Penbritin Syrup 125mg / 5ml

1. Name Of The Medicinal Product

Penbritin Syrup (125 mg/5 ml)

2. Qualitative And Quantitative Composition

When reconstituted each 5 ml contains 125 mg ampicillin as Ampicillin Trihydrate.

3. Pharmaceutical Form

Powder for oral suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.

Parenteral usage is indicated where oral dosage is inappropriate.

4.2 Posology And Method Of Administration

Usual adult dosage (including elderly patients):
Ear, nose and throat infections:	250mg four times a day.
Bronchitis:	Routine therapy:	250mg four times a day.
High-dosage therapy:	1 g four times a day.
Pneumonia:		500 mg four times a day.
Urinary tract infections:	500 mg three times a day.
Gonorrhoea:	2 g orally with 1 g probenecid as a single dose.
Repeated doses are recommended for the treatment of females.
Gastro-intestinal infections:	500-750 mg three to four times daily.
Enteric:	Acute:	1-2 g four times a day for two weeks.
Carriers:	1-2 g four times a day for four to twelve weeks.
Usual children's dosage (under 10 years):
Half adult routine dosage.

All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.

Renal Impairment:

In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional normal dose should be administered after the procedure.

Administration:

Oral

4.3 Contraindications

Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.

Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

Contains sodium benzoate.

Sodium content: Each 5 ml contains 16.7 mg of sodium. This sodium content should be included in the daily allowance of patients on sodium restricted diets.

Sucrose: Each 5 ml contains approximately 3.6g of sucrose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.

In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.

Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Pregnancy: Animal studies with ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, ampicillin may be considered appropriate.

Lactation: During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of ampicillin during lactation are not available.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, pruritus and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely.

Renal effects: Interstitial nephritis can occur rarely.

Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis has been reported rarely.

Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely.

Prolongation of bleeding time and prothrombin have also been reported rarely.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Ampicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ampicillin trihydrate is an oral antibiotic, active against a wide range of Gram-negative and Gram-positive organisms.

5.2 Pharmacokinetic Properties

Absorption: The oral administration of 250 mg and 500 mg of ampicillin on a fasting stomach produces maximum serum levels of ± 2 and ± 4 mcg per ml, respectively, after 2 hours. Bioavailability is 30 to 40%. The absorption of orally administered ampicillin can be diminished by food.

Distribution: Serum protein binding ampicillin is about 20 %. Plasma half-life is between 1 and 1½ hours.

Ampicillin diffuses into most tissues and body fluids. Its presence in therapeutic concentrations has been detected in, among others, bronchial secretions sinuses, saliva, CSF (variable percentage depending on the degree of meningeal inflammation), bile, serous membranes and middle ear.

Crosses the meningeal barrier: There is little ampicillin diffusion into the cerebrospinal fluid, except in cases of inflamed meninges, in which it can reach therapeutic concentrations when administered in high doses and especially by the intravenous route.

Cross the placenta: Ampicillin diffuses through the placenta.

Passes into mother's milk: Ampicillin is detected in small quantities in mothers' milk.

Metabolism and Excretion: Ampicillin is eliminated chiefly through the urine. Approximately 30% of the dose administered orally and over 60 % of the dose administered parenterally are eliminated in active form in the urine during the 24 hours which follow the administration of ampicillin. Urinary concentrations are higher following parenteral administration.

A small percentage is eliminated in the bile where high concentrations are found. Excretion may be delayed in cases of renal failure in accordance with its severity.

5.3 Preclinical Safety Data

Not relevant.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Benzoate

Sodium Chloride

Apricot Dry Flavour

Caramel Dry Flavour

Peppermint Extra Dry Flavour

Methyl Polysiloxane

Sodium Citrate Anhydrous

Sucrose

6.2 Incompatibilities

None known

6.3 Shelf Life

Powder: 3 years

Once dispensed, the products remain stable for 14 days when stored at 2-8^oC in a refrigerator.

