methamphetamine

meth-am-FET-a-meen hye-droe-KLOR-ide

Oral route(Tablet)

Methamphetamine has a high potential for abuse and it should be tried only in weight reduction programs for patients in whom alternative therapy has been ineffective. Administration for prolonged periods of time in obesity may lead to drug dependence and must be avoided .

Commonly used brand name(s)

In the U.S.

• Desoxyn

Available Dosage Forms:

• Tablet, Extended Release


• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine (class)

Uses For methamphetamine

Methamphetamine belongs to the group of medicines called central nervous system (CNS) stimulants. methamphetamine is used to treat attention-deficit hyperactivity disorder (ADHD). Methamphetamine increases attention and decreases restlessness in patients who are overactive, unable to concentrate for very long or are easily distracted, and have unstable emotions. It is also used as part of a total treatment program that also includes social, educational, and psychological treatment .

Methamphetamine is also used as a part of short-term plan, along with a low calorie diet, for weight reduction in obese patients who have not been able to lose weight on other therapies .

Methamphetamine may also be used for other conditions as determined by your doctor .

methamphetamine is available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs methamphetamine .

Before Using methamphetamine

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 methamphetamine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methamphetamine in children below 12 years of age for weight loss. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of methamphetamine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment of dosage in patients receiving methamphetamine .

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

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using methamphetamine 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.

• Ritonavir

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

• Agitation, anxiety or tension or


• Arteriosclerosis (hardening of the arteries), severe or


• Drug abuse or dependence, history of or


• Glaucoma or


• Heart disease or


• High blood pressure, moderate or severe or


• Hyperthyroidism—methamphetamine should not be used in patients with these conditions .

• Heart problems or defects or


• High blood pressure, mild or


• Mental illness (e.g., aggressive behavior, hostility, psychosis, mania, family history of suicide, bipolar illness, depression) or


• Seizures, history of or


• Thyroid problems—Use with caution. Serious side effects may occur .

• Tourette's syndrome, history of or other tics—Children and their families should be checked by their doctor for this condition before taking methamphetamine .

Proper Use of methamphetamine

Take methamphetamine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence) .

If you think methamphetamine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor .

methamphetamine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions .

It is best not to take methamphetamine late at night because it may cause sleeplessness .

Dosing

The dose of methamphetamine 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 methamphetamine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (tablets):
  
  • For attention-deficit hyperactivity disorder:
    
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) one or two times a day. Your doctor may increase your dose if needed.
    
    
    • Children younger than 6 years of age—Dose must be determined by your doctor .
    
    
  
  
  • For obesity:
    
    • Adults, teenagers, and children 12 years of age and older—5 mg taken ½ hour (30 minutes) before each meal.
    
    
    • Children younger than 12 years of age—Use is not recommended .
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using methamphetamine

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

If you will be taking methamphetamine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely .

Do not take methamphetamine within 14 days of taking an MAO inhibitor such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

methamphetamine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to methamphetamine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

If you have been using methamphetamine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on amphetamines are:

• A strong desire or need to continue taking the medicine.


• A need to increase the dose to receive the effects of the medicine.


• Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) occurring after the medicine is stopped .

methamphetamine may cause slow growth. If your child is using methamphetamine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly .

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

methamphetamine 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

• Agitation


• delusions


• hallucinations

Incidence not known

• Blurred vision


• chest discomfort or pain


• difficulty breathing


• dizziness


• faintness


• false or unusual sense of well-being


• fast, pounding, or irregular heartbeat or pulse


• headache


• nervousness


• pounding in the ears


• restlessness


• shakiness in legs, arms, hands, or feet


• shortness of breath


• sleeplessness


• swelling of feet or lower legs


• trembling or shaking of hands or feet


• trouble sleeping


• troubled breathing


• twitching, twisting, or uncontrolled repetitive movements of tongue, lips, face, arms, or legs


• unable to sleep


• uncontrolled vocal outbursts and/or tics (uncontrolled repeated body movements)


• unusual tiredness or weakness

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

Symptoms of overdose

• Change in consciousness


• dark-colored urine


• diarrhea


• discouragement


• feeling sad or empty


• fever


• irritability


• lack of appetite


• loss of consciousness


• loss of interest or pleasure


• mood or mental changes


• muscle cramps or spasms


• muscle pain or stiffness


• nausea


• panic state


• physical attempt to injure


• rapid breathing


• seizures


• stomach cramps


• sweating


• trouble concentrating


• trouble sleeping


• violent actions


• 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:

