tretinoin Topical

TRET-i-noin

Commonly used brand name(s)

In the U.S.

• Atralin


• Avita


• Refissa


• Renova


• Retin-A


• Retin-A Micro


• Tretin-X

In Canada

• Rejuva-A


• Stieva-A Cream


• Stieva-A Cream Forte


• Stieva-A Gel


• Stieva-A Solution


• Vitamin A Acid

Available Dosage Forms:

• Gel/Jelly


• Solution


• Liquid


• Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Retinoid

Uses For tretinoin

Tretinoin is used to treat acne. It works partly by keeping skin pores clear.

One of the tretinoin creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and by slowing down the way the body removes skin cells that may have been harmed by the sun. Tretinoin works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by sun or the natural aging process.

Tretinoin may also be used to treat other skin diseases as determined by your doctor.

Tretinoin is available only with your doctor's prescription.

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

• Keratosis follicularis (skin disorder of small, red bumps)


• Verruca plana (flat warts)

Before Using tretinoin

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 tretinoin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tretinoin 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 tretinoin have been done only in adult patients, and there is no specific information comparing use of tretinoin in children with use in other age groups. Children are unlikely to have skin problems due to the sun. In older children treated for acne, tretinoin is not expected to cause different side effects or problems than it does 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 tretinoin in patients 50 years of age and older with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 tretinoin, 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 tretinoin 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.

• Aminocaproic Acid


• Aprotinin


• Tetracycline


• Tranexamic Acid

Using tretinoin 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.

• Fluconazole


• Ketoconazole


• Voriconazole

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

• Dermatitis, seborrheic or


• Eczema or


• Sunburn—Use of tretinoin may cause or increase the irritation associated with these problems

Proper Use of tretinoin

It is very important that you use tretinoin only as directed. Do not use more 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 cause irritation of the skin.

Do not apply tretinoin to windburned or sunburned skin or on open wounds.

Do not use tretinoin in or around the eyes or lips, or inside of the nose. Spread the medicine away from these areas when applying. If the medicine accidentally gets on these areas, wash with water at once.

tretinoin usually comes with patient directions. Read them carefully before using the medicine.

Before applying tretinoin, wash the skin with a mild soap or cleanser and warm water by using the tips of your fingers. Then gently pat dry. Do not scrub your face with a sponge or washcloth. Wait 20 to 30 minutes before applying tretinoin to make sure the skin is completely dry. Applying tretinoin to wet skin can irritate the skin.

To use the cream or gel form of tretinoin:

• Apply just enough medicine to very lightly cover the affected areas, and rub in gently but well. A pea-sized amount is enough to cover the whole face.

To use the solution form of tretinoin:

• Using your fingertips, a gauze pad, or a cotton swab, apply enough tretinoin solution to cover the affected areas. If you use a gauze pad or a cotton swab for applying the medicine, avoid getting it too wet. This will help prevent the medicine from running into areas not intended for treatment.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

Dosing

The dose of tretinoin 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 tretinoin. 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 topical dosage forms (cream, gel, or solution):
  
  • For acne:
    
    • Adults and teenagers—Apply to the affected area(s) of the skin once a day, at bedtime.
    
    
  
  


• For cream dosage form (brand name Renova only):
  
  • For fine wrinkles, dark spots, or rough skin caused by the sun:
    
    • Adults up to 50 years of age—Apply to the affected area(s) of the skin once a day, at bedtime.
    
    
    • Adults 50 years of age and older—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of tretinoin, 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.

The gel product is flammable and should be kept away from fire or excessive heat.

Precautions While Using tretinoin

During the first 3 weeks you are using tretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. It may take longer than 12 weeks before you notice full improvement of your acne, even if you use the medicine every day. Check with your health care professional at any time skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

You should avoid washing the skin treated with tretinoin for at least 1 hour after applying it.

Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation might occur.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as tretinoin:

• Any other topical acne product or skin product containing a peeling agent (such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur)


• Hair products that are irritating, such as permanents or hair removal products


• Skin products that cause sensitivity to the sun, such as those containing spices or limes


• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions


• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers

Using these products along with tretinoin may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it does not cause a problem with any other topical products that you might use during the day. Check with your doctor before using topical medicines with tretinoin.

During the first 6 months of use, avoid overexposing the treated areas to sunlight, wind, or cold weather. The skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. However, you should not stop using tretinoin unless the skin irritation becomes too severe. Do not use a sunlamp .

To help tretinoin work properly, regularly use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats, and apply creams, lotions, or moisturizers often.

Check with your doctor at any time your skin becomes too dry and irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation and may include the following:

• For patients using tretinoin for the treatment of acne:
  
  • Regular use of water-based creams or lotions helps to reduce skin irritation or dryness that may be caused by the use of tretinoin.
  
  


• For patients using tretinoin for the treatment of fine wrinkling, dark spots, and rough skin caused by the sun:
  
  • tretinoin should be used as part of an ongoing program to avoid further damage to your skin from the sun. This program includes staying out of the sun when possible or wearing proper clothing or hats to protect your skin from sunlight.
  
  
  • Regular use of oil-based creams or lotions helps to reduce skin irritation or dryness caused by the use of tretinoin.
  
