Capsule, hard

Brown-reddish, opaque gelatin capsules overprinted with “BETA-ADALAT” and the Bayer cross.

4. Clinical Particulars

4.1 Therapeutic Indications

Management of hypertension and of chronic stable angina pectoris where therapy with either a calcium channel blocker or a beta-blocker prove inadequate.

4.2 Posology And Method Of Administration

Adults:

Hypertension: One capsule daily swallowed with water. If necessary, the dosage may be increased to one capsule dosed every 12 hours. Patients can be transferred to the combination from other antihypertensive treatments with the exception of clonidine (see Section 4.4).

Angina: One capsule every 12 hours swallowed with water. Where additional efficacy is necessary, prophylactic nitrate therapy or additional nifedipine may be of benefit.

Elderly:

Dosage should not exceed one capsule daily in hypertension or one capsule twice daily in angina.

The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients.

Children:

There is no paediatric experience with Beta-Adalat and therefore this preparation should not be used in children.

General:

Patients with renal or hepatic insufficiency may require lower dosages of Beta-Adalat, (see Section 4.4).

Beta-Adalat should not be taken with grapefruit juice (see Section 4.5).

4.3 Contraindications

Beta-Adalat should not be administered to patients with known hypersensitivity to atenolol, nifedipine or other dihydropyridines because of the theoretical risk of cross-reactivity.

Beta-Adalat should not be administered to patients with a history of wheezing or asthma or a tendency to bronchospasm (obstructive respiratory disease/bronchial asthma). (Label warning: Do not use if you have a history of wheezing or asthma.)

Beta-Adalat must not be administered to women capable of child-bearing or to nursing mothers.

Beta-Adalat must not be used in the presence of second or third degree heart block, sick sinus syndrome, sino-atrial block, in patients with evidence of overt heart failure or inadequately treated heart failure or decompensated heart failure, NYHA grades III and IV.

Beta-Adalat should not be used in cardiogenic shock, clinically significant aortic stenosis, unstable angina pectoris, or during or within one month of a myocardial infarction.

Beta-Adalat should not be used for the treatment of acute attacks of angina.

The safety of Beta-Adalat in malignant hypertension has not been established.

Beta-Adalat should not be used for secondary prevention of myocardial infarction.

Beta-Adalat must not be used in conjunction with other drugs with a cardio-depressant action, e.g. verapamil, as conduction disturbances may ensue.

Beta-Adalat should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction (see Section 4.5).

Beta-Adalat should not be used in pronounced bradycardia (resting heart rate before treatment less than 50 beats/min), hypotension with systolic pressure less than 90 mm Hg, or in the late stages of circulatory disturbances in the hands and legs or in severe peripheral arterial circulatory disturbances.

Beta-Adalat should not be used in patients with a decline in the pH of the blood (acidosis).

In patients with phaeochromocytoma, Beta-Adalat must be administered only after prior therapy with alpha-blockers.

Beta-Adalat must not be given with simultaneous administration of monoamine oxidase inhibitors (MAO inhibitors).

Beta-Adalat must not be used in patients with marked renal impairment (i.e. creatine clearance below 15 ml/min/1.73m², serum creatine greater than 600 micromol/litre).

4.4 Special Warnings And Precautions For Use

Cardiac

Particular care should be taken with patients with conduction defects or whose cardiac reserve is poor. However, in patients already treated with a beta-adrenoceptor antagonist, and/or where signs of cardiac failure have been controlled, Beta-Adalat may be substituted with care if necessary.

Beta-Adalat should only be used with caution in patients with controlled congestive heart failure. Evidence of this condition worsening should be regarded as an indication to discontinue therapy.

Beta-Adalat may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Beta-Adalat will not prevent possible rebound effects after cessation of other antihypertensive therapy, (see Section 4.5).

In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta-blockers should be used with caution as aggravation of these disorders may occur.

Care should be taken in prescribing a beta-adrenoceptor blocking drug with Class I anti-dysrhythmic agents such as disopyramide.

One of the pharmacological actions of beta-adrenoceptor blocking drugs is to reduce heart rate. In the rare instances where symptoms may be attributable to the slow heart rate at a dose of one capsule daily, the drug should be discontinued.

Ischaemic pain has been reported in a small proportion of patients within one to four hours of the introduction of nifedipine therapy. Although a "steal" effect has not been demonstrated, patients experiencing this effect should discontinue Beta-Adalat.

