Mentax Cream

Pronunciation: byoo-TEN-a-feen
Generic Name: Butenafine
Brand Name: Mentax

Mentax Cream is used for:

Treating certain fungal infections of the skin. It may also be used to treat other conditions as determined by your doctor, which may not be listed in the professional package insert.

Mentax Cream is a topical antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it.

Do NOT use Mentax Cream if:

• you are allergic to any ingredient in Mentax Cream

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

Before using Mentax Cream:

Some medical conditions may interact with Mentax Cream. 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

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

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

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

• Mentax Cream works best if it is used at the same time(s) each day.


• Wash and completely dry the affected area. Gently rub the medicine in until it is evenly distributed.


• Use enough cream to cover the affected areas and the healthy skin close to the affected areas.


• Wash your hands immediately after using Mentax Cream.


• Do not cover the area with bandages or other dressings unless directed by your health care provider.


• Continue to use Mentax Cream for the full treatment time recommended by your health care provider, even though symptoms have gotten better.


• If you miss a dose of Mentax Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mentax Cream.

Important safety information:

• Do not use Mentax Cream for other skin conditions at a later time.


• Mentax Cream is for external use only. Avoid contact with nose, mouth, and eyes. If you get Mentax Cream in your eyes, immediately rinse out with cool tap water.


• Mentax Cream is not for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Mentax Cream during pregnancy. It is unknown if Mentax Cream is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of Mentax Cream:

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:

Burning; inflammation; irritation; itching; redness; stinging.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Mentax 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. Mentax Cream may be harmful if swallowed.

Proper storage of Mentax Cream:

Store Mentax Cream at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. Keep Mentax Cream out of the reach of children and away from pets.

General information:

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


• Mentax Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mentax Cream. 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 Mentax resources

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

Compare Mentax with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Montelukast Granules

Pronunciation: mon-te-LOO-kast
Generic Name: Montelukast
Brand Name: Singulair

Montelukast Granules are used for:

Prevention and long-term treatment of asthma. It is also used in certain patients to relieve runny nose caused by allergies and to prevent asthma attacks caused by exercise. It may also be used for other conditions as determined by your doctor.

Montelukast Granules are a leukotriene receptor antagonist. It works by blocking a substance called leukotriene, which helps to decrease certain asthma and allergy symptoms.

Do NOT use Montelukast Granules if:

• you are allergic to any ingredient in Montelukast Granules

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

Before using Montelukast Granules:

Some medical conditions may interact with Montelukast Granules. 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 are having an asthma attack


• if you have liver problems


• if you have a history of mental or mood problems, or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Montelukast Granules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain anticonvulsants (eg, phenobarbital) or rifampin because they may decrease Montelukast Granules's effectiveness

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

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

• An extra patient leaflet is available with Montelukast Granules. Talk to your pharmacist if you have questions about this information.


• Take Montelukast Granules by mouth with or without food.


• Do not open the packet until you are ready to use it.


• Montelukast Granules may be placed directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of soft food at cold or room temperature before swallowing. Soft foods that may be used include applesauce, mashed carrots, rice, or ice cream. Be sure to swallow the entire spoonful right away (within 15 minutes). Do not store mixed medicine for future use.


• Do not put the granules in liquid other than baby formula or breast milk. However, you may drink liquids after swallowing the granules or granule mixture.


• Continue to use Montelukast Granules even if you feel well. Do not miss any doses.


• If you miss a dose of Montelukast Granules, 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 Montelukast Granules.

Important safety information:

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


• Montelukast Granules will not stop an asthma attack once one has started. Be sure you always carry appropriate medicine (eg, bronchodilator inhalers) with you in case of an asthma attack.


• Contact your doctor right away if your short-acting inhaler use increases or if use exceeds the 24-hour maximum prescribed by your doctor. Contact your doctor if your asthma worsens.


• Do not decrease your dose or stop using Montelukast Granules or other asthma medicines without first checking with your doctor.


