Top PLR Content Marketing Saba: August 2012

Wednesday 29 August 2012

Nafrinse Solution

Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N

What is Nafrinse Solution (fluoride topical)?

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

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

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

What is the most important information I should know about Nafrinse Solution (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

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

Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I discuss with my healthcare provider before using Nafrinse Solution (fluoride topical)?

Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.

Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use Nafrinse Solution (fluoride topical)?

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

Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.

Swish this medication in your mouth without swallowing. Then spit it out.

Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

Overdose symptoms may result if you swallow large amounts of fluoride while using it.

What should I avoid while using Nafrinse Solution (fluoride topical)?

Do not swallow fluoride topical. Spit it out after use.

Nafrinse Solution (fluoride topical) side effects

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

discolored teeth;

weakened tooth enamel; or

any changes in the appearance of your teeth.

Less serious side effects may include:

stomach upset;

headache; or

weakness.

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

What other drugs will affect Nafrinse Solution (fluoride topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Compare Nafrinse Solution with other medications

Prevention of Dental Caries

Where can I get more information?

Your pharmacist can provide more information about fluoride topical.

See also: Nafrinse side effects (in more detail)

Sunday 26 August 2012

Allergy Relief Multi-Symptom

Generic Name: acetaminophen, chlorpheniramine, and phenylephrine (a SEET a MIN oh fen, KLOR fen EER a meen, FEN ill EFF rin)

Brand Names: Alka-Seltzer Plus Cold, Allergy Relief Multi-Symptom, Comtrex Flu Therapy, Comtrex Severe Cold & Sinus, Contac Cold+Flu, Dristan Cold Multi Symptom Formula, Protid, Robitussin Nighttime Nasal Relief, Sinus Congestion & Pain Nighttime, Tylenol Allergy Multi-Symptom, Tylenol Children's Plus Cold, Tylenol Sinus Congestion and Pain Cool Burst Day Night, Tylenol Sinus Congestion Nighttime

What is Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine 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 acetaminophen, chlorpheniramine, and phenylephrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen, chlorpheniramine, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of chlorpheniramine. Do not use this medicine 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 before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine 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 this medicine if you have:

liver disease, cirrhosis, or a history of alcoholism;

a blockage in your digestive tract (stomach or intestines);

diabetes;

kidney disease;

epilepsy or other seizure disorder;

cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

enlarged prostate or urination problems;

low blood pressure;

pheochromocytoma (an adrenal gland tumor); or

if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether acetaminophen, chlorpheniramine, and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, 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. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

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.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when 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. 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of chlorpheniramine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, 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:

chest pain, rapid pulse, fast or uneven heart rate;

confusion, hallucinations, severe nervousness;

tremor, seizure (convulsions);

easy bruising or bleeding, unusual weakness;

urinating less than usual or not at all;

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

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

Less serious side effects may include:

dizziness, drowsiness;

mild headache;

dry mouth, nose, or throat;

constipation;

blurred vision;

feeling nervous; or

sleep problems (insomnia);

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 Allergy Relief Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

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

leflunomide (Arava);

topiramate (Topamax);

zonisamide (Zonegran);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

bladder or urinary medications;

blood pressure medication;

a bronchodilator;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, 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 Allergy Relief Multi-Symptom resources

Allergy Relief Multi-Symptom Use in Pregnancy & Breastfeeding
Allergy Relief Multi-Symptom Drug Interactions
0 Reviews for Allergy Relief Multi-Symptom - Add your own review/rating

Alka-Seltzer Plus Cold MedFacts Consumer Leaflet (Wolters Kluwer)

Dryphen MedFacts Consumer Leaflet (Wolters Kluwer)

Protid Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Tylenol Allergy Multi-Symptom MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Allergy Relief Multi-Symptom with other medications

Cold Symptoms
Sinus Symptoms

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and phenylephrine.

Friday 24 August 2012

Norgalax

1. Name Of The Medicinal Product

NORGALAX

2. Qualitative And Quantitative Composition

Norgalax contains the active ingredient Docusate Sodium 0.12 g in each 10 g micro-enema:

3. Pharmaceutical Form

Rectal gel.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic treatment of constipation whenever an enema is required and for the preparation of the colon and rectum for endoscopic examination.

