Ibu-1A Pharma

Ibu-1A Pharma may be available in the countries listed below.

Ingredient matches for Ibu-1A Pharma

Ibuprofen

Ibuprofen is reported as an ingredient of Ibu-1A Pharma in the following countries:

• Germany

International Drug Name Search

Sulfamylon Solution

Pronunciation: MA-fe-NIDE
Generic Name: Mafenide
Brand Name: Sulfamylon

Sulfamylon Solution is used for:

Treating or preventing skin infections in patients with serious burns. Sulfamylon Solution is used in combination with other medicines.

Sulfamylon Solution is an antibacterial agent. It works by killing sensitive bacteria in a way that is not exactly known.

Do NOT use Sulfamylon Solution if:

• you are allergic to any ingredient in Sulfamylon Solution

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

Before using Sulfamylon Solution:

Some medical conditions may interact with Sulfamylon Solution. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have glucose-6-phosphate dehydrogenase deficiency, kidney problems, or lung or breathing problems

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

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

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

• Sulfamylon Solution is for external use only. Do not inject Sulfamylon Solution or take it by mouth.


• Wash your hands thoroughly before and after application of Sulfamylon Solution.


• Cover the burn area with one layer of fine mesh gauze. Wet an appropriate burn dressing with Sulfamylon Solution until leaking is noticeable. Place the dressing in contact with the wound. Secure the dressing in place as directed by your doctor or health care provider.


• The dressing should be kept wet. Follow the directions provided by your doctor or health care provider for re-wetting and changing the dressing.


• Follow the directions provided by your doctor for bathing or washing the affected area.


• To prevent or clear up your infection completely, continue using Sulfamylon Solution for the full course of treatment even if you feel better in a few days. Do not miss any doses.


• If you miss a dose of Sulfamylon Solution, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sulfamylon Solution.

Important safety information:

• Sulfamylon Solution may be harmful if swallowed. If you or someone you know may have taken Sulfamylon Solution by mouth, contact your local poison control center or emergency room immediately.


• LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Sulfamylon Solution with extreme caution in CHILDREN younger than 3 months of age. Safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Sulfamylon Solution:

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:

Blistering, burning sensation, itching, redness, or pain at the application site.

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); bleeding of the skin; dark urine; fast or irregular heartbeat; rapid breathing; softening or thinning of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.

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: Sulfamylon 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.

Proper storage of Sulfamylon Solution:

Store Sulfamylon Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Sulfamylon Solution may be stored for up to 28 days if the container has not been opened. Once the container has been opened, throw away any unused medicine after 48 hours. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sulfamylon Solution out of the reach of children and away from pets.

General information:

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


• Sulfamylon Solution 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 Sulfamylon Solution. 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.

More Sulfamylon resources

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

Compare Sulfamylon with other medications

• Burns, External

Pneumovax 23

Generic Name: pneumococcal vaccine polyvalent (Intramuscular route, Subcutaneous route)

NOO-moe-KOK-al VAX-een pol-ee-VAY-lent

Commonly used brand name(s)

In the U.S.

• Pneumovax 23


• Pnu-Imune 23

In Canada

• Prevnar

Available Dosage Forms:

• Solution

Therapeutic Class: Vaccine

Uses For Pneumovax 23

Pneumococcal polyvalent vaccine is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the polyvalent 23 pneumococcal vaccine. Other polyvalent pneumococcal vaccines may be available in countries other than the U.S.

Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; bacteremia, which is a severe infection in the blood; and possibly death. These problems are more likely to occur in older adults and persons with certain diseases or conditions that make them more susceptible to a pneumococcal infection or more apt to develop serious problems from a pneumococcal infection.

Unless otherwise contraindicated, immunization (vaccination) against pneumococcal disease is recommended for all adults and children 2 years of age and older, especially:

• Older adults, especially those 65 years of age and older.


• Adults and children 2 to 64 years of age with chronic illnesses.


• Adults and children 2 to 64 years of age with sickle cell disease, those with spleen problems or without spleens, and those who are to have their spleens removed.


• Adults and children 2 to 64 years of age who are at increased risk for pneumococcal disease because of another illness (e.g., heart disease, lung disease, asthma, diabetes, alcoholism, liver disease, or kidney disease). People who smoke cigarettes should also receive the vaccine.