  

tretinoin Side Effects

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

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

• Burning feeling or stinging skin (severe)


• lightening of skin of treated area, unexpected


• peeling of skin (severe)


• redness of skin (severe)


• unusual dryness of skin (severe)

Rare

• Darkening of treated skin

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

More common

• Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine


• chapping or slight peeling of skin (mild)


• redness of skin (mild)


• unusual dryness of skin (mild)


• unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

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

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

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

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

More tretinoin Topical resources

• Tretinoin Topical Use in Pregnancy & Breastfeeding
• Tretinoin Topical Drug Interactions
• Tretinoin Topical Support Group
• 42 Reviews for Tretinoin Topical - Add your own review/rating

• Atralin Consumer Overview


• Avita Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Avita Prescribing Information (FDA)


• Refissa Prescribing Information (FDA)


• Renova Emollient Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Renova Consumer Overview


• Retin-A Prescribing Information (FDA)


• Tretin-X Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare tretinoin Topical with other medications

• Acne
• Lichen Sclerosus
• Necrobiosis Lipoidica Diabeticorum
• Photoaging of the Skin

pravastatin

Generic Name: pravastatin (PRAV a STAT in)

Brand Names: Pravachol

What is pravastatin?

Pravastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Pravastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Pravastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.

Pravastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors

Pravastatin is used in adults and children who are at least 8 years old.

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

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

You should not take pravastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease. Stop taking this medication and tell your doctor right away if you become pregnant.

Before taking pravastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily.

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Avoid eating foods that are high in fat or cholesterol. Pravastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

There are many other drugs that can increase your risk of serious medical problems if you take them together with pravastatin. 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.

Pravastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

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

You should not take pravastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease.

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

• history of liver disease;


• history of kidney disease;


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder; or

  
  


• 
  

  if you drink more than 2 alcoholic beverages daily.

  
  

In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

• 
  

  gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);

  
  


• 
  

  medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or

  
  


• 
  

  drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take pravastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking pravastatin. Pravastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking pravastatin.

How should I take pravastatin?

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.

Pravastatin is usually taken once a day, with or without food. Take the medicine at the same time each day. Your doctor may occasionally change your dose to make sure you get the best results.

You may need to stop using pravastatin for a short time if you have:

• 
  

  uncontrolled seizures;

  
  


• 
  

  an electrolyte imbalance (such as high or low potassium levels in your blood);

  
  


• 
  

  severely low blood pressure;

  
  


• 
  

  a severe infection or illness; or

  
  


• 
  

  surgery or a medical emergency.

  
  

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

Pravastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take pravastatin on a long-term basis for the treatment of high cholesterol. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

See also: Pravastatin 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.

What should I avoid while taking pravastatin?

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 1 hour after or 4 hours before you take pravastatin.

Avoid eating foods that are high in fat or cholesterol. Pravastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with pravastatin. Discuss the use of grapefruit products with your doctor.

Pravastatin side effects

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

• 
  

  unexplained muscle pain, tenderness, or weakness;

  
  


• 
  

  fever, unusual tiredness, and dark colored urine;

  
  


• 
  

  chest pain;

  
  


• 
  

  swelling, weight gain, urinating less than usual or not at all; 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:

• 
  

  headache;

  
  


• 
  

  mild muscle pain;

  
  


• 
  

  diarrhea;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  dizziness.

  
  

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.

Pravastatin Dosing Information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.

Usual Adult Dose for Myocardial Infarction -- Prophylaxis:

Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.

Usual Adult Dose for Revascularization Procedures -- Prophylaxis:

Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.

Usual Adult Dose for Ischemic Stroke -- Prophylaxis:

Initial dose: 40 mg once daily.
Maintenance dose: 40 to 80 mg once daily.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

8 to 13 years: 20 mg orally once daily
14 to 18 years: 40 mg orally once daily

What other drugs will affect pravastatin?

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

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  spironolactone (Aldactone, Aldactazide); or

  
  


• 
  

  any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin).

  
  

This list is not complete and other drugs may interact with pravastatin. 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 pravastatin resources

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

• pravastatin Advanced Consumer (Micromedex) - Includes Dosage Information


• Pravastatin MedFacts Consumer Leaflet (Wolters Kluwer)


• Pravastatin Prescribing Information (FDA)


• Pravachol Prescribing Information (FDA)


• Pravachol Monograph (AHFS DI)


• Pravachol Consumer Overview

Compare pravastatin with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Ischemic Stroke, Prophylaxis
• Myocardial Infarction, Prophylaxis
• Revascularization Procedures, Prophylaxis

Where can I get more information?

• Your pharmacist can provide more information about pravastatin.

See also: pravastatin side effects (in more detail)

Loprox Gel

Dosage Form: Gel

FOR DERMATOLOGIC USE ONLY.

NOT FOR USE IN EYES.

Rx Only

Loprox Gel Description

LOPROX® Gel (ciclopirox) 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only.

Each gram of LOPROX® Gel contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP.

LOPROX® Gel is a white, slightly fluid gel.

The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Loprox Gel - Clinical Pharmacology

Mechanism of Action

Ciclopirox acts by chelation of polyvalent cations (Fe3+ or Al3+) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.

In vitro studies showed that ciclopirox inhibited the formation of 5-lipoxygenase inflammatory mediators (5-HETE and LTB4) and also inhibited PGE2 release in a cell culture model. In vivo, ciclopirox inhibited inflammation in an arachidonic acid-induced murine ear edema model. The clinical significance of these findings is unknown.

Pharmacokinetics

A comparative study of the pharmacokinetics of LOPROX® Gel, and LOPROX® Cream (ciclopirox olamine) 0.77% in 18 healthy males indicated that systemic absorption of ciclopirox from LOPROX® Gel was higher than that of LOPROX® Cream. A 5 gm dose of LOPROX® Gel produced a mean (±SD) peak serum concentration of 25.02 (±20.6) ng/mL total ciclopirox and 5 gm of LOPROX® Cream produced 18.62 (±13.56) ng/mL total ciclopirox. Approximately 3% of the applied ciclopirox was excreted in the urine within 48 hours after application, with a renal elimination half-life of about 5.5 hours.