Cessation of therapy with a beta-adrenoceptor blocking drug in patients with ischaemic heart disease should be gradual, if necessary initiating replacement therapy at the same time, to prevent exacerbation of angina pectoris.

Caution should be exercised when transferring patients from clonidine to beta-adrenoceptor blocking drugs. If beta-adrenoceptor blocking drugs are given concurrently, clonidine should not be discontinued until several days after withdrawal of the beta-adrenoceptor blocking drug.

Caution should be exercised in patients with severe hypotension (systolic pressure <90 mm Hg).

Caution should be exercised in cases of first degree heart block or mild heart failure, NYHA grade II.

Beta-blockers may increase the number and duration of anginal attacks in patients with Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Therefore, beta₁ selective blockers such as atenolol should be used with care.

Obstructive airways disease

Although cardioselective (beta₁) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should not be administered to patients with reversible obstructive airways disease.

Renal impairment

Dosage should not exceed one capsule daily in patients with renal dysfunction. The use of the combination is contra-indicated in patients with marked renal impairment, (see Section 4.3).

In dialysis patients with malignant hypertension and hypovolaemia, a marked decrease in blood pressure can occur.

Hepatic impairment

Care should be taken in patients with marked hepatic impairment. Although no dosage adjustment is suggested from the systemic availability of the monocomponents in patients with cirrhosis, hypertensive patients with clinically significant liver disease have not been studied. Nifedipine is metabolised primarily by the liver and therefore patients with liver dysfunction should be carefully monitored.

Anaesthesia

It is not advisable to withdraw beta-adrenoceptor blocking drugs prior to surgery in the majority of patients. However, care should be taken when using anaesthetic agents such as ether, cyclopropane and trichloroethylene. Vagal dominance, if it occurs, may be corrected with atropine (1-2 mg intravenously).

Diabetes

The use of nifedipine in diabetic patients may require adjustment of their control.

Beta-Adalat modifies the tachycardia of hypoglycaemia.

Beta-Adalat may mask the signs of thyrotoxicosis.

General

The benefits and risks must be carefully considered before drugs containing beta-receptor blockers (such as Beta-Adalat) are used in patients with a history or family history of psoriasis, patients with a history of severe hypersensitivity reactions and patients on desensitisation therapy (decreased adrenergic counter-regulation).

Whilst nifedipine is contra-indicated in pregnancy, particular care must be exercised when administering nifedipine in combination with i.v. magnesium sulphate to pregnant women.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Known Interactions

As with other dihydropyridines, nifedipine should not be taken with grapefruit juice as elevated plasma concentrations occur, due to a decreased first pass metabolism. As a consequence, the blood pressure lowering effect of nifedipine may be increased. After regular intake of grapefruit juice, this effect may last for at least three days after the last ingestion of grapefruit juice.

The antihypertensive effect of nifedipine can be potentiated by simultaneous administration of cimetidine.

When used in combination with nifedipine, serum quinidine levels may be suppressed regardless of dosage of quinidine. Therefore, monitoring of quinidine plasma levels and if necessary adjustment of the quinidine dosage are recommended. The pharmacokinetics of nifedipine may also be altered when used in combination with quinidine. It is therefore recommended to monitor blood pressure, and if necessary reduce the nifedipine dosage.

Phenytoin induces the cytochrome P450 3A4 system. Upon co-administration with phenytoin, the bioavailability of nifedipine is reduced and thus its efficacy weakened. When both drugs are concomitantly administered, the clinical response to nifedipine should be monitored and, if necessary, an increase of the nifedipine dose considered. If the dose of nifedipine is increased during co-administration of both drugs, a reduction of the nifedipine dose should be considered when the treatment with phenytoin is discontinued.

Beta-Adalat should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction (see Section 4.3).

Concomitant use of prostaglandin synthease inhibiting drugs (e.g. ibuprofen, indomethacin) may decrease the hypotensive effects of beta-blockers. When Beta-Adalat is administered simultaneously with reserpine, alpha-methyldopa, clonidine, guanethidine, guanfacine, or cardiac glycosides, the heart rate may decline more markedly, and stimulus conduction may be delayed.

Beta-Adalat can increase the plasma levels of digoxin and theophylline. Monitoring is therefore recommended, and in some cases a reduction of the dose may be necessary.

Beta-Adalat should be used with great caution in patients who are receiving concomitant myocardial depressants such as chloroform, lignocaine, procainamide, beta-adrenoceptor stimulants such as isoprenaline, or alpha-adrenoceptor stimulants such as noradrenaline.