• If your asthma is sensitive to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), continue to avoid those medicines as directed by your doctor.


• Montelukast Granules should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.


• Some patients taking Montelukast Granules have developed mental or mood changes, including suicidal thoughts or actions. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Montelukast Granules while you are pregnant. It is not known if Montelukast Granules are found in breast milk. If you are or will be breast-feeding while you use Montelukast Granules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Montelukast Granules:

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:

Cough; dizziness; headache; indigestion; nausea; stomach upset or pain; stuffy nose; tiredness; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); aggressive behavior; agitation; chest pain; dark urine; disorientation; fever; flu-like symptoms; hallucinations; irregular heartbeat; mental or mood changes; new or worsening wheezing or other breathing problems; numbness or tingling of the hands or feet; seizures; severe or persistent stomach pain; severe sinus inflammation; suicidal thoughts or actions; swelling; tremor; unusual bruising or bleeding; upper respiratory tract infection; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Montelukast 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 hyperactivity; severe or persistent headache; stomach pain; unusual drowsiness or restlessness; unusual thirst; vomiting.

Proper storage of Montelukast Granules:

Store Montelukast Granules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Montelukast Granules out of the reach of children and away from pets.

General information:

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


• Montelukast Granules 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 Montelukast Granules. 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 Montelukast resources

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

Compare Montelukast with other medications

• Asthma
• Asthma, Maintenance
• Bronchospasm Prophylaxis
• COPD
• Hay Fever

Respontin Nebules

1. Name Of The Medicinal Product

Respontin_TM Nebules_TM

2. Qualitative And Quantitative Composition

1ml or 2ml plastic ampoules containing 0.25mg/ml of Ipratropium Bromide Ph.Eur.

3. Pharmaceutical Form

Oral inhalation solution via a nebuliser.

4. Clinical Particulars

4.1 Therapeutic Indications

Respontin Nebules are indicated for the treatment of reversible airways obstruction.

4.2 Posology And Method Of Administration

The recommended dose is:

Adults : 0.4 to 2ml solution (100-500 micrograms) up to four times daily.

Children (3 to 14 years): 0.4 to 2ml solution (100-500 micrograms) up to three times daily.

The volume of ipratropium bromide solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser used. If dilution is necessary use only sterile sodium chloride 0.9% solution.

There is no specific information on the use of the isotonic nebuliser solution in the elderly. Clinical trials with the previously available hypotonic formulation included patients over 65 years and no adverse reactions specific to this age group were reported.

4.3 Contraindications

Known hypersensitivity to any components of the formulation or to atropine.

4.4 Special Warnings And Precautions For Use

Use of the nebuliser solution should be subject to close medical supervision during initial dosing. There have been rare reports of paradoxical bronchospasm associated with the administration of ipratropium bromide nebuliser solution. The patient should be advised to seek medical advice should a reduced response become apparent.

Patients must be instructed in the correct administration of Respontin Nebules and warned not to allow the solution or mist to enter the eyes. Acute angle-closure glaucoma has been reported rarely when ipratropium bromide has been used in conjunction with nebulised β₂-agonist bronchodilators. Protection of the eyes appears to prevent any increase in intra-ocular pressure and patients who may be susceptible to glaucoma should be warned specifically of the need for ocular protection. Inhaled doses of ipratropium bromide up to 1mg have not been associated with elevation of intra-ocular pressure.

Use anticholinergic agents with caution in patients with prostatic hypertrophy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is evidence that the concurrent administration of ipratropium bromide and sympathomimetic drugs produces a greater relief of bronchospasm than either drug given alone. Ipratropium bromide has been shown to produce effective bronchodilatation in patients receiving β-adrenergic blocking agents.

4.6 Pregnancy And Lactation

Ipratropium bromide has been in general use for several years and there is no definite evidence of ill-consequence during pregnancy. Animal studies have shown no hazard. Nevertheless, medicines should not be used in pregnancy, especially during the first trimester, unless the expected benefit is thought to outweigh any possible risk to the fetus.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Anticholinergic side-effects are unlikely at therapeutic doses, but some patients may experience a dry mouth. Urinary retention and constipation have only rarely been reported with ipratropium bromide. There is no evidence that in the therapeutic dose range, ipratropium bromide has any adverse effect on bronchial secretion.