In a study of LOPROX® Gel, 16 men with moderate to severe tinea cruris applied approximately 15 grams/day of the gel for 14.5 days. The mean (±SD) dose-normalized values of Cmax for total ciclopirox in serum were 100 (±42) ng/mL on Day 1 and 238 (±144) ng/mL on Day 15. During the 10 hours after dosing on Day 1, approximately 10% of the administered dose was excreted in the urine.

Microbiology

Ciclopirox is a hydroxypyridinone antifungal agent that inhibits the growth of pathogenic dermatophytes. Ciclopirox has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Indications and Usage for Loprox Gel

Superficial Dermatophyte Infections

LOPROX® Gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.

Seborrheic Dermatitis

LOPROX® Gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.

Contraindications

LOPROX® Gel is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

LOPROX® Gel is not for ophthalmic, oral, or intravaginal use.

Keep out of reach of children.

Precautions

If a reaction suggesting sensitivity or chemical irritation should occur with the use of LOPROX® Gel, treatment should be discontinued and appropriate therapy instituted. A transient burning sensation may occur, especially after application to sensitive areas. Avoid contact with eyes. Efficacy of LOPROX® Gel in immunosuppressed individuals has not been studied. Seborrheic dermatitis in association with acne, atopic dermatitis, Parkinsonism, psoriasis and rosacea has not been studied with LOPROX® Gel. Efficacy in the treatment of plantar and vesicular types of tinea pedis has not been established.

Information for Patients

The patient should be told the following:

1. Use LOPROX® Gel as directed by the physician. Avoid contact with the eyes and mucous membranes. LOPROX® Gel is for external use only.


2. Use the medication for fungal infections for the full treatment time even though symptoms may have improved, and notify the physician if there is no improvement after 4 weeks.


3. A transient burning/stinging sensation may be felt. This may occur in approximately 15% to 20% of cases, when LOPROX® Gel is used to treat seborrheic dermatitis of the scalp.


4. Inform the physician if the area of application shows signs of increased irritation or possible sensitization (redness with itching, burning, blistering, swelling, and/or oozing).


5. Avoid the use of occlusive dressings.


6. Do not use this medication for any disorder other than that for which it is prescribed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site.

The following battery of in vitro genotoxicity tests was conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster cells, with and without metabolic activation (positive); gene mutation assays in the HGPRT-test with V79 Chinese hamster cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5000 mg/kg.

Pregnancy

Teratogenic effects

Pregnancy Category B

Reproduction studies of ciclopirox revealed no significant evidence of impaired fertility in rats exposed orally up to 5 mg/kg body weight (approximately 5 times the maximum recommended topical human dose based on surface area). No fetotoxicity was shown due to ciclopirox in the mouse, rat, rabbit, and monkey at oral doses up to 100, 30, 30, and 50 mg/kg body weight, respectively (approximately 37.5, 30, 44, and 77 times the maximum recommended topical human dose based on surface area). By the dermal route of administration, no fetotoxicity was shown due to ciclopirox in the rat and rabbit at doses up to 120 and 100 mg/kg body weight, respectively (approximately 121 and 147 times, respectively, the maximum recommended topical human dose based on surface area).

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. LOPROX® Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when LOPROX® Gel is administered to a nursing woman.

Pediatric Use

The efficacy and safety of LOPROX® Gel in pediatric patients below the age of 16 years have not been established.

Adverse Reactions

In clinical trials, 140 (39%) of 359 subjects treated with LOPROX® Gel reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.

Loprox Gel Dosage and Administration

Superficial Dermatophyte Infections

Gently massage LOPROX® Gel into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

Seborrheic Dermatitis of the Scalp

Apply LOPROX® Gel to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

How is Loprox Gel Supplied

LOPROX® Gel (ciclopirox) 0.77% is supplied in 30 g tubes (NDC 99207-013-30), 45 g tubes (NDC 99207-013-45), and 100 g tubes (NDC 99207-013-01).

Store at 15°– 30°C (59°– 86°F).

Prescribing Information as of July 2005

Manufactured for:

MEDICIS, The Dermatology Company®

Scottsdale, AZ 85258

REG TM MEDICIS

03-6081; 156090/A

LOPROX  ciclopirox  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-013 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength ciclopirox (ciclopirox) Active 7.7 MILLIGRAM  In 1 GRAM Water Inactive   Isopropyl Alcohol Inactive   Octyldodecanol Inactive   Dimethicone Copolyol 190 Inactive   Carbomer 980 Inactive   Sodium Hydroxide Inactive   Docusate Sodium Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-013-30 30 g (GRAM) In 1 TUBE None 2 99207-013-45 45 g (GRAM) In 1 TUBE None 3 99207-013-01 100 g (GRAM) In 1 TUBE None

Revised: 11/2006MEDICIS, The Dermatology Company

More Loprox Gel resources

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

Compare Loprox Gel with other medications

• Cutaneous Candidiasis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Lodrane 24 24-Hour Sustained-Release Capsules

Pronunciation: brome-fen-EER-a-meen
Generic Name: Brompheniramine
Brand Name: Lodrane 24

Lodrane 24 24-Hour Sustained-Release Capsules are used for:

Treating and preventing symptoms of hay fever, other allergies, and colds. It may also be used for other conditions as determined by your doctor.