4.2 Posology And Method Of Administration

Adults: use one micro-enema. If required, a second micro-enema may be used on the same or the next day.

Children: not recommended for children under 12 years old.

Norgalax is to be administered rectally. Remove the protective cap and insert the applicator into the rectum, squeezing gently until the tube is empty. A drop of the gel may be used as a lubricant if required.

4.3 Contraindications

Haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, ileus and known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

As with all laxatives, Norgalax should not be administered chronically. Prolonged use can precipitate the onset of an atonic non-functioning colon and hypokalaemia.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of docusate enema or oral docusate in pregnant women. Animal studies with oral docusate are insufficient with respect to effects on pregnancy and embryonic foetal development.

The potential risk for humans is unknown. As minimal systemic absorption cannot be ruled out following rectal application, Norgalax should be used in pregnancy only if the benefits outweigh the risks.

Lactation

It is unknown whether docusate is excreted in human breast milk. Animal studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. A decision on whether to continue/discontinue breast-feeding or continue/discontinue therapy with NORGALAX should be made taking into account the benefit of breast-feeding to the child and the benefit of NORGALAX therapy to the woman.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea

Skin disorders: urticaria

Hepatic disorders: cases of hepatotoxicity have been reported with oral intake of docusate taken together with other laxatives.

4.9 Overdose

Overdose will lead to excessive purgation which should be treated symptomatically.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Docusate sodium is an anionic surfactant and used as a faecal softening agent. It is considered to ease constipation by increasing the penetration of fluid into the faeces thereby causing them to soften. Norgalax is usually effective in 5 to 20 minutes.

5.2 Pharmacokinetic Properties

Norgalax has a local effect in the rectum. Minimal absorption cannot be ruled out even with a rectal application.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on studies of acute toxicity, repeated dose toxicity and in-vitro genotoxicity. Docusate sodium has been shown to exhibit developmental toxicity in rodents at oral doses that are maternally toxic and sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. High oral doses given during lactation reduced pup weight and survival which was attributed to docusate and its metabolites present in the milk of the dams.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol

Sodium carboxymethyl cellulose

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

The shelf life is 4 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

A polyethylene tube with fixed applicator and a cap closure, containing 10g of gel in pack sizes of 6 and 100 tubes.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Norgine Limited

Norgine House

Widewater Place

Moorhall Road

Harefield

UXBRIDGE

Middlesex UB9 6NS

United Kingdom

8. Marketing Authorisation Number(S)

PL 0322/0065.

9. Date Of First Authorisation/Renewal Of The Authorisation

February 1999

10. Date Of Revision Of The Text

July 2010

Thursday 23 August 2012

cefixime

sef-IX-eem

Commonly used brand name(s)

In the U.S.

Suprax

Available Dosage Forms:

Tablet

Powder for Suspension

Therapeutic Class: Antibiotic

Pharmacologic Class: 3rd Generation Cephalosporin

Uses For cefixime

Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, cefixime will not work for colds, flu, or other virus infections.

cefixime is available only with your doctor's prescription.

Before Using cefixime

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 cefixime, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cefixime 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefixime in children. However, safety and efficacy have not been established in infants younger than 6 months of age.

Geriatric

No information is available on the relationship of age to the effects of cefixime in geriatric patients.

Pregnancy

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

Breast Feeding

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. 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 cefixime

Take cefixime 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.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using cefixime for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of cefixime 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 cefixime. 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 forms (suspension or tablets):
- For infections:
  - Adults and children above 12 years of age and weighing more than 50 kilograms (kg)—400 milligrams (mg) once a day or 200 mg every 12 hours.
  - Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose or divided in two doses (4 mg/kg every 12 hours).
  - Infants up to 6 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of cefixime, 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

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.

Store the oral liquid either at room temperature or in the refrigerator. Throw away any unused medicine after 14 days.