Incidence not known

• Bad, unusual, or unpleasant (after)taste


• change in taste


• constipation


• decreased interest in sexual intercourse


• dry mouth


• hives or welts


• inability to have or keep an erection


• indigestion


• itching


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


• passing of gas


• redness of skin


• skin rash


• 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: methamphetamine 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 methamphetamine resources

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

• methamphetamine Concise Consumer Information (Cerner Multum)


• Methamphetamine Prescribing Information (FDA)


• Methamphetamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Desoxyn Monograph (AHFS DI)


• Desoxyn Prescribing Information (FDA)

Compare methamphetamine with other medications

• ADHD
• Obesity

Slo-Niacin

Generic Name: niacin (Oral route)

NYE-a-sin

Commonly used brand name(s)

In the U.S.

• Niacinol


• Niacor


• Niaspan


• Nicotinex


• Slo-Niacin

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Capsule


• Capsule, Extended Release


• Elixir

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Vitamin B

Chemical Class: Nicotinic Acid (class)

Uses For Slo-Niacin

Niacin is used to help lower high cholesterol and fat levels in the blood. This may help prevent medical problems caused by cholesterol and fat clogging the blood vessels.

Some strengths of niacin are available only with your doctor's prescription.

Importance of Diet

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, Slo-Niacin is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using This Medicine

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

There is no specific information comparing the use of niacin for high cholesterol in children with use in other age groups. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

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. Although there is no specific information comparing the use of niacin for high cholesterol in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than in younger adults.

Pregnancy

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

Breast Feeding

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.

• Atorvastatin


• Cerivastatin


• Lovastatin


• Pitavastatin


• Rosuvastatin


• Simvastatin

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.

• Warfarin

Interactions with Food/Tobacco/Alcohol

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

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

• Ethanol

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:

• Bleeding problems or


• Diabetes mellitus (sugar diabetes) or


• Glaucoma or


• Gout or


• Liver disease or history of jaundice


• Low blood pressure or


• Stomach ulcer—Niacin may make these conditions worse

• Kidney problems—Niacin (extended release tablets) may make your kidney problems worse.

Proper Use of niacin

This section provides information on the proper use of a number of products that contain niacin. It may not be specific to Slo-Niacin. Please read with care.

Use this medicine only as directed by your doctor. Do not use more or less of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

Remember that niacin will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.

If this medicine upsets your stomach, it may be taken with meals or milk. If stomach upset (nausea or diarrhea) continues, check with your doctor.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole. Do not crush, break, or chew before swallowing. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

For patients taking the extended-release tablet form of this medicine:

• Swallow the tablet whole. If the tablet is scored, it may be broken, but not crushed or chewed, before being swallowed.


• Tablet (Niaspan) should be taken at bedtime after a low-fat snack.


• To decrease flushing of your face (redness), take aspirin or ibuprofen (e.g., Advil, Motrin) 30 minutes before taking tablet (Niaspan).


• Avoid drinking alcohol or hot drinks around the time you take your tablet (Niaspan). This helps decrease flushing of your face (redness).


• Take this medication exactly as your doctor ordered. If you stop taking this medication for any period of time, contact your doctor prior to restarting taking niacin.

Dosing

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

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

• For oral dosage form (extended-release capsules, extended-release tablets, oral solution, or regular tablets):
  
  • For treatment of high cholesterol:
    
    • Adults and teenagers—500 milligrams to 2 grams one to three times a day: use and dose will be determined by your doctor. Do not exceed the amount the doctor prescribes.
    
    
    • 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.

Precautions While Using Slo-Niacin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and if you should continue to take it.

Do not stop taking niacin without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Do not take vitamins or other dietary supplements unless they have been discussed with your doctor. This especially includes vitamins or dietary supplements that contain niacin or similar ingredients.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause you to feel dizzy or faint, especially when you get up from a lying or sitting position. Getting up slowly may help. This effect should lessen after a week or two as your body gets used to the medicine. However, if the problem continues or gets worse, check with your doctor.