Lodrane 24 24-Hour Sustained-Release Capsules are an antihistamine. It works by blocking the action of histamine, a chemical released during allergic reactions.

Do NOT use Lodrane 24 24-Hour Sustained-Release Capsules if:

• you are allergic to any ingredient in Lodrane 24 24-Hour Sustained-Release Capsules


• you are breast-feeding


• you have narrow-angle glaucoma, or a peptic or stomach ulcer


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


• you are taking sodium oxybate (GHB) or you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 14 days

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

Before using Lodrane 24 24-Hour Sustained-Release Capsules:

Some medical conditions may interact with Lodrane 24 24-Hour Sustained-Release Capsules. 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 an enlarged prostate, difficulty urinating or severe constipation


• if you have an overactive thyroid, asthma, increased pressure in the eyes, glaucoma, heart disease, or high blood pressure

Some MEDICINES MAY INTERACT with Lodrane 24 24-Hour Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of severe drowsiness may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lodrane 24 24-Hour Sustained-Release Capsules 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 Lodrane 24 24-Hour Sustained-Release Capsules:

Use Lodrane 24 24-Hour Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lodrane 24 24-Hour Sustained-Release Capsules may be taken with food if it upsets your stomach.


• Swallow whole. Do not break, crush, or chew before swallowing.


• If you miss a dose of Lodrane 24 24-Hour Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lodrane 24 24-Hour Sustained-Release Capsules.

Important safety information:

• Lodrane 24 24-Hour Sustained-Release Capsules may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lodrane 24 24-Hour Sustained-Release Capsules. Using Lodrane 24 24-Hour Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Lodrane 24 24-Hour Sustained-Release Capsules. Lodrane 24 24-Hour Sustained-Release Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Risk of side effects may be increased with high doses or prolonged use. Do NOT exceed the recommended dose or take Lodrane 24 24-Hour Sustained-Release Capsules for longer than prescribed without checking with your doctor.


• Use Lodrane 24 24-Hour Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness, drowsiness, dry mouth, and trouble urinating.


• Use Lodrane 24 24-Hour Sustained-Release Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• Lodrane 24 24-Hour Sustained-Release Capsules may interfere with results of some lab tests, including allergy skin tests. Inform lab attendants that you are taking Lodrane 24 24-Hour Sustained-Release Capsules.


• PREGNANCY and BREAST-FEEDING: It is unknown if Lodrane 24 24-Hour Sustained-Release Capsules can cause harm to the fetus. If you become pregnant while taking Lodrane 24 24-Hour Sustained-Release Capsules, discuss with your doctor the benefits and risks of using Lodrane 24 24-Hour Sustained-Release Capsules during pregnancy. It is unknown if Lodrane 24 24-Hour Sustained-Release Capsules are excreted in breast milk. Do not breast-feed while taking Lodrane 24 24-Hour Sustained-Release Capsules.

Possible side effects of Lodrane 24 24-Hour Sustained-Release Capsules:

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

Dizziness; drowsiness; dry mouth, throat, and nose; thickening of mucus in nose or throat.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever; mental or mood changes; shortness of breath; sore throat; unusual bleeding or bruising; unusual tiredness or weakness.

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: Lodrane 24 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bizarre behavior; constipation; enlarged pupils; excitement; flushing; hallucinations; seizures; severe dizziness; severe drowsiness.

Proper storage of Lodrane 24 24-Hour Sustained-Release Capsules:

Store Lodrane 24 24-Hour Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Lodrane 24 24-Hour Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Lodrane 24 24-Hour Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Lodrane 24 24-Hour Sustained-Release Capsules are 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 Lodrane 24 24-Hour Sustained-Release Capsules. 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 Lodrane 24 resources

• Lodrane 24 Side Effects (in more detail)
• Lodrane 24 Use in Pregnancy & Breastfeeding
• Lodrane 24 Drug Interactions
• Lodrane 24 Support Group
• 6 Reviews for Lodrane 24 - Add your own review/rating

Compare Lodrane 24 with other medications

• Allergic Reactions
• Cold Symptoms
• Hay Fever
• Urticaria

Flagyl

Generic Name: Metronidazole
Class: Antiprotozoals, Miscellaneous
VA Class: AM900
CAS Number: 443-48-1

• 
  

  Carcinogenic in mice and rats.^{152 156 197 430 495}

  
  


• 
  

  Avoid unnecessary use; reserve for use in approved indications..^{152 156 197 430 495} (See Uses.)

  
  

Introduction

Antibacterial and antiprotozoal;.^{152 197 430 494 495} nitroimidazole derivative.⁴⁹⁴

Uses for Flagyl

Bone and Joint Infections

Adjunct for treatment of bone and joint infections caused by Bacteroides, including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus).^{152 197 495}

Endocarditis

Treatment of endocarditis caused by Bacteroides (including the B. fragilis group).^{152 197 495}

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, endomyometritis, tubo-ovarian abscess, postsurgical vaginal cuff infection) caused by Bacteroides (including the B. fragilis group), Clostridium, Peptococcus niger, or Peptostreptococcus.^{152 197 495}

Treatment of acute pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.^{199 341 496} Metronidazole is included in PID regimens to provide coverage against anaerobes.³⁴¹

When a parenteral regimen is indicated for PID, an initial regimen of IV cefoxitin and IV or oral doxycycline is recommended followed by oral doxycycline; if tubo-ovarian abscess is present, some experts recommend that the oral follow-up regimen include metronidazole (or clindamycin) in addition to doxycycline.³⁴¹