If Beta-Adalat is administered simultaneously with another beta-blocker, in addition to a more marked decrease in the blood pressure, heart failure may develop. Simultaneous administration of intravenous beta -receptor blockers must therefore be avoided.

In patients with a hypoglycaemic metabolic disorder simultaneously treated with Beta-Adalat and insulin or oral antidiabetics, normalisation of the condition may be delayed, and the symptom of hypoglycaemia, tachycardia, be masked. Regular monitoring of the blood glucose is therefore necessary.

When Beta-Adalat is administered simultaneously with calcium antagonists of the verapamil or diltiazem type or antiarrhythmics, there may be a more marked decrease in the blood pressure, a decline in the heart rate, and disturbances of heart rhythm. Careful monitoring of the blood pressure and ECG is therefore necessary. Concomitant intravenous administration of calcium antagonists must be avoided during treatment with Beta-Adalat.

As diltiazem decreases the clearance of nifedipine, the combination of both drugs should be administered with caution.

Simultaneous therapy with noradrenaline or adrenaline as well as the administration of MAO-inhibitors can lead to an excessive increase in blood pressure.

Since simultaneous therapy with narcotics or antiarrhythmics adversely affects cardiac output, the anaesthetist should be informed that the patient is being treated with Beta-Adalat. If possible, Beta-Adalat should not be discontinued before the operation. However, it must be borne in mind that in the course of interaction of atenolol with narcotics or antiarrhythmics, cardiac output may be reduced more markedly, since the cardiac depressant effects (negative inotropism) of atenolol with narcotics or antiarrhythmics may be additive.

The action of non-depolarising muscle relaxant drugs may be potentiated by Beta-Adalat.

Nifedipine may increase the spectrophotometric values of urinary vanillylmandelic acid falsely. However, HPLC measurements are unaffected.

Simultaneous administration of cisapride and nifedipine or quinupristin/dalfopristin and nifedipine may lead to increased plasma concentrations of nifedipine. Consequently, the blood pressure should be monitored and, if necessary, the nifedipine dose reduced.

Potentiation of the blood pressure-lowering action must be anticipated when Beta-Adalat is used in combination with other antihypertensives or with diuretics, vasodilators, nitrates, narcotics, tricyclic antidepressants, barbiturates or phenothiazines, (see Section 4.4).

Theoretical Interactions

Nifedipine is metabolised via the cytochrome P450 3A4 system and, therefore, there are theoretical interactions for drugs which are known to inhibit this enzyme system (e.g. erythromycin, ketoconazole, itraconazole, fluconazole, fluoxetine, indinavir, nelfinavir, ritonavir, amprenavir and saquinavir). Although no formal in vivo interaction studies have been performed with these drugs, co-administration can be expected to lead to an increase in plasma concentrations of nifedipine. Blood pressure should therefore be monitored and, if necessary, a reduction in the nifedipine dose considered.

A clinical study investigating the potential of a drug interaction between nifedipine and nefazodone has not yet been performed. Nefazodone is known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore an increase in nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. When nefazodone is given together with nifedipine, the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.

Tacrolimus has been shown to be metabolised via the cytochrome P450 3A4 system. Upon co-administration of both drugs, the tacrolimus plasma concentrations should be monitored and, if necessary, a reduction in the tacrolimus dose considered.

Although no formal interaction studies have been performed between nifedipine and carbamazipine, phenobarbitone or valproic acid, these drugs have been shown to alter the plasma concentrations of a structurally similar calcium channel blocker. A decrease (carbamazipine, phenobarbitone) or an increase (valproic acid) in nifedipine plasma concentrations and hence an alteration in efficacy cannot be excluded.

4.6 Pregnancy And Lactation

Beta-Adalat is contra-indicated in women capable of child-bearing.

The safety of nifedipine for use in human pregnancy has not been established. Evaluation of experimental animal studies has shown reproductive toxicity consisting of embryotoxicity and teratogenic effects at maternally toxic doses.

Beta-Adalat is contra-indicated in nursing mothers, as nifedipine and atenolol may be present in breast milk.

In single cases of in vitro fertilisation calcium antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function. In those men who are repeatedly unsuccessful in fathering a child by in vitro fertilisation, and where no other explanation can be found, calcium antagonists like nifedipine should be considered as possible causes.