4.9 Overdose

Inhaled doses of 5mg produce an increase in heart rate and palpitation but single doses at 2mg have been given to adults and 1mg to children without causing side-effects. Single doses of ipratropium bromide 30mg by mouth cause anticholinergic side effects but these are not severe and do not require specific reversal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ipratropium bromide is an anticholinergic bronchodilater which affects airways function primarily through its neural effects on the parasympathetic nervous system. Ipratropium bromide blocks the acetylcholine receptors on smooth muscle in the lung. Stimulation of these receptors normally produces contraction and depending on the degree of activation, bronchoconstriction. Thus ipratropium bromide will cause bronchodilatation.

5.2 Pharmacokinetic Properties

Ipratoprium bromide is a quaternary ammonium compound which is poorly absorbed from the gastro-intestinal tract, and is slow to cross mucous membranes and the blood/brain barrier. Following, inhalation, uptake into the plasma is minimal, a peak blood concentration is obtained 1½ to 3 hours after inhalation. Excretion is chiefly via the kidneys.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Chloride	Ph.Eur
Diluted Phosphoric Acid	Ph.Eur
Purified Water	Ph.Eur

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25^OC. Protect from light.

This product contains no preservative. A new Nebule should be used for each dose. A Nebule should be opened immediately before administration and any remaining solution should be discarded. Any unused Nebules should be discarded four weeks after opening the foil pack.

6.5 Nature And Contents Of Container

1 or 2 ml low density polyethylene ampoules in boxes of 20 in strips of 5 or 10.

6.6 Special Precautions For Disposal And Other Handling

The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube. Intermittent positive pressure ventilation (IPPV) may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

As many nebulisers operate on a continuous flow basis, it is likely that some nebulised drug will be released into the local environment. Ipratropium bromide should therefore be administered in a well-ventilated room, particularly in hospitals where several patients may be using nebulisers at the same time. Do not allow the solution or mist to enter the eyes.

Administrative Data

7. Marketing Authorisation Holder

Glaxo Wellcome UK Limited, trading as Allen & Hanburys,

Stockley Park West,

Uxbridge,

Middlesex,

UB11 1BT.

8. Marketing Authorisation Number(S)

PL10949/0275

9. Date Of First Authorisation/Renewal Of The Authorisation

15^th April 2003

10. Date Of Revision Of The Text

September 1997

11. Legal Status

POM.

Leucovorin Tablets

Dosage Form: tablet
LEUCOVORIN CALCIUM TABLETS USP

 Rx only

Leucovorin Tablets Description

Leucovorin calcium tablets USP contain either 5 mg or 25 mg leucovorin as the calcium salt of N-[4-[[(2-amino-5-formyl-1, 4, 5, 6, 7, 8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. This is equivalent to 5.4 mg or 27.01 mg of anhydrous leucovorin calcium, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 25 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.

Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only.

The structural formula is as follows:

C20H21CaN7O7 M. W. 511.5

Leucovorin Tablets - Clinical Pharmacology

Leucovorin is a racemic mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-isomer, known as Citrovorum factor, or (-)-folinic acid. Leucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “one-carbon” moieties. Following oral administration, leucovorin is rapidly absorbed and enters the general body pool of reduced folates. The increase in plasma and serum folate activity (determined microbiologically with Lactobacillus casei) seen after oral administration of leucovorin is predominantly due to 5-methyltetrahydrofolate.

Twenty normal men were given a single, oral 15 mg dose (7.5 mg/m2) of leucovorin calcium and serum folate concentrations were assayed with L. casei. Mean values observed (± one standard error) were:

1. 
   
   1. 
      
      1. 
         
