Pepcid AC

Generic Name: famotidine (Oral route)

fam-OH-ti-deen

Commonly used brand name(s)

In the U.S.

• Heartburn Relief


• Pepcid


• Pepcid AC

Available Dosage Forms:

• Tablet


• Powder for Suspension


• Tablet, Chewable


• Tablet, Disintegrating

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Histamine H2 Antagonist

Uses For Pepcid AC

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. It is also used to treat certain conditions where there is too much acid in the stomach (e.g., Zollinger-Ellison syndrome, endocrine tumors).

Famotidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.

This medicine is available with your doctor's prescription and also without a prescription. For the prescription form, there is more medicine in each tablet. Your doctor will have special instructions on the proper use and dose for your medical problem.

Before Using Pepcid AC

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of famotidine in children.

Geriatric

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

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. 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.

• Atazanavir


• Dasatinib


• Delavirdine


• Rilpivirine


• Tizanidine


• Tolazoline

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.

• Cefditoren Pivoxil


• Cefpodoxime Proxetil


• Cyclosporine


• Itraconazole

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of famotidine

This section provides information on the proper use of a number of products that contain famotidine. It may not be specific to Pepcid AC. Please read with care.

Take this medicine exactly as directed by your doctor or as directed on the package. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Keep using this medicine for the full time of treatment, even if you begin to feel better.

Measure the oral liquid with a marked measuring spoon or medicine cup. The average household teaspoon may not hold the right amount of liquid.

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 forms (suspension, tablets):
  
  • To treat stomach ulcers:
    
    • Adults—20 milligrams (mg) one or two times per day or 40 mg once a day at bedtime.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose at bedtime or divided in two doses. The total dose is usually not more than 40 mg per day.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    • Adults—20 milligrams (mg) two times per day.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
    
    
    • Infants 3 months to 1 year of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day.
    
    
    • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose once a day.
    
    
  
  
  • To treat erosive esophagitis (heartburn):
    
    • Adults—10, 20, or 40 milligrams (mg) two times per day.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
    
    
  
  
  • To treat too much stomach acid (Zollinger-Ellison syndrome):
    
    • Adults—20 milligrams (mg) every 6 hours. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Throw away any unused oral liquid after 30 days.

Precautions While Using Pepcid AC

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

If your condition does not improve, or if it become worse, check with your doctor.

Pepcid AC 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

• Bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• bloody, black, or tarry stools


• chest pain


• chills


• cough or hoarseness


• diarrhea


• fever


• fever with or without chills


• general feeling of tiredness or weakness


• high fever


• itching


• joint or muscle pain


• lower back or side pain


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• sore throat


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


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain


• anxiety


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• clay-colored stools


• dark urine


• depression


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dry mouth


• fainting


• false sense of well-being


• fast, irregular, pounding, or racing heartbeat or pulse


• headache


• hives


• hyperventilation


• irritability


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


• loss of appetite


• loss of bladder control


• loss of consciousness


• mood swings


• nausea


• nervousness


• noisy breathing


• personality changes


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


• rash


• restlessness


• seizures


• shaking


• skin rash


• swelling around the eyes


• tightness in the chest


• total body jerking


• trouble with sleeping


• troubled with breathing


• unpleasant breath odor


• vision changes


• vomiting of blood


• wheezing


• yellow eyes or skin

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

Less common

• Difficulty having a bowel movement (stool)

Rare

• Swelling of the breasts or breast soreness in both females and males

Incidence not known

• Abdominal or stomach discomfort


• blemishes on the skin


• change in taste or bad, unusual or unpleasant (after) taste


• continuing ringing or buzzing or other unexplained noise in the ears


• decreased interest in sexual intercourse


• difficulty with moving


• dry skin


• fear


• hair loss or thinning of the hair


• hearing loss


• hives or welts


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• mood or mental changes


• muscle cramps


• muscle stiffness


• pimples


• redness of the skin


• redness of the white part of the eyes


• seeing, hearing, or feeling things that are not there


• sleeplessness


• unable to sleep


• weight loss

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: Pepcid AC side effects (in more detail)