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

Precautions While Using cefixime

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

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

Cefixime may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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

cefixime 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

Diarrhea

loose or frequent stools

Less common

Abdominal or stomach pain

agitation

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

chest pain

chills

clay-colored stools

coma

confusion

cough

dark urine

decreased urine output

depression

difficulty with swallowing

dizziness

fast heartbeat

feeling of discomfort

fever

general tiredness and weakness

headache

hives

hostility

inflammation of the joints

irritability

itching

joint or muscle pain

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

lethargy

light-colored stools

loss of appetite

lower back or side pain

muscle aches

muscle twitching

nausea and vomiting

painful or difficult urination

pale skin

pinpoint red spots on the skin

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

rapid weight gain

rash

red skin lesions, often with a purple center

red, irritated eyes

seizures

shortness of breath

sore throat

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

stupor

swelling of the face, ankles, or hands

swollen glands

swollen lymph glands

tightness in the chest

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting of blood

wheezing

yellow eyes or skin

Incidence not known

Abdominal or stomach cramps or tenderness

back, leg, or stomach pains

cough or hoarseness

coughing up blood

diarrhea, watery and severe, which may also be bloody

difficulty with breathing

general body swelling

increased menstrual flow or vaginal bleeding

increased thirst

nosebleeds

pain paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

sudden decrease in the amount of urine

unpleasant breath odor

unusual weight loss

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

belching

bloated

excess air or gas in the stomach or intestines

full feeling

heartburn

hives or welts

indigestion

itching of the vagina or genital area itching or pain of the genital area

pain during sexual intercourse

passing gas

redness of the skin

stomach discomfort, upset, or pain

thick, white vaginal discharge with no odor or with a mild odor

white patches in the mouth or throat or on the tongue

white patches with diaper rash

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: cefixime side effects (in more detail)

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More cefixime resources

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

cefixime Concise Consumer Information (Cerner Multum)

Cefixime Professional Patient Advice (Wolters Kluwer)

Cefixime MedFacts Consumer Leaflet (Wolters Kluwer)

Cefixime Monograph (AHFS DI)

Suprax Prescribing Information (FDA)

Compare cefixime with other medications

Bladder Infection
Bronchitis
Gonococcal Infection, Disseminated
Gonococcal Infection, Uncomplicated
Kidney Infections
Otitis Media
Pneumonia
Sinusitis
STD Prophylaxis
Tonsillitis/Pharyngitis
Upper Respiratory Tract Infection
Urinary Tract Infection

Golytely

Generic Name: polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate (Oral route)

pol-ee-ETH-i-leen GLYE-kol 3350, poe-TAS-ee-um KLOR-ide, SOE-dee-um bye-KAR-bo-nate, SOE-dee-um KLOR-ide, SOE-dee-um SUL-fate

Commonly used brand name(s)

In the U.S.

Colyte

Colyte with Flavor Packs

GaviLyte-C with Flavor Pack

Golytely

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Laxative, Hyperosmotic

Uses For Golytely

The polyethylene glycol (PEG) and electrolytes solution is used to clean the colon (large bowel or lower intestine) before certain tests or surgery of the colon. The PEG-electrolyte solution is usually taken by mouth. However, sometimes it is given in the hospital through a nasogastric tube (a tube inserted through the nose).

The PEG-electrolyte solution acts like a laxative. It causes liquid stools or mild diarrhea. In this way, it flushes all solid material from the colon, so the doctor can have a clear view of the colon.

The PEG-electrolyte solution is available only with your doctor's prescription.

Before Using Golytely

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

Although there is no specific information comparing use of PEG-electrolyte solution in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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

PotassiumPolyethylene Glycol

Sodium BicarbonateSodium Chloride

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.

Amantadine

Atropine

Belladonna

Belladonna Alkaloids

Benztropine

Biperiden

Clidinium

Darifenacin

Dicyclomine

Eplerenone

Glycopyrrolate

Hyoscyamine

Methscopolamine

Oxybutynin

Procyclidine

Scopolamine

Solifenacin

Tolterodine

Trihexyphenidyl

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.