• Adults and children 2 to 64 years of age who are living in special environments or social settings (e.g., Alaskan Natives and certain American Indian populations), and residents of nursing homes and other long-term-care facilities.


• Adults and children 2 to 64 years of age with decreased disease-fighting ability (e.g., those with human immunodeficiency virus (HIV) infection, organ or bone marrow transplantations, and cancer).

Immunization (vaccination) against pneumococcal infection is not recommended for infants and children younger than 2 years of age, because these persons cannot produce enough antibodies to the vaccine to protect them against a pneumococcal infection.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Pneumovax 23

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

Use of pneumococcal polyvalent vaccine is not recommended in infants and children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pneumococcal polyvalent vaccine in the elderly. However, elderly patients are more likely to have unwanted effects which may require caution in patients receiving this vaccine.

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 receiving this vaccine, 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.

Receiving this vaccine 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.

• Varicella Virus Vaccine

Receiving this vaccine 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.

• Rituximab

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 vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain disease or


• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well in patients with these conditions.

• Heart or blood vessel disease or


• Lung disease—Use with caution. May increase risk for more serious side effects.

• Moderate to severe acute illness—Patients with this condition should receive the vaccine at a delayed time.

• Thrombocytopenic purpura (blood disorder)—Use with caution. May make this condition worse.

Proper Use of pneumococcal vaccine polyvalent

This section provides information on the proper use of a number of products that contain pneumococcal vaccine polyvalent. It may not be specific to Pneumovax 23. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of the muscles or under the skin, usually in the thigh or upper arm.

Pneumococcal vaccine is usually given only once to each person. Additional injections are only given for special cases, because of the possibility of more frequent and more severe side effects.

Precautions While Using Pneumovax 23

If you have more than one doctor, be sure they all know that you have received pneumococcal vaccine polyvalent 23 so that they can put the information into your medical records. This vaccine is usually given only once to each person, except in special cases.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.

The pneumococcal polyvalent vaccine will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.

Pneumovax 23 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 or nurse immediately if any of the following side effects occur:

More common

• Chills

Less common

• Body aches or pain


• cough


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Rare

• Fever over 102.2 °F (39 °C)

Incidence not known

• Black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine or stools


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


• decreased movement of the legs


• difficulty with breathing or swallowing


• dizziness


• eye pain


• fast heartbeat


• feeling of discomfort


• general feeling of discomfort or illness


• headache


• hives


• inflammation of the joints


• itching, especially of the feet or hands


• itching, pain, redness, swelling, tenderness, or warmth on the skin


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


• muscle aches


• pinpoint red spots on the skin


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


• rapid weight gain


• rash


• shortness of breath


• swollen lymph glands


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


• tightness in the chest


• tingling of the hands or feet


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose


• unusual bleeding or bruising


• unusual tiredness or weakness (sudden and severe)


• unusual weight gain or loss


• wheezing

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

• Difficulty with moving


• lack or loss of strength


• muscle aching or cramping


• muscle pains or stiffness


• redness, soreness, hard lump, swelling, tenderness, or pain at the injection site


• swollen joints

Less common or rare

• Aches or pain in the joints or muscles


• fever of 101 °F (38.3 °C) or less


• swollen glands


• vague feeling of bodily discomfort

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: Pneumovax 23 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 Pneumovax 23 resources

• Pneumovax 23 Side Effects (in more detail)
• Pneumovax 23 Use in Pregnancy & Breastfeeding
• Pneumovax 23 Drug Interactions
• 0 Reviews for Pneumovax 23 - Add your own review/rating

• Pneumovax 23 Prescribing Information (FDA)


• Pneumovax 23 Concise Consumer Information (Cerner Multum)


• Pneumovax 23 MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pneumovax 23 with other medications

• Pneumococcal Disease Prophylaxis

metyrosine

me-TYE-roe-seen

Commonly used brand name(s)

In the U.S.

• Demser

Available Dosage Forms:

• Capsule

Therapeutic Class: Antihypertensive

Pharmacologic Class: Tyrosine Hydroxylase Inhibitor

Uses For metyrosine

Metyrosine belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension) caused by a disease called pheochromocytoma (a noncancerous tumor of the adrenal gland).

Metyrosine reduces the amount of certain chemicals in the body. When these chemicals are present in large amounts, they cause high blood pressure.

Metyrosine is available only with your doctor's prescription.