When an oral regimen is indicated for PID, an single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime is recommended in conjunction with oral doxycycline (with or without oral metronidazole).^{199 341 496} Alternatively, if a parenteral cephalosporin is not feasible and the community prevalence and individual risk for gonorrhea is low, a regimen of oral levofloxacin or oral ofloxacin (with or without oral metronidazole) may be considered.⁴⁹⁶

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis, intra-abdominal abscess, liver abscess) caused by susceptible Bacteroides (including the B. fragilis group), Clostrium, Eubacterium, P. niger, or Peptostreptococcus.^{152 197 495}

Meningitis and Other CNS Infections

Treatment of CNS infections (including meningitis, brain abscess) caused by Bacteroides (including the B. fragilis group).^{152 197 495}

Respiratory Tract Infections

Treatment of respiratory tract infections (including pneumonia) caused by Bacteroides (including the B. fragilis group).^{152 197 495}

Septicemia

Treatment of septicemia caused by Bacteroides (including the B. fragilis group) or Clostridium.^{152 197 495}

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by Bacteroides (including the B. fragilis group), Clostridium, Fusobacterium, P. niger, or Peptostreptococcus.^{152 197 495}

Amebiasis

Treatment of acute intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica.^{100 152 153 197 364 368 370} Oral metronidazole or oral tinidazole followed by a luminal amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.^{100 153 364 368 370}

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.^{199 292 297 298 302 341 365 366 430}

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).³⁴¹ In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.³⁴¹

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.³⁴¹

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;³⁴¹ alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.³⁴¹ The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.³⁴¹

Regardless of regimen used, relapse or recurrence is common;^{287 295 297 298 300 302 307 341 365} an alternative regimen (e.g., topical therapy when oral therapy was used initially) may be used in such situations.^{297 341}

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.³⁴¹

Balantidiasis

Alternative to tetracycline for treatment of balantidiasis† caused by Balantidium coli.^{100 153}

Blastocystis hominis Infections

Treatment of infections caused by Blastocystis hominis†.^{100 153 368 371 372} May be effective, but metronidazole resistance may be common.¹⁵³

Clinical importance of B. hominis as a cause of GI pathology is controversial;^{100 153 368 371 372} unclear when treatment is indicated.^{100 368 371} Some clinicians suggest treatment be reserved for certain individuals (e.g., immunocompromised patients) when symptoms persist and no other pathogen or process is found to explain their GI symptoms.^{100 368}

Clostridium difficile-associated Diarrhea and Colitis

Treatment of Clostridium difficile-associated diarrhea and colitis† (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis).^{100 125 126 127 128 129 131 132 312 313 314 315 316 344 345 443 444 445 446 447}

Drugs of choice are metronidazole and vancomycin; ^{100 312 313 314 315 316} metronidazole generally preferred and vancomycin reserved for those with severe or potentially life-threatening colitis, patients in whom metronidazole-resistant C. difficile is suspected, patients in whom metronidazole is contraindicated or not tolerated, or those who do not respond to metronidazole.^{100 126 127 312 313 314 315 316 322 323 406 443 444 445 446 447 448}

Crohn’s Disease

Mangement of Crohn’s disease† as an adjunct to conventional therapies.^{101 102 103 104}

Has been used with^{467 468 471 475 476 477 485} or without ciprofloxacin;^{101 102 103 104 105 469 470 471 472 473 474 478 479 484 485 486} for induction of remission of mildly to moderately active Crohn’s disease†.^{101 102 103 104 105 467 468 469 471 472 473 474 475 476 477 478 479 484}

Has been used for refractory perianal Crohn’s disease†.^{102 104 105 470 471 474 478 479 485 486}

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis†.¹⁵³ Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.¹⁵³

Dracunculiasis

Treatment of dracunculiasis† caused by Dracunculus medinensis (guinea worm disease).¹⁵³

Treatment of choice is slow extraction of worm combined with wound care.¹⁵³ Metronidazole is not curative, but decreases inflammation and facilitates worm removal.¹⁵³

Giardiasis

Treatment of giardiasis†.^{100 153 367 452} Drugs of choice are metronidazole, tinidazole, or nitazoxanide;^{100 153 367 452} alternatives are paromomycin, furazolidone (no longer commercially available in the US), or quinacrine (not commercially available in the US).^{100 153 367}

Treatment of asymptomatic carriers of giardiasis†.^{100 367} Treatment of such carriers not generally recommended, except possibly in patients with hypogammaglobulinemia or cystic fibrosis or in an attempt to prevent household transmission of the disease from toddlers to pregnant women.¹⁰⁰

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer); eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Used in a multiple-drug regimen that includes metronidazole, tetracycline, and bismuth subsalicylate and a histamine H₂-receptor antagonist.⁴⁵⁵ If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.⁴⁵⁵

Nongonococcal Urethritis

Treatment of recurrent and persistent urethritis† in patients with nongonococcal urethritis who have already been treated with a recommended regimen (i.e., azithromycin, doxycycline, erythromycin, ofloxacin or levofloxacin).³⁴¹

Oral metronidazole or oral tinidazole used in conjunction with oral azithromycin (if azithromycin was not used in the initial regimen) is the regimen recommended by CDC for recurrent and persistent urethritis in patients who were compliant with their initial regimen and have not been re-exposed.³⁴¹

Rosacea

Treatment of inflammatory lesions (papules and pustules) and erythema associated with rosacea† (acne rosacea).^{137 139 145 146 148 168 180 181} Topical metronidazole may be preferred to oral metronidazole.^{137 181}