Alacepril

Amiloride

Benazepril

Canrenoate

Captopril

Cilazapril

Delapril

Enalaprilat

Enalapril Maleate

Fosinopril

Imidapril

Indomethacin

Licorice

Lisinopril

Moexipril

Pentopril

Perindopril

Quinapril

Ramipril

Spirapril

Spironolactone

Temocapril

Trandolapril

Triamterene

Zofenopril

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.

Dasatinib

Itraconazole

Licorice

Interactions with Food/Tobacco/Alcohol

Proper Use of polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate

This section provides information on the proper use of a number of products that contain polyethylene glycol, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate. It may not be specific to Golytely. Please read with care.

Your doctor may have special instructions for you, depending on the type of test you are going to have. If you have not received such instructions or if you do not understand them, check with your doctor in advance.

Take the PEG-electrolyte solution exactly as directed . Otherwise, the test you are going to have may not work and may have to be done again.

It will take close to 3 hours to drink all of the PEG-electrolyte solution. The first bowel movement may start an hour or so after you start drinking the solution. Continue drinking all the solution to get the best results, unless otherwise directed by your doctor.

Do not eat anything for at least 3 hours before taking the PEG-electrolyte solution. If you do so, the colon may not get completely clean. If you are drinking the PEG-electrolyte solution the evening before the test, you may drink clear liquids (e.g., water, ginger ale, decaffeinated cola, decaffeinated tea, broth, gelatin) up until the time of the test. However, check first with your doctor.

For patients using the powder form of this medicine :

The powder must be mixed with water before it is used. Add lukewarm water to the fill mark on the bottle.

Shake well until all the ingredients are dissolved.

Do not add any other ingredients, such as flavoring, to the solution.

After you mix the solution, you must use it within 48 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.

For cleaning the colon:
- For oral dosage forms (oral solution and powder for oral solution):
  - Adults and teenagers—Drink one full glass (8 ounces) of the PEG-electrolyte solution rapidly every ten minutes. If you sip small amounts of the solution, it will not work as well.
  - Children—The amount of PEG-electrolyte solution taken is based on body weight and must be determined by your doctor. It is usually 25 to 40 milliliters (mL) per kilogram (kg) (11.3 to 18.2 mL per pound) of body weight per hour.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Golytely Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Skin rash

More common

Bloating

nausea

Less common

Abdominal or stomach cramps

irritation of the anus

vomiting

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: Golytely side effects (in more detail)

More Golytely resources

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

Colyte Prescribing Information (FDA)

Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)

GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)

MoviPrep Prescribing Information (FDA)

MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)

MoviPrep Consumer Overview

NuLYTELY Prescribing Information (FDA)

NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Golytely with other medications

Bowel Preparation
Constipation, Chronic
Gastrointestinal Decontamination

Sunday 12 August 2012

Phenylephrine/Potassium Guaiacolsulfonate Liquid

Pronunciation: fen-ill-EF-rin/poe-TASS-ee-uhm gwie-ah-kole-SULL-foe-nate
Generic Name: Phenylephrine/Potassium Guaiacolsulfonate
Brand Name: KGS-PE

Phenylephrine/Potassium Guaiacolsulfonate Liquid is used for:

Relieving symptoms of congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Phenylephrine/Potassium Guaiacolsulfonate Liquid is a decongestant and expectorant combination. It works by constricting blood vessels and shrinking swollen and congested nasal tissues (mucous membranes) and by thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Phenylephrine/Potassium Guaiacolsulfonate Liquid if:

you are allergic to any ingredient in Phenylephrine/Potassium Guaiacolsulfonate Liquid

you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Phenylephrine/Potassium Guaiacolsulfonate Liquid:

Some medical conditions may interact with Phenylephrine/Potassium Guaiacolsulfonate Liquid. 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 fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, or an overactive thyroid

if you have chronic cough

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

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Phenylephrine/Potassium Guaiacolsulfonate Liquid may be increased

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine because side effects may be increased by Phenylephrine/Potassium Guaiacolsulfonate Liquid

Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Phenylephrine/Potassium Guaiacolsulfonate Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Potassium Guaiacolsulfonate Liquid 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 Phenylephrine/Potassium Guaiacolsulfonate Liquid:

Use Phenylephrine/Potassium Guaiacolsulfonate Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Phenylephrine/Potassium Guaiacolsulfonate Liquid may be taken with or without food.