Before Using metyrosine

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 metyrosine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to metyrosine 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

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

Geriatric

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

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. 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.

Other Medical Problems

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

• Kidney disease or


• Liver disease—Effects of metyrosine may be increased because of slower removal from the body

• Mental depression (or history of) or


• Parkinson's disease—Metyrosine may make these conditions worse

Proper Use of metyrosine

Take metyrosine only as directed by your doctor. Do not take more or less of it than your doctor ordered.

To help you remember to take your medicine, try to get into the habit of taking it at the same times each day.

Dosing

The dose of metyrosine 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 metyrosine. 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 (capsules):
  
  • Adults and children 12 years of age and older: 1000 milligrams to 3000 milligrams (1 to 3 grams) a day, divided into four doses.
  
  

Missed Dose

If you miss a dose of metyrosine, 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 metyrosine

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

While taking metyrosine, it is important that you drink plenty of fluids and urinate often. This will help prevent kidney problems and keep your kidneys working well. If you have any questions about how much you should drink, check with your doctor.

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

Before having any kind of surgery (including dental surgery), tell the medical doctor or dentist in charge that you are taking metyrosine.

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

metyrosine 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:

More common

• Diarrhea


• drooling


• trembling and shaking of hands and fingers


• trouble in speaking

Less common

• Anxiety


• confusion


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


• mental depression

Rare

• Black, tarry stools


• blood in urine or stools


• unusual bleeding or bruising


• muscle spasms, especially of neck and back


• painful urination


• pinpoint red spots on skin


• restlessness


• shortness of breath


• shuffling walk


• skin rash and itching


• swelling of feet or lower legs


• tic-like (jerky) movements of head, face, mouth, and neck


• unusual tiredness or weakness

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

• Drowsiness

Less common

• Decreased sexual ability in men


• dryness of mouth


• nausea, vomiting, or stomach pain


• stuffy nose


• swelling of breasts or unusual milk production

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

More common

• Diarrhea

Also, after you stop taking metyrosine, you may have feelings of increased energy or you may have trouble sleeping. However, these effects should last only for two or three days.

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: metyrosine 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 metyrosine resources

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

• metyrosine Concise Consumer Information (Cerner Multum)


• Metyrosine MedFacts Consumer Leaflet (Wolters Kluwer)


• Demser Prescribing Information (FDA)

Compare metyrosine with other medications

• Pheochromocytoma

Mysoline

primidone

Dosage Form: tablet
Mysoline®

(primidone, USP)

Anticonvulsant

Rx only

Mysoline Description

Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula:

Mysoline* (primidone) is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.

Mysoline 50 mg and 250 mg tablets contain the following inactive ingredients: Microcrystalline Cellulose, NF; Lactose, USP; Methylcellulose, USP; Sodium Starch Glycolate, NF; Talc, USP; Sodium Lauryl Sulfate, NF; Magnesium Stearate, NF; Water, USP, Purified.

Mysoline 250 mg tablets also contain Ferric Oxide Yellow, NF.

_______________________________________________________________________________

* Registered trademark of Valeant Pharmaceuticals North America.

ACTIONS

Mysoline raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone's antiepileptic action is not known.

Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.

Indications and Usage for Mysoline

Mysoline, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

Contraindications

Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS).

Warnings

The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDS), including Mysoline, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by indication for antiepileptic drugs in the pooled analysis

Indication	Placebo Patients with Events Per 1000 Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events Per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Mysoline or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Usage in Pregnancy

To provide information regarding the effects of in utero exposure to Mysoline, physicians are advised to recommend that pregnant patients taking Mysoline enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

The effects of Mysoline in human pregnancy and nursing infants are unknown.

Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship.

There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors leading to birth defects, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorders are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential. Neonatal hemorrhage, with a coagulation defect resembling vitamin K deficiency, has been described in newborns whose mothers were taking primidone and other anticonvulsants. Pregnant women under anticonvulsant therapy should receive prophylactic vitamin K1 therapy for one month prior to, and during, delivery.

Precautions

The total daily dosage should not exceed 2 g. Since Mysoline therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made every six months.

In Nursing Mothers

There is evidence in mothers treated with primidone, the drug appears in the milk in substantial quantities. Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of Mysoline-treated mothers be taken as an indication that nursing should be discontinued.