Slo-Niacin 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:

Less commonWith prolonged use of extended-release niacin

• Darkening of urine


• light gray-colored stools


• loss of appetite


• severe stomach pain


• 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

• Abdominal pain


• feeling of warmth


• flushing or redness of skin, especially on face and neck


• headache


• rash


• runny nose


• sneezing


• stuffy nose

With high doses

• Diarrhea


• dizziness or faintness


• dryness of skin


• fever


• frequent urination


• itching of skin


• joint pain


• muscle aching or cramping


• nausea or vomiting


• side, lower back, or stomach pain


• swelling of feet or lower legs


• unusual thirst


• unusual tiredness or weakness


• unusually fast, slow, or irregular heartbeat

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: Slo-Niacin 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 Slo-Niacin resources

• Slo-Niacin Side Effects (in more detail)
• Slo-Niacin Use in Pregnancy & Breastfeeding
• Drug Images
• Slo-Niacin Drug Interactions
• Slo-Niacin Support Group
• 1 Review for Slo-Niacin - Add your own review/rating

• Slo-Niacin Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Slo-Niacin nicotinic acid Concise Consumer Information (Cerner Multum)


• Niacin Monograph (AHFS DI)


• Niacin MedFacts Consumer Leaflet (Wolters Kluwer)


• Niacor Prescribing Information (FDA)

Compare Slo-Niacin with other medications

• High Cholesterol
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
• Niacin Deficiency
• Pellagra

Germolene Antiseptic First Aid Wash

1. Name Of The Medicinal Product

Germolene Antiseptic First Aid Wash

also available as Germolene Bites and Stings Spray

2. Qualitative And Quantitative Composition

Phenol 1.20% w/v, chlorhexidine digluconate solution 1.33% w/v equivalent to chlorhexidine digluconate 0.25% w/v.

For excipients, see 6.1

3. Pharmaceutical Form

Cutaneous spray, solution

4. Clinical Particulars

4.1 Therapeutic Indications

As an antiseptic and cleansing agent (to help prevent secondary infection) and local anaesthetic for symptomatic relief of minor cuts and grazes, minor burns and scalds and blisters, stings and insect bites, spots and other minor skin disorders.

4.2 Posology And Method Of Administration

Route of administration: External application to the skin.

All age groups: Use undiluted. Spray onto the affected area to wash away debris and dirt. If necessary use cotton wool or a clean tissue to remove dirt and excess liquid. Repeat procedure if necessary.

4.3 Contraindications

Known hypersensitivity to any of the constituents.

4.4 Special Warnings And Precautions For Use

If symptoms persist or if skin irritation occurs, stop using and consult your doctor.

Keep out of the reach and sight of children.

For external use only.

Keep away from eyes, ears and mouth.

If you accidentally spray this product in your eye, wash thoroughly with water.

Consult a doctor promptly if contact is made with eyes or if product is swallowed.

Do not use as a mouth wash or gargle.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rarely local irritation, rashes and other skin reactions may occur.

4.9 Overdose

Repeated topical application

Frequently repeated topical application on the same site could theoretically lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

Accidental or deliberate oral ingestion

The product would only be expected to be harmful if orally ingested in very large quantities. This is unlikely due to the unpleasant taste of the product. In such a case, the primary concern would be the phenol intake which can cause nausea, vomiting, diarrhoea, headache and, in large amounts, excitement of respiratory stimulation leading to drowsiness and coma. The lethal dose of phenol has been estimated to be 15 grams.

Treatment

Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Phenol - antiseptic and local anaesthetic.

Chlorhexidine digluconate - antiseptic.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cocamidopropylamine oxide solution (30%)

Denatured ethanol B

Perfume Medic 9884

Bitrex solution (0.25%)

Ponceau 4R (E124)

Purified water

6.2 Incompatibilities

Chlorhexidine is incompatible with anionic agents

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

A clear, straight-sided, oval, PVC bottle with a pump spray, containing 50, 100, 150 or 200 ml. Each bottle may be contained in a boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

Trading as Bayer plc, Consumer Care Division

8. Marketing Authorisation Number(S)

PL 0010/0261

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 1 July 2000

Date of renewal of authorisation: 16 October 2000

10. Date Of Revision Of The Text

June 2005

cortisone

Generic Name: cortisone (KOR ti sone)

Brand Names: Cortone Acetate

What is cortisone?

Cortisone is a steroid that prevents the release of substances in the body that cause inflammation.

Cortisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

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

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Before taking cortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your dosage needs may change if you have surgery, are ill, are under stress, or have a fever or infection. Do not change your medication dose or schedule without your doctor's advice. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using cortisone. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Wear a medical alert tag or carry an ID card stating that you take cortisone. Any medical care provider who treats you should know that you take steroid medication.

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

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

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

• 
  

  liver disease (such as cirrhosis);

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a history of malaria;

  
  


• 
  

  tuberculosis;

  
  


• 
  

  osteoporosis;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  herpes infection of the eyes;

  
  


• 
  

  stomach ulcers, ulcerative colitis, or diverticulitis;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  high blood pressure.

  
  

It is not known whether cortisone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Cortisone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using cortisone.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take cortisone?

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

Your doctor may occasionally change your dose to make sure you get the best results.

Your dosage needs may change if you have surgery, are ill, are under stress, or have a fever or infection. Do not change your medication dose or schedule without your doctor's advice. Tell your doctor about any illness or infection you have had within the past several weeks.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using cortisone. Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Wear a medical alert tag or carry an ID card stating that you take cortisone. Any medical care provider who treats you should know that you take steroid medication. Store at room temperature away from moisture, heat, and light.

See also: Cortisone dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose of cortisone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking cortisone?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using cortisone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid drinking alcohol while you are taking cortisone.

Cortisone 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:

• 
  

  problems with your vision;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath;

  
  


• 
  

  severe depression, unusual thoughts or behavior, seizure (convulsions);

  
  


• 
  

  bloody or tarry stools, coughing up blood;

  
  


• 
  

  pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  sleep problems (insomnia), mood changes;

  
  


• 
  

  acne, dry skin, thinning skin, bruising or discoloration;

  
  


• 
  

  slow wound healing;

  
  


• 
  

  increased sweating;

  
  


• 
  

  headache, dizziness, spinning sensation;

  
  


• 
  

  nausea, stomach pain, bloating; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

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.

Cortisone Dosing Information

Usual Adult Dose for Adrenal Insufficiency:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Shock:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Hemolytic Anemia:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Erythroblastopenia:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Loeffler's Syndrome:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Sarcoidosis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Berylliosis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Lymphoma:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Nephrotic Syndrome:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Uveitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Iritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Keratitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Conjunctivitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Iridocyclitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Chorioretinitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Choroiditis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Systemic Lupus Erythematosus:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Dermatomyositis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Ankylosing Spondylitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Bursitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Osteoarthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Rheumatoid Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Gouty Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Psoriatic Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Epicondylitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Pediatric Dose for Adrenal Insufficiency:

0.5 mg to 0.75 mg/kg/day orally given in equally divided doses every 8 hours. Alternatively, 0.25 mg to 0.35 mg/kg IM once daily

What other drugs will affect cortisone?

Many drugs can interact with cortisone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  aspirin (taken on a daily basis or at high doses);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  
  


• 
  

  seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there are many other drugs that can interact with cortisone. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More cortisone resources

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

• Cortisone MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortisone Acetate Monograph (AHFS DI)

Compare cortisone with other medications

• Adrenal Insufficiency
• Ankylosing Spondylitis
• Berylliosis
• Bursitis
• Chorioditis
• Chorioretinitis
• Conjunctivitis
• Dermatomyositis
• Epicondylitis, Tennis Elbow
• Erythroblastopenia
• Gouty Arthritis
• Hemolytic Anemia
• Idiopathic Thrombocytopenic Purpura
• Iridocyclitis
• Iritis
• Keratitis
• Loeffler's Syndrome
• Lymphoma
• Nephrotic Syndrome
• Osteoarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Sarcoidosis
• Shock
• Systemic Lupus Erythematosus
• Uveitis

Where can I get more information?

• Your pharmacist can provide more information about cortisone.

See also: cortisone side effects (in more detail)

Indomax

Indomax may be available in the countries listed below.