         1. Time to peak serum folate concentration: 1.72 ± 0.08 hours,
         
         
         2. Peak serum folate concentration achieved: 268  ± 18 ng/mL,
         
         
         3. Serum folate half-disappearance time: 3.5 hours.
         
         
      
      
   
   

Oral tablets yielded areas under the serum folate concentration-time curves (AUCs) that were 12% greater than equal amounts of leucovorin given intramuscularly and equal to the same amounts given intravenously.

Oral absorption of leucovorin is saturable at doses above 25 mg. The apparent bioavailability of leucovorin was 97% for 25 mg, 75% for 50 mg and 37% for 100 mg.

Indications and Usage for Leucovorin Tablets

Leucovorin calcium tablets USP are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.

Contraindications

Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12. A hematologic remission may occur while neurologic manifestations continue to progress.

Warnings

In the treatment of accidental overdosage of folic acid antagonists, leucovorin should be administered as promptly as possible. As the time interval between antifolate administration (e.g., methotrexate) and leucovorin rescue increases, leucovorin’s effectiveness in counteracting hematologic toxicity decreases.

Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.

Delayed methotrexate excretion may be caused by a third space fluid accumulation (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of leucovorin or prolonged administration may be indicated. Doses higher than those recommended for oral use must be given intravenously.

Leucovorin may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil.1 Concomitant granulocytopenia and fever were present in some but not all of the patients.

The concomitant use of leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.

Precautions

General

Parenteral administration is preferable to oral dosing if there is a possibility that the patient may vomit or not absorb the leucovorin. Leucovorin has no effect on other established toxicities of methotrexate such as the nephrotoxicity resulting from drug and/or metabolite precipitation in the kidney.

Drug Interactions

Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible children.

Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin enter CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate.

Leucovorin may enhance the toxicity of fluorouracil (see WARNINGS).

Pregnancy

Teratogenic Effects:

Pregnancy Category C

Animal reproduction studies have not been conducted with leucovorin. It is also not known whether leucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Leucovorin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when leucovorin is administered to a nursing mother.

Pediatric Use

See Drug Interactions subsection.

Adverse Reactions

Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin.

Overdosage

Excessive amounts of leucovorin may nullify the chemotherapeutic effect of folic acid antagonists.

Leucovorin Tablets Dosage and Administration

Leucovorin calcium tablets are intended for oral administration. Because absorption is saturable, oral administration of doses greater than 25 mg is not recommended.

Impaired Methotrexate Elimination or Inadvertent Overdosage

Leucovorin rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see WARNINGS). Leucovorin 15 mg (10 mg/m2) should be administered IM, IV, or PO every 6 hours until serum methotrexate level is less than 10 -8 M. In the presence of gastrointestinal toxicity, nausea, or vomiting, leucovorin should be administered parenterally.

Serum creatinine and methotrexate levels should be determined at 24 hour intervals. If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10 -6 M or the 48 hour level is greater than 9 x 10 -7 M, the dose of leucovorin should be increased to 150 mg (100 mg/m2) IV every 3 hours until the methotrexate level is less than 10 -8 M. Doses greater then 25 mg should be given parenterally (see CLINICAL PHARMACOLOGY).

Hydration (3 L/d) and urinary alkalinization with sodium bicarbonate should be employed concomitantly. The bicarbonate dose should be adjusted to maintain the urine pH at 7 or greater.

The recommended dose of leucovorin to counteract hematologic toxicity from folic acid antagonists with less affinity for mammalian dihydrofolate reductase than methotrexate (i.e., trimethoprim, pyrimethamine) is substantially less, and 5 to 15 mg of leucovorin per day has been recommended by some investigators.

Patients who experience delayed early methotrexate elimination are likely to develop reversible non-oliguric renal failure. In addition to appropriate leucovorin therapy, these patients require continuing hydration and urinary alkalinization, and close monitoring of fluid and electrolyte status, until the serum methotrexate level has fallen to below 0.05 micromolar and the renal failure has resolved.