Tetanus

Adjunct in treatment of tetanus caused by C. tetani.^{100 489}

Trichomoniasis

Treatment of symptomatic and asymptomatic trichomoniasis when Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).^{100 152 153 197 199 297 298 302 337 338 339 341}

Drug of choice is metronidazole or tinidazole.^{100 153 199 297 302 337 338 339 341} Goal of treatment is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission; to achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated.^{153 199 297 302 339 341}

If treatment failure occurs with initial metronidazole treatment and reinfection is excluded, alternative regimens using metronidazole or tinidazole can be used.^{153 199 341} If retreatment is ineffective, consultation with an expert (available through CDC) is recommended.³⁴¹

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of postoperative anaerobic bacterial infections in patients undergoing colorectal surgery.^{109 110 111 112 156 495} Preferred regimens are IV cefoxitin alone; IV cefazolin and IV metronidazole; oral erythromycin and oral neomycin; or oral metronidazole and oral neomycin.^{110 112 490}

Perioperative prophylaxis in patients undergoing appendectomy†;^{109 111 110 112 113} used in conjunction with cefazolin.¹¹⁰ Preferred regimens for appendectomy (nonperforated) are IV cefoxitin alone or IV cefazolin and IV metronidazole.¹¹⁰

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction with IM ceftriaxone and oral azithromycin or doxycycline.^{199 341}

Flagyl Dosage and Administration

Administration

Administer orally^{152 197 430} or by continuous or intermittent IV infusion.^{156 495} Do not administer by rapid IV injection because of the low pH of the reconstituted product.^{156 495}

In the treatment of serious anaerobic infections, parenteral route usually is used initially and oral metronidazole substituted when warranted by patient’s condition.^{152 197}

Oral Administration

Administer extended-release tablets at least 1 hour before or 2 hours after meals.⁴³⁰

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Commercially available metronidazole injection for IV infusion does not need to be diluted or neutralized prior to IV administration.^{156 495}

Metronidazole hydrochloride powder for injection must by reconstituted, diluted, and then neutralized prior to IV administration.¹⁵⁶

Reconstitution and Dilution

Reconstitute metronidazole hydrochloride powder for injection by adding 4.4 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or bacteriostatic sodium chloride injection to the vial containing 500 mg of metronidazole.¹⁵⁶ The reconstituted solution contains approximately 100 mg of metronidazole/mL and has a pH of 0.5–2.¹⁵⁶

The reconstituted metronidazole hydrochloride solution must be further diluted with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer’s injection to a concentration of ≤8 mg/mL.¹⁵⁶

The reconstituted and diluted metronidazole hydrochloride solution must then be neutralized by adding approximately 5 mEq of sodium bicarbonate injection for each 500 mg of metronidazole.¹⁵⁶ The addition of sodium bicarbonate to the metronidazole hydrochloride solution may generate carbon dioxide gas and it may be necessary to relieve gas pressure in the container.¹⁵⁶

Rate of Administration

IV infusions usually are infused over 1 hour.^{156 495}

Dosage

Available as metronidazole^{152 156 197 430 495} and metronidazole hydrochloride;¹⁵⁶ dosage expressed in terms of metronidazole.¹⁵⁶

Pediatric Patients

General Dosage in Neonates†

Oral or IV

Neonates <1 week of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 g, 7.5 mg/kg every 24 hours in those weighing 1.2–2 kg, or 7.5 mg/kg every 12 hours in those weighing >2 kg.¹⁰⁰

Neonates 1–4 weeks of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 kg, 7.5 mg/kg every 12 hours in those weighing 1.2–2 kg, and 15 mg/kg every 12 hours in those weighing >2 kg.¹⁰⁰

General Dosage in Children ≥1 Month of Age†

Oral

15–35 mg/kg daily in 3 divided doses.¹⁰⁰ AAP states oral route inappropriate for severe infections.¹⁰⁰

Amebiasis

Entamoeba histolytica Infections

Oral

35–50 mg/kg daily in 3 divided doses given for 7–10 (usually 10) days;^{152 153 197 370} follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin).¹⁵³

Bacterial Vaginosis†

Oral

Children weighing <45 kg: 15 mg/kg daily (up to 1 g) in 2 divided doses given for 7 days.¹⁰⁰

Adolescents: 500 mg twice daily for 7 days.¹⁰⁰

Balantidiasis†

Oral

35–50 mg/kg daily in 3 divided doses given for 5 days.¹⁵³

Blastocystis hominis Infections†

Oral

20–35 mg/kg daily in 3 divided doses given for 10 days may improve symptoms in some patients.¹⁰⁰

Crohn’s Disease†

Oral

10–20 mg/kg daily (up to 1 g daily) has been recommended for children with mild perianal Crohn’s disease† or those intolerant to sulfasalazine or mesalamine.⁴⁸⁷

Clostridium difficile-associated Diarrhea and Colitis†

Oral

30–50 mg/kg daily in 3 or 4 equally divided doses given for 7–10 days (not to exceed adult dosage).^{100 445 446}

Dientamoeba fragilis Infections†

Oral

20–40 mg/kg daily in 3 divided doses given for 10 days.¹⁵³

Dracunculiasis†

Oral

25 mg/kg daily (up to 750 mg) in 3 divided doses given for 10 days.¹⁵³ Is not curative, but may decrease inflammation and facilitate worm removal.¹⁵³

Giardiasis†

Oral

15 mg/kg daily in 3 divided doses given for 5–7 days.^{153 367 452}

Nongonococcal Urethritis†

Oral

Recurrent or persistent urethritis in adolescents: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).³⁴¹