Ingredient matches for Indomax

Indometacin

Indometacin is reported as an ingredient of Indomax in the following countries:

• Bangladesh

International Drug Name Search

Levocarnitine

Class: Other Miscellaneous Therapeutic Agents
VA Class: TN900
Chemical Name: (R)-3-carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium hydroxide
Molecular Formula: C₇H₁₅NO₃
CAS Number: 541-15-1
Brands: Carnitor

Introduction

Amino acid derivative;^{10 12 13} naturally occurring substance required in mammalian energy metabolism.^{1 2 4 7 10 11 12 13}

Uses for Levocarnitine

Primary Systemic Carnitine Deficiency

Orally for treatment of primary systemic carnitine deficiency, in addition to supportive and other therapy as indicated by the patient’s condition;^{2 10} designated an orphan drug by FDA for this use.⁶

Secondary Carnitine Deficiency Resulting from an Inborn Error of Metabolism

Orally and parenterally for acute or chronic treatment in patients with secondary carnitine deficiency resulting from an inborn error of metabolism;^{1 2 10} designated an orphan drug by FDA for this use.⁶

Carnitine Deficiency in Patients with End-stage Renal Disease Undergoing Dialysis

Parenterally for prevention and treatment of carnitine deficiency in patients with end-stage renal disease undergoing dialysis (dialysis-related carnitine disorder);^{1 7 10} designated an orphan drug by FDA for this use.⁶

Effects of supplemental carnitine on manifestations of carnitine deficiency and on clinical outcomes in patients with end-stage renal disease undergoing dialysis not determined.^{1 8 11}

Levocarnitine Dosage and Administration

General

• 
  

  Secondary Carnitine Deficiency Associated with an Inborn Error of Metabolism.

  
  


• 
  

  Obtain plasma carnitine concentrations prior to initiation of parenteral therapy.¹

  
  


• 
  

  Perform weekly and monthly monitoring of blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition of patient.¹

  
  


• 
  

  Plasma free carnitine concentrations should be 35–60 mcmol/L.¹

  
  


• 
  

  End-stage Renal Disease Patients undergoing Hemodialysis

  
  


• 
  

  Obtain blood levocarnitine concentrations prior to therapy to establish levocarnitine deficiency.³

  
  


• 
  

  Some experts recommend evaluating clinical response at 3-month intervals following initiation of drug, considering dosage adjustment to lowest effective dosage once desired outcome for specific manifestation has been attained, and discontinuing drug if clinical improvement has not occurred within 9–12 months.⁷

  
  

Administration

Administer orally (as a solution or tablets), by direct IV injection, or by IV infusion.^{1 2}

Oral Administration

Solutions may be administered alone or dissolved in beverages or other liquid foods to reduce taste fatigue.² Slowly administer solution in evenly spaced doses throughout the day (i.e., at least 3 or 4 hours apart), preferably during or following meals, to maximize tolerance; adverse GI reactions may result from rapid administration of solution.²

Periodically monitor blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition of patient.²

Closely monitor tolerance to drug during first week of administration and following any dosage increases.²

IV Administration

For solution compatibility information, see Compatibility under Stability.

Vials are for single use only.¹

Rate of Administration

Secondary carnitine deficiency associated with an inborn error of metabolism, direct IV injection: Slowly over 2–3 minutes.¹

Carnitine deficiency in patients with end-stage renal disease undergoing dialysis, direct IV injection: Slowly over 2–3 minutes into the venous return line after each dialysis session.¹

Dosage

Decreasing the dosage of oral levocarnitine may diminish or eliminate drug-related patient body odor or GI symptoms if present.^{2 11}

Pediatric Patients

Primary Systemic Carnitine Deficiency

Oral

Pediatric patients (≤18 years of age): Initially, 50 mg/kg daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart); slowly increase dosage while assessing tolerance and therapeutic response.^{2 3} (See General and also Administration, under Dosage and Administration.)

Usual recommended dosage range is 50–100 mg/kg daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart), up to a maximum total daily dosage of 3 g.^{2 3}

Exact dosage based on clinical response.² Administer increased dosages with caution and only when clinical and biochemical considerations make it seem likely that increased dosages will be of benefit.²

Secondary Carnitine Deficiency Associated with an Inborn Error of Metabolism

Oral

Pediatric patients (≤18 years of age): Initially, 50 mg/kg daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart); slowly increase dosage while assessing tolerance and therapeutic response.^{2 3} (See General and also Administration, under Dosage and Administration.)