Take Phenylephrine/Potassium Guaiacolsulfonate Liquid with a full glass of water unless your doctor directs otherwise.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

If you miss a dose of Phenylephrine/Potassium Guaiacolsulfonate Liquid, 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 Phenylephrine/Potassium Guaiacolsulfonate Liquid.

Important safety information:

Phenylephrine/Potassium Guaiacolsulfonate Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenylephrine/Potassium Guaiacolsulfonate Liquid. Using Phenylephrine/Potassium Guaiacolsulfonate Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Do not take diet or appetite control medicines while you are taking Phenylephrine/Potassium Guaiacolsulfonate Liquid without checking with you doctor.

Do NOT exceed the recommended dose or use/take Phenylephrine/Potassium Guaiacolsulfonate Liquid for longer than prescribed without checking with your doctor.

Phenylephrine/Potassium Guaiacolsulfonate Liquid contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

Phenylephrine/Potassium Guaiacolsulfonate Liquid may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Phenylephrine/Potassium Guaiacolsulfonate Liquid.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Phenylephrine/Potassium Guaiacolsulfonate Liquid.

Use Phenylephrine/Potassium Guaiacolsulfonate Liquid with caution in the ELDERLY because they may be more sensitive to its effects.

Caution is advised when using Phenylephrine/Potassium Guaiacolsulfonate Liquid in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Phenylephrine/Potassium Guaiacolsulfonate Liquid, discuss with your doctor the benefits and risks of using Phenylephrine/Potassium Guaiacolsulfonate Liquid during pregnancy. It is unknown if Phenylephrine/Potassium Guaiacolsulfonate Liquid is excreted in breast milk. Do not breast-feed while taking Phenylephrine/Potassium Guaiacolsulfonate Liquid.

Possible side effects of Phenylephrine/Potassium Guaiacolsulfonate Liquid:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: Phenylephrine/Potassium Guaiacolsulfonate 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Phenylephrine/Potassium Guaiacolsulfonate Liquid:

Store Phenylephrine/Potassium Guaiacolsulfonate Liquid 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 Phenylephrine/Potassium Guaiacolsulfonate Liquid out of the reach of children and away from pets.

General information:

If you have any questions about Phenylephrine/Potassium Guaiacolsulfonate Liquid, please talk with your doctor, pharmacist, or other health care provider.

Phenylephrine/Potassium Guaiacolsulfonate Liquid 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 Phenylephrine/Potassium Guaiacolsulfonate Liquid. 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 Phenylephrine/Potassium Guaiacolsulfonate resources

Phenylephrine/Potassium Guaiacolsulfonate Side Effects (in more detail)
Phenylephrine/Potassium Guaiacolsulfonate Use in Pregnancy & Breastfeeding
Phenylephrine/Potassium Guaiacolsulfonate Drug Interactions
Phenylephrine/Potassium Guaiacolsulfonate Support Group
0 Reviews · Be the first to review/rate this drug

Chlor-Trimeton Nasal Decongestant

Generic Name: pseudoephedrine (Oral route)

soo-doe-e-FED-rin

Commonly used brand name(s)

In the U.S.

12 Hour Cold Maximum Strength

Biofed

Cenafed

Chlor-Trimeton Nasal Decongestant

Contac 12-Hour

Dimetapp Decongestant

Efidac 24 Pseudoephedrine

ElixSure Congestion Children's

Genaphed

Pediacare Decongestant Infants

Simply Stuffy

Sudafed

Available Dosage Forms:

Capsule, Extended Release

Tablet, Chewable

Tablet, Extended Release

Solution

Syrup

Liquid

Tablet

Capsule

Capsule, Liquid Filled

Suspension

Therapeutic Class: Decongestant

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For Chlor-Trimeton Nasal Decongestant

Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Chlor-Trimeton Nasal Decongestant

Allergies

Pediatric

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

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 pseudoephedrine in the elderly with use in other age groups.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Guanethidine

Methyldopa

Midodrine

Interactions with Food/Tobacco/Alcohol

Proper Use of pseudoephedrine

This section provides information on the proper use of a number of products that contain pseudoephedrine. It may not be specific to Chlor-Trimeton Nasal Decongestant. Please read with care.