Tetanus†

Oral

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.¹⁰⁰

IV

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.¹⁰⁰

Trichomoniasis†

Oral

Prepubertal children weighing <45 kg: 15 mg/kg daily in 3 divided doses (up to 2 g daily) given for 7 days.^{100 153}

Adolescents: A single 2-g dose or 500 mg twice daily for 7 days.¹⁰⁰

Prophylaxis in Sexual Assault Victims†

Oral

Preadolescent children weighing <45 kg: 15 mg/kg daily given in 3 divided doses for 7 days given in conjunction with IM ceftriaxone and either oral azithromycin or oral erythromycin.^{100 341}

Adolescents and preadolescent children weighing ≥45 kg: A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.^{100 341}

Adults

Anaerobic Bacterial Infections

Serious Infections

Oral

7.5 mg/kg every 6 hours (up to 4 g daily).^{152 156 197}

IV, then Oral

An initial IV loading dose of 15 mg/kg followed by IV maintenance doses of 7.5 mg/kg every 6 hours.^{156 495} After clinical improvement occurs, switch to oral metronidazole (7.5 mg/kg every 6 hours).^{156 495}

Total duration of treatment usually is 7–10 days, but infections of bone and joints, lower respiratory tract, or endocardium may require longer treatment.^{156 495}

Gynecologic Infections

Pelvic Inflammatory Disease

Oral

500 mg twice daily given for 14 days; used in conjunction with a single IM dose of ceftriaxone (250 mg), cefoxitin (2 g with oral probenecid 1 g), or another parenteral cephalosporin (e.g., cefotaxime) and 14-day regimen of oral doxycycline (100 mg twice daily).^{341 496}

Alternatively, 500 mg twice daily given for 14 days; used in conjunction with a 14-day regimen of oral ofloxacin (400 mg twice daily) or levofloxacin (500 mg once daily).^{199 341 496} Regimens containing a fluoroquinolone should only be considered when a parenteral cephalosporin is not feasible and the community prevalence and individual risk of gonorrhea is low.⁴⁹⁶

Amebiasis

Entamoeba histolytic Infections

Oral

750 mg 3 times daily given for 5–10 (usually 10) days for intestinal amebiasis^{152 153 197 364 368 370} or 500–750 mg 3 times daily given for 5–10 (usually 10) days for amebic liver abscess.^{152 197 364 368 370} Alternatively, amebic liver abscess has been treated with 2.4 g once daily given for 1 or 2 days.³⁶⁴

Follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin) after metronidazole.^{153 364 368 370}

IV

500 mg every 6 hours for 10 days.³⁶⁴

Bacterial Vaginosis

Nonpregnant Women

Oral

Conventional tablets: 500 mg twice daily given for 7 days.^{100 199 286 297 298 300 301 302 341 366} A single 2-g dose has been used (e.g., for patients who may be noncompliant with the multiple-dose regimen),^{120 122 199 292 297} but appears to be less effective than other regimens and is no longer recommended by CDC.³⁴¹

Extended-release tablets: 750 mg once daily given for 7 days.^{199 341 416 417 430}

Pregnant Women

Oral

Conventional tablets: 500 mg twice daily or 250 mg 3 times daily given for 7 days.^{341 416 417}

Contraindicated during first trimester of pregnancy.^{152 197 430} In addition, single-dose regimens not recommended in pregnant women because of the slightly higher serum concentrations attained, which may reach fetal circulation.¹⁵²

Balantidiasis†

Oral

750 mg 3 times daily given for 5 days.¹⁵³

Blastocystis hominis Infections†

Oral

750 mg 3 times daily given for 10 days may improve symptoms in some patients.^{100 153}

Crohn’s Disease†

Oral

400 mg twice daily^{101 103 105} or 1 g daily has been effective for treatment of active Crohn’s disease†.^{467 472 473 475 476 482} For treatment of refractory perineal disease, 20 mg/kg (1–1.5 g) given in 3–5 divided doses daily has been employed.^{102 103 104 105 478 486}

Clostridium difficile-associated Diarrhea and Colitis†

Oral

750 mg to 2 g daily in 3 or 4 divided doses given for 7–14 days.^{125 126 129 131 132 133 313 314}

Dose-ranging studies to determine comparative efficacy have not been performed; most commonly employed regimens are 250 mg 4 times daily or 500 mg 3 times daily given for 10 days.^{443 444 445 446}

IV

500–750 mg every 6–8 hours; use when oral therapy is not feasible.^{134 161 162 313 342 343 445}

Dientamoeba fragilis Infections†

Oral

500–750 mg 3 times daily given for 10 days.¹⁵³

Dracunculiasis†

Oral

250 mg 3 times daily given for 10 days.¹⁵³ Is not curative, but may decrease inflammation and facilitate worm removal.¹⁵³

Giardiasis†

Oral

250 mg 3 times daily given for 5–7 days.^{153 367 452}

Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral

250 mg in conjunction with tetracycline (500 mg) and bismuth subsalicylate (525 mg) 4 times daily (at meals and at bedtime) for 14 days; these drugs should be given concomitantly with an H₂-receptor antagonist in recommended dosage.⁴⁵⁵

Nongonococcal Urethritis†

Oral

Recurrent or persistent urethritis: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).³⁴¹

Tetanus†

IV

500 mg every 6 hours given for 7–10 days.⁴⁸⁹

Trichomoniasis

Initial Treatment

Oral

2 g as a single dose^{152 153 199 341} or in 2 divided doses.¹⁵² Alternatively, 500 mg twice daily given for 7 days^{153 199 341} or 375 mg twice daily given for 7 days.^{199 197} Manufacturer also recommends 250 mg 3 times daily given for 7 days.¹⁵²