Some patients will have abnormalities in methotrexate elimination or renal function following methotrexate administration, which are significant but less severe. These abnormalities may or may not be associated with significant clinical toxicity. If significant clinical toxicity is observed, leucovorin rescue should be extended for an additional 24 hours (total 14 doses over 84 hours) in subsequent courses of therapy. The possibility that the patient is taking other medications which interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be reconsidered when laboratory abnormalities or clinical toxicities are observed.

How is Leucovorin Tablets Supplied

Leucovorin Calcium Tablets USP, 5 mg are available as white, round, unscored, biconvex tablets, debossed with b on one side and 484 on the other side, packaged in bottles of 30, 100 and 1000 tablets.

Leucovorin Calcium Tablets USP, 25 mg are available as pale green, round, unscored, biconvex tablets, debossed with b on one side and 485 on the other side, packaged in bottles of 25 and 500 tablets.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant

closure (as required).

Protect from light and moisture.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

1. Grem JL, Shoemaker DD, Petrelli NJ, Douglas HO. Severe and fatal toxic effects observed in treatment with high- and low-dose leucovorin plus 5-fluorouracil for colorectal carcinoma. Cancer Treat Rep 1987;71:1122.


2. Link MP, Goorin AM, Miser AW et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med 1986;314:1600-1606.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Iss. 8/2011

PRINCIPAL DISPLAY PANEL

Leucovorin Calcium Tablets USP 5 mg* 30s Label Text

NDC 0555-0484-01

LEUCOVORIN

CALCIUM

Tablets USP

5 mg*

Rx only

30 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Leucovorin Calcium Tablets USP 25 mg* 25s Label Text

NDC 0555-0485-27

LEUCOVORIN

CALCIUM

Tablets USP

25 mg*

Rx only

25 TABLETS

TEVA

LEUCOVORIN CALCIUM  leucovorin calcium  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0484 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code b;484 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0484-01 30  In 1 BOTTLE None 2 0555-0484-02 100  In 1 BOTTLE None 3 0555-0484-05 1000  In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071198	10/03/2011

LEUCOVORIN CALCIUM  leucovorin calcium  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0485 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEUCOVORIN CALCIUM (LEUCOVORIN) LEUCOVORIN 25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   ALUMINUM OXIDE

Product Characteristics Color GREEN (pale green) Score no score Shape ROUND Size 8mm Flavor Imprint Code b;485 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0485-27 25  In 1 BOTTLE None 2 0555-0485-04 500  In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071199	10/03/2011

Labeler - Barr Laboratories Inc. (802716563)

Revised: 10/2011Barr Laboratories Inc.

Umecta Emulsion

urea

Dosage Form: topical emulsion
Umecta Mousse PI

Description

Rx only

For topical use only

Not for ophthalmic use


Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin



Each gram of Umecta® emulsion and topical suspension contains 40% urea,

butylated hydroxytoluene, butyrospermum parkii fruit oil, disodium EDTA,

glyceryl stearate, glycine soja sterol, helianthus annuus oil, purified water, stearic

acid, sodium polyacrylate, and triethanolamine.

Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of

skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates

and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement

of the nail plate.

Pharmacokinetics

The mechanism of action of topically applied urea is not yet known.

Indications and Uses

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly

where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful

for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis,

eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

This medication is to be used as directed by a physician and should not be used to treat any

condition other than that for which it was prescribed. If redness or irritation occurs,

discontinue use.

Pregnancy Category C

Animal reproduction studies have not been conducted with Umecta. It is also not known

whether Umecta can cause fetal harm when administered to a pregnant woman

or can affect reproductive capacity. Umecta should be given to a pregnant

woman only if clearly needed.

Nursing Monthers

It is not known whether or not this drug is secreted in human milk. Because many drugs are

secreted in human milk, caution should be exercised when Umecta is administered

to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Adverse Reactions

Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing

the medication.

Dosage and Administration

Apply Umecta Emulsion/topical suspension or Umecta mousse to affected

skin twice per day or as directed by a physician. Rub in until completely

absorbed.