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More Pepcid AC resources

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

• Pepcid AC MedFacts Consumer Leaflet (Wolters Kluwer)


• Famotidine Professional Patient Advice (Wolters Kluwer)


• Famotidine Monograph (AHFS DI)


• Pepcid Consumer Overview


• Pepcid Prescribing Information (FDA)


• Pepcid Injection Prescribing Information (FDA)

Compare Pepcid AC with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Indigestion
• Pathological Hypersecretory Conditions
• Peptic Ulcer
• Stomach Ulcer
• Upper GI Hemorrhage
• Urticaria
• Zollinger-Ellison Syndrome

Pediatex TDM Suspension

Pronunciation: SOO-doe-e-FED-rin/trye-PROE-li-deen/DEX-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Triprolidine/Dextromethorphan
Brand Name: Pediatex TDM

Pediatex TDM Suspension is used for:

Relieving symptoms of hay fever, allergies, or the common cold, including cough, nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy or watery eyes. It may also be used for other conditions as determined by your doctor.

Pediatex TDM Suspension is an antihistamine, decongestant, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pediatex TDM Suspension if:

• you are allergic to any ingredient in Pediatex TDM Suspension


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


• you are unable to urinate or are having an asthma attack


• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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

Before using Pediatex TDM Suspension:

Some medical conditions may interact with Pediatex TDM Suspension. 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 adrenal gland problems (eg, an adrenal gland tumor), a heart problem (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

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

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


• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Pediatex TDM Suspension's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Pediatex TDM Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pediatex TDM Suspension

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

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

• Pediatex TDM Suspension may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use.


• 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 Pediatex TDM Suspension and are taking it regularly, 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 Pediatex TDM Suspension.

Important safety information:

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


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Pediatex TDM Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Avoid drinking alcohol while you are taking Pediatex TDM Suspension.


• Do not take diet or appetite control medicines while you are taking Pediatex TDM Suspension without checking with your doctor.


• If your symptoms do not get better within 7 days, if they get worse, or if they occur along with a fever, headache, or rash, check with your doctor.


• Diabetes patients - Pediatex TDM Suspension may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• Pediatex TDM Suspension has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Pediatex TDM Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do not exceed the recommended dose or take Pediatex TDM Suspension for longer than prescribed without checking with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pediatex TDM Suspension.


• Pediatex TDM Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pediatex TDM Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Pediatex TDM Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pediatex TDM Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Pediatex TDM Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Pediatex TDM Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Pediatex TDM Suspension is not recommended for use in CHILDREN younger than 6 years without first checking with your doctor.


• Caution is advised when using Pediatex TDM Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Pediatex TDM Suspension while you are pregnant. Pediatex TDM Suspension is found in breast milk. Do not breast-feed while taking Pediatex TDM Suspension.

Possible side effects of Pediatex TDM Suspension:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; upset stomach; vomiting; 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); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of the mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

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.

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; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pediatex TDM Suspension:

Store Pediatex TDM Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pediatex TDM Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Pediatex TDM Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Pediatex TDM Suspension 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 Pediatex TDM Suspension. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

Solpadeine Max Soluble Tablets

1. Name Of The Medicinal Product

Solpadeine Max Soluble Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph. Eur. 500 mg, Codeine Phosphate Hemihydrate Ph. Eur. 12.8 mg and Caffeine Ph Eur 30 mg.

3. Pharmaceutical Form

Effervescent tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Solpadeine Max Soluble Tablets are recommended for the relief of headache, migraine, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica.

4.2 Posology And Method Of Administration

For oral administration

Adults (including the elderly)

2 tablets dissolved in at least half a tumbler of water up to four times a day if necessary.

Do not take more than 8 tablets in 24 hours.

Children

Not recommended for children under 12 years of age.

Do not take for more than 3 days continuously without medical review.