6.4 Special Precautions For Storage

Do not store above 25^oC.

Once dispensed, store at 2-8^oC in a refrigerator (14 days).

6.5 Nature And Contents Of Container

White flint glass bottle fitted with aluminium roll-on-pilfer-proof (ROPP) cap.

Powder for reconstitution to 100ml.

6.6 Special Precautions For Disposal And Other Handling

If dilution of the reconstitution syrup is required, Syrup BP should be used.

7. Marketing Authorisation Holder

Chemidex Pharma Limited

Chemidex House

Egham Business Village,

Crabtree Road, Egham, Surrey

TW20 8RB

United Kingdom

8. Marketing Authorisation Number(S)

PL 17736/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

25th February 2005

10. Date Of Revision Of The Text

09/10/2007

Topcare All Day Allergy D

Dosage Form: tablet
Topco All Day Allergy D Drug Facts

Active ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat


• nasal congestion


• reduces swelling of nasal passages


• temporarily relieves sinus congestion and pressure


• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease


• thyroid disease


• diabetes


• glaucoma


• high blood pressure


• trouble urinating due to an enlarged prostate gland


• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• do not use more than directed


• drowsiness may occur


• avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.


• you get nervous, dizzy, or sleepless


• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

• if breast-feeding: not recommended


• if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not break or chew tablet; swallow tablet whole

adults and children 12 years and over	take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over	ask a doctor
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Questions or comments?

1-888-423-0139

Principal Display Panel

Original Prescription Strength

12 Hour

All Day Allergy D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg

antihistamine/nasal decongestant

Allergy & Congestion

12 Hour Relief of: Sneezing, Runny Nose, Sinus Pressure, Itchy, Watery Eyes, Itchy Throat or Nose, Nasal Congestion

Indoor & Outdoor Allergies

Actual Size

Compare to Zyrtec-D® active ingredients

All Day Allergy D Carton

Topcare All Day Allergy D  cetirizine hcl, pseudoephedrine hcl  tablet, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-176 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (one side white one side light yellow) Score no score Shape ROUND Size 12mm Flavor Imprint Code 5029;5;120 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-176-53 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-176-53) 2 36800-176-62 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-176-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077170	05/19/2008

Labeler - Topco Associates LLC (006935977)

Revised: 06/2009Topco Associates LLC

More Topcare All Day Allergy D resources

• Topcare All Day Allergy D Side Effects (in more detail)
• Topcare All Day Allergy D Use in Pregnancy & Breastfeeding
• Topcare All Day Allergy D Drug Interactions
• Topcare All Day Allergy D Support Group
• 3 Reviews for Topcare All Day Allergy D - Add your own review/rating

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• Hay Fever

Monistat 1 Topical

Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Aloe Vesta 2-N-1 Antifungal


• Aloe Vesta Antifungal


• Baza Antifungal


• Carrington Antifungal


• Derma Gran AF


• DiabetAid Antifungal Foot Bath


• Fungoid


• Lotrimin AF


• Micatin


• Micro-Guard


• Mitrazol


• Monistat 1


• Monistat Derm


• Neosporin AF


• QC Miconazole Nitrate


• Secura Antifungal


• Soothe & Cool Inzo Antifungal


• Tetterine


• Therasoft Antifungal


• Triple Care Antifungal


• Triple Care EPC


• Zeasorb-AF

Available Dosage Forms:

• Lotion


• Tablet, Effervescent


• Cream


• Ointment


• Powder


• Kit


• Gel/Jelly


• Tincture


• Spray

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For Monistat 1

Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.

Some of these preparations may be available without a prescription.

Before Using Monistat 1

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

Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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. Although there is no specific information comparing use of topical miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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.

Proper Use of miconazole

This section provides information on the proper use of a number of products that contain miconazole. It may not be specific to Monistat 1. Please read with care.

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

• Shake well before using.