How Supplied

Umecta® (urea, 40%) emulsion/topical suspension supplied in a:


4 oz. plastic tube (emulsion)

NDC 68712-004-03


8 oz. plastic tube (emulsion)

NDC 68712-004-01

Manufactured for:

JSJ Pharmaceuticals

Charleston, SC 29401

Toll Free: 1-800-499-4468

www.jsjpharm.com

www.umecta.com

UMECTA   UREA urea   emulsion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68712-004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 400 mg  in 1 g

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM   SHEA BUTTER   BUTYLATED HYDROXYTOLUENE   SOYBEAN OIL   SUNFLOWER OIL   GLYCERYL MONOSTEARATE   WATER   STEARIC ACID   TROLAMINE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68712-004-01 227 g In 1 TUBE None 2 68712-004-02 3 g In 1 PACKET None 3 68712-004-03 120 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2004

Labeler - JSJ Pharmaceuticals (615074866)

Establishment
Name	Address	ID/FEI	Operations
Harmony Labs		105803274	manufacture

Revised: 12/2010JSJ Pharmaceuticals

More Umecta Emulsion resources

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

Compare Umecta Emulsion with other medications

• Dermatological Disorders
• Dry Skin
• Pityriasis rubra pilaris

mecasermin Subcutaneous

me-ka-SER-min

Commonly used brand name(s)

In the U.S.

• Increlex


• Iplex

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Uses For mecasermin

Mecasermin injection is a man-made version of insulin-like growth factor-1 (IGF-1) hormone. IGF-1 is produced in the liver and plays an important role in childhood growth. Mecasermin is used to replace IGF-1 in children who are severely lacking it in their bodies.

mecasermin is available only with your doctor's prescription.

Before Using mecasermin

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 mecasermin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mecasermin 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 mecasermin injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in the geriatric population. Safety and efficacy have not been established.

Pregnancy

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Closed epiphyses (e.g., growth centers in the bones show no more growth potential) or


• Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)—Should not be used in patients with these conditions.

• Diabetes or


• Enlarged tonsils or


• Head injury or


• Scoliosis (abnormally curved spine), or history of—Use with caution. May make these conditions worse.

• Hypothyroidism (underactive thyroid) or


• Nutrition deficiencies—These problems should be corrected first before starting treatment with mecasermin.

Proper Use of mecasermin

Your doctor will prescribe your child's exact dose and tell you how often it should be given. mecasermin is given as a shot under your child's skin. mecasermin must not be injected into a vein or muscle.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using mecasermin at home, your doctor will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.

mecasermin must be taken 20 minutes before or 20 minutes after a snack or meal. Never let your child skip a meal once your child received mecasermin.

Use a new needle and syringe each time you inject the medicine to your child.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites (e.g., upper arms, thighs, buttocks, or abdomen) on your body. This will help to prevent skin problems.

Do not use the medicine if it looks cloudy or has particles in it.

Dosing

The dose of mecasermin 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 mecasermin. 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 injection dosage form:
  
  • For treatment of growth failure caused by IGF-1 deficiency:
    
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.04 to 0.08 milligram (mg) per kg (0.018 to 0.036 mg per lb) of body weight injected under the skin two times a day. Your doctor may then increase the dose, if needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store in the refrigerator. Do not freeze.

You may keep the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze the solution and protect it from direct heat and light.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using mecasermin

Your doctor will need to check your child's progress at regular visits while your child is using mecasermin. Be sure to keep all appointments.

Talk with your doctor if you notice or the child feels that mecasermin is causing too much growth.

mecasermin may cause hypoglycemia (low blood sugar) with the following symptoms that you should be aware of: anxiety; blurred vision; chills; cold sweats; coma; confusion; cool, pale skin; depression; dizziness; fast heartbeat; headache; increased hunger; nausea; nervousness; nightmares; seizures; shakiness; slurred speech; or unusual tiredness or weakness. It is important to have a source of sugar such as orange juice, candy, soda, glucose gel, or milk, if these symptoms occur.

Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if the child has low blood sugar.

You should avoid participating in high risk activities, such as driving, within 2 to 3 hours after receiving the medicine, especially at the beginning of mecasermin treatment.

mecasermin may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after your child receive the medicine.

mecasermin may enlarge your child's tonsils. Call your doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. Your doctor may want to check your child's tonsils regularly while using mecasermin.

mecasermin may cause a dislocation in the hip bone. Check with your doctor right away if your child has a limp or pain in the hip or knee.

mecasermin contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

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

mecasermin Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety


• bluish skin color of the fingertips


• blurred vision


• breathlessness


• chest pain


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• dizziness


• fast heartbeat


• headache


• increased hunger


• loss of hearing


• nausea


• nervousness


• nightmares


• rapid growth of normal cells of the thymus (no symptoms)


• seizures


• shakiness


• slurred speech


• thickening of the skin


• unusual tiredness or weakness

Incidence not known

• Change in the ability to see colors, especially blue or yellow


• cough


• difficult or labored breathing


• difficulty with swallowing


• hives or welts


• itching


• itching or hives at the injection site


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


• limp


• pain in the hip or knee


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


• redness of the skin


• shortness of breath


• skin rash


• tightness in the chest


• vomiting


• wheezing

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

Symptoms of overdose

• Anxiety


• arm or leg pain


• backache


• changes in vision


• excessive sweating


• extreme weakness


• frequent urination


• increase in hands and feet size


• increased thirst


• increased volume of pale, diluted urine


• joint pain


• stop in menstruation

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

• Abnormal response of the tympanic membrane to air pressure


• difficulty with moving


• difficulty with swallowing


• ear pain


• earache


• large, flat, blue or purplish patches in the skin


• muffled hearing


• muscle pain or stiffness


• redness or swelling in the ear


• sense of fullness in the ear


• snoring


• sore throat


• voice changing

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 mecasermin Subcutaneous resources

• Mecasermin Subcutaneous Use in Pregnancy & Breastfeeding
• Mecasermin Subcutaneous Drug Interactions
• Mecasermin Subcutaneous Support Group
• 0 Reviews for Mecasermin Subcutaneous - Add your own review/rating

Compare mecasermin Subcutaneous with other medications

• Primary IGF-1 Deficiency

Emo-Cort Scalp Solution Topical application

Generic Name: hydrocortisone butyrate (Topical application route)

hye-droe-KOR-ti-sone BUE-ti-rate

Commonly used brand name(s)

In the U.S.

• Locoid


• Locoid Lipocream

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Ointment


• Lotion


• Cream


• Solution

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Emo-Cort Scalp Solution

Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Emo-Cort Scalp Solution

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone butyrate

This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Emo-Cort Scalp Solution. Please read with care.

It is very important that you use this medicine only as directed by your doctor. 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 unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 atopic dermatitis:
  
  • For topical dosage forms (cream and lotion):
    
    • Children 3 months to 18 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  

• For redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream and ointment):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

• For seborrheic dermatitis:
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Emo-Cort Scalp Solution

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

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

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Emo-Cort Scalp Solution 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 common

• Burning sensation of skin


• flushing or redness of skin


• itching skin


• red, scaling, or crusted skin


• scaly rash


• skin irritation


• unusually warm skin

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the 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

• Acne or pimples


• lightening of normal skin color

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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 Emo-Cort Scalp Solution Topical application resources

• Emo-Cort Scalp Solution Topical application Use in Pregnancy & Breastfeeding
• Emo-Cort Scalp Solution Topical application Drug Interactions
• Emo-Cort Scalp Solution Topical application Support Group
• 15 Reviews for Emo-Cort Scalp Topical application - Add your own review/rating

Compare Emo-Cort Scalp Solution Topical application with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Fenofibric Acid

Pronunciation: FEN-oh-FYE-bric AS-id
Generic Name: Fenofibric Acid
Brand Name: Fibricor

Fenofibric Acid is used for:

Lowering high cholesterol and triglyceride levels in the blood. It also increases high-density lipoprotein (HDL, "good") cholesterol levels. It is used along with an appropriate diet. It may also be used in combination with other cholesterol-lowering medicines.