4.3 Contraindications

Solpadeine Max Soluble Tablets are contraindicated in patients with hypersensitivity to paracetamol, codeine, caffeine or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Solpadeine Max Soluble Tablets contain 427 mg sodium in each tablet. This should be taken into account where the patient has been placed on a restricted sodium intake e.g. patients with hypertension, cardiac or renal insufficiency, oedema or pregnancy.

Care is advised in the administration of Solpadeine Max Soluble Tablets to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

• Do not exceed the stated dose.

• Patients should be advised not to take other paracetamol-containing or codeine-containing products concurrently.

• If symptoms persist consult your doctor

• Keep out of the reach of children.

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

The label will state:

Front of pack

• Can cause addiction

• Use for 3 days only

Back of pack

• Solpadeine Max Soluble Tablets are for the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least four hours after taking any other painkiller before you take this medicine. For: migraine, headache, dental pain, period pain, backache, arthritic & rheumatic pain, strains & sprains and sciatica.

• If you need to take this medicine continuously for more than 3 days you should see your doctor or pharmacist

• This medicinec ontains codeine which can cause addiction if you take continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse

The leaflet will state:

Headlines section (to be prominently displayed)

• This medicine is for the short term treatment of acute moderate pain when other painkillers have not worked

• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take this medicine for headaches for more than 3 days it can make them worse.

Section 1: What the medicine is for:

• Solpadeine Max Soluble Tablets are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They can be used for migraine, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica.

Section 2: Before taking

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than 3 days it can make them worse.

• Usually it is safe to take this medicine while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

Section 3: Dosage

• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist

• This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Side effects

• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10 am – 2 pm Monday – Friday) or fill in a paper form available from your local pharmacy.

• How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

      • You need to take the medicine for longer periods of time

      • You need to take more than the recommended dose

      • When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Opioid analgesics should be given with care to patients receiving monoamine oxidase inhibitors (MAOI) and for two weeks after stopping MAOI treatment. Opioid analgesics may antagonise the gastrointestinal effects of metoclopromide and domperidone and may delay the absorption of mexiletine. The effect of CNS depressants such as alcohol, anxiolytics, hypnotics, tricyclic antidepressants and antipsychotics may be potentiated by codeine; these interactions are unlikely to be significant at the dosage involved.

4.6 Pregnancy And Lactation

Do not use this product if pregnant or breast feeding without medical advice.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Codeine may cause constipation, nausea, vomiting, vertigo, difficulty with micturition, dry mouth, rashes, urticaria, dizziness and drowsiness according to dosage and individual susceptibility.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptons of restlessness and irritability may result when treatment is stopped.

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

Regularly consumes ethanol in excess of recommended amounts.

Or

Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Caffeine

Symptoms and signs

Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.

Management

Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose. The CNS effects of overdose may be treated with intravenous sedatives.

Summary

Treatment of overdose with Solpadeine Max Soluble Tablets requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of codeine and caffeine toxicity being managed symptomatically.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a well established analgesic.

Caffeine has a stimulatory effect on the central nervous system and possesses a weak diuretic action.

Codeine phosphate has moderate analgesic and weak cough-suppressant effects.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of the drug in plasma reaches a peak in 30 – 60 minutes and the plasma half-life is 1- 4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.

Codeine phosphate is well absorbed after administration and distributes widely throughout the body. 86% of an oral dose is excreted in the urine within 24 hours, 40–70% of this being free or conjugated codeine, 5-15% free or conjugated morphine, 10-20% free or conjugated norcodeine.

Caffeine is rapidly but irregularly absorbed after oral administration, absorption is pH-related. After an oral dose of 100 mg, peak plasma concentration of 1.5-2 μg/ml are attained within 1-2 hours. Plasma half-life is between 4-10 hours. Caffeine rapidly distributes throughout the body water, and is approximately 15% bound to plasma proteins. In 48 hours, 45% of a dose is excreted in the urine as 1methylxanthine and 1-methyluric acid.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol

Sodium saccharin

Sodium bicarbonate

Sodium lauryl Sulphate

Citric acid

Sodium carbonate

Polyvidone

Silicone fluid.

6.2 Incompatibilities

None known.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

The product should be protected from light and moisture.