Usual recommended dosage range is 50–100 mg/kg daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart), up to a maximum total daily dosage of 3 g.^{2 3}

Exact dosage depends on clinical response.² Administer increased dosages with caution and only when clinical and biochemical considerations make it seem likely that increased dosages will be of benefit.²

IV

Pediatric patients (≤18 years of age): 50 mg/kg every 3 or 4 hours administered by slow, direct IV injection over 2–3 minutes or by IV infusion; do not administer less frequently than every 6 hours.^{1 3} Subsequent total daily dosage of approximately 50 mg/kg, adjusted as required and given in divided doses (i.e., every 3 or 4 hours), is recommended.¹

In pediatric patients (≤18 years of age) with severe metabolic crisis, a loading dose has often been administered, followed by an equivalent dose over the following 24 hours.^{1 3} These patients underwent close supervision and monitoring of plasma levocarnitine concentrations, with subsequent dosage adjusted accordingly.³ In individual case reports, highest total daily dosage administered has been 300 mg/kg.^{1 3}

Carnitine Deficiency in Patients with End-stage Renal Disease Undergoing Dialysis

IV

Pediatric patients (≤18 years of age): Initially, 10–20 mg/kg (preferably 10 mg/kg) of dry body weight administered by slow, direct IV injection over 2–3 minutes into the venous return line after each dialysis session.^{1 3}

Initiation of therapy may be prompted by trough (i.e., predialysis) plasma levocarnitine concentrations that are below normal (40–50 mcmol/L).¹

Adjust dosage based on trough (i.e., predialysis) plasma levocarnitine concentrations; dosage reductions (e.g., to 5 mg/kg after dialysis) may be initiated as early as the third or fourth week of therapy.^{1 3}

Adults

Primary Systemic Carnitine Deficiency

Therapy with Levocarnitine Tablets

Oral

990 mg 2 or 3 times daily, depending on clinical response.²

Therapy with Levocarnitine Oral Solution

Oral

Initially, 1 g daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart); slowly increase dosage while assessing tolerance and therapeutic response.^{2 3} (See General and also Administration, under Dosage and Administration.)

Usual recommended dosage range for a 50-kg patient is 1–3 g daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart).^{2 3}

Administer increased dosages with caution and only when clinical and biochemical considerations make it seem likely that increased dosages will be of benefit.²

Secondary Carnitine Deficiency Resulting from an Inborn Error of Metabolism

Therapy with Levocarnitine Tablets

Oral

990 mg 2 or 3 times daily, depending on clinical response.²

Therapy with Levocarnitine Oral Solution

Oral

Initially, 1 g daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart); slowly increase dosage while assessing tolerance and therapeutic response.^{2 3} (See General and also Administration, under Dosage and Administration.)

Usual recommended dosage range for a 50-kg patient is 1–3 g daily, given in 2 or 3 divided doses (administer each dose at least 3 or 4 hours apart).^{2 3}

Administer increased dosages with caution and only when clinical and biochemical considerations make it seem likely that increased dosages will be of benefit.²

IV

50 mg/kg every 3 or 4 hours administered by slow, direct IV injection over 2–3 minutes or by IV infusion; do not administer less frequently than every 6 hours.^{1 3} Subsequent total daily dosage of approximately 50 mg/kg, adjusted as required and given in divided doses (i.e., every 3 or 4 hours), is recommended.^{1 3}

In patients with severe metabolic crisis, a loading dose often has been administered, followed by an equivalent dose during the following 24 hours.^{1 3} These patients underwent close supervision and monitoring of plasma levocarnitine concentrations, with subsequent dosage adjusted accordingly.³ In individual case reports, highest total daily dosage administered has been 300 mg/kg.^{1 3}

Carnitine Deficiency in Patients with End-stage Renal Disease Undergoing Diaysis

IV

Initially, 10–20 mg/kg of dry body weight administered by slow, direct IV injection over 2–3 minutes into the venous return line after each dialysis session.¹

Initiation of therapy may be prompted by trough (i.e., predialysis) plasma levocarnitine concentrations that are below normal (40–50 mcmol/L).¹

Adjust dosage based on trough (i.e., predialysis) plasma levocarnitine concentrations; dosage reductions (e.g., to 5 mg/kg after dialysis) may be initiated as early as the third or fourth week of therapy.¹

Prescribing Limits

Pediatric Patients

Primary Carnitine Deficiency

Oral

Pediatric patients (≤18 years of age): In individual case reports, maximum 3 g daily.^{2 3}

Secondary Carnitine Deficiency Associated with an Inborn Error of Metabolism

Oral

Pediatric patients (≤18 years of age): In individual case reports, maximum 3 g daily.^{2 3}

