Rinstead Pastilles Discontinued
 

Pills
 

ED Pills

ED Drugs
 

Rinstead Sugar Free Pastilles


1. Name Of The Medicinal Product

Rinstead Sugar Free Pastilles

2. Qualitative And Quantitative Composition

Menthol BP 0.033% w/w

Cetylpyridinium chloride BP 0.128% w/w

3. Pharmaceutical Form

Pastille.

4. Clinical Particulars 4.1 Therapeutic Indications

For the temporary relief of pain and discomfort from recurrent mouth ulcers and denture sore spots.

4.2 Posology And Method Of Administration

Adults and children over 12 years:

Allow one pastille to dissolve slowly in the mouth about every two hours.

4.3 Contraindications

Hypersensitivity to cetylpyridinium chloride or menthol or to any component of the formulation.

4.4 Special Warnings And Precautions For Use

If symptoms persist, a physician or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

The safety of Rinstead Sugar Free Pastilles in pregnancy and lactation has not been established. Therefore, this product should only be used in pregnancy when considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Sensitisation to the product is a possible undesirable effect.

4.9 Overdose

If overdose is suspected, this should be treated symptomatically with gastric lavage and supportive therapy, if indicated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Menthol, applied locally in low concentrations, provides a soothing effect.

Cetylpyridinium chloride is an antiseptic, active against a wide spectrum of micro-organisms.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

Cetylpyridinium chloride is poorly absorbed and is excreted mainly via the faeces.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tartaric acid

Amaranth, Rinstead Oils

Sodium ricinoleate (50% sln)

Acesulfame potassium

Acacia gum

Sorbitol

Silicone Antifoam

Vegetable Oil

Beeswax

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Aluminium foil/clear PVC blister strips contained in a cardboard carton. Pack sizes of 12, 24, 30, 36 and 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 00025/0586

9. Date Of First Authorisation/Renewal Of The Authorisation

16 April 1996 / 16 April 2001

10. Date Of Revision Of The Text

22 January 2011

11. LEGAL CATEGORY

GSL

© Merck Sharp & Dohme Limited 2011. All rights reserved.

Rinstead SFP/01-11/02


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Boots Catarrh Pastilles


Boots Catarrh Pastilles

(Eucalyptus Oil, Menthol, Pumilio Pine Oil)

relieves catarrh, coughs and colds

45 g

Read all of this carton for full instructions.

What this medicine is for

This medicine contains menthol, eucalyptus and pumilio oils, which relieve chesty coughs and have antiseptic properties. It can be used to relieve the symptoms of congestion caused by catarrh, coughs and colds.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains glucose and sucrose) Talk to your pharmacist or doctor: If you are pregnant or breastfeeding

Information about some of the ingredients: Each pastille contains a total of 0.8 g of glucose and sucrose. This should be taken into account by people with diabetes. The colour E122 in this medicine may cause allergic reactions.

How to take this medicine

Check the inner bag is not broken before use. If it is, do not use the pastilles.

Adults and children of 12 years and over: Suck one pastille when you need to.

Don’t take more than 20 pastilles in 24 hours.

Suck each pastille slowly until it dissolves.

Do not give to children under 12 years.

Do not take more than the amount recommended.

If symptoms do not go away, talk to your doctor.

If you take too many pastilles: Talk to a pharmacist or doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the pastilles. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

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

Use by the date on the end flap of the carton.

Active ingredients

Each pastille contains Eucalyptus Oil 0.02% v/w, Menthol 0.8% w/w, Pumilio Pine Oil 0.6% v/w.

Also contains: modified starch, sucrose, glucose syrup, marshmallow liquid extract, vegetable oil, beeswax, water, thymol, carmoisine (E122).

PL 00094/0009

Text prepared 8/09

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by The Marketing Authorisation holder

Ernest Jackson and Co Crediton Devon EX17 3AP

If you need more advice ask your pharmacist.


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Mycostatin Pastilles


Generic Name: nystatin (oral) (nye STAH tin)
Brand Names: Bio-Statin, Mycostatin, Mycostatin Pastilles, Nilstat

What is nystatin?

Nystatin is an antifungal medication.

Oral nystatin is used to treat yeast infections of the mouth.

Nystatin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about nystatin? Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. What should I discuss with my healthcare provider before taking nystatin?

Nystatin is not absorbed through your stomach. It will not treat fungal infections in any part of your body other than your mouth. Talk to your doctor if you have another type of fungal infection such as athlete's foot, jock itch, ringworm, or a vaginal yeast infection.

Oral nystatin is in the FDA pregnancy category C. This means that it is not known whether nystatin will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether nystatin will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. How should I take nystatin?

Take nystatin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take the oral tablets with a full glass of water.

The troches, or pastilles, should be allowed to dissolve in your mouth. Do not chew or swallow them. Suck on one troche at a time until it is completely dissolved.

Shake the suspension well before measuring a dose.

Use a dose-measuring cup, spoon, or dropper to measure the specified dose of the suspension. Swish the suspension around in your mouth, then either spit it out or swallow it, depending upon the instructions given by your doctor.

Take all of the nystatin that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Store the Bio-Statin brand of nystatin tablets and powder and the Mycostatin Pastilles in the refrigerator. Store all other nystatin capsules, tablets, and suspension at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a nystatin overdose include nausea, stomach upset, vomiting, and diarrhea.

What should I avoid while taking nystatin?

There are no restrictions on foods, beverages, or activities during treatment with nystatin unless your doctor directs otherwise.

Nystatin side effects Stop taking nystatin and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Side effects are not likely to occur with nystatin. Continue to take nystatin and talk to your doctor if you experience

nausea or stomach upset,

vomiting, or

diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect nystatin?

Since nystatin is not absorbed by your body, drug interactions are not expected. Talk to your doctor and pharmacist before taking other prescription or over-the-counter medicines.

More Mycostatin Pastilles resources Mycostatin Pastilles Side Effects (in more detail) Mycostatin Pastilles Use in Pregnancy & Breastfeeding Mycostatin Pastilles Drug Interactions Mycostatin Pastilles Support Group 0 Reviews for Mycostatin Pastilles - Add your own review/rating Nystatin MedFacts Consumer Leaflet (Wolters Kluwer) Nystatin Professional Patient Advice (Wolters Kluwer) Nystatin Monograph (AHFS DI) Bio-Statin Advanced Consumer (Micromedex) - Includes Dosage Information Bio-Statin Powder MedFacts Consumer Leaflet (Wolters Kluwer) Mycostatin Prescribing Information (FDA) Mycostatin MedFacts Consumer Leaflet (Wolters Kluwer) Mycostatin Topical Advanced Consumer (Micromedex) - Includes Dosage Information Compare Mycostatin Pastilles with other medications Gastrointestinal Candidiasis Oral Thrush Where can I get more information? Your pharmacist has additional information about nystatin written for health professionals that you may read.

See also: Mycostatin Pastilles side effects (in more detail)


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Boots Easy Breathing Pastilles


1. Name Of The Medicinal Product

Boots Easy Breathing Pastilles

2. Qualitative And Quantitative Composition

Sylvestris Pine Oil

0.3% V/W

Abietis Oil BPC 1949

0.3% V/W

Menthol BP

0.6% W/W

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Pastille

4. Clinical Particulars 4.1 Therapeutic Indications

For the relief of catarrhal symptoms and coughs

4.2 Posology And Method Of Administration

One pastille to be dissolved slowly in the mouth as required.

ADULTS, THE ELDERLY AND CHILDREN OF 12 YEARS AND OVER:

Do not take more than 18 pastilles in 24 hours.

CHILDREN 6 – 12 YEARS:

Do not take more than 12 pastilles in 24 hours.

Not recommended for children under 6 years old.

4.3 Contraindications

Hypersensitivity to any of the ingredients

4.4 Special Warnings And Precautions For Use

Keep out of reach and sight of children. If symptoms persist consult your doctor.

Contains a total of 1.3g of sucrose and glucose per pastille. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None reported

4.6 Pregnancy And Lactation

The use of Catarrh Pastilles during pregnancy and lactation is not restricted.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Isolated cases of hypersensitivity reactions including anaphylaxis, angioedema, bronchospasm, rash, urticaria and flushing have been reported with menthol-containing preparations.

4.9 Overdose

No example of overdose has been reported.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

All the actives have decongestant properties.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

There is no preclinical data available specific to the product.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Granulated sugar

Modified starch

Liquid Glucose BPC

Peppermint oil

Eucalyptus oil

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

60 months for the unopened pack.

3 months after opening the 45g pack.

6 months after opening the 500g pack.

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Tied polythene bag, 500 g

Securitainer, 500 g

Heat-sealed laminated sachet integral with carton, 45 g

6.6 Special Precautions For Disposal And Other Handling

None specific to the packs.

7. Marketing Authorisation Holder

Ernest Jackson & Co Ltd

High Street

Crediton

Devon, EX17 3AP, UK

8. Marketing Authorisation Number(S)

PL 0094/5014R

9. Date Of First Authorisation/Renewal Of The Authorisation

First granted 23 April 1987 / Renewed June 2004

10. Date Of Revision Of The Text

July 2011


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Meggezones


1. Name Of The Medicinal Product

Meggezones

2. Qualitative And Quantitative Composition

Each pastille contains menthol 16.0mg BP

3. Pharmaceutical Form

Pastille.

4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic relief of sore throats, coughs, colds, catarrh and nasal congestion.

4.2 Posology And Method Of Administration

Allow one pastille to dissolve slowly in the mouth as required.

Maximum daily dose : Adults - 15 pastilles; children aged 6 to 12 years - 10 pastilles; children aged under 6 years - 5 pastilles.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Hypersensitivity to the product is a possible side effect. Contact dermatitis may occur with menthol products.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety in pregnancy and lactation has not been established. However menthol-containing products have been used for many years with no ill effect.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Systemic effects due to overdosage are most unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Menthol in pastille formulation relieves catarrh and other symptoms associated with colds.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

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 SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Modified starch, antifoam 1510, sucrose, liquorice extract powder, liquid glucose (80%) solid (1963); peppermint oil; benzoin; water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Once opened keep in a cool dry place.

6.5 Nature And Contents Of Container

PVC blister packs with aluminium seal in a cardboard box. Packs contain 3, 8, 24, 36 or 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Schering-Plough Ltd

Shire Park

Welwyn Garden City

Hertfordshire

AL7 1TW

UK

8. Marketing Authorisation Number(S)

PL 0201/0104

9. Date Of First Authorisation/Renewal Of The Authorisation

5 May 1988 / 5 May 1993

10. Date Of Revision Of The Text

November 1998

11. Legal Status

GSL

Meggezones/UK/02-10/1


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MEDIJEL PASTILLES


1. Name Of The Medicinal Product

MEDIJEL PASTILLES

2. Qualitative And Quantitative Composition

Lignocaine Hydrochloride BP

0.25 % w/w

Aminacrine Hydrochloride BP 1968

0.025 %w/w

3. Pharmaceutical Form

Soft Pastille

4. Clinical Particulars 4.1 Therapeutic Indications

The quick effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing.

4.2 Posology And Method Of Administration

Place pastille against affected area and let it dissolve slowly. Repeat as necessary.

Each pastille weighs approximately 1.2g, i.e. 3mg of Lignocaine Hydrochloride and 0.3mg of Aminacrine Hydrochloride.

Medijel Pastilles can be used as directed for adults and children.

4.3 Contraindications

Hypersensitivity to the active substances or to any other of the ingredients.

Contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special Warnings And Precautions For Use

If symptoms persist longer than 7 days following the use of the product, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Medijel Pastilles during pregnancy and lactation has not been established, but is considered not to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypersensitivity reactions to Lignocaine have been reported on rare occasions.

4.9 Overdose

Maximum safe dosage for a 70kg adult is 750mg for Lignocaine (Goodman & Gilman, page 313). A pack of Medijel pastilles contains approximately 75mg of Lignocaine Hydrochloride - overdose is not a problem.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lignocaine Hydrochloride is well documented in Martindale 28th Edition page 900 - 904 and Goodman & Gilman, chapter 15 and pages 767 - 770.

Lignocaine Hydrochloride was first introduced in 1948 and is one of the most widely used local anaesthetics. However, it produces more prompt, more intense, longer lasting and more extensive anaesthesia than does an equal concentration of procaine (Peak anaesthesia within 2-5 minutes). Local anaesthetics are drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They have good powers of penetration and their action is reversible. Their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.

Aminacrine Hydrochloride is a slow acting disinfectant. It exerts germicidal action against bacteria and fungi. It is also used as a surgical and endodontic irrigant and to treat local infections of the ear, mouth and throat. Its exact mode of action is not known but it involves disruption of certain metabolic pathways.

5.2 Pharmacokinetic Properties

Lignocaine is readily absorbed through mucous membranes. They exert their effects in the form of the non-ionised base. Lignocaine undergoes first-pass metabolism in the liver and bioavailablity is low after administration by mouth. It is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed by amidases to various compounds, including glycineexylidide which has reduced activity but a longer elimination half-life. Less than 10% of a dose is excreted unchanged via the kidneys. The metabolic products are excreted in the urine.

Aminacrine Hydrochloride if administered systematically is rapidly eliminated through the kidney (0.2 g being eliminated from the blood in 30 minutes. Medijel Pastilles dose 0.15mg Aminacrine Hydrochloride).

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 SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hydroxypolyethoxydodecane HSE, Gelatin BP, Liquid Glucose BPC 1963, Sucrose EP,

Peppermint Oil BP, Levomenthol BP, Ethyl VanillinNF, Standard Green SE142,

Dextrose Monhydrate BP, Water (potable)

6.2 Incompatibilities

None encountered.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

No special storage conditions.

6.5 Nature And Contents Of Container

Aluminium Foil/Polyethylene laminate within coated boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

DDD Limited

94, Rickmansworth Road

Watford, Hertfordshire

United Kingdom

WDI8 7JJ

8. Marketing Authorisation Number(S)

PL 0133/5001R

Legal Status: Pharmacy Only

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 1972

10. Date Of Revision Of The Text

August 2009


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Mouth and throat products


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Topical mouth and throat products include agents such as antifungals, antiseptics, cough suppressants and saliva substitutes. They are used to treat conditions of the mouth and throat such as oral thrush, dry mouth, sore throat and tickly cough.

See also

Medical conditions associated with mouth and throat products:

Aphthous Stomatitis, Recurrent Aphthous Ulcer Cold Sores Cough Gastrointestinal Candidiasis Gingivitis Herpes Simplex Mucositis Nasal Congestion Oral and Dental Conditions Oral Thrush Pain Periodontitis Tonsillitis/Pharyngitis Xerostomia Drug List: Cepacol-Dual-Relief-Spray Neutrasal-Powder Mycelex-Troche Aphthasol Atridox Betasept-Liquid Bio-Statin-Powder Biopatch Calgon-Vesta Caphosol-Solution Cepacol-Sore-Throat-Lozenges Cetacaine-Liquid Chloraseptic-Lozenges Chlorostat Chlorostat-4 Denti-Care-Denti-Rinse Dyna-Hex Exactacain-Topical-Anesthetic-Spray First-Mouthwash-Blm Hibiclens-Liquid Hibistat Mycostatin Mycostatin-Pastilles Nilstat Peridex-Solution Periochip Periogard-Solution Perisol-Oral-Rinse Salivart-Spray Scrub-Care Spectrum-4 Vicks-Formula-44-Sore-Throat-Spray
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Boots Antiseptic Sore Mouth Pastilles


1. Name Of The Medicinal Product

Boots Sore Mouth Pastilles

2. Qualitative And Quantitative Composition

Active ingredient

mg

2.4 - Dichlorobenzyl alcohol

1.29

3. Pharmaceutical Form

Deep orange-coloured, pleasantly flavoured, concave-convex, well glazed pastille with corrugations on the upper convex surface.

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of sore mouths.

4.2 Posology And Method Of Administration

Adults and children over 3 years: Allow a pastille to dissolve slowly in the mouth every two or three hours during the day, keeping the pastille near the painful area.

Elderly : There is no need for dosage reduction in the elderly.

For oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Not recommended for children under 3 years.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of this product during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity reactions and soreness of the tongue

4.9 Overdose

No specific symptoms associated with overdosage, other than nausea, vomiting, diarrhoea and soreness of the tongue. Treatment, if required, should be symptomatic.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dichlorobenzyl alcohol has antiseptic properties.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Silicone antifoam 1510

Glycerin

Annatto WSA acid stab liquid biocon

Purity gum 40 Nat Starch and chemical

Lycasin 80/55 Roquette

Potable water

Adipic acid

Myrrh tincture

Levomenthol natural

Clove leaf oil

Sweet orange oil special IFF

Capol 3073B

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store in a dry place below 25°C.

6.5 Nature And Contents Of Container

Clear cellulose film coated with nitrocellulose and heat-sealed to form a bag. Each bag is packed in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL00014/5370R

9. Date Of First Authorisation/Renewal Of The Authorisation

2 April 1973

10. Date Of Revision Of The Text

February 2011


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Aclaro PD Emulsion


hydroquinone
Dosage Form: topical emulsion
Aclaro PD Description Hydroquinone is 1,4-benzenediol.  Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol with a pKa of 9.96. Chemically, hydroquinone is designated as p–dihydroxybenzene; the empirical formula is C6H6O2; molecular weight 110.1. The structural formula is:
ACTIVE INGREDIENT: hydroquinone USP 4%. Other Ingredients: ascorbic acid, benzyl alcohol, butyl methoxydibensoyl methane, C12-15 alkyl benzoate, cetearyl ethylhexanoate, cetyl alcohol, cetyl esters, cetyl palmitate, DEA – cetyl phosphate, dimethicone, dimethylacrylamide/acrylic acid/polystyrene ethyl methacrylate copolymer, disodium EDTA, ethylhexyl methoxycinnamate, glycerine, glycolic acid, hydroxyl ethyl cellulose, phenoxyethanol, propylene glycol (and) BHA (and) citric acid, purified water, sodium hydroxide solution,stearic acid.
Clinical Pharmacology Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa)1 and suppression of other melanocyte metabolic processes.2 Indications and Usage Aclaro PD® is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma. Contraindications

Aclaro PD® is contraindicated in any patient that has a prior history of hypersensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on
children (12 years and under) has not been established.

Warnings A. Caution: Hydroquinone is a depigmenting agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
B.Test for skin sensitivity before using Aclaro PD® (hydroquinone USP 4%) bioadhesive emulsion by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching, vesicle formation, or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes
should be avoided. If no lightening effect is noted after two months of treatment, use of Aclaro PD® bioadhesive emulsion should be discontinued.
C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocyte activity. The sunscreens in Aclaro PD® bioadhesive emulsion provide the necessary sun protection during therapy. During and after the use of Aclaro PD® bioadhesive emulsion, sun exposure should be limited or sun-protective clothing should be used to cover the treated areas to prevent repigmentation.
D. Keep this and all medications out of the reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.
E. On rare occasions, a gradual blue-black darkening of the skin may occur. If this occurs, the product should be discontinued and a physician contacted immediately.
Precautions

See Warnings


A. Pregnancy Category C: Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.

B. Nursing mothers: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when hydroquinone is used by a nursing mother.

C. Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.


Adverse Reactions No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately. Overdosage

There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Dosage and Administration

Aclaro PD® bioadhesive emulsion should be applied to the affected areas twice daily, or as directed by a physician. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

How Supplied

Aclaro PD® (hydroquinone USP 4%)bioadhesive emulsion is available in a: 1.5 ounce airless pump bottle NDC 68712-015-02

Store at controlled room temperature: 15?-30? C (59?–86? F)


Manufactured for:
Innocutis Holdings LLC
Charleston, SC 29401
Toll free: 1-800-499-4468
www.innocutis.com
www.Aclaro4.com
February 2011
U.S. Pat. No.: 5,942,243


ACLARO PD  HYDROQUINONE
hydroquinone  emulsion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68712-015 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID   BENZYL ALCOHOL   AVOBENZONE   ALKYL (C12-15) BENZOATE   CETEARYL ETHYLHEXANOATE   CETYL ALCOHOL   CETYL ESTERS WAX   CETYL PALMITATE   DIETHANOLAMINE CETYL PHOSPHATE   DIMETHICONE   EDETATE DISODIUM   OCTINOXATE   GLYCERIN   GLYCOLIC ACID   HYDROXYETHYL CELLULOSE (140 CPS AT 5%)   PHENOXYETHANOL   BUTYLATED HYDROXYANISOLE   PROPYLENE GLYCOL   CITRIC ACID MONOHYDRATE   WATER   SODIUM HYDROXIDE   STEARIC ACID   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68712-015-02 42.5 g In 1 BOTTLE, PUMP None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2011
Labeler - Innocutis Holdings LLC (071501252) Establishment Name Address ID/FEI Operations Sonar Products 104283945 manufacture Revised: 12/2011Innocutis Holdings LLC More Aclaro PD Emulsion resources Aclaro PD Emulsion Side Effects (in more detail)Aclaro PD Emulsion Use in Pregnancy & BreastfeedingAclaro PD Emulsion Support Group0 Reviews for Aclaro PD - Add your own review/rating Compare Aclaro PD Emulsion with other medications Dermatological Disorders
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Benadryl Skin Allergy Relief Cream


1. Name Of The Medicinal Product

Benadryl Skin Allergy Relief Cream

Benadryl Allergy Skin Cream

2. Qualitative And Quantitative Composition

Benadryl Allergy Skin Cream contains:

1% w/v diphenhydramine hydrochloride Ph Eur

8% w/v zinc oxide Ph Eur

0.1% w/v racemic camphor Ph Eur.

3. Pharmaceutical Form

Cream.

4. Clinical Particulars 4.1 Therapeutic Indications

Benadryl Allergy Skin Cream is indicated for the relief of irritation associated with urticaria, herpes zoster and other minor skin affections and alleviate the discomforts of sunburn, prickly heat, insect bites and nettle stings. In infants it may be used for hives.

4.2 Posology And Method Of Administration

Adults:

Topical. Benadryl Allergy Skin Cream may be applied to the affected area, three or four times daily.

Children and Infants:

Topical. As for adults.

The Elderly:

Topical. As for adults.

4.3 Contraindications

Do not use on chicken pox or measles or exudative dermatoses, unless supervised by a doctor. Do not use on extensive areas of the skin except as directed by a doctor. Do not use any other drugs containing diphenhydramine while using this product.

4.4 Special Warnings And Precautions For Use

Benadryl Allergy Skin Cream should not be applied to raw, or broken surfaces or mucous membranes as this may result in percutaneous absorption giving rise to systemic effects. Avoid contact with the eyes. If a burning sensation or rash develops or if the condition persists, treatment should be discontinued. If necessary, remove by washing with soap and water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The safety of Benadryl Allergy Skin Cream in pregnancy and lactation has not been established. Like any medicine, Benadryl Allergy Skin Cream should only be used if the possible benefits outweigh the potential risks involved. Diphenhydramine is known to be absorbed through the skin. Diphenhydramine crosses the placental barrier and is secreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, sensitivity, eczematous reactions and photosensitivity have been reported after topical application of antihistamines. If this occurs, treatment should be discontinued.

4.9 Overdose

Symptoms and signs

Accidental ingestion or excessive absorption of Benadryl Allergy Skin Cream may lead to dose-related signs of diphenhydramine toxicity. These include drowsiness and sedation with anti-cholinergic symptoms prevailing. Camphor may produce nausea, vomiting and dizziness. At higher doses, delirium leading to coma, ataxia, increased muscle reflexes and cloniform convulsions may appear.

Treatment

The stomach should be emptied by lavage and aspiration. In cases of acute poisoning, activated charcoal may be useful. A sodium sulphate purgative may be given. Convulsions may be controlled with diazepam or thiopental sodium. In the case of camphor poisoning, lipid haemodialysis or resin haemoperfusion may be useful.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benadryl Allergy Skin Cream contains diphenhydramine hydrochloride, zinc oxide and camphor. Diphenhydramine is a powerful antihistamine and local anaesthetic (antipruritic). In concentrations of between 0.1 – 3.0 %, camphor depresses cutaneous receptors and is an effective analgesic, anaesthetic and antipruritic, which provides a feeling of coolness when applied topically.

5.2 Pharmacokinetic Properties

Benadryl Allergy Skin Cream is intended only for topical application to the skin. At the recommended dose little of the active ingredients will be absorbed. Percutaneous penetration of diphenhydramine and camphor has been demonstrated during inappropriate use of these compounds separately, but has not been quantified.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

White ceresin

Cetostearyl alcohol

Ferric oxide red (E172)

Ferric oxide yellow (E172)

Sorbitan stearate

Propyl hydroxybenzoate

Propylene glycol

Polysorbate 60

Perfume oil soleil 78087

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Benadryl Allergy Skin Cream is stored in a 42 g epoxy phenolic-based lacquered aluminium tube with a white, polyethylene or polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

None applicable.

Administrative Data 7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

5th January 2000

10. Date Of Revision Of The Text

2 December 2009


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eflornithine topical


Generic Name: eflornithine topical (ee FLOOR nih theen)
Brand Names: Vaniqa

What is eflornithine topical?

Eflornithine interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where eflornithine topical is applied.

Eflornithine topical is used to reduce unwanted facial hair in women. Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. Eflornithine topical will help you manage your condition and improve your appearance.

Eflornithine topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about eflornithine topical? Eflornithine topical is for external use only.

Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.

Who should not use eflornithine topical? Do not use eflornithine topical if you have had an allergic reaction to it in the past. Eflornithine topical is in the FDA pregnancy category C. This means that it is not known whether eflornithine topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether eflornithine passes into breast milk. Do not use eflornithine topical without first talking to your doctor if you are breast-feeding a baby. Eflornithine topical has not been approved for use by children younger than 12 years of age. How should I use eflornithine topical? Apply eflornithine topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Eflornithine topical will help you manage your condition and improve your appearance.

Eflornithine topical is for external use only.

Eflornithine topical is usually applied twice daily, at least eight hours apart, or as directed by your doctor.

Wash your hands before and after each application of eflornithine topical.

Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying eflornithine topical. Apply a thin layer of eflornithine topical to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.

Cosmetics or sunscreen may be used after applying eflornithine topical, but you should wait a few minutes to allow the treatment to be absorbed before applying them.

Do not wash the treatment areas for at least 4 hours after application of eflornithine topical. Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse them thoroughly with water and contact your doctor.

Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.

Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.

Store eflornithine topical at room temperature away from moisture and heat. Do not allow the medication to freeze. What happens if I miss a dose?

If you miss a dose of eflornithine topical, skip the dose you missed and apply your next regularly scheduled dose as directed. Do not apply a double dose of this medication or try to "make up" a missed dose.

What happens if I overdose?

An overdose of eflornithine topical is not likely to occur. If the cream has been ingested, or if you suspect an overdose has occurred, contact your doctor, hospital emergency room, or poison control center for advice.

What should I avoid while using eflornithine topical? Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse thoroughly with water and contact your doctor. Eflornithine topical side effects

Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.

Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Eflornithine topical Dosing Information

Usual Adult Dose for Hirsutism:

Apply a thin layer of eflornithine topical cream to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice a day, allowing at least 8 hours between applications or as directed by a physician.
Continue to use hair removal techniques as needed in conjunction with eflornithine. Apply eflornithine at least 5 minutes after hair removal. Cosmetics or sunscreens may be applied over treated areas after cream has dried.

What other drugs will affect eflornithine topical?

Before using eflornithine topical, talk to your doctor if you are taking any other prescription or over-the-counter medications, especially if you are using any other topical preparations. You may not be able to use eflornithine topical, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with eflornithine topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

More eflornithine topical resources Eflornithine topical Side Effects (in more detail) Eflornithine topical Dosage Eflornithine topical Use in Pregnancy & Breastfeeding Eflornithine topical Support Group 8 Reviews for Eflornithine - Add your own review/rating Vaniqa Monograph (AHFS DI) Vaniqa Topical Advanced Consumer (Micromedex) - Includes Dosage Information Vaniqa Cream MedFacts Consumer Leaflet (Wolters Kluwer) Vaniqa Consumer Overview Compare eflornithine topical with other medications Hirsutism Where can I get more information? Your pharmacist has additional information about eflornithine topical written for health professionals that you may read.

See also: eflornithine side effects (in more detail)


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Parafon DSC



Dosage Form: tablet
Parafon DSC (chlorzoxazone) Parafon DSC Description

Each caplet (round shaped tablet) contains:

Chlorzoxazone                    500 mg

Inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, docusate Sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium benzoate, D&C yellow No. 10 alum. Lake, FD&C blue no. 1 alum. Lake HT

Parafon DSC - Clinical Pharmacology

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

Indications and Usage for Parafon DSC

Chlorzoxazone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Contraindications

Chlorzoxazone tablets are contraindicated in patients with known intolerance to the drug.

Warnings

Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g. AST, ALT, alkaline phosphatase and bilirubin).

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy

The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.

Precautions

Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

Adverse Reactions

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

Overdosage Symptoms

Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment

Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

Parafon DSC Dosage and Administration Usual Adult Dosage

One caplet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1 ? caplets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

How is Parafon DSC Supplied

Chlorzoxazone tablets 500 mg Tablets, (round shaped tablet, light green, imprinted "555/585" and "Barr" scored).

NDC 68387-375-90, bottles of 90
NDC 68387-375-30, bottles of 30

Dispense in tight container as defined in the USP/NF.

Store at controlled room temperature (15°–30°C, 59°–86°F).

Manufactured for:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, Ms 39232

R4

Package Label - Principal Display Panel – 90-count Bottle, 500 mg Tablets

NDC 68387-375-90

Rx Only


Parafon DSC 
chlorzoxazone  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68387-375 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorzoxazone (Chlorzoxazone) Chlorzoxazone 500 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   CROSCARMELLOSE SODIUM   DOCUSATE SODIUM   ANHYDROUS LACTOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM BENZOATE   D&C YELLOW NO. 10   FD&C BLUE NO. 1   Product Characteristics Color GREEN (light green) Score 2 pieces Shape ROUND Size 17mm Flavor Imprint Code 555;585;Barr Contains          Packaging # NDC Package Description Multilevel Packaging 1 68387-375-90 90 TABLET In 1 BOTTLE None 2 68387-375-30 30 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089895 06/20/2004
Labeler - Keltman Pharmaceuticals Inc. (362861077) Establishment Name Address ID/FEI Operations Barr Laboratories, Inc. 824749340 MANUFACTURE Revised: 02/2010Keltman Pharmaceuticals Inc. More Parafon DSC resources Parafon DSC Side Effects (in more detail) Parafon DSC Use in Pregnancy & Breastfeeding Drug Images Parafon DSC Drug Interactions Parafon DSC Support Group 10 Reviews for Parafon DSC - Add your own review/rating Compare Parafon DSC with other medications Muscle Spasm
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Floxapen Capsules 500mg (Actavis UK Ltd)


1. Name Of The Medicinal Product

Floxapen Capsules 500mg

2. Qualitative And Quantitative Composition

Floxapen Capsules (Flucloxacillin Capsules BP) containing 500 mg flucloxacillin as Flucloxacillin Sodium BP.

3. Pharmaceutical Form

Capsule, hard

Caramel coloured hard gelatin capsules printed with '

4. Clinical Particulars

Flucloxacillin is an isoxazolyl penicillin of the ?-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including ?-lactamase-producing staphylococci and streptococci.

4.1 Therapeutic Indications

Floxapen is indicated for the treatment of infections due to sensitive Gram-positive organisms, including ?-lactamase-producing staphylococci and streptococci. Typical indications include:

Skin and soft tissue infections:

   

Boils

Cellulitis

Infected burns

Abscesses

Infected skin conditions

Protection for skin grafts

Carbuncles

e.g. ulcer, eczema, and acne

Impetigo

Furunculosis

Infected wounds

 

Respiratory tract infections:

   

Pneumonia

Lung abscess

Empyema

Sinusitis

Pharyngitis

Otitis media and externa

Tonsillitis

Quinsy

 

Other infections caused by Floxapen-sensitive organisms:

   

Osteomyelitis

Urinary tract infection

 

Enteritis

Meningitis

 

Endocarditis

Septicaemia

 

Floxapen is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery.

Parenteral usage is indicated where oral dosage is inappropriate.

4.2 Posology And Method Of Administration

Depends on the age, weight and renal function of the patient, as well as the severity of the infection.

Usual adult dosage (including elderly patients)

Oral - 250 mg four times a day.

Osteomyelitis, endocarditis - Up to 8 g daily, in divided doses six to eight hourly.

Surgical prophylaxis - 1 to 2 g IV at induction of anaesthesia followed by 500 mg six hourly IV, IM or orally for up to 72 hours.

Usual children's dosage

2-10 years: half adult dose.

Under 2 years: quarter adult dose.

Abnormal renal function: In common with other penicillins, Floxapen usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an extension of dose interval should be considered. Floxapen is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during, or at the end of the dialysis period.

Administration

Oral: Oral doses should be administered half to one hour before meals.

4.3 Contraindications

Flucloxacillin should not be given to patients with a history of hypersensitivity to ?-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.

Flucloxacillin is contra-indicated in patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with flucloxacillin, careful enquiry should be made concerning previous hypersensitivity reactions to ?-lactams.

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

If anaphylaxis occurs flucloxacillin should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with adrenaline (epinephrine). Ensure adequate airway and ventilation and give 100% oxygen. IV crystalloids, hydrocortisone, antihistamine and nebulised bronchodilators may also be required.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction, patients

The use of flucloxacillin (like other penicillins) in patients with renal impairment does not usually require dosage reduction. In the presence of severe renal failure (creatinine clearance less than 10ml/min), however, a reduction in dose or an extension of dose interval should be considered because of the risk of neurotoxicity (see section 4.2).

During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended.

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

Floxapen capsules contain 51 mg sodium per g. This should be included in the daily allowance of patients on sodium restricted diets.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Probenecid decreases the renal tubular secretion of flucloxacillin. Concurrent administration of probenecid delays the renal excretion of flucloxacillin.

In common with other antibiotics, flucloxacillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy: Animal studies with flucloxacillin have shown no teratogenic effects. The product has been in clinical use since 1970 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effects. The decision to administer any drug during pregnancy should be taken with the utmost care. Therefore flucloxacillin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Lactation: Trace quantities of flucloxacillin can be detected in breast milk. The possibility of hypersensitivity reactions must be considered in breast-feeding infants. Therefore flucloxacillin should only be administered to a breast-feeding mother when the potential benefits outweigh the potential risks associated with the treatment.

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

The following convention has been utilised for the classification of undesirable effects:- Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare ( <1/10,000).

Unless otherwise stated, the frequency of the adverse events has been derived from more than 30 years of post-marketing reports.

Blood and lymphatic system disorders

Very rare: Neutropenia (including agranulocytosis) and thrombocytopenia. These are reversible when treatment is discontinued. Haemolytic anaemia.

Immune system disorders

Very rare: Anaphylactic shock (exceptional with oral administration) (see Item 4.4 Warnings), angioneurotic oedema.

If any hypersensitivity reaction occurs, the treatment should be discontinued. (See also Skin and subcutaneous tissue disorders).

Gastrointestinal disorders

*Common: Minor gastrointestinal disturbances.

Very rare: Pseudomembranous colitis.

If pseudomembranous colitis develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.

Hepato-biliary disorders

Very rare: Hepatitis and cholestatic jaundice. (See Section 4.4 Special Warnings and Special Precautions for Use). Changes in liver function laboratory test results (reversible when treatment is discontinued).

These reactions are related neither to the dose nor to the route of administration. The onset of these effects may be delayed for up to two months post-treatment; in several cases the course of the reactions has been protracted and lasted for some months. Hepatic events may be severe and in very rare circumstances a fatal outcome has been reported. Most reports of deaths have been in patients

Skin and subcutaneous tissue disorders

*Uncommon: Rash, urticaria and purpura.

Very rare: Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

(See also Immune system disorders).

Musculoskeletal and connective tissue disorders

Very rare: Arthralgia and myalgia sometimes develop more than 48 hours after the start of the treatment.

Renal and urinary disorders

Very rare: Interstitial nephritis.

This is reversible when treatment is discontinued.

General disorders and administration site conditions

Very rare: Fever sometimes develops more than 48 hours after the start of the treatment.

*The incidence of these AEs was derived from clinical studies involving a total of approximately 929 adult and paediatric patients taking flucloxacillin.

4.9 Overdose

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

Flucloxacillin is not removed from the circulation by haemodialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Properties: Flucloxacillin is a narrow-spectrum antibiotic of the group of isoxazolyl penicillins; it is not inactivated by staphylococcal ?-lactamases.

Activity: Flucloxacillin, by its action on the synthesis of the bacterial wall, exerts a bactericidal effect on streptococci except those of group D (Enterococcus faecalis) staphylococci. It is not active against methicillin-resistant staphylococci.

5.2 Pharmacokinetic Properties

Absorption: Flucloxacillin is stable in acid media and can therefore be administered either by the oral or parenteral route. The peak serum levels of flucloxacillin reached after one hour are as follows.

- After 250 mg by the oral route (in fasting subjects): Approximately 8.8 mg/l.

- After 500 mg by the oral route (in fasting subjects): Approximately 14.5mg/l.

- After 500 mg by the IM route: Approximately 16.5 mg/l.

The total quantity absorbed by the oral route represents approximately 79% of the quantity administered.

Distribution: Flucloxacillin diffuses well into most tissue. Specifically, active concentrations of flucloxacillin have been recovered in bones: 11.6 mg/l (compact bone) and 15.6 mg/l (spongy bone), with a mean serum level of 8.9 mg/l.

Crossing the meningeal barrier: Flucloxacillin diffuses in only small proportion into the cerebrospinal fluid of subjects whose meninges are not inflamed.

Crossing into mother's milk: Flucloxacillin is excreted in small quantities in mother's milk.

Metabolism: In normal subjects approximately 10% of the flucloxacillin administered is metabolised to penicilloic acid. The elimination half-life of flucloxacillin is in the order of 53 minutes.

Excretion: Excretion occurs mainly through the kidney. Between 65.5% (oral route) and 76.1% (parenteral route) of the dose administered is recovered in unaltered active form in the urine within 8 hours. A small portion of the dose administered is excreted in the bile. The excretion of flucloxacillin is slowed in cases of renal failure.

Protein binding: The serum protein-binding rate is 95%.

5.3 Preclinical Safety Data

No further information of relevance to add.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Capsule content:

Magnesium stearate

Capsule shell:

Gelatin

Titanium dioxide (E171)

Black iron oxide (E172)

Yellow iron oxide (E172)

Red iron oxide (E172)

Printing ink:

Shellac (E904)

Propylene glycol (E1520)

Sodium hydroxide (E524)

Povidone

Titanium dioxide (E171)

6.2 Incompatibilities

None known.

6.3 Shelf Life

Tray foil blister: 24 months

Other Packaging: 12 months

6.4 Special Precautions For Storage

Floxapen Capsules in Original Packs should be stored in a dry place. Floxapen Capsules in reclosable containers should be stored in a cool, dry place.

6.5 Nature And Contents Of Container

Floxapen Capsules 500 mg: Aluminium canister - 50 and 100; Glass bottle with screwcap - 50 and 100; Polypropylene tube with polyethylene closure - 50 and 100; Aluminium foil - 12; Aluminium/PVC Blister with an aluminium overseal (tray foil blister pack) -28

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjav?kurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

12th October 2007

10. Date Of Revision Of The Text

12/05/2010

11 DOSIMETRY (IF APPLICABLE) 12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
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PanOxyl 5 Aquagel 5%w / w Gel


1. Name Of The Medicinal Product

PanOxyl 5 Aquagel 5%w/w Gel

PanOxyl Aquagel 5

2. Qualitative And Quantitative Composition

Benzoyl peroxide 5% w/w. Also contains propylene glycol.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gel

4. Clinical Particulars 4.1 Therapeutic Indications

The product is indicated for use in the topical treatment of acne vulgaris.

4.2 Posology And Method Of Administration

Treatment should normally begin with PanOxyl Aquagel 2.5. Apply to the affected areas once daily. Washing prior to application enhances the efficacy of the preparation.

The reaction of the skin to benzoyl peroxide differs in individual patients. The higher concentration in PanOxyl Aquagel 5 or 10 may be required to produce a satisfactory response.

4.3 Contraindications

PanOxyl Aquagel should not be prescribed for patients with a known hypersensitivity to benzoyl peroxide.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes, mouth and mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas.

During the first few days of treatment a moderate reddening and peeling will occur. During the first few weeks of treatment a sudden increase in peeling will occur in most patients. This is not harmful and will normally subside within a day or two if treatment is discontinued. If excessive irritation, redness or peeling occurs, discontinue use.

The product may bleach dyed fabrics.

PanOxyl 5 Aquagel contains propylene glycol. Propylene glycol may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There are no restriction on the use of PanOxyl Aquagel in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

None

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Benzoyl peroxide has sebostatic and keratolytic activity coupled with antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. Its use in the treatment of acne is well established.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable. Benzoyl peroxide has been in widespread use for many years.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Carbomer 940

Di-isopropanolamine

Propylene glycol

Polyoxyethylene lauryl ether

Sodium lauryl sulphate

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Internally lacquered aluminium tubes with screw caps. Licensed pack sizes: 40g and 50g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of PanOxyl Aquagel 5.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0058

9. Date Of First Authorisation/Renewal Of The Authorisation

21st August 1984

10. Date Of Revision Of The Text

18 October 2011


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Polytar AF


1. Name Of The Medicinal Product

Polytar AF

2. Qualitative And Quantitative Composition

Tar Blend 1% w/w, Zinc Pyrithione 1% w/w in a shampoo base

Tar Blend comprises:

Pine tar, Cade oil, Coal Tar Solution, Arachis Oil extract of Coal Tar.

3. Pharmaceutical Form

Medicated Shampoo

4. Clinical Particulars 4.1 Therapeutic Indications

Polytar AF is indicated in the topical treatment of scalp disorders such as dandruff, seborrhoeic dermatitis and psoriasis.

4.2 Posology And Method Of Administration

Shake the bottle before use. Wet the hair and massage Polytar AF into the hair, scalp and surrounding skin. Leave for 2-3 minutes, then rinse thoroughly.

Polytar AF should be used two or three times weekly for at least 3 weeks or until the condition clears.

4.3 Contraindications

Polytar AF should not be used by patients with known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. Tar products may cause skin irritation, rashes and, rarely, photosensitivity. Zinc pyrithione may cause dermatitis, should this occur, Polytar AF should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The safety of Polytar AF in human pregnancy and lactation has not been established.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None.

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tar blend:

Tars suppress DNA synthesis in hyperplastic skin, this inhibits mitotic activity and protein synthesis. By decreasing proliferation and dermal infiltration, they promote a return to normal keratinisation. Tars also have vasoconstricting astringent and antipruritic properties.

Zinc Pyrithione:

Zinc Pyrithione has antibacterial and antifungal properties. It is fungicidal against the pathogenic yeasts of the pityrosporum genus which are implicated in dandruff and seborrhoeic dermatitis.

5.2 Pharmacokinetic Properties

Not Applicable.

5.3 Preclinical Safety Data

Not Applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Coconut diethanolamide

Triethanolamine Lauryl Sulphate

Carbomer

Sodium Hydroxide

Hypromellose

Octoxinol

Glycerol

Imidurea

Purified Water

6.2 Incompatibilities

None

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25oC

6.5 Nature And Contents Of Container

High density polyethylene bottles of 25ml, 65ml, 150ml, 250ml, 350ml, 400ml, 1000ml

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Polytar AF.

7. Marketing Authorisation Holder

GlaxoSmithKline UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as Stiefel

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8. Marketing Authorisation Number(S)

PL 19494/0061

9. Date Of First Authorisation/Renewal Of The Authorisation

16th March 1992.

10. Date Of Revision Of The Text

20 December 2010


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Anusol HC Suppository


ocortisone acetate
Dosage Form: suppository

Anusol-HC®

25-mg Suppository

(Hydrocortisone Acetate)

Anusol HC Suppository Description

Each Anusol-HC® 25-mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy (11?)- with the following structural formula:

Anusol HC Suppository - Clinical Pharmacology

In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces.

Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.

Indications and Usage for Anusol HC Suppository

For use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritis ani.

CONTRAINDICATION

 Anusol-HC® suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

Precautions

Do not use unless adequate proctologic examination is made.

If irritation develops, the product should be discontinued and appropriate therapy instituted.

In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

Information for Patients

Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.

Pregnancy Category C

In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well-controlled studies in pregnant women. Anusol-HC® suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

It is not known whether this drug is excreted in human milk, and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Anusol-HC® suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Adverse Reactions

The following local adverse reactions have been reported with corticosteroid suppositories.

1. Burning                       4. Dryness  7. Allergic contact dermatitis  2. Itching  5. Folliculitis 8. Secondary infection 3. Irritation 6. Hypopigmentation                     Drug Abuse and Dependence

Drug abuse and dependence has not been reported in patients treated with Anusol-HC® suppositories.

Overdosage

If signs and symptoms of systemic overdosage occur, discontinue use.

Anusol HC Suppository Dosage and Administration

Usual dosage: One suppository in the rectum morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.

How is Anusol HC Suppository Supplied

Anusol-HC® 25-mg Suppositories are white, cylinder shaped, with one end tapered. Package of 12 suppositories (NDC 65649-411-12) and package of 24 suppositories (NDC 65649-411-24).

Store at 20°-25°C (68°-77°F). See USP Controlled Temperature. Store away from heat. Protect from freezing.

Rx only.

Prescribing Information as of March 2005.

Manufactured for: Salix Pharmaceuticals, Inc., Morrisville, NC 27560

 

 OPENING INSTRUCTIONS

Avoid excessive handling of the suppository. It is designed to melt at body temperature.

1. Separate plastic film at top opening and pull downward.

2. Continue pulling downward to almost the full length of the suppository.

3. Gently remove the suppository from the film pocket.

 

                                                                                                                                                                 6415

                                                                                                                                                                 Rev. 3/05 3000263-C

PACKAGE LABEL PRINCIPAL DISPLAY PANEL -  Anusol-HC® 12 Suppositories Carton Label

NDC  65649-411-12

Rx only

Store at 20°-25°C (68°-77°F). See USP Controlled Temperature. Store away from heat. Protect from freezing 

Anusol - HC®   

(Hydrocortisone Acetate in a

Hydrogenated Vegetable Oil Base)

25 mg                                 12 Suppositories


 


ANUSOL HC 
hydrocortisone acetate  suppository Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65649-411 Route of Administration RECTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE 25 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED PALM OIL   SILICON DIOXIDE   BUTYLATED HYDROXYANISOLE   Product Characteristics Color WHITE (WHITE) Score      Shape OVAL (cylinder with one end tapered) Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 65649-411-12 12 SUPPOSITORY In 1 BOX None 2 65649-411-24 24 SUPPOSITORY In 1 BOX None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/01/2004
Labeler - Salix Pharmaceuticals, Inc (793108036) Establishment Name Address ID/FEI Operations Paddock Laboratories, Inc. 086116803 MANUFACTURE Revised: 02/2011Salix Pharmaceuticals, Inc More Anusol HC Suppository resources Anusol HC Suppository Side Effects (in more detail) Anusol HC Suppository Use in Pregnancy & Breastfeeding Anusol HC Suppository Drug Interactions Anusol HC Suppository Support Group 0 Reviews for Anusol HC - Add your own review/rating Compare Anusol HC Suppository with other medications Anal Itching Hemorrhoids Proctitis
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Klaron



Dosage Form: lotion
Klaron® (sodium sulfacetamide lotion) Lotion, 10% Klaron Description

Each mL of Klaron® (sodium sulfacetamide lotion) Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of purified water; propylene glycol; lauramide DEA (and) diethanolamine; polyethylene glycol 400, monolaurate; hydroxyethyl cellulose; sodium chloride; sodium metabisulfite; methylparaben; xanthan gum; EDTA and simethicone.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is N'-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Klaron - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Klaron Lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Klaron Lotion to their face, back, chest and shoulders every 12 hours for 28 days. The percentage of the applied dose of Klaron Lotion excreted in the urine as sulfacetamide plus sulfanilamide, ranged from 0.08 to 0.33%.

INDICATIONS

Klaron Lotion is indicated in the topical treatment of acne vulgaris.

Contraindications

Klaron Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Klaron Lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS section).

Precautions General

For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sodium sulfacetamide can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of the reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy – Category C

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

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Klaron Lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Klaron Lotion. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Klaron Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Klaron Lotion had adverse reactions of erythema, itching and edema. It has been reported that sodium sulfacetamide may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of medication has to be discontinued.

Klaron Dosage and Administration

Apply a thin film to affected areas twice daily.

How is Klaron Supplied

4 FL OZ (118mL) bottles (NDC 0066-7500-04).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].
Shake well before using. Keep tightly closed.

Prescribing information as of July 2010.
Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 118mL Bottle Carton

NDC 0066-7500-04

Klaron®

sodium
sulfacetamide
lotion

Lotion, 10%

FOR TOPICAL USE ONLY

One 4 fl oz (118mL) Bottle

DERMIK®

sanofi aventis


Klaron 
sulfacetamide sodium  lotion Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0066-7500 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 10 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   propylene glycol   Lauric Diethanolamide   diethanolamine   polyethylene glycol 400   sodium chloride   sodium metabisulfite   methylparaben   xanthan gum   EDETIC ACID   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0066-7500-04 118 mL In 1 BOTTLE, PLASTIC None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019931 12/23/1996
Labeler - Dermik Laboratories (824676584) Establishment Name Address ID/FEI Operations sanofi-aventis Canada Inc. 251046934 MANUFACTURE Revised: 12/2011Dermik Laboratories
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Dimetriose


1. Name Of The Medicinal Product

Dimetriose

2. Qualitative And Quantitative Composition

Gestrinone 2.5mg capsule

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard white, size no. 4 gelatin capsules containing a white to slightly yellow powder. The capsule will be printed ”roussel” and logo.

4. Clinical Particulars 4.1 Therapeutic Indications

Therapeutic treatment of endometriosis.

4.2 Posology And Method Of Administration

Adults:-

Gestrinone is for oral administration to adult females only.

The dose is one capsule twice a week. To ensure that pregnant patients are not treated, it is essential that the first dose is taken on the first day of the menstrual cycle.

The second dose should be taken three days later. Thereafter, gestrinone capsules should be taken on the same two days of the week (preferably at the same time) every week for the duration of the treatment, which will normally be six months.

Should one dose be missed, then a capsule should be taken as soon as possible and the original sequence maintained.

Should two or more doses be missed, treatment should be discontinued and therapy re-started on the first day of the new cycle, following a negative pregnancy test and according to the usual dosage schedule.

Children & Elderly Adults :-

Treatment with gestrinone is not appropriate.

4.3 Contraindications

1. Known hypersensitivity to gestrinone or to any of the excipients

2. Pregnancy.

3. Lactation.

4. Severe cardiac, renal or hepatic insufficiency.

5. Metabolic and/or vascular disorders during previous oestrogen and/or progestogen therapy.

4.4 Special Warnings And Precautions For Use

1. The possibility of pregnancy must be ruled out before starting treatment, especially in the case of pre-existing amenorrhoea.

Gestrinone, at the recommended dose, may inhibit ovulation in some women, but pregnancies can occur with this treatment and gestrinone must not be relied on for contraception.

As concurrent administration of oral contraceptives may modify the action of gestrinone, it is, therefore, essential that barrier methods are used throughout treatment as the use of gestrinone is totally contra-indicated in pregnancy.

2. Because gestrinone may occasionally cause some degree of fluid retention, patients with cardiac or renal dysfunction require close monitoring.

3. Monitor ALAT, ASAT, cholesterol fractions in hyperlipidaemic subjects and blood sugar levels in diabetics.

4. Gestrinone will cause a decrease in the concentration of thyroid-binding globulin. Hence there will be a decrease in serum total levothyroxine levels. This is without clinical significance as free levothyroxine levels remain within the reference range as do thyroid-stimulating hormone levels.

5. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration of anti-epileptic drugs or rifampicin may result in accelerated metabolism of gestrinone.

4.6 Pregnancy And Lactation

Gestrinone is specifically contraindicated in pregnancy and lactation.

Administration should be discontinued if a patient is found to be pregnant as animal studies have shown embryotoxicity in some species, albeit at doses well in excess of those used clinically.

The possibility of pregnancy must be ruled out before starting treatment.

4.7 Effects On Ability To Drive And Use Machines

There is no evidence that gestrinone directly impairs the ability to drive or to operate machines.

4.8 Undesirable Effects

Spotting has been reported in some patients both during the first few weeks and throughout treatment.

Acne, oily skin, fluid retention, weight gain, hirsutism, voice change, hair loss and other androgen-type effects have been reported by some patients.

Other unwanted reactions recorded during gestrinone therapy include transient increases in liver transaminases, headache, gastro-intestinal disturbance, change in libido, hot flushes, decrease in breast size, nervousness and depression, cramp, change in appetite, arthralgia and isolated cases of benign intracranial hypertension.

4.9 Overdose

Acute toxicity studies in animals indicate that serious reactions are unlikely as an immediate results of a single excessive dose.

In the case of acute dosage, the drug should be removed by emesis or gastric lavage if ingestion is recent and the patient kept under observation in case of delayed reaction.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antigonadotrophin, ATC code: G03XA02

Gestrinone, a synthetic steroid hormone, is an antiprogestin: it is not an oestrogen-progestogen combination. Gestrinone has an inhibitory effect on endometrial tissue. It is believed to act by direct inhibition of the synthesis-release mechanisms of pituitary gonadotrophins and a direct antagonist action on endometrial tissues.

5.2 Pharmacokinetic Properties

Gestrinone shows linear pharmacokinetics after oral administration of 1.25mg, 2.5 or 5mg. The peak concentration appears between 2.8 and 3.1 hours after administration.

The plasma half life is about 24 hours.

Three days after administration blood levels are only 5% of the maximum plasma concentration. The steady state is reached by the second administration, which is three days after the initial dose, therefore there is virtually no risk of accumulation under normal conditions of use.

Investigation of the absolute bioavailability in a subject after gestrinone administration demonstrates that after oral administration, absorption is virtually complete and first pass metabolism is negligible.

Gestrinone undergoes important hepatic metabolism, essentially through hydroxylation processes, resulting in the formation of conjugated metabolites.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

The product contains Colloidal Silicon Dioxide, Maize Starch, Microcrystalline Cellulose, Lactose, Magnesium Stearate, and Talc.

The white opaque capsule shell contains Titanium Dioxide (BP) and Gelatin BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Store below 25°C protected from light.

6.5 Nature And Contents Of Container

Dimetriose capsules are supplied in blister packs of 8 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0311

9. Date Of First Authorisation/Renewal Of The Authorisation

07 November 2007

10. Date Of Revision Of The Text

6 February 2008

Legal category: POM


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Brolene Eye Drops


1. Name Of The Medicinal Product

Brolene Eye Drops.

2. Qualitative And Quantitative Composition

Propamidine isetionate 0.1% w/v.

3. Pharmaceutical Form

Eye drops.

4. Clinical Particulars 4.1 Therapeutic Indications

Propamidine isetionate is an aromatic diamidine disinfectant which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

4.2 Posology And Method Of Administration

One or two drops up to four times daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3 Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4 Special Warnings And Precautions For Use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye drops are unsuitable for use with hard or soft contact lenses.

The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

Hypersensitivity may occur.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

4.9 Overdose

Topical overdosage not applicable. Oral ingestion of a full 10ml bottle is unlikely to cause any toxic effects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Propamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of organisms. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli, the activity of the diamidines being retained in the presence of organic matter such as tissue fluids, pus and serum.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ammonium chloride, Sodium chloride, Benzalkonium chloride, Sodium hydroxide, Water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

Once opened the drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, 7 days after first opening.

6.4 Special Precautions For Storage

Store below 25oC.

6.5 Nature And Contents Of Container

10 ml plastic dropper bottle and tamper-proof cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 04425/0197

9. Date Of First Authorisation/Renewal Of The Authorisation

07 November 2002

10. Date Of Revision Of The Text

12 April 2010

LEGAL CLASSIFICATION

P


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Sulfacetamide Topical



Dosage Form: suspension
SULFACETAMIDE SODIUM
TOPICAL SUSPENSION USP, 10%

Rx only

Sulfacetamide Topical Description

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically sulfacetamide sodium is N' -[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Sulfacetamide Topical - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.

Indications and Usage for Sulfacetamide Topical

Sulfacetamide Sodium Topical Suspension USP, 10% is indicated in the topical treatment of acne vulgaris.

Contraindications

Sulfacetamide Sodium Topical Suspension USP, 10% is contraindicated for use by patients having a known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS section).

Warnings

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS section).

Sulfacetamide Sodium Topical Suspension USP, 10% contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people (see CONTRAINDICATIONS section).

Precautions

General: For external use only. Keep away from eyes. If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. Sulfacetamide sodium can cause reddening and scaling of the skin. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

Keep out of reach of children.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy- Category C: Animal reproduction studies have not been conducted with Sulfacetamide Sodium Topical Suspension USP, 10%. It is also not known whether Sulfacetamide Sodium Topical Suspension USP, 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide Sodium Topical Suspension USP, 10% should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well controlled studies of Sulfacetamide Sodium Topical Suspension USP, 10% in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

Nursing Mothers: It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of Sulfacetamide Sodium Topical Suspension USP, 10%. Systemically administered sulfonamides are capable of producing kernicterus in the infants of lactating women. Small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. Because many drugs are excreted in human milk, caution should be exercised in prescribing for nursing mothers.

Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

In controlled clinical trials for the management of acne vulgaris, the occurrence of adverse reactions associated with the use of Sulfacetamide Sodium Topical Suspension USP, 10% was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sulfacetamide Sodium Topical Suspension USP, 10% had local adverse reactions of erythema, itching and edema. It has been reported that sulfacetamide sodium may cause local irritation, stinging and burning. While the irritation may be transient, occasionally, the use of the medication has to be discontinued.

Sulfacetamide Topical Dosage and Administration

Apply a thin film to affected areas twice daily.

How is Sulfacetamide Topical Supplied

Sulfacetamide Sodium Topical Suspension USP, 10%, is supplied in

    118 mL bottles    NDC 0168-0382-04

Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].

Shake well before using. Keep tightly closed.

E. FOUGERA & CO.
A division of Nycomed US Inc.
MELVILLE, NEW YORK 11747

I2382A
R11/07
#280

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CONTAINER LABEL

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION USP, 10%

USUAL DOSAGE: Shake well before using. Apply a thin film to the affected areas twice daily. See package insert for full prescribing information.

WARNING: Keep away from eyes. For external use only. Keep out of reach of children.

Store at Controlled Room Temperature 20°-25°C (68°-77°F) [see USP]. Keep tightly closed.

Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% contains 100 mg of sulfacetamide sodium in a vehicle consisting of purified water, propylene glycol, lauramide DEA (and) diethanolamine, polyethylene glycol 400 monolaurate, hydroxyethyl cellulose, sodium chloride, sodium metabisulfite, methylparaben, xanthan gum, EDTA and simethicone.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 118 mL (4 fl oz) CARTON

NDC 0168-0382-04

FOUGERA ®

SULFACETAMIDE

SODIUM TOPICAL

SUSPENSION

USP, 10%

Rx only

118 mL (4 fl oz)

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747


SULFACETAMIDE SODIUM 
sulfacetamide sodium  suspension Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0168-0382 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sulfacetamide sodium (sulfacetamide) sulfacetamide sodium 100 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   sodium chloride   sodium metabisulfite   edetate disodium   xanthan gum   propylene glycol   methylparaben   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0168-0382-04 118 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077015 08/28/2008
Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424) Registrant - Nycomed US Inc. (043838424) Establishment Name Address ID/FEI Operations Nycomed US Inc. 174491316 MANUFACTURE Establishment Name Address ID/FEI Operations Nycomed US Inc. 043838424 ANALYSIS Revised: 09/2009E. FOUGERA & CO., A division of Nycomed US Inc. More Sulfacetamide Topical resources Sulfacetamide Topical Use in Pregnancy & Breastfeeding Sulfacetamide Topical Support Group 0 Reviews for Sulfacetamide Topical - Add your own review/rating Compare Sulfacetamide Topical with other medications Seborrheic Dermatitis Secondary Cutaneous Bacterial Infections
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