6.5 Nature And Contents Of Container

Laminate strips packed into cardboard cartons containing 8, 16, 20, 24 or 32 tablets.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS.

8. Marketing Authorisation Number(S)

PL 00071/0234

9. Date Of First Authorisation/Renewal Of The Authorisation

19/01/1984 / 28/02/2003

10. Date Of Revision Of The Text

07/11/2011

Clear Eyes

Generic Name: naphazoline ophthalmic (na FAZ oh leen)

Brand Names: AK-Con, Albalon, Allerest Eye Drops, Clear Eyes, Degest 2, Estivin II, Nafazair, Naphcon, Naphcon Forte, VasoClear, Vasocon

What is Clear Eyes (naphazoline ophthalmic)?

Naphazoline ophthalmic causes constriction of blood vessels in the eyes. It also decreases itching and irritation of the eyes.

Naphazoline ophthalmic is used to relieve redness, burning, irritation, and dryness of the eye caused by wind, sun, and other minor irritants.

Naphazoline ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Clear Eyes (naphazoline ophthalmic)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

What should I discuss with my healthcare provider before using Clear Eyes (naphazoline ophthalmic)?

Do not use naphazoline ophthalmic if you have glaucoma, except under the supervision of your doctor.

Before using this medication, tell your doctor if you

• 
  

  have any type of heart condition, including high blood pressure;

  
  


• 
  

  take any medicines to treat a heart condition;

  
  


• 
  

  have asthma;

  
  


• 
  

  have diabetes; or

  
  


• 
  

  have thyroid problems.

  
  

You may not be able to use naphazoline ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Naphazoline ophthalmic is in the FDA pregnancy category C. This means that it is not known whether naphazoline ophthalmic will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether naphazoline passes into breast milk. Do not use naphazoline ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Clear Eyes (naphazoline ophthalmic)?

Use naphazoline eye drops exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these instructions, ask your doctor, pharmacist, or nurse to explain them to you.

Wash your hands before and after using the eye drops.

To apply the eye drops:

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

• 
  

  Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down your tear duct. Repeat the process in the other eye if needed..

  
  

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen. Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye. Do not use any eye drop that is discolored or has particles in it. Store naphazoline ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to be harmful. If you do suspect an overdose, or if the drops have been ingested (taken by mouth), contact an emergency room or poison control center for advice.

What should I avoid while using Clear Eyes (naphazoline ophthalmic)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying naphazoline ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Naphazoline ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

Do not use naphazoline ophthalmic more often or continuously for longer than 48 to 72 hours without consulting a doctor. Chronic use of this medication may damage the blood vessels (veins and arteries) in the eyes. Consult a doctor if your symptoms do not improve or appear to worsen.

Clear Eyes (naphazoline ophthalmic) side effects

If you experience any of the following serious side effects, stop using naphazoline ophthalmic and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; or hives);

  
  


• 
  

  an irregular or fast heart rate; or

  
  


• 
  

  high blood pressure (severe headache, blurred vision, or flushed skin).

  
  

Other, less serious side effects may be more likely to occur. Continue to use naphazoline ophthalmic and talk to your doctor if you experience

• 
  

  burning, stinging, pain, or increased redness of the eye;

  
  


• 
  

  tearing or blurred vision;

  
  


• 
  

  headache;

  
  


• 
  

  tremor;

  
  


• 
  

  nausea;

  
  


• 
  

  sweating;

  
  


• 
  

  nervousness;

  
  


• 
  

  dizziness; or

  
  


• 
  

  drowsiness.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Clear Eyes (naphazoline ophthalmic)?

Do not use other eye medications during treatment with naphazoline ophthalmic except under the direction of your doctor.

Although drug interactions between naphazoline ophthalmic and drugs taken by mouth are not expected, they can occur. Before using this medication, tell your doctor if you are taking any of the following medicines:

• 
  

  a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil); or

  
  


• 
  

  a beta-blocker such as propranolol (Inderal), metoprolol (Lopressor, Toprol XL), or labetalol (Normodyne, Trandate).

  
  

You may not be able to use naphazoline ophthalmic, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with naphazoline ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Clear Eyes resources

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

• Clear Eyes Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Clear Eyes Advanced Consumer (Micromedex) - Includes Dosage Information


• Albalon Prescribing Information (FDA)


• Naphcon Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Naphcon Prescribing Information (FDA)


• Naphcon Forte Prescribing Information (FDA)


• Vasocon Prescribing Information (FDA)

Compare Clear Eyes with other medications

• Eye Dryness/Redness
• Eye Redness/Itching

Where can I get more information?

• Your pharmacist has additional information about naphazoline ophthalmic written for health professionals that you may read.

See also: Clear Eyes side effects (in more detail)

ProAir HFA

Generic Name: albuterol (Inhalation route)

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.

• Accuneb


• ProAir HFA


• Proventil


• Proventil HFA


• ReliOn Ventolin HFA


• Ventolin


• Ventolin HFA

In Canada

• Alti-Salbutamol Inhalation Aerosol


• Apo-Salvent


• Salbutamol


• Salbutamol Nebuamp


• Salbutamol Respirator Solution


• Ventolin Inhaler


• Ventolin Nebules P.F.


• Ventolin Respirator


• Ventolin Rotacaps

Available Dosage Forms:

• Aerosol Powder


• Solution


• Capsule


• Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For ProAir HFA

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

• Hyperkalemia (too much potassium in the blood).

Before Using ProAir HFA

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in children 4 years of age and older and albuterol inhalation solution (e.g., Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the aerosol in children younger than 4 years of age and for the solution in children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of albuterol inhalation solution (e.g., Accuneb®) in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

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.

• Acebutolol


• Alprenolol


• Arotinolol


• Atenolol


• Atomoxetine


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Furazolidone


• Iproniazid


• Isocarboxazid


• Labetalol


• Landiolol


• Lazabemide


• Levobetaxolol


• Levobunolol


• Linezolid


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Nipradilol


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Rasagiline


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., arrhythmia) or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Hypokalemia (low potassium in the blood) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to ProAir HFA. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (e.g., Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

• Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.


• Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.


• Connect the nebulizer to the face mask or mouthpiece.


• Use the face mask or mouthpiece to breathe in the medicine.


• Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.


• Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (e.g., Proair® HFA) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the aerosol inhaler:

• The inhaler should be at room temperature before you use it.


• Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.


• Remove the cap and look at the mouthpiece to make sure it is clean.


• Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.


• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.


• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.


• Hold your breath for about 10 seconds, then breathe out slowly.


• If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.


• When you have finished all of your doses, rinse your mouth with water and spit the water out.


• Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.


• If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.


• After using the inhaler, wash the mouthpiece again and dry it completely.


• If the mouthpiece becomes blocked, washing it will help.

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 inhalation aerosol dosage form (inhaler):
  
  • For preventing bronchospasm:
    
    • Adults, teenagers, and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  
  • For preventing exercise-induced bronchospasm:
    
    • Adults, teenagers, and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  


• For inhalation solution dosage form (used with a nebulizer):
  
  • For preventing bronchospasm:
    
    • Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
    
    
    • Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your child's 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 canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

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 ProAir HFA

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

• Your symptoms do not improve or they become worse after using this medicine.


• Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

ProAir HFA 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

• Fast, irregular, pounding, or racing heartbeat or pulse


• shakiness in the legs, arms, hands, or feet


• trembling or shaking of the hands or feet

Less common

• Abdominal or stomach pain


• bladder pain


• bloody or cloudy urine


• chest discomfort


• chest pain


• cough or hoarseness


• cough producing mucus


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• dizziness


• feeling of warmth


• fever or chills


• frequent urge to urinate


• hives


• itching


• loss of appetite


• lower back or side pain


• nausea


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


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


• runny nose


• shortness of breath


• skin rash


• sore throat


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tightness in the chest


• unusual tiredness or weakness


• weakness


• wheezing

Rare

• Hives or welts


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


• noisy breathing


• redness of the skin


• swelling of the mouth or throat


• trouble breathing

Incidence not known

• Agitation


• anxiety


• arm, back, or jaw pain


• chest tightness or heaviness


• confusion


• convulsions


• decreased urine


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


• drowsiness


• dry mouth


• extra heartbeats


• fainting


• flushed, dry skin


• fruit-like breath odor


• hallucinations


• headache


• increased hunger


• increased thirst


• increased urination


• irritability


• lightheadedness


• muscle pain or cramps


• nervousness


• nightmares


• numbness or tingling in the hands, feet, or lips


• pounding in the ears


• rapid, deep breathing


• restlessness


• shakiness


• slow or fast heartbeat


• stomach cramps


• sweating


• unexplained weight loss


• unusual feeling of excitement


• vomiting

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

• Body aches or pain


• congestion


• fever


• runny nose


• tender, swollen glands in the neck


• trouble with swallowing


• voice changes

Less common

• Difficult, burning, or painful urination


• earache


• headache, severe and throbbing


• muscle or bone pain


• pain


• redness of the skin


• redness or swelling in the ear


• redness, swelling, or soreness of the tongue


• sleeplessness


• sneezing


• stuffy nose


• swelling


• tenderness


• trouble in holding or releasing urine


• trouble sleeping


• unable to sleep


• warmth on the skin

Rare

• Sleepiness or unusual drowsiness

Incidence not known

• Bad, unusual, or unpleasant (after) taste


• change in taste


• feeling of constant movement of self or surroundings


• gagging


• rough, scratchy sound to voice


• sensation of spinning


• tightness in the throat

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: ProAir HFA side effects (in more detail)

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

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

More ProAir HFA resources

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

• ProAir HFA Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• ProAir HFA Prescribing Information (FDA)


• Albuterol Prescribing Information (FDA)


• Albuterol Professional Patient Advice (Wolters Kluwer)


• Albuterol Monograph (AHFS DI)


• Albuterol MedFacts Consumer Leaflet (Wolters Kluwer)


• AccuNeb Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Accuneb Prescribing Information (FDA)


• Airet Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Proventil Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• Proventil Consumer Overview


• Proventil HFA Prescribing Information (FDA)


• Proventil HFA Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• Proventil Repetabs Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ventolin Prescribing Information (FDA)


• Ventolin Consumer Overview


• Vospire ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare ProAir HFA with other medications

• Asthma, acute
• Asthma, Maintenance
• Bronchospasm Prophylaxis
• COPD, Acute
• COPD, Maintenance

Ed-APAP

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

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

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

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

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

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

Know the amount of acetaminophen in the specific product you are taking.

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 acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

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.

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

You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:

• liver disease; or


• 
  

  a history of alcoholism.

  
  

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 acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen 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. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

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

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.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

  you still have pain after 7 days of use (or 5 days if treating a child);

  
  


• 
  

  you have a skin rash, ongoing headache, or any redness or swelling; or

  
  


• 
  

  if your symptoms get worse, or if you have any new symptoms.

  
  

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. 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.

What should I avoid while taking acetaminophen?

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.

Acetaminophen side effects

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

• 
  

  nausea, upper stomach pain, itching, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

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 acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

• 
  

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

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medications;

  
  


• 
  

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

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

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

  
  


• 
  

  seizure medications.

  
  

This list is not complete and there may be other drugs that can interact with acetaminophen. 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 Ed-APAP resources

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

• acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)


• Acetaminophen Monograph (AHFS DI)


• Acetazolamide Monograph (AHFS DI)


• Apra Advanced Consumer (Micromedex) - Includes Dosage Information


• Apraclonidine Hydrochloride Monograph (AHFS DI)


• Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Consumer Overview


• Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Ofirmev Prescribing Information (FDA)


• Paracetamol Consumer Overview


• Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Tylenol Consumer Overview


• Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ed-APAP with other medications

• Fever
• Muscle Pain
• Pain
• Sciatica

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

See also: Ed-APAP side effects (in more detail)