For patients taking pseudoephedrine extended-release capsules:

Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

Swallow the tablet whole.

Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Dosing

For nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  - Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  - Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  - Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
  - Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  - Infants and children up to 12 years of age—Use is not recommended .

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.

Precautions While Using Chlor-Trimeton Nasal Decongestant

If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.

Chlor-Trimeton Nasal Decongestant Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

Rare - more common with high doses

Convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

irregular or slow heartbeat

shortness of breath or troubled breathing

Symptoms of overdose

Convulsions (seizures)

fast breathing

hallucinations (seeing, hearing, or feeling things that are not there)

increase in blood pressure

irregular heartbeat (continuing)

shortness of breath or troubled breathing (severe or continuing)

slow or fast heartbeat (severe or continuing)

unusual nervousness, restlessness, or excitement

More common

Nervousness

restlessness

trouble in sleeping

Less common

Difficult or painful urination

dizziness or light-headedness

fast or pounding heartbeat

headache

increased sweating

nausea or vomiting

trembling

unusual paleness

weakness

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: Chlor-Trimeton Nasal Decongestant side effects (in more detail)

More Chlor-Trimeton Nasal Decongestant resources

Chlor-Trimeton Nasal Decongestant Side Effects (in more detail)
Chlor-Trimeton Nasal Decongestant Use in Pregnancy & Breastfeeding
Chlor-Trimeton Nasal Decongestant Drug Interactions
0 Reviews for Chlor-Trimeton Nasal Decongestant - Add your own review/rating

Compare Chlor-Trimeton Nasal Decongestant with other medications

Nasal Congestion

Saturday 11 August 2012

Ursofalk Capsules

URSOFALK

URSODEOXYCHOLIC ACID 250mg

Please read this leaflet carefully before you start to take your medicine.
It does not contain complete information about your treatment. If you have any other questions, or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all your medicine. You may want to read it again.

The name of this medicine is Ursofalk. The active ingredient is ursodeoxycholic acid and each capsule contains 250mg of this ingredient. These capsules also contain maize starch, silicon dioxide, magnesium stearate, gelatin and titanium dioxide.

Each carton of Ursofalk is available in pack sizes of 60 and 100 capsules.

Ursodeoxycholic acid is a bile salt which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts. It is also used to lower the amount of cholesterol excreted in the bile.

Product Licence Holder:

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

Manufactured by:

Dr Falk Pharma GmbH

D-79041 Freiburg

Germany

Ursofalk may be used to treat the following:

A type of liver disease known as primary biliary cirrhosis (PBC).

Certain types of gallstones known by doctors as cholesterol or radiolucent gallstones.

Before taking Ursofalk

If the answer to any of the following questions is yes, tell your doctor.

Are you allergic to any of the ingredients?

Are you pregnant, think you may be pregnant or are trying to become pregnant?

Have you been told that you have another type of stone (non-cholesterol or radioopaque gallstone) or that your gall bladder doesn’t work properly?

Are you taking an oral contraceptive or any other female hormones such as hormone replacement therapy?

Are you taking cholestyramine, colestipol, clofibrate or any other medicine to lower your blood cholesterol?

Are you taking an adsorbent such as charcoal?

Are you taking any antacids or medicines for indigestion?

Are you taking cyclosporin?

Are you taking any other medicines which your doctor does not know about?

Taking Ursofalk

It is important to take Ursofalk as directed by your doctor. The usual adult dose is one or two capsules taken two to four times daily. The dose for a child may be less. The label will tell you how many to take and how often, but if it does not or you are unsure ask your doctor or pharmacist. If you are being treated for gallstones take the last dose with food before you go to bed.

The capsules should be swallowed whole with a glass of water.

You may need to take Ursofalk for many months for it to work.