Information for Patients

Suicidal Thinking and Behavior - Patients, their caregivers, and families should be counseled that AEDs, including Mysoline, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Usage in Pregnancy section).

Please refer to the Mysoline Medication Guide provided with the product for more information.

Adverse Reactions

The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistant or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to Mysoline and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.

Mysoline Dosage and Administration

Adult Dosage

Patients 8 years of age and older who have received no previous treatment may be started on Mysoline according to the following regimen using either 50 mg or scored 250 mg Mysoline tablets:

Days 1 to 3: 100 to 125 mg at bedtime.

Days 4 to 6: 100 to 125 mg b.i.d.

Days 7 to 9: 100 to 125 mg t.i.d.

Day 10 to maintenance: 250 mg t.i.d.

For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg Mysoline tablets in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d.

INITIAL: ADULTS AND CHILDREN OVER 8
KEY: •=50 mg tablet; ●=250 mg tablet
DAY	1	2	3	4	5	6
AM				••	••	••
NOON
PM	••	••	••	••	••	••
DAY	7	8	9	10	11	12
AM	••	••	••	●	Adjust to Maintenance
NOON	••	••	••	●
PM	••	••	••	●

Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 μg/mL.

In Patients Already Receiving Other Anticonvulsants

Mysoline should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with Mysoline alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.

Pediatric Dosage

For children under 8 years of age, the following regimen may be used:

Days 1 to 3: 50 mg at bedtime.

Days 4 to 6: 50 mg b.i.d.

Days 7 to 9: 100 mg b.i.d.

Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.

For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

How is Mysoline Supplied

Mysoline Tablets

Each square-shaped, scored, yellow tablet, identified by "Mysoline 250" and an embossed M, contains 250 mg of primidone, in bottles of 100 (NDC 66490-691-10)

Each square-shaped, scored, white tablet, identified by "Mysoline 50" and an embossed M, contains 50 mg of primidone, in bottles of 100 (NDC 66490-690-10)

The appearance of these tablets is a trademark of Valeant Pharmaceuticals North America.

Store at 20°C-25°C (68°F-77°F).

[See USP controlled room temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured by:

Piramal Healthcare Ltd.

Plot No. 67-70, Sector - 2, Pithampur, 454775,

Dist. Dhar, Madhya Pradesh, INDIA

Distributed by:

Valeant Pharmaceuticals North America

One Enterprise

Aliso Viejo, CA 92656 U.S.A.

Part No. EM 10142/b

Rev. 07/10

MEDICATION GUIDE

Mysoline ( My-so- lean)

(primidone)

Tablets

Read this Medication Guide before you start taking Mysoline and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

Do not stop taking Mysoline without first talking to your healthcare provider.

Stopping Mysoline suddenly can cause serious problems.

Mysoline can cause serious side effects, including:

Like other antiepileptic drugs, Mysoline may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying


• attempts to commit suicide


• new or worse depression


• new or worse anxiety


• feeling agitated or restless


• panic attacks


• trouble sleeping (insomnia)


• new or worse irritability


• acting aggressive, being angry, or violent


• acting on dangerous impulses


• an extreme increase in activity and talking (mania)


• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.


• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Mysoline without first talking to a healthcare provider.

• Stopping Mysoline suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Mysoline?

Mysoline is a prescription medicine used alone or with other medicines to treat people with:

• generalized tonic-clonic (grand mal) seizures


• complex partial (psychomotor) seizures


• partial (focal) epileptic seizures.

Who should not take Mysoline?

Do not take Mysoline if you:

• have a genetic disorder called porphyria


• are allergic to phenobarbital

What should I tell my healthcare provider before taking Mysoline?

Before you take Mysoline, tell your healthcare provider if you:

• have or have had depression, mood problems or suicidal thoughts or behavior


• have any other medical conditions


• are pregnant or planning to become pregnant. Mysoline may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Mysoline. You and your healthcare provider will decide if you should take Mysoline while you are pregnant.
  
  • If you become pregnant while taking Mysoline, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
  
  


• are breastfeeding or plan to breastfeed. Mysoline can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mysoline.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Mysoline with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take Mysoline?

Take Mysoline exactly as prescribed. Your healthcare provider will tell you how much Mysoline to take and when to take it.

• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.


• Do not stop taking Mysoline without first talking to your healthcare provider. Stopping Mysoline suddenly can cause serious problems.