Theoretically, beta-blockers such as atenolol cause a decrease in placental blood flow, which can result in intrauterine foetal death, and immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonates. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.

4.7 Effects On Ability To Drive And Use Machines

Reactions to the drug, which vary in intensity from individual to individual, may impair the ability to drive or to operate machinery. This applies particularly at the start of treatment, on changing the medication and in combination with alcohol.

4.8 Undesirable Effects

Beta-Adalat is well tolerated. Side effects occur predominantly at the beginning of treatment or at high doses, and are generally mild and transient. In clinical studies, the undesired events reported are usually attributed to the pharmacological actions of its components. The following undesired events, listed by body system, have been reported:

Beta-Adalat

Cardiovascular:	flushing; oedema
CNS:	headache; dizziness
Digestive system:	gastrointestinal disturbance
Others:	fatigue

Atenolol monotherapy

Cardiovascular:	disturbances of AV conduction; bradycardia; heart failure deterioration; postural hypotension which may be associated with syncope; cold and cyanotic extremities; in susceptible patients: precipitation of heart block, intermittent claudication, Raynaud's phenomenon (cold extremities)
CNS:	confusion; mood changes; nightmares; psychosis and hallucinations; sleep disturbances of the type noted with other beta-blockers
Digestive system:	dry mouth
Metabolic:	hyperglycaemia which may cause latent diabetes mellitus to become manifest, or lead to deterioration in pre-existing diabetes; should a hypoglycaemic metabolic disorder develop in a patient with diabetes, it must be borne in mind that, under treatment with Beta-Adalat, normalisation of the condition may be delayed and the symptom of hypoglycaemia, tachycardia, be masked
Haematological:	purpura; thrombocytopenia
Skin:	alopecia; psoriasiform skin reactions; exacerbation of psoriasis; skin rashes
Musculo-skeletal:	joint reactions (lupus erythematosus-like syndrome)
Neurological:	paraesthesia; myasthenia
Respiratory:	bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints
Special senses:	visual disturbances; dry eyes
Urogenital:	impotence
Others:	an increase in ANA (antinuclear antibodies) has been observed, however the clinical relevance of this is not clear

Nifedipine monotherapy

Most side-effects are consequences of the vasodilatory effects of nifedipine and usually regress on withdrawal of therapy. Side-effects of nifedipine such as flushing and headache may occur at the beginning of the treatment. They are, however, mostly slight and diminish with continuous use. Other undesirable effects reported were:

Cardiovascular:	palpitations; tachycardia; syncopal episodes with initial dose due to blood pressure decrease; gravitational oedema; vasodilatation (flush, sensation of warmth, erythromelalgia); hypotension
CNS:	headache; dizziness; asthenia; lethargy; vertigo
Neurological:	paraesthesia; nervousness; tremor; mood changes
Digestive system:	altered bowel habit; nausea; feeling of repletion; gingival hyperplasia which usually regresses on withdrawal of therapy; disturbances of liver function such as increased transaminase or intra-hepatic cholestasis; rare cases of hypersensitivity-type jaundice have been reported
Metabolic:	initial hyperglycaemia
Skin:	pruritus; urticaria; exanthema; erythema; exfoliative dermatitis and photosensitive dermatitis; gynaecomastia in older men on long term therapy, which usually regresses on withdrawal of therapy
Hypersensitivity:	systemic allergic reactions
Musculo-skeletal:	myalgia
Respiratory:	dyspnoea
Special senses:	visual disturbances
Urogenital:	increased frequency of micturition; impotence may occur rarely
Haemic and lymphatic system:	purpura; agranulocytosis

As with other sustained release dihydropyridines, exacerbation of angina pectoris may occur rarely at the start of treatment with sustained release formulations of nifedipine. The occurrence of myocardial infarction has been described although it is not possible to distinguish such an event from the natural course of ischaemic heart disease.

4.9 Overdose

Clinical effects

As far as treatment is concerned, elimination of active substances and the restoration of stable cardiovascular conditions have priority.

The symptoms of overdosage may include bradycardia, hypotension, hypoglycaemia, acute cardiac insufficiency and bronchospasm.

These signs may not be fully manifested until several hours after ingestion.

Treatment

General treatment should include close supervision, treatment in an intensive care ward, the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of plasma and plasma substitutes to treat hypotension and shock.