IV

Pediatric patients (≤18 years of age): In individual case reports, total daily dosage of up to 300 mg/kg has been administered.^{1 3}

Carnitine Deficiency in Patients with End-stage Renal Disease Undergoing Dialysis

IV

Doses >20 mg/kg have not been shown to provide additional benefit.^{7 3}

Adults

Secondary Carnitine Deficiency Associated with an Inborn Error of Metabolism

IV

In individual case reports, total daily dosage of up to 300 mg/kg has been administered.^{1 3}

Carnitine Deficiency in Patients with End-stage Renal Disease Undergoing Dialysis

IV

Doses >20 mg/kg have not been shown to provide additional benefit.⁷

Special Populations

No special population dosage recommendations at this time.^{1 2} (See Renal Impairment under Cautions.)

Cautions for Levocarnitine

Contraindications

Manufacturer states none known.^{1 2}

Warnings/Precautions

Specific Populations

Pregnancy

Category B.^{1 2}

Lactation

Distributed into milk in cows; not known whether levocarnitine distributes into human milk.^{1 2} Consider discontinuance of nursing or the drug.^{1 2}

Pediatric Use

Dosage of levocarnitine in pediatric patients ≤18 years of age was based on specific patient case record observations rather than on studies that specifically defined age by protocol.^{1 2 3}

Renal Impairment

Safety and efficacy of oral levocarnitine not established in patients with renal impairment.^{1 2}

Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in patients with end-stage renal disease undergoing dialysis may result in accumulation of potentially toxic metabolites, trimethylamine (TMA) and trimethyloxamine (trimethylamine-N-oxide [TMAO]), since these metabolites are normally excreted in urine.^{1 2 3 7}

Safety of IV levocarnitine has been established in patients with end-stage renal disease.^{1 3}

Common Adverse Effects

Oral therapy: Transient nausea and vomiting,² abdominal cramps,² diarrhea,² body odor.²

Parenteral therapy: Transient nausea and vomiting,¹ body odor,¹ gastritis.¹ Patients on chronic hemodialysis may experience injection site reactions,¹ headache,¹ pain,¹ diarrhea,¹ flu syndrome,¹ pharyngitis,¹ infection,¹ hypertension,¹ vomiting,¹ abdominal pain,¹ hypotension,¹ dizziness,¹ increased cough,¹ chest pain,¹ hypercalcemia,¹ accidental injury,¹ asthenia,¹ nausea,¹ fever,¹ anemia,¹ hypervolemia,¹ paresthesia,¹ rhinitis,¹ or dyspnea.¹

Seizures reported in patients, with or without preexisting seizure activity, receiving either oral or IV levocarnitine.^{1 2 12} Increased seizure frequency and/or severity also reported in patients with preexisting seizure activity.^{1 2}

Levocarnitine Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is about 15–16% following oral administration and correction for endogenous plasma levocarnitine concentrations.^{1 2 4}

Peak plasma concentrations attained 3.3–3.4 hours following oral administration.^{1 2 4}

Distribution

Extent

Rate and extent of distribution from plasma into erythrocytes appear to be minor or negligible.⁴

Plasma Protein Binding

Does not appear to bind to plasma proteins or albumin.^{1 2 4}

Elimination

Metabolism

Metabolized principally to TMAO and γ-butyrobetaine in GI tract by bacteria.^{1 2 4 5 7}

Elimination Route

In healthy adults, approximately 9% of dose excreted in urine as levocarnitine (uncorrected for endogenous urinary excretion) following oral administration.^{1 2 3}

Approximately 58–65% of a dose excreted (as levocarnitine and metabolites) in urine and feces in 5–11 days following oral administration of radiolabeled drug to patients receiving a high carnitine diet and additional carnitine supplements for 15 days.^{1 2 3 5} About 4–8 and <1% of administered radiolabeled dose excreted in urine as levocarnitine and in feces as total carnitine, respectively.^{1 2 3 5} TMAO principally excreted in urine (8–49% of administered radiolabeled dose) and γ-butyrobetaine principally excreted in feces (0.44–45% of administered radiolabeled dose).^{1 2 3 5}

Approximately 76% of dose excreted in urine within 24 hours following direct IV injection.^{1 2}

Half-life

Mean distribution and apparent terminal half-lives are approximately 0.6 and 17.4 hours, respectively, using plasma concentrations uncorrected for endogenous levocarnitine following direct IV injection.^{1 2}

Special Populations

Potentially toxic metabolites, TMA and TMAO, may accumulate in patients with severely compromised renal function or in patients with end-stage renal disease undergoing dialysis.^{1 2 7} (See Renal Impairment under Cautions.)