If you accidentally take too many capsules either contact your doctor as soon as possible or go to the nearest hospital casualty department.

If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label.

If you go into hospital or visit a dentist or another doctor tell them you are taking this medicine.

If you become pregnant whilst taking Ursofalk tell your doctor.

Like all medicines, Ursofalk may occasionally cause side-effects in some people. Normally these are mild but if you experience the following effect stop taking the capsules and tell your doctor as soon as possible.

Diarrhoea.

If you experience any other undesirable effects then tell your doctor or pharmacist, particularly if they are severe or persistent.

Storing Ursofalk

You may store your Ursofalk capsules wherever you like. Keep them out of the reach of children because your medicine could harm them.

Check the expiry date on the side of the carton or blister pack and do not use the capsules if this date has been passed.

If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.

If the capsules look to be deteriorating in any way, do not take them, and return them to the pharmacist.

Date leaflet prepared: November 2004.

PL 10341/0006.

This leaflet provides a summary of the information available on your medicine.

This information applies only to Ursofalk. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.

You may also wish to contact the following national organisation which offers help, advice and local support groups:

Primary Biliary Cirrhosis Foundation

54 Queen Street

Edinburgh

EH2 3NS

Telephone:0131 225 8586

REMEMBER: This medicine is yours. Never give it to others. It may not be suitable for them even if their symptoms are the same as yours.

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

60004516

GB/01.05

Metoclopramide 10mg Tablets

1. Name Of The Medicinal Product

Metoclopramide 10mg Tablets

2. Qualitative And Quantitative Composition

Active constituents: metoclopramide hydrochloride BP 10.55* mg.

*10.55 mg equivalent to 10mg anhydrous metoclopramide hydrochloride BP.

3. Pharmaceutical Form

White uncoated tablet. Side one embossed “a” and “M/10” on either side of breakline, intended for oral administration to human beings.

4. Clinical Particulars

4.1 Therapeutic Indications

In patients above 20 years:

Anti-emetic and accelerator of gastric emptying.

In patients below 20 years:

The use of metoclopramide in patients under 20 years should be restricted to the following: Severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, as an aid to gastrointestinal intubation, and as part of the premedication before surgical procedures.

4.2 Posology And Method Of Administration

For use as directed by the physician.

Route of Administration

Oral

Adults 20 years and over: 10 mg three times daily

For patients of less than 60 kg see below

Young adults and children:

Metoclopramide should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation. In the treatment of this group attention should be given to body weight.

Young adults

15-19 years 60 kg and over	10 mg three times daily
30-59 kg	5 mg three times daily

Tablets should not be used in children under the age of 15.

In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at a reduced dosage. Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.

4.3 Contraindications

Metoclopramide should not be used in patients with pheochromocytoma as it may induce an acute hypertensive response.

Metoclopramide should not be used in patients with gastro-intestinal obstruction, perforation or haemorrhage; Metoclopramide should not be used during the first 3-4 days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.

Metoclopramide is contra-indicated in patients who have previously shown hypersensitivity to Metoclopramide or any of its components.

Metoclopramide is contraindicated in neonates.

4.4 Special Warnings And Precautions For Use

If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.

Care should be exercised in epileptic patients and patients being treated with other centrally acting drugs

Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria.

Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as the phenothiazines, particular care should be exercised in the event of these drugs being prescribed concurrently.

Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used (see 4.8. undesirable effects).

The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy. (See section 4.8)

Metoclopramide should be used with care in combination with other serotonergic drugs including SSRIs. (See section 4.5)

Special care should be taken in cases of severe renal and hepatic insufficiency. (See section 4.2)

Patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Actions of metoclopramide on the gastrointestinal tract are antagonized by anticholinergics and opioid analgesics.

The effect of metoclopramide on gastric motility may modify the absorption of other drugs from the gastrointestinal tract. Drugs known to be affected in this way include aspirin and paracetamol.

Metoclopramide moderately increases the absorption of ciclosporin and raises its blood levels.

Metoclopramide may enhance and prolong the neuromuscular blocking effects of Suxamethonium and Mivacurium.