Fenofibric Acid is a lipid-lowering agent. It works by increasing a certain substance that helps to remove triglycerides from the blood. This also helps the body to decrease the amount of other bad cholesterol in the blood.

Do NOT use Fenofibric Acid if:

• you are allergic to any ingredient in Fenofibric Acid or to fenofibrate


• you have gallbladder problems, liver problems (including cirrhosis) or unexplained abnormal liver function tests


• you have severe kidney problems or are receiving dialysis


• you are breast-feeding

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

Before using Fenofibric Acid:

Some medical conditions may interact with Fenofibric Acid. 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 or other substances


• if you have a history of diabetes, underactive thyroid, heart problems (eg, heart blood vessel problems), gallstones, pancreatitis, kidney or liver problems, or certain muscle problems (myopathy)


• if you have a history of blood clots in your veins or lungs (deep vein thrombosis or pulmonary embolism)


• if you are very overweight, have an inactive lifestyle, or you drink large amounts of alcohol


• if you are taking a beta-blocker (eg, propranolol), estrogen, or thiazide diuretic (eg, hydrochlorothiazide)

Some MEDICINES MAY INTERACT with Fenofibric Acid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of serious muscle problems leading to kidney failure may be increased


• Immunosuppressants (eg, cyclosporine) or other medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin), or probenecid because they may increase the risk of Fenofibric Acid's side effects


• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Fenofibric Acid

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

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

• Take Fenofibric Acid by mouth with or without food.


• If you also take a bile acid-binding resin (eg, cholestyramine), do not take it within 4 to 6 hours before or 1 hour after taking Fenofibric Acid. Check with your doctor if you have any questions.


• Fenofibric Acid is most effective when used with a diet that reduces the intake of cholesterol and saturated fats, and an exercise program.


• Take Fenofibric Acid on a regular schedule to get the most benefit from it. Taking Fenofibric Acid at the same time each day will help you remember to take it.


• Continue to take Fenofibric Acid even if you feel well. Do not miss any doses.


• If you miss a dose of Fenofibric Acid, 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. Do not take more than 1 dose of Fenofibric Acid in the same day unless your doctor tells you otherwise.

Ask your health care provider any questions you may have about how to use Fenofibric Acid.

Important safety information:

• Fenofibric Acid may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fenofibric Acid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Follow the diet, exercise, and weight loss program given to you by your health care provider.


• Do NOT take more than the recommended dose without checking with your doctor.


• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.


• Lab tests, including liver function, kidney function, blood cholesterol, and complete blood cell counts, may be performed while you use Fenofibric Acid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Fenofibric Acid with caution in the ELDERLY; they may be more sensitive to its effects, especially severe muscle problems.


• Fenofibric Acid should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Fenofibric Acid can cause harm to the fetus. If you become pregnant or plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fenofibric Acid while you are pregnant. It is not known if Fenofibric Acid is found in breast milk. Do not breast-feed while taking Fenofibric Acid.

Possible side effects of Fenofibric Acid:

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:

Back pain; headache; stomach pain.

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); calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; decrease in the amount of urine produced; fever, chills, or persistent sore throat; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fenofibric Acid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fenofibric Acid:

Store Fenofibric Acid between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fenofibric Acid out of the reach of children and away from pets.

General information:

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


• Fenofibric Acid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fenofibric Acid. 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 Fenofibric Acid resources

• Fenofibric Acid Side Effects (in more detail)
• Fenofibric Acid Dosage
• Fenofibric Acid Use in Pregnancy & Breastfeeding
• Fenofibric Acid Drug Interactions
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• Fenofibric Acid Prescribing Information (FDA)


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