Stability

Storage

Oral

Tablets

25°C.²

Solution

25°C.²

Parenteral

Injection

25°C.¹ Discard unused portions.¹

IV solutions containing levocarnitine 0.5– 8 mg/mL prepared in 0.9% sodium chloride injection or lactated Ringer’s injection appear to be stable at 25°C for up to 24 hours in PVC plastic bags.^{1 3}

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility¹

Compatible
Ringer’s injection, lactated1
Sodium chloride 0.9%1

ActionsActions

• 
  

  Carrier molecule; facilitates long-chain fatty acid entry into cellular mitochondria, and delivers substrate for oxidation and subsequent energy production.^{1 2 4 8 10 11 12 13}

  
  


• 
  

  May promote excretion of excess organic or fatty acids in patients with defects in fatty acid metabolism and/or specific organic acid metabolic disorders that result in accumulation of acyl-coenzyme A (acyl-CoA) esters.^{1 2}

  
  


• 
  

  In patients with secondary carnitine deficiency, eliminates acyl-CoA compounds by promoting formation of acylcarnitine, which is quickly excreted.^{1 2 4 10}

  
  


• 
  

  Increases plasma levocarnitine concentrations in patients with end-stage renal disease undergoing hemodialysis.¹

  
  


• 
  

  Not demonstrated to be a vitamin; no recommended dietary allowance (RDA) established.¹³

  
  

Advice to Patients

• 
  

  Advise patients to drink levocarnitine oral solution alone or dissolved in beverages or other liquid foods to reduce taste fatigue.²

  
  


• 
  

  Advise patients to drink levocarnitine oral solution slowly in evenly spaced doses throughout the day (at least 3 or 4 hours apart).²

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, as well as any concomitant illnesses.^{1 2}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 2}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{1 2} (See Cautions.)

  
  

Preparations

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

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

Levocarnitine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*
Oral	Solution	500 mg/5 mL*	Carnitor (with parabens)	Sigma-Tau
			Carnitor SF (with parabens; sugar-free)	Sigma-Tau
			Levocarnitine Oral Solution (with parabens)	Hi-Tech, Rising
	Tablets	330 mg*	Carnitor (with povidone)	Sigma-Tau
			Levocarnitine Tablets (with povidone)	Hi-Tech, Rising
Parenteral	Injection, for IV use only	200 mg/mL*	Carnitor	Sigma-Tau
			Levocarnitine Injection (preservative-free)	American Regent, Bedford, Sicor

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

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References

1. Sigma-Tau Pharmaceuticals, Inc. Carnitor (levocarnitine) injection prescribing information. Gaithersburg, MD; 2004 Mar.

2. Sigma-Tau Pharmaceuticals, Inc. Carnitor (levocarnitine) tablets and oral solution and Carnitor SF (levocarnitine) sugar-free oral solution prescribing information. Gaithersburg, MD; 2007 May.

3. Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD: Personal communication.

4. Evans AM, Fornasini G. Pharmacokinetics of L-carnitine. Clin Pharmacokinet. 2003; 42:941-67. [PubMed 12908852]

5. Rebouche CJ. Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism. 1991; 40:1305-10. [PubMed 1961125]

6. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm). Accessed 2007 Oct 22.

7. Eknoyan G, Latos DL, Lindberg J et al. Practice recommendations for the use of L-carnitine in dialysis-related carnitine disorder: National Kidney Foundation Carnitine Consensus Conference. Am J Kidney Dis. 2003; 41:868-76. [PubMed 12666074]

8. . II. Clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease in adults. Am J Kidney Dis. 2006; 47:(Suppl 3) S16-85.

10. . American Association of Clinical Endocrinologists medical guidelines for the clinical use of dietary supplements and nutraceuticals. Endocr Pract. 2003; 9:417-70. [PubMed 14583426]

11. Anon. Carnitine. Med Lett Drugs Ther. 1986; 28:88-9. [PubMed 3747937]

12. Anon. L-carnitine. Med Lett Drugs Ther. 2004; 46:95-6. [PubMed 15557875]

13. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:265-6.

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