Since extrapyramidal reactions may occur with metoclopramide, Phenothiazines and Tetrabenazine, care should be exercised in the event of coadministration of these drugs.

Metoclopramide should be used with care in association with other drugs acting at central dopamine receptors, such as levodopa, bromocriptine pergolide.

The use of Metoclopramide with serotonergic drugs may increase the risk of serotonin syndrome.

Metoclopramide may reduce plasma concentrations of atovaquone.

4.6 Pregnancy And Lactation

Neither clinical experience nor animal tests in several mammalian species have indicated a teratogenic effect.

Not to be used in pregnancy unless there are compelling reasons and should not be used in the first trimester.

During lactation metoclopramide is found in breast milk, therefore it should not be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

Metoclopramide may cause side effects including drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

4.8 Undesirable Effects

Blood and lymphatic disorders:

Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of Metoclopramide. If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue.

Methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency particularly in neonates.

Immune system disorders:

Very rarely hypersensitivity, including anaphylaxis has been reported.

Endocrine disorders:

Raised serum prolactin levels have been observed during metoclopramide therapy; this may result in galactorrhoea, irregular periods and gynaecomastia.

Psychiatric disorders:

Rarely, restlessness, confusion, agitation and anxiety have been reported in patients receiving metoclopramide therapy.

Depression has been reported extremely rarely.

Nervous system disorders:

Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, have been reported. The incidence of dystonic reactions, particularly in children and young adults, is increased if daily dosages higher than 0.5mg per kg body weight are administered. Dystonic reactions include: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra-ocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required an anticholinergic anti-Parkinsonian drug, or a benzodiazepine may be used.

Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the drug, particularly in children and young adults (see Section 4.4.).

Tardive dyskinesia, which may be persistent, has been reported as a side effect in elderly patients undergoing longterm therapy with metoclopramide. Prolonged therapy in such patients should be carefully reviewed. The likelihood of the occurrence of this serious effect is increased when neuroleptic agents are used concurrently.

Very rare occurrences of the neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of creatine phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.

Drowsiness, lassitude, dizziness and tremor may occur.

Eye disorders:

Visual disturbances have been reported.

Vascular disorders:

Acute hypertension may occur in patients with phaeochromocytoma (see section 4.3).

Hypotension has been reported.

Respiratory, thoracic and mediastinal disorders:

Dyspnoea.

Gastrointestinal disorders:

Diarrhoea, oedema of the tongue.

Skin and subcutaneous tissue disorders:

A small number of skin reactions such as rashes, urticaria, pruritus and oedema have been reported.

General disorders and administration site conditions:

Oedema.

4.9 Overdose

Possible symptoms of overdosage include drowsiness, disorientation and extrapyramidal reactions. In cases of overdosage, acute dystonic reactions have occurred. An anticholinergic, anti-parkinsonian drug may be used to control extrapyramidal reactions, a benzodiazepine may also be effective. General supportive measure should be instituted. Treatment for extrapyramidal disorders is only symptomatic (benzodiazepines in children).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

None stated.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose	BP
Maize starch	BP
Povidone	BP
Industrial methylated spirits	BP
Aerosil/moisture*
Magnesium Stearate	BP
Maize starch	BP

*Aerosil/Moisture

Colloidal Silicon Dioxide BP/Ph.Eur.

Purified water BP

6.2 Incompatibilities

None stated.

6.3 Shelf Life

48 months (securitainers).

24 months (blister packs).

6.4 Special Precautions For Storage

Protect from light.

Store in a cool dry place.

6.5 Nature And Contents Of Container

Tablets are contained in polypropylene securitainers with tamper evident polypropylene caps. Packs sizes of 21, 28, 56, 84, 100, 112 and 500.

Tablets are packed in blister of 28.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

12-16 Addiscombe Road

Croydon

Surrey

CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0123

9. Date Of First Authorisation/Renewal Of The Authorisation

25 July 2001

10. Date Of Revision Of The Text

20 July 2011

Wednesday 29 August 2012

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Sunday 26 August 2012

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Friday 24 August 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Thursday 23 August 2012

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