• From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

• If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 aerosol powder, aerosol solution, cream , and powder dosage forms:
  
  • For fungus infections:
    
    • Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
  
  


• For cream and lotion dosage forms:
  
  • For sun fungus:
    
    • Adults and children—Apply to the affected area(s) of the skin once a 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.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Monistat 1

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

Monistat 1 Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

• Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

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 Monistat 1 Topical resources

• Monistat 1 Topical Use in Pregnancy & Breastfeeding
• Monistat 1 Topical Drug Interactions
• Monistat 1 Topical Support Group
• 8 Reviews for Monistat Topical - Add your own review/rating

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• Cutaneous Candidiasis
• Oral Thrush
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Vaginal Yeast Infection

Cerezyme

Generic Name: imiglucerase (Intravenous route)

im-i-GLOO-ser-ase

Commonly used brand name(s)

In the U.S.

• Cerezyme

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Enzyme

Uses For Cerezyme

Imiglucerase is used to treat Gaucher's disease caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for your body to use fats.

Imiglucerase is available only from your doctor.

Before Using Cerezyme

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

Although there is no specific information comparing use of imiglucerase in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 imiglucerase in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Proper Use of Cerezyme

This medicine helps control and reverse problems caused by Gaucher's disease. Therefore, you must continue to receive it if you expect to keep your condition under control. You may have to receive imiglucerase for the rest of your life. If Gaucher's disease is not treated, it can cause serious blood, liver, skeletal, or spleen problems.

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 Gaucher's disease:
  
  • For injection dosage form:
    
    • Adults and children—The dose is based on body weight and must be determined by your doctor. The usual dose is 15 to 60 Units per kilogram (kg) (6.8 to 27 Units per pound) of body weight injected into a vein over one to two hours. The dose may be repeated several times a week to once every 2 weeks, depending on your condition. Later your doctor may lower your dose.
    
    
  
  

Precautions While Using Cerezyme

It is important that your doctor check your progress while you are receiving imiglucerase to make sure that the dosage is correct for you.

Cerezyme 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.

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

Less common

• Abdominal discomfort


• decrease in blood pressure, decrease in frequency of urination


• dizziness


• headache


• itching


• nausea


• rash

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

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

See also: Cerezyme side effects (in more detail)

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

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

More Cerezyme resources

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

• Cerezyme Prescribing Information (FDA)


• Cerezyme Consumer Overview


• Cerezyme Monograph (AHFS DI)


• Cerezyme MedFacts Consumer Leaflet (Wolters Kluwer)


• Imiglucerase Professional Patient Advice (Wolters Kluwer)

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• Gaucher Disease
• Thrombocytopenia

Topcare Anti-Diarrheal

Generic Name: loperamide

Dosage Form: tablet
Topco Anti-Diarrheal Tablets Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Uses

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

• fever


• mucus in the stool


• a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics

When using this product

• tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

• symptoms get worse


• diarrhea lasts for more than 2 days


• you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea


• find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information

• store between 20-25°C (68-77°F)


• do not use if printed foil under cap is broken or missing (Bottle Only)


• do not use if carton or blister unit is broken or torn (Blister Only)


• see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10, FD&C blue no. 1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

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Easy to Swallow

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal Tablets

Controls the Symptoms of Diarrhea, Including Travelers’ Diarrhea

Actual Size

Compare to Imodium® A-D active ingredient

Each Caplet (Capsule-Shaped Tablet) Contains 2 mg Loperamide Hydrochloride

Anti-Diarrheal Tablets Carton

TOPCARE ANTI DIARRHEAL  loperamide hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-224 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color GREEN Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code L2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-224-91 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-224-91) 2 36800-224-53 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-224-53) 3 36800-224-62 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-224-62) 4 36800-224-80 1 BOTTLE In 1 CARTON contains a BOTTLE 4 96 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-224-80)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075232	02/26/2003

Labeler - Topco Associates LLC (006935977)

Revised: 08/2009Topco Associates LLC

More Topcare Anti-Diarrheal resources

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

Compare Topcare Anti-Diarrheal with other medications

• Diarrhea
• Diarrhea, Acute
• Diarrhea, Chronic
• Lymphocytic Colitis
• Traveler's Diarrhea

Miochol-E, 20mg, Powder and Solvent for Solution for Intraocular Irrigation

1. Name Of The Medicinal Product

Miochol^®-E, 20mg, Powder and Solvent for Solution for Intraocular Irrigation.