Retreatment

Oral

500 mg twice daily given for 7 days.^{297 341} If repeated failure occurs, CDC recommends 2 g once daily given for 5 days.^{297 341} Others recommend retreatment with 2–4 g daily for 7–14 days if metronidazole-resistant strains are involved.^{153 199}

Do not administer repeat courses of treatment unless presence of T. vaginalis is confirmed by wet smear and/or culture and an interval of 4–6 weeks has passed since the initial course.^{152 197}

If treatment of resistant infection is guided by in vitro susceptibility testing under aerobic conditions, some clinicians recommend that T. vaginalis strains exhibiting low-level resistance (minimum lethal concentration [MLC] <100 mcg/mL) be treated with 2 g daily for 3–5 days, those with moderate (intermediate) resistance (MLC 100–200 mcg/mL) be treated with 2–2.5 g daily for 7–10 days, and those with high-level resistance (MLC >200 mcg/mL) be treated with 3–3.5 g daily for 14–21 days.^{124 302 338 340} Because strains with high-level resistance are difficult to treat,^{124 297 302 338 340} CDC recommends that patients with culture-documented infection who do not respond to repeat regimens at dosages up to 2 g daily for 3–5 days and in whom the possibility of reinfection has been excluded should be managed in consultation with an expert (available through CDC).^{297 341}

Perioperative Prophylaxis

Colorectal Surgery

IV

0.5 g given at induction of anesthesia (within 0.5–1 hour prior to incision); used in conjunction with IV cefazolin (1–2 g).¹¹⁰

Manufacturer recommends 15 mg/kg by IV infusion over 30–60 minutes 1 hour prior to the procedure and, if necessary, 7.5 mg/kg by IV infusion over 30–60 minutes at 6 and 12 hours after the initial dose.^{156 495} The initial preoperative dose must be completely infused approximately 1 hour prior to surgery to ensure adequate serum and tissue concentrations of metronidazole at the time of incision.^{156 495} Prophylactic use of metronidazole should be limited to the day of surgery and should not be continued for more than 12 hours after surgery.^{156 495}

Oral

2 g with oral neomycin sulfate (2 g) given at 7 p.m. and 11 p.m. on day before surgery; used in conjunction with appropriate diet and catharsis.¹¹⁰

Prophylaxis in Sexual Assault Victims†

Oral

A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.^{100 341}

Special Populations

Hepatic Impairment

Decrease dosage in patients with severe hepatic impairment and monitor plasma concentrations of the drug.^{152 156 160 197 430 495}

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic function.^{152 197 430}

Cautions for Flagyl

Contraindications

• 
  

  Hypersensitivity to metronidazole or other nitroimidazole derivatives.^{152 156 197 430 495} Cautious desensitization has been used in some situations when use of metronidazole was considered necessary.^{341 436} (See Hypersensitivity Reactions and Desensitization under Cautions.)

  
  


• 
  

  First trimester of pregnancy.^{152 197 430}

  
  


• 
  

  Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.⁴⁵⁵

  
  

Warnings/Precautions

Warnings

Seizures and Peripheral Neuropathy

Seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with metronidazole.^{152 156 197 430 495}

Persistent peripheral neuropathy reported in some patients receiving prolonged therapy.⁴³⁰ If abnormal neurologic signs develop, promptly discontinue drug..^{152 156 197 430}

Use with caution in those with CNS diseases.^{152 197 430}

Sensitivity Reactions

Hypersensitivity Reactions and Desensitization

Hypersensitivity reactions, including urticaria, pruritus, erythematous rash, flushing, nasal congestion, fever, and fleeting joint pains sometimes resembling serum sickness, have been reported with metronidazole.^{152 156 197 430 495}

Because there are no effective alternatives to metronidazole in the US for treatment of trichomoniasis, CDC states that desensitization can be attempted in patients with metronidazole hypersensitivity.³⁴¹ The possibility that desensitization may be hazardous should be considered⁴³⁵ and adequate procedures (e.g., established IV access, BP monitoring) and therapies (e.g., epinephrine, corticosteroids, antihistamines, oxygen) for management of an acute hypersensitivity reaction should be readily available.⁴³⁵ Pretreatment (e.g., with an antihistamine and/or corticosteroid) also should be considered.⁴³⁵

Desensitization has been performed by administering increasing doses of IV metronidazole incrementally until a therapeutic dose was achieved, at which time oral dosing was initiated.⁴³⁵ In this regimen, an initial 5-mcg dose of IV metronidazole was given and the dose increased at 15- to 20-minute intervals to 15, 50, 150, and 500 mcg and then to 1.5, 5, 15, 30, 60, and 125 mg.⁴³⁵ After the 125-mg IV dose, dosing was switched to oral metronidazole and doses of 250, 500, and 2 g were given at 1-hour intervals.⁴³⁵ For trichomoniasis, desensitization dosing can be stopped after the 2-g dose.⁴³⁵ Patient should be monitored for ≥4 hours after the last dose (24 hours if there was any evidence of a reaction).⁴³⁵

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of metronidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^{152 197 430 495}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{152 197 430 495} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{152 197 430 495}

Surgical procedures should be performed in conjunction with metronidazole therapy when indicated.^{152 156 197 430 495}

In mixed aerobic and anaerobic infections, anti-infectives appropriate for treatment of aerobic bacteria should be used in conjunction with metronidazole.^{152 156 197 430 495}

History of Blood Dyscrasia