• If you take too much Mysoline, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Mysoline?

• Mysoline can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Mysoline without first discussing this with your healthcare provider. Taking Mysoline with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.


• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Mysoline affects you. Mysoline can slow your thinking and motor skills.

What are the possible side effects of Mysoline?

See "What is the most important information I should know about Mysoline?".

Mysoline may cause other serious side effects including:

• Sleepiness that can be severe, especially when you first start taking Mysoline.


• Mysoline may rarely cause blood problems. Symptoms may include:
  
  • fever, swollen glands, or sore throat that come and go or do not go away
  
  
  • Frequent infections or an infection that does not go away
  
  
  • tiredness
  
  
  • shortness of breath
  
  


• Mysoline may rarely cause allergic reactions. Symptoms may include:
  
  • skin rash
  
  
  • hives
  
  
  • sores in your mouth
  
  
  • blistering or peeling skin
  
  

The most common side effects of Mysoline include:

• problems with walking and moving


• feelings of dizziness, spinning, or swaying (vertigo)

These are not all the possible side effects of Mysoline. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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

How should I store Mysoline?

Store Mysoline at room temperature between 68ºF to 77ºF (20ºC to 25ºC) in a tight, light-resistant container

Keep Mysoline and all medicines out of the reach of children.

General Information about Mysoline

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mysoline for a condition for which it was not prescribed. Do not give Mysoline to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Mysoline. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Mysoline that is written for health professionals.

For more information, go to www.VALEANT.com or call 1-877-361-2719

What are the ingredients in Mysoline?

Active Ingredient: primidone

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, methylcellulose, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, talc, purified water and ferric oxide yellow (250 mg tablet only)

VALEANT®

Pharmaceuticals North America

Aliso Viejo, CA 92656

Issued July 2010

This Medication Guide has been approved by the U.S. Food and Drug Administration

Part No. EM 10142/b

Rev. 07/10

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

NDC 66490-691-10

Rx Only

Mysoline®

(primidone, USP)

ORIGINAL

TABLET

DESIGN &

FORMULATION

250 mg

SEALED FOR

YOUR PROTECTION

100 Tablets

VALEANT®

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NDC 66490-690-10

Rx Only

Mysoline®

(primidone, USP)

50 mg

SEALED FOR

YOUR PROTECTION

100 Tablets

VALEANT®

Mysoline  primidone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66490-690 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Primidone (Primidone) Primidone 50 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   lactose Monohydrate   Methylcellulose (15 CPS)   sodium starch glycolate type a potato   talc   sodium lauryl sulfate   Magnesium stearate

Product Characteristics Color WHITE Score 2 pieces Shape SQUARE Size 6mm Flavor Imprint Code Mysoline;50;M Contains

Packaging # NDC Package Description Multilevel Packaging 1 66490-690-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA009170	06/24/2009

Mysoline  primidone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66490-691 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Primidone (Primidone) Primidone 250 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   lactose Monohydrate   Methylcellulose (15 CPS)   sodium starch glycolate type a potato   talc   sodium lauryl sulfate   Magnesium stearate   ferric oxide yellow

Product Characteristics Color YELLOW Score 2 pieces Shape SQUARE (square-shaped) Size 10mm Flavor Imprint Code Mysoline;250;M Contains

Packaging # NDC Package Description Multilevel Packaging 1 66490-691-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA009170	06/24/2009

Labeler - Valeant Pharmaceuticals North America (831922468)

Establishment
Name	Address	ID/FEI	Operations
Piramal Healthcare Limited		862202793	MANUFACTURE

Revised: 08/2010Valeant Pharmaceuticals North America

More Mysoline resources

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

• Mysoline Concise Consumer Information (Cerner Multum)


• Mysoline MedFacts Consumer Leaflet (Wolters Kluwer)


• Mysoline Monograph (AHFS DI)


• Mysoline Advanced Consumer (Micromedex) - Includes Dosage Information


• Primidone Professional Patient Advice (Wolters Kluwer)

Compare Mysoline with other medications

• Seizures

Maxidone

Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)

Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone

What is Maxidone (acetaminophen and hydrocodone)?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

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

What is the most important information I should know about Maxidone (acetaminophen and hydrocodone)?

Tell your doctor 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 take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. 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. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Maxidone (acetaminophen and hydrocodone)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone. Tell your doctor 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.