Excessive bradycardia can be countered with atropine 1-2 mg intravenously. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. Intravenous calcium gluconate combined with metaraminol may be beneficial for hypotension induced by nifedipine. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 - 10 microgram/kg/minute by intravenous infusion may be given. Dobutamine, due to its positive inotropic effects could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

For bronchospasm: inhalation of beta₂ - stimulants such as salbutamol (2 puffs), or orciprenaline sulphate (0.5-1.0 mg) slowly iv. For generalised convulsions, administration of diazepam slowly intravenously is recommended.

Other possible treatments in cases of life-threatening intoxication are:

Pacemaker therapy, artificial ventilation and haemodialysis (atenolol) or plasma separation (nifedipine).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC codes:

C08C A55

Selective calcium channel blocker (dihydropyridine derivative) with mainly vascular effects.

Nifedipine, combinations.

C07F B03

Beta blocking agents, selective, and other antihypertensives.

Atenolol with other antihypertensives.

Atenolol is classified as a beta₁-selective (cardioselective) beta-adrenoceptor antagonist with no membrane-stabilising activity and no partial agonist activity. It is clearly the most hydrophilic of the currently available beta-blockers, and thus demonstrates poor penetration of cell membrane lipids. Atenolol has marked negative inotropic and chronotropic effects, thereby reducing cardiac output, myocardial oxygen demand, and blood pressure, particularly during exercise.

Nifedipine is a calcium antagonist of the 1,4-dihydropyridine type. Calcium antagonists reduce the transmembrane influx of calcium ions through the L-type calcium channels into the cell. Nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels.

The fixed combination of nifedipine 20 mg and atenolol 50 mg is designed for the antihypertensive treatment of patients whose blood pressure is inadequately controlled on monotherapy. This combination of a cardioselective, hydrophilic beta₁-adrenoceptor antagonist (atenolol), and a potent, specific calcium antagonist (nifedipine) lowers blood pressure to a greater extent than either of its individual components.

Nifedipine's tendency to increase heart rate and plasma renin activity is counteracted by beta-adrenoceptor blockade, while the tendency of atenolol to increase peripheral resistance is counterbalanced by the vasodilatation and reflex increase in sympathetic tone induced by the calcium antagonist.

There is no evidence of clinically significant negative inotropic, dromotropic or chronotropic effects with the combined use of nifedipine and atenolol in man compared with treatment with atenolol alone. Similarly, the chronic renal pharmacodynamic effects of the fixed combination are not dissimilar to the use of atenolol alone; the acute natriuretic, uricosuric and diuretic effects of nifedipine alone are not seen following chronic use of the fixed combination in man.

5.2 Pharmacokinetic Properties

The fixed combination of nifedipine 20 mg (slow release) and atenolol 50 mg is bioequivalent to its individual drug components, and there is no evidence of pharmacokinetic interaction between the two drugs.

In the elderly, the half life of nifedipine alone is increased from approximately 5½ hours to 9 hours, but peak plasma levels are unchanged.

The pharmacokinetics of atenolol 50 mg when dosed in free combination with nifedipine 20 mg (slow release) in the elderly were consistent with the published atenolol experience in demonstrating an approximately 45% increase in systemic bioavailability, with increased blood levels 24 hours after dosing in the elderly.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Nifedipine tablets: microcrystalline cellulose, maize starch, lactose, polysorbate 80, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (E171) and red iron oxide (E172).

Atenolol granules: heavy magnesium carbonate, maize starch, sodium lauryl sulphate, gelatin, magnesium stearate.

Capsule shell: red iron oxide (E172), titanium dioxide (E171) and gelatin.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Blister packs composed of PVC/PVDC foil backed with aluminium foil: 36 months.

Blister packs composed of PP foil backed with aluminium foil: 24 months.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

Blister packs composed of PVC/PVDC foil, backed with aluminium foil, each containing 28 capsules.

Blister packs composed of PP foil, backed with aluminium foil, each containing 28 capsules.

6.6 Special Precautions For Disposal And Other Handling

No additional information

7. Marketing Authorisation Holder

Bayer plc,

Bayer House,

Strawberry Hill,

Newbury

Berkshire

RG14 1JA

United Kingdom

Trading as Bayer plc, Bayer Schering Pharma.

8. Marketing Authorisation Number(S)

PL 0010/0155

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 25 July 1988

Date of last renewal: 19 September 2001

10. Date Of Revision Of The Text

2nd May 2008

LEGAL CATEGORY

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Saturday 30 June 2012

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