2. Qualitative And Quantitative Composition

Each powder vial contains 20mg acetylcholine chloride.

Miochol-E contains 10mg/ml of acetylcholine chloride, (20mg in 2ml) upon reconstitution.

For excipients, see section 6.1.

3. Pharmaceutical Form

Powder and Solvent for Solution for Intraocular Irrigation.

Vial: white solid or powder

Ampoule: clear, colourless solution

Filter: syringe filter

4. Clinical Particulars

4.1 Therapeutic Indications

To obtain rapid and complete miosis after delivery of the lens in cataract surgery as well as in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid complete miosis is required.

4.2 Posology And Method Of Administration

Miochol-E is for intraocular irrigation only. A freshly prepared 1% solution should be used in the anterior chamber of the eye during surgery.

Adults and Elderly

In most cases a satisfactory miosis, which will last for approximately 20 minutes, is produced in seconds by 0.5 - 2.0ml. A second application may be made at the discretion of the surgeon if prolonged miosis is required.

Children

Safety and effectiveness in children has not been established.

Route of administration: Intraocular irrigation during surgery.

4.3 Contraindications

There are no known contra-indications to the use of Miochol-E in cataract or anterior segment surgery.

4.4 Special Warnings And Precautions For Use

If miosis is to be obtained quickly and completely, obstructions to miosis such as anterior or posterior synechiae may require surgery prior to administration of Miochol-E. In cataract surgery Miochol-E should be used only after delivery of the lens.

If blister or paper backing is damaged or broken, sterility of the Miochol-E vial cannot be assured.

Aqueous solutions of Miochol-E are unstable. The solution should therefore be prepared immediately before use. Any remainder should be discarded.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine and carbachol have been ineffective when used in patients treated with topical non-steroidal anti-inflammatory agents.

4.6 Pregnancy And Lactation

The safety and efficacy of Miochol-E in pregnancy and lactation have not been established. Miochol-E should not be used in pregnant or lactating patients.

4.7 Effects On Ability To Drive And Use Machines

Not applicable

4.8 Undesirable Effects

Adverse reactions which are indicative of systemic absorption have been reported rarely in the literature. Symptoms include bradycardia, hypotension, flushing, breathing difficulties and sweating. Isolated cases of corneal oedema, corneal clouding and corneal decompensation have been reported with the use of Miochol-E, although a causal relationship has not been established.

4.9 Overdose

The symptoms of overdosage are likely to be effects resulting from systemic absorption, ie bradycardia, hypotension, flushing, breathing difficulties and sweating. Atropine sulphate (0.5 - 1mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Adrenaline (0.1 - 1mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Acetylcholine is a physiological neuromediator of postganglionic parasympathetic nerve fibres (muscarinic action), skeletal muscles and ganglia of the sympathetic system (nicotinic action).

The ocular parasympathetic receptors of the muscarinic type are very numerous and localised:

• at the level of the pupillary sphincter, whose contraction causes miosis

• at the level of the ciliary muscle, whose contraction allows accommodation and facilitates the flow of the aqueous humor by opening of the trabecular meshwork. In addition, the acetylcholine can have an inhibitory effect on the aqueous secretion. These two last factors result in a decrease in the intraocular pressure.

• at the level of the lacrimal glands, whose stimulation causes tearing.

5.2 Pharmacokinetic Properties

Topical: Not applicable.

5.3 Preclinical Safety Data

The active ingredient of Miochol-E is acetylcholine, a natural neurohormonal transmitter the pharmacological activity and toxicity of which have been clearly defined. The effect of Miochol has been demonstrated in several animal studies. The addition of electrolytes in Miochol-E resulted in very good local tolerability in the cat. Given that a low single dose of acetylcholine is administered by the intraocular route, the risk of systemic toxicity is very low.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Vial:

Mannitol

Ampoule:

sodium acetate trihydrate

magnesium chloride hexahydrate,

potassium chloride

calcium chloride dihydrate

water for injections

6.2 Incompatibilities

None known.

The filter hub is recommended only for use with Miochol-E.

6.3 Shelf Life

Unopened:	18 months
Opened:	Use immediately after reconstitution

6.4 Special Precautions For Storage

Do not store above 25°C. Do not freeze. Do not resterilise.

6.5 Nature And Contents Of Container

Miochol-E is supplied as packs containing 1 blister and 1 filter hub.

Packs are subjected to antimicrobial treatment with ethylene oxide.

One blister contains:

- vial containing powder; clear, colourless type 1 glass with rubber stopper and plastic cap.

- ampoule containing solvent: clear, colourless type 1 glass ampoule with One Point cut (OPC).

One filter hub with 5 micron filter, luer lock (CE marking number : CE 0123)

6.6 Special Precautions For Disposal And Other Handling

The reconstituted preparation is a clear, colourless solution.

Warning: Do not use if blister or peelable backing is damaged or broken. Open under aseptic conditions only. The contents of the blister can be guaranteed as sterile.

Directions for preparing Miochol-E

1. Inspect unopened blister to ensure that it is intact. Peel open blister.

2. Aseptically transfer the ampoule, vial and syringe tip filter hub to sterile field. Maintain asepsis during preparation of solution.

3. Aseptically attach a sterile 18 to 20 gauge, bevelled needle to the luer tip of a sterile disposable syringe with twisting motion to assure secure fit.

4. Break open the ampoule containing the solvent. The One Point Cut (OPC) ampoule must be opened as follows: Hold the bottom part of the ampoule with the thumb pointing to the coloured point. Grasp the top of the ampoule with the other hand, positioning the thumb at the coloured point and press back to break at the existing cut under the point.

5. Remove the needle protector and withdraw the solvent from the ampoule into the syringe. Discard ampoule.

6. Remove and discard plastic cap from top of vial.

7. Insert the needle through the centre of the vial stopper.

8. Transfer the solvent from the syringe to the vial.

9. Shake gently to dissolve drug.

10. Slowly withdraw the solution from the vial through the needle into the syringe.

11. Discard needle.

12. Aseptically open tip filter hub pouch.

13. Aseptically attach filter hub onto luer tip of syringe with a twisting motion to assure secure fit.

14. Aseptically attach a sterile blunt tip irrigation cannula to male luer of filter prior to intraocular irrigation.

15. Discard appropriately after use. Do not reuse the filter hub.

The solution must be mixed just before use since aqueous solutions of acetylcholine are unstable. Only clear and colourless solutions should be used.

Miochol-E should not be re-sterilised. The filter hub is recommended only for use with Miochol-E. Aspiration through the filter is not recommended. However, if utilised, discard needle and syringe filter to prevent recontamination of fluids during injection.

Do not aspirate and inject through the same filter.

Do not use unless a clear and colourless solution is produced.

For single use only. Discard any unused solution.

7. Marketing Authorisation Holder

Dr. Gerhard Mann

Chem.-Pharm. Fabrik GmbH

Brunsbuetteler Damm 165-173

13581 Berlin

Germany

8. Marketing Authorisation Number(S)

PL13757/0017

9. Date Of First Authorisation/Renewal Of The Authorisation

Not applicable

10. Date Of Revision Of The Text

May 2011

11. LEGAL CATEGORY

POM

Chlo-Amine

Generic Name: chlorpheniramine (KLOR fen IR a meen)

Brand Names: AHist, Aller-Chlor, Allergy Relief, C.P.M., Chlo-Amine, Chlor-Mal, Chlor-Trimeton, Chlor-Trimeton Allergy SR, Chlorphen, ChlorTan, Ed Chlor-Tan, Ed ChlorPed, PediaTan, TanaHist-PD, Triaminic Allergy, Wal-finate

What is Chlo-Amine (chlorpheniramine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Chlorpheniramine is used to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

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

What is the most important information I should know about Chlo-Amine (chlorpheniramine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take chlorpheniramine if you are allergic to it.

Ask a doctor or pharmacist before taking chlorpheniramine if you have glaucoma, a stomach ulcer, severe constipation, kidney disease, urination problems, an enlarged prostate, or a thyroid disorder.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine is contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Chlorpheniramine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine.

What should I discuss with my healthcare provider before taking Chlo-Amine (chlorpheniramine)?

Do not take this medication if you are allergic to chlorpheniramine. Do not use chlorpheniramine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  severe constipation;

  
  


• 
  

  kidney disease;

  
  


• 
  

  urination problems or an enlarged prostate; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category B. Chlorpheniramine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Chlorpheniramine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

How should I take Chlo-Amine (chlorpheniramine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Take this medication with a full glass of water. Take chlorpheniramine with food or milk if it upsets your stomach. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Chlo-Amine (chlorpheniramine)?

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine is contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease perspiration and you may be more prone to heat stroke.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine.

Chlo-Amine (chlorpheniramine) side effects

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

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  confusion, extreme drowsiness;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness; or

  
  


• 
  

  weak or shallow breathing.

  
  

Less serious side effects may include:

• 
  

  mild dizziness, drowsiness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

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

What other drugs will affect Chlo-Amine (chlorpheniramine)?

Other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine. Tell your doctor if you regularly use any of these medicines.

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

• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  probenecid (Benemid, Probalan);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

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

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro-Banthine); or

  
  


• 
  

  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;

  
  

This list is not complete and other drugs may interact with chlorpheniramine. 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 Chlo-Amine resources

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

• Ahist MedFacts Consumer Leaflet (Wolters Kluwer)


• Aller-Chlor Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Chlorpheniramine Maleate/Tannate, Dexchlorpheniramine Maleate Monograph (AHFS DI)


• Ed ChlorPed Suspension Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Pediox-S Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• QDALL AR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Chlo-Amine with other medications

• Allergic Reactions
• Cold Symptoms
• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine.

See also: Chlo-Amine side effects (in more detail)

Voriconazole

Pronunciation: VOR-i-KON-a-zole
Generic Name: Voriconazole
Brand Name: Vfend

Voriconazole is used for:

Treating certain fungal infections.

Voriconazole is an azole antifungal. It works by blocking fungal cell wall growth, which results in the death of the fungus.

Do NOT use Voriconazole if:

• you are allergic to any ingredient in Voriconazole


• you have untreated low blood calcium, magnesium, or potassium levels


• you are taking astemizole, a barbiturate (eg, phenobarbital), cabazitaxel, carbamazepine, cisapride, crizotinib, dronedarone, an ergot alkaloid (eg, ergotamine), erythromycin, everolimus, fluconazole, lurasidone, pimozide, quinidine, rifabutin, rifampin, rivaroxaban, sirolimus, St. John's wort, terfenadine, or ticagrelor

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

Before using Voriconazole:

Some medical conditions may interact with Voriconazole. 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 allergic to other azole antifungals (eg, fluconazole, itraconazole)


• if you have a history of heart problems (eg, cardiomyopathy, irregular heartbeat); an abnormal electrocardiogram (ECG) (a type of heart test); or low blood calcium, magnesium, or potassium levels


• if you have liver problems (eg, cirrhosis), kidney problems, pancreas problems, a weakened immune system, or a blood disease (eg, blood or bone marrow cancer)


• if you have ever been on chemotherapy or have had a stem cell transplant


• if you have taken fluconazole within the last 24 hours


• if you are taking ritonavir. Voriconazole should not be taken with certain doses of ritonavir

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

• Medicines that may harm the kidney because the risk of kidney side effects may be increased. Ask your doctor or pharmacist if you are unsure if any of your medicines might affect the kidney


• Medicines that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat


• Many other prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood flow problems, blood thinning, cancer, diabetes, drug dependence, heartburn or reflux, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, mental or mood problems, pain, seizures, stomach or bowel problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Voriconazole. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Voriconazole

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

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

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


• Voriconazole is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Voriconazole at home, a health care provider will teach you how to use it. Be sure you understand how to use Voriconazole. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Voriconazole if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• To clear up your infection completely, use Voriconazole for the full course of treatment. Keep using it even if you feel better in a few days.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Voriconazole, use it as soon as possible. If it is more than 6 hours after the missed 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 Voriconazole.

Important safety information:

• Voriconazole may cause blurred vision or sensitivity to light. These effects may be worse if you take it with alcohol or certain medicines. Use Voriconazole with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Avoid driving at night while you are using Voriconazole.


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


• Uncommonly, some patients have experienced a reaction while receiving Voriconazole. Tell your doctor right away if you develop flushing, fever, sweating, fast heartbeat, chest tightness, shortness of breath, faintness, nausea, itching, or rash while you are receiving Voriconazole.


• Certain types of skin cancers (eg, melanoma, squamous cell) have been reported in patients who became sensitive to sunlight while taking Voriconazole for a long period of time. Contact your doctor if you notice a change in the appearance of a mole or other unusual skin change or growth. Discuss any questions or concerns with your doctor.


• Voriconazole may make your eyes more sensitive to sunlight. It may help to wear sunglasses. Avoid strong, direct sunlight.


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


• If your symptoms do not get better within a few days or if they get worse, check with your doctor.


• Women who may become pregnant should use effective birth control (eg, birth control pills) while using Voriconazole. Talk with your doctor if you have questions about effective birth control.


• Lab tests, including eye exams, liver and kidney function, and pancreas function, may be performed while you use Voriconazole. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Voriconazole should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Voriconazole may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Voriconazole while you are pregnant. It is not known if Voriconazole is found in breast milk. Do not breast-feed while taking Voriconazole.

Possible side effects of Voriconazole:

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:

Blurred vision; headache; nausea; sensitivity to light; sensitivity to the sun; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; black, tarry stools; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; flushing; hallucinations; mental or mood changes (eg, depression); mouth sores; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or headache; shortness of breath; speech changes; sudden, severe nausea or vomiting; suicidal thoughts or actions; swelling of the arms or legs; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or stomach pain; loss of appetite; itching); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual skin change or skin growth; unusual sweating or weakness; unusual tiredness; unusual vaginal bleeding; vision changes (eg, color vision change, persistent or severe blurred vision or sensitivity to light).

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: Voriconazole 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 Voriconazole:

Voriconazole is usually handled and stored by a health care provider. If you are using Voriconazole at home, store Voriconazole as directed by your pharmacist or health care provider. Keep Voriconazole out of the reach of children and away from pets.

General information:

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


• Voriconazole 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 Voriconazole. 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 Voriconazole resources

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

• Voriconazole Prescribing Information (FDA)


• Voriconazole Professional Patient Advice (Wolters Kluwer)


• Voriconazole Monograph (AHFS DI)


• voriconazole Advanced Consumer (Micromedex) - Includes Dosage Information


• Vfend Advanced Consumer (Micromedex) - Includes Dosage Information


• Vfend Prescribing Information (FDA)


• Vfend Consumer Overview

Compare Voriconazole with other medications

• Aspergillosis, Invasive
• Blastomycosis
• Candida Infections, Systemic
• Coccidioidomycosis, Meningitis
• Cutaneous Fungal Infection
• Esophageal Candidiasis
• Eumycetoma
• Fungal Infection, Internal and Disseminated
• Fungal Meningitis
• Fungal Pneumonia
• Fusariosis
• Ocular Fungal Infection
• Pseudoallescheriosis
• Systemic Fungal Infection