To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  Addison's disease or other adrenal gland disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Maxidone (acetaminophen and hydrocodone)?

Take exactly as prescribed. Never take acetaminophen and hydrocodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

What happens if I miss a dose?

Since acetaminophen and hydrocodone 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 use 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 and hydrocodone 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 extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid while taking Maxidone (acetaminophen and hydrocodone)?

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

Maxidone (acetaminophen and hydrocodone) 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 at once if you have any of these serious side effects:

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  problems with urination; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  anxiety, dizziness, drowsiness;

  
  


• 
  

  mild nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  headache, mood changes;

  
  


• 
  

  blurred vision;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  dry mouth.

  
  

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

What other drugs will affect Maxidone (acetaminophen and hydrocodone)?

Do not take acetaminophen and hydrocodone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

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

• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with acetaminophen and hydrocodone. 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 Maxidone resources

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

• Maxidone Advanced Consumer (Micromedex) - Includes Dosage Information


• Maxidone Prescribing Information (FDA)


• Co-gesic Prescribing Information (FDA)


• Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Prescribing Information (FDA)


• Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Liquicet Prescribing Information (FDA)


• Lorcet Plus Prescribing Information (FDA)


• Lortab Prescribing Information (FDA)


• Lortab Consumer Overview


• Lortab MedFacts Consumer Leaflet (Wolters Kluwer)


• Norco Consumer Overview


• Norco Prescribing Information (FDA)


• Vicodin Consumer Overview


• Vicodin Prescribing Information (FDA)


• Vicodin ES Prescribing Information (FDA)


• Vicodin HP Prescribing Information (FDA)


• Xodol Prescribing Information (FDA)


• Zolvit Prescribing Information (FDA)


• Zydone Prescribing Information (FDA)

Compare Maxidone with other medications

• Back Pain
• Cough
• Pain
• Rheumatoid Arthritis

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and hydrocodone.

See also: Maxidone side effects (in more detail)

Boots Maximum Strength Cold & Flu Relief Direct Dose Blackcurrant

1. Name Of The Medicinal Product

Boots Cold & Flu Max Direct Sachets Blackcurrant Flavour or

Boots Maximum Strength Cold & Flu Relief Direct Dose Blackcurrant

2. Qualitative And Quantitative Composition

Active ingredients	mg/sachet
Paracetamol	1000.0
Phenylephrine hydrochloride	*12.2
*This is equivalent to 10mg phenylephrine base.
For excipients, see 6.1

3. Pharmaceutical Form

Oral powder

A white to off-white unit-dose powder with the odour and flavour of blackcurrants.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms associated with the common cold and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Oral administration.

Adults and children 12 and over: One single-dose container. The product is taken orally without water.

The dose may be repeated every 4 hours.

No more than four doses should be taken in 24 hours.

Children under 12 years: Not to be given to children under 12 without medical advice.

Elderly: There is no indication that dosage need be modified in the elderly.

4.3 Contraindications

Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors. Hypersensitivity to paracetamol, phenylephrine or any other ingredient.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently.

Label warnings: Do not exceed the stated dose. Keep all medicines out of the reach and sight of children. Contains paracetamol (panel). If symptoms persist consult your doctor. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and β-blockers. Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of the risk of hypertensive crisis.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. 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.

4.6 Pregnancy And Lactation

Due to the vasoconstrictive properties of phenylephrine the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh the risk. There is no information on use in lactation.

Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

Phenylephrine hydrochloride: Rarely, high blood pressure with headache, vomiting and palpitations, which are only likely to occur with overdose. Also rare reports of allergic reactions.

4.9 Overdose

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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. α-receptor blocking agent.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Phenylephrine: Phenylephrine is a post-synaptic α-receptor agonist with low cardioselective β-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T2 of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates >80%) which are excreted in urine.

Phenylephrine: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethyl cellulose

Ascorbic acid

Glyceryl tristearate

Tartaric acid

Sodium carbonate anhydrous

Aspartame

Blackcurrant flavour

Sweet flavour

Xylitol

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C and store in the original package.

6.5 Nature And Contents Of Container

Polyethylene terephthalate/aluminium/polyethylene sachets.

Pack size: 10

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL00014/0635

9. Date Of First Authorisation/Renewal Of The Authorisation

19 July 2002

10. Date Of Revision Of